Q ~ Trust Trump's Plan ~ 05/17/21 Vol.351, Q Day 1298

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ROW	VAERS ID	Vaccine	Age	Sex	Adverse Event Description
1	0927491-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Female	throwing up; fever; body aches; her whole intestines hurt; it was horrible; thought she had contracted COVID-19; thought she had contracted COVID-19; tired; This is a spontaneous report from a contactable consumer. A 54-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140), via an unspecified route of administration on left arm on 17Dec2020 at 19:15, at a single dose for vaccination. Medical history included ongoing ulcerative colitis, onset date was unknown, but when she was about 25 years of age. Concomitant medication included ongoing azathioprine for ulcerative colitis, started probably 5-10 years ago and taken daily since. In the past, she took different products for ulcerative colitis off and on when she had an episode. This patient reported she was administered her first Pfizer COVID-19 Vaccine injection on 17Dec2020 and was just kind of tired on 17Dec2020; but she had onset of serious reactions to the COVID-19 Vaccine starting 18Dec2020 for 2 days straight and then as suddenly as the events started they suddenly stopped after 2 days with no lasting effects. She called to ask if there is any data about if the second dose of the COVID-19 Vaccine will be just like the first shot or if the events are just hit or miss; she is really hoping not to be that sick again with the second dose. Serious reactions to the COVID-19 Vaccine further described as sick for like 2 days straight. Afternoon of 18Dec2020 she was throwing up; had fever; body aches; thought she had contracted COVID-19 in between injection and onset of symptoms; she had no lung issues; her whole body hurt; she could not stop throwing up; her whole intestines hurt; it was horrible; she could not hold anything down for like 2 straight days and then just left on 20Dec2020. Scheduled date for second dose was on 06Jan2021, she has no plan to change dose schedule. The outcome of the event of tired recovered in Dec2020, while other events recovered on 20Dec2020.
2	0950424-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Female	about 1 hour after shot i started getting bad stomach pain in the upper stomach and all over stomach and intestine cramps and 3 days later i still have them. also still have lots of nausea. body aches all over. swelling ankles more on right side, headache, fell sick all over. no treatment just staying in bed.
3	0961410-1	COVID19 (COVID19 (MODERNA))	40-49 years	Female	Starting 11 days after injection (1/20) the injection site is painful, red, hot to touch, hard, and spreading. It looks like cellulitis. Also, 1 day after receiving the vaccine (1/12) I bent over and I had terrible pain in my abdomen and it felt like my intestines were in a knot and I saw stars. This lasted for a few hours and has recurred a few more times since after bending.
4	0965153-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Male	10 min after vaccine-twitch in left calf, quad twitching, bicep, glute--only twitching on left side for first 30 min following vaccination Then after 30 minutes it switched to right side twitching (twitching not painful) Employee also had trouble breathing at that moment and was diaphoretic--Rapid Response Called VSS--employee returned to work Two hours later employee experienced diaphoresis, presyncope--went to Emergency Dept at this time--all labs and tests came back WNL 1/7: Fever 100, twitching continues (superficial) 1/7-14-superficial twitching throughout body 1/14-1/15?twitching seems to go deeper--in intestine, deep in LRQ 1/22 still having these twitches (not painful, just disturbing/odd)--Employee estimates these twitches happen 20x an hour
5	0967313-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Female	Felt chills, myalgia, malaise, nausea, GI disturbances in intestines (rumbling), bad headache (these have all lasted for about 24 hours so far
6	0975420-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Male	pt developed a partial small bowel obstruction which required surgical intervention. He was found to have an adhesive band compressing the small intestine. There was no other signs of pathology in the abdomen. The pts only other surgical procedure was a right inguinal hernia repair which was distant from the site of the band. The pt began with persistent nausea, crampy pain and vomiting 5 days after his first dose of the Pfizer vaccine.
7	0980692-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Male	Little muscle twitches; felt muscle twitches really deep in his abdomen, almost like in the intestines; Low grade fever; Muscle soreness; Muscle tiredness; Hands were a little shaky; Very diaphoretic; This is a spontaneous report from a contactable other Nurse. This 44-year-old Nurse (Patient) reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) at single dose for vaccination in Jan2021 around 9:45am. Relevant medical history included ongoing Mild shrimp allergy and ongoing Hypertension. Relevant concomitant drugs included amlodipine at 10 mg once daily for Hypertension since Feb2020 and ongoing. Prior Vaccinations (within 4 weeks): None. Family Medical History Relevant to AE(s) was None. The patient was administered the COVID Vaccine around 9:45am; about 10 minutes later he had onset of little muscle twitches on the left side of his body that started in the calf then the glute, then the quadricep, then the bicep and then just started bouncing around everywhere on left side. Approximately a half an hour after that those little muscle twitches started on the right side of his body. Now the little muscle twitches are just everywhere; his hand, his heel, right now as he is speaking he is having the little muscle twitches in his heel; This event has been ongoing since onset; but changed today around 5:00am when he felt muscle twitches really deep in his abdomen, almost like in the intestines which is probably impossible, but it feels like it is not just muscular now, like it is happening in his intestines which concerns him. The little muscle twitches do not hurt, he thinks that is probably why he has waited a week to call; but the fact that they are ongoing and changed today, worsened is unsettling. He reported since that first dose of COVID Vaccine was administered he has also had low grade fever; muscle soreness; muscle tiredness. He reported that a rapid response team was called immediately because of the initial reaction he had. Later that day his hands were a little shaky, he got very diaphoretic and the nurses on the unit of the hospital said he almost fell which he does not recall at all; in response to those events he was taken to the emergency department where they did a complete workup including labs: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), checked his heart and everything was fine; no notable results from any of those tests. The patient was not admitted to the hospital; under observation in emergency room only. Outcome of events Little muscle twitches, Low grade fever, Muscle soreness and Muscle soreness was not resolved, outcome of other events was unknown. Information about lot/batch number has been requested.
8	0986732-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Female	4:30 I had a bowel movement; colon felt funny on descending side; Had dinner around 6:30 pm and about 9:00 pm, I took vitamins and I started feeling queasy and nauseous. Laid there about an hour trying to keep food down. Decided I was still hungry and Had a hard boiled egg. But got nauseous again. Mouth started to water and I vomited everything that was in my stomach - intense vomiting. My intestines on left side after that was on fire- pain was so intense that my husband to ER (Emergency Room). They did a CAT scan - Colitis going on in there. They gave me morphine. The pain (on left side of intestine) continues for about another week but not as intensely as it was at first. I saw my GI Dr yesterday and colonoscopy and and EDG in March. I have pain meds that I was given and I have about four left and I am using them sparingly so I won't feel that pain anymore. So it is still there.
9	0990608-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Female	loose stools; gut hurting; Headache; This is a spontaneous report from a contactable consumer reported for self. This 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 10:30 arm right way high at single dose for covid-19 immunisation. Her 2nd dose is schedules for 09Feb2021. She states that the Lot and Expiry were not written, it just says (Name) for healthcare professional or clinical site. This was her first dose for the Covid 19 vaccine she received, it says Pfizer. Medical history included stomach ulcer, Resection of Small Intestines, 18 months ago, it was complete right side resection of the small intestine, it was pre colon cancer and they took out 10 inches, AFib, It was discovered almost exactly a year ago (from 2020), Graves' disease, headaches. Concomitant drug included rivaroxaban (XARELTO) for Atrial fibrillation and a blood pressure medication. The patient previously received Flu shot in Sep2020 at 75 year old for immunization and shingles shot in 2020 for immunization. The last 2 vaccines she got were shingles and Flu shot, and this last year 2020, for the first time in her life she had a little bit of a reaction, it was in particular, the shingles shot, she felt unwell. The reaction she was speaking of with the shingles shot earlier was that she just felt unwell, but not severe. It was for about a day. She has no name and no Lot number for the Flu shot and Shingles shot, what ever the Flu shot was for 2020, she got it in Sep2020. She went to drug store, the shingles shot was the new 2 shot shingles or something like that, in which it is also 2 doses. She only had trouble the 1st time, it was the little reaction and next time there was no reaction or vice versa, but nothing severe. She kept thinking, she was a worry wart. She thought that she must have Covid 19. Her daughter laughed at her and said that she did not have covid because she did not have the correct symptoms for covid, but she has to ask it would not help her if she was going to die. Her husband and her had the first dose Friday at like 10:30AM, she Lives an hour away from the site. She had not felt one thing in her arm, no soreness no puffiness, no redness. She was having trouble with her Gut hurting and she was running to the bathroom with loose stools. She did not have a temperature and she does not have any aches and pain. It was diarrhea but not watery, there was some form to it. The gut symptoms started on the same day, possibly in the evening, about 19:00 at night. The Loose stools also started on the 15Jan2021 around the same time. During the night, last night, more so in the middle of the night, her gut really started to feel better, but she has had 2 bowel movements this morning, but it was still very soft. The Loose stools are still on going, but she felt better this morning. She didn't feel ""sicky."" She felt she was going to live. She has never had a fever. She did have a headache on 15Jan2021, especially when she was worrying. Lab data included investigation: She had physical for the year in Nov2020. Outcome of the event loose stools, headache was resolving. Outcome of the event gut hurting was recovered on 18Jan2021. Information on the Lot/Batch number has been requested.""
10	0991754-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Female	Started with fever, chills, lethargy, headache and nausea around 0900 on 1/28/21. By 1500 I had severe nausea which resulted in vomiting (water and dry heaving) with a small amount of blood (small clots) with first time vomiting. Then at 1700 I could barely move with severe body aches and headache. Attempted to drink some water and eat soup, but intestines burned too much. Slept from 0800 on 1/28/21 through till 0830 on 1/29/21 with very minimal waking. Only left my bed to throw up one time and use the restroom one time. Took Tylenol around the clock. Upon waking on 1/29/21 noticed a petechiae type rash on both sides of my face, sore throat and mild headache (took tylenol). 1/30/21 no symptoms and facial rash slowly disappearing.
11	0992257-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Male	I was asked to sit down for 15 mins in the observation chair. I started to feel a warm feeling in the arm went back to work.The next day arm was sore at the injection site went away that night. On Friday night started vomiting and diarrhea at the same time.After 3 days following Monday I went to ER stayed 2 wks 12 days with blockage small intestine.
12	1000105-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Female	feeling nauseous; vomiting; indigestion; belching; This is a spontaneous report from a Pfizer-sponsored Program, from a contactable consumer. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: Mar2021), intramuscular on 15Jan2021 on left arm at a single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient got her first shot for the vaccine last Friday afternoon (15Jan2021). Yesterday early evening (19Jan2021), she was feeling nauseous and was vomiting. She wanted to know if it was an adverse effect from the COVID-19 vaccine even though it was the 4th day after getting the COVID-19 vaccine. She also mentioned that she ate a bunch of pistachios and wasn't sure if that was a contributing factor to what she was experiencing. The patient experienced indigestion, belching, and vomiting on 19Jan2021. She is feeling okay now and asked if that was normal. She confirmed contact details. She was asking if it was normal to have the side effects 4 days after getting the vaccine. She is so much better and has not vomited since 07:30 this morning. She has improved within the last hour. She still has tightness in her upper intestines, but it could be because she is hungry since she has not had anything since yesterday. She is glad she is feeling better. Stated the indigestion could be from all the pistachios that she ate at work. She took tums. She still had indigestion and ate a small dinner. She kept vomiting after, and it was more of a liquid. She put her glasses on. She has a hard time seeing the lot number on the card she was provided, stating it is so small Dose reported as 30mcg or 0.3ml. The outcome of the events was recovering.
13	1002220-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Female	Intestine discomfort, multiple bowel movements (no diarrhea), chills, feverish (but no fever), muscle aches. I'm reporting this 24 hours after getting the 2nd Pfizer shot. Reaction started overnight. Don't know at this time how long this will last. Have not called doctor. Taking Tylenol.
14	1002461-1	COVID19 (COVID19 (MODERNA))	50-59 years	Female	10 minutes after vaccine--throat became tight, some scattered itching, O2 sat to 93%, lungs mild-moderate decreased air movement. Took Proair inhaler, 10 mg Prednisone, 25 mg Benadryl. 1 hour after injection symptoms resolved and sat up to 98+% and lung clear moving better air per the RN monitoring for reactions. 1 day post injection-- exhausted, spordaic and severe muscle cramps, chills 2 day post injection, chills better, muscle cramps stronger, abdominal muscles and intestines cramping
15	1007731-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	rapid heart beat followed by loss of breath. Couldn't get breath. Slight nausea called the nurse and she called 911. Then started in my intestines with numerous BMs that progressed to diarrhea . Breathing subsided back to normal within a half hour but the intestines continued through the next day.
16	1021608-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Female	Two days after receiving the vaccine, I began to have the feeling that my insides (as in my ""guts"" or my intestines) were on fire. I didn't have diarrhea, but the feeling was very intense and I had to go to bed. I took Pepto Bismal, hoping it would alleviate the awful feeling. It wasn't like any other stomach or intestinal upset I've ever had. It literally felt as though my insides were ""on fire"", inflamed. The feeling persisted for 2 days and then went away. During that time, I just ate tea and toast and hoped that I wouldn't see any blood in my stool. It was very frightening.""
17	1034581-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	I had chills, fever, headache, pain in lungs, cough, pain in abdoman, pain in intestines, vomiting, weak. had to be in bed 8 days
18	1035929-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Female	I started with diarrhea a few days after I received my second dose of the vaccine. It has got worse over the course of a week. I took immodium and peto bismol with some relief. I also have pains in my intestines. The pains only started in the last couple of days. I have a Dr. Appt today 2/17/21
19	1036003-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	I had my first dose on 1/11 I had dizziness and rapid heartbeat and light Flu-like symptoms On2/8 I had my second dose and the injection site got very sore. I experienced flu like symptoms of achiness, fever, chills. I also had diarrhea and I felt like my intestines were on fire. my arm turned red and was incredibly itchy
20	1036754-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Female	massive headache, 11 hours post vaccination at midnight. Extreme arm pain, throbbing, burning, joints felt swollen, extreme abdominal pain (like someone wrenching my intestines and organs), aching neck, body pains and felt like I was freezing btwn midnight and 3 am. Had lay still in a fetal position for it to calm down at 3am.
21	1037719-1	COVID19 (COVID19 (PFIZER-BIONTECH))	80+ years	Male	bleeding internally in small intestine; cut Eliquis in half; rash on shoulder and neck; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-013205) license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: 2021125505) on 05-Feb-2021 and was forwarded to BMS on 08-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of SMALL INTESTINAL HAEMORRHAGE (bleeding internally in small intestine) in 86-year-old male patient who received apixaban (Eliquis) tablet for an unknown indication. The occurrence of additional non-serious events is detailed below. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for Prevention. Product or product use issues identified: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (cut Eliquis in half). Concurrent medical conditions included Gout (diagnosed two or three years ago). On an unknown date, the patient started Eliquis (Oral) 2.5mg half tablet by mouth twice daily. On 07-Jan-2021, the patient started Covid-19 Vaccine (Intramuscular) intramuscular injection in right arm. Further treatment periods at the same dose started on 01-Feb-2021. In January 2021, the patient experienced RASH (rash on shoulder and neck). On an unknown date, the patient experienced SMALL INTESTINAL HAEMORRHAGE (seriousness criterion medically significant). The patient was treated with salicylic acid (Eucerin [Salicylic Acid]) for Rash. The action taken with Eliquis(Oral) was unknown. At the time of the report, SMALL INTESTINAL HAEMORRHAGE outcome was unknown and RASH did not resolve. Cardiologist recommended patient to take apixaban for palpitation of the heart that he has every so often. Eliquis at 2.5mg tablet twice a day and then patient found out he was bleeding to death, clarifies he was bleeding internally in his small intestine. So he cut his Eliquis in half and he was currently taking half of 2.5mg tablet twice a day. He got the Pfizer covidl19 shot. He has developed a rash on his shoulder and neck. He also stopped using his laundry soap since he was not sure if it was his laundry soap. For Eliquis(Oral), the reporter did not provide any causality assessments.; Sender's Comments: BMS Medical Evaluation Comment: This patient had small intestine hemorrhage while on apixaban. Based on the anticoagulant nature of apixaban, its contributory role in small intestine hemorrhage is considered possible.
23	1039085-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Female	Severe pain in muscles, bones, stomach and intestines. Severe chills, to the point that the chattering chipped a tooth. Diarrhea, vomiting, to the point that I was unable to keep even water down for about the first 36 hours. The shaking subsided, but the chills and severe muscle pain continued for three days. My bowels are still painful after three full days, but skin and muscle pain has subsided. During the three days of pain, I slept about 20 out of 24 hours. When awake, I tried to read but was unable to concentrate. Same for TV.
24	1042333-1	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	Female	fatigue (sleeping most of the day)/tired; fatigue (sleeping most of the day); headaches; pain in her teeth like she has cavities; a color to her spit like gangrene; bad breath; kidney pain; urinary urgency; foul smell to urine; fever; feeling totally just like she had no blood in her body; as weak as a kitten; could not hardly get out of bed; felt sicker than having the virus; felt like she was going to fall out getting out of bed; making very poor decisions; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 28Jan2021 at a single dose for COVID-19 immunization. Medical history included SARS-CoV-2 infection (hospitalized for 3 days; quarantined at her assisted living facility for 14 days after discharge), gangrene (small intestine when she was younger), and lives at assisted living facility. The patient's concomitant medications were not reported. The patient experienced fatigue (sleeping most of the day)/tired, headaches, pain in her teeth like she has cavities, a color to her spit like gangrene, bad breath, kidney pain, urinary urgency, foul smell to urine, fever, feeling totally just like she had no blood in her body, as weak as a kitten, could not hardly get out of bed, felt sicker than having the virus, felt like she was going to fall out getting out of bed, and making very poor decisions on an unspecified date. All of the events were reported to have caused hospitalization. The clinical course was reported as follows: The patient received the vaccine five days after quarantine from previous COVID-19 infection. It was reported that she did not test positive for COVID-19 but did come down with the COVID-19 virus and was taken to the hospital immediately previously. She reported that she was currently taking unspecified antibiotics for the previous COVID-19 infection. The patient reports that she felt sicker since she got the vaccine than when she had the virus. She slept for 24 hours a day for 4 to 5 days, and only woke up to use the bathroom and when she got up, it felt like she was going to fall out. She also had a bad headache and just did not feel well. She was having really horrible headaches just prior to going to the hospital, some of the worst headaches she ever had. Her teeth, all of her teeth hurt, they just felt like if she pushed on them too much they would fall out; and it was like she had a toothache everywhere in her mouth. She felt really tired at the time of reporting as well. After she got the vaccine, she started feeling sick and was making very poor decisions about things. The clinical outcome of all of the events was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
27	1056470-1	COVID19 (COVID19 (MODERNA))	80+ years	Female	Blood Pressure did not decrease significantly post medication; Blood Pressure increased to 224; Pain (Grade 8 out of 10) under breast line, chest and across the back shoulder blades; Intestine blockage; Constipation Continued (Initiated 3 days prior to Vaccination); A spontaneous report was received from a consumer concerning a 91-year-old, female patient who developed Pain (Grade 8 out of 10) under breast line, chest and across the back shoulder blades, Constipation Continued (Initiated 3 days prior to Vaccination), Blood Pressure increased to 224, Blood Pressure Did not decrease significantly post medication, Intestine blockage, and Reduced Pain (Grade 4 out of 10 now) post Bowel Movement. The patient's medical history included constipation. Concomitant product use was not provided by the reporter. On 28JAN2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:031L20A) intramuscularly in the upper arm for prophylaxis of COVID-19 infection. On 28JAN2021 patient received the first dose of Moderna COVID-19 vaccine. For three days prior to vaccination patient was constipated and did not have a Bowel Movement at all. After the vaccination patient had pain (Grade 8 out of 10) under breast line, chest and across the back-shoulder blades. The evening of 28JAN2021 she visited the Emergency Room because of the pain. ER nurse reported patient Blood Pressure went up to 224 and was very high. Patient was treated with BP medication, but BP did not change significantly. This led to patient being admitted to the hospital at for overnight for observations. All tests were negative. She was diagnosed as ""Intestines were blocked"". She was released on 29JAN2021. She had a BM 6 days later on 03FEB2021. The pain is better (Grade 4 out of 10 now). The outcome of the events was unknown; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.""
28	1059697-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Female	Had severe pain in lower intestine. Pain similar to labor pains. Difficulty evacuating. Lasted 30 minutes or more. BM was solid at first then watery.
29	1060555-1	COVID19 (COVID19 (MODERNA))	40-49 years	Female	For the first 24 hours had arm muscle ache and muscle pain from shoulder to elbow, difficult to lift my arm up above rib height. Within 12 hours from vaccination began to experience significant fatigue. At 26 hours from time of vaccination sudden onset of nausea, vomiting and stomach cramps, then within the next hour experienced diarrhea and chills. Stomach cramps felt like my stomach and intestines were being wrung out like a wet towel, after a few hours of diarrhea and chills went to sleep and symptoms subsided.
30	1061314-1	COVID19 (COVID19 (MODERNA))	65-79 years	Male	Fairly strong headache in the middle of the night. Took 500mg acetaminophen, which worked well. Awakened Saturday morning to the call of diarrhea. After four additional visits to the toilet in the next two hours, I started keeping track of these episodes. Over a period of 24 hours (Sat 8am-Sun 8am) I HAD to visit the toilet 31 times. Each episode was accompanied by a serious need to evacuate my bowels. Lots of pressure and pain in my intestines, every time. The first 4-5 sessions had considerable content, but after that, the almost-liquid movements could have been captured in 2 tablespoons (not a lot of content). After about 12 visits, which required vigorous wiping to remove the gelatinous remains, my long-dormant hemorrhoids started bleeding bright red and rather profusely. By the 18th visit they had reduced to pinkish smears, and remained that way until the present. I also became very tired and sluggish after about 8 hours of repeated toilet visits. The diarrhea episodes continued all night, allowing me only short cat-naps in between episodes of gnashing pain. After 24 hours (Sunday morning), the diarrhea episodes reduced in intensity and frequency, but the near-liquid consistency has remained through till just now (Sunday evening) where the content is slowly growing (about 1/2 cup) and beginning to have a little more solid appearance. I have been napping all day.
31	1063018-1	COVID19 (COVID19 (MODERNA))	80+ years	Male	The local hospice agency notified us that this patient was now under their care. The patient is experiencing severe intestinal inflammation to the point that he was admitted to the hospital for shortness of breath due to the inflammation of the intestines reducing space for the expansion of his lungs within the chest cavity. He discharged from the hospital under hospice care.
32	1063271-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Female	all symptoms lasted less than 24 hours, I went to the ER because I thought it was my gallbladder, RUQ pain CT scan ordered and shows intestines were inflamed, they thought I was constipated. I went home and took tylenol for management. I had 4 sessions of severe projectile vomitting and felt relief right after. I never felt ill I only had pain and vomitting.
33	1073485-1	COVID19 (COVID19 (MODERNA))	65-79 years	Male	Nausea; Chills; Cramps in intestines; Vomiting; Temperature of 99.4; muscle spasms; Headache; Felt lethargic; Felt tired; Dark urine like motor oil gold; like having a bad flu.; A spontaneous report was received from a Consumer concerning a 70-years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea. Patient went to bed and his muscles involuntary contracted and curled himself in a fetal ball The patient's medical history was not provided. Relevant concomitant medications were not reported. On 17-FEB-2021, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 18-FEB-2021, the patient experienced Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea. Patient went to bed and his muscles involuntary contracted and curled himself in a fetal ball. His wife took him to the ER at Hospital on the 18-FEB-2021 in the afternoon but patient decided that he would rather go home. The patients temperature was 99.4. Treatment information was provided as Tylenol for headache and Something for nausea and to relax muscles at the hospital. Action taken with mRNA-1273 in response to the events was not reported. On 18-FEB-2021, the outcome of the event's Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea was considered as unknown. At the time of this report, the outcome of the event's Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
34	1074559-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	Sucralfate 1gram 1tablet 4 times a day, Omeprazole DR 40 mg 1 a day. Muscle cramps in several areas at the same time. Dizzy, burning in my stomach and large intestines. nauseous, stool turned yellow for 7 days and burned my rectum, was very painful!! Then there was blood in my stool. I was also weak. I'm afraid to take second shot because of the issues I had with the first shot!! I have never experienced anything like that before. My stomach was so swollen I was afraid it would burst.I was having trouble breathing, short of breath when I walked. Heart rate would would go to 111 beats on Friday but that got better.
35	1074844-1	COVID19 (COVID19 (MODERNA))	30-39 years	Female	I started having abdominal pain and bloating around 9 pm. Pain continued to worsen to the point I was throwing up. Took some gas x to see if that helped. It did not. Pain got so bad that I went to er. They thought it was my appendix, how ever CT showed my appendix was good. I had and still have inflammation in my intestines and still have right side pain not sure if it is related to the vaccine or not
36	1075866-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Female	Intestines froze up, can?t breathe normally and my tumor and abdomen has been inflamed. My spouse also got a shot and has been projectile vomiting and has flu like symptoms. Both of us are lethargic.
37	1086018-1	COVID19 (COVID19 (MODERNA))	65-79 years	Male	Bell's Palsy; voice was sort of ugly; A spontaneous report was received from a consumer who is a 67-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and his voice was sort of ugly/dysphonia and Bell's palsy/facial paralysis. The patient's medical history included hypertension, triple bypass, operation in stomach and intestine and depression. No relevant concomitant medications were reported. On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection. On 29 Jan 2021, the patient stated he woke up at 0800 and noticed his voice sounded ugly. When he looked in the mirror his face looked crooked. The patient went to the hospital and was diagnosed with Bell's palsy. The patient stated he was discharged home the following day. He was given unspecified steroids. Treatment information included unspecified steroids. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, voice was sort of ugly/dysphonia and Bell's palsy/facial paralysis, were considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
38	1091223-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Female	I had to run for the bathroom with sudden-onset diarrhea. No cramps, not much pain to speak of--just a little. My intestines have cleaned themselves OUT beginning last night and continuing to today (noon). I will be feeling nothing and then suddenly--have to RUN for the bathroom, and don't be late.
39	1096729-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Female	2/27/21 back of the neck started swelling, intestines gurgling, and a headache. 2/28/21 swelling to entire upper body and severe headache. Right front side a rib pushed out. Slept sitting straight up, could not put pressure on my spine at all. Spouse drove me to the chiropractor on 3/1/21 to have the rib adjusted. Six hours later my heart was literally pounding out of my chest for about a minute. Next day the swelling started to subside and can breathe again. Could lean back on my spine without any issues. Chiropractor on 3/3/21 and will go back next week. Intestines are still gurgling and 3/12/21 experienced diarrhea.
40	1100244-1	COVID19 (COVID19 (MODERNA))	60-64 years	Female	Bloody diarrhea; Loss of appetite; Skin on her back started to peel; Lower intestine is sore; Feeling queasy; chills; Fever of 101.1F that took about 3 days to break; Soreness at the injection site; Tired; A spontaneous report was received from a consumer concerning a 62 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling queasy, loss of appetite, nausea, lower intestine is sore, bloody diarrhea, fever of 101.1F that took about 3 days to break, skin on her back started to peel, soreness at the injection site and tired. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10 FEB 2021 prior to the onset of the events, the patient received her second dose of two planned doses of mRNA-1273 (lot/batch:041L20A) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, the patient experienced the events feeling queasy, loss of appetite, nausea, lower intestine is sore, fever of 101.1F that took about 3 days to break, skin on her back started to peel, soreness at the injection site, tired and on unknown date event bloody diarrhea as medically significant serious criteria. Laboratory details were not provided. Treatment medication included Baby Aspirin. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events feeling queasy, loss of appetite, nausea, lower intestine is sore, bloody diarrhea, fever of 101.1F that took about 3 days to break, skin on her back started to peel, soreness at the injection site, tired was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
41	1101040-1	COVID19 (COVID19 (MODERNA))	60-64 years	Male	Relatively severe pain Rt. side lower back, side and moving to front intestine area. Persistent vomiting until 10:00 pm. Entire event from 12:15 pm until 10:00 pm. Mild pain and soreness all day next day (Sunday Feb. 28)
42	1105774-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	Sent: 3/4/2021 7:55 AM Subject: Non-Urgent Medical Question For a full week now, I have been battling diarrhea and a very hyperactive stomach and intestines. Provider prescribed some bentyl Sunday to ease my cramping. At early onset I had some nausea too. I'm wondering if I don't need some blood work, whatever you think and maybe recheck my TSH too. Dr. already ordered a UA with culture which were both negative. That was done because of back pain over left kidney a couple of weeks ago. Diagnosis: Theo. My intestines have never been right since my surgery, but this gassiness and hyperactivity is much more extreme. I tried Metamucil and it blew my guts up even worse. I know I'm due for a CT scan. I see Dr. March 22. I'm trying to hold off until then because I want to discuss with him why I prefer to have all scans at specific facility. I just wanted to get your advice since it's been a week now. I did get my second Moderna vaccine on February 15 and Fulvestrant injections on Feb. 22. My issues started on Feb. 25. Oddly, right now as I'm typing this, my gut is much calmer. Yesterday was my worst day with diarrhea. 3/13/21 ER for back pain - transferred to second hospital - remains admitted there as of 3/16/21 History of Present Illness: Patient is a 68-year-old female with known metastatic ovarian cancer under active treatment since 2004, currently on fulvestrant after a massive debulking surgery by Dr. last July (2020). Patient presented to outlying emergency room with flank pain & transferred here with severe bilateral hydronephrosis on imaging. Patient had severe left flank pain about 2 weeks ago. Treated with tylenol, motrin, and heat and pain eventually dissipated. Then Tuesday and Wednesday pt did a lot of yard work and lifting. Thursday patient woke up with excruciating right flank pain. Nothing has made it better. Patient has tried ice, heat, tramadol Tylenol, Motrin, steroids and pain persists. Additionally patient having nausea and vomiting. She has started to have burning with urination. Pain is excruciating stabbing. Radiates to the groin. Patient has also started running fevers today. She feels pretty miserable. Also patient notes difficulty with her bowels since her last surgery. Prior to surgery she took Linzess every day. Since surgery it has been suggested she does not need this medication. Patient does note little to no notice when her bowels decide to move. Severe significant gas. Other times patient feels quite constipated. UA suggests possible infection with positive nitrites, 1+ leukocyte esterase and 3+ blood. WBC 2.1, Cr 1.0, K 3.0 CT scan with multiple abnormalities, but most notably severe bilateral hydronephrosis without obvious obstructing lesion. Multiple scattered nodular densities concerning for metastatic disease. Patient transferred for higher level of care and urology consultation.
43	1108546-1	COVID19 (COVID19 (MODERNA))	50-59 years	Female	About 3.5 hrs after my 1st shot I had a sudden onset of nausea for about 5 minutes (no throwing up) followed by abdominal pain for about 20 minutes. After these, I had an episode of very loose stool and some mild diarrhea but only once. For the remainder of the day my abdominal area was sore if I pushed slightly on the area. Arm soreness the day of the shot was mild. On the day after the shot almost no arm soreness except when I put pressure on the arm. Noticed some intestinal gurgling after I got up in the morning (6:15am) for about 1 hour. After being up for about 1.5hrs I began to feel very, very tired (around 8:15am). This tiredness would come and go in waves. Also during this time I would random short lived shooting pains (in lower left arm and also left intestine area). Also on the 2nd day around 10am by entire rib cage was tender to the touch or when reaching up. I am still experiencing this tenderness which definitely hurts if I cough. Moving around verses just sitting has helped to lessen the tiredness. Also eating seems to lessen it as well. This is everything I have had up until 26 hours after the 1st shot.
44	1113713-1	COVID19 (COVID19 (PFIZER-BIONTECH))	80+ years	Female	My mother called me when she was going to get her second vaccination. She was alive and well and living independently at her home. She could walk, talk, make her own food, wash and dry her own clothes and take her own baths. After taking the second vaccination she went down hill. She became sicker and sicker and eventually she started coughing up blood. She decided to go to the hospital, another Hospital of facility. I don't know what the treatment was at that hospital but she was soon transferred to facility and that is where I was notified she was in the hospital and visited her there. After arriving they intubated her and said she had blood clots in her brain and heart. When I saw her after she transferred from Hospital to the Hospital I noticed one arm was swollen. Her legs were as they have been for the last 20 years and looked okay to me--no discoloration other than her regular discoloring at one right ankle and the same old same old slight swelling in the left ankle. The doctors and nurses were putting the blame on her legs but you could tell things were happening else where. But as she got worse and worse at the hospital her right arm become more and more swollen with dark bruises appearing--the hospital staff took pictures. The left arm continued to swell and did not look normal at all. She apparently had bleeding in her left lung from a blood clot. She had three areas of her brain that add clots and some bleeding. She was constipated and gaseous when they cleaned her. They didn't treat her constipation which made being intubated worse because I feel that caused her intestines to swell, thus she also had bleeding in her intestines. My mother died on March 17, 2021 at hospital in ICU. I was told they could not treat the blood clots because of the bleeding in her lung, intestines and brain.
45	1115266-1	COVID19 (COVID19 (PFIZER-BIONTECH))	80+ years	Female	choking experience; throat tickled; dizziness; bowel movements all afternoon which is a common allergic reaction; bowel movements all afternoon which is a common allergic reaction; Her heart started to pound/a rapid heartbeat; her ears started to ring (a pounding in her ears); had pressure in her jaw, chest, head, ears, and allover; high adrenal stimulance; excreted 1 cup of urine more than what she usually does; high pressure; dehydrated; couldn't sleep; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 01Mar2021 13:30 (at 80 years old) as single dose for covid-19 immunisation. Medical history included irritable bowel syndrome, allergic to gluten, lecithin, and other barky parts of plants, high pressure, she did not hear very well, left breast surgery, skin cancer. She had a small skin cancer taken off each of her legs, one removed in Jan2020 and one removed in Feb2020. They are all healed up and they are fine, it was not the bad kind. There were no concomitant medications. The patient experienced choking experience in which her throat tickled, and dizziness, dehydrated, her heart started to pound (a rapid heartbeat), her ears started to ring (a pounding in her ears), she had pressure in her jaw, chest, head, ears, and allover, she had high pressure, excreted 1 cup of urine more than what she usually does, couldn't sleep due to high adrenal stimulance, bowel movements all afternoon which is a common allergic reaction all on 01Mar2021 with outcome of unknown. Clinical course was reported as follows. She mentioned that she was fine for 20-30 minutes to an hour after she got home. That afternoon, she noticed that her bowel movement was regular, constant, and repeating which was not normal and would typically indicate SIBO (Small intestine bowel overflow) in which the colon empties everything. She mentioned that this was indicative of her gluten allergy. She reported having had bowel movements all afternoon which is a common allergic reaction she has to plants like lectin and gluten especially due to the irritable bowel system-her whole bowel system will empty and she will have to replace 2 days worth of food. With this event starting 01Mar2021 her bowels just kept emptying and emptying. During dinner while she was eating and watching tv, her heart started to pound (a rapid heartbeat), her ears started to ring (a pounding in her ears), she had pressure in her jaw, chest, head, ears, and allover, she had high pressure, and a choking episode in which her throat tickled, and dizziness that she couldn't get up. She took hot water for the tickling sensation and took one aspirin for the other symptoms, but she still did not feel very well. She went to bed at 9pm but couldn't sleep due to high adrenal stimulance, she only slept like 2-3 hours long which she can get from Novocaine with her teeth. She got up 3 times and excreted a cup of urine per time. In the morning, she woke up and excreted 1 cup of urine more than what she usually does. She got herself weighed and had a weight of 109lbs versus the normal 122lbs which indicated that she was really dehydrated so she took her fluids and ate breakfast. Other than this, she mentioned that she got up today and felt fine and feels that in 2 days she will be fine. She felt pretty good and she was going to run but did not dare burn any more calories or fluids so she is sitting still and taking it easy. Regarding outcome of event she reported the pounding pressure like high blood pressure are better, fine# she had a normal breakfast# she can get around and do whatever she needs around the house except she needs now to spend the day recouping from the dehydration so she needs pay attention to what she eats and drinks. She mentions that she runs 3-4 miles a day and tries to be active for her age. She is asking if she can take the 2nd dose in 3 weeks. She is unsure if this is an allergic reaction or something psychological. The outcome of the event was reported as recovering.
46	1118258-1	COVID19 (COVID19 (MODERNA))	40-49 years	Female	Abdominal Ascites beginning 3 weeks post 2nd dose Moderna vaccination. Patient treated with paracentesis once weekly at the hospital. Ongoing issue. Unable to receive paracentesis last week due to location of fluid/intestines. Patient was also taken off of Capecitabine and put back on other cancer med used previously, pt does not remember name of this medication. Patient is holding Metformin as well due to alterations of blood sugar.
47	1120364-1	COVID19 (COVID19 (MODERNA))	60-64 years	Female	Cramping in intestines. Loose stool 6:30 til 3 am on 3/19/21, 7:30 am on 3/21/21 cramping still at 11:30 while completing this form. Lack of appetite.
48	1132491-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Male	Lose of blood found to be from small intestine; Cardiac arrest; Going into shock; Rash all over face; Hemoglobin low; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) dose 1 via an unspecified route of administration on 05Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications in two weeks included atorvastatin 40 mg, gabapentin 300 mg, amlodipine 5 mg, losartan 100 mg, aspirin [acetylsalicylic acid] 81 mg and potassium. The patient previously took tylenol and codeine and both experienced allergies. No other vaccine in four weeks. The patient experienced rash all over face, lose of blood found to be from small intestine, hemoglobin low, cardiac arrest, going into shock on 05Feb2021. Events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 6 days due to above events. Covid test post vaccination included Nasal swab with Negative result on 11Mar2021. Treatment included blood transfusion. The outcome of events was not recovered. Information on the lot/batch number has been requested.
49	1133625-1	COVID19 (COVID19 (MODERNA))	40-49 years	Female	an hour after injection dizziness, nausea and numbness in the arm of injection. About an hour and a half after injection left side of face felt tingling and numb. The feeling was similar to the affects of dental numbing. Chills and joint pain started about 2 hours after injection and were relieved by taking Advil. At 7am the next morning I had severe stomach cramping and diarrhea. My whole body ached and my muscles and joints were sore. I had full body chills coming in waves and severe nausea. I had diarrhea throughout the day with severe sharp stabbing burning stomach cramps and pain. These symptoms lasted throughout the day. Everything I ate caused severe stabbing burning cramps in the stomach and lower intestines and immediate diarrhea. I had strong bile diarrhea several times yesterday and I have had bile colored diarrhea several times today 3/25 as well as the same stabbing sharp burning stomach pain. The symptoms of body aches and chills have gone away and lasted about 36 hours after the shot but I still cannot eat, and I have bile just pouring out of me. I had my gallbladder removed 2.5 years ago. The stabbing burning pain after eating or drinking feels like the pain I had prior to removing my gallbladder. I am afraid to eat anything because of the burning pain, cramps and diarrhea.
50	1135729-1	COVID19 (COVID19 (MODERNA))	Unknown	Female	surgery for twisted intestine; issue with their throat, was not being able to swallow; A spontaneous report was received from a Consumer concerning an 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Volvulus and Dysphagia. The patient's medical history was not provided. No relevant concomitant medications were e reported. On 13-FEB-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 015M20A) in the Anatomical location unspecified for prophylaxis of COVID-19 infection. On 27-Feb-2021, the patient experienced the events Volvulus and Swallowing impaired and the patient was hospitalized for 12 days. The patient underwent surgery for twisted intestine. The patient had an issue with their throat that has not been settled and was not being able to swallow. It was not related to the vaccine at all. The patient was discharged on 11-Mar-2021. The second dose was scheduled on 13-Mar-2021. As they could not drive and take their second dose. it will be re-scheduled. Laboratory details were not provided. Treatment details were included sodium chloride 1 gm 3 tablets by mouth three times a day with meals and potassium chloride 2 tablets by mouth everyday for 5 doses. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events Volvulus and Swallowing impaired was unknown. The reporter did not provide the causality between the events Volvulus and Swallowing impaired and the study drug.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
51	1137690-1	COVID19 (COVID19 (MODERNA))	65-79 years	Male	The day after the second shot (Wed. 3/17/21), I developed pains in my intestines and started to run a temperature. It ultimately got so bad that I ended up in the ER with a 104 degree temperature and bad pains on March 19th. After a series of tests it was determined to be Diverticulitis which I never had before. I am not sure it is related to the Covid shot, but, it is interesting that it started the day after the second shot.
52	1143546-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Male	Severe stomach pain; Gastroenteritis; swollen and inflamed intestines; swollen and inflamed intestines; Mesenteric Adenitis; Multiple kidney cyst confirmed by CT scan; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Feb2021 13:30 (lot number: EN6198) as single dose for COVID-19 immunisation. The patient's medical history included hypertension, and allergies to penicillin. The patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced severe stomach pain, gastroenteritis, swollen and inflamed intestines, mesenteric adenitis, and multiple kidney cyst confirmed by CT scan, all on 09Mar2021 19:00. The events resulted to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for 1 day. Prior to vaccination, the patient had no COVID. Patient was tested for COVID post vaccination. The patient underwent lab tests and procedures which included qualitative PCR: negative on 10Mar2021. Therapeutic measures were taken as a result of the events. The patient had no other vaccine for four weeks and had other medications in two weeks. Vaccine facility type was school or student health clinic. The outcome of the events were not recovered.
53	1143816-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Female	couldn't breathe or drive; heart throbbing in chest for a few minutes - very scary; front right rib popped out; lack of appetite; swelling at back of neck/ entire upper body swelled up; intestines gurgling; headache/severe headache; Swelling in rib cage, collar bone; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9261, expiration date was unknown), via an unspecified route of administration, administered in the left arm on 12Feb2021 at 12:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as the public health clinic/facility. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiration date was unknown) on 22Jan2021 at 12:00 PM in the left arm at the age of 50 years, for COVID-19 immunization. Relevant medical history included Graves' disease from an unknown date and unknown if ongoing and had her thyroid removed on an unspecified date. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) for Graves' disease as she had her thyroid removed; levothyroxine sodium (SYNTHROID) for Graves' disease as she had her thyroid removed; and doxycycline taken for an unspecified indication; all start and stop date were not reported. The patient previously took codeine and had known allergy to this drug. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. The patient was not tested for Covid post vaccination. On 27Feb2021 at 06:00, the patient experienced swelling at back of neck, intestines gurgling, and headache. On 28Feb2021, the patient's entire upper body swelled up and her front right rib popped out; she had severe headache, lack of appetite, and slept sitting straight up as she could not put pressure on spine or lay down. On 01Mar2021, the patient's spouse took the patient to a chiropractor to adjust rib as she couldn't breathe or drive. Six (6) hours later on 01Mar2021, the patient experienced heart throbbing in chest for a few minutes - very scary. Swelling in rib cage, collar bone from an unspecified date in on Feb2021, and neck were subsiding by 11 pm. On 03Mar2021, the patient had her second chiropractic (chiro) visit to adjust neck. On 13Mar2021, gastronol was given for gurgling and the patient still had no appetite. The swelling was all better. The patient would need to go to the chiropractor about four more times to keep adjusting rib back in place. The adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all the events, which included chiropractic care for rib adjustment and gastronol. The patient recovered from the events ""swelling at back of neck/ entire upper body swelled up and swelling in rib cage, collar bone"" on an unspecified date, while the patient was not recovered from the rest of the events.""
54	1157170-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Male	received dose one of vaccine on Sunday around 6pm. On Monday evening I started to have some lower bowel or intestine pain. It got worse through the night and had bad cramping in morning. I tried going BM and could not. After getting up and moving around a bit I was able to have a solid stool, but it did hurt a little. It also hurt when I went to urinate. Later that day I had 99 to 100 fever. For the next 2 days I was better but I did have some lower abdominal pain and tenderness.
55	1162120-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Female	This is a spontaneous report received from a contactable female consumer reported for herself that a 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6203, Expiration date: unknown) via an intramuscular route on left arm on 08Mar2021 at 13:10 (at the age of 65-year-old) as a single dose for COVID-19 Immunization. The patient medical history included ongoing Autonomic neuropathy (Affected her digestive tract. Lost teeth, part of esophagus, gall bladder, stomach and large part of small intestine), Clostridium difficile, several anaphylactic reactions (immediate anaphylactic reaction with bee sting), malnutrition, walker, hypoglycemic, dermatitis from gloves, Hives for several medication (Reglan, compazine, levaquin, cipro, doxycylcine, zpac, arithromycin, sulfa drugs-macrodantin, chorhexadine, tropomate tramadol, msl4, codeines, hydrocodone, oxycodone, ultracept, Carries 4 epi pens in different locations), allergy: corticosteroids, on J tube 12 years, PICC line for 3 years, stomach had to be taken out (A tiny pouch was made where they connected what was left of her esophagus to small intestine. The pouch is the size of a quarter). The patient concomitant medication included teduglutide (GATTEX, Lot number: 1908G, expiration date: Apr2023) ongoing at a dose of 5ml, daily; dicyclomine (capsule, expiration date: 16Mar2022) ongoing at 10mg (2 capsules 3 minutes before meals and bedtime) from an unknown date in 2002; sucralfate (expiration date: Oct2021) ongoing at 100kg/m3, 4 times a day for help keep food down, colesevelam hydrochloride (expiration date: May2022) ongoing at 625mg, twice a day for help aide digestion, fludrocortisone (tablet, expiration date: 23Jan2022), ondansetron (ZOFRAN, Lot number: ON0820008-A, Expiration date : Jan2024) ongoing at 8mg as needed for nausea; midodrine (Expiration date: 22Oct2021) ongoing from 2018 at a dose of 5mg, thrice a day for orthostatic hypotension; alprazolam (tablet) at a dose of 1 mg; ongoing gabapentin. On 8Mar2021, with 5 minutes after vaccination had an anaphylactic reaction- Was taken by ambulance-Caller couldn't breathe or swallow- tongue was thick, couldn't breathe, Tachycardia, chest hurt and felt bruised afterwards, Nausea, Constipated, Oxygen level was down to 90, legs and arms were flapping, could not swallow, felt like she had brain fog. Nurse watched her carefully and she was sent to sit for 30 minutes. The doctor gave her a shot of Epinephrine and it backfired, so she didn't get it. The other doctor got it and the ambulance was there working on her. Oxygen level was down to 90 and was given Decadron. Her legs and arms were flapping due to her disease, because epinephrine was a vasodilator. It was reported that in ambulance patient Was being asked questions and she couldn't talk on 08Mar2021. The patient was taken to the hospital and was given more benadryl, and more epinephrine. Then she felt better over the next few days. She saw her own physician the next day and was given Solumedrol in her tush, 40 mg prednisone twice a day, for 3 days. The patient felt her cognitive skills were not working well the first few days and could not walk very well, even with her walker on an unknown date in Mar2021and dropped 5 dishes in one day. Caller provided information regarding article from British government stating people with history of anaphylaxis should not take Pfizer vaccine. Article stated FDA is still working with Pfizer on this. The patient states she should never have been given that shot and requests for compensation. The patient reported that she was never been so afraid in life. The patient had hematoma after 3 sticks for IV in ambulance on 08Mar2021 and had warm hot packs on it. The patient Oxygen level was low and was given 2liters nasal cannula, which was bumped up to 4 liters. The patient felt like a robot, did not have good control of legs or arms and flailing like baby when epinephrine was given. The patient took Fludrocortisone for Adrenal insufficiency, With all the steroids, should have felt fabulous but didn't. The patient Clarified Epinephrine junior was given in the thigh and backfired. Was given Epinephrine in her other thigh, Was given Benadryl at Vaccine facility. In emergency room patient received Famotidine IV 20mg/50ml STAT 1 dose, Sodium Chloride 0.9% 1000 ml over one hour STAT for hydration, Another sodium chloride 0.9% 1,000ml, Another sodium chloride 0.9% 1,000ml and discharged from emergency room after 6 hours. The patient stated she could not have second COvid-19 Vaccine that was scheduled for this coming Monday. The patient had undergone laboratory test on08Mar2021 potassium was 2.9, EKG was abnormal (tachycardia) and standard blood work was unknown. The outcome of the events anaphylactic reaction was recovering, tongue was swollen was recovered on an unknown date in Mar2021 while for other events was unknown. Follow-up Information has been requested.; Sender's Comments: Based on known drug safety profile and close temporal association the event of Anaphylactic reaction is assessed as related to the suspect vaccine BNT162B2. As there is limited information in the case provided for gait disturbance, adrenal insufficiency and injection site haematoma, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
56	1164484-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	Tested positive for COVID-19 January 11th 2021. Feb 26th 2021 went in to get the first COVID vaccine around 1130 with Public Health. COVID vaccine manufacturer was Moderna. Given in the left deltoid, IM. Patient did stay an extra 30 minutes post vaccine b/c she has lots of allergies. About an hour After the vaccine she experienced pain in her left arm and up into her neck on the left side. Symptoms are very simulair to something that she ingested and had an allergic reaction to in the past. Felt okay the first day, second day (2-27-2021) she had chills, fatigue, aches and pains. Started to feel like she was improving on Monday around the 28th of February 2021. Fever was down. Still felt fatigued. Nose felt like it was runnng, itching. Experienced dry eyes, started using the eye drops more frequently. Ear canals were itching. She noticed a tickle in her throat later. Not conscious of everything all the same time, she just didn't feel well overall. Vagina and anus were itching. Started to use the estradiol compound daily hoping that might help. Itchy all over and then realized that the reaction was sort of the same reaction she had in the past with the statin medication. Few days after that had abdominal bloating and cramping, also loose stool and finally diarrhea. Around that same time she reports that she was very dizzy and saw stars, had to sit down, did not actually faint. Denies any fainting episodes, but felt faint. Resolved after 5-10 minutes of sitting down, did not feel clear headed after that for several days. Did do her daily walk, starting on 2-28-2021, felt like she had less stamina. Feels more tired in general still now. Does regret getting the COVID vaccine now. Took some benadryl at the time of the reaction and at hs PRN, benadryl makes her feel drowsy. Takes zyrtec, flonase daily and singulair. Pt's husband is a physician, and he prescribed a Medrol dose-pak, which did not seem to help. At the time was taking all of her prescribed medications amlodipine, benazepril. Has taken pepcid for heart burn in the past, was not taking it as the time. Taking prn omeprazole. Denies experiencing any wheezing. Experienced Generalized swelling of eyelids, face, hands, feet. Tongue is kind of swollen today, and she feels like it has been swollen on and off since the vaccine. Prior to the vaccine she felt pretty good overall. Went out for a few days and went skiing with her family. Has a place out of town that she deep cleaned, felt like maybe she over did it, but she recovered after she rested briefly. Was due for the second vaccine last week. She held off until she could discuss with her doctor, and they discussed that she should not have any further doses. Physically she felt that she should not receive the 2nd vaccine. Continued symptoms include itchy throat (tickle), vaginal and anal itching all day every day. Itching has become a little more like soreness of the tissues. No bruising. Patient has not had the shingles vaccine (Shingrix), thinks she should not get it now. She has pretty much avoided getting vaccines throughout her life b/c she has had poor reactions to flu shots in the past as well. One year, we tried a ""half-dose"" regimen of the flu shot, giving 0.5ml IM , waiting one month and repeating 0.5ml IM. She did tolerate this well with no reported adverse outcome and did not get influenza that year though it was very active in the community. Since the Moderna vaccine, pt describes Abd distention, bloating of small intestine, ""I look 6 months pregnant."" pt states her stomach has been like this since the COVID vaccine reaction.""
57	1175599-1	COVID19 (COVID19 (MODERNA))	40-49 years	Female	On 2/25/21 I received my first Moderna vaccine. Later that day, I started to experience some brain fog and fatigue. this resolved itself after approximately 4 hours. On 3/3/21 I took my dose of Humira that I use for Crohn's Disease and about 3 hours later experienced extreme fatigue. I have been on Humira for 3.5 years and I have never experienced a reaction to the Humira like this. On 3/4/21, the next day after taking my Humira, I once again experienced extreme fatigue, a very bad headache and horrible brain fog to the point where the things I was reading on my computer and things people were saying to me was not making sense. I was also very nauseated and had severe diarrhea. I was tested for Covid just to be sure and I was negative. I went home and fell asleep and slept for 6 hours. I did feel better upon waking up. Approximately one week later I experienced a sever migraine with visual disturbances. On 3/15/21 I began having a Crohn's flare. I had been in remission for 3.5 years with my last colonoscopy in October of 2019 showing this and that my Crohn's ulcers had improved. I went to the ER on 3/16/21 in severe pain, was found to be in a flare with inflammation and swelling in my small intestine and a partial blockage. I was admitted to the hospital for 2 days where I received IV steroids and fluids. I was sent home on oral prednisone and now have to add additional medication to my Humira regimen for my Crohn's. I am sure that some will say that none of this is related to the Moderna vaccine I received, but I have had no issues with my Crohn's in 3.5 years until I had this vaccine. All of my issues this past month coincide with receiving the vaccine and I have never had any side effects whatsoever from the Humira. In fact, it's always made me feel better when I've been due to take it, so I know that my symptoms are not from the Humira. I cannot say for sure if the vaccine caused my issues, however, it's pretty coincidental that I was feeling good and otherwise healthy until I had this vaccine.
58	1179656-1	COVID19 (COVID19 (JANSSEN))	50-59 years	Female	After the vaccine I woke up about 3am throwing up and had diarrah all day. I felt so bad all day that by 9pm I went to the ER and was advised my intestines were inflamed and diagnosed with Colitis. I was prescribed Augumentin to take for 7 days and tylenol for pain and to follow up with my PCP.
59	1188237-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Female	Got vaccine on 4/7 at 10-10:30 am approximately By 1 pm I was sleepy and woke up at 3 By 4-5 pm I had chills, body ache, no fever, nausea, heart palpitations, feeling that my blood is on fire, mild sore arm By 6-8 pm I was vomiting a lot and also going to the bathroom loose no diarrhea All night I felt sick and had raising thoughts in my mind. I have sensitivity to noises as well. On 4/8 I woke up very sick. Kept throwing up water and liquids. Couldn?t eat. By 1 pm I have thrown up some more The raising thoughts and things in my mind bother me 3 pm my veins in the back of my knees are hurting I have the feeling that I can feel my kidneys, liver, intestines Took Tylenol 9 pm and still feeling sick 4/9 still nauseous and with a pounding headache Took Tylenol By 8 pm I?m feeling a bit better
60	1188314-1	COVID19 (COVID19 (JANSSEN))	65-79 years	Female	pain in large intestines, bloating, diarrhea headaches fuzzy brain (confusion, hard to focus) dizziness (lingering 6daysafter inoculation) extreme fatigue (still tired 6 days after inoculation)
61	1189787-1	COVID19 (COVID19 (MODERNA))	40-49 years	Female	Shaking first 15-20 minutes, dizzy, clammy, then subsided, immediate feeling of diarrhea, got home used bathroom, then fine, elevated temp by 8 pm 101, tried to lay down, rolling around in dyscomfort and could feel every part of body, pain in ribs, lungs, intestines, long bones, joints, at 1 am began to violently vomit every 30, to then 15 minutes until 4 am when husband gave me 4 mg of Zofran. Worst vomitting I have ever experienced and felt like I could not breathe through the wretching. very scary. If not vomitting was shaking so severly the bed shook. temp at about 101.5 Spoke to Manager, she informed me they do not report vomiting and it is completely normal! I know NOONE that has been sick like that with any of the three vaccines!!!! I was still fevering until Friday afternoon.
62	1191455-1	COVID19 (COVID19 (MODERNA))	50-59 years	Male	The morning after I woke up, I had intense abdominal cramping. The cramping was high in the gut area. I figured it was an adverse side effect. The cramping did not subsist night or day and the intensity was great. I called my GI on Monday and got an appointment. When I saw him, he ordered a CT scan and put me on a strong antibiotic thinking that it was an infection, not related to the vaccine. Meanwhile I had a CT scan and blood workup. The CT scan came back with significant swelling and inflammation in my small intestines. Five miserable days later my GI took me off of the antibiotic and was now talking about putting my on a strong steroid. (Budesonide) Then, due to tremendous cramping I went to the ER where they did another CT Scan, blood workup as well. They did see less swelling and that gave us hope that the steroid was working. Finally, I got a endoscopy where they took six biopsies. We are still waiting on the biopsies but they doctor said the inflammation was going done but that my stomach lining was particularly red. That is where it stands today just past one month. The pain is going down but both of my healthcare professionals are warned me against getting the second dose of the vaccine. They are both convinces this is a rare type of allergic reaction to the vaccine.
63	1201947-1	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	Unknown	On March 18 sore on the right arm, 3/19 chills,fever, cough, taste was off by salty every tasted like pure salt even a piece of candy. Back pain on lower back and stomach pains and inflammation of the stomach. Started with very painful back pain went to the doctor and gave him antibiotics and pain medicines and since he was not recovering with the medication they admitted him to the hospital on 4/9 with a blood clot in the portal vain causing no draining from liquids to the intestines and was placen on blood thinners
64	1201988-1	COVID19 (COVID19 (MODERNA))	30-39 years	Female	Moderna COVID-19 Vaccine EUA Developed chills around 8:30pm 4/6 and that continue for a few hours, then 101.8 fever throughout the night. Tired and weak in morning, low fever 99 rest of day. Possibly unrelated, but next day on 4/8 developed abdominal cramping at around same time, 8:30pm, and nausea. Vomited 5+ times and was admitted to the ER. No exact cause, but possible food poisoning was given and intestine issues.
65	1204806-1	COVID19 (COVID19 (MODERNA))	50-59 years	Female	Arm - hurt; I got a little fatigued - by the next day after the vaccine. One pain in particular - on the 17th - I felt it inside of me toward the right front of my waist. Where the appendix could be hurting. It would hurt more when I was walking. I didn't feel it when I was sedentary with sitting. At night, I would feel it like a cramp when I was lying down. On the 18th, it was hurting more. I had bloodwork appt coming up on that Thursday. The pain continued and was getting stronger. By Wednesday, I started feeling pain going down my right leg and up in my back. Thursday - bloodwork. I saw the doctor on Friday. Had an examination - they figured out it was not the appendix. They thought it was gas. But I don't suffer from gas. They prescribed pills for nerves - to release nerves inside intestines and OTC gas pills. It relieved it a little but didn't go away. They concluded it was a nerve thing connecting from my back. They gave me another medication for the back pain. Gabapentin and Baclofen.
66	1204971-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	Blood clot in large intestines which caused loss of blood supply and oxygen so it rotted which in turn rotted her small intestine and bowels which all had to be removed shut down her kidneys and liver
67	1205025-1	COVID19 (COVID19 (MODERNA))	30-39 years	Female	Saturday April 10th at 5 pm: Back pain in the thoracic area, pain when breathing, breathing was short, pain when taking deep breaths. Monday 12th at 2 am: abdominal pain and bloating: pain similar to gastritis around the Cardia or diaphragm area. Pain in my intestines as I feel my digestion move, probably the large intestine. Pain in my back, in the lumbar area related to the abdominal pain. All pain was manageable. I didn't go to the doctor.
68	1206886-1	COVID19 (COVID19 (MODERNA))	60-64 years	Female	abscess/mass in her intestine; lower abdominal pain; Terrified to receive the 2nd dose; itching; Postponed 2nd dose of the vaccine; urticaria (Hives) all over her body.; This spontaneous case was reported by a consumer and describes the occurrence of ABSCESS INTESTINAL (abscess/mass in her intestine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced URTICARIA (urticaria (Hives) all over her body.). On 25-Mar-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (Postponed 2nd dose of the vaccine). On 01-Apr-2021, the patient experienced PRURITUS (itching). On an unknown date, the patient experienced ABSCESS INTESTINAL (abscess/mass in her intestine) (seriousness criteria hospitalization and medically significant), ABDOMINAL PAIN LOWER (lower abdominal pain) and FEAR (Terrified to receive the 2nd dose). On 25-Mar-2021, INCOMPLETE COURSE OF VACCINATION (Postponed 2nd dose of the vaccine) had resolved. At the time of the report, ABSCESS INTESTINAL (abscess/mass in her intestine), ABDOMINAL PAIN LOWER (lower abdominal pain) and URTICARIA (urticaria (Hives) all over her body.) had not resolved and PRURITUS (itching) and FEAR (Terrified to receive the 2nd dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
69	1207364-1	COVID19 (COVID19 (JANSSEN))	18-29 years	Female	Around 5:00 PM after having gotten my shot, I arrived home from a drive down to meet my sister. Precautions were taken, masks were worn, safe social distance was maintained and I have no reason to believe any of the symptoms I experienced upon returning home were related to anything other than the vaccine, particularly since first that is how vaccines work and second one of my friends who was vaccinated at the same time as me at the clinic was going through similar pains. It started as a discomfort in my intestines or possibly just below my stomach in general. I thought my pants were too tight but just in case I let my mom take over driving the rest of the way home. When I got to the house, I had about an hour of usable time left before I went into a complete state of delirium. We're not sure how high my fever actually got before my mom woke up and checked in on me at 9:00 PM, but after having pulled the covers away I registered at 102.5ª F. I was screaming in a half-awake and half-asleep nightmare, trying to get someone to come help me and unable to get anyone's attention. I would, as a result, like to insist that it be added to recommendations to not be alone after getting the vaccine! For the whole first night! I believe that I genuinely could have died. My brain was melting for lack of more proper medical terminology, and I stopped being able to understand and speak my own first language in an incredibly confused state. This was entirely a result of two simultaneous factors: Fever and Chills. First, the fever made my skin ache. Wearing any clothing hurt. But once I took off my pants in exchange for some breezy shorts, I was covered in goosebumps and feeling frozen even though it was solidly in the 70s. I claimed under blankets and still couldn't get warm enough. The backs of my thighs were insanely hot in comparison to the fronts of them, so I just warmed my body under 3 layers of blankets trying to get the chills to go away. I did that for about four hours during which time I was basically constantly screaming incoherently.
70	1215648-1	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	Male	bruises are darker than normal since he has started Eliquis; Constipation; swollen index finger and swollen toe/determined to be gout; felt lousy; This is a spontaneous report from a contactable consumer, based on information received by Pfizer. This spontaneous case was reported by a physician and describes the occurrence of GOUT (swollen index finger and swollen toe/determined to be gout), FATIGUE (felt lousy), CONTUSION (bruises are darker than normal since he has started Eliquis) and CONSTIPATION in 92-year-old male patient who received apixaban (Eliquis) tablet (batch no. 1790398) for Venous thromboembolism. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for an unknown indication. The patient's past medical history included Large intestine infection, Hypercoagulability and Constipation. Concurrent medical conditions included Gout. In February 2021, the patient started Eliquis (batch no. 1790398) (Oral) at an unspecified dose twice a day. On an unknown date, the patient started Covid-19 Vaccine (unknown route). On 27-Mar-2021, the patient experienced FATIGUE (felt lousy). On 29-Mar-2021, the patient experienced GOUT (swollen index finger and swollen toe/determined to be gout). On an unknown date, the patient experienced CONTUSION (bruises are darker than normal since he has started Eliquis) and CONSTIPATION. The action taken with Eliquis(Oral) was unknown. At the time of the report, GOUT, CONTUSION and CONSTIPATION outcome was unknown and FATIGUE resolved. For Eliquis(Oral), the reporter did not provide any causality assessments. The reporter stated that he was put on Eliquis for ninety days and has used it for thirty days so far. He has had some issues that require an enema. Concomitant medications included: dark Cherry Extract - started on or after 29-Mar-2021. The reporter stated that he had been taking Eliquis for 45 days for blood clots that stemmed from a colon infection with secondary hypercoagulability. On Saturday 27-Mar-2021, the patient had his second injection of the Pfizer Covid vaccine. After receiving the vaccine, he said he felt lousy and had common side effects for a vaccine that lasted for about 2 days. On 29-Mar-2021 he woke up with a swollen index finger and swollen toe and this was determined to be gout. The gout in his index finger he had before. The patient stated that whenever he got bruises he had noticed that the bruises were darker than normal since he had started Eliquis. The patient also stated that he has had considerable constipation that started before Eliquis, but still persisted at times and he had treated with enemas. Patient was a retired physician. Follow-up (30Mar2021): This is a follow-up spontaneous report from a contactable physician, based on information received by Pfizer Most recent follow-up information was received from a physician on 30-Mar-2021 included the following: the event adverse event nos was amended as information on adverse events were received, new events and suspect product added, patient attributes, medical history, product attributes and narrative updated.
72	1221012-1	COVID19 (COVID19 (MODERNA))	65-79 years	Male	small intestine got blocked and due to blockage blood supply stopped; started having blood clot thrombosis both in his right leg as well as left leg; Missed the 2nd dose; Blocked small intestine; This spontaneous case was reported by a nurse and describes the occurrence of SMALL INTESTINAL OBSTRUCTION (Blocked small intestine), INTESTINAL ISCHAEMIA (small intestine got blocked and due to blockage blood supply stopped) and THROMBOSIS (started having blood clot thrombosis both in his right leg as well as left leg) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse effect (No relevant medical history reported) and Surgery. Concomitant products included thyroid medication for an unknown indication, cholesterol medication. On 13-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced SMALL INTESTINAL OBSTRUCTION (Blocked small intestine) (seriousness criterion medically significant). On 13-Mar-2021, the patient experienced INTESTINAL ISCHAEMIA (small intestine got blocked and due to blockage blood supply stopped) (seriousness criterion medically significant), THROMBOSIS (started having blood clot thrombosis both in his right leg as well as left leg) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose). On 13-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose) had resolved. At the time of the report, SMALL INTESTINAL OBSTRUCTION (Blocked small intestine), INTESTINAL ISCHAEMIA (small intestine got blocked and due to blockage blood supply stopped) and THROMBOSIS (started having blood clot thrombosis both in his right leg as well as left leg) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications included thyroid medication and cholesterol medication. Patient called in to report that he received his 1st dose of Moderna vaccine on 13Feb2021 in left arm at 10.30 am and his 2nd dose of Moderna vaccine was scheduled on 13Mar2021. On 13Mar2021he went to Emergency Room (ER) and he had major surgery on small intestine, patient mentioned that his small intestine got blocked and due to blockage the blood supply was stopped and the intestine started to die. On that day, the patient underwent a surgical procedure which the doctor had to take out 12 inches of small intestine and stapled back. He was hospitalized for five days. Five to seven days after his surgery, he developed blood clot thrombosis in his right and left legs. Treatment for the event included blood thinner, which he has been on for 45 days. It was reported that the second dose of Moderna vaccine was missed due to hospitalization for the events and the blood thinner that he was on. Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: reporter added, product indication added, event added(missed dose), event assessment done, additional info added( Source Document and mail document added); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
73	1222617-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Male	Worst sickness/flu like symptoms I have ever experienced. Bad dehydration, diarrhea, throwing up, fatigue, light headed, chills, fainting/passing out. Had to diarrhea over 30 times in one day, throw up several times. Went to emergency room for treatment. IV treatment plus anti naseau and anti cramping Medication. Cramping was severe in upper intestine. Symptoms have decreased, but still linger after 2 weeks of 2nd shot. Concern if side effects are permeant. I still very tired/fatigued, have cramping, dirahaha, throwing up, aches muscles and joints- not feeling like myself and regret taking the vaccine if it results in lifelong side effects.
74	1224399-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Female	lower pelvic pain that progressed into severe pain over the next day; pain with bowel movements; difficulty to sit; weight loss; 4 hours after injection developed again the severe pain; pelvic mass; This is a spontaneous report from a contactable Physician (for herself). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 28Jan2021 (Batch/Lot number was not reported), age at vaccination of 43-years-old , as single dose for covid-19 immunisation. Medical history included rubber sensitivity from an unknown date and unknown if ongoing (known allergy Latex - contact) and COVID-19 infection (prior to vaccination, the patient was diagnosed with COVID-19). The patient was not pregnant and was not pregnant at the time of vaccination. The patient received first dose of BNT162B2 (lot number EL1284), on 07Jan2021 12:00 PM, vaccine location Arm Left and experienced lower pelvic pain that progressed into severe pain over the next day, pain with bowel movements, difficulty to sit, weight loss, resulted in hospitalisation for one day for suspected pelvic mass. Facility where the most recent COVID-19 vaccine was administered: Health Clinic/Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included daily multivitamin. The patient received 2nd on 28Jan2021 and 4 hours after injection, she developed again the severe pain experienced after the first injection require pain management. Underwent laparoscopic surgery for removal of pelvic mass and lysis of adhesions of intestines. Prior to the 1st vaccine on 07Jan2021 I had no pelvic pain or intestinal issues, no prior surgery and had maintained a very active lifestyle. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based from known drug safety profile and temporal occurrence, the causal association of the reported events in relation to suspected drug BNT162B2 cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
75	1226088-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Female	I received the shot through my employer, at a High School. I experienced stomach pain 4 hours after shot. Initially I thought it was upset stomach from dinner, but everyone else was fine and my condition worsed. My intestines felt inflamed. I had intermittent diarrhea. 6 days later I went to Urgent Care as it was clear to me that there was something wrong.
76	1226670-1	COVID19 (COVID19 (MODERNA))	Unknown	Unknown	Severe GI bleeding. This required hospitalization from 04/03/2021 - 04/10/2021, with no know source found for GL bleed. I was admitted to medical Center with a Hemoglobin of 6 and received a total of 4 blood transfusions. My hemoglobin was 7.4 upon discharge. On Friday, morning, Apr 16, 2021, I was taken to Medical Center, and found to have a Hemoglobin of 4.8 with severe GI bleeding. I received 3 blood transfusion and they found an atrial bleed in my small intestines. Surgery was completed on that day to stop the bleeding at Medical Center. I was discharged at 11:30, today, Apr 18,2021.
77	1230428-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	After shot #2 I had gut micro-biome distress, bloating, constipation, large intestine full, small intestine not getting full, so block between large and small intestine. Drank smooth move tea, massage bloated tummy, had acupuncture to help ... mostly drank tea and water for a few days. Finally had some relief, but now 5 days later I am still not back to normal gut function. I am taking probiotic tablets with meals.
78	1233502-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Male	Abdominal pain, Portal Vein Thrombosis (Blood clots in veins to the Liver, Spleen and Large Intestine) Treatment - Heparin drip and then converted over to the blood thinner Xarelto Recommended that I follow up with my primary care physician and seek the advice of a Hematologist
79	1233712-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Male	In the days after my first covid shot, the number of bowel movements started to climb from 15 a day to over 30 a day. I also developed difficulties with urination and a sense of urgency. By the time of my second shot, I was seeing blood in my stool. The first shot may have triggered an infection or sever inflammation in my small intestines, as I had my large intestine removed in 2015. My doctor asked me to report this as other of his patients have seen similar issues.
80	1237074-1	COVID19 (COVID19 (JANSSEN))	40-49 years	Female	Within first 2 hours: dizziness Between 1-7pm: Faster heartbeat Nausea Soreness in sacrum Lower intestine and vagina sore/tight On/off sore throat & metallic taste similar to when sick in December At 8:15pm: Chills Fever - temp 99.3 (normal is 97.5) Heels sore 10:20pm - Fever - temp 100.4 4:30am - Fever - temp 101.2 9:30am - Fever - temp 99.6 12:30pm - Temp back to normal at 97.5 Minor, dull headache for 2-3 days after Then, starting on around April 8, I have been feeling, and still feel today: soreness in my left heel, inflammation all over my body, slightly faster heartbeat, sensations in gland areas of my body (lips, neck, groin, etc), headache that comes and goes.
81	1240875-1	COVID19 (COVID19 (JANSSEN))	Unknown	Female	HAD PERIOD; PAIN; SWEATING; SLIGHT HEADACHE CONTINUES ON AND OFF; FEVERISH; JOINT PAIN; PERIOD CRAMPS THAT PROGRESSED AND GOT WORSE; LOWER INTESTINES DISCOMFORT; CRAMPING; ON AND OFF ALL NIGHT; HEAD, NECK, AND EARS WERE LITTLE ITCHY; DIZZY ON AND OFF; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride for allergy multiple. On 07-APR-2021, the subject experienced head, neck, and ears were little itchy. On 07-APR-2021, the subject experienced dizzy on and off. On 07-APR-2021, the subject experienced period cramps that progressed and got worse. On 07-APR-2021, the subject experienced lower intestines discomfort. On 07-APR-2021, the subject experienced cramping. On 07-APR-2021, the subject experienced on and off all night. On 07-APR-2021 20:45, the subject experienced sweating. On 07-APR-2021 20:45, the subject experienced slight headache continues on and off. On 07-APR-2021 20:45, the subject experienced feverish. On 07-APR-2021 20:45, the subject experienced joint pain. On 08-APR-2021, the subject experienced had period. On 08-APR-2021, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head, neck, and ears were little itchy, and dizzy on and off on 07-APR-2021, had not recovered from slight headache continues on and off, and the outcome of joint pain, feverish, sweating, had period, lower intestines discomfort, period cramps that progressed and got worse, pain, cramping and on and off all night was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
82	1241059-1	COVID19 (COVID19 (JANSSEN))	65-79 years	Female	ZOMBIE LIKE; NO ENERGY; This spontaneous report received from a patient via a company representative concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dykinesia with parkinson's disease, covid-19, diverticulosis of intestine, opioid dependence, repeated fall, ventricular tachycardia, continuous positive airway pressure, and flopping like a fish. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included amantadine hydrochloride for dykinesia with parkinson's disease, carbidopa/entacapone/levodopa for dykinesia with parkinson's disease, carbidopa/levodopa for dykinesia with parkinson's disease, rotigotine for dykinesia with parkinson's disease, levodopa for dykinesia with parkinson's disease, and flopping like a fish, calcium, carvedilol, celecoxib, colecalciferol, entacapone, estradiol, ezetimibe, fluoxetine, gabapentin, hydrocodone, loratadine, mirabegron, nortriptyline, ramipril, tapentadol hydrochloride, and vitamin e nos. On 16-MAR-2021, the subject experienced zombie like. On 16-MAR-2021, the subject experienced no energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from zombie like, and no energy on 20-MAR-2021. This report was non-serious.
83	1244354-1	COVID19 (COVID19 (MODERNA))	50-59 years	Female	covid like symptoms, couldnt lift arms, rash over body, blocked intestine,
84	1245428-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	could not urinate; no sleep; lost 9 pounds; pulse rate is high in the 90s; could not defecate; constant pain in the colon on the left side, pain in my intestines; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (could not urinate) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history.). On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY RETENTION (could not urinate) (seriousness criterion medically significant), INSOMNIA (no sleep), WEIGHT DECREASED (lost 9 pounds), HEART RATE INCREASED (pulse rate is high in the 90s), DYSCHEZIA (could not defecate) and ABDOMINAL PAIN (constant pain in the colon on the left side, pain in my intestines). At the time of the report, URINARY RETENTION (could not urinate), INSOMNIA (no sleep), WEIGHT DECREASED (lost 9 pounds), HEART RATE INCREASED (pulse rate is high in the 90s), DYSCHEZIA (could not defecate) and ABDOMINAL PAIN (constant pain in the colon on the left side, pain in my intestines) outcome was unknown. The patient used blood thinners as concomitant medication. Patient states she took laxatives and other over-the-medications as treatment. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: This case concerns a 73-year-old female with a serious unexpected event of urinary retention, and non-serious unexpected dyschezia, abdominal pain, weight decreased and insomnia. Event onset with unknown latency after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 73-year-old female with a serious unexpected event of urinary retention, and nonserious unexpected dyschezia, abdominal pain, weight decreased and insomnia. Event onset with unknown latency after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
85	1249110-1	COVID19 (COVID19 (MODERNA))	50-59 years	Female	This was my second dose of Moderna vaccine. On April 19 I was vaccinated at about 5:30 pm . That night at about 12 pm , around 6 hours after vaccination I woke up with diarrhea and painful cramps in lower left quadrant . Diarrhea continued for about 2 hours. More than 3 times and after they stopped the cramps continued all through the night. In the morning again I vomited once and then evacuated and saw blood in my feces . Saw blood about 3 times more after that. I do no know if currently I have permanent damage in my intestines or gastrointestinal system. I have persisting headaches and migraines still after 4 days . As I write I have a dull migraine .
86	1255037-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Female	Seven strictures resulting in a loss of 12 to 18 inches of small intestine; Sore leg muscle; This is a non-interventional study report from the marketing program received from a non-contactable 59-year-old female consumer (patient) based on information received by Pfizer that: A 59-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205 and Expiration date was not reported), via intramuscular on 09Mar2021 as SINGLE DOSE for covid-19 immunization; adalimumab (HUMIRA), subcutaneous from 2019 (Batch/Lot Number: 1136916) to 17Feb2021, at 40 mg, citrate free (40 mg,1 in 1 wk) for moderate to severe adult Crohn's disease. Medical history included depression, hypertension, appendicectomy from 2010 to an unknown date, Nonsmoker and abstains from alcohol. Concomitant medications included celecoxib (CELEXA) taken for depression; pindolol (PINDOLOL) taken for hypertension. In Nov2020, the patient experienced seven strictures resulting in a loss of 12 to 18 inches of small intestine. On 09Mar2021, the patient experienced sore leg muscle. Seriousness of the event seven strictures resulting in a loss of 12 to 18 inches of small intestine was reported as hospitalized and medically significant. The patient underwent lab tests and procedures which included biopsy: no significant findings on 05Feb2021, colonoscopy: stricture on Nov2020, laparoscopy: seven strictures on 05Feb2021. Adalimumab was permanently withdrawn on 17Feb2021.On 05Feb2021, the Seven strictures resulting in a loss of 12 to 18 inches of small intestine resolved. On 10Mar2021, the Sore leg muscle resolved. Causality for HUMIRA 40MG/0.4ML (ADALIMUMAB): The reporter causality for the event(s) of Seven strictures resulting in a loss of 12 to 18 inches of small intestine and Sore leg muscle with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. Company opinion is that there is no reasonable possibility that the events of Seven strictures resulting in a loss of 12 to 18 inches of small intestine and Sore leg muscle are related to HUMIRA 40MG/0.4ML(ADALIMUMAB). No follow-up attempts are possible. No further information is expected.
88	1255066-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Female	Vomiting; Diarrhea; lost alot of weight; diverticulitis; brain fog, can't think clearly; stomach pains; violently ill; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient' medical history and concomitant medications were not reported. The patient experienced vomiting and diarrhea. Mostly diarrhea. The vomiting started 05Mar2021 in the middle of the night. She was vomiting so much she went to the Emergency room by ambulance. They kept her in the hospital for a couple of days, but she did not have diarrhea at this time. It was like three days later that she suddenly became violently ill. At the time she did not tie it to the vaccine administration, she thought she had food poisoning or something. She then had severe diarrhea. She cannot recall the exact onset date of when the diarrhea began. She can't get the dates together because she knows she became very sick. Patient recalls that when she got out of the hospital, she was having stomach pains. The stomach pains were feeling more severe on 18Mar2021. On 19Mar2021, she went to a check up with her gynecologist for an annual check up and did tell her gynecologist about the stomach pain and having a lot of stomach issues, but the doctor had no idea about it, she's a gynecologist. The patient's gastroenterologist thought maybe she had diverticulitis not related to the Pfizer COVID-19 vaccine and on 27Mar2021, they started her on Cipro and Flagyl, but the diarrhea just kept getting worse even with the meds and its just been getting worse and worse and worse. Cipro and Flagyl were stopped after 5 days because her gastroenterologist told her that maybe all of her flora was cleared out, and the flora was causing the diarrhea. No one knows what was causing her diarrhea. Oddly enough, she was feeling a little better today. She feels like she doesn't have diarrhea today, but she doesn't know because sometimes she has diarrhea for a couple of hours and then she feels just fine for a couple of hours. She also has brain fog. She was feeling like she could not think straight. She confirmed she does not have this feeling today. It got really bad after the second shot. The brain fog started between the time of first and second shot, when she had the diarrhea. It was like a week to ten days after the first shot, but she does not know exactly when brain fog started. It comes and goes, doesn't have it right now, and didn't have it yesterday. She stated that the brain fog seems to have gone away about 5 days ago. She had all these blood tests and cat scan and they all came back negative that she is in perfect health. She has no other issue except this constant diarrhea. Caller states she doesn't have any issues with any of her abdominal organs, her gall bladder and intestines are all fine. She has lost 5 pounds explaining that a month ago she weighed 136 pounds and now she weighs 130 pounds. The diarrhea is without any known medical known ideology and is very debilitating because she has lost a lot of weight. The outcome of events was reported as ""unknown"". Follow-up attempts are completed. The following information on the batch number has been requested.""
89	1255204-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Male	Severe Headache; Muscle ache; Abdominal pain; lost his appetite; had a horrible feeling in his stomach, almost like the stomach flu; cold and had trouble maintaining his body heat; significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week; nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick; Sore Arm; Runny Nose with Mucous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162B2, via an unspecified route of administration, administered in Arm Left on 31Mar2021 (Batch/Lot Number: EN6206) (at age of 61-year-old) as single dose for COVID-19 immunisation. Medical history included Slightly Diabetic from 2009 to an unknown date. The patient stated he doesn't smoke or do drugs, or drink and he tried to eat good healthy food. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 10Mar2021 (at age of 61-year-old) (Lot number: EN6200) and experienced sore arm and runny nose with mucous. The patient experienced sore arm on 01Apr2021, runny nose with mucous on 01Apr2021, nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick on 02Apr2021 , severe headache on 07Apr2021, muscle ache on 05Apr2021, abdominal pain on 02Apr2021, lost his appetite on 02Apr2021, had a horrible feeling in his stomach, almost like the stomach flu on 02Apr2021, cold and had trouble maintaining his body heat on 02Apr2021, significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week on 02Apr2021.Clinical course: The patient had his second shot last Wednesday, 31MAR2021, and he was calling to report his adverse side effects. The patient stated he had a sore arm which was okay and runny nose with mucous, which was similar to his experience with his first shot, but then things went downhill. The patient stated with the first vaccine, he had arm pain that evening and it really wasn't bad. Stated there was an hour where it was really intense like he got shot up with something pretty powerful, he had a yucky feeling like when you catch the flu and get the first kick and then it went away. Stated he had a runny nose that first came on and lasted pretty much until he got the second vaccine, stated it got not so severe and heavy and decreased until the second shot and then went up again. Stated with the second vaccine he lost his appetite and he developed nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick. Clarified he did not have vomiting or diarrhea. Stated he just had a horrible feeling in his stomach, almost like the stomach flu. The patient stated yesterday (07Apr2021) was bad and he spent the last 2 days in bed. Stated while he was sick, her ate half a sandwich, that was all he could stomach and could eat. Stated he had significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week. Stated looking at his waist line he can tell he has lost weight. Clarified most of the pain was in his lower abdominal pelvis region, large intestine area. Stated he had a severe headache yesterday (07Apr2021). Clarified that it has significantly improved. Stated he still felt tension in his head but nothing compared to yesterday (07Apr2021) with the pounding migraine type of headache. Stated he was cold and had trouble maintaining his body heat. The patient clarified the phases of his events mimic the flu but unlike the flu, he wasn't coughing, but he was having the physical pain of the flu but not the normal symptoms you would expect like heavy mucous, coughing, sneezing, like if he had the flu or a cold, but he felt like he was going through the flu. Stated he had muscle aches. States his back is normally okay but he injured it in the past and it started to hurt especially at the points that were injured. The patient stated just before he called, his husband brought him some soup and he just finished that and he didn't feel immediately sick after eating something so it seems to have significantly improved. Caller states yesterday (07Apr2021) was the worst. Stated he has isolated, he didn't have to go out and lives in the mountains, he only goes out for groceries and they bring it out to him. Stated he did go to the hospital where he received the vaccine, he could have picked up something at the hospital. Stated he hasn't exposed himself to anything, no bars, gym, church, he is not hanging out with anyone, he maintained as restrictive environment as one could have and he wears a mask when they are putting the groceries in his vehicle. Restated that yesterday (07Apr2021) and last night were the worst and everything has significantly improved. Treatment: Been in bed for the last 36 hours, today (08Apr2021) he is actually up enjoying a beautiful day. The events did not result in emergency room visit or physician office visit. AE(s) following prior vaccinations: Every time got flu shot, and he didn't get them anymore, he got sick as a dog for a couple of weeks, with yellow phlegm. Stated he thought it was supposed to protect him, why is he so sick and hacking up phlegm? Stated maybe he is one of those people that doesn't do well with vaccines. Stated this is a new type of vaccine MRNA and it could just be him. Stated not all vaccines, it seems like flu vaccine kicks him in the keister but has had other vaccines like the MMR and no issues with that, no pain no nothing. The outcome of events Sore Arm was resolved on 03Apr2021 and Runny Nose with Mucous was resolved on 06Apr2021 and of the rest of events was Resolving. No follow-up attempts are possible; No further information is expected.
90	1255562-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Female	there is some sort of inflammation going on with that.; CPK test is strange; facial sagging, sagging eyelids went away/Neurological inflammation went away/Pain went away; flushing; Warmth; Low grade fever; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 10Apr2021 (Batch/Lot Number: EW0153) as SINGLE DOSE for covid-19 immunisation. Patient did not receive Other medications in two weeks of vaccination. Medical history included sjogren's syndrome from 2002 and ongoing. Patient stated dry eyes and dry mouth were part of this diagnosis and less lubricating fluid in joints which gets worse as you age. patient is not sure if her body destroying her peripheral nervous system is part of this syndrome, it is still idiopathic. Unknown if peripheral neuropathy is associated with this syndrome, raynaud's syndrome about 2002, give or take 1 or 2 years at the Medical Center, ongoing, postural orthostatic tachycardia syndrome (2002), patient feet would turn red, white and blue. In order to do nerve conduction studies, they have to put her hands and feet in warm water to bring up the temperature to get accurate results, ongoing, allergy Started since she was a child. Patient states she has allergies to about 40 different medications, anaphylactic reaction to Naprosyn sodium, allergic to Atarax. Levaquin is bad and Patient lost consciousness, had to have CT done to see if Patient suffered a concussion, her blood pressure plummeted, ongoing, hypermobility syndrome diagnosed about 2-3 years ago. This is also referred to as double jointedness and can also be looked at as a connective tissue disease. It has wide range of effects on the body, ongoing, arthritis unsure of what type, doctors are discussing rheumatoid, Peripheral Rheumatoid Arthritis. Has had for quite a while. Has had aches and pains for so long. Since Patient early 30's. Maybe 1998. Contractures showing up in her hands they are thinking it is some form of rheumatoid or other autoimmune arthritis, possibly osteo. It is becoming far more pronounced, ongoing. Seizure Verbatim: Nocturnal seizures Class 3, left temporal lobe where abnormal electrical activity was found. About 10 years ago, rapid eye movement sleep behaviour disorder from 2002 and ongoing. Rapid eye movement sleep behavior disorder Diagnosed in 2002. Patient acts out her dreams. Diagnosed from sleep study, ongoing. Thrombocytopenia Verbatim: Thrombocytopenia physician watching her for this since the beginning of 2021. Doctors are watching her platelets. Patient bruises easy and because patient is at the age her mother was diagnosed. Patient mother has a history of Thrombocytopenia. History of this disorder with the females on her mother's side, mother and grandmother. Could be a genetic variant, ongoing, hypothyroidism thyroid nodules crushed her thyroid. Diagnosed 5 years ago and has to take Synthroid, endometriosis Connective Tissue Disorder, abnormal cavity. Diagnosed about 6-7 years ago. Had a Hysterectomy. Doctors could not find one ovary and one fallopian tube. Its all over her intestines. Patient had allergies of Plaquenil, antihistamines and non-steroidal antinflammatories, urinary tract infection and patient had Flu shot vaccine and had a sore arm. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. After she received the covid vaccine on 10 Apr 2021, she felt warm for a change. She could feel her eyes opening up and noticed her hands, shoulder, back and joints do not hurt. There are some joints in her hands that have scar tissue with a bump, her hands were no longer red or purple and swelling started to recede. Hands are no longer swollen or red. Out of all the different treatments, this has never happened. She still does not have redness or swelling. She is scheduled for her second vaccine on 01May2021. Caller stated she has not started any new medication 2 weeks prior to the vaccine or any after the vaccine. She is on palliative care and there are medications that she takes on daily basis. She has been on the same doses. Reports she revamped her own medications in the past because she felt like she was being overmedicated. She got rid of a bunch of junk last year and somethings she added back in at a much lower dose. No further details provided. Blood tests don't catch everything since she is genetically predisposed to giving false negatives. If she is in a flare up, the c reactive protein test, in the past, it always came in normal and now it is documented there is some sort of inflammation going on with that. Her CPK test is strange, it is a test for destruction of muscle tissue, 600 is considered high and she has scored as high as 3000. A lot of stuff going on and it is hard to separate when technology and research is not there yet. Her symptoms are treated as they emerge. The patient's facial sagging, sagging eyelids went away/neurological inflammation went away/pain went away. The patient experienced flushing, warmth/low grade fever on 10Apr2021, there is some sort of inflammation going on with that on an unspecified. CPK test was strange on an unspecified date. Outcome of flushing and warmth/low grade fever was resolved, and outcome of all other events was unknown. No follow up attempts are possible, no further information is expected.
91	1258979-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Male	On April 17th, approximately 2 weeks after receiving the second shot, I woke up to use the bathroom at which point I passed an extreme amount of blood from my rectum along with what appeared to be remnants of blood clots. I took myself to the hospital who confirmed that hemorrhaging and blood clots had formed behind the site of my old ostomy scar inside of my intestines. I had no other signs of ulcerative colitis when scoped and no active flare, only this clotting that arose specifically after this second vaccine dose.
92	1259588-1	COVID19 (COVID19 (PFIZER-BIONTECH))	18-29 years	Female	After getting the shot, I felt great and normal, not expecting to get side effects. Exactly a week after getting the shot, I woke up with a fever of 101.2. The night before, I was experiencing lower right back pain, thinking it was a pulled muscle, but the pain was still present in the morning and it was painful. The rest of the day I had chills, fatigue, fever, lower back pain, and no appetite. The next day I experienced the same things, plus headache. I was able to control my fever wit Mortin. The 3rd day I woke up with pain in intestine area as well in my back. I had realized that I had not pooped for several days and I feel that I might have been constipated. I was feeling better on that third day, with on and off fevers and fatigue. The 4th day I only experienced a fever and it went away throughout the day which was promising. 5th day I woke up feeling great and completely normal. So I experienced Flu like symptoms, plus back and muscles aches and constipation. I took 2 extra strength tylenol everyday along with 1 Motrin and sudafed Claritin D. I drank lots of water and hot teas. 4 days till i felt better.
93	1261484-1	COVID19 (COVID19 (MODERNA))	80+ years	Male	ruptured appendix; Cramps in his lower intestine; Shoulder started getting a little sore; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS PERFORATED (ruptured appendix) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SIMVASTATIN, ALLOPURINOL and TOPIRAMATE for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced ARTHRALGIA (Shoulder started getting a little sore). On 13-Jan-2021, the patient experienced GASTROINTESTINAL PAIN (Cramps in his lower intestine). On an unknown date, the patient experienced APPENDICITIS PERFORATED (ruptured appendix) (seriousness criterion hospitalization). At the time of the report, APPENDICITIS PERFORATED (ruptured appendix) had resolved and GASTROINTESTINAL PAIN (Cramps in his lower intestine) and ARTHRALGIA (Shoulder started getting a little sore) outcome was unknown. The patient took Tums antacids which helped for a little while and he took milk on 14-Jan-2021. For ruptured appendix, patient had surgery in the hospital. Although a temporal association exists, based on the current available information, the mechanism of action of mRNA-1237 vaccine and the pathophysiology of appendicitis, the event of appendicitis perforated is assessed as unlikely related. The event of gastrointestinal pain is in consistence with the symptoms of appendicitis perforated. The causality of the event of arthralgia is assessed as possibly related. Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: An event ruptured appendix was added with treatment information.; Sender's Comments: Although a temporal association exists, based on the current available information, the mechanism of action of mRNA-1237 vaccine and the pathophysiology of appendicitis, the event of appendicitis perforated is assessed as unlikely related. The event of gastrointestinal pain is in consistence with the symptoms of appendicitis perforated. The causality of the event of arthralgia is assessed as possibly related.
94	1261687-1	COVID19 (COVID19 (PFIZER-BIONTECH))	80+ years	Female	Was diagnosed with Covid/first dose of the vaccine on 23Feb2021, and she took a COVID test and received positive results on 20Mar2021; Was diagnosed with Covid/first dose of the vaccine on 23Feb2021, and she took a COVID test and received positive results on 20Mar2021; batch she received her dose from was bad; This is a spontaneous report from a Pfizer-sponsored program by contactable consumer. An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CLA266) via unspecified route of administration in arm, on 23Feb2021, as a single dose (at the age of 82-year-old) for COVID-19 immunisation. The patient medical history included high blood pressure (for 40 years well controlled with medication), large intestines are gone, whole family had Covid before she did (her daughter and her two teenage children that live with her had Covid) and Ileostomy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medication included amlodipine at a dose of 25 mg for high blood pressure. The patient had undergone COVID-19 test and resulted in positive on 20Mar2021. Patient was calling because she received a letter last week dated 16Mar2021, saying that she had contacted Pfizer, saying that her vaccine was not efficacious before she received her positive results. That makes the patient concerned that maybe the batch she received her dose from was bad. Patient stated she was supposed to get her second dose on 13Mar2021, but she did not go. The patient reported that she didn't have symptoms, at the time of her shot, and she moved out to prevent herself from getting it. Later on, 26th (as reported) she started to have symptoms. The patient was not sure if she could have the second dose according to the CDC (centers for disease control and prevention) she has to wait at least 90 days since she had COVID. The patient received Vitamin D as a treatment to Covid. The patient did not visit physician office and emergency room. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
95	1261821-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Unknown	unknown bleeding; nausea; lightheaded; GI bleed; cardiac arrest; bleed in small intestine; This is a spontaneous report from a contactable consumer (patient's daughter). A 70-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Right on 26Feb2021 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. Vaccine Administered at Military Facility was no. Patient received the first dose of vaccine on 05Feb2021 at age of 70 years old for covid-19 immunization and experienced rash on face, loss of blood found to be from small intestine, hemoglobin low, cardiac arrest, going into shock. The patient medical history and concomitant medications were not reported. The patient experienced unknown bleeding (death, hospitalization, medically significant) on 10Mar2021, nausea (hospitalization) in 2021 with outcome of unknown, lightheaded (hospitalization) in 2021 with outcome of unknown, gastrointestinal (GI) bleed (medically significant) in 2021 with outcome of unknown, cardiac arrest (medically significant) in 2021 with outcome of unknown, bleed in small intestine (medically significant) in 2021 with outcome of unknown. Patient went to the hospital on 10Mar2021 with nausea and lightheaded. Endoscopy found GI bleed in 2021. Received blood went into cardiac arrest. Sent to another hospital found bleed in small intestine. Patient experienced unknown bleeding on 10Mar2021, which required visit to Emergency room/ intensive care unit on 18Mar2021 and received treatment, it resulted in death. The patient died on 18Mar2021. An autopsy was not performed.; Reported Cause(s) of Death: unknown bleeding
96	1261984-1	COVID19 (COVID19 (MODERNA))	50-59 years	Male	VTE legs, large intestine, & lungs Narrative: Patient reports received his first COVID vaccine dose of Moderna on 2/17/21 and reports in the early morning of 2/23/21 he began feeling pain in his right side. Patient states he thought his appendix had burst and he went to get checked out. Patient states they ran test and could not determine what was wrong, so he was sent to hospital. Patient states they found clots in his legs, large intestine, and lungs. States he underwent surgery to remove the clot from his large intestine and he now on Eliquis. Patient states he was ""perfectly healthy"" before receiving the COVID vaccine. Active meds: Ibuprofen 800mg TID for pain, Lidocaine 5% patch; 1 patch daily for 12 hours, and Sodium fluoride 1.1% oral cream; apply to mouth 1-2 times daily when brushing teeth""
97	1263560-1	COVID19 (COVID19 (PFIZER-BIONTECH))	80+ years	Male	Per patient's Daughter the patient developed blood clots in his small intestine on 4/13/2021 and died 4/22/21 with physicians unable to explain how or why he developed these clots while on apixaban. She requested his case be reported and reviewed in hopes it helps make the vaccines safer if that was what caused the clots.
98	1265193-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Male	Right after the shot I had a weird taste in my mouth which laster for the entire day and would come back and forth over the next 10 days. 2 nights after the shot I woke up around 5am having pain around the kidney area on the left side. Slept on the other side and went ok. Next night same pain around 5am, this time I couldn?t sleep after. Then 3/4 days after the shot, pain in my groins and intestines. It feels really irritated and pain varies from 1 to 4.5 on a scale of 10 throughout the days. It?s been now 10 days since the shot and this pain is not getting away or improving. Sometimes I also experience pain in the left side of my stomach as well but it?s much less frequent than groins and intestines.
99	1266361-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Female	April 22, 2021 morning my auntie got her first dose of Pfizer vaccine. She happily shared here vaccine experience with family member and relative. April 23 morning, she told us she has severe abdominal pain, has the need to have a bowel movement, but she was defecated. She also told us that she vomit couple times already, then she has no more energy to talk. She got into the hospital and she was announced death right after midnight at 12:04 April 25th. Reason of death given is ""septic shock secondary to ischemic bowel & intra-abdominal sepsis"". But it is the blood clots issue that is causing it. I was told that after my auntie got into hospital the very next day after Pfizer vaccine, hospital later found out that my auntie has blood blockage issue that is causing blood couldn't flow to her intestines. The acid in her blood was very high, 6+. After more than 6 hours without blood to her intestines, her intestines tissues start dying and turned black color. Doctor found out about this at the night of April 23, 2021 nighttime. April 22, 2021 morning is the day my auntie got her Pfizer covid vaccine. There is a very high chances of the Pfizer vaccine is causing the blood clots that lead to blood blockages.""
100	1272193-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Male	initially began as what felt like jolts to my chest area from inside my chest over five days beginning on March 31, 21 @ 1:20am; next on April 01, 2021 @ 12:02am; then April 02, 2021 @1:02am; then April 03, 2021 @ 1:36am; and on April 04, 2021 @ 2:46am. I ended up in the emergency room the afternoon of Sunday March 04, 2021 with severe chest, abdominal, and intestinal pain. I followed up with doctors on April 05, 2021; April 09, 2021; and April 28, 2021 with continued painful symptoms described below. All they has done so far is 1) took a chest X-ray, 2) taken blood, and 3) referred me to a sleep laboratory. The X-ray and blood work came back negative per ER. Symptoms: 1. Inability to sleep. most nights feels as if I just drank five cups of coffee before bed. When I am able to fall asleep, pain and/or jolts coming from inside my trunk/core area wake me up within about an hour. 2. Constant pain coming from my chest, abdomen, and intestines. Intestinal and abdominal pain (gut wrenching, pain/burning sensation, cramps). At times feels like radiation or waves/currents are passing through my intestines/trunk. I wake up with intestines feeling sore. I also have discomfort when I eat or drink something the following morning. Also, my trunk/core area feels tight all day and night. I constantly feel a burning sensation in my chest and gut areas. The discomfort in my chest area (tightness, burning sensation) with occasional burst of pain the size of a nickel that comes from the left side of my chest and underneath my rib cage. 3. Limbs twitch/jerk on their own (both hands, both feet, neck, both shoulders, both legs, fingers) during the day and during the night. tingling sensations in legs. 4. ringing in the ears with headaches. 5. Woke up from sleep due to both nostrils getting clogged while I slept; woke up gasping for air. 6. Penis no longer has the same sensation and difficulty with erection.
101	1273903-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Male	Small intestines constricted mimicking pancreatitis / small partial bowel obstruction. Blood test ruled out pancreatitis. CT scan showed constriction/ causing obstruction. Morphine relaxed bowel and no more issues were there. They had engaged the on call surgeon, but he didn't examine till following day and he only put stethoscope to the chest in two places and released me/patient, suggesting no cause for pain other than vaccine. The on call doctor did a very thorough exam and talked to surgeon before he saw me/patient. There are no lasting effects. The small bowel didn't even hurt when examined the following morning.
102	1279949-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Male	5 days after the first shot-severe gastric pain (which went away after 1 hour) and then chills for 5 days & fever & weakness-- ater 5 days, I was 100% ok--- Exactly 5 days after teh 2nd dose, the same gastric pain arose in same spot--lower intestines--followed by onset of intestinal colitis & severe rectal wall inflammation-- I have no previous history of either--
103	1280295-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	1st dose pain in right side near small intestine 4 days after vaccine, doctor did blood work, ct scan 2nd dose sharp pain in left lower back morning after, chills same day as vaccine - ER gave muscle relaxers, did blood work, urine test taking advil have continued warm/inflammatory feeling in abdomen 4 days after 2nd shot
104	1281989-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Female	Within a few hours I experienced severe stomach cramping. The cramping has turned into chronic gut pain, possibly ovarian/uterus. Its become uncomfortable for me to even walk, which is surprising because I'm very active and fit. I can press into my lower right gut and feel isolated pain, like the vaccine put a hole in my intestines. It doesn't hurt to digest food, but when my bowel is activated I feel jolts of pain in the localized spot.
105	1285881-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Female	This are sysmptoms that I feel after the vaccine and that continued and worsened but there is no way for me to assert that this is due to the vaccine, I can say that nothing else changed in my day to day other than getting the vaccine,and I am reporting in case other people had the same reactions. I had brain cramps, my right leg got swollen and I have been on and off feeling pressure on the inside part of that knee, nausea, shortness of breath, and after six days of these I got very strong diarrhea and taquichardia that would not go away after 12 hours. So I ended up going to the emergency room. The overall diahrrea lasted for 10 days, and after eating a bland diet for two weeks I am finally seeing the cramps in my intestine go away. Three weeks after the vaccine I finally started to feel normal again.
106	1286627-1	COVID19 (COVID19 (PFIZER-BIONTECH))	80+ years	Female	Severe diarrhea for three days, Extreme swelling of stomach. Extreme abdominal pain. Additional swollen area on left side of intestines. Shingles like pain in abdominal skin and flesh.
107	1288440-1	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	Female	she has been diagnosed with a GI infection and is currently experiencing bloody stools.; she has been diagnosed with a GI infection and is currently experiencing bloody stools.; she got sick; I have been having joint pain ever since I got the first dose and don't feel like maybe should take it today.; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program and also via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration, on 31Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she had her first dose of Pfizer Covid-19 vaccine on 31Mar2021 and was scheduled to take her second dose on 26Apr2021. On an unspecified date in 2021, she got sick and was admitted at the ER and was told that she has an inflammation and infection in her intestine/colon. She was diagnosed with GI infection and experiencing bloody stools at the time of the report. She also reported that she was having joint pain ever since she got the first dose and did not feel like taking the vaccine. The outcome of the events was unknown. Information about Lot/Batch number has been requested.
108	1289206-1	COVID19 (COVID19 (UNKNOWN))	65-79 years	Male	Massive gi bleed with perforation of intestines and pneumoperitoneum.
109	1292279-1	COVID19 (COVID19 (PFIZER-BIONTECH))	18-29 years	Female	My muscles were extremely sore over the course of one to two weeks. Every day a new muscle group was very sore. It started at my shoulders then worked down my body with a new muscle group every days even my knee ankle and wrist joints were sore. My upper back muscles remained sore for the full two weeks. Also, my abdominal region and intestines were affected. I had intense constipation, which relates to the muscle tension felt throughout the week. the constipation has been going on for a few weeks now even to the second dose.
110	1293936-1	COVID19 (COVID19 (MODERNA))	60-64 years	Female	On the 2nd night after receiving the 1st shot of Moderna vaccine, I experienced intense abdominal pain. It was like if someone was pulling and twisting my intestines. The pain was acute for about 1hr, then it started fading with renewed but shorter periods of more intense pain. I thought of peritonitis, and if the pain didn't subside I might have called an ambulance. I just decided to lay low and let the pain pass. It was scary. The next day on May 3rd, I awoke with rush over my upper body,. Little bubbles was dispersed across my abdomen, shoulders, sides but were few and not dense, so I let it pass. Currently the rush is still on, thankfully don't have the abdominal pain any longer. However, I am not sure that I shall get the 2nd Moderna shot. I won't survive the intestines twisting pain if increased.
111	1294830-1	COVID19 (COVID19 (MODERNA))	50-59 years	Male	colon stenosis; unspecified disorder of intestine; dry skin; Laceration; Wound healing delayed; bruise; nightmares; general body pain; Muscle ache; fatigue; fever; chills; This spontaneous case was reported by a non-health professional and describes the occurrence of LARGE INTESTINAL STENOSIS (colon stenosis) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for an unknown indication. The patient's past medical history included Stomach pain, Diarrhea (two to three formed stools per day), Constipation and Surgery (Surgery to remove affected portions of his intestines.) in 1991. On 23-Jun-2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 mg. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LARGE INTESTINAL STENOSIS (colon stenosis) (seriousness criterion medically significant), GASTROINTESTINAL DISORDER (unspecified disorder of intestine), DRY SKIN (dry skin), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed), CONTUSION (bruise), NIGHTMARE (nightmares), PAIN (general body pain), MYALGIA (Muscle ache), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). At the time of the report, LARGE INTESTINAL STENOSIS (colon stenosis), GASTROINTESTINAL DISORDER (unspecified disorder of intestine), DRY SKIN (dry skin), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed), CONTUSION (bruise), NIGHTMARE (nightmares), PAIN (general body pain), MYALGIA (Muscle ache), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) outcome was unknown. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. Company comment: Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
113	1296019-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	Sore Arm within about 2 hours. Chills; temperature spiked at 101, then settled to 100 degrees for several hours starting abut 1:30 PM on the first day until about 20 hours later (from 1:30 PM) gradually went down to 99 degrees and then by the third early morning it was back to the normal 98.x range. During this same time period, feverish, body aches in arms, neck, face, and teeth (not the legs), really bad headache, discomfit in intestines and for about a 2 hour period I felt like I had heartburn. Early morning on the third day at about 2-6 AM, I was now sweating but all other symptoms had abated.
114	1298905-1	COVID19 (COVID19 (MODERNA))	50-59 years	Male	Colon stenosis; Unspecified disorder of intestine; Post-procedural pain; Surgical scar; Laceration; Wound healing delayed; Bruise; Nighmare; Chills; Muscle aches; Fever; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LARGE INTESTINAL STENOSIS (Colon stenosis) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced LARGE INTESTINAL STENOSIS (Colon stenosis) (seriousness criterion medically significant), GASTROINTESTINAL DISORDER (Unspecified disorder of intestine), PROCEDURAL PAIN (Post-procedural pain), SCAR (Surgical scar), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed), CONTUSION (Bruise), NIGHTMARE (Nighmare), CHILLS (Chills), MYALGIA (Muscle aches), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, LARGE INTESTINAL STENOSIS (Colon stenosis), GASTROINTESTINAL DISORDER (Unspecified disorder of intestine), PROCEDURAL PAIN (Post-procedural pain), SCAR (Surgical scar), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed) and CONTUSION (Bruise) had not resolved and NIGHTMARE (Nighmare), CHILLS (Chills), MYALGIA (Muscle aches), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medicines were reported. No treatment information were reported. Action taken with the drug in response to events was not applicable. Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of fatigue, chills, pyrexia, and myalgia. This case was linked to (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of fatigue, chills, pyrexia, and myalgia.
116	1301111-1	COVID19 (COVID19 (PFIZER-BIONTECH))	18-29 years	Male	Diarrhea, blood in stool, grabbing at groin area (patient is nonverbal). Increased ulcerative colitis meds, had stool tested and the result was severe inflammation of the intestines. Patient is on steroid currently for this condition.
117	1302601-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Female	o ED Course Medical decision making arrival to ED 5:54 am on 5/10/21 Patient with altered mental status from an unknown cause. Her pupils were dilated and slow to react and she was in some respiratory distress and very diaphoretic. At this point airway was controlled 5 oh endotracheal intubation using the glide scope and during the intubation patient was noted for copious amounts of dark brown vomitus coming from her esophagus which was guaiac positive. Her blood pressure was low she was sedated initially with propofol etomidate was used for the intubation however because of her hypotension the propofol was slowed and she was given Versed which did seem to control her agitation and maintain her blood pressure. Patient had IV fluid initiated wide open and CT scan was obtained of head chest abdomen pelvis given the fact that her altered mental status could be from some kind of intracerebral catastrophe and the patient's abdominal exam being unobtainable certainly possible that her GI bleeding could be from a perforated viscus. CT scan of the brain does not demonstrate any stroke that appears to be acute however there may be some ischemia present although it may be remote and an MRI will need to be done when the patient is more stable. CT of the chest abdomen pelvis shows what is likely an aspiration pneumonia on the right as well as a perforated viscus in her abdomen. Radiology feels is probably somewhere in the right colon terminal ileum. At this point the patient was given Cipro and Flagyl and that should also aid with her aspiration pneumonia. Her blood pressure did start to decrease her temperature was noted to be elevated at 101.8. She was given Tylenol rectally and fluids were allowed to run wide open. Her blood pressure continued to decline and Levophed was instituted. Case was discussed in detail with surgery and she will go to the OR immediately. Her temperature continued to rise and was 104.5 upon transfer to the operating room as blood pressure was 78 systolic ED COURSE: o ED Course Medical decision making Patient with altered mental status from an unknown cause. Her pupils were dilated and slow to react and she was in some respiratory distress and very diaphoretic. At this point airway was controlled 5 oh endotracheal intubation using the glide scope and during the intubation patient was noted for copious amounts of dark brown vomitus coming from her esophagus which was guaiac positive. Her blood pressure was low she was sedated initially with propofol etomidate was used for the intubation however because of her hypotension the propofol was slowed and she was given Versed which did seem to control her agitation and maintain her blood pressure. Patient had IV fluid initiated wide open and CT scan was obtained of head chest abdomen pelvis given the fact that her altered mental status could be from some kind of intracerebral catastrophe and the patient's abdominal exam being unobtainable certainly possible that her GI bleeding could be from a perforated viscus. CT scan of the brain does not demonstrate any stroke that appears to be acute however there may be some ischemia present although it may be remote and an MRI will need to be done when the patient is more stable. CT of the chest abdomen pelvis shows what is likely an aspiration pneumonia on the right as well as a perforated viscus in her abdomen. Radiology feels is probably somewhere in the right colon terminal ileum. At this point the patient was given Cipro and Flagyl and that should also aid with her aspiration pneumonia. Her blood pressure did start to decrease her temperature was noted to be elevated at 101.8. She was given Tylenol rectally and fluids were allowed to run wide open. Her blood pressure continued to decline and Levophed was instituted. Case was discussed in detail with surgery and she will go to the OR immediately. Her temperature continued to rise and was 104.5 upon transfer to the operating room as blood pressure was 78 systolic CRITICAL CARE: o Critical Care Indication patient was critically ill... o Critical Care Indication Patient was critically ill with a high probability of imminent or life threatening deterioration. o Critical Care Time Spent 75-104 minutes (1 hour 15 minutes-1 hour 44 minutes) 2 hours and 50 minutes ED WORKING DIAGNOSIS: Perforated abdominal viscus (R19.8): Status: Active Septic shock (A41.9): Status: Active DISCHARGE/ADMISSION/TRANSFER DISPOSITION: o Disposition admitted o Admit To To OR CONDITION ON DISCHARGE/ADMISSION/TRANSFER: o Condition Critical Date of OR Procedure o Date of Procedure 05/10/2021 10:01 Pre Op Dx, Post Op Dx, Procedure o Pre Operative Diagnosis: Perforated viscus o Post Operative Diagnosis: Ischemic bowel, most likely from shower emboli. Most of the small intestine and large intestine was affected. o Procedure: Exploratory laparotomy, ICG injection for evaluation of perfusion Indication and Consent Findings: . Findings: Even after the ICG injection. There was spotty tissue necrosis from mid jejunum all the way through sigmoid colon. Most areas were blackened with a foul smell. There was some highlighted areas secondary to the ICG but not a significant amount that would lend for an anastomosis. Black ascites was present throughout the abdomen. Unfortunately after much contemplation there was no surgical intervention. Procedure Procedure: Patient was placed in supine position. Was intubated in the emergency room so, we were able to proceed with resuscitation through our anesthesia team. Patient's abdomen was prepped and draped in usual fashion. Proceeded to make a midline incision. The blood supply in the subcutaneous tissues did not even bleed. Appeared to be darkened and almost coagulated. As we entered through the fascia we were able to open the peritoneum between 2 hemostats. The large rush of free air through from the abdomen. We then proceeded to open the abdomen for the length of her incision. This was done with electrocautery. From here there was a black ascites present within the abdomen. There was a large amount of dead intestine that we could immediately see. I worked my way to the ligament of Treitz. There was no adhesions so this was easily found. That intestine did appear to be pink. It lasted for about a foot. After that area everything was either black or purple in color with a few pink spots in between. This went all the way down to the terminal ileum where pneumatosis was visualized. We then looked at the colon from cecum through rectum. It appeared to be blackened as well. Not knowing whether all of this intestine was dead or not especially with patient being hypotensive I injected ICG dye approximately 2 cc. This was to evaluate perfusion. Unfortunately perfusion was no better than what I could visualize. I could not even find enough room of the colon or small intestine to make an anastomosis. Was very hard decision, however, we did not resect any bowel. I closed the patient's abdomen. Patient will be taken to ICU on ventilator. Discussed with daughter with pastor present.
118	1305152-1	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	Female	Loss of appetite; Now experiencing digestive issues; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the past Monday midmorning (05Apr2021) at single dose for COVID-19 immunization. The patient's medical history included that part of her intestine removed two and a half years ago. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. It was reported that, the patient was currently (Apr2021) experiencing digestive issues and a loss of appetite. The patient asked whether digestive issues had been seen as side effects and that how long the side effects usually last, whether up to second dose. The patient further enquired if she could take her probiotics. The outcome of the events was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
119	1310981-1	COVID19 (COVID19 (MODERNA))	50-59 years	Female	Event at time of dose: vasovagal syncope, left/right hands/arms paralysis, mid and lower stomach/intestines start of paralysis; treatment: 50 m Benadryl shot, visit to ER; event approximately 2 weeks after dose: both calves tingling, left leg tingling/pain, left forearm tingling, left pinky and ring finger numbness; treatment: doctor visit, MRI, heart EKG, stress test, echocardiogram.
120	1312860-1	COVID19 (COVID19 (MODERNA))	30-39 years	Female	thought she was suffering from a stroke; anemia; double vertigo; blood clots, thick blood; dissociated; liver spazzed; slurring words; could not speak; possible underlying autoimmune disorder where genetic composition may have triggered this; malabsorption; looked very pale; heart disease; blood pressure was elevated, blood pressure was 190/130, uncontrolled and unspecified hypertension; severe vasculitis on the right side of brain; Thyroid calcification/thyroid had a lot of calcium build up; interstitial markings on lungs/doctor stated looked like COVID lungs; hands were so swollen that could not clench it; face was swollen; electrical shooting pain from the right brain stem of the neck; vision was blurry; stuttering; paranoid; confused; not able to recognize her daughter; hands were very stiff; stomach was bloated/looked 6 months pregnant; lethargic; bile dumps which then leads to inflammation of her intestines; clots the size of golf balls/soaked through a 24 count box of super tampons in 24 hours/period was very bright red; stomach was inflamed; period started 10 days early, which is completely abnormal for her menstrual cycle; severe ovarian pain that was up very high; could feel her hormones whooshing through her veins/foggy head/feeling funky/ felt stoned/ daydream dazes; irritable; migraine; stabbing pain; kidney pain; period pain; lightheaded; pimple in the back of her head; headache; chills; fatigue, tired; fever of 102.6F/fever which lasted another 12 hours; nausea; body aches, muscles started to ache; diarrhea; significant abdominal pain from the cramping due to heaving from the nausea; cramping/lot of cramping in the groin and thigh area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (thought she was suffering from a stroke), HYPERTENSION (blood pressure was elevated, blood pressure was 190/130, uncontrolled and unspecified hypertension), CENTRAL NERVOUS SYSTEM VASCULITIS (severe vasculitis on the right side of brain), AUTOIMMUNE DISORDER (possible underlying autoimmune disorder where genetic composition may have triggered this), THROMBOSIS (blood clots, thick blood) and INTERSTITIAL LUNG DISEASE (interstitial markings on lungs/doctor stated looked like COVID lungs) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Gallbladder removal. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced MUSCLE SPASMS (cramping/lot of cramping in the groin and thigh area), ABDOMINAL PAIN (significant abdominal pain from the cramping due to heaving from the nausea), DIARRHOEA (diarrhea), PYREXIA (fever of 102.6F/fever which lasted another 12 hours), NAUSEA (nausea), MYALGIA (body aches, muscles started to ache), CHILLS (chills) and FATIGUE (fatigue, tired). On 10-Apr-2021, the patient experienced HEADACHE (headache). On 12-Apr-2021, the patient experienced ACNE (pimple in the back of her head). On 13-Apr-2021, the patient experienced MENSTRUAL DISORDER (period started 10 days early, which is completely abnormal for her menstrual cycle), ADNEXA UTERI PAIN (severe ovarian pain that was up very high), FEELING ABNORMAL (could feel her hormones whooshing through her veins/foggy head/feeling funky/ felt stoned/ daydream dazes), IRRITABILITY (irritable), MIGRAINE (migraine), PAIN (stabbing pain), RENAL PAIN (kidney pain), DYSMENORRHOEA (period pain), DIZZINESS (lightheaded), GASTRITIS (stomach was inflamed), GASTROINTESTINAL INFLAMMATION (bile dumps which then leads to inflammation of her intestines) and HEAVY MENSTRUAL BLEEDING (clots the size of golf balls/soaked through a 24 count box of super tampons in 24 hours/period was very bright red). On 14-Apr-2021, the patient experienced LETHARGY (lethargic). On 15-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (hands were very stiff), ABDOMINAL DISTENSION (stomach was bloated/looked 6 months pregnant), PERIPHERAL SWELLING (hands were so swollen that could not clench it), SWELLING FACE (face was swollen), NECK PAIN (electrical shooting pain from the right brain stem of the neck), VISION BLURRED (vision was blurry), DYSPHEMIA (stuttering), PARANOIA (paranoid), CONFUSIONAL STATE (confused) and MEMORY IMPAIRMENT (not able to recognize her daughter). On 16-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (thought she was suffering from a stroke) (seriousness criterion hospitalization), HYPERTENSION (blood pressure was elevated, blood pressure was 190/130, uncontrolled and unspecified hypertension) (seriousness criterion hospitalization prolonged), CENTRAL NERVOUS SYSTEM VASCULITIS (severe vasculitis on the right side of brain) (seriousness criterion medically significant), INTERSTITIAL LUNG DISEASE (interstitial markings on lungs/doctor stated looked like COVID lungs) (seriousness criterion medically significant), PALLOR (looked very pale), CARDIAC DISORDER (heart disease) and THYROID CALCIFICATION (Thyroid calcification/thyroid had a lot of calcium build up). On 19-Apr-2021, the patient experienced AUTOIMMUNE DISORDER (possible underlying autoimmune disorder where genetic composition may have triggered this) (seriousness criterion medically significant) and MALABSORPTION (malabsorption). On an unknown date, the patient experienced THROMBOSIS (blood clots, thick blood) (seriousness criteria disability and medically significant), ANAEMIA (anemia), VERTIGO (double vertigo), DISSOCIATION (dissociated), LIVER DISORDER (liver spazzed), DYSARTHRIA (slurring words) and APHASIA (could not speak). The patient was hospitalized from 16-Apr-2021 to 17-Apr-2021 due to CEREBROVASCULAR ACCIDENT and HYPERTENSION. On 10-Apr-2021, PYREXIA (fever of 102.6F/fever which lasted another 12 hours) and CHILLS (chills) had resolved. On 12-Apr-2021, MUSCLE SPASMS (cramping/lot of cramping in the groin and thigh area), MYALGIA (body aches, muscles started to ache) and FATIGUE (fatigue, tired) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (thought she was suffering from a stroke), CENTRAL NERVOUS SYSTEM VASCULITIS (severe vasculitis on the right side of brain), AUTOIMMUNE DISORDER (possible underlying autoimmune disorder where genetic composition may have triggered this), THROMBOSIS (blood clots, thick blood), INTERSTITIAL LUNG DISEASE (interstitial markings on lungs/doctor stated looked like COVID lungs), IRRITABILITY (irritable), PAIN (stabbing pain), DIZZINESS (lightheaded), MUSCULOSKELETAL STIFFNESS (hands were very stiff), ABDOMINAL DISTENSION (stomach was bloated/looked 6 months pregnant), GASTRITIS (stomach was inflamed), PERIPHERAL SWELLING (hands were so swollen that could not clench it), SWELLING FACE (face was swollen), NECK PAIN (electrical shooting pain from the right brain stem of the neck), VISION BLURRED (vision was blurry), DYSPHEMIA (stuttering), PARANOIA (paranoid), CONFUSIONAL STATE (confused), MEMORY IMPAIRMENT (not able to recognize her daughter), PALLOR (looked very pale), CARDIAC DISORDER (heart disease), MALABSORPTION (malabsorption), ANAEMIA (anemia), VERTIGO (double vertigo), THYROID CALCIFICATION (Thyroid calcification/thyroid had a lot of calcium build up), GASTROINTESTINAL INFLAMMATION (bile dumps which then leads to inflammation of her intestines), LETHARGY (lethargic), ACNE (pimple in the back of her head), DIARRHOEA (diarrhea), DISSOCIATION (dissociated), LIVER DISORDER (liver spazzed), DYSARTHRIA (slurring words), APHASIA (could not speak), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown, HYPERTENSION (blood pressure was elevated, blood pressure was 190/130, uncontrolled and unspecified hypertension) and FEELING ABNORMAL (could feel her hormones whooshing through her veins/foggy head/feeling funky/ felt stoned/ daydream dazes) had not resolved, MENSTRUAL DISORDER (period started 10 days early, which is completely abnormal for her menstrual cycle), ADNEXA UTERI PAIN (severe ovarian pain that was up very high), RENAL PAIN (kidney pain), DYSMENORRHOEA (period pain), HEAVY MENSTRUAL BLEEDING (clots the size of golf balls/soaked through a 24 count box of super tampons in 24 hours/period was very bright red) and ABDOMINAL PAIN (significant abdominal pain from the cramping due to heaving from the nausea) had resolved and MIGRAINE (migraine) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 102.6 (High) fever of 102.6F. In April 2021, Neurological examination: abnormal (abnormal) neurological damage to the hippocampus of the central cranial. On 16-Apr-2021, Blood pressure measurement: 190/130 (abnormal) 190/130 and 175/99 (abnormal) 175/99 after treatment with Metoprolol. On 16-Apr-2021, Chest X-ray: interstitial markings of her lungs (abnormal) interstitial markings of her lungs. On 16-Apr-2021, Computerised tomogram: interstitial markings of her lungs (abnormal) interstitial markings of her lungs. On 16-Apr-2021, Magnetic resonance imaging: severe vasculitis on the right side of her brain (abnormal) severe vasculitis on the right side of her brain. On 16-Apr-2021, Neurological examination: 3/5 tests failed (abnormal) 3/5 tests failed. On 19-Apr-2021, Stool analysis: abnormal (abnormal) showed she was putting out too much potassium, magnesium. On 28-Apr-2021, Blood pressure measurement: 145/90 (abnormal) 145/90. On 28-Apr-2021, Heart rate: 90 (High) was not coming under 90 bpm. On 28-Apr-2021, Magnetic resonance imaging: blood clots, thick blood, anemia (abnormal) blood clots, thick blood, anemia. Action taken with mRNA-1273 in response to the events was not Applicable. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-095842 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
121	1312870-1	COVID19 (COVID19 (MODERNA))	65-79 years	Male	appendix burst; bowel leak where the appendix attaches to the bowel; fighting an infection after getting his Appendix out; about 65 days from first vaccine dose; This spontaneous case was reported by a patient and describes the occurrence of APPENDICITIS PERFORATED (appendix burst) and LARGE INTESTINE PERFORATION (bowel leak where the appendix attaches to the bowel) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced APPENDICITIS PERFORATED (appendix burst) (seriousness criterion hospitalization). On 06-Apr-2021, the patient experienced OFF LABEL USE (about 65 days from first vaccine dose). On an unknown date, the patient experienced LARGE INTESTINE PERFORATION (bowel leak where the appendix attaches to the bowel) (seriousness criterion hospitalization) and POST PROCEDURAL INFECTION (fighting an infection after getting his Appendix out). The patient was hospitalized for 14 days due to APPENDICITIS PERFORATED. The patient was treated with Surgery (appendix removed) for Appendicitis perforated. On 26-Feb-2021, APPENDICITIS PERFORATED (appendix burst) had resolved. On 06-Apr-2021, OFF LABEL USE (about 65 days from first vaccine dose) had resolved. At the time of the report, LARGE INTESTINE PERFORATION (bowel leak where the appendix attaches to the bowel) and POST PROCEDURAL INFECTION (fighting an infection after getting his Appendix out) outcome was unknown. Not Provided mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date. Concomitant product use was not provided by the reporter. Treatment medication included antibiotics for 3 weeks. The patient was on total parenteral nutrition until last Saturday (understood as 01-May-2021). Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship in unlikely. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: additional events reported (fighting an infection after getting his Appendix out, about 65 days from first vaccine dose); Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship in unlikely.
122	1312884-1	COVID19 (COVID19 (MODERNA))	Unknown	Female	Osteoarthritis aggravated; Recurred Intestinal tubing; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of UNEVALUABLE EVENT (Recurred Intestinal tubing) and OSTEOARTHRITIS (Osteoarthritis aggravated) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Crohn's disease. Relevant history includes alcohol abstinence and non tobacco user. Osteoarthritis aggravated started at an unknown date in March 2020 and stopped at an unknown in 2020. The patient's past medical history included Gastric bypass in 2004 and Knee replacement in June 2020. Concurrent medical conditions included Osteoarthritis since 2019 and Gastrointestinal tube insertion since February 2020. In March 2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 milligram every two weeks. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced UNEVALUABLE EVENT (Recurred Intestinal tubing) (seriousness criterion hospitalization). On an unknown date, the patient experienced OSTEOARTHRITIS (Osteoarthritis aggravated) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to UNEVALUABLE EVENT. In March 2021, UNEVALUABLE EVENT (Recurred Intestinal tubing) had resolved. At the time of the report, OSTEOARTHRITIS (Osteoarthritis aggravated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Computerised tomogram: recurred intestinal tubing (abnormal) Recurred intestinal tubing. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was hospitalized for two days due to recurred intestinal tubing. She had a laparoscopic procedure to visualized the intestine and it there was no cramping or tumor that was found and the intestine was clear. She was told that it was resolved by itself and no additional treatment or procedure was needed at that time. She was scheduled for an Esophagogastroduodenoscopy to determine the cause of recurred intestinal tubing. The alternative etiology for the event Recurred Intestinal Tubing was reported as could be due to previous gastric bypass surgery. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
125	1320961-1	COVID19 (COVID19 (JANSSEN))	65-79 years	Female	Extreme pain in stomach with continued diarrhea 4/15/21-5/1/21. Visited Dr. 4/26/21 who ordered CT scan. Visited DR. 4/28/21. Dr. admitted me to Hospitalon 4/28/21. Dr. performed Colonoscopy with Biopsy and Endoscopy on4/30/21. Diagnosis with Enteritis inflammation of the small intestine.
127	1326532-1	COVID19 (COVID19 (MODERNA))	50-59 years	Female	I threw up within an hour of the first dose of the vaccine. Three days after the vaccine I had extremely swollen Lymph nodes I have been suffering from severe fatigue and low white blood cell counts. My RBC and WBC count was dropping within one week after the vaccine. My Platelet count was also dropping. My intestines were inflamed, and I have suspected Endometriosis. I now have Hypokalemia as well. I have never had that before. I was in the ER twice in March with low Potassium even though I was taking some Potassium. I later had severe abdominal pain and I had inflamed intestines which were confirmed during an ER visit, I have muscle and joint aches and I have been diagnosed with Osteoporosis since getting the vaccine. I have tried multiple medications to control my hypertension and nothing has worked yet. I feel awful and extremely fatigued after five months and I am dealing with all the new conditions that have been diagnosed since receiving the first dose of the vaccine. I have not been able to work since January. My blood work is still at threshold after five months. My intestines are inflamed and sometimes distended. I have seen Neurologists, Oncologist, Endocrinologist, Sleep Disorder Neurologist, Nephrologist, Gynecologist, Cardiologist, Gastroenterologist.
128	1329588-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Female	it felt like she was going to die/not feeling great; blood pressure is high, diastolic blood pressure was up to 161; This is spontaneous report from contactable consumer (patient). This 49-year-old female patient received the second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 23Apr2021 11:00 (Batch/Lot Number: ER8731) as single dose for Covid-19 vaccine. Medical history included problems with intestines 8 years before, high blood pressure in 2008 or 2009 with diastolic blood pressure usually goes no higher than 109, acid reflux in 2002 or 2003, all ongoing, 13 surgeries including one for a brain aneurysm. Concomitant medications included amlodipine for blood pressure measurement from an unspecified start date to 27Apr2021; hyoscyamine for problems with intestines and ongoing; ondansetron hydrochloride (ZOFRAN) for stomach and ongoing; esomeprazole sodium (NEXIUM) for acid reflux and ongoing. She had no side effects from the first dose of the Pfizer Covid-19 vaccine Injection on 02Apr2021 (Lot Number EP7533) on Right arm for Covid-19 vaccine. She ended up having a pretty bad reaction to the Covid-19 vaccine. The following day after receiving the Covid-19 vaccine, on 24Apr2021, she started not feeling great. Her blood pressure was high, but the lower number usually doesn't go higher than 109. The patient reported that her diastolic blood pressure was up to 161 on 24Apr2021. Pfizer Covid-19 vaccine made her blood pressure go through the roof on 24Apr2021 where they were afraid that she was going to have a stroke or heart attack. The patient was in hospital for blood pressure was through the roof from 26Apr2021 to 27Apr2021. Her blood pressure going through the roof made her felt like she was going to die. She was on amlodipine 2.5 mg and because her blood pressure got so high they adjusted it to 10 mg. Her physician prescribed her Lisinopril 40 mg once daily. Her physician called in the lisinopril 40 mg to the pharmacy when increased patient's dosage of amlodipine from 2.5 mg to 10 mg. Her physician informed her that the Amlodipine takes a week to be effective. She was given lisinopril in the emergency room and that lisinopril is faster acting to lower blood pressure. The patient was now taking both Amlodipine 10 mg and Lisinopril 40 mg once daily in the morning and knock on wood she's been doing fine. Lisinopril did not lower her blood pressure and she had to go back to the emergency room. She ended up having to get beta blockers, meclizine, and lorazepam. All 3 of the medications work together to keep her blood pressure down. Her physician informed her that she should have already gone to the hospital and prescribed an additional high blood pressure medication. The patient reported that the new blood pressure medication didn't work so she went to the emergency room on 26Apr2021. Her blood pressure returned to normal on 07May2021 or 08May2021. Blood pressure spiked on 24Apr2021 and she felt like she was going to die required a visit to emergency room. The patient reported that she went to the emergency room three times. She went to the emergency room on 26Apr2021 and was kept overnight until 27Apr2021. She had to go back to the emergency room on 27Apr2021, after she was discharged. The patient also reported that she went to the emergency room the third time on 28Apr2021. The emergency room staff performed brain tests, X-rays, CT scans, MRIs in Apr2021, and couldn't find any reason for the patient's blood pressure to be elevated. The physicians at the emergency room were assuming that the Pfizer Covid-19 vaccine is what caused the caller's elevated blood pressure because that was the only thing that was different. They performed tons of blood work in Apr2021 while she was in the emergency room and it all came back normal. CT scan abdomen, brain, and chest without contrast on 26Apr2021 and on 27Apr2021, X-ray on 26Apr2021 are all normal. The outcome of blood pressure is high was recovered in May2021. The outcome of other event was unknown
129	1330709-1	COVID19 (COVID19 (JANSSEN))	30-39 years	Male	After my vaccine I experienced sweats, fever body aches and had stomach pain for three days. I had arm pain for about three weeks as well. On Monday afternoon, I still had stomach pains, fever and leg cramps. I went to see my doctor and he performed exams on me and was told I had swelling of my intestine. My digestive tract has been profusely slow since receiving the J&J vaccine. They also ran some tests to check if I had any blood clots. I still experiencing full digestive tract issues and slowness.
130	1332715-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Female	entire intestines hurt her; back pain/sharp pain in the lower back; Back pain felt like nerve inflammation like sciatica; Back pain felt like nerve inflammation like sciatica; sore pain in the spine area/pain can change from day to day; it can be on both sides of spine, or tailbone; right side neck pain (felt like a pulled muscle); sharp shoulder blade pain/shooting pain in the hips when she walks; right ear, it felt swollen; hearing was muted- approximately 20% hearing loss, could not hear clear sounds/partial hearing loss/ dulled, similar to wearing a thick hat/transferred to her other ear; Feeling like a pressure on her ear; little pinkish rash/pinkish marbled rash; felt woozy; felt a little drunk or funny; felt a little drunk or funny; She currently has these symptoms, limited movement; difficulty walking, can't walk fast; felt like body could not hold her weight anymore; She can't bend over without pain and is unable to get things on the bottom of the refrigerator or pots in the kitchen; jerking muscle in the left thigh and right thigh; felt a heaviness on her face, felt like a heavy mask on it even when the mask was removed; Pain is a stabbing pain very painful and then the stabbing pains come and go and feels like a pulling pain, like a nerve pain; numbness in buttocks and central part of buttocks like tingling pins and pricks; numbness in buttocks and central part of buttocks like tingling pins and pricks/tingling sensation in both hands and both feet; pain in buttocks; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 25Apr2021 at 16:15 (at the age of 35 years old) (Lot Number: EW0176, unknown expiration) as 1st dose, single for COVID-19 immunization. Medical history included ongoing penicilline allergy since at the age of 17 years old (manifested by breathing issues, tightness in neck, all swollen up) and currently the patient does not have a thyroid. Concomitant medications included levothyroxine sodium (SYNTHROID) and liothyronine sodium (CYTOMEL), both ongoing as the patient does not have a thyroid. The patient previously took codeine and experienced allergy (at the age of 17 years old). A few minutes after receiving the vaccine on 25Apr2021, the patient experienced right side neck pain (felt like a pulled muscle) and sharp shoulder blade pain. She got the vaccine in her right arm but had no arm pain. Then in her right ear, it felt swollen and her hearing was muted- approximately 20% hearing loss, could not hear clear sounds. Feeling like a pressure on her ear with partial hearing loss. It was dulled, similar to wearing a thick hat. Then it transferred to her other ear. Her face was feeling swollen, but it was not swollen, and she had a little pinkish rash but just under her mask. She didn't have any breathing problems. She asked the (name) staff member if these symptoms were normal. Patient was sitting in the waiting area of (name) pharmacy after administered the COVID-19 vaccine; all of these symptoms started happening around 3-4 minutes after receiving the vaccine. She would say within first 15 minutes after the COVID-19 vaccine was administered, it affected her other ear, where both ears had the muted hearing sensation which lasted about 2 hours. These side effects lasted about 1-2 hours and resolved on their own, no ointments were used. About 15 minutes after receiving the vaccine, she started having back pain, felt woozy, and felt a little drunk or funny. About 45 minutes later, she had sharp pain in the lower back, shooting pain in the hips when she walks. She currently has these symptoms, limited movement, difficulty walking, can't walk fast. After that, she was in bed all day and could barely make it to the bathroom. She previously was very healthy and regularly took long walks. Her back and hips feel sore. Back pain felt like nerve inflammation like sciatica where she got sharp pain in her lower back that felt like immediate inflammation. She got to the point where she was not able to sit straight, felt like body could not hold her weight anymore. She can't bend over without pain and is unable to get things on the bottom of the refrigerator or pots in the kitchen. She is unable to wash her hands together, she felt like her back can't support her weight. She had to wash one hand at a time. She is unable to get out of bed regularly, she has to roll out of bed. It has been 9 days from the vaccine and is still having shooting pains in her hips and jerking muscle in the left thigh and right thigh and it felt like nerves pulling string in the right leg which lasted only like 30-45 seconds. Before she went to the (name) pharmacy for the COVID-19 vaccine, she had never had any sorts of back issues, no strain, no health problems in that area. She told her husband she was going to have to lay on the ground or go home, so they left. She can't walk more than 10-15 minutes. She left the pharmacy, and when she got in the car about 20 minutes after she had gotten the vaccine, she felt a heaviness on her face, felt like a heavy mask on it even when the mask was removed. She felt initially that her face was swollen, like it was pressed, but there was no visual swelling that she could see in the mirror. When she took her mask off the triangular area where the mask had covered she could see a little more of a rash, like pinkish marbled rash but it would go away in about 45 minutes to 1 hour, started to slowly fade away. She felt that if it was a rash it would be all over her face; but this area was only where the face mask had been. She had no injury that could have caused that. The pain the next day was so bad, she was not able to sit or stand. She was barely rolling out of bed, had to hold on to furniture and walls to make it to bathroom. She is still not able to fully bend down. She has limit in movement. She still has pain, it did improve since the first day; but she still gets like a sore pain in the spine area, lower spine like a shooting pain from hips to connection where her legs meet bone which is still there. The pain can change from day to day; it can be on both sides of spine, or tailbone, hips, joints from where her legs attach to the hip area. Pain is a stabbing pain very painful and then the stabbing pains come and go and feels like a pulling pain, like a nerve pain but there is constant soreness in that area; on top of that still has the stabbing pain; this has been going on for the last 9 days did not have a break from this. She has tried massaging the area, tried Bengay on her back, tried ketoprofen (Ketonal), tried Capsaicin patches, Voltaren for the pain but none of those have helped the pain. Pain is a deep pain. The only thing that has helped it is like hot or thermal water bottle that you fill up with hot water which helps mute the pain to where it is manageable and helps her fall asleep at night. She still feels pain at time of call feels like a spinal injury. She experienced for 3 days; she would say on day number 3 (in 2021), the pain moved from the lower back to the half of buttocks on both sides and started getting numbness in buttocks and central part of buttocks like tingling pins and pricks feeling for maybe a day or 2 then it resolved. She still has pain in buttocks and hips and the pain can move to lower back and will hurt in lower back. Then on 04May2021, symptoms like entire intestines hurt her, she wasn't eating, it started at night when she was going to bed; so she is thinking maybe the pain is radiating to other parts of body to like her lower abdominal area; she used the hot water rubber bottle to relax muscles. She does not have the tingling sensation in her buttocks any longer; but does have tingling sensation in both hands and both feet that she sometimes feels, it is ongoing most of the time and is pretty severe. She feels pain getting up and down, still having pain; She is glad she can walk, because before walking was not very possible for her. She also tried a little bit of a back massage where she lay on her back and kind of wobbled on massager, but it doesn't help; the pain does not feel muscular it feels like something with the nerves. When she walks, she feels pain around her spine and lower back central part of spine, hips or lower back, like someone literally stabbed her in the back. She has seen her doctor on 03May2021 and was suggested seeing a neurologist before getting her second shot which is due 17May2021. Doctor ordered a blood panel and urine test and are still waiting for results (unknown results) taken on 03May2021. The patient asked if these are side effects of the vaccine. The patient did not know if she should or should not get the second dose relative to these events as of yet; second dose is scheduled for 17May2021. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The events resulted in physician office visit. Patient was not hospitalized. The patient recovered from events right side neck pain (felt like a pulled muscle), ""right ear, it felt swollen"", partial hearing loss, pressure on her ear, little pinkish rash/pinkish marbled rash, and jerking muscle in the left thigh and right thigh on 25Apr2021. The patient also recovered from event numbness in buttocks and central part of buttocks in 2021. The patient was recovering from events limited movement, difficulty walking, and heaviness on face. Outcome of events ""felt woozy, felt a little drunk or funny"", and ""entire intestines hurt her"" were unknown. While the patient had not yet recovered from the remaining events. No follow-up attempts are needed. No further information is expected.""
131	1336627-1	COVID19 (COVID19 (MODERNA))	50-59 years	Female	* Headache - alleviated by drinking lots of water or Gatorade - I believe it's actually dehydration; I do drink lots of coffee but no more than normal so the headache is unusual. This was worst the day after the shot; mostly resolved after that. * Intestines feel like I've eaten bricks, and defecation changed to be more dense and perhaps darker. Not constipated. Gatorade also seems to help intestines feel better. This was worst the day after the shot. * Did get tired feeling a little more easily/faster than usual. * Some soreness in shoulder about a 4 square inch area surrounding shot; mostly resolved after two days All the above-listed reactions much better two days after the shot, and better still three days after shot. Not entirely resolved yet.
132	1340202-1	COVID19 (COVID19 (JANSSEN))	65-79 years	Male	BLOOD CLOT; This spontaneous report received from a consumer concerned a 76 year old male. The patient's weight was 82 kilograms, and height was not reported. The patient's past medical history included angina pectoris, peptic ulcer disease, and tension headache, and concurrent conditions included asthma, atherosclerotic heart disease of native coronary artery, benign hypertension, stage 3 chronic kidney disease, chronic obstructive pulmonary disease with acute exacerbation, cirrhosis of liver, diabetes mellitus type 2, generalized osteoarthritis, morbid obesity, mixed hyperlipidemia, stenosis of bilateral carotid artery, peripheral vascular disease, malignant neoplasm large intestine, carotid artery occlusion, and hepatocellular carcinoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: cabozantinib s-malate (tablet, oral, batch number was not reported) 40 mg, 4 times every 1 day, from 04-MAR-2021 for hepatocellular/liver cancer. Concomitant medications included apixaban, atorvastatin calcium, carvedilol, ergocalciferol, hydrocodone bitartrate/paracetamol, levothyroxine sodium, losartan potassium, mecobalamin, metformin hydrochloride, salbutamol sulfate, tadalafil, tamsulosin hydrochloride, and vitamin b complex. On 03-APR-2021, the patient experienced blood clot. On an unspecified date in Apr-2021 the patient was hospitalized for one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210530464-covid-19 vaccine ad26.cov2.s-Blood clot. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, MEDICAL HISTORY
134	1340863-1	COVID19 (COVID19 (MODERNA))	50-59 years	Female	First shot soreness in left arm and a slight headache. 2nd Shot extreme muscle pain, joint pain. Fever of 101. Difficulty thinking, fatigue. Extreme arm soreness. Raised welt at the injection site. I took Tylenol and Motrin on a rotating schedule barely made a difference with pain and fever. Fever went down to 100.5. Difficult time sleeping due to extreme joint and muscle pain. Additionally, squeezing feeling in intestines.
135	1343555-1	COVID19 (COVID19 (MODERNA))	50-59 years	Female	perforated intestine
136	1346618-1	COVID19 (COVID19 (MODERNA))	30-39 years	Male	Patient had Ileoanal anastomosis (J-pouch) surgery in 2000 and minor corrective surgery related to the pouch in 2015. This event required a 15 day hospital stay due to severe abdominal cramps, pain, vomiting and diarrhea. It was a suspected Crohn's flareup with stricture or blockage complications. Vomiting and diarrhea began late 2/24. Patient went to emergency room next morning and was subsequently admitted. Multiple diagnostic imaging (X-ray, MRI, CT Scans, etc) showed narrowing of the small intestines above J-pouch. Scope was completed on day 9 of the hospital stay. Scope showed no narrowing or blockages, root cause of vomiting, diarrhea and severe abdominal pain unknown. Patient had been doing well for several years after 2015 surgery.
137	1347326-1	COVID19 (COVID19 (JANSSEN))	40-49 years	Female	Headache, chills, body aches, muscle aches, fatigue. Next day, symptoms worsened. Worsened on third day. No fever. Fourth day nausea. into fifth day. Sixth day vomiting. Seventh day severe diarrhea, pain in shoulder blades. Eighth day severe cramping in intestines, fatigue, back pain and dizziness. Ninth day symptoms continued. Tenth day chills and traveling pain left leg to hip. No medication administered. Went to Emergency Room.
138	1347458-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Male	Within 2 weeks of my second Pfizer COVID-19 immunization injection I started experiencing: (1) severe diahara, (2) severe constipation, (3) severe flatulency, (4) severe pain in my duodenal area. (5) severe pain in my back just behind my duodenum, (6) severe pain across my upper small intestine loop just below my rib cage starting on my right side traveling across the described path to my left side, and (7) severe pain in my shoulder. The pain has gotten worse and sometimes travels down into my large intestine intensifying at approximately the juncture of my large intestine with my colon. I am weak and lethargic sleeping much more than normal. The pain is getting unbearable!
139	1348462-1	COVID19 (COVID19 (PFIZER-BIONTECH))	18-29 years	Male	After receiving 2nd shot. next day I woke up early morning around 7 AM. I felt the bottom of my intestine constantly swirling / spinning. Another symptom at the same time throughout the whole day, back of my tongue or throat was constantly building up saliva.
140	1349137-1	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	Female	sweating; vomiting; bacteria in her intestines; This is a spontaneous report from a contactable consumer. A 94-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reported stated that on Tuesday after receiving the shot, her grandmother, who is usually sitting in a wheelchair, was leaning forward while seated and began sweating ""sweating a lot in head and in her hair and then started vomiting"" on an unspecified date. The patient was transported to the ER by ambulance for evaluation but was later sent home, they found that she had a bacteria in her intestines. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.""
141	1353532-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Female	mild sepsis; It was normal, except her bladder, because it was so swollen she felt like she couldn't empty it completely; swelling in her brain; thyroid felt swollen; gained 10 pounds overnight of fluid.; lymph nodes got huge; headache; Her tongue feels swollen; Pain in all her organs; Her arm was so sore/ sore left arm; so she had it put in her left hip/ sore left hip. It was sore for about 2 weeks; gained 10 pounds overnight of fluid. Her kidneys, bladder, intestines, stomach and she felt swollen and her liver too; affected her brain and speech/difficulty pronouncing words; Affected her brain and speech; allergic reaction; experienced a personality change; feeling puffy; felt like she had a tourniquet around her neck/Her organs felt swollen; cognitive issues; Throat swelling; pain in the part of her liver; couldn't remember where she put things; muscles did not work right; bladder infection; She was so cranky; Intense stomach ache; This is a spontaneous report received from a contactable consumer (patient reported for herself) from a Pfizer- sponsored program. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 08Apr2021 at the age of 64 years old (Lot Number: ER8732) as 2nd dose, single for covid-19 immunisation. Medical history included Cancer: Gerson Therapy; Autoimmune disorder; allergies ongoing; Parvovirus B19: exposed to Parvo B virus, it's called the 5th Disease, she had a rare reaction to it and it gave her Rheumatoid Arthritis ongoing, Fibromyalgia ongoing, Multiple Sclerosis ongoing and Behcet's like overnight; allergies to food (she got swelling, intense depression, suicidal tendencies, and a fight or flight response), drugs (Tylenol and Aspirin, basically any pain killer, Percocet and Darvocet), air, dirt, trees, and bugs. It runs in her family; inflammation. Concomitant medications included ongoing fish oil (FISH OIL); ongoing curcuma longa (TURMERIC [CURCUMA LONGA]); several other supplements; ongoing Benadryl for allergies when need. The patient previously received the first dose of BNT162B2 on 19Mar2021 09:00 at the age of 64 years old (lot number: EN6207) in Left arm for Covid-19 immunization and experienced allergic reaction, throat itchy, numbness on her left side/ Legs were like spaghetti and she felt like the scarecrow in Wizard of Oz, lungs itchy and inflamed, coughing, barking asthma cough, Speech slurred, Oxygen level felt like it was in the 80s (80%), muscles not responding, Crooked walk, died 6 times and experienced an out of body experience. Vaccination Facility Type was Hospital. Vaccine was not Administered at any Facility. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Caller wanted to know about the need for booster dose; Was it going to be like the first or second dose of the vaccine. Caller wanted to know the ingredient of the Pfizer covid vaccine. She said she took both of the doses and had a bad reactions from it. Caller stated she had a lot of issues with the first dose but not as bad as second dose. The second dose almost killed her and affected her brain and speech. She had the Pfizer Covid-19 vaccine, and experienced a bad reaction after both doses. Caller asking what was in the vaccine that could cause her bad reaction. She never had a reaction to any vaccine. She had allergies and autoimmune disorder. Her arm was so sore/ sore left arm the first time. It was difficult to get in and out of car for 3 weeks, but she recovered completely. She helps the handicap people, so she had it put in her left hip/ sore left hip. It was sore for about 2 weeks, but she recovered completely. Caller added she needed to decipher what was written on the vaccination card. She wished they would write better. She used her glasses. Caller took no pharmaceuticals, just Benadryl for allergies when need. The Hospital where she received her vaccine was used and created by another facility, but not a an offsite facility. But for them to use also. Caller added she was cured of everything she had from the Therapy. After the second dose: She started same day as vaccine on 08Apr2021. She did her protocol that time, and as far as breathing and that, it was not like the first dose, but towards the evening she had an auto immune response that lasted for 3 weeks. She felt like she experienced mild sepsis and gained 10 pounds overnight of fluid. Her kidneys, bladder, intestines, stomach and she felt swollen and her liver too. When this happened it started with feeling puffy that evening and lasted for 3 weeks. Caller added if she was exposed to a virus, or had an allergic reaction this happens. Caller added even her lymph nodes got huge and thyroid felt swollen, felt like she had a tourniquet around her neck. That lasted for 3 weeks. It was bad the 1st week. That caused a severe headache that started on the 3rd day and lasted 4 days. It was really bad on the 1st day and she wanted to go to the Emergency Room. She took Benadryl and Ibuprofen, and a Doctor told her she shouldn't take Ibuprofen because of Covid. She was allergic to Tylenol and Aspirin, basically any pain killer, Percocet and Darvocet, Everything except Ibuprofen. Caller did not have the bottle to provide details. She usually put Ibuprofen in her Benadryl bottle for her inflammation. That was the only thing that she took. She took Turmeric and fish oil and several other supplements. Her headache peaked on the 4th day, and she took the Ibuprofen and was better the next day. Throat swelling started on the 5th day and lasted and was still causing her difficulty pronouncing words. Her tongue felt swollen. Her cognitive issues started the 4th day of her headache and was intense. It continued, but was much, much better. She did her normal protocol, and had gotten by, but it was not normal. Her organs felt swollen and the doctor did a test. It was normal, except her bladder, because it was so swollen she felt like she couldn't empty it completely. The muscles did not work right and she got an bladder infection and received antibiotics, about 2 weeks after the injection, because her bladder wasn't working right. Urine test: infection. Intense stomach ache: started at the time her headache stated after 3 days along with the headache and ended with her doing the Therapy. They lasted for 4 weeks. Pain in all her organs: started the 3rd day after the second dose. The pain started, she felt swelling and it lasted for 3 weeks, actually, for 4 weeks, the pain in the part of her liver by her stomach. She experienced a personality change and she wouldn't have the vaccine again. She couldn't remember where she put things, started on the 7th day after her second dose and lasted until the Therapy made her feel better. Finally, after 4 weeks, she recovered completely and was pretty much back normal now. Caller added she was a happy person and was with her Cancer. People asked how she did it. But with this experience she literally wanted to hurt someone or kill herself, and no it was not normal. She was so cranky. She was sure it was the swelling in her brain. With her food allergies she got swelling, intense depression, suicidal tendencies, and a fight or flight response. She wanted to leave her life, it was scary. Caller added she did not feel like this now. For the Vaccine Indication: Caller added that people that need it most, didn't want it. Because of her autoimmune disorder, she was a long huller and she had died 6 times, so she was willing to try it and take it and deal with the side effects. She was hoping it would not cause any. Her boyfriend died at Christmas. After 24 hours he was dead. He had a mild sepsis from a virus. He has Autoimmune disease. If she got Covid, she didn't want to end up like him and see her arms and legs amputated. Caller asked if anyone else had reported symptoms she had experienced. Caller asked to clarify details of her symptoms of suicide and killing and hurting others. Caller denied she was experiencing this at time of call. Therapeutic measures were taken as a result of events headache, Personality change, couldn't remember where she put things, bladder infection. The outcome of the events Pain in arm, Pain in hip, Personality change, couldn't remember where she put things, Stomach ache was recovered on an unspecified date, of cognitive issues was recovering, of the other events was unknown.
142	1354350-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Female	I have a gluten autoimmune disease. It has been described by an immunologist as Celiac on steroids. Ingestion of gluten (even cross contamination) causes a breakdown in every single organ. Some of the symptoms include: deep skin lesions (can see bone), bleeding ulcers throughout intestines (including mouth, ear canals, intestines), stomach cramps, mitral valve prolapse, asthma, pneumonia, drop in IQ by 30 points, depression, anxiety, pro to bone fractures, and so forth. I accidently had gluten 2 weeks ago at a restaurant. I did not have any symptoms of my gluten autoimmune...none. (I have had my gluten autoimmune since 2 years of age.) The only difference from my last episode of gluten cross contamination and my incident 2 weeks ago was receiving the Pfizer vaccine for COVID-19. I am curious as to see why this is. I am not willing to eat a loaf of bread, but I am curious as to why the Vaccine reduced my reaction to gluten.
143	1355262-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Male	4/20/2021- I awoke to fatigue, nausea, and a 101.9 temperature. 4/23/2021- After seeing no signs of improvement, I visited my primary care physician, who had blood drawn for tests. Morning of 4/26/2021 ? I was contacted by my primary care physician?s office with results of the blood work. I was referred to a gastroenterologist due to critically high liver enzyme levels. My AST(ASGOT) was shown to be 825. Afternoon 4/26/2021: The gastroenterologist explained that my AST was roughly 40 times higher than normal. He said levels this high could not be caused by hepatitis A, B, C, or Auto-immune hepatitis. More blood was drawn at the gastroenterologist?s office. The results showed: Bilirubin Total of 2.2, Bilirubin Direct of 1.38, Alkaline Phosphate of 360, AST of 1,222, ALT of 2,314, Ferritin, Serum of 737. The gastroenterologist told me to go to the hospital if I developed jaundice or became too fatigued to get out of bed. 4/28/2021? CAT scan. Results were inconclusive. 5/2/2021- Developed jaundice. I spoke with the gastroenterologist?s office and got appointment for 5/4/2021. The gastroenterologist changed his mind and had me admitted to hospital on 5/4/2021. While in the hospital blood was drawn frequently. Peaks levels reached during the hospital stay were as follows: Bilirubin Total of 14.0, Bilirubin Direct of 11.53, Alkaline Phosphate of 346, AST of 1,522, ALT of 2,550. I had an ultrasound and endoscopy performed while in the hospital. The endoscopy looked at my bile duct, liver, and small intestine. Tissue was taken from the small intestine which ruled out celiac disease. Tissue was taken from my liver and biopsied. The gastroenterologist said the liver appeared to have suffered medication induced hepatitis. He said, in his opinion this was caused by the Pfizer COVID-19 vaccine. At the time I was taking no other medicine other than a once a day multi-vitamin. 5/7/2021 I left hospital. 5/18/2021-Latest blood work results: Bilirubin Total of 14.7, Alkaline Phosphate of 369, AST of 268, ALT of 593. Future: I have an upcoming appointment with a hepatologist to determine extent of liver damage.
144	1356092-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Female	+10 mins, strange taste in mouth, excess saliva +25 mins, numbness in lower half of face and lips, twinge/cramp feeling in heart area +30 mins, sinus clearing and drainage (still continuing 5 hours later) +45 mins, itching under left side of tongue in thi
145	1357123-1	COVID19 (COVID19 (MODERNA))	65-79 years	Male	running nightly fevers; Body became very rigid; Walking with a walker; small intestine removal; Aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (running nightly fevers) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No reported medical history. Concomitant products included ATORVASTATIN, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), GABAPENTIN, LAMOTRIGINE (LAMICTAL), LOSARTAN, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), TIMOLOL, FLUTICASONE PROPIONATE (XHANCE) and THIAMAZOLE (METHIMAZOLE) for an unknown indication. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced PYREXIA (running nightly fevers) (seriousness criterion hospitalization). On an unknown date, the patient experienced MUSCLE RIGIDITY (Body became very rigid), GAIT DISTURBANCE (Walking with a walker), SURGERY (small intestine removal) and MYALGIA (Aches and pain). On 12-May-2021, PYREXIA (running nightly fevers) had resolved. At the time of the report, MUSCLE RIGIDITY (Body became very rigid), GAIT DISTURBANCE (Walking with a walker), SURGERY (small intestine removal) and MYALGIA (Aches and pain) outcome was unknown. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, causality in relation to the vaccine can not be excluded however the event of fever for 2 months is unlikely related to the vaccine; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, causality in relation to the vaccine can not be excluded however the event of fever for 2 months is unlikely related to the vaccine.
146	1357194-1	COVID19 (COVID19 (PFIZER-BIONTECH))	18-29 years	Female	brief episode of faintness; Unexpected severe abdominal (large intestine) and rectal pain lasting three days.; Unexpected severe abdominal (large intestine) and rectal pain lasting three days.; Rapid heart beat for 1-2 days; fatigue; chills; joint pain; nausea; low fever; headache; swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 28-year-old via an unspecified route of administration in the left arm on 08May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included IBS-D (irritable bowel syndrome - diarrhea), generalized anxiety, and on birth control. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included paroxetine for an unspecified indication; and ethinylestradiol, norethisterone (BALZIVA) for contraception, both therapy dates were not reported. The patient previously took metaxalone (SKELAXIN) as muscle relaxer but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 27-year-old on 17Apr2021 in the left arm for covid-19 immunisation. The patient did not receive other vaccine in the last four weeks prior to vaccination. On 10May2021, the patient had an unexpected severe abdominal (large intestine) and rectal pain lasting three days. The patient also had rapid heartbeat for 1-2 days and brief episode of faintness. It was further reported that there was a combined with expected side effects which included fatigue, chills, joint pain, nausea, low fever, headache, and swollen lymph node. The adverse events did not require treatment. The patient has not been covid tested post vaccination. The outcome of the events was recovering. Information about lot/batch number has been requested.
147	1363975-1	COVID19 (COVID19 (MODERNA))	80+ years	Male	Developed blood clot; Sever pain in his stomach; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed blood clot) and ABDOMINAL PAIN UPPER (Sever pain in his stomach) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016L20A) for COVID-19 vaccination. Concomitant products included RIVAROXABAN (XARELTO), AMLODIPINE, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR) for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Sever pain in his stomach) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Developed blood clot) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 28-Apr-2021 to 04-May-2021 due to ABDOMINAL PAIN UPPER and THROMBOSIS. The patient was treated with Surgery (leading to two and half feet of his small intestine removed) for Thrombosis. At the time of the report, THROMBOSIS (Developed blood clot) and ABDOMINAL PAIN UPPER (Sever pain in his stomach) outcome was unknown. Patient started having severe pain in his stomach on 27-Apr-2021. He was taken to the hospital on 28-Apr-2021, patient's doctor said that he had a clot in his intestine and that caused the pain, was operated removed to two and half feet of his small intestine. Patient was discharged from the hospital on 04-May-2021. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Company Comment : Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
148	1365004-1	COVID19 (COVID19 (JANSSEN))	65-79 years	Male	Shingles all over body. Patient reports having shingles on penis and buttocks. Also reports MD stated having shingles on his bowels/intestine.
149	1366860-1	COVID19 (COVID19 (MODERNA))	30-39 years	Female	Tingly from head to toe; Short of breath; Chest is like tight; Pains in intestine; Tired; Headache; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Tingly from head to toe), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest is like tight), GASTROINTESTINAL PAIN (Pains in intestine), FATIGUE (Tired) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. No Medical History information was reported. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PARAESTHESIA (Tingly from head to toe) (seriousness criterion medically significant), DYSPNOEA (Short of breath) (seriousness criterion medically significant), CHEST DISCOMFORT (Chest is like tight) (seriousness criterion medically significant), GASTROINTESTINAL PAIN (Pains in intestine) (seriousness criterion medically significant), FATIGUE (Tired) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PARAESTHESIA (Tingly from head to toe), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest is like tight), GASTROINTESTINAL PAIN (Pains in intestine), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Side effects started after 20 minutes of receiving the shot. Patient went to the hospital. Patient stated that she was sleeping well and drinking lots of water. Concomitant product use was not provided by the reporter. Treatment for the event included ibuprofen. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
150	1366978-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Female	horrible burning feeling like a lit candle in the lower intestines and fire in stomach/ felt like she was on fire, body was on fire inside her body; red bumps on my right arm/red bumps in little clusters, cluster of red dots; diarrhea; stomach upset; severe stomach pain; flushed cheeks across her nose/cheeks flushed for 1 hour; my cheeks turn pink; brain fog/felt very loosie; Fatigue/tired; little sore arm/minor sore left arm; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6205, Expiry Date: Jun2021), via an unspecified route of administration, administered in left arm on 25Feb2021 16:30 as single dose for covid-19 immunisation. Medical history included GERD/gastrooesophageal reflux disease, high cholesterol, ongoing high blood pressure, breast cancer and had radiation for that in 1992, high triglycerides, thyroid removal in 2007, stroke 2012, ongoing oxygen therapy (24 hours a day for 3 years) and allergies to neglect and wheat. Patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) she takes it because she has no thyroid; acetylsalicylic acid (ASPIRIN (E.C.)) 325 mg for high blood pressure; salbutamol (ALBUTEROL HFA), omeprazole, fenofibrate, atorvastatin, lisinopril, latanoprost. She had things wrong with her and she was on several medication beside the oxygen. She had to take a 325 mg of 'Bayer Aspirin' (not clarified) every morning because she had stroke in 2012. She takes at night she takes some eye drops, her eye doctor gave so that she does not get Glaucoma. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. She received normal medications for high blood pressure, fenofibric, within 2 weeks of vaccination. The patient previously received influenza vaccine (FLU) shot for immunization and she has never had a reaction. Patient was nervous about receiving the vaccine because she was on oxygen therapy 24 hours a day in addition to being on a number of medications which include: medication for high blood pressure, Synthroid, Aspirin 325mg every morning, and ""a couple of things for breathing"" such as Albuterol and Respimat inhaler ""which helps you get rid of carbon dioxide from your lungs."" She just expresses concern because ""her body is compromised."" She saw on TV that the CEO of Pfizer was discussing the possibility of a third booster shot. Patient was scheduled for next shot on 25Mar2021. She got first Pfizer dose on 25Feb2021 around 4:30 in the afternoon on Thursday, and when she got the first dose cheeks got really pink and they stayed like that for an hour or so and then they went away and she thought it was okay for her to (incomplete sentence). She had all different ones, the first one started right away, as soon as she got the shot she felt very 'loosie' (Not clarified) about 20 minutes later when she was sitting there and waiting. Then when she got, she noticed her cheeks were really pink. Some went away about an hour. Then she had some fatigue and a little sore arm for the next 48 hours but she was okay. But then on 28Feb2021 (yesterday) 48 hours after the shot, suddenly she had diarrhea, very violently and then that was last night and she was so having it and she felt like she was on fire, she felt like her body was on fire inside her body, and she kept drinking."" She had pills she had to take every day. No she took nothing. When she had the diarrhea over night from last night almost 48 hours all night long she had diarrhea couple times, and she had diarrhea this morning. She felt like somebody lit a match inside her body and it's like burning from inside, and started drinking water. On continuous home O2, takes synthroid and lisinopril. She experienced flushed cheeks across her nose which lasted a few hours. The first 48 hours she had a minor sore left arm, fatigue, and brain fog. At 48 hours after the vaccine administration, she had to take lisinopril and 5 mins later she experienced violent diarrhea. Later that night felt ""fire inside my body like someone had lit fire"" started drinking water, ""eventually it went away. She called to ask if it was ok to take peptobismol. On 01Mar2021 (Today) she felt way better. She experienced quite a lot of side effects after getting the 1st dose. She said that she was not easy going up. After she got home, she mentioned that her cheeks flushed for 1 hour. She gets flushed usually but this was more pink than usual which went through her nose. The flushing was not hot and swollen. She also experienced horrible burning feeling like a lit candle in the lower intestines and a fire in the stomach 4 days later after the diarrhea on 04Mar2021. She was advised to take Pepto-bismol and water for that and she was fine. She was very tired, fatigued, and her brain was foggy for 4-5 days. She also mentioned that she took some of her high blood medications which made her stomach upset but she ensured to take it with food the next time and it did not happen again. It was challenging and was a wild day. It's been 8 days since and she has mentioned that she's okay now and is breathing better than she usually does, especially on 05Mar2021 (today). She also feels that she has more stamina, improvement in her lungs. She said that it was very strange but she is very happy and is wonderful. She has been on Oxygen for 24 hours a day for 3 years and is more at risk for COVID. She is asking if this is normal and for what to do with the 2nd dose. She was advised to refer to healthcare provider for further discussion. As soon as she had the shot, her cheeks turn pink and she couldn't see it until she got home because of the mask and she does not know if cheeks were pink because of the mask or what but it was only lasted for short time and then went away. She did not have any swelling or heat or anything but when she started, she had very few symptoms except fatigue. Then on the third day or fourth day, she started with diarrhea and a very severe stomach pain and now in the last couple of days she started with these red bumps on my right arm in Mar2021."" She had the shot on left arm but has these red bumps in little clusters, cluster of red dots, you can feel them and they are raised up and she does not know if something bite her or if this a side effect. It has been several weeks now. It was on shoulder in two different places and it is kind of like three or four of them at one location. ""Now, my cheeks are pink again and it has been two weeks now. She does not understand why. She should not be having any side effect at all and she was all (voice feeble) twenty-four hours a day. No treatment received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events stomach pain, stomach upset was not recovered; for other events was unknown. No follow-up attempts are needed. No further information is expected.""
151	1367129-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Male	chest pain made him go to the emergency room because it was too much, it was multiple throughout the day not just one time; his penis sensations are a lot different; has had a bad headache where it feels like he has vibrating inside of his head, in his chest and in his abdomen; when he falls asleep he wakes up in an hour; getting shocked in the middle of the night when he is sleeping- in his chest and intestines; getting shocked in the middle of the night when he is sleeping- in his chest and intestines; limbs twitch; This is a spontaneous report from a contactable consumer. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: ER8732; Expiration Date: 31Jul2021), 1ST DOSE SINGLE via an unspecified route of administration, administered in Arm Left on 27Mar2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chest pain made him go to the emergency room because it was too much, it was multiple throughout the day not just one time, has had a bad headache where it feels like he has vibrating inside of his head, in his chest and on 31Mar2021, when he falls asleep he wakes up in an hour 31Mar2021, getting shocked in the middle of the night when he is sleeping- in his chest and intestines on 31Mar2021, getting shocked in the middle of the night when he is sleeping- in his chest and intestines on 31Mar2021, limbs twitch on 31Mar2021, his penis sensations are a lot different. It was reported that 5 days after he got the first dose of the COVID vaccine he started getting pains and the major thing is at night. If he falls asleep, he wakes up in an hour and that has been every night for a month and a half. That is the main thing that is pissing him off. He confirms that he is having issues with his chest and his intestines like he mentioned previously and he has started keeping track and has kept a journal of the pains. This stuff is new. He has never experienced this before and it has been happening every day starting 5 days after when he got the COVID vaccine. He had the COVID vaccine on 27Mar2021 and on 31Mar2021 he got the first shock in his chest at 0120 in the morning when he was sleeping. Then that went on for a week, he had it on 31Mar2021, 01Apr2021, 02Apr2021, 03Apr2021 and 04Apr2021 where he was getting shocked in the middle of the night when he is sleeping. On 04Apr2021 he had to go to the emergency room and have them look at him. But since 31Mar2021 he has been getting up every hour after he falls asleep. This was all worse when it first started because he has never experienced anything like this. The first shock he had was a hard feeling in his chest and then he couldn't go back to sleep. It is so bad. After he went to the emergency room, that is when it started being not as much of a shock pain that woke him up but he was still waking up every hour. The pains are in his upper chest and in his intestines. Also his limbs twitch and he has had a bad headache where it feels like he has vibrating inside of his head, in his chest and in his abdomen. He confirmed that these also began on 31Mar2021 and have been happening whenever they want and he has never experienced all of that before. Never. Everything has all stayed the same. The sad part is that he just thinks that he is getting used to this ""new normal"" because he is now going on the second month of this and his body is adapting but this is not normal. Also, he guesses that he shouldn't be shy now but the last thing is that his penis sensations are a lot different and he didn't notice until the first time that he was having relations with his wife after the COVID vaccine and it is all different. He noticed and she did too as far as whenever they were trying to have relations. It has been more than once, it has been every time they have tried afterwards. He says his doctor is going to send him to a sleep lab but he wasn't expecting that. He thought that maybe he would need to go somewhere else. But there he will go to sleep and be hooked up and they will read his whole body and tell the reason why he is waking up every hour. The outcome of the event headache, sleep disorder, chest discomfort, muscle twitching was not recovered and penis order, headache was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.""
152	1367181-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Female	Has all those nerve damage in her intestine and they are not working; She has nerve and muscle damage in intestine and that is why she cannot eat; Has all those nerve damage in her intestine and they are not working; She has nerve and muscle damage in intestine and that is why she cannot eat; She hasn't been able to eat; This is a spontaneous report from a contactable consumer. A 76-year-old female patient (reporter's mother) at the age of 76 years old received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient previously had first dose of BNT162B2 for covid-19 immunisation. patient had the Pfizer Covid vaccine about a month ago and about 10 days after her second vaccine, she is in hospital and she hasn't been able to eat since. She is probably going to die this week. They say that there is no blockage but she has all those nerve damage in her intestine and they are not working. reporter don't know if it is related to the vaccine or not but reporter wanted to ask if anybody else is having this problem. She has nerve and muscle damage in intestine and that is why she cannot eat. She has been fed with an IV for a month now. reporter stated it just happened 10 days after her second shot, she was fine before that. She had some other health problems and issues and other things as she is an old lady, she has had some other health things but reporter don't know if it is related or not but reporter wanted to call and see if one are getting other calls about this, about nerve damage or maybe information or what was going on. Outcome of the events was unknown. Information on lot number/batch number was requested.
153	1367190-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Female	bradycardia and tachycardia episodes; bradycardia and tachycardia episodes; sudden onset chest pain; small vessel stroke in her brain stem; diagnosed with dysautonomia; diagnosed with POTS; Shortness of breath; fine hand tremors; burning hand syndrome; GI burning and belching / burning abdomen; GI burning and belching; blood pressure issues; chest discomfort; exercise intolerance; little waves of hot flashes; O2 sat variations; not well; light headedness and profound weakness; light headedness and profound weakness; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received BNT162B2 (lot number: EM9809 or EM9509) second dose on 18Feb2021 (vaccination age 67-year-old) on left arm at single dose for COVID-19 immunization. Medical history included ongoing Trigeminal neuralgia from Dec2020 (diagnosed 5 month ago after shingles vaccine), continuously being worked up by her primary for autoimmune disorders, she had a stroke in her brainstem. Concomitant medications included carbamazepine (TEGRETOL) for Trigeminal neuralgia (Has been taking for 5 months since being diagnosed with trigeminal neuralgia. She mentions its the only thing that calms the nerve down). Historical vaccine included BNT162B2 (lot number: EN5318) first dose on 25Jan2021 (vaccination age 67-year-old) on forearm left deltoid for Covid-19 immunization and shingles vaccine Shingrix on 17Dec2020 (vaccination age 67-year-old) for immunization and developed a neuropathy (3-4 days later) and trigeminal neuralgia 4 days post-shingles vaccine. 10 days post second dose of Covid vaccine (28Feb2021), she developed sudden onset of chest pain and lightheadedness and profound weakness. She was driving to her son's house and got to the nearest hospital and she was worked up for a blood clot and a heart attack. Everything came up negative but she had bradycardia. So, she was put on a 20 day monitor and she had signs of tachycardia, bradycardic episodes with activity and exercise intolerance. She is still continuing with the chest pain and she ended up in the emergency room two more times, hospitalized once, and she had a angiogram. The cardiologist gave her a diagnosis of POTS and the internal medicine gave her a diagnosis of dysautonomia. She is continuously being worked up by her primary for autoimmune disorders. Finally, her primary doctor threw up her hands and said ""I don't know"" because she continued to have other symptoms like light headedness, and shortness of breath. Of course, it is all linked to random surges of fine hand tremors and her heart would start racing where she may just be standing at the sink. Cardiology didn't want to do anything with her because she was in normal sinus rhythm. The caller explains she was told they saw a lot of tachycardia and bradycardia but she was in normal sinus rhythm, she didn't belong with a cardiologist. Five months ago, she got the shingles vaccine and developed trigeminal neuralgia 4 days post-shingles vaccine. At that point they did an MRI of the brain, thinking maybe she had MS because that is one of the side effects of MS, but she didn't. She had a normal MRI. She has been to neurology and has had a lot of testing done. She knows the long hauler's with COVID are coming up with dysautonomia. However, she has had multiple Covid tests and is very, very safe. She does not believe that she had Covid, but she does believe this may be a reaction to both the shingles vaccine with the trigeminal neuralgia and the Covid vaccine. Before these vaccines, she was on absolutely no medications and was completely healthy. These 2 vaccines, whether it's in her genetic system or whatever, but she continues to have GI burning, belching and burning hands. They did another MRI and found she had a small vessel stroke in her brain stem. There are so many things that are happening to her right now. She is also seeing rheumatology. She just is not well. Though the CDC doesn't know about her newer symptoms, she reported to the CDC what she had at the time. They haven't gotten back to her on either of them. Five months ago was the shingles vaccine and she would have thought they would have reached back out to her because it is truly too coincidental that she takes a shingles vaccine and 3-4 days later develop a neuropathy, and the shingles vaccine is supposed to prevent neuropathy. She is so active. She walked coast to coast, and now literally just even walking up a flight of stairs, her heart rate goes up to 115 to 120. She can be at rest and her heart rate can be in the 40's. She is also having blood pressure issues as well. Her blood pressure can be 89/46 and then be 152/90, so she is just kind of an ""autonomic nervous system mess"". Her primary care referred her to a neurologist and a rheumatologist whom she will be seeing Wednesday. She doesn't know what other specialties she may ended up seeing. The MRI was supposed to help find reasons for all these symptoms, but in fact, all it did was add another condition to her already perplexing condition. She submitted one report via CDC for the shingles vaccine on 17Dec2020, which three days later, she had trigeminal neuralgia. Her symptoms are ongoing and it's not disappearing like she had hoped. It keeps progressing and she keeps getting new symptoms. Sudden onset chest pain: Was 10 days after the vaccine, while driving to her son's house. She also developed light headedness and profound weakness. She went to the hospital (ER) and was sent home. 3 days later, she was still having significant chest pain so she went back into the ER. She was on a monitor that was showing all of these tachycardic and bradycardic episodes. She wasn't getting contacted but she was still having pain. The third time she went into the ER, she was admitted to the hospital. They transported her to cardiac care and they did an angiogram, which is when she was given the diagnosis of dysautonomia and POTS. The neurologist says that she does not have POTS because she is not presenting with consistent orthostatic hypotension and tachycardia when he does the TILT test. However, she has a lot of autonomic symptoms, so the doctor decided to do an MRI. Her previous doctor was doing all of this autoimmune testing that was coming back negative. She was tested for an adrenal tumor and had urine tests which got ruled out because she is surging, it is obvious she is having adrenal surges. The caller doesn't believe her doctor was convinced he would see anything on the MRI, so when he called her and told her she had a small vessel stroke in the pons/ medulla area, he thought maybe it could attribute to the symptoms. However, these new GI symptoms she is having does not fit. Therefore, they are continuing to do more studies like gastric emptying, a skin biopsy, CAT scan and an angiogram. She is meeting with a rheumatologist on Wednesday. She also adds she will probably do an MRI of the abdomen because she is having such a burning abdomen. She is waking up in the middle of the night with her abdomen just on fire. It seems like she is continuing to just add new symptoms. The chest pain goes away and she only gets it when she gets tachycardia or when she is taking a walk- it's not having it continuously. She had burning hand syndrome, it was burning hands in a bath, which that that lasted an hour when she was getting out of the bath and she hasn't had that since. Everything is kind of a weird conglomerate of dysfunction, like the blood pressure variations, O2 sat variations. She just wants answers. She is adjusting and adapting. But, she does wants to bring this to Pfizer's attention because maybe genetically there is something in her that even though the COVID vaccine is not a live virus, the idea is to mimic the live virus to give you immunity, and long hauler's are experiencing some of these symptoms that she is having, Not that Pfizer is going to do anything differently- she is still encouraging vaccines and she is not telling many people because she doesn't want people to use this as an excuse to not get the Covid vaccine. Caller confirms the dates of all of these events were reported to the CDC. Her doctor would have all of the dates including the dates of the angiogram, ER visits, the findings, and then the testing dates. Dates are unknown by the caller. She confirms she was in the emergency room 3 times, she was admitted and transferred to Cardiac care on the third time. She believes she was admitted for 3 days. She believes she was admitted in the evening, they did the angiogram the next day and she was discharged the following day. The MRI that was sent in 01 Dec 2020 was negative for anything. The MRI that was done last Thursday, 07 May or 09May2021 showed an infarct. So, she did have an MRI that was clear in December and then the recent MRI showed the stroke. They are doing a CAT scan angiogram 28May2021. She explains she has no lifestyle history for developing a stroke. She wasn't even on baby aspirin or any statins. Now, they are now wanting to put her on statins. Before this, she had no history. She confirms her ER visits and one hospitalization were after the COVID vaccine and was all based on chest pain. The caller confirms the only thing that happened to her after the shingles vaccine was that she was in excruciating pain and then the doctor got an MRI going and determined she had trigeminal neuralgia. She was never hospitalized or went to the ER for the shingles vaccine. The chest pain she still gets on and off. Last night, she had it. She can get chest pain when she is walking. The chest pain is not continuous and consistent, it's more based on activity. Last night, her whole intestines were burning and she noticed ""oh I'm feeling some chest discomfort"". She is not worried about the chest pain anymore because she knows it is either a bradycardia that her chest is unhappy with or tachycardia that her heart is unhappy with and it's giving her discomfort. Her heart rate can literally go from 50 (which is bradycardic) to 120 in less than 5 -10 seconds. Her heart just goes racing like she is having a marathon, that's how fast it goes. It will last this way for a minute and her heart rate will eventually meander it's way down so that's why she thinks she is getting chest pain. She works with elders and wanted to keep the world and community safe. She wanted to get back into the world and see her mother who is in a nursing home. Caller mentions she was taking 200mg twice a day of the Tegretol (before the COVID vaccine). She had to up her dosage because she had another outbreak so now her dose is 300mg, twice a day. She clarifies a tooth infection flared up her trigeminal neuralgia. All of the auto immune results were negative, except the MRI, which she thinks is the only thing that was positive. She is doing an autonomic test in September. At this point, her doctor has given a diagnosis of dysautonomia and she is presenting as such. Her neurologist is needing verification and so he is not giving her a diagnosis even though she has all of the symptoms of dysautonomia. Vaccination Facility Type: administered it to their elder care home. The event chest pain required a visit to Emergency Room and Physician Office (has weekly telephone visits because she keeps getting different symptoms. They are scratching their heads trying to figure out what other testing is needed. She is now developing little waves of hot flashes and is not having a fun time. She was living a very healthy lifestyle and was always energetic previous to this). The patient was hospitalized for 3 days. Family Medical History Relevant to AEs was No, other than her mother has hereditary angioedema. She hasn't been tested so does not even know if that is significant. She knows she has been reading about long hauler's having dysautonomia and a whole array of neurological symptoms. It is kind of intriguing as well as kind of suspicious. Everything is being managed well by her primary doctor who is very concerned and is doing everything she can to try and find and answer. The caller is very curious if there is a lot of funding, would she be put into a link and a pool to be involved in some studies or something? Is it something genetic? There is certainly enough money out to do this work. Caller is questioning if she would get a booster given that she is questioning if she should get a booster because she doesn't know. She doesn't know if she is going to get the second shingles vaccine. She does not know what it could result in for her given these 2 complications with these 2 vaccines. Causality: Because she had the shingles vaccine and developed trigeminal neuralgia, which is a neuropathic, and then getting the Covid vaccine and having all of these symptoms, it is just too coincidental. She is going to talk to her doctor about MS since she is presenting with gut things which is more ""MS-ish"". MS is hard to diagnose so she doesn't know, they are still testing. At this point, because all the boxes checked besides the last MRI, she is leaning towards the COVID vaccine being the cause of her symptoms. The causality for event sudden onset chest pain was related. The outcome of the events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events bradycardia, tachycardia, chest pain and brain stem stroke cannot be excluded. The available information upon initial assessment is limited, especially as a definitive diagnosis was not available. The patient was reported to have pre-existing trigeminal neuralgia and previous brainstem stroke and is being worked up for autoimmune disorders; the role of these conditions in the development of the symptoms also cannot be ruled out. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.""
154	1373290-1	COVID19 (COVID19 (MODERNA))	30-39 years	Female	Borderline septic; Small bowel obstruction; Post surgery ileus; Stomach still hurt; Was not able to use the restroom; Severe abdominal pain; Back pain; Vomiting; Soreness at the injection site; Fatigue; Loss of appetite; Flu-like symptoms.; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SMALL INTESTINAL OBSTRUCTION (Small bowel obstruction), SEPSIS (Borderline septic) and POSTOPERATIVE ILEUS (Post surgery ileus) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20a and 013m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse reaction with Flu shot. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite), INFLUENZA LIKE ILLNESS (Flu-like symptoms.), VACCINATION SITE PAIN (Soreness at the injection site) and FATIGUE (Fatigue). On 07-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach still hurt), CONSTIPATION (Was not able to use the restroom), ABDOMINAL PAIN (Severe abdominal pain), BACK PAIN (Back pain) and VOMITING (Vomiting). On 08-Feb-2021, the patient experienced SMALL INTESTINAL OBSTRUCTION (Small bowel obstruction) (seriousness criteria hospitalization and medically significant) and SEPSIS (Borderline septic) (seriousness criteria hospitalization and medically significant). On 12-Feb-2021, the patient experienced POSTOPERATIVE ILEUS (Post surgery ileus) (seriousness criterion medically significant). The patient was hospitalized from 08-Feb-2021 to 11-Feb-2021 due to SMALL INTESTINAL OBSTRUCTION. The patient was treated with MAGNESIUM CITRATE on 12-Feb-2021 for Postoperative ileus, at a dose of UNK dosage form and Surgery for Small intestinal obstruction. On 14-Feb-2021, POSTOPERATIVE ILEUS (Post surgery ileus) had resolved. In February 2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms.), ABDOMINAL PAIN UPPER (Stomach still hurt), CONSTIPATION (Was not able to use the restroom), ABDOMINAL PAIN (Severe abdominal pain), BACK PAIN (Back pain), VACCINATION SITE PAIN (Soreness at the injection site), FATIGUE (Fatigue) and VOMITING (Vomiting) had resolved. At the time of the report, SMALL INTESTINAL OBSTRUCTION (Small bowel obstruction), SEPSIS (Borderline septic) and DECREASED APPETITE (Loss of appetite) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Computerised tomogram: abnormal (abnormal) Showed a small bowel obstruction and was borderline septic.. In February 2021, Pathology test: normal (normal) Part of the removed intestine was sent to pathology, nothing was found.. In 2021, X-ray: inconclusive (Inconclusive) Inconclusive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. On 08 Feb 2021, due to severe abdominal pain and back pain patient went to emergency room. Patient was diagnosed with small bowel obstruction with borderline septic during the emergency room visit. Patient had surgery in which 10 inches of small intestines was removed and had resectioning. On 12 Feb 2021, patient experienced post surgery ileus and NG tube was placed, patient's stomach pumped, and magnesium citrate was given via the NG tube to clear. Patient stayed in the hospital and was released on 14 Feb 2021. Patient had bloodwork done to rule out blood disorders or clotting disorders and the results were pending at the time of this report. Action taken with mRNA-1273 in response to the events was not applicable. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
155	1373940-1	COVID19 (COVID19 (MODERNA))	30-39 years	Male	First dose: my face went numb and tongue felt itchy 1.5 hours roughly for symptoms. No common side effects; Second dose: calling it a panic attack. Racing heart, felt like I was passing out, mental fogging, trouble swallowing lasted about 1.5 - 2 hours. After 2nd dose I had the normal side effects, headache, chills, body aches fatigue.. After about 2 days of common side effects I noticed I was having trouble swallowing and it felt like I was being choked pulse food regurgitation and diarrhea. It kept getting worse and worse after a week or so of hell I get an emergency endoscopy showing I have eosinophilic esophagitis. I?ve been put on all sorts of meds that are supposed to be treating this but nothing is working. It?s been near a month now and 2 weeks have been on a hard core elimination diet symptoms are persistent and discomfort it spreading to what feels like intestines, kidneys and possibly other locations I now have to go in for a colonoscopy soon as the meds should be working and discomfort is spreading. Loads of headaches can?t sleep with all the discomfort. Never hungry. Possible permanent esophagus damage maybe more everything is still being diagnosed and no one is really finding any answers why. For the last 6 years I?ve been on a health kick working out almost daily and eating very healthy. No symptoms no warning signs these one or more diseases it has all just started out of the blue post vaccine nothing else in my life has changed.
156	1385282-1	COVID19 (COVID19 (MODERNA))	30-39 years	Female	I had a fever of 104 for 3 days, but my intestines were so painful for weeks afterwards. It is now 4 months after and I am still having gastro issues and have been to my Gastroenterologist, my PCP, had a colonoscopy and endoscopy, and have had to be on hardcore pain killers and have missed a lot of work due to the side effects from the vaccine.
157	1388264-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Female	I received my first dose on 4/27/21 I felt some lumps around my right clavicle bone and a burning sensation on 4/28/21. On 4/29/21 I started having pain and burning sensation under my right armpit radiating to my breast area. I contacted my doctor she said it was probably my lymph nodes that were swollen. On 5/10/21 I started having pain on my right leg and some swelling. I went to the urgent care on 5/11/21 they told me to watch out for shingles. I wanted to make sure it wasn't a blood clot. On 5/12/21 I started having abdominal pain on my right side, I went to the Urgent care and they did a CT scan showing my small intestine and appendix inflamed. I was transferred to the Emergency room and admitted the same day. I had an appendectomy on 5/15/21. I went for my second dose on 5/21/21 I went to do blood work on 5/27/21 and I received a call from my doctors office that my Liver Enzymes were super high.
158	1389127-1	COVID19 (COVID19 (MODERNA))	18-29 years	Male	Acute localized lower back pain along with localized lower abdominal pain. Difficult to explain sensations, almost like a catch in lower-mid spine, along with abdominal pain in relatively the same area. Feels like someone kicked me square in the middle of the spine. Possibly kidney pain? Tends to come in intense waves of pain, with a lingering dull ache seperating the more intense spasms. The abdominal pain reminds me of a bowel obstruction I had a while back, almost like someone has taken a section of my intestines with both hands and is violently stretching it apart. No diahrrea, or constipation - as far as I can tell. Lying down or propping and supporting the back does nothing to help with the back pain. Neither does any OTC pain relievers such as Acetaminophen or Naproxen, and as a result sleep is very difficult.
159	1389177-1	COVID19 (COVID19 (MODERNA))	50-59 years	Female	12 hours after getting the vaccine I woke up at 1 am sicker than a dog. I got the runs and it felt like I had the flu and the runs have not stopped. It took a few days until I went to the doctor maybe a couple of weeks. It was my primary doctor and I let her know what happened. They did a Colonoscopy and it showed my small intestine was all acting up. They switch my medication to Budesonide it did not work so we switch to Elmiron and that did not work so I am back to my Pentasa.
160	1390969-1	COVID19 (COVID19 (PFIZER-BIONTECH))	6-17 years	Male	inflammation in his intestines and his stomach; petechial rash on his legs, which is still getting a little bit worse; HSP; stomach pain/extreme stomach pain started again and so on/intermittent stomach pain/lower left abdominal pain; lower left abdominal pain and he doubled over in pain and started vomiting; Caller states again he had intermittent pain throughout the day; vomited about three times in total, it wasn't like excessive vomiting; didn't feel well/feel sick again; This is a spontaneous report from a contactable consumer (patient's parent). A 13-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0164, expiration date: 31Aug2021), at the age of 13 years old, in left arm on 14May2021 16:00 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient was a normal 13 years old, he doesn't take anything, he's active. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The vaccines administered on same date with BNT162B2 was none. The previous immunization with the Pfizer vaccine was none. The patient previously received the flu shot every year and experienced no adverse event. On 16May2021, about 48 hours after the vaccination, the patient started having stomach pain in the middle of the night. It began 16May2021 in the evening and into 17May2021, the patient was having stomach pain and not feeling well. Reporter stated the patient woke her up. Reporter stated they thought it was some food he ate. Reporter stated they tested his covid antibodies and they also personally at home on 17May2021 night, they tested him with a home kit for covid just to double check because nobody really brought it up and it was negative also. Reporter confirmed the home covid test was done on 17May2021. Reporter stated there was no known exposure, they just did it to make sure he didn't have covid. The patient was taken to the emergency room on 18May2021. Reporter stated they were waiting because patient felt good during the day and they thought nothing was wrong, but then the extreme stomach pain started again and so on 18May2021, she took him to the local emergency room. Reporter stated they didn't do much other than push on his stomach, she was worried about appendicitis. Reporter stated they didn't worry too much, but she thought maybe it was his appendix. The doctor examined him and said he had a stomach issue and released him with medicine and that was the 18May2021. On 19May2021 and 20May2021, the patient would get intermittent stomach pain, again thinking it was a stomach bug or something. On 20May2021, the patient experienced petechial rash on his legs. Reporter called the pediatrician and again the patient was having intermittent stomach pain and kept having it intermittently. The patient would feel fine then feel sick again then on the 22May2021, the patient had more bad stomach pain and some vomiting so he wound up back in the emergency department, it was a different one than the first on 22May2021. The patient did a lot of blood work, his labs came back good, but he did not do a CAT scan, but reporter tried to do everything else, tested patient for covid, antibodies and everything and they sent him home again on the 22May2021. The patient had intermittent pain again throughout 23May2021 then on 24May2021, he went to visit the pediatrician just for a visit and they were thinking its Henoch-Schonlein purpura (HSP) which is an autoimmune response and they still didn't have a diagnosis for his stomach. Reporter stated patient was perfectly fine at the pediatrician, then when they got home, he started having lower left abdominal pain and he doubled over in pain and started vomiting. The patient vomited about three times in total, it wasn't like excessive vomiting. Reporter stated the pain would bring it on, he does have a rash, which is still getting a little bit worse. Reporter stated they took him back to the emergency room, they did a CAT scan and that showed he had inflammation in his intestines and his stomach so they kept him in the hospital. The patient was admitted on 24May2021 when he visited the emergency room for the third time. Reporter stated because patient was in pain, they admitted him to watch him. Reporter stated they were worried about the patient having intussusception with the bowel, where his bowel can go inside each other and can create a blockage, so they wanted to admit him to make sure that didn't happen. Reporter stated the worst of the stomach pain was on 25May2021, which would have been at 19:00. The patient had not had an episode since then, he hadn't had an attack like that since. The whole week before from 17May2021, or the 16May2021 when it started through 25May2021, it was very intermittent of a lot of pain. So far, knock on wood, the patient hadn't had it since 25May2021 at 19:00 and hopefully tonight it won't happen. Reporter stated it will be about 48 hours of not having the bad pain. Reporter stated he still has some pain, but not like where she had to rush him to the emergency room. The patient's vomiting ended on 24May2021 or 25May2021. He had recovered completely from vomiting so far. The patient was released on 26May2021 with a diagnosis of HSP, which was an auto immune response, and he'd never had this happen before. Reporter stated if she googled HSP, it said it can still get worse, but it was not the worst case of HSP. Reporter stated the patient has never had anything like this before, he was perfectly fine, they made it through covid and didn't get covid and he is a healthy kid so she thought Pfizer should know. The outcome of the events HSP, stomach pain, petechial rash was not recovered. The outcome of vomiting was recovered on 24May2021 or 25May2021. The outcome of the events inflammation in intestines and stomach, didn't feel well/feel sick, intermittent pain and lower left abdominal pain was unknown. No follow-up attempts are needed. No further information is expected.
161	1395878-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Female	Received Shot, experienced dizziness, confusion immediately Evening of first day: was tired, did not feel ""right"". Next Day: Very tired, but hands and muscles in legs began to ache 2 days after shot: Stomach became severely swollen and painful. Felt like an endometriosis flare. Had extreme diarrhea for three days. Voiding roughly 12 times per day. Sore rectum, lower stomach, intestines. These symptoms of soreness lasted for 3 days or so. 3 days after shot: severe sadness. Crying, couldn't shake it. Pain all over body. Over the next week my body became more and more sore. My feet began to cramp and fold inwards like they were trying to bend in half. I could not sit on any hard surface as my legs and back hurt too bad to sit on anything but piles of pillows. I could not walk well as my feet were very sore. A week after shot began feeling electric shock feelings throughout my legs. Zaps of electricity. Hands still very sore. Legs felt like I'd lifted weights for a week. Day 10 following shot still experiencing severe pain. Heart began racing. Resting heart rate would jump to 130 upon standing. Still having episodes of heart racing. Forearm began spasming and would cause my middle and ring fingers on my right hand to contract and close against my palm. Could not hold right hand steady. Still experiencing pins and needles in hand and arm. Spasming and contractions stopped after a few days. While I understand that many of these are known side effects, I was also lead to believe that these side effects would last 3 days or so. These have lasted well beyond that window.""
162	1396279-1	COVID19 (COVID19 (MODERNA))	50-59 years	Female	One week after vaccine at 9 am I felt a rash on my arm it burn it was hot and then I had abdominal pain spasm on my stomach on Feb 24 I stayed home from work. My intestines were hurting I was inflamed Brain fog and vertigo I had to quit work because it hasn't stopped and went to the doctor and said my IBS flared up. I went to the ER and the doctor there advised to wait on taking 2nd dose for right now. In the ER they did a CT scan but they didn't see anything big.
163	1396777-1	COVID19 (COVID19 (MODERNA))	30-39 years	Male	Extreme abdominal pain went to the Emergency room. CT scan diagnosed to be Edema of small intestines. Treated with pills to slow down intestine and bowel movement every few hours for 3 days. Pain relieved the next day.
164	1402449-1	COVID19 (COVID19 (MODERNA))	60-64 years	Female	Patient hospitalized for Diverticulitis of intestine with abscess within 6 weeks of receiving COVID vaccination.
165	1402779-1	COVID19 (COVID19 (MODERNA))	40-49 years	Female	I had a headache instantly after receiving the vaccine. At 03:00AM, on 04/04, I woke up and started vomiting for the next 3 hours. I was able to stop enough to get my children up and then I started to vomit again. I took some anti-nausea medication (promethazine and Ondansetron) it helped a little, but I kept throwing it back up. My children called 911 and they sent an ambulance for me. They gave me another ondansetron, but I had used a suppository. They took me to a ER. While at the ER they performed a lot of tests. There was an abdominal CT, transvaginal ultrasound because of the stomach pain, I had an EKG and a lot of blood work. They gave me medication for my migraine and I was given an IV. I also received something for the pain in my stomach, but I don't recall what it was. I was given enough medication to where I could finally get a little rest. The results that they came back with was that there was free fluid in my belly, there were spots on the scans around my ovaries and uterus and there was a lot of swelling in my intestines and stomach. I was referred to a couple other different doctors. Six months prior to receiving the vaccine, I went into septic shock and my heart briefly stopped. There was a lot of damage to different systems of my body after that happened. The doctors were not sure what kind of reaction I had. They weren't sure if it was a coincidence with what I already had going on, or if it was the vaccine. I also had a false positive pregnancy test and if I test, it still shows positive. They drew blood to verify that I was not pregnant. I went to an OBGYN and now I need to go to an gastroenterologist. I also followed up with my PCP.
166	1403661-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Female	I had a strong pepper feeling in my throat. It felt like a ball of pepper was in my throat. I was able to breath but I had to keep clearing my throat. My face, eyes, and throat started swelling up. I was rushed to the ER. My throat was dry. They immediately gave me the EpiPen. My body started acting uncontrollably. I was shaking and shivering and going through a bunch of uncontrolled body movements. They gave me oxygen. I had an IV in my left arm and they gave me injections in my right arm. I was very dizzy. They continued to observe me, they drew my blood. More doctors came in and they told me not to get the second dose of the vaccine. I was transported to hospital by ambulance. 2 o'clock in the morning they told me I could go home and they gave me a prescription. I was very jittery. It was hard for me to walk. I went home with the prescription. Around 7 o'clock in the morning I woke to take my prescription. I had heart problems. I was still dizzy, jittery, and nervous. I called my PCP to put in my prescription and was told to go back to urgent care immediately. My eyes, nose, lips, and throat swelled. I could still breath but my tongue felt different. After they saw me again, I got another EpiPen in my leg. I started shaking uncontrollably again. They injected me in my right arm to calm down the reactions. I was kept there till 9pm that day. It was difficult for me to walk again. I went home and laid down. They gave me prednisone for 7 days. On the 3rd day I was having heart problems again. During that time I didn't have a appetite. My intestines felt like they were trying to come out of my body. I was very uncomfortable. I had gas. I put myself on a schedule to eat soup. I was very nauseous. Those symptoms lasted for 6 weeks. I couldn't drive for 4 weeks. I was still dizzy. I was able to sleep for 4 hours. I couldn't remember things. I have a cough that hasn't gone away. My doctors told me I am anaphylaxis.
167	1405790-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Male	It felt like his intestines were twisting in knots; diarrhea; joint pain; chills; muscle pain; tiredness/exhausted; dizziness; weakness/lost strength; Arm pain; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0179), dose 1 via an unspecified route of administration, administered in left arm on 20May2021 10:00 (at 62-year-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included ongoing HIV positive from an unspecified date (reported as 5-6 years ago), ongoing immunocompromised due to being HIV positive. History: Patient has been taking BIKTARVY daily ever since he became HIV positive which was years ago. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for HIV positive. He did have vaccinations but he had them way longer than the 4 weeks prior to receiving his first dose of the COVID vaccine. No events following prior vaccinations. The patient stated he received his first dose of the Pfizer COVID-19 vaccine on 20May2021 and this weekend 29May2021 into 30May2021 he developed diarrhea, joint pain, chills, muscle pain, tiredness, dizziness and weakness. He's not sure if he had food poisoning over the weekend or what, but he has been suffering. He received his first dose on 20May2021, and the next dose wasn't due until 10Jun2021. He was reading through the literature and he sees that there are issues with immunocompromised people and all the medications that make a person immunocompromised which he is on. He has been reading the side effects and he has experienced diarrhea from hell, joint pain, he had chills, muscle pain and tiredness. He mentioned he did have some arm pain. He mentioned he didn't have anything soon, it was a little over a week. He also experienced dizziness and weakness, he felt like he lost strength or something like that. It may be coincidental and he could have gotten food poisoning or something over the weekend. Patient clarified his symptoms began on Saturday night, 29May2021 into Sunday, 30May2021. On 31May2021, his symptoms were a little milder, but then towards afternoon, his symptoms started back up. It felt like his intestines were twisting in knots and his diarrhea was back. He mentioned he had been taking Pepto Bismol and Alka-Seltzer. He confirmed the arm pain and diarrhea were still ongoing, however, the rest of his symptoms had pretty much improved. He clarified if he does too much too quick, his tiredness comes back. He felt like he was just zapped, he felt exhausted. The events did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included weight: 157-158 lbs on an unspecified date. The outcome of events arm pain and diarrhea was not recovered, outcome of the other events was recovering.
168	1407808-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Male	The day of vaccination, I went home and I was feeling fine. I started to get nauseated. I had Diarrhea. The nausea lasted for more than a week. I tried to hydrate as much as possible but the Diarrhea wouldn't stop. On March 24 I couldn't do anything because the Diarrhea began to become severe. I went to the ER and they said I had colitis and I was dehydrated. They told me to follow up with my PCP the next day. I was told to get Imodium. I was also told to start a brat diet. Colitis is inflammation that causes bleeding in the large intestine. They doctor said it could of been inflammation in large intestine due to the vaccine. As of now everything has gone back to normal.
169	1410137-1	COVID19 (COVID19 (MODERNA))	65-79 years	Male	I had infection in lower intestine, the infection lasted about a week. I was treated with antibiotics - 1st time ever having an infection in intestines. I went to the ER and waited for 8HRS which they were very busy and never treated me. I went to a gastro MD who referred me to my GP who prescribed the medication. I ran fever and had symptoms and pain at first, I thought it was a kidney stone but ended up being an infection. My GP did order a CT Scan that?s how the infection was located. Symptoms resolved after a week.
170	1413856-1	COVID19 (COVID19 (MODERNA))	18-29 years	Male	nausea and diarrhea after 1st dose. 100.6 fever, and reports feeling like intestines were twisting up.
171	1414545-1	COVID19 (COVID19 (MODERNA))	60-64 years	Male	I started having gastrointestinal issues. I went to see Dr. after a week of taking Pepto-Bismol, antacid tablets and loperamide hydrochloride. He prescribed pantoprazole sodium 40 mg. After 2 weeks of using the medication, my problem didn't go away. After that I went to see Dr. he prescribed famotidine. I went back a third time and saw Dr. He ran some blood work and he told me to discontinue taking the famotidine and continue with pantoprazole. He told me that if it continues that he would refer me to a GI specialist. After a couple weeks, I was referred to a GI specialist. I am seeing Dr. I went and saw Dr. and he suggested an endoscopy. I had one done on 06/04/2021. He said it looked like there is an ulcer, but it did not perforate the stomach and he said that I have H-pylori. I had a follow-up appointment on 06/17 where Dr. prescribed me to take amoxicillin, omeprazole and clarithromycin. As of today, with the antibiotics it's causing me to have diarrhea several times a day. I am eating a lot of vegetables, fruits and only pork or beef. If I eat any fried foods or meat, it causes me to have black stools with blood in it. The doctor told me that it was my upper intestines that are affected. Dr. did advise me to not take my pravastatin while I'm taking my antibiotics. I was advised by all of the doctors to stop taking the ibuprofen and naproxen and switch to Tylenol. I am scheduled for a colonoscopy 07/19.
172	1419816-1	COVID19 (COVID19 (MODERNA))	18-29 years	Male	This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (Bad seizures) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 106B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included VSD (patient had heart and lung problems when he was born (VSD ). heart murmur.), Bronchopulmonary dysplasia (patient had heart and lung problems when he was born (BPD-bronchopulmonary dysplasia)), Epilepsy, Prematurity, Aspiration pneumonia, Gastroschisis, Inappropriate schedule of vaccine administered and Breathing arrested. Concomitant products included TOPIRAMATE (TOPAMAX) and GABAPENTIN (NEURONTIN) for Seizures, QUETIAPINE FUMARATE (SEROQUEL), SERTRALINE HYDROCHLORIDE (ZOLOFT), CLONAZEPAM (KLONOPIN), LACOSAMIDE (VIMPAT), TRAZODONE, BACLOFEN (LIORESAL), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), CIMETIDINE (TAGAMET [CIMETIDINE]) and EPINEPHRINE (EPIPEN) for an unknown indication. On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced SEIZURE (Bad seizures) (seriousness criterion medically significant), CHEST PAIN (Chest Pain), URTICARIA (Big old welts / Hives), HEART RATE INCREASED (elevated heart rate) and PYREXIA (On and off fever). On an unknown date, the patient experienced CONDITION AGGRAVATED (condition aggravated/ seizures). The patient was treated with HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) at a dose of 50 mg three times a day. At the time of the report, SEIZURE (Bad seizures), CHEST PAIN (Chest Pain), URTICARIA (Big old welts / Hives), CONDITION AGGRAVATED (condition aggaravted/ seizures), HEART RATE INCREASED (elevated heart rate) and PYREXIA (On and off fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Heart rate increased: high (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was born between twenty two and a half and twenty three and a half weeks. Mother states she had German measles/Rubella while pregnant and was bleeding every week. patient was born with his intestine outside which had to be put back inside. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
173	1420577-1	COVID19 (COVID19 (MODERNA))	60-64 years	Male	In March IBS started which I?ve never had before. Everything I ate turned into what felt like rocks , I got so constipated I couldn?t use the bathroom. I started to become nauseated every day. I was up every hour of the night. I tried drinking water to flush my body and stomach, I had trouble eating. I ended up losing 3lbs a week up to 20 lbs. total. I ended up in ER on March 17, 2021. I had to be wheeled in because I was so weak, I couldn?t walk. I had CT scans and bloodwork done. I was sent home after I had a bowel movement. I was also given laxative to take at home. I went to the ER again on 4/23/21 @ 5pm ( 2nd ER visit ) I had CT Scans with contrast, enema, and lab work. I was also hooked up to an IV. I had no blockages from CT Scan. The CT Scan showed impaction, I had to drink stuff in ER to flush system and was given another enema. Once I had a bowel movement I was released with laxative. I now take generic brand laxative and generic brand of medication every day. I was advised that it could take my intestines a long time to return to normal. After following up with doctor, he decided I needed to have a scope done on my lower GI. I am still having complications.
174	1422540-1	COVID19 (COVID19 (JANSSEN))	50-59 years	Female	56-year-old very pleasant female with a known history of alcohol dependence and cirrhosis along with tobacco dependence and underlying nonoxygen dependent COPD who presented to the ER on 6/16 with uncontrolled diarrhea that started suddenly 2 weeks after getting her johnson and johnson vaccine on 5/5/21 associated with significant weight loss and persistent nausea and acute renal failure. She initially presented to her PCP on 5/25 complaining of urinary urgency for the past few months. She denied any frequency or dysuria but reported that her urine had an odor and an orange color. During that visit urine was positive for nitrates and leukocyte esterase she also had bilirubin in her urine and was given a 7-day course of Macrobid. There was not enough urine to send to the lab for culture. She then went to the emergency room that evening because her PCP contacted her that her potassium was low and she was sent to the emergency room during that visit she reported developing diarrhea she was given potassium and discharged home. She followed up with her PCP on 6/1 to follow-up on her ER visit and reported that the antibiotic was helping her urinary tract infection she continued to complain of some urinary urgency and it was recommended she have a urine culture done again which showed pansensitive E. coli which despite being sensitive to Macrobid she did not respond so she was prescribed 5 more days of Cipro. She reported that she quit drinking alcohol on 5/19/21 but admitted to drinking a beer now and then. Patient had her Johnson & Johnson COVID-19 vaccination on 5/5 and reports she was tired for a day or 2 afterwards and then felt better but then 2 weeks thereafter she felt terrible with associated development of nausea, weight loss, new diarrhea which has continued to progress to developing significant diarrhea and weight loss and fatigue for which she presented back to the ER on 6/16 with acute renal failure, uncontrolled diarrhea, hyponatremia and hypokalemia and metabolic acidosis. Imaging showed pancolitis, colonoscopy performed show diffuse bowel wall edema. She remains hospitalized as of 6/23/21. Stool pathogens panel and stool C. difficile x2 are both negative but the diarrhea is persistent and severe. Pt reports gi symptoms bagan 2 weeks after receiving her J and J vaccine associated with nausea, abd pain and development of diarrhea. CT of the abdomen pelvis showed a pan colitis and enteritis. colonoscopy was normal other than showing sign mucosal edema. Pathology negative for malignancy but the terminal ileum shows prominent peyers patches which are the immune sensors of the intestine.. stool o and P neg. Lactoferrin/fecal leukocytes is neg. fecal fat pending. stool ob neg. esr and crp markedly elevated.- budesonide 9mg was started, Added imodium q6h and acidophilous qid. rheumatoid factor neg, antinuclear and antimitochondrial antibodies neg, antineutrophilic cytoplasmic antibodies neg, anti-Saccharomyces cerevisiae antibodies neg and antithyroid peroxidase antibodies neg ,celiac ds panel neg. stool ob neg.. renal failure is felt due to acute tubular necrosis from severe diarrhea and poor po intake. She remains hospitalized in serious condition as of 6/23/21.
175	1424420-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Female	Patient state that one week after the shot she stated having a mensuration discharge. Went to the Dr. pap smear was given on June 3rd and all test came back normal.. She is one year into mesopause. June 5th. Headache, fever over 100.2 and body was very week. Went too urgent care on June 7th. They took more test and samples. Negative for COVID. all test was normal except white blood cells were high. June 8th went to PCP more test were taken. Inflammation enzymes marker was high. June 10th fever went away. June 13th developed water stool. The stool and the discharge are still ongoing. June 18th went to urgent care more test. White blood cells were high again but still no cause of infection. June 24 went back to the Dr. ultrasound was performed. Came back normal. Patient believes that something from the shot has lounged into her Reproductive and intestine to cause these problems.
176	1426150-1	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	Female	nausea; at the end she felt the gurgling and distress of her lower intestines; at the end she felt the gurgling and distress of her lower intestines; she experienced diarrhea for 45 minutes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included allergic to MSG (monosodium glutamate), allergic to soy, and allergic to NSAIDs. Concomitant medications were not reported. It was reported that she received the first dose of the Covid vaccine and within 14 minutes of administration, on an unspecified date, she experienced diarrhea for 45 minutes. She reports that it was so intense, and she would also experience waves of nausea. It was reported that she had one of the side effects with the Covid vaccine. It's listed diarrhea as one of side effects. She wanted to know when that is usually seen because she had the first shot and stayed the 15 minutes like she was supposed to and at the end she felt the gurgling and distress of her lower intestines on an unspecified date. She made it home and made it to the bathroom and had 45 minutes of intense diarrhea, like you would get with a colonoscopy prep. Also had a case of nausea since she had the intense diarrhea. She asked if it was typically seen with this vaccine or due to her nerves of getting the vaccine and being enclosed in a building for the first time in over a year or was it being in a room in line with 40-50 other people. She wanted to know when do this side effect was seen and does it occur within 15 minutes of the shot. She asked was it a side effect and if it was safe for her to get the second shot. She asked if diarrhea occurs 15 minutes or hours after receiving the Covid vaccine. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.
177	1426845-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Female	Swollen lymph nodes Right side of body neck, underarm and groin areas; Fever; Headache; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 07Apr2021 at 1545, as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, melanoma and squamous cell skin cancers and small intestines bacterial overgrowth and also had drug allergy to erythromycin antibiotic. The patient did not take any concomitant medications within two weeks of vaccination. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 at 1730, as a single dose for COVID-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19 and also did not receive any other vaccine within four weeks of vaccination. Since the vaccination, patient not tested positive for COVID-19. On 04Apr2021 at 0300, the patient experienced Swollen lymph nodes on the right side of body at neck, underarm and groin areas and also had fever, headache and diarrhea. Therapeutic measures were not taken. The clinical outcome of all events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
178	1429545-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Male	Crisis Hypertension, Thrombocytopenia with internal bleeding from stomach and intestines (replaced 4 pints of blood), shortness of breath.
179	1433423-1	COVID19 (COVID19 (MODERNA))	65-79 years	Male	I had a headache. I felt wiped out. I was exhausted and I hadn't done anything. I think I started having a fever. Not a high one but one that got my attention. I basically slept. I took Tylenol and went to bed and stayed there for awhile. Then the symptoms went away. Went to ER on May 13th at midnight (so Friday morning). I never had thrown up as much in my life as I had that Thursday night - it was black liquid - they think it was liver bile. They put a nasal to gastric tube in me for 12 days. Admitted to hospital on 14th - They were initially removing all the liquid in the stomach which was really distended. They were pulling more than a liter every 12 hours of liquid - that's what I saw next to my bed. It was black for three or 4 days and then it turned to gastric juices which were gold colored. They operated on me on 5/16/2021 and they pulled out. (I had had an operation in 2007 for an umbilical hernia) - that scar tissue from that 2007 operation incarcerated the small intestine - 19 inches of it - so they removed those 19 inches. It took awhile for my gastric tract to reset after that. I have severe sleep apnea - the last time I was tested I stopped breathing 68 times every hour - for 12 nights I couldn't take my CPAP mask because of the nasal/gastric tube. I didn't sleep those 12 nights. I got the point I was having delusions.
180	1440938-1	COVID19 (COVID19 (MODERNA))	80+ years	Female	I had internal bleeding from ulcers in my stomach and small intestine and I had Afib. May 15th - I went to ER - I went to Hospital. I was transferred from there because they didn't have a GI doctor on staff - to Hospital.. I received blood transfusions 8 units of blood. Was put on several medications. Medications - I was put on Amiodaron and Dojoxin (that was stopped so I'm not taking it now - I didn't need it anymore); put on Ferrous Sulfate; Pantoprazole; - those were the new ones I was put on. Have almost recovered.
181	1449469-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	Bacterial pneumonia; COPD exacerbation; Unintentional weight loss; Sepsis; Nausea; Body ache; Temperature upto 102; Vomiting; Runny nose; Sore throat; Congestion; Diarrhea; bilateral conjunctivitis; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of SEPSIS (Sepsis), PNEUMONIA BACTERIAL (Bacterial pneumonia), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD exacerbation) and ABNORMAL LOSS OF WEIGHT (Unintentional weight loss) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Thyroid nodule (Benign, BX done on 6jun2014), Cholelithiasis, Cranial nerve paralysis, Diverticulosis (Diverticulosis of intestine without bleeding, unspecified intestinal tract location), Hepatic lesion, Smoker, Inguinal hernia repair, Colon operation in 2016 and Thermal ablation. Concurrent medical conditions included COPD (Exacerbation) since 06-Jun-2014, Hypokalemia (Started potassium for 3 days, rechecking K+ today), Anemia (Started daily iron, after hospital visit), Malnutrition, Idiopathic osteoporosis, Thyroid disorder, Unspecified disorder of adrenal glands, Lung nodule and Weight loss. Concomitant products included SALBUTAMOL SULFATE (PROAIR HFA) from 01-May-2021 to an unknown date and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 24-Apr-2017 to an unknown date for COPD, GENTAMICIN (GENTAMYCIN EYE/EAR DROPS) from 09-Jun-2021 to an unknown date for Conjunctivitis. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced CONJUNCTIVITIS (bilateral conjunctivitis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant), PNEUMONIA BACTERIAL (Bacterial pneumonia) (seriousness criteria hospitalization and medically significant), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD exacerbation) (seriousness criterion hospitalization), ABNORMAL LOSS OF WEIGHT (Unintentional weight loss) (seriousness criterion hospitalization), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), DIARRHOEA (Diarrhea), NAUSEA (Nausea), MYALGIA (Body ache), PYREXIA (Temperature upto 102) and VOMITING (Vomiting). The patient was hospitalized from 26-Jun-2021 to 28-Jun-2021 due to SEPSIS. The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) (oral) on 11-Jun-2021 for Cough, at a dose of 4 mg; CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) at a dose of UNK dosage form; LEVOFLOXACIN (LEVAQUIN) at a dose of UNK dosage form; FLUCONAZOLE at a dose of UNK dosage form; GUAIFENESIN (MUCINEX) at a dose of UNK dosage form; PANTOPRAZOLE at a dose of UNK dosage form and PREDNISONE at a dose of UNK dosage form. At the time of the report, SEPSIS (Sepsis), PNEUMONIA BACTERIAL (Bacterial pneumonia), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD exacerbation), ABNORMAL LOSS OF WEIGHT (Unintentional weight loss), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), DIARRHOEA (Diarrhea), CONJUNCTIVITIS (bilateral conjunctivitis), NAUSEA (Nausea), MYALGIA (Body ache), PYREXIA (Temperature upto 102) and VOMITING (Vomiting) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2021, Blood pressure measurement: 130/72 (Inconclusive) BP : 130/72 Manual(Sitting, left arm, standard). On 09-Jun-2021, Body temperature: 97.9 (Inconclusive) temp:97.9 degree F. On 09-Jun-2021, Heart rate: 76 (normal) Regular. On 09-Jun-2021, Oxygen saturation: 98 percent (Inconclusive) P.OX : 98%. On 11-Jun-2021, Influenza virus test: negative (Negative) negative. On 11-Jun-2021, SARS-CoV-2 test: negative (Negative) negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Previous lab data of the patient include fall risk screening on 8sep2020 √ low risk, depression screening on 8sep2020, Mammogram screening on 6dec2019 √ normal, Bone density study on 10may2018, declined screening √ PAP; SHINGLE VACCINE, Screening AAA on 28jun2017 √ Normal ; MRI, Colonoscopy screening on 19may2017 √ abnormal repeats 3years, Pneumovax on 1may2018 - normal. It was reported that the patient went out of state and could not receive her second dose. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patientªs history of COPD is a co suspect for some of the events. This case was linked to MOD-2021-201168 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patientªs history of COPD is a co suspect for some of the events.
182	1453716-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Male	Feeling hot and cold; Cramping; He lost weight in the hospital; He wasn't feeling well; He just had the feeling of being tired; blockage in the lower intestines.; Hard time going to the bathroom; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 64-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot number:ER8732) via an unspecified route of administration administered in left arm on 16-Apr-2021 at 10:30 (at age of 64-years-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient underwent lab test and procedures include cholesterol and result was unknown on unspecified and colonoscopy on 10May2021 result was unknown. It was reported that the patient received the first dose of the Pfizer covid vaccine and was in the hospital for blockage in the lower intestines on 17Apr2021. The patient wanted to know if that is associated with the Pfizer covid vaccine. He stated his nephew was a police dispatcher and got a call where someone else have reported similar issue what the patient has experienced. The patient did not know what vaccine that person had or age and gender of that person. The patient wanted to know about if Pfizer was going to get the FDA approval for the Covid vaccine. The patient reported that he had both doses and he was fine right now but when he had the first dose he was, he got it 16Apr2021 and he had some side effects the next day, on 17Apr2021 he was having cramping and he woke up and was feeling hot and cold and ended up in the hospital with a blockage in his intestine and he was wondering if that could have been anything that was related the vaccine. The patient has lost weight in the hospital, he thinks he was about 145 lbs now. It was reported that the patient was fine the whole day he got the vaccine, he ran errands and did things he needed to do, he went to bed and woke up and felt hot and cold and on 17Apr2021, he was having hard time going to the bathroom. He called his son and told him he wasn't feeling well on an unspecified date in Apr2021 and his son came over and called his other son who is a fireman and he told them to call the ambulance so they did and they took him to the hospital and they couldn't figure out, he was asking them and they had no answer, he just seen on the website and he has been wanting to call but he wasn't going to but he did so that they would have it documented. He confirms when the cramping and feeling of hot and cold and difficulty using the bathroom began it was after midnight and the date was 17Apr2021. When asked if the feeling of hot and cold is ongoing, he says he was in the hospital for 8 days. When asked if the feeling of hot and cold is ongoing or has it recovered, he says he just had the feeling of being tired on an unspecified date in Apr2021 and out of it even after the fact. He does not if it had to do with vaccine or if it was something, he had going on prior to that. The ER doctor told him it was possible that when he got the vaccine whatever could have been going on and put his system in overload. He confirms he was admitted to the hospital due to blockage in the intestine supposedly, the lower intestine. He says that is recovered, everything got taken care of, he had to schedule a colonoscopy after he got out of the hospital. He does not know why they couldn't have done it there while he was in the hospital. He was contemplating the second dose; it was scheduled on 07-May-2021 and he had his scheduled colonoscopy for 10-May-2021 and he didn't know what he should do. People were telling him do it or not to do it but his doctor told him to go ahead and get it so he followed what he said and he did get it. The hospitalization dates were from 17Apr2021 until 24Apr2021 was the day that he got out. He had blood work done for cholesterol in the hospital and he sees a cardiologist doctor for the cholesterol. They did blood work in the hospital every day, he has no idea what the results were. The events feeling hot and cold, cramping and hard time going to the bathroom after midnight and the middle of the night lead the patient to emergency room visit. He didn't know whether to call but it has been playing on his mind. He is sure they have given millions of doses and he did not know if it could be anything to do the vaccine. The outcome of events blockage in the lower intestines, feeling of hot and cold was recovered and outcome of other events was unknown. Follow-up attempts are needed: Further information has been requested.
183	1459016-1	COVID19 (COVID19 (PFIZER-BIONTECH))	80+ years	Female	Fever chills; Weakness; Muscle soreness; Tiredness; Joint pain; Cough; Hurts to Breathe; Hives at Injection Site/hives all over; Skin and Eyes Burning and Itching/her whole body is hot and itching; Couldn't Sleep; sweating and felt hot; Skin and Eyes Burning and Itching; sweating and felt hot; Sinuses and Nose Plugged Up; Diarrhea and Upset Stomach; Stomach Hurting; Diarrhea and Upset Stomach; Stomach Hurting; No Appetite; Sinuses and Nose Plugged Up; Diarrhea and Upset Stomach; Stomach Hurting; sickness; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 88-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 13:30 (Batch/Lot Number: EN6202) as dose 2, single for covid-19 immunisation (reason: giving them and because she had bone marrow disease and doctor thought she should get it) at doctor office. Medical history included 2 aortic valve replacements (last one was replaced 3 years ago in May and the first one was replaced 5 years ago), ongoing autoimmune disease and ongoing acid reflux, bone marrow disease and Covid. Concomitant medication(s) included prednisone (5mg once a day by mouth; she had been taking it for a number of years for a condition auto immune disease and she has to take it for the rest of her life) taken for autoimmune disorder, and pantoprazole (40mg once a day by mouth; started probably 5years ago) taken for acid reflux, start and stop date were not reported. The patient previously took BNT162B2 (Lot: EM9809) as dose 1, single on 12Feb2021 for covid-19 immunisation; flu vaccine for asthma (when she got a flu shot years ago, she had to go to ER for an asthma attack from that; it was way back in the 1990s; NDC, Lot, Expiration: Unknown). No investigation assessment was done. No vaccines administered on same date of the Pfizer suspect. No Prior Vaccinations (within 4 weeks). Family medical history relevant to adverse event was none. The patient experienced sickness on 05Mar2021; fever chills on an unspecified date, sinuses and nose plugged up; diarrhea and upset stomach; stomach hurting; no appetite on 08Mar2021; sweating and felt hot; and skin and eyes burning and itching/her whole body is hot and itching; and couldn't sleep on 12Mar2021; hives at injection site/hives all over on 14Mar2021, hurts to breathe on 15Mar2021; cough on 17Mar2021; tiredness; joint pain on 21Mar2021; muscle soreness on 22Mar2021, weakness on 23Mar2021. Therapeutic measures were taken as a result of this with BENADRYL, Z PACK, MYLANTA AND TYLENOL. Clinical course was as follow: The patient stated that she wondered if should've even had the vaccine. The patient had Covid in Mar2020 (a year ago in March) and she had long haulers until Jan2021. In March, her hematologist called and said she could get vaccine and stated that she shouldn't have. She stated that the second one made her really sick. This sickness was getting too long. Her second dose of the vaccine was on 05Mar2021. She was so tired; stated she doesn't feel good. She stated that she felt like she has long haulers all over again, it was horrible. Stated she felt like she shouldn't have gotten the second one. States she was doing okay with first one. Caller states that she already gave up a whole year of her life because of this. She tried to call before, but she didn't wait to talk to someone, she had to go somewhere. The patient stated that she had hives, tiredness, problems with her intestines, got really sick, her skin and eyes started to burn, she felt like she had hives all over, her skin was burning, she was sweating and felt hot, stated on the 14th it really got bad, her whole body was hot and itching. States that she took a BENADRYL and felt better the next 2 days and then started getting sinuses and nose plugged up and it hurt when she was breathing, had a slight fever, and her skin was itchy. She states that she went to doctor on 15Mar2021 (physician office visit), and he didn't think too much of it because her oxygen was okay. States that she felt worse, she was coughing bad, felt terrible, her muscles ache, and when she was hot, she couldn't sleep, now all she wanted to do was sleep and she had fever and chills. She was supposed to do exercises, but she couldn't, and it started two days ago. States she was not coughing as much but it was still hard and hurting. It was some of her joints, not all of her joints were hurting like when she had long haulers. Fever and chills started when her sinuses started acting up. The fever and chills kept getting occasional slips in and out. Her fever was not high but enough to get the chills. Sinuses and nose plugged up: it came and went with MUCINEX and it helped a little. Her intestinal problems were diarrhea that started on 08Mar2021 and upset stomach. She had a problem and it hurt terrible for days after. No appetite lasted for one week, so probably ended 15Mar2021. Caller states that she felt a little better but can't get rid of her cough. Couldn't Sleep: started when she had the burning and lasted a little after because she had to get herself together again. She could only sleep three hours at time. Skin and Eyes Burning and Itching: The burning and itching went away for a while, but it was back again because she had been lying in bed and tired, stated that it was not so bad. The burning stopped 15Mar2021 when the hives were gone, but she stated that right now it was back, her skin gets hot and then starts burning and itching. Patient stated that she did not have too much problems with first but this second, oh my god. She thought she got it too soon after having long haulers. She got rid of that in Jan2021 and was feeling good but now she felt terrible again. States there were no tests, she didn't have any. She was so weak, and she was having a hard time now, and she was doing so good. She was worried about her heart and valves. She guessed that call handler couldn't help her either, she stated that she didn't know what to do to feel better. She thought she had better call and report it. She has already gone to doctor and had only gone to him for 2 years, but hopefully he knew enough about her. She states that she probably should call him because she wasn't getting any better. The outcome for hives at injection site/hives all over was recovered on 15Mar2021, skin and eyes burning and itching/her whole body is hot and itching was not recovered, muscle soreness was not recovered, weakness was not recovered, cough was not recovered, tiredness was not recovered, joint pain was not recovered, fever chills was not recovered, sinuses and nose plugged up was unknown, diarrhea and upset stomach; stomach hurting was recovered on 11Mar2021, hurts to breathe was recovering , couldn't sleep was unknown, no appetite was recovered on 15Mar2021, sickness was unknown, sweating and felt hot was not recovered , sinuses and nose plugged up was unknown, skin and eyes burning and itching was not recovered, sweating and felt hot was not recovered. No follow-up attempts are possible. No further information is expected.
184	1460200-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Female	I started having issues with not being able to not have a bowel movement. After about six days, I contacted doctor and he ordered an x-ray and my system was full of stool. He had me do a laxative clean out. He thought it was a fluke - as they didn't see any blockages. Six years ago - they removed part of my intestine because of a blockage. And then a few days later, it happened again and I did a full clean out again. And every since then I have been taking a laxatives and drinking prune juice until I can get in and get a procedure done - I have a consultation scheduled in middle of October (they are so behind). They'll see what needs to be done next to see what is causing this. My doctor thinks it's an narrowing due to an adhesion due to my intestinal surgery. In the meantime, I will go to ER if I get worse.
185	1461758-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	Severe diarrhea and destruction of part of her intestine and subsequent sepsis. ER doctors ""could not rule out the vaccine as a contributing factor."" It was suggested she have a portion of her intestines removed. She refused and went on a high dose of antibiotics. She was hospitalized in the ICU and eventually released to a nursing home when stabilized. She never regained control of her bowels or had a solid bowel movement. Her antibiotics were reduced and she again suffered severe abdominal pain and a distended abdomen and return of sepsis. She went back to ER and was told this would keep happening if she did not have the damaged portion of her intestine removed. She elected to go home on hospice, where she died. Her kidney doctor also relayed to her family that this reaction was a direct result of the vaccine. When the family questioned reporting this event, every healthcare provider backed off from admitting it was a result of the vaccine or stated they were not the primary physician and thus was not for them to report.""
186	1463972-1	COVID19 (COVID19 (MODERNA))	40-49 years	Female	Patient stated that about 5 days after receiving 2nd dose she had a mild stroke, she was having seizures, she was a ventilator at the hospital when she was taken, 2 blood transfusion, large intestine enlarged, heart is enlarged , liver is enlarged,. Patient stated that she is still having seizures
187	1464453-1	COVID19 (COVID19 (JANSSEN))	50-59 years	Male	Numbness in fingers, toes, and left side of face. Some nausea in stomach and intestines Dizziness and unbalance Malaise with any kind of physical exertion Stiffness/pain in the lower back of head
188	1466082-1	COVID19 (COVID19 (PFIZER-BIONTECH))	6-17 years	Male	is experiencing symptoms of Henoch-Schonlein Purpura (HSP), which consists of the inflammation of small blood vessels.; is experiencing symptoms of Henoch-Schonlein Purpura (HSP), which consists of the inflammation of small blood vessels.; About one week after the second Covid 19 vaccine the symptoms flared up again/Second dose: Henoch-Schonlein Purpura; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's father). A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EW0179) via an unspecified route of administration, administered in left arm on 21May2021 (16-year-old at the time of vaccination) as dose 2, single dose for covid-19 immunization. Medical history included ongoing crohn's disease (only one in the family with Crohn's disease). Concomitant medication(s) included infliximab (REMICADE) taken for crohn's disease and somatropin (NUTROPIN) taken for blood growth hormone both the products from an unspecified start date and ongoing. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EW0176) via an unspecified route of administration, administered in arm left on 30Apr2021, as single dose for COVID-19 immunization and experienced Henoch-Schonlein Purpura, red blotches under his skin and blotches on his legs, vasculitis on his bowel, severe stomach pain and on his legs it looked like vasculitis. It was reported that on 21May2021 the patient received the second dose of vaccine and on an unspecified date in May2021 patient experienced symptoms of henoch-schonlein purpura (HSP), which consists of the inflammation of small blood vessels and one week after the dose of vaccine the symptoms of henoch-schonlein purpura flared up again and it can appear on the skin, intestines, joints and where small blood vessels started to leak. The reporter further stated that his son took the first dose of Covid-19 vaccine and developed Henoch-Schonlein Purpura (HSP) and stated as HSP is inflammation in the small blood vessels most commonly in children and it affects the skin, intestines and joints with leaking blood vessels. On his son's legs it looked like a vasculitis. His son had these red blotches under his skin. It didn't hurt. He also got vasculitis on his bowel. He had a colonoscopy to diagnosis the vasculitis on his bowel. His son was being treated with steroids. HSP was a chronic condition, and his son has been dealing with it from the last month. The doctor advised him to call Pfizer to report this information and to find out if there is data or any other complaints or notification for HSP from the Pfizer Covid 19 vaccine. He stated that patient does have other medical conditions as he had Crohn's disease and receives a Remicade infusion every 6 weeks, and he also takes Nutropin for growth hormones. When probing indication for receiving the Covid 19 vaccine he reports convenience because he would have to wear a mask here or there or answer if he's vaccinated or not vaccinated. He didn't decide to receive the Covid 19 vaccine in concerns of his health. He reported that patient never had a positive Covid 19 virus test, the PCR test or the Rapid test. The reporter thought that patient's symptoms began on or around 07May2021 after receiving the first Covid 19 vaccine and the symptoms subsided, and the doctor gave the ok to receive the second covid-19 vaccine. His symptoms did improve prior to the second Covid 19 vaccine. About one week after the second Covid 19 vaccine the symptoms flared up again. Now it's 23Jun2021 and he still has symptoms. He estimates his son was seen at the doctor on 04Jun2021 with a colonoscopy on 09Jun2021. The reporter also mentioned that If Pfizer reaches out to him he does have photographs of his son's legs he can share. He really does believe the HSP came from the Covid 19 vaccine, but that could be one in a million. He stated that he was not calling to discuss symptoms. On an unspecified date, the patient underwent lab tests and procedures which included blood test which result showed no abnormalities and urine analysis which result did showed blood which also indicates HSP, and on 09Jun2021 colonoscopy which result was unspecified. The outcome of all the events was not resolved. Information on lot/batch number was available. Additional information has been requested.
189	1466534-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Male	Extreme abdominal pain, seemingly in lower intestine. Headache. Fever.
190	1470676-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	Severe stomach pain. Went to ER. Sent home with medicine. More severe stomach pain. Diagnosed with a stomach blockage. Had to have emergency surgery. Had to remove 7 or 8 inches o f small intestines. Leakage from incision site.
191	1481639-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Female	20 minutes after injection I felt lightheaded. After drinking some water and sitting for 40 minutes I drove home. My body felt impaired as though I wasn't fully cognitive, my heart rate increased and it was harder to breathe. I stayed home and watched tv all day and felt those symptoms subside. I went to bed that night and woke up at 1 am. I went to the bathroom and had a small bowel movement and afterwards my lower abdomen became hard and swollen as if there was a half a melon sticking out. My pain was intense at about an 8 on a scale of 1-10. I drank some detox and digestion herbal tea to try to help. The pain lasted about 3 hours. About 2 days later, I went to the bathroom and what looked like dead cells came out in the toilet through my rectum. My doctor thinks that it may have been the lining of my intestines from the inflammation. This was from the first vaccine and for the record I will not take another.
192	1482803-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Unknown	severe burning in my chest and my intestine; severe burning in my chest and my intestine; Vertigo; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number EW0176, expiration date unspecified), via an unspecified route of administration, administered in arm right on 07May2021 as single dose for covid-19 immunization (71 year when vaccinated) at a pharmacy. Medical history included osteoporosis from an unknown date. The patient's concomitant medications were not reported. On 07May2021, the patient experienced slight headache few hours after the shot. On an unknown date couple of days later the patient had severe burning in my chest and my intestine and had a really severe headache and had vertigo pretty bad. The patient reports of going to doctor tomorrow and wanted to have some Prednisone to calm all this down also wanted to make sure it will not be going to interfere if the patient decide to take the second shot in the next 3weeks. I has been a week since the first dose and was concerned because patient is not well. The patient was is treated with Tylenol 500mg sometime take 1 or 2. The outcome of the events was reported as unknown at the time of report. No follow-up attempts are possible. No further information is expected.
193	1482827-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Female	last night her ear glands that are under her ear at the neck area hurt her which is close to jaw bone meets her ear; feels achy all over her body; Sore throat; Cough; do not have any strength; intestines feels like she is cramping; feeling very sick; This is a spontaneous report from a Pfizer sponsored program (patient). A 67-year-old consumer female reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170) via an unspecified route of administration on 19May2021 at 10:00 hours (at age of 67-year-old female), in right arm as dose 2, single for COVID-19 immunization. Medical history of the patient included hysterectomy (start date and ongoing status unknown). It was mentioned that there was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines were administered and had no relevant family history. The patient did not receive any prior vaccines within 4 weeks. No adverse event following prior vaccinations. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0153) via an unspecified route of administration on 28Apr2021 (at age of 67-year-old female) in right upper arm as dose 1, single for COVID-19 immunization. On 19May2021 patient felt sick. Caller was wondering since her grandchildren would visit her today and wanted to know if her grandchildren would be contagious since she was sick. The same day about 6 hours after the shot is when it started caller stated she had a sore throat. She had cough, ten hours after the shot she felt achy all over her body, did not have any strength, her intestines felt like she was cramping, caller stated she knew that they were not menstrual cramps since she had a hysterotomy. On 20May2021 her ear glands that were under her ear at the neck area hurt her which was close to jaw bone meets her ear. Caller inquired if it was ok to call her family doctor would they know the answer. Caller stated she would just call her doctor The patient received treatment with Tylenol. She did not require any emergency room and physician office visit. No relevant test was reported. The outcome of felt sick was unknown and for intestines feels like she is cramping was recovered on 20May2021 and the other events had not recovered. Additional information was requested.
194	1483562-1	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	Female	This is a spontaneous report from a contactable consumer (friend). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Reporters friend had the second Pfizer shot and was hospitalized because she had an allergic reaction (Duration was not clarified for the Hospitalization). She was swelling and have hives and they were from 5 days and still looks like almost 2 weeks for her to cover from the allergic reaction and now, she had some intestinal problems and they think, her intestine were inflamed and calling regards to take hive. They wanted to know was that a report on reaction to COVID. Outcome of the events was unknown. Information on the lot/batch number has been requested.
195	1486265-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Female	I had terrible diarrhea; Symptoms of neuralgia; This is a spontaneous report received from a contactable consumer. A 54-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6201) via an unspecified route of administration in right arm on 08Mar2021 at 04:00 as dose 1 single (at the age of 54-year-old) for COVID-19 immunization. Medical history included Multiple sclerosis, Ileostomy, Blood clot in my arm back in 2014, Crohn's Disease. Concomitant medications included gabapentin 100 mg capsule, valaciclovir hydrochloride (VALTREX) 1 g, 3 times a day, diazepam 2.5 mg tablet, 3 times a day, ondansetron (ZOFRAN MELT), oxycodone 7.5 g, tablet 4 times a day, lansoprazole (PREVACID) 20 mg, once a day, vedolizumab (ENTYVIO) 300 mg for Crohn's disease. It was reported that (after first dose) patient experienced terrible diarrhea and symptoms of the neuralgia and then she was lucky enough to have her Entyvio 300 mg for Crohn's and it helped somewhat diarrhea. Patient received second dose of BNT162b2 on 29 of the March. It was reported that coming out the second dose on 29th immediately was really bad like pain and shortness of breath and she have had a back surgery so and she always feel bad so I did not think anything of it but then she ended up after the second dose into ER and discovered that my Crohn's had caused really bad flare up. Her foot was looking strange but she just was too tired and left ER. She went back to the hospital and couple days later they told me that actually she had deep vein thrombosis now in her legs. She also had superficial clot in that left leg that was the pain began on the edges through eventually the vaccine is basically started and that it's started the Crohn's flare up and now on but I always trying to get back on a shorter time period of Entyvio and she was also on blood thinners now for a blood clot. She have had a blood clot in my arm back in 2014 and also have had it before. So she was kind of fine now because which is she don't know, you know what to do but I just want to make sure it just got reported because I have seen Johnson & Johnson and other getting reports of products. Consumer stated, Because of diarrhea and Crohn's problem she was down to 91 and now in hospital they gave me Prednisone 40 mg, Tablet so the things are coming up. I am just above 100 right now but I have been in the hospital for 5 days now with the clot and Crohn's Flare. Consumer stated, Yes I had Multiple Sclerosis and I have Crohn's disease with ileostomy and I have an ileostomy where I no longer use my large intestine, I just use a bag. So, I just have the small intestine and I have a flare. When probed if still experiencing the events, Consumer stated, Yes she was still experiencing, the arm is much better now. You know that's not really sore. Crohn's is terrible and the blood clot they have me on the Xarelto. She was getting a bit tired and the pain it's pretty bad and Neuralgia is still pretty bad. The diarrhea was getting better so I am just trying to get healthy enough to leave the hospital. So, I can get on Entyvio because her insurance won't allow them to do the Entyvio in the hospital. So it's kind of frustrating but she was also experiencing extreme shortness of breath, extreme fatigue she couldn't get any oxygen to her muscles. She was realizing that was the blood clot. Consumer further stated, She was just wondering had you been hearing any reports of blood clots from the BioNTech Pfizer at all. The patient underwent lab tests and procedures which included endoscopy: nil, sigmoidoscopy: nil, Ultrasound of legs: nil on an unspecified date. The outcome of the event terrible diarrhea was unknown and outcome of the event neuralgia was not recovered. No follow-up attempts are needed. No further information is expected.
196	1487327-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Female	Patient presented to the ED on 6/7/2021 and was subsequently hospitalized for Diverticulitis of large intestine without perforation or abscess with bleeding. Patient had second dose on 6/17/2021. On 6/22/2021 patient presented to the ED and was subsequently hospitalized for bright red rectal bleeding. These visits are within 6 weeks of receiving COVID vaccination.
197	1489819-1	COVID19 (COVID19 (PFIZER-BIONTECH))	80+ years	Female	The clicking of the bone is a situation; Left brother's house about 2100, doesn't even remember driving away; The caller states or passed out or what the heck ever is going on with the caller's brain; The second dose Pfizer Covid 19 Vaccine was given in the right arm and had the bad side effect of excruciating pain 3.5 hours later and the pain was for some reason was in left arm.; In the evening, after done driving around doing shopping on that Saturday, 15MAY2021, did not know she fell asleep on the couch with the radio on; Had wobbly ankles, knees and hips; Had blurry eyes; Tiredness; After receiving the second dose Pfizer Covid 19 Vaccine, was what thought was a blood clot coming from the nasal area; It was extreme pain. It has not done anything but stayed in the muscle occasionally; This is a spontaneous report from a contactable consumer. This 81-year-old female consumer (patient) reported for herself. An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0176, Expiration date: 20Aug2021), via intramuscular, administered in right arm on 15May2021 (at the age of 81-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0164, Expiration date: 20Aug2021), via intramuscular, administered in right arm on 24Apr2021 at 12:15 or 12:30 (at the age of 81-year-old) as DOSE 1, SINGLE. The patient medical history includes Pneumonia cryptococcal (Dormant Lung disease cryptococcus), Osteopenia, Pancreatic disorder, Crohn's disease and Colectomy (2002), Cancer, Diabetes mellitus and Polyp, aphasia and seizures (1996). Dormant Lung disease cryptcoccus, this comes from pigeons, bats and birds poo flying in the air. With allergies the caller breathed it in on some far at the time in year 2000. Checked every year since year 2000. Gastroenterologist after many undisclosed solution for drastic weight loss since year 2018, now several tests have determined the caller's pancreas and stomach are not cooperating with each other. The caller has many issues with what the Gastroenterologist are doing with the caller, she feels like a Guinea pig. Concomitant medications include PANCREATIN (CREON) for Pancreatic disorder, AMITRIPTYLINE for Cerebral disorder and CYANOCOBALAMIN (B12-VITAMIIN). The patient was taking concomitant products creon because stomach and pancreas not cooperating with each other. In relation back up to brain thing drug for that is Amitriptyline. Began taking probably 12 years ago, 10 years ago at least. B12 was taking for memory, began taking probably 4 years ago courtesy of all the testing the general physician had done. The caller states she was lacking in so much and will be on this for the rest of life. Amitriptyline was supposed to take 10mg pill twice a day but don't take twice a day. Caller is getting antsy about putting too many chemicals in the body. When the caller is crying again will take more amitriptyline. So far just upset about current Pfizer situation. Only member to have Crohn's disease and intestines removed. Gall bladder, caller has not gotten. Cancer, diabetes and polyps in family history. On 15May2021, after the vaccination, the patient experienced bad side effects of excruciating pain 3.5 hours later and the pain was for some reason was in left arm. This arm pain lasted off and on for two days. It was extreme pain. It has not done anything but stayed in the muscle occasionally, and the shoulder joint was picking occasionally, on the left and the caller still had the clicking. The pain was a normal like grade of 2 to 3 type pain at the time of this report. Whenever the caller twinges the pain happens on its own. Patient also experienced wobbly ankles, knees and hips. The caller's walking was terrible, caller states this is just persisting but at a lower level. The caller is concerned because she is a fracture risk person because of osteopenia. Patient experienced blurry eyes and tiredness. The caller usually gets blurry eyes when the caller is not hydrated enough because of loss of weight and the ileostomy bag itself is free flowing so the caller's retention is not good to begin with. The caller clarifies the infectious disease doctor when the caller was reviewed in April, prior to receiving the Pfizer Covid Vaccines, knew the caller was under weight and severely effected because the caller wears an ileostomy bag due to Chron's disease and intestines being removed twice. The caller's absorption is not normal to begin with. When the doctor's office authorized the caller to get the Pfizer Covid 19 Vaccine in the first place it was within a 20 minute response time and nobody evidently checked the caller's chart prior to approving the caller to get this serious serious of Pfizer Covid Vaccines. Which is why the caller is so annoyed. The patient fell asleep on the couch with the radio on. The caller woke up to her surprise not knowing that she had even gone to sleep for a God knows unknown period. The caller continued to listen to all her favorite shows on the Saturday night radio and it happened again, the caller doesn't know the time it was the caller fell asleep again, patient also states that she passed out or what the heck ever is going on with the caller's brain. Patient also experienced tiredness, she states she delivered the grocers and unloaded the groceries and was really wiped out. She also experienced impaired driving ability that on the way back from her brothers house she doesn't even remember driving away at about 21:00. She states God knows how many minutes later in the caller's driveway sitting at the steering wheel of the caller's car. The caller has no recollection of what transpired in the 12 miles from the brother's house to the caller's house. Patient also experienced blood clot coming from the nasal area on 15May2021. It was a tiny blood clot, not normal, red from end to end. A hair, two or three like hair from the head coming out of the left nostril when the caller blew her nose. Tiny, red tipped white, no pain, no drip, nothing except naturally what came out when the caller blew her nose, hardly. caller states this went away and didn't last at all. on 16May2021, the next day with pain in the arm was off and on. On 17May2021 patient called the doctor's office and listed all of her side effects and passed the message to whatever nurse on duty and the nurse consults the doctor. The caller had been told to do the report to Pfizer for anything wrong. Also, the caller went to the Urgent Care, they told the caller she could not get her B12 shot for memory. The caller states her memory is not too good at the present time. The event blood clot from nose assessed as serious. The patient underwent lab test includes loss of wight 97 lbs at the time of vaccine. The outcome of the event thrombosis was recovered on 15May2021. The outcome of the events loss of consciousness, Somnolence, Joint stiffness, Blurry vision, Fatigue, impaired driving ability and Bone disorder was unknown and The outcome of the event pain in arm and myalgia was recovering.
198	1489821-1	COVID19 (COVID19 (PFIZER-BIONTECH))	6-17 years	Male	covid_test_name_post_vaccination=PCR covid_test_result=Positive; Condition worsen; pericardial effusion; develop GI; Heavier Insomia; dierrea; vomiting; fever; Headache; Hypotensive; Dehydrated; Developed into MISC; Patient said he had 4 vaccines; PCR resulted as positive on 17Jun2021 Nasal Swab; This is a spontaneous report received from a contactable other-HCP (father) reported for old son (patient). A 15-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0173 F) via an unspecified route of administration in left arm on 07Jun2021 as dose 2, single for COVID-19 immunization. Medical history included ongoing known allergy in mosquito bite (sketter syndrome) an allergic reaction to mosquito bites, as his son has grown up it has become less and less relevant. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Dose:01 Lot number: EW0171 Anatomical Location: Arm left) on 17May2021 for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations dates of birth or immunizations are not available. It was reported that my son traveled on 16May2021. Covid test prior traveling negative. On Jun2021, 4 days after vaccination develop GI, heavier insomia, dierrea, vomiting, fever, hypotensive, dehydraeted. On 11Jun2021 experienced pericardial effusion. On an unknown date Jun2021, developed into MISC and was intubated. The patient was hospitalized from 14 Jun 2021 to 6 Jul 2021. Treatment was received. On 15Jun2021, admission at (withheld), (Hidratation IV and IVIGs). On 16Jun2021 condition worsen and Intubated in (withheld). On 17Jun2021, transfer to (withheld) (7 days at PICU, another 7 at pediatrics). On Jun2021, developed a strong insomnia and headache. Events resulted in emergency room/department or urgent care. Treatment received for the adverse event was MISC protocol IVIGsAnakinra, esteroids and others. On an unknown date, Patient said he had 4 vaccines. His son spent 7 days in the ICU and 7 days in the pediatric unit was discharged from the hospital yesterday. Reported that other researchers studying MIS-C in children have seen how the epithelium cells in the intestine become loose, then the protein goes through the blood stream and can start a cytokine storm and asked if we have studies regarding how much S protein is being produced by different age groups; can it be checked how much S protein is going into the bloodstream to see adverse effects of the vaccine and stated he needs more data to see if his son was possibly infected with Covid during his vaccination period or what he previously infected and absolutely asymptomatic. Most MIS-C occurs 4-6 weeks after having Covid. States that for his son to travel he had to have antigen testing, which was negative. His son did well until 3-4 days after the second shot. States at that time his son became ill with vomiting, diarrhea, headache, and insomnia. She took her son to the hospital and they found him to be hypotensive and dehydrated. They started intravenous fluids and their protocols; the hospital did not have all the required medications for their son and recommended he be transferred to (withheld) Hospital. He was very tired and they decided to put him on ventilation for the ambulance drive. States that when they arrived in (withheld), his son was placed in ICU where he was on the ventilator for 5 days, the recuperating for 2 more days. His son was then moved throughout the hospital system until his discharge yesterday. His son's insomnia may have started before he left for the (withheld). States that it was worsened after the vaccine, his son mentioned after his hospitalization that he was actually given 4 shots the day he got his vaccines, assumed it to be some kind of delirium from his son being in the ICU for so long, stated he told his son that was not possible that he got 4 vaccines at once because of the paperwork you have to fill out to get the vaccine, the lady at the vaccination site told him to sit down and then gave shothim four shots. The patient underwent lab tests and procedures which included IgG and IgM resulted as positive on 15Jun2021, PCR resulted as negative on 15Jun2021 Nasal Swab, PCR resulted as positive on 17Jun2021 Nasal Swab. The clinical outcome of the event developed MIS-C and was intubated, vomiting, dierrea, headache, insomnia, hypotensive, dehydrated on an unknown date 2021 was resolved and the event pericardial effusion, develop GI, fever was resolving, the event condition worsen, Vaccination failure, patient said he had 4 vaccines and PCR resulted as positive on 17Jun2021 Nasal Swab was unknown; Sender's Comments: Based on the limited information currently available, the causal association between the event Insomnia, Diarrhea, vomiting, fever, Drug ineffective, COVID-19, Headache, overdose and the suspect drug cannot be excluded. Also, there is limited information in the case provided, the causal association between the event Multisystem inflammatory syndrome in children, Pericardial effusion, Gastrointestinal inflammation, Condition worsened, Hypotensive, Dehydration and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
199	1490518-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Male	Started with metallic taste in mouth that evening after 2nd shot, then chills for a solid couple of days. Metallic taste came back and chills went away. On Saturday, June 19th I got violently sick throwing up with diarrhea. The next week I had same event. I have since dealt with a metallic taste in my mouth again and gallbladder pains and pains in my intestines, with issues having bowel movements. When I eat the metallic taste increases and have more severe pains. I'm currently involved in a CT scan, Ultrasound, and now waiting to schedule a nuclear med test. I have been researching now that more people have reported gallbladder issues as well as the metallic taste.
200	1497405-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Male	fatigue; still having lower intestine cramping; Votimed 3 times starting; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8730) via an unspecified route of administration in the arm left on 25Mar2021 at 11:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux (esophageal), and diverticulitis. The patient did not receive any other medications within 2 weeks of vaccination. The patient was allergic to penicillin. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6202) via an unspecified route of administration in the arm left on 4Mar2021 at 11:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, at 17:00 the patient experienced vomited 3 times. From 25March2021 at 17:00 to 26March2021 at 18:00, patient experienced diarrhea and again diarrhea started from 28March2021 at 18:00 to 29March2021. On 26March, the patient experienced fatigue, lower intestine cramping and still have it and forwarded on. The patient did not receive any treatment for the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events diarrhea, vomited, fatigue and lower intestine cramping were not resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.
201	1497451-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Female	Sepsis; appendicitis; intussusception of the distaileum; allergy attack; fever 100.6-102.6; Upset stomach; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN6204) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Pending clarification) (Batch/Lot Number: ER8730) as SINGLE DOSE for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included breast cancer survivor, unspecified allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) taken for immunisation on 12Feb2021. The patient received other medications within 2 weeks of vaccination. The patient experienced allergy attack, fever 100.6-102.6, upset stomach on 23May2021, on 26May2021 Computerised tomogram (CT) showed intussusception of the dista ileum. Went to emergency room (ER), treated for sepsis. Surgery 26May2021 showed appendix wrapped around small intestine forcing telescoping. Appendix and adhesions and lymph node removed. Biopsy showed appendicitis. Adverse events resulted in emergency room/department or urgent care and hospitalization. Patient was admitted to hospitalization for 3 days. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Covid test (Nasal Swab): negative on 26May2021, and Covid test (Saliva Test): negative on 25May2021. The outcome of the events was recovered.
202	1498258-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Male	increase pain in stomach and intestine also increase spread of nephropathy from feet to lower legs and forearms and hands
203	1498402-1	COVID19 (COVID19 (JANSSEN))	65-79 years	Female	fever ,swelling of face and throat, red rash all over upper body. intestines swelled. epipen, benadryl, prednisone starting at 4pm. still taking benadryl and prednisone
204	1501701-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Female	Swelling of intestines (leading to severe diverticulitis-never had before) Swelling of ovary (5x) Swellng of liver Swelling of mesentery Spleen pain Stomach pain Heart palpitations Continued stomach and intestine issues
205	1507984-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Male	headache; Little bit of cough; sinus discomfort; difficulty in breathing; This is a spontaneous report from a Pfizer sponsored Program. A contactable consumer (Wife) reported that a 75-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left (Left shoulder) on 26Feb2021 (at the age of 75-year-old) (Lot Number: EN6205, NDC number, UPC number, Expiry Date: Unknown) as dose 1, single for covid-19 immunisation. Medical history included Blood pressure high, anxiety, High cholesterol, Thyroid issues, breaks out itching terrible, for his allergies, he was constipated from Jan2021 (He just couldn't get his bowel movement there are some arteries that run from stomach to small intestine and that were narrowing). Concomitant medication(s) included citalopram (40 mg, tablet, once a day) taken for anxiety; atorvastatin (40 mg, once a day, tablet) taken for High cholesterol; levothyroxine (112 mcg, once a day, tablet) taken for Thyroid issues; fexofenadine (180 mg, tablet, once a day as needed) taken for itching terrible and for his allergies; amlodipine (generic Norvasc, 10 mg, tablet, once a day) taken for high blood pressure; for all start and stop date were not reported. On an unspecified date, the patient experienced headache, little bit of cough, sinus discomfort, difficulty in breathing. Caller was calling to report some adverse events (headache, sinus, difficulty in breathing, cough) experienced by her husband. She mentioned that they got the 1st vaccine shot together on 26Feb2021 and are scheduled for 2nd shot tomorrow (19Mar2021). She wants to know if her husband can still get the vaccine tomorrow despite the adverse events. Additional Information for Concomitant Products Levothyroxine: Indication: Reporter stated, ""Thyroid issues."" Dates for Concomitant Products Fexofenadine: (Start: Unspecified Stop: Unspecified). Additional Information for Concomitant Products Fexofenadine: Reporter stated, ""Once in a while he just breaks out itching terrible, for his allergies, she guess."" Reporter stated, "" Reporter just had a question, my husband and Reporter just had first Pfizer Covid shot on 26Feb2021 and now they are due to have our second shot due for tomorrow but about last week her husband just had a headache, little bit of cough, some sinus discomfort, he was pretty blocked up, but he finally get up today feeling like he could breathe better, Reporter was just wondering since patient was having headache and all these other little symptoms, should patient have his second shot tomorrow"". When paraphrased the concern reporter confirmed the same and stated, ""Right, he had a sinus discomfort, he was little stuffed up, he has little bit of cough almost every day, anyway reporter didn't know if these symptoms were could have come from his last shot specially the headache or its just normal for him to like since he got headache and stuff anyway, he should go and have his second shot tomorrow because the papers that they gave us when he got his first shot the headache especially could be a side effect from and reporter was like he already got a headache that's her question that should we go and get his second shot anyway. Email address: Reporter stated, ""They did not have an email, They did not have a computer. Reporter stated, ""No, her husband was a Pharma and reporter was a homemaker."" Facility of vaccination details: Email address: Reporter stated, ""No, she don't have that."" Expiration date, NDC# and UPC#, Reporter stated, ""Reporter was not seeing it on the card they gave us at the clinic. Site of Administration of vaccine: Left shoulder. Other medications: Reporter stated, ""He has some thyroid issues, he takes Synthroid (later clarified as Levothyroxine), for his high blood pressure, it was generic Norvasc, 10 mg, once a day, tablet (further not clarified). Diagnosis date of High Blood pressure, High Cholesterol and anxiety, reporter stated, ""reporter could not because he was having issue for years and reporter could not remember when he was diagnosed with the stuff."" Laboratory work: Reporter stated, ""Yes, in Jan2021, he was not feeling good so we take him to the emergency room and they found out that he was constipated. He just couldn't get his bowel movement they saw and reporter could not tell you want kind it was, they saw and understand that he was constipated, there are some arteries that run from stomach to small intestine and that were narrowing, doctor said that when they are narrowing bowel don't work, so reporter did not know they did enemas and told him to take bunch of stuff and it took couple of weeks but we got him going again and he has seen a specialist, he has seen a doctor, did ultrasound and did some work studies of his abdomen and checked out that artery and that specialist didn't think it was bad enough, they put the stuff in, so that was last in January."" Date of the test, reporter stated, "" reporter did not think this all worth it, its 05Jan2021, we took him to the emergency he had complete blood count, comprehensive metabolic panel, 'CT' abdomen, ECG, chest X-ray."" Still experiencing events: Reporter stated, ""Headache was now about for a week now, his headache was little left, and when he got up he could breathe a little better, his sinus discomfort seems like every morning he got all stuffed up, he just coughed little bit in the morning, he just cleared out, but that was kind of normal for him but reporter was just wondering if some of those symptoms were from first shot and he should go for second shot."" Treatment: Reporter stated, ""No, he was showing Primary Physician for years for sinus and stuff."" The outcome of events was recovering. Follow-up (31May2021): Follow-up attempts completed. No further information expected.""
206	1508885-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Female	intense gastric/stomach pain; pain still persisted; intense abdominal cramping, which was around, either right below the stomach, or right around that large intestine; Sore left arm; discomfort for two days that went up into her chest a little bit, but the predominant gastro location; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EW01a8 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm left on 01Jul2021 at 21:50 (at the age of 35-year-old) as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included small heart, and pains on the left side of her chest prior to vaccination. She stated that she did not know if it was a condition, she just found out recently she has a small heart, but she was a pretty petite girl, and did not know if that was normal for her. Family history included she had an immunocompromised parent who received the Pfizer BioNtech Covid-19 Vaccine and her dad had a heart attack after Moderna vaccination. She stated she didn't really want to comment too much because she did think he had pre-existing conditions, they did not have a great relationship so she really could not give a lot of information on him, she couldn't even tell his favorite color. The patient's concomitant medications were not reported. The patient previously took Panmist and experienced reaction to Panmist. She stated that Panmist sent her central nervous system out of whack, and added, compared the ingredients and it was said that nothing was in the Pfizer vaccination that was in Panmist. She stated that it occurred around the age of 12 years, and form or how medication was taken was unknown. On 01Jul2021, the patient experienced intense gastric/stomach pain, pain still persisted, intense abdominal cramping, which was around, either right below the stomach, or right around that large intestine, sore left arm, discomfort for two days that went up into her chest a little bit, but the predominant gastro location. Clinical course: The patient stated that she received the first dose of the Pfizer BioNTech covid-19 Vaccine on 01Jul2021 and experienced intense gastric pain for about 20 minutes and subsided. The pain still persisted for about 2 days. She also experienced abdominal cramping for about 2-3 days. The patient stated that she got her first shot 01Jul2021, which was really exciting, but about twenty minutes after she got her shot, she started having really intense gastro pains, and it did not come out either end, it was not vomiting or diarrhea, it was just pain. She added that lasted a few minutes, then for about two days, it wasn't acid reflux, but it was that whole kind of feeling for two days. She did not have a history of acid reflux, she was 35, pretty good so far, on a lot of boxes, she wa pretty healthy. Her question really was regarding that pre-covid checklist, on page six of the pre-vaccination checklist, it said if you have any gastrointestinal reactions, that you shouldn't get the second shot. She asked, was that true. She stated, if this sounds familiar at all, she did not know if it would give her peace of mind that it's not necessarily uncommon, because she hadn't really heard anyone having this that she knew. She got the shot from pharmacy around 21:40 or 21:50, she tried to go at a minimal time, she cared for a immunocompromised individual, so she needed the most minimal traffic as possible. She clarified the symptoms occurred before 22:30. There was a real discomfort for two days around that same area, that almost went up into her chest a little bit, but the predominant gastro location. She confirmed after forty-eight hours, it did completely resolve. She had the sore arm, which was fine, she's just more concerned about that gastro cramping, and why it said not to get the second shot, she just wants to know, she did not want to screw up. It was her left arm, and it occurred later that same night, but she immediately started wrapping it with cold rags and exercising it, and she did not experience a big issue with that, due to the proactive measures she was taking to try to heal the muscle. She stated by the full second day, she was doing well compared to a lot of people, and she confirmed the sore arm had resolved by 03Jul2021. Caller confirms the gastro pain was fully resolved by Sunday, 04Jul2021, it was all relieved, it was all ok, she was on alert. She confirmed the time of vaccination as 21:50. She was pretty healthy overall and was not on any medications and still was not, she didn't even take ibuprofen or anything like that for her arm, she just wrapped it and exercised it. She stated that she had been having pains on the left side of her chest prior to vaccination, but she thought it's stress induced, because her x-ray looked okay. She thought it's just from the isolation and extreme measures. Investigations: she stated no, but added, the weekend prior to her getting the shot, she ended up in urgent care for her mom, and caller got looked at for her chest, and they referred her to a cardiologist, but her tests were scheduled for this week, so Tuesday of this week, 06Jul2021, she had blood work and they did an x-ray. She clarified this was for the previous chest pain that she had prior to getting vaccinated and not for the symptoms reported after the vaccine. She confirmed it was a chest x-ray, and states everything looked fine. She added, there was a number she needed to ask the doctor about, that was low, but she didn't understand it. She stated she did not know what lab was low, she would have to pull it up. She stated she would hate for this to be correlated with the vaccination, when there was no science to it whether it was related to that experience or not. The outcome of the event sore left arm was resolved on 03Jul2021 and other events were resolved on 04Jul2021. Follow-up attempts are completed. No further information is expected.
207	1512935-1	COVID19 (COVID19 (MODERNA))	40-49 years	Male	Patient presented to the ED and was subsequently hospitalized for Diverticulitis of large intestine with perforation without bleeding within 6 weeks of receiving COVID vaccination.
208	1515571-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Male	On May 31st I went to Medical Center. When I went there, I went to the ER, and they did a blood test because I had stomach pains from my stomach to my intestines back and forth. I was nauseated every morning I woke up. When they did the blood test, they found that my liver enzymes where higher for AST and ALP. They were higher than normal in the 500 range and the highest was 660. They also did a CT scan and ultrasound but didn't find anything. My liver and gallbladder were okay. I got discharged then I went to my PCP and had more blood test done. The results were slightly lower than what I had in the ER. My PCP referred me to a liver specialist. I was still experiencing stomach pains and nausea. I didn't experience and vomiting or diarrhea. The liver specialist did a test for EBV. They concluded that I did have EBV. In the meantime, I had an MRI, and the internal organs of my abdomen were good. My liver doctor may do a liver biopsy to see if my counts are still high and if something is still going on with my liver.
209	1522744-1	COVID19 (COVID19 (MODERNA))	60-64 years	Male	Patient hospitalized for Diverticulitis of large intestine without perforation or abscess without bleeding for 2 hours on 5/6/2021. On 5/20/2021 patient hospitalized for same diagnosis. These visits are within 6 weeks of receiving COVID vaccination.
210	1524844-1	COVID19 (COVID19 (MODERNA))	18-29 years	Female	Fluid around her heart; Thickening in her intestines; Fever of 101ªF; Began vomiting; Having pain in her belly, where her gallbladder is, then complained that it was moving to other side; Felt nauseated/Feel like have to puke; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (Fluid around her heart) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immune system disorder, Kidney stones, Asplenia (No spleen) and IQ test abnormal. On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced NAUSEA (Felt nauseated/Feel like have to puke). On 18-Jun-2021, the patient experienced ABDOMINAL PAIN (Having pain in her belly, where her gallbladder is, then complained that it was moving to other side). On 21-Jul-2021, the patient experienced PERICARDIAL EFFUSION (Fluid around her heart) (seriousness criteria hospitalization and medically significant). On 24-Jul-2021, the patient experienced VOMITING (Began vomiting). On 27-Jul-2021, the patient experienced PYREXIA (Fever of 101ªF). On an unknown date, the patient experienced GASTROINTESTINAL WALL THICKENING (Thickening in her intestines). The patient was hospitalized from 21-Jul-2021 to 22-Jul-2021 due to PERICARDIAL EFFUSION. The patient was treated with NAPROXEN SODIUM (NAPROXEN [NAPROXEN SODIUM]) ongoing since an unknown date at a dose of 500 mg; COLCHICINE ongoing since an unknown date at a dose of .6 milligram once a day; AMOXICILLIN, CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM [AMOXICILLIN;CLAVULANATE POTASSIUM]) at a dose of 875/125 and Surgery (pericardiocentesis) for Pericardial effusion. At the time of the report, PERICARDIAL EFFUSION (Fluid around her heart), ABDOMINAL PAIN (Having pain in her belly, where her gallbladder is, then complained that it was moving to other side), GASTROINTESTINAL WALL THICKENING (Thickening in her intestines), NAUSEA (Felt nauseated/Feel like have to puke), VOMITING (Began vomiting) and PYREXIA (Fever of 101ªF) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Echocardiogram: abnormal (abnormal) moderate fluid around her heart. On 25-Jul-2021, Bacterial test: negative (Negative) Negative. On 27-Jul-2021, Body temperature: 101 (High) 101 degrees Fahrenheit. It was reported that there was a little thickening in patient intestines. Patient took medicine for 4 days, then patient's mother stopped it because doctor was uncertain of cause of thickening. Patient was also prescribed Pepcid, but she's presently not taking. No concomitant medications were provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
211	1529154-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Female	After the 2nd dose I started noticing I was experiencing some gastrointestinal issues that were getting worse like GERD. I was burping up a lot of acid and had weird stomach issues I couldn't explain. A few weeks ago i got really sick out of nowhere and my diet or nothing had changed. I went to the ER and they gave me steroids and said I had pancolitis (inflammation all over my intestines). I went home and Took the steroids and got worse. I was pooping blood and fat and couldn't keep anything down, either throw it up or poop it out. I went back to the ER and was admitted for a week and now on heavy steroids. They said the pancolitis got worse and the steroids they gave wasn't helping.
212	1530784-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Female	veins in the back of my knees are hurting; On 4/8 I woke up very sick; By 1 pm I was sleepy and woke up at 3; By 4-5 pm I had chills; By 4-5 pm I had body ache; nausea; heart palpitations; mild sore arm; By 6-8 pm I was vomiting a lotOn 4/8 I woke up very sick. Kept throwing up water and liquids; All night I felt sick9 pm and still feeling sick; sensitivity to noises as well; had raising thoughts in my mind. The raising thoughts and things in my mind bother me.; I have the feeling that I can feel my kidneys, liver, intestines; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the arm left on 07Apr2021 at 10:00(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included alprazolam (MANUFACTURER UNKNOWN,0.5mg) 3 in the night from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 the patient experienced sleepy by 13:00 and woke up at 15:00. By 16:00-17:00 she had chills, body ache, no fever, nausea, heart palpitations, feeling that her blood was on fire, mild sore arm. By 18:00-20:00 she was vomiting a lot and also going to the bathroom loose no diarrhea. All night she felt sick and had raising thoughts in her mind. She had sensitivity to noises as well. On 08Apr2021 she woke up very sick. Kept throwing up water and liquids. Couldn't eat. By 13:00 she have thrown up some more. The raising thoughts and things in her mind bother her. By 15:00 her veins in the back of her knees are hurting. She have the feeling that she can feel her kidneys, liver, intestines 21:00 and still feeling sick. No therapeutic measures were taken as a result of the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sleepy by 13:00 and woke up at 15:00. By 16:00-17:00 she had chills, body ache, no fever, nausea, heart palpitations, feeling that her blood was on fire, mild sore arm. By 18:00-20:00 she was vomiting a lot and also going to the bathroom loose no diarrhea. All night she felt sick and had raising thoughts in her mind. She have sensitivity to noises as well. On 08Apr2021 she woke up very sick. Kept throwing up water and liquids. Couldn't eat. By 13:00 she have thrown up some more. The raising thoughts and things in her mind bother her. By 15:00 her veins in the back of her knees are hurting. She have the feeling that she can feel her kidneys, liver, intestines. 21:00 and still feeling sick were not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.
213	1534180-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Female	racing heartbeat; difficulty breathing/Labored breathing; This is a spontaneous report from a contactable consumer (patient ). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN9581; Expiration Date: 31May2021) via an unspecified route of administration, administered in Arm Left on 16Feb2021 14:30 (at age of 67-year-old) as dose 1, 0.3 ML single for COVID-19 immunization. Medical history included acid reflux (for six years) from 2015 to an unknown date, chronic stomach problem (has a chronic stomach problem, which she has had for a while. Came from an antibiotic. She had MRSA in her toe and was on two very strong antibiotics. Thought she had small intestine bacterial overgrowth. Had been taking Probiotics, 20 billion. Probiotics did not cure it or get rid of the overgrowth but helped her eat more food than just a turkey sandwich day and night) from an unknown date and unknown if ongoing, couldn't walk (was on another antibiotic and was in such severe pain in her knee she couldn't walk for a week. Cannot remember the name of that antibiotic) from an unknown date and unknown if ongoing. Family history included heart trouble (everybody was dead on both sides of her family. There was a strong history of heart trouble of both sides of the family, but not racing heart. Stated she did not have heart troubles) from an unknown date and unknown if ongoing. The patient's concomitant medications included lactobacillus Nos (CULTURELLE) ongoing since Nov2020 (helps her eat more food and has definitely made an improvement. Stated culturelle was not a cure but had helped her to a certain point. She would not go off of it) for acid reflux and chronic stomach problem. The patient previously took xifaxan (clarified the only antibiotic to get rid of the C-bo was xifaxan. She did not take it because the side effects were like flagyl. Confirmed she has no NDC/Lot/Exp for xifaxan) and had experienced drug intolerance, metronidazole (clarified she took the generic of flagyl, metronidazole manufacturer: Teva; Dose: 500mg; one tablet every 12 hours. Took Metronidazole and the very next day had the blisters all over the place) and experienced blister. Reporter states after receiving the first dose on 20Feb2021 her heartbeat was racing and had difficulty in breathing, for 1 hour (reported as on the 5th day after getting the first dose of the vaccine) and again on the 6th day, lasted for 3 hours. Her heart was going like it was mad. Had trouble and labored breathing, but not to the point where she needed help. Felt like her whole body was vibrating. Heart was racing. It was terrible. Caller wanted to know if she should receive her second dose as scheduled next week, Tuesday 09Mar2021, after the AEs that she had experienced. The patient underwent lab tests and procedures on an unspecified date which included heart rate increased, racing. The outcome of both the events was unknown. No follow-up attempts are possible. No further information is expected.
214	1545642-1	COVID19 (COVID19 (JANSSEN))	30-39 years	Female	I went to the hospital with severe stomach pain that was radiating to my back. It was causing me to have diarrhea, nausea, vomiting. At some point a stool had turned black so they thought I had a GI bleed, but they did a CT scan and they said my colon and my intestine were severely inflamed. I was hospitalized for 3 days so they could give me round the clock antibiotic treatments. When I was discharged they put me on a 7 day antibiotic. I followed up with my PCP and made him aware of the situation and now I am just waiting for September 2nd to get a colonoscopy performed. I am still experiencing the same symptoms. No vomiting, no black stools, stomach and back pain are not as bad.
215	1548272-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	stomach pain; an uncomfortable feeling in my intestines; very loose stool; I can eat, but not like used to do; fatigued; felt a little listless and not as active; felt a little listless and not as active; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LISTLESS (felt a little listless and not as active), DECREASED ACTIVITY (felt a little listless and not as active), PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach pain) and ABDOMINAL DISCOMFORT (an uncomfortable feeling in my intestines) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced LISTLESS (felt a little listless and not as active), DECREASED ACTIVITY (felt a little listless and not as active) and PAIN IN EXTREMITY (sore arm). On 07-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL DISCOMFORT (an uncomfortable feeling in my intestines), DIARRHOEA (very loose stool), DECREASED APPETITE (I can eat, but not like used to do) and FATIGUE (fatigued). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 07-Feb-2021, LISTLESS (felt a little listless and not as active), DECREASED ACTIVITY (felt a little listless and not as active) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL DISCOMFORT (an uncomfortable feeling in my intestines), DIARRHOEA (very loose stool), DECREASED APPETITE (I can eat, but not like used to do) and FATIGUE (fatigued) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
216	1550525-1	COVID19 (COVID19 (MODERNA))	Unknown	Female	It felt like somebody was walking on my intestines, it was as sore as can be; I thought I was gunna faint; The sweat and heat hit me; I guess you call it flushing, your body overheats; It would hurt here and then it would hurt there, but basically it would hurt in all of my joints, like the flu; I got so weak; fever of 101.7; chills; it's like my body couldn't stop moving; got up in the middle of the night several times; It felt like I had extreme pain in my joints, neck, one in my ear, one in my eye, like it moved to; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101.7), CHILLS (chills), PSYCHOMOTOR HYPERACTIVITY (it's like my body couldn't stop moving), SLEEP DISORDER (got up in the middle of the night several times) and PAIN (It felt like I had extreme pain in my joints, neck, one in my ear, one in my eye, like it moved to) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (fever of 101.7), CHILLS (chills), PSYCHOMOTOR HYPERACTIVITY (it's like my body couldn't stop moving), SLEEP DISORDER (got up in the middle of the night several times), PAIN (It felt like I had extreme pain in my joints, neck, one in my ear, one in my eye, like it moved to), INFLUENZA LIKE ILLNESS (It would hurt here and then it would hurt there, but basically it would hurt in all of my joints, like the flu) and FATIGUE (I got so weak). On 19-Feb-2021, the patient experienced FLUSHING (I guess you call it flushing, your body overheats), ABDOMINAL PAIN (It felt like somebody was walking on my intestines, it was as sore as can be), DIZZINESS (I thought I was gunna faint) and HYPERHIDROSIS (The sweat and heat hit me). At the time of the report, PYREXIA (fever of 101.7), CHILLS (chills), PSYCHOMOTOR HYPERACTIVITY (it's like my body couldn't stop moving), SLEEP DISORDER (got up in the middle of the night several times), PAIN (It felt like I had extreme pain in my joints, neck, one in my ear, one in my eye, like it moved to), FLUSHING (I guess you call it flushing, your body overheats), INFLUENZA LIKE ILLNESS (It would hurt here and then it would hurt there, but basically it would hurt in all of my joints, like the flu), ABDOMINAL PAIN (It felt like somebody was walking on my intestines, it was as sore as can be), DIZZINESS (I thought I was gunna faint), HYPERHIDROSIS (The sweat and heat hit me) and FATIGUE (I got so weak) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment details were provided. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR
217	1551032-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	Red rash on the injection site; Rash got bigger and was pink in the center and bright red on the borders; baseball ball; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash on the injection site), VACCINATION SITE ERYTHEMA (Rash got bigger and was pink in the center and bright red on the borders) and VACCINATION SITE SWELLING (baseball ball) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (Red rash on the injection site), VACCINATION SITE ERYTHEMA (Rash got bigger and was pink in the center and bright red on the borders) and VACCINATION SITE SWELLING (baseball ball). At the time of the report, VACCINATION SITE RASH (Red rash on the injection site), VACCINATION SITE ERYTHEMA (Rash got bigger and was pink in the center and bright red on the borders) and VACCINATION SITE SWELLING (baseball ball) was resolving. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other relevant concomitant medications included Blood pressure medication, Thyroids medication, Sleeping pill, Stomach medication and Intestine problems medication. Treatment information included Ice on the injection site.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
218	1551869-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	thickening of my tongue; itchy; lower intestines rumbled; arms felt heavy; Patient has not had second dose; Thowing up/Threw up that night; Felt like boiling water pouring down arm; Super tired; Felt dizzy; Arm and fingers felt sluggish for the day; Horrible migraine; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (thickening of my tongue), PRURITUS (itchy), GASTROINTESTINAL SOUNDS ABNORMAL (lower intestines rumbled), LIMB DISCOMFORT (arms felt heavy) and DIZZINESS (Felt dizzy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Allergy NOS (History of bad allergies (unspecified)). On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced DIZZINESS (Felt dizzy), SLUGGISHNESS (Arm and fingers felt sluggish for the day), MIGRAINE (Horrible migraine), VOMITING (Thowing up/Threw up that night), VACCINATION SITE PAIN (Felt like boiling water pouring down arm) and FATIGUE (Super tired). On an unknown date, the patient experienced TONGUE DISORDER (thickening of my tongue), PRURITUS (itchy), GASTROINTESTINAL SOUNDS ABNORMAL (lower intestines rumbled), LIMB DISCOMFORT (arms felt heavy) and PRODUCT DOSE OMISSION ISSUE (Patient has not had second dose). On 26-Jan-2021, MIGRAINE (Horrible migraine) and FATIGUE (Super tired) had resolved. At the time of the report, TONGUE DISORDER (thickening of my tongue), PRURITUS (itchy), GASTROINTESTINAL SOUNDS ABNORMAL (lower intestines rumbled), LIMB DISCOMFORT (arms felt heavy), DIZZINESS (Felt dizzy), SLUGGISHNESS (Arm and fingers felt sluggish for the day), VOMITING (Thowing up/Threw up that night) and VACCINATION SITE PAIN (Felt like boiling water pouring down arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not had second dose) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Concomitant medications and treatment information was not provided. The patient has not gotten the second dose. She is afraid of having the second dose. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Based on the current available information and strong temporal association between the use of the product and the start date of the event, and excluding all other etiologies, a causal relationship cannot be excluded. Tiredness, vaccination site pain and vomiting are consistent with the known safety profile of the vaccine. Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Follow-up information received captured additional adverse events, medical history and reporter details.; Reporter's Comments: Based on the current available information and strong temporal association between the use of the product and the start date of the event, and excluding all other etiologies, a causal relationship cannot be excluded. Tiredness, vaccination site pain and vomiting are consistent with the known safety profile of the vaccine.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
219	1551951-1	COVID19 (COVID19 (MODERNA))	80+ years	Male	pain in intestines; nose bleed; headache was terrible; shoulder and arm kind of sore; Hurt everywhere (head, shoulders, stomach, rib cage, back); A spontaneous report was received from a healthcare professional concerning a 81-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in the intestines, blood in mouth, headache , shoulder and arm soreness, and hurting everywhere all through their body. The patient's medical history included Crohn's disease. Concomitant medications reported were atorvastatin calcium and gabapentin. On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient began experienced pain in the intestines, shoulder and arm. It was also reported that the patient woke up with blood in the mouth, from a nose bleed. On 27 Jan 2021, the patient experienced headache , shoulder and arm soreness and pain everywhere all through their body, so much pain could not lay in bed, could not lay down or sit up, hurt everywhere (head, shoulders, stomach, rib cage, back). Treatment details included Vicodin.. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, intestine pain, blood in mouth, headache, shoulder and arm soreness, pain everywhere, was considered recovered/ resolved on 01 Feb 2021.; Reporter's Comments: The events were consistent with increased risk of complications associated with Crohn's disease confounded by elderly age of patient. Company assessed the events to be unlikely related to company product.
220	1555428-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Male	05.19.2021: - I experienced lightheadedness, sore arm, sore shoulder. Took Advil to relieve soreness. 05.28.2021-06.04.20121: - I started feel like my stomach is bloated-feels full. 06.05.2021: - Stomach continues to feel bloated-feels full. I started to feel a mild abdominal pain in the evening; the pain progressively - pain intensified through the early morning. 06.06.2021: - Abdominal pain continued. vomited. Took tums & relieved the pain for a couple of hours. 06.07-08.2021: I called Doctor Office & met with Doctor since my primary care physician was not available. I explained to Doctor what I was experiencing; he instructed me to go the Emergency Room directly. I headed to the Hospital Emergency Room and was later admitted to the hospital (See below for details). Result: CT ABD PEL W IV CON CT ABDOMEN AND PELVIS RADIOLOGIST MD. HISTORY: 55 years Male, presents with periumbilical pain x 3 days- diarrhea . COMPARISON: None. TECHNIQUE: Helical axial contiguous CT images through the abdomen and pelvis following the administration of IV contrast. Oral contrast was not administered. Sagittal and coronal reformats were reconstructed and reviewed. FINDINGS: Limitations: None. Lower chest: There is a small linear bands at the medial aspect of the right middle lobe. There are bilateral dependent changes. Liver: There is a too small to characterize hypodensity at the left liver lobe.. Spleen: Unremarkable. Gallbladder: Unremarkable. Pancreas: Unremarkable. Adrenal Glands: Normal Kidneys: There is a 1.3 cm cortical cyst at midportion of the left kidney. There is a diffuse multiple tries cortical hypodensity at the lower portion of the left kidney.. Stomach: Unremarkable. Bowel: There is no bowel obstruction. There is mild diffuse dilatation of the small bowel loops with liquid contents. There is abrupt transition of the caliber at the distal small bowel loops/terminal ileum compatible with bowel obstruction. Appendix: There are no signs of acute appendicitis. Vessels: Aorta is normal in caliber. PAGE 1 EXAMS CT ABD PEL W IV CON Peritoneum: Unremarkable. Lymph nodes: There is no lymphadenopathy Urinary bladder: Unremarkable. Reproductive: Unremarkable. Bones: Unremarkable. Soft tissues: Unremarkable. IMPRESSION: Small bowel obstruction with transition point at the distal small bowel/terminal ileum of indeterminate etiology. Thank you for allowing us to participate in the care of your patient. This CT was performed using the most up-to-date dose reduction software and techniques (including automated exposure control, adjustment of the MA and/or kV according to patient size, and iterative reconstruction technique) in accordance with our continuing efforts to minimize radiation dose while maximizing the diagnostic quality of our images. Released for the hospital. Restricted to soft food diet. I still am experiencing abdominal discomfort but no extreme pain. 06.11.2021: Met with Dr. for follow-up visit as instructed by attending physician as Hospital Center. 06.15.2021: - I received my 2nd COVID shot no significant adverse reaction; however, I continue to experience abdominal discomfort through 06.19.2021. 06.20-21.2021: - I started to feel my abdominal discomfort transitioning pain. The abdominal pain progressively intense; I started to sweat profusely. I was discovered by my spouse on the bed face down but responsive and was taken to the Hospital Emergency Room. 06.21-07-01.2021: Encounter Diagnosis Abdominal pain (Discharge Diagnosis) - 6/21/21 Bowel perforation (Discharge Diagnosis) - 6/21/21 Intussusception intestine (Discharge Diagnosis) - 6/21/21 Pneumoperitoneum (Discharge Diagnosis) - 6/21/21 Elevated liver enzymes level (Discharge Diagnosis) - 6/30/21 Sepsis, unspecified organism (Final) - Acute respiratory failure, unspecified whether with hypoxia or hypercapnia (Final) - Perforation of intestine (nontraumatic) (Final) - Peritonitis, unspecified (Final) - Severe sepsis with septic shock (Final) - Intussusception (Final) - Fistula of intestine (Final) - Disruption of external operation (surgical) wound, not elsewhere classified, initial encounter (Final) - Family history of diabetes mellitus (Final) - Essential (hemorrhagic) thrombocythemia (Final) - Contact with and (suspected) exposure to COVID19 (Final) - Family history of ischemic heart disease and other diseases of the circulatory system (Final) - Meckel's diverticulum (displaced) (hypertrophic) (Final) - Removal of other organ (partial) (total) as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure (Final) - Personal history of other medical treatment (Final) - Personal history of nicotine dependence (Final) - Other long term (current) drug therapy (Final) - Discharge Disposition: Home - 01 PREOPERATIVE DIAGNOSIS: 1.Pneumoperitoneum 2.Small bowel intussusception 3. Hollow viscus perforation POSTOPERATIVE DIAGNOSIS: 1.Small bowel perforation 2. Meckel's Diverticulum 3. Intraluminal small bowel mass 4. Large Pelvic abscess 5.Purulent peritonitis PROCEDURE PERFORMED: 1.Exploratory laparotomy 2.Small bowel resection 3.Abdominal washout 4.Placement of Negative pressure temporary abdominal wound closure device 07.06.2021 - Appointment with Dr. (Infectious disease). Patient is doing well post-surgery and was cleared to return. 07.07.2021: - Appointment with Dr. - post exploratory laparotomy, bowel resection open abdomen June 21, 2021 and return to operating room for small-bowel anastomosis and abdominal closure June 23, 2021.Patient recovering appropriately. Patient states he has been cleared to travel back. Patient instructed to follow-up with his primary care physician and seek gastroenterology referral for colonoscopy to be completed at least 6 weeks after the time of surgery 07.28.2021: Appointment with Dr. for follow up visit as instructed by attending physician in Hospital. Dr. recommended 4-8 weeks for recovery with gradual return to work and to schedule an appointment with Dr 08.05.2021: Appointment Dr. Patient is doing well status post-surgery. In hindsight, I am not sure what could have or would have been done differently to prevent the course of events that occurred. The intensity of his work-up was determined by his symptoms and he was symptom-free shortly after presenting to the emergency department. It is interesting to note that both episodes occurred shortly after both doses of his Covid vaccination. I am not sure of the causative link.
221	1555429-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Male	05.19.2021: - I experienced lightheadedness, sore arm, sore shoulder. Took Advil to relieve soreness. 05.28.2021-06.04.20121: - I started feel like my stomach is bloated-feels full. 06.05.2021: - Stomach continues to feel bloated-feels full. I started to feel a mild abdominal pain in the evening; the pain progressively - pain intensified through the early morning. 06.06.2021: - Abdominal pain continued. vomited. Took tums & relieved the pain for a couple of hours. 06.07-08.2021: I called Family Practice & met with Dr since my primary care physician was not available. I explained to Dr what I was experiencing; he instructed me to go the Emergency Room directly. I headed to the Emergency Room and was later admitted to the hospital (See below for details). Result: CT ABD PEL W IV CON CT ABDOMEN AND PELVIS RADIOLOGIST: HISTORY: 55 years Male, presents with periumbilical pain x 3 days- diarrhea . COMPARISON: None. TECHNIQUE: Helical axial contiguous CT images through the abdomen and pelvis following the administration of IV contrast. Oral contrast was not administered. Sagittal and coronal reformats were reconstructed and reviewed. FINDINGS: Limitations: None. Lower chest: There is a small linear bands at the medial aspect of the right middle lobe. There are bilateral dependent changes. Liver: There is a too small to characterize hypodensity at the left liver lobe.. Spleen: Unremarkable. Gallbladder: Unremarkable. Pancreas: Unremarkable. Adrenal Glands: Normal Kidneys: There is a 1.3 cm cortical cyst at midportion of the left kidney. There is a diffuse multiple tries cortical hypodensity at the lower portion of the left kidney.. Stomach: Unremarkable. Bowel: There is no bowel obstruction. There is mild diffuse dilatation of the small bowel loops with liquid contents. There is abrupt transition of the caliber at the distal small bowel loops/terminal ileum compatible with bowel obstruction. Appendix: There are no signs of acute appendicitis. Vessels: Aorta is normal in caliber. PAGE 1 Signed Report (CONTINUED) CT ABD PEL W IV CON Peritoneum: Unremarkable. Lymph nodes: There is no lymphadenopathy Urinary bladder: Unremarkable. Reproductive: Unremarkable. Bones: Unremarkable. Soft tissues: Unremarkable. IMPRESSION: Small bowel obstruction with transition point at the distal small bowel/terminal ileum of indeterminate etiology. Thank you for allowing us to participate in the care of your patient. This CT was performed using the most up-to-date dose reduction software and techniques (including automated exposure control, adjustment of the MA and/or kV according to patient size, and iterative reconstruction technique) in accordance with our continuing efforts to minimize radiation dose while maximizing the diagnostic quality of our images. Released for the hospital. Restricted to soft food diet. I still am experiencing abdominal discomfort but no extreme pain. 06.11.2021: Met with Dr. for follow-up visit as instructed by attending physician as Hospital Center. 06.15.2021: - I received my 2nd COVID shot no significant adverse reaction; however, I continue to experience abdominal discomfort through 06.19.2021. 06.20-21.2021: - I started to feel my abdominal discomfort transitioning pain. The abdominal pain progressively intense; I started to sweat profusely. I was discovered by my spouse on the bed face down but responsive and was taken to the Emergency Room. 06.21-07-01.2021: Encounter Diagnosis Abdominal pain (Discharge Diagnosis) - 6/21/21 Bowel perforation (Discharge Diagnosis) - 6/21/21 Intussusception intestine (Discharge Diagnosis) - 6/21/21 Pneumoperitoneum (Discharge Diagnosis) - 6/21/21 Elevated liver enzymes level (Discharge Diagnosis) - 6/30/21 Sepsis, unspecified organism (Final) - Acute respiratory failure, unspecified whether with hypoxia or hypercapnia (Final) - Perforation of intestine (nontraumatic) (Final) - Peritonitis, unspecified (Final) - Severe sepsis with septic shock (Final) - Intussusception (Final) - Fistula of intestine (Final) - Disruption of external operation (surgical) wound, not elsewhere classified, initial encounter (Final) - Family history of diabetes mellitus (Final) - Essential (hemorrhagic) thrombocythemia (Final) - Contact with and (suspected) exposure to COVID19 (Final) - Family history of ischemic heart disease and other diseases of the circulatory system (Final) - Meckel's diverticulum (displaced) (hypertrophic) (Final) - Removal of other organ (partial) (total) as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure (Final) - Personal history of other medical treatment (Final) - Personal history of nicotine dependence (Final) - Other long term (current) drug therapy (Final) - Discharge Disposition: Home - 01 PREOPERATIVE DIAGNOSIS: 1.Pneumoperitoneum 2.Small bowel intussusception 3. Hollow viscus perforation POSTOPERATIVE DIAGNOSIS: 1.Small bowel perforation 2. Meckel's Diverticulum 3. Intraluminal small bowel mass 4. Large Pelvic abscess 5.Purulent peritonitis PROCEDURE PERFORMED: 1.Exploratory laparotomy 2.Small bowel resection 3.Abdominal washout 4.Placement of Negative pressure temporary abdominal wound closure device 07.06.2021 - Appointment with Dr. (Infectious disease). Patient is doing well post-surgery and was cleared to return to home state. 07.07.2021: - Appointment with Dr. - post exploratory laparotomy, bowel resection open abdomen June 21, 2021 and return to operating room for small-bowel anastomosis and abdominal closure June 23, 2021.Patient recovering appropriately. Patient states he has been cleared to travel back to home state. Patient instructed to follow-up with his primary care physician and seek gastroenterology referral for colonoscopy to be completed at least 6 weeks after the time of surgery 07.28.2021: Appointment with Dr. for follow up visit as instructed by attending physician in Hospital. Dr. recommended 4-8 weeks for recovery with gradual return to work and to schedule an appointment with Dr. 08.05.2021: Appointment Dr. Patient is doing well status post-surgery. In hindsight, I am not sure what could have or would have been done differently to prevent the course of events that occurred in another state. The intensity of his work-up was determined by his symptoms and he was symptom-free shortly after presenting to the emergency department. It is interesting to note that both episodes occurred shortly after both doses of his Covid vaccination. I am not sure of the causative link.
222	1563490-1	COVID19 (COVID19 (MODERNA))	80+ years	Male	very sick,very sick for atleast a week or more; problems with memory; blurred vision; Brain fog; have lost all since of time space and location; feeling of very hot sensation heat of some type passing through my intestines/passing some heat through my intestine; memory loss; gut discomfort/ very bad stomachic problems feels like hot claw marks in my intestines; Pain; Stomach on fire, very bad stomach problems; Chills; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), DYSPEPSIA (Stomach on fire, very bad stomach problems), ILLNESS (very sick,very sick for atleast a week or more), VISION BLURRED (blurred vision) and FEELING ABNORMAL (Brain fog) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Very tired). On 07-Mar-2021, the patient experienced PAIN (Pain) and DYSPEPSIA (Stomach on fire, very bad stomach problems). On an unknown date, the patient experienced ILLNESS (very sick,very sick for atleast a week or more), VISION BLURRED (blurred vision), FEELING ABNORMAL (Brain fog), DISORIENTATION (have lost all since of time space and location), FEELING HOT (feeling of very hot sensation heat of some type passing through my intestines/passing some heat through my intestine), AMNESIA (memory loss) and ABDOMINAL DISCOMFORT (gut discomfort/ very bad stomachic problems feels like hot claw marks in my intestines). At the time of the report, PAIN (Pain), DYSPEPSIA (Stomach on fire, very bad stomach problems), ILLNESS (very sick,very sick for atleast a week or more), VISION BLURRED (blurred vision), FEELING ABNORMAL (Brain fog), DISORIENTATION (have lost all since of time space and location), FEELING HOT (feeling of very hot sensation heat of some type passing through my intestines/passing some heat through my intestine), CHILLS (Chills) and FATIGUE (Very tired) outcome was unknown and AMNESIA (memory loss) and ABDOMINAL DISCOMFORT (gut discomfort/ very bad stomachic problems feels like hot claw marks in my intestines) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medication was reported. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Email On 18-May-2021: Email: New AEs added. Ongoing issues. On 10-Jul-2021: Email included additional events (temporo-spatial disorientation, feeling hot, memory loss, feeling abnormal, abdominal discomfort), outcome of events memory loss and abdominal discomfort.
223	1564458-1	COVID19 (COVID19 (MODERNA))	Unknown	Female	Injection site swelling; Injection site pain; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure, Neuropathy and Bacterial infection (Patient is taking antibiotic for small intestine bacterial overgrowth). On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication include medicine for blood pressure and neuropathy. Also an antibiotic for SIBO. No treatment information was provided.
224	1580694-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	rash and a sinus infection; rash and a sinus infection; stomach stress, like in the intestine; the shoulder aches there and there is the red rash; rash on the arm and a bump red, very red; It was hot; there was just pain; appeared a red bubble, or red bump, and it was hot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash and a sinus infection), SINUSITIS (rash and a sinus infection), ABDOMINAL DISCOMFORT (stomach stress, like in the intestine), INJECTION SITE ERYTHEMA (appeared a red bubble, or red bump, and it was hot) and RASH ERYTHEMATOUS (rash on the arm and a bump red, very red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), RIVAROXABAN (XARELTO), BUPROPION, TOPIRAMATE (TOPAMAX) and FUROSEMIDE for an unknown indication. On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (appeared a red bubble, or red bump, and it was hot), INJECTION SITE WARMTH (It was hot) and INJECTION SITE PAIN (there was just pain). On 02-Feb-2021, the patient experienced RASH ERYTHEMATOUS (rash on the arm and a bump red, very red). On an unknown date, the patient experienced RASH (rash and a sinus infection), SINUSITIS (rash and a sinus infection), ABDOMINAL DISCOMFORT (stomach stress, like in the intestine) and ARTHRALGIA (the shoulder aches there and there is the red rash). The patient was treated with AZITHROMYCIN for Sinus infection, at an unspecified dose and frequency. On 29-Jan-2021, INJECTION SITE ERYTHEMA (appeared a red bubble, or red bump, and it was hot) and INJECTION SITE WARMTH (It was hot) had resolved. At the time of the report, RASH (rash and a sinus infection), SINUSITIS (rash and a sinus infection), ABDOMINAL DISCOMFORT (stomach stress, like in the intestine), RASH ERYTHEMATOUS (rash on the arm and a bump red, very red), ARTHRALGIA (the shoulder aches there and there is the red rash) and INJECTION SITE PAIN (there was just pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
225	1580864-1	COVID19 (COVID19 (MODERNA))	Unknown	Male	diarrhea; achy; Tired; sore shot arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore shot arms), DIARRHOEA (diarrhea), MYALGIA (achy) and FATIGUE (Tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Diverticulitis (three one feet sections of his intestines removed and wore an ostomy bag for one and one-half years), Heart attack in 2015, Hartmann's pouch procedure in 2016 and Arterial stent insertion. Concurrent medical conditions included Type 2 diabetes mellitus. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore shot arms), MYALGIA (achy) and FATIGUE (Tired). On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, PAIN IN EXTREMITY (sore shot arms), DIARRHOEA (diarrhea), MYALGIA (achy) and FATIGUE (Tired) outcome was unknown. The patient had sensitive stomach and got diarrhea from eating too much beef, fish, dairy products. His diarrhea has been yellow and smelly and severe. Concomitant medications were not provided. Treatment information was not reported. This case was linked to MOD-2021-043706.
226	1595028-1	COVID19 (COVID19 (MODERNA))	Unknown	Male	Sore shot arm; Tired and achy; Tired and achy; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Sore shot arm), PAIN (Tired and achy), DIARRHOEA (Diarrhea) and FATIGUE (Tired and achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Diverticulitis (Severe diverticulitis and had three one feet sections of his intestines removed and wore an ostomy bag for one and one-half years) in 2014, Heart attack (and got two stents in his arteries in the heart) in 2015 and Hartmann's pouch procedure (was reversed in 2016) in 2014. Concurrent medical conditions included Type 2 diabetes mellitus and Gastric disorder (has a sensitive stomach and gets diarrhea from eating too much beef, fish, dairy products, etc.). On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIMB DISCOMFORT (Sore shot arm), PAIN (Tired and achy), DIARRHOEA (Diarrhea) and FATIGUE (Tired and achy). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhea, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Sore shot arm), PAIN (Tired and achy) and FATIGUE (Tired and achy) outcome was unknown and DIARRHOEA (Diarrhea) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product information was not provided by the reporter. It was reported that the diarrhea has been yellow and smelly and severe. This case was linked to MOD-2021-028292 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Additional Information received. Patient's medical history and event information updated.
227	1601758-1	COVID19 (COVID19 (MODERNA))	50-59 years	Male	This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea), ABDOMINAL DISTENSION (Felt bloated Stomach intestines and grown, (whole area)), PAIN (Felt aches and pain all throughout the body), ARTHRALGIA (Severe pain upper left back and front hip) and CHILLS (Chills) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Felt bloated Stomach intestines and grown, (whole area)), PAIN (Felt aches and pain all throughout the body), ARTHRALGIA (Severe pain upper left back and front hip) and CHILLS (Chills). On 05-Mar-2021, the patient experienced HEADACHE (Headache). On 22-Mar-2021, DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Felt bloated Stomach intestines and grown, (whole area)), PAIN (Felt aches and pain all throughout the body), ARTHRALGIA (Severe pain upper left back and front hip), CHILLS (Chills) and HEADACHE (Headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-067006.
228	1603030-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	Heart hurts; Her throat is doing something funny; Has ringing in her ears worse than any tinnitus; Body pain is level 8; Somebody had to come over and care for her; Intestines hurt; Her vision was blurry; Felt stabbing pains in abdomen and back just like someone stabbing me; Right hand was so swollen she couldn't hold anything; Never had pain like this in her life; Left arm swelled to point where she couldn't make a fist; Edema went through her body, face, and neck; Felt like spinning metals; Screaming headache that was the worst migraine ever; Unable to put any pressure on feet; Feel pins and needles on whole body; General malaise and fatigue and could not stay awake; General malaise and fatigue and could not stay awake; General malaise and fatigue and could not stay awake; Arm started swelling instantly; Nauseous but did not throw up.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left arm swelled to point where she couldn't make a fist), GENERALISED OEDEMA (Edema went through her body, face, and neck), VERTIGO (Felt like spinning metals), MIGRAINE (Screaming headache that was the worst migraine ever) and GAIT INABILITY (Unable to put any pressure on feet) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Chronic disease. Concomitant products included NEFAZODONE HYDROCHLORIDE (SERZONE), PRAMIPEXOLE DIHYDROCHLORIDE (MIRAPEX), VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), DIAZEPAM (VALIUM), ASCORBIC ACID (VITAMIN C ACID), CINNAMON [CINNAMOMUM VERUM], VITAMIN D NOS, MENAQUINONE-7 (VITAMIN K 2), CALCIUM LEVOMEFOLATE (METHYL FOLATE) and METHYLCOBALAMIN for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (Left arm swelled to point where she couldn't make a fist), GENERALISED OEDEMA (Edema went through her body, face, and neck), VERTIGO (Felt like spinning metals), MIGRAINE (Screaming headache that was the worst migraine ever), GAIT INABILITY (Unable to put any pressure on feet), PARAESTHESIA (Feel pins and needles on whole body), MALAISE (General malaise and fatigue and could not stay awake), HYPERSOMNIA (General malaise and fatigue and could not stay awake), PAIN (Never had pain like this in her life), FATIGUE (General malaise and fatigue and could not stay awake), VACCINATION SITE SWELLING (Arm started swelling instantly) and NAUSEA (Nauseous but did not throw up.). On 01-Apr-2021, the patient experienced MALAISE (Somebody had to come over and care for her), ABDOMINAL PAIN UPPER (Intestines hurt), VISION BLURRED (Her vision was blurry), ABDOMINAL PAIN (Felt stabbing pains in abdomen and back just like someone stabbing me) and PERIPHERAL SWELLING (Right hand was so swollen she couldn't hold anything). On 02-Apr-2021, the patient experienced CHEST PAIN (Heart hurts), THROAT IRRITATION (Her throat is doing something funny), TINNITUS (Has ringing in her ears worse than any tinnitus) and PAIN (Body pain is level 8). At the time of the report, PERIPHERAL SWELLING (Left arm swelled to point where she couldn't make a fist), GENERALISED OEDEMA (Edema went through her body, face, and neck), VERTIGO (Felt like spinning metals), MIGRAINE (Screaming headache that was the worst migraine ever), GAIT INABILITY (Unable to put any pressure on feet), PARAESTHESIA (Feel pins and needles on whole body), MALAISE (General malaise and fatigue and could not stay awake), HYPERSOMNIA (General malaise and fatigue and could not stay awake), MALAISE (Somebody had to come over and care for her), ABDOMINAL PAIN UPPER (Intestines hurt), VISION BLURRED (Her vision was blurry), ABDOMINAL PAIN (Felt stabbing pains in abdomen and back just like someone stabbing me), PERIPHERAL SWELLING (Right hand was so swollen she couldn't hold anything), CHEST PAIN (Heart hurts), THROAT IRRITATION (Her throat is doing something funny), TINNITUS (Has ringing in her ears worse than any tinnitus), PAIN (Never had pain like this in her life), PAIN (Body pain is level 8), FATIGUE (General malaise and fatigue and could not stay awake), VACCINATION SITE SWELLING (Arm started swelling instantly) and NAUSEA (Nauseous but did not throw up.) outcome was unknown. Relevant concomitant medications also included chloryphyll. Treatment details included morphine. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-066390 (Patient Link).
229	1603904-1	COVID19 (COVID19 (MODERNA))	Unknown	Female	pain in the intestines; fever; colic in her intestines; fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (colic in her intestines), PAIN (pain in the intestines), the first episode of PYREXIA (fever), VOMITING (vomiting) and the second episode of PYREXIA (fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B4A and 023M20A) for an unknown indication. The patient's past medical history included No adverse event. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 05-Mar-2021, the patient experienced ABDOMINAL PAIN (colic in her intestines), the first episode of PYREXIA (fever) and VOMITING (vomiting). On 02-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (pain in the intestines) and the second episode of PYREXIA (fever). At the time of the report, ABDOMINAL PAIN (colic in her intestines) and VOMITING (vomiting) had resolved and PAIN (pain in the intestines) and the last episode of PYREXIA (fever) had not resolved.
230	1603915-1	COVID19 (COVID19 (MODERNA))	60-64 years	Female	pain in the intestines; fever; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN and PYREXIA in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 016B4A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced GASTROINTESTINAL PAIN and PYREXIA. At the time of the report, GASTROINTESTINAL PAIN and PYREXIA outcome was unknown.
231	1604439-1	COVID19 (COVID19 (MODERNA))	Unknown	Male	Caller was in the hospital when his second dose was scheduled and missed that dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Caller was in the hospital when his second dose was scheduled and missed that dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Diverticulitis (because of his diverticulitis an infection occurred causing a resection of his large intestine and an ileostomy) since an unknown date. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Caller was in the hospital when his second dose was scheduled and missed that dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Caller was in the hospital when his second dose was scheduled and missed that dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient had pre-planned hospitalization to undergo surgery due to underlying historical medical condition of diverticulitis. Treatment included surgery of the large intestines, ileostomy and aspiration. This report refers to a case of incomplete course of vaccination for mRNA-1273, with no associated AEs. Follow-up received on 14-APR-2021 included no new information Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: NNI
232	1606934-1	COVID19 (COVID19 (MODERNA))	80+ years	Female	Never had that pain before, still had almost every day little pain left; cramps in her intestine, never had that before; strange felling in her stomach; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Never had that pain before, still had almost every day little pain left), GASTROINTESTINAL PAIN (cramps in her intestine, never had that before) and ABDOMINAL DISCOMFORT (strange felling in her stomach) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 042L204) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced ABDOMINAL PAIN (Never had that pain before, still had almost every day little pain left), GASTROINTESTINAL PAIN (cramps in her intestine, never had that before) and ABDOMINAL DISCOMFORT (strange felling in her stomach). The patient was treated with LIDOCAINE HYDROCHLORIDE (ASPERCREME WITH LIDOCAINE) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (Never had that pain before, still had almost every day little pain left), GASTROINTESTINAL PAIN (cramps in her intestine, never had that before) and ABDOMINAL DISCOMFORT (strange felling in her stomach) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Computerised tomogram: normal (normal) shows nothing. In February 2021, Imaging procedure: normal (normal) shows nothing. In February 2021, Ultrasound abdomen: normal (normal) shows nothing. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided.
233	1609757-1	COVID19 (COVID19 (MODERNA))	40-49 years	Female	Colonoscopy showed polyp was benign; Generalised aching; Fatigue; Fever; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LARGE INTESTINE POLYP (Colonoscopy showed polyp was benign), PAIN (Generalised aching), FATIGUE (Fatigue) and PYREXIA (Fever) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis. Concurrent medical conditions included Ulcerative colitis (moderate to severe). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On 26-Feb-2021, the patient experienced LARGE INTESTINE POLYP (Colonoscopy showed polyp was benign). On an unknown date, the patient experienced PAIN (Generalised aching), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, LARGE INTESTINE POLYP (Colonoscopy showed polyp was benign), PAIN (Generalised aching), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Colonoscopy: abnormal (abnormal) Benign polyp about the size of a dime. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. On an unknown date, patient received 1st dose COVID-19 vaccine manufactured by unknown, lot number unknown, expiration date unknown. Based on current available information and the temporal association between product use and he start date of the events a causal relationship cannot be excluded except for the event of Large intestine polyp which is unlikely. Treatment included polypectomy (on 26 Feb 2021, doctor removed a polyp and recommended a follow-up colonoscopy in one year).; Reporter's Comments: The reporter's causality for the events of colonoscopy showed polyp was benign was not provided. The reporter's causality for the events of fatigue, body aches, and fever with Humira (adalimumab) was no reasonable possibility. Abbvie's opinion is that there is no reasonable possibility that the events of colonoscopy showed polyp was benign, fatigue, body aches, and fever are related to Humira (adalimubab).; Sender's Comments: Based on current available information and the temporal association between product use and he start date of the events a causal relationship cannot be excluded except for the event of Large intestine polyp which is unlikely.
235	1610952-1	COVID19 (COVID19 (MODERNA))	50-59 years	Female	tinnitus seemed to be louder / tinnitus had an additional layer of sound / tinnitus kicked up and is nonstop / now getting a high pitch joined in the whishing and sometimes a low pitch; really tired; big knot where the shot was administered; area itched like crazy; soreness in arm; bad headache in the front part of head; gets whoozy; brain fog / missing words; Stress; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), TINNITUS (tinnitus seemed to be louder / tinnitus had an additional layer of sound / tinnitus kicked up and is nonstop / now getting a high pitch joined in the whishing and sometimes a low pitch), DIZZINESS (gets whoozy), FEELING ABNORMAL (brain fog / missing words) and STRESS (Stress) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Tinnitus. Concurrent medical conditions included Gastritis. Concomitant products included TRAZODONE for Sleep disorder due to a general medical condition, THYROID (ARMOUR THYROID), ZINC, MAGNESIUM, CALCIUM, FLUOXETINE HYDROCHLORIDE (PROZAC) and VITAMIN C [ASCORBIC ACID] for an unknown indication, VITAMIN D NOS and CALCIUM CARBONATE, MAGNESIUM CARBONATE, MAGNESIUM TRISILICATE, SODIUM BICARBONATE (PEPPERMINT INDIGESTION). On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DIZZINESS (gets whoozy), FEELING ABNORMAL (brain fog / missing words), STRESS (Stress) and HEADACHE (bad headache in the front part of head). On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm), VACCINATION SITE MASS (big knot where the shot was administered) and VACCINATION SITE PRURITUS (area itched like crazy). On 18-Apr-2021, the patient experienced TINNITUS (tinnitus seemed to be louder / tinnitus had an additional layer of sound / tinnitus kicked up and is nonstop / now getting a high pitch joined in the whishing and sometimes a low pitch) and FATIGUE (really tired). At the time of the report, PAIN IN EXTREMITY (soreness in arm), TINNITUS (tinnitus seemed to be louder / tinnitus had an additional layer of sound / tinnitus kicked up and is nonstop / now getting a high pitch joined in the whishing and sometimes a low pitch), DIZZINESS (gets whoozy), FEELING ABNORMAL (brain fog / missing words), STRESS (Stress), VACCINATION SITE MASS (big knot where the shot was administered), VACCINATION SITE PRURITUS (area itched like crazy), FATIGUE (really tired) and HEADACHE (bad headache in the front part of head) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Patient Has inflammation in the intestines. Patient is on a low fodmap diet for food triggers and lactose is one of the triggers. No treatment information was provided Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-089247, US-MODERNATX, INC.-MOD-2021-089281 (E2B Linked Report). This case was linked to MOD-2021-089264 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-089247: US-MODERNATX, INC.-MOD-2021-089281:
236	1613472-1	COVID19 (COVID19 (MODERNA))	Unknown	Male	leg cramps; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (leg cramps) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Spinal disorder and Gastrointestinal disorder (Patient has medical condition where the pressure on his intestine causes the cramps.). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (leg cramps). At the time of the report, MUSCLE SPASMS (leg cramps) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided.
237	1617618-1	COVID19 (COVID19 (MODERNA))	40-49 years	Male	rec'd 3rd dose (booster - dt autoimmune UC and transplant patient) Within 48 hours developed fever 100.7 and sore throat - appears to have triggered an ulcerative colitis flare in mouth and throat when prior to this has never had ulcerative colitis in this area, has only had issues in lower intestines.
238	1619618-1	COVID19 (COVID19 (MODERNA))	50-59 years	Male	Sickness; Passed 77 days after the first dose; Irritated stomach lining; Severe and constant cramps in small intestine/pain was more intense/same amount of pain; Headache; Inflammation in the small intestine; Lost 14 pounds; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 27-May-2021. The most recent information was received on 16-Jun-2021 and was forwarded to Moderna on 16-Jun-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL PAIN (Severe and constant cramps in small intestine/pain was more intense/same amount of pain), GASTROINTESTINAL INFLAMMATION (Inflammation in the small intestine), GASTRITIS (Irritated stomach lining), WEIGHT DECREASED (Lost 14 pounds) and ILLNESS (Sickness) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LANSOPRAZOLE (PREVACID) from 01-Jan-2008 to an unknown date for Gastritis bile acid. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced GASTROINTESTINAL PAIN (Severe and constant cramps in small intestine/pain was more intense/same amount of pain) and HEADACHE (Headache). In March 2021, the patient experienced GASTROINTESTINAL INFLAMMATION (Inflammation in the small intestine) and WEIGHT DECREASED (Lost 14 pounds). In April 2021, the patient experienced GASTRITIS (Irritated stomach lining). On 27-May-2021, the patient experienced OFF LABEL USE (Passed 77 days after the first dose). On an unknown date, the patient experienced ILLNESS (Sickness). The patient was treated with BUDESONIDE for Intestinal cramps, at a dose of 3 mg three times a day; BUDESONIDE for Intestinal cramps, at a dose of 3 mg twice a day; BUDESONIDE for Intestinal cramps, at a dose of 3 mg once a day; HYOSCYAMINE SULFATE for Intestinal cramps, at a dose of 0.125 mg and RIFAXIMIN at a dose of 550 mg. On 27-May-2021, OFF LABEL USE (Passed 77 days after the first dose) had resolved. At the time of the report, GASTROINTESTINAL PAIN (Severe and constant cramps in small intestine/pain was more intense/same amount of pain) and HEADACHE (Headache) had not resolved and GASTROINTESTINAL INFLAMMATION (Inflammation in the small intestine), GASTRITIS (Irritated stomach lining), WEIGHT DECREASED (Lost 14 pounds) and ILLNESS (Sickness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: inconclusive (Inconclusive) Inconclusive. In March 2021, Computerised tomogram: inconclusive (Inconclusive) Inflammation in the small intestine. In March 2021, Magnetic resonance imaging: normal (normal) MRI was clear. In April 2021, Endoscopy: abnormal (abnormal) Very irritated stomach lining. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Treatment mediation included antispasmodic drugs for gastrointestinal pain and antibiotic which was stopped later. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-JUN-2021 contains significant information: Added patient demographics, concomitant medications, treatment medications and new events and updated laboratory results of MRI , Endoscopy and event outcome from unknown to not recovered for gastrointestinal pain and headache.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
239	1621207-1	COVID19 (COVID19 (MODERNA))	65-79 years	Male	Post procedural bleeding; Internal hemorrhoids; enlarged prostate; Colonic polyp; cervical pain; pain; Low platelets; This spontaneous case was reported by a physician and describes the occurrence of POST PROCEDURAL HAEMORRHAGE (Post procedural bleeding), HAEMORRHOIDS (Internal hemorrhoids), PROSTATOMEGALY (enlarged prostate), LARGE INTESTINE POLYP (Colonic polyp) and NECK PAIN (cervical pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 03L120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease aggravated. Previously administered products included for Product used for unknown indication: PLAVIX, Lipitor, statin, clopidogrel and atorvastatin. Past adverse reactions to the above products included No adverse event with Lipitor, PLAVIX, atorvastatin, clopidogrel and statin. Concurrent medical conditions included Drug allergy (allergic to lipitor), Drug allergy (allergy to Plavix, reaction to Plavix are scratching and itchiness to the point of bleeding), Drug allergy (allergy to statins), Tobacco user (uses cigarette sticks a pack per day), Alcohol use (rarely drink), Pain, Nerve damage, Acid reflux (esophageal), Insomnia, Enlarged prostate, Spastic colon, Vomiting, Nausea, Back pain, Neck pain, Blood pressure high and Sinusitis. Concomitant products included LANSOPRAZOLE (PREVACID) for Acid reflux (esophageal), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergic sinusitis, MONTELUKAST for Allergy, OXYCODONE for Back pain, AMLODIPINE and METOPROLOL for Blood pressure high, MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for Enlarged prostate, TRAZODONE for Insomnia, ONDANSETRON for Nausea and Vomiting, GABAPENTIN for Nerve damage and Pain, DICYCLOMINE [DICYCLOVERINE] for Spastic colon, MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC), ACETYLSALICYLIC ACID, ASCORBIC ACID (ASPIRIN COMPOUND [ACETYLSALICYLIC ACID;ASCORBIC ACID]), VITAMIN D3, FOLIC ACID and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication. In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form(s) once a week. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POST PROCEDURAL HAEMORRHAGE (Post procedural bleeding), HAEMORRHOIDS (Internal hemorrhoids), PROSTATOMEGALY (enlarged prostate), LARGE INTESTINE POLYP (Colonic polyp), NECK PAIN (cervical pain), PAIN (pain) and PLATELET COUNT DECREASED (Low platelets). At the time of the report, POST PROCEDURAL HAEMORRHAGE (Post procedural bleeding), NECK PAIN (cervical pain) and PAIN (pain) had resolved and HAEMORRHOIDS (Internal hemorrhoids), PROSTATOMEGALY (enlarged prostate), LARGE INTESTINE POLYP (Colonic polyp) and PLATELET COUNT DECREASED (Low platelets) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Biopsy: unknown (Inconclusive) Inconclusive. On 26-Jan-2021, Colonoscopy: abnormal (abnormal) showed a three polyps and one internal hemorrhoids. On an unknown date, Platelet count: decreased (Low) Decreased. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NECK PAIN (cervical pain) and PAIN (pain) to be probably related. No further causality assessments were provided for POST PROCEDURAL HAEMORRHAGE (Post procedural bleeding), HAEMORRHOIDS (Internal hemorrhoids), PROSTATOMEGALY (enlarged prostate), LARGE INTESTINE POLYP (Colonic polyp) and PLATELET COUNT DECREASED (Low platelets). Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-195640, MOD-2021-195640 (Patient Link); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
241	1621775-1	COVID19 (COVID19 (MODERNA))	Unknown	Male	feels tired; Today he is having intestine issues/ tummy issues; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (Today he is having intestine issues/ tummy issues) and FATIGUE (feels tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced GASTROINTESTINAL DISORDER (Today he is having intestine issues/ tummy issues). On an unknown date, the patient experienced FATIGUE (feels tired). At the time of the report, GASTROINTESTINAL DISORDER (Today he is having intestine issues/ tummy issues) and FATIGUE (feels tired) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact
242	1626614-1	COVID19 (COVID19 (MODERNA))	60-64 years	Female	Mouth numbness; pain in intestines; sore arm; Nausea; Low grade fever; Chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Mouth numbness), GASTROINTESTINAL PAIN (pain in intestines), PAIN IN EXTREMITY (sore arm), NAUSEA (Nausea) and PYREXIA (Low grade fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No concomitant medications reported. Concurrent medical conditions included Autoimmune disorder, Gastrointestinal disorder (Late stage.), Sclerosis multiple, Lupus erythematosus, Vitamin deficiency, Allergy (shellfish), Food allergy (fish), Allergy (pork), Allergy, Allergy (pollen), Allergy (tree), Allergy (grass), Allergy (certain metals) and Allergy (make up). On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (Mouth numbness), GASTROINTESTINAL PAIN (pain in intestines), PAIN IN EXTREMITY (sore arm), NAUSEA (Nausea), PYREXIA (Low grade fever), CHILLS (Chills) and FATIGUE (tiredness). At the time of the report, HYPOAESTHESIA ORAL (Mouth numbness), GASTROINTESTINAL PAIN (pain in intestines), PAIN IN EXTREMITY (sore arm), NAUSEA (Nausea), PYREXIA (Low grade fever), CHILLS (Chills) and FATIGUE (tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: negative (Inconclusive) Negative. Adverse events experienced after getting 2th vaccine are: sore arm, low grade fever, Nausea, mouth numbness and stabbing pain in intestines Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Significant F/U received, Chills and fatigue events added.
243	1629284-1	COVID19 (COVID19 (JANSSEN))	40-49 years	Female	Severe abdominal pain started on 6-27-21. Went to ER on 6-28-21 they did ultrasound on gallbladder & prescribed pain medication & was released. Went to ER on 6-29-21 with severe abdominal pain, they done a CT scan was admitted with diagnosis of Mesenteric Venous Thrombosis(blood clots in veins to intestines & liver). At Hospital was given Heparin, via intravenous until released on 7-4-21. Hospital released me on 7-4-21 with prescript of Eliquis with multiple follow-up doctors appointments
244	1632402-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Female	severe pain started on 6/24/21 and she went to the emergency room on 6/26/21 and they ran a CAT scan and it was determined it was her appendix, on 6/26/2021 they transported her to the hospital because they couldn't get to her appendix, at the hospital she was on heavy doses of antibotics, after a few days they did another CAT SCAN and it now was worse, the doctor was unable to get to her appendix because it was surrounded like a wall.. on 7/1/21 she came home and stayed on antibiotics, on 7/14/21 she is at the hospital and her appendix was removed and 6 inches of her intestine was removed after that she stayed in the hospital 6 more days.
245	1632407-1	COVID19 (COVID19 (MODERNA))	50-59 years	Female	BODY ACHES. LOOSE STOOL. CHILLS AND EXTREME HOT. SKIN SENSITIVITY. HEADACHE. JOINT PAIN. EYES HURT. DIZZINESS. INTESTINES FELT INFLAMED. SOMETIMES SYPMTOMS NOT ALL AT THE SAME TIME.
246	1635547-1	COVID19 (COVID19 (MODERNA))	65-79 years	Female	Productive cough; runny nose; sore throat; SOB; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCTIVE COUGH (Productive cough), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat) and DYSPNOEA (SOB) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The patient's past medical history included Cholelithiasis (Other cholelithiasis without obstruction), Hepatic lesion (Liver lesion), Cranial nerve paralysis, Diverticulosis (Diverticulosis of intestine without bleeding, unspecified intestinal tract location), Lung nodule, Unspecified disorder of adrenal glands (Lesion of adrenal gland), Weight loss, Thyroid nodule (Benign-BX done on 6-6-2014), Smoker (Former smoker), Fatigue, Inguinal hernia repair, Colon operation in 2016 and Thermal ablation (Thermal tumor removed in left neck). Previously administered products included for an unreported indication: PNEUMOVAX (normal T/D- 10-5-2021) on 01-May-2018. Family history included Renal cancer (Mother), Parkinson's disease (Father) and Diabetes mellitus (Brother, sister, first degree relatives). Concurrent medical conditions included Malnutrition, Hypokalemia, Anemia, Thyroid disorder (Thyroid dysfunction), Idiopathic osteoporosis and Shortness of breath. Concomitant products included SALBUTAMOL SULFATE (PROAIR HFA) from 05-Jan-2017 to an unknown date and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 26-Jun-2017 to an unknown date for COPD, MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 07-Apr-2021 at 11:02 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (Productive cough), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat) and DYSPNOEA (SOB). At the time of the report, PRODUCTIVE COUGH (Productive cough), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat) and DYSPNOEA (SOB) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2019, Mammogram: inconclusive (normal) inconclusive. On 19-May-2021, Colonoscopy: inconclusive (abnormal) inconclusive. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. social history was given as : caffeine use- coffee, carbonate beverages Exercise history : House work, yardwork, moderate, walking 6-week Health maintenance : medicare wellness visit (8-SEP-2020) Blood pressure monitoring Fall risk screening (8-AUG-20210) Low risk Depression screening (8-AUG-2020) Bone density study(10-MAY-2021) Declined screening: PAP, SHINGLES VACC Annual wellness visit (14-MAY- 2018) Screening of AAA (28-JUN-2017) normal:MRI This case was linked to MOD-2021-241819 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Followup received on 30-Jun-2021 contains non significant information Email instructions were provided On 30-Jun-2021: Followup received on 30-Jun-2021 contains non significant information On 08-Jul-2021: Patient demographics, medical history, lab history, concomitant medications and events were updated.
247	1636574-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Female	Within 3-4 weeks of receiving my second dose, I started having abdominal bloating and diarrhea. I went to see my doctor and described my symptoms. I was later diagnosed with an infection in my small intestine. Within 2-4 weeks of treatment for that, I started to notice fatigue and low grade fevers. I was later diagnosed with Reactivated Epstein Barre Virus. My viral load was 30 times higher than it should be. 21 was considered normal and I was at 600+. Within 2 weeks after that, I experienced severe abdominal pain. I went to the ER. By the time I got to the hospital, the pain was worse. The pain moved from my right side of my abdomen to my back and right shoulder. I was diagnosed with fatty liver. I had a severe electrolyte imbalance, blood in my urine, severely low blood pressure and it hurt to breathe. I did a follow-up with my PCP, and most of my lab work has improved. As of today, I am waiting on results for my urinalysis. The only thing still abnormal is the protein in my urine. At the ER, my protein showed low, but at my PCP, my protein was showing high (this was from a blood sample.) During this timeframe, I have been having hormonal imbalance. I've had low estradiol levels. My DHEA has improved, but my AMH has gone down. I'm showing a decrease in fertility. I've never had any complications with this before.
248	1636827-1	COVID19 (COVID19 (MODERNA))	40-49 years	Female	First Dose: Saturday, April 24, 2021 Got my first dose of the vaccine. Several different sensations in short duration in different parts of my body. Right arm is really sore along with a stiff neck and stiff shoulder area. Headache on left forehead and lower abdomen/intestines hurt. Sunday, April 25, 2021 Right arm is very sore, still have stiff neck/shoulder area and headache on left forehead. Monday, April 26, 2021 Very sore/painful knee joints - both knees. Lower back hurts. Right wrist hurts on bottom to pick things up or set them down. Tuesday, April 27, 2021 Numbness on right side of body: face (eye socket to chin), ear, neck, shoulder, arm, back, glute, thigh and calf. Lower back hurts. Called my Doctor?s office and the nurse said to go to the ER if there is weakness with the numbness. Wednesday, April 28, 2021 Pain in right lower back, right groin area, top of pelvic bone and right calf. Thursday, April 29, 2021 No longer keeping daily notes of biggest issues, though many are persisting. Right arm still sore to the touch. Waking up with right shoulder blade, shoulder, elbow and wrist numb. Face going numb on right side and places on right leg going numb. Second Dose: Tuesday, May 25, 2021 Got my second dose of the vaccine and it was extremely painful. It felt like he inserted the needle way too high on my arm. Right hip and groin area hurt. Lower back hurts-mostly the right side. Sick to my stomach-feel like I am going to throw up. Both shoulder blades hurt. Spine/Vertebrae are tender to the touch. Neck is stiff. Left elbow and shoulder hurt. Have a headache. Knees and knee joints hurt. Have chills, couldn?t get warm, and had to sleep with a heating pad. Wednesday, May 26, 2021 Left shoulder hurts really bad. Have a headache. Woke up sweating. Right shoulder blade hurts. Have sore/stiff neck. Ribs on left side hurt, left elbow hurts, left jaw/chin hurts, left wrist hurts. Thursday, May 27, 2021 Right cheek is numb. Left arm and rib are still sore. Bump appeared on left arm. Friday, May 28, 2021 Left foot 2nd toe is red, burning and painful and 3rd and 4th toe hurt. Bump is still on arm. Saturday, May 29, 2021 Bump is still on arm. Right cheek, elbow area and hand are numb. Left foot second toe is still red. Sunday, May 30, 2021 Right cheek is numb. Monday, May 31, 2021 Right elbow, shoulder blade and cheek are still numb/achy. Wednesday, August 25, 2021 I feel like everything should have resolved by now but I am still having issues. I stopped keeping daily notes in May, but have kept a running list of issues. Here are the issues I am still having, some almost daily and some occasionally: Right arm is sore to the touch. Issue between fingers on right hand itches and wakes me up at night. I wake up with shoulder blade, shoulder, elbow and wrist numb. Face goes numb almost everyday on the right side and occasionally on the left side. I sometimes drool when awake as well as when asleep. I have insomnia. Vision both near and far has gotten worse. I have strange dreams that startle me awake. Right leg still has spots that go numb in the thigh but mostly in the calf. I am uncertain if these continuing issues will become permanent.
249	1639774-1	COVID19 (COVID19 (MODERNA))	60-64 years	Male	Infected fistula in buttocks; Abscess; This spontaneous case was reported by a physician and describes the occurrence of INFECTED FISTULA (Infected fistula in buttocks) and ABSCESS (Abscess) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease. The patient's past medical history included Coronary artery occlusion in November 2019, Stoma creation in 2017, Colon cancer in 2017, Cardiac arrhythmia in December 2019, Dehydration in August 2017, Night sweats on 19-Mar-2021, Chronic kidney disease stage 3, Alcohol use (FIVE COCKTAILS A WEEk) in 1975, Smoker (A PACK A WEEK) in 2006, Obstruction, Ostomy obstruction in 2017, Stent placement (he had blockage in heart artery and cardiologist placed a stent in the heart) in December 2019, Stent placement (he had heart stent placement) in 2021 and Surgery (surgery to reconnect intestines and remove ostomy because of dehydration.) in August 2019. Concomitant products included PRASUGREL for Coagulation disorder, METOPROLOL for Heart rate abnormal, ATORVASTATIN for Hypercholesteraemia, FENOFIBRATE, ATORVASTATIN CALCIUM, FUROSEMIDE (LASIX [FUROSEMIDE]), OMEPRAZOLE, METOPROLOL SUCCINATE, PRASUGREL HCL and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. In May 2021, the patient experienced ABSCESS (Abscess). On 11-Jun-2021, the patient experienced INFECTED FISTULA (Infected fistula in buttocks). At the time of the report, INFECTED FISTULA (Infected fistula in buttocks) and ABSCESS (Abscess) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2019, Blood pressure measurement: high (High) ELEVATED BLOOD PRESSURE. In November 2019, Computerised tomogram: abnormal (abnormal) Blockage in the artery of the heart. In February 2020, Cardiac stress test: normal (normal) Basically ok. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient's lab data included: November 2019 CHEST X-RAY: Unknown results. December 2020 STRESS TEST: Unknown result. The patient was treated with FLAGYL. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
250	1640504-1	COVID19 (COVID19 (MODERNA))	50-59 years	Male	He had some cramps in his lower intestine; Couldn't go to the bathroom; He has some vertigo when he wakes up; sweaty; feels recovered and was able to exercise,feeling better; first 2 vaccines of Pfizer and again third one of moderna on 16 Jun 2021; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN (He had some cramps in his lower intestine), MOBILITY DECREASED (Couldn't go to the bathroom), VERTIGO (He has some vertigo when he wakes up), HYPERHIDROSIS (sweaty) and THERAPEUTIC RESPONSE UNEXPECTED (feels recovered and was able to exercise,feeling better) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. No medical history was provided by the reporter. Concurrent medical conditions included Bladder cancer and Heart attack. Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CARVEDILOL, SPIRONOLACTONE and ATORVASTATIN for an unknown indication. On 26-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL PAIN (He had some cramps in his lower intestine), MOBILITY DECREASED (Couldn't go to the bathroom), VERTIGO (He has some vertigo when he wakes up), HYPERHIDROSIS (sweaty), THERAPEUTIC RESPONSE UNEXPECTED (feels recovered and was able to exercise,feeling better) and WRONG PRODUCT ADMINISTERED (first 2 vaccines of Pfizer and again third one of moderna on 16 Jun 2021). At the time of the report, GASTROINTESTINAL PAIN (He had some cramps in his lower intestine), MOBILITY DECREASED (Couldn't go to the bathroom), VERTIGO (He has some vertigo when he wakes up), HYPERHIDROSIS (sweaty), THERAPEUTIC RESPONSE UNEXPECTED (feels recovered and was able to exercise,feeling better) and WRONG PRODUCT ADMINISTERED (first 2 vaccines of Pfizer and again third one of moderna on 16 Jun 2021) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) Blood pressure is 150/125. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication has been reported.
251	1640504-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Male	He had some cramps in his lower intestine; Couldn't go to the bathroom; He has some vertigo when he wakes up; sweaty; feels recovered and was able to exercise,feeling better; first 2 vaccines of Pfizer and again third one of moderna on 16 Jun 2021; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN (He had some cramps in his lower intestine), MOBILITY DECREASED (Couldn't go to the bathroom), VERTIGO (He has some vertigo when he wakes up), HYPERHIDROSIS (sweaty) and THERAPEUTIC RESPONSE UNEXPECTED (feels recovered and was able to exercise,feeling better) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. No medical history was provided by the reporter. Concurrent medical conditions included Bladder cancer and Heart attack. Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CARVEDILOL, SPIRONOLACTONE and ATORVASTATIN for an unknown indication. On 26-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL PAIN (He had some cramps in his lower intestine), MOBILITY DECREASED (Couldn't go to the bathroom), VERTIGO (He has some vertigo when he wakes up), HYPERHIDROSIS (sweaty), THERAPEUTIC RESPONSE UNEXPECTED (feels recovered and was able to exercise,feeling better) and WRONG PRODUCT ADMINISTERED (first 2 vaccines of Pfizer and again third one of moderna on 16 Jun 2021). At the time of the report, GASTROINTESTINAL PAIN (He had some cramps in his lower intestine), MOBILITY DECREASED (Couldn't go to the bathroom), VERTIGO (He has some vertigo when he wakes up), HYPERHIDROSIS (sweaty), THERAPEUTIC RESPONSE UNEXPECTED (feels recovered and was able to exercise,feeling better) and WRONG PRODUCT ADMINISTERED (first 2 vaccines of Pfizer and again third one of moderna on 16 Jun 2021) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) Blood pressure is 150/125. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication has been reported.
252	1644400-1	COVID19 (COVID19 (MODERNA))	Unknown	Female	UTI; Infection in her intestine/gastritis; GERD; Kidney infection; Woke up sick; I have been sick; I feel like I'm dying; Intentional product use issue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I have been sick), NEAR DEATH EXPERIENCE (I feel like I'm dying), MALAISE (Woke up sick), KIDNEY INFECTION (Kidney infection), URINARY TRACT INFECTION (UTI), GASTRITIS (Infection in her intestine/gastritis) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 12-May-2021, the patient experienced ILLNESS (I have been sick) (seriousness criterion hospitalization) and NEAR DEATH EXPERIENCE (I feel like I'm dying) (seriousness criteria hospitalization and medically significant). On 13-May-2021, the patient experienced MALAISE (Woke up sick) (seriousness criterion hospitalization). On 07-Jun-2021, the patient experienced KIDNEY INFECTION (Kidney infection) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI) (seriousness criterion hospitalization), GASTRITIS (Infection in her intestine/gastritis) (seriousness criterion hospitalization), GASTROOESOPHAGEAL REFLUX DISEASE (GERD) (seriousness criterion hospitalization) and INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Adverse event, at a dose of Medication regimen was finished 2 weeks ago.; LEVOFLOXACIN (LEVAQUIN) for Adverse event, at an unspecified dose and frequency and LEVOFLOXACIN (LEVAQUIN) (intravascular) for Adverse event, at an unspecified dose and frequency. On 20-May-2021, MALAISE (Woke up sick) had resolved. On 11-Jun-2021, KIDNEY INFECTION (Kidney infection) outcome was unknown. At the time of the report, ILLNESS (I have been sick), NEAR DEATH EXPERIENCE (I feel like I'm dying), URINARY TRACT INFECTION (UTI), GASTRITIS (Infection in her intestine/gastritis) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant treatment was reported. Treatment include unspecified antibiotics and PPI inhibitors. Company comment: Very limited information regarding the events has been provided at this time. Further information has been requested. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up contains non-significant information. On 04-Aug-2021: Significant follow up received on 04-Aug-2021, updated reporter information (reporter address), vaccine information (dose number, batch/lot number and anatomical location) and additional events (kidney infection, UTI, Gastritis and GERD).; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
253	1645364-1	COVID19 (COVID19 (MODERNA))	65-79 years	Male	diverticulitis related to the colon and intestine; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (diverticulitis related to the colon and intestine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 011M20A) for COVID-19 vaccination. Medical history was not provided. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D 3), LEVOTHYROXINE SODIUM, CARVEDILOL, CLONIDINE HYDROCHLORIDE (CLONIDINE HCL), ALLOPURINOL, FAMOTIDINE, TELMISARTAN and SPIRONOLACTONE for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced DIVERTICULITIS (diverticulitis related to the colon and intestine) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 12 days due to DIVERTICULITIS. At the time of the report, DIVERTICULITIS (diverticulitis related to the colon and intestine) outcome was unknown. As treatment the patient received antibiotic (not specified). Patient never had a flare up or anything like that in the past. Company Comment: An alternative explanation is that the serious unexpected event of Diverticulitis with the onset latency of 3 months 27 days following the mRNA-1273 vaccination was more consistent with the increased risk due to age, diet and lifestyle factors.; Sender's Comments: An alternative explanation is that the serious unexpected event of Diverticulitis with the onset latency of 3 months 27 days following the mRNA-1273 vaccination was more consistent with the increased risk due to age, diet and lifestyle factors.
254	1645766-1	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	Female	Seizures; This is a spontaneous report from a contactable consumer (Patient) or other non-health care professional. This is a report received from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history included immunodeficiency, I'm immunocompromised, gastrointestinal disorder from an unknown date and unknown if ongoing. Recently she had undergone several surgeries, radiology, and chemotherapy for a problem in my lower intestine. The patient concomitant medications were not reported. The patient previously took dilantin [phenytoin sodium] for seizure, levetiracetam for seizure. On an unspecified date patient had previous episodes of seizures. She would want to know if the Pfizer-BioNTech COVID-19 Vaccine would ""trigger"" seizures. Outcome of event was unknown. Information on the lot/batch number has been requested.""
255	1645815-1	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	Female	severe diarrhea; sharp pain in lower back; tired more than usual; very little arm pain/soreness in her arm; sleepiness; exhausted; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number unknown), via an unspecified route of administration in Arm on an unspecified date in 2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number unknown), via an unspecified route of administration in Arm on an unspecified date in 2021 as DOSE 1, SINGLE for COVID-19 immunization and flipped out after her first. It was reported that some had the typical side effects, but the severe side effects the patient had, the patient had some kind of sharp pain in her lower back. The back pain was strange, it was not ongoing, but came on suddenly, acutely. The patient was at the hospital from 5:30 to 6pm on about, it would have been 27Mar2021, the patient got the vaccine later in the day, it was more than 24 hours, but less than 48 hours. The patient went in and was there for 12 hours at least, more than that. The patient got out about 7am the next morning. The lower back pain was sharper and painful, they said it was related to inflammation in lower intestine, which the patient thought was bizarre, as the patient left the ER, another guy was wheeled in with side effects. No further details provided. The patient experienced severe diarrhea on 28Mar2021, it was not ongoing, the patient got out of the ER on Sunday 28Mar2021. The patient had very little arm pain on an unspecified date in 2021, started within 24 hours of the injection, it was minimal for the patient, that lasted for maybe three days at most. The patient experienced sleepiness, no headache within 16 or 17 hours of injection, the patient got it at 11 or 12 in the morning. The next morning at 0400 or 0500, the patient woke up, could not go back to sleep, later that day, the patient wanted to go back, was exhausted, but the patient got up at 0400. The patient was unsure why she woke up and could not sleep, might be other reasons. The patient had concerns about the vaccine. The patient stated that the hope was the vaccine would prevent the patient from getting sick, in short term. The patient also experienced very tired, tired more than normal on an unspecified date in 2021. The patient stated that she was healthy. Patient underwent X-ray which showed inflammation in her lower intestine on an unspecified date in 2021. Outcome of the events tired more than usual, sleepiness and exhausted was unknown. Outcome of the events sharp pain in lower back, severe diarrhea and very little arm pain/soreness in her arm was reported as recovered on an unspecified date in 2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
256	1646458-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Male	in Apr2021 he was diagnosed with Colon Cancer; This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program. This consumer reported different events for different vaccine doses for the same patient. This is one of the two reports. A 67-year-old male patient received dose 2 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 22Feb2021 (at the age of 67-years-old) (Batch/Lot Number: EL9264) single, for COVID-19 immunization. Medical history included pancreatitis from 2020, heart attack from an unknown date and unknown if ongoing (2 heart attacks about a decade ago), high blood pressure (he is on a medication for this and it is under control), high cholesterol (he is on a medication for this and all his levels are healthy), stroke from Dec2017, and COPD (for which the patient takes no medications for). Last year he was sent for a test to determine if he had pancreatic cancer, it was to a specialist in (withheld), the name of the procedure is unknown but they go down into the small intestine with a contrast into the pancreas and as a result of that he got pancreatitis, he lost 50lbs in 6 months getting over that. Prior to the pancreatitis, he has had 2 heart attacks back about a decade ago. He had a triple bypass about 6 years ago 2014 or 2015 the outcome was no problems at all, the only time a cardiologist comes was when he has to be cleared for some other procedure. They have him on Plavix daily dose for a blood thinner. In 2017, he suffered a series of strokes in the back of the brain, that's where the damage was, located in the artery that comes up from brain and forms a Y, there was a blockage in there, an inch of the blood vessel collapsed, there was leakage there and found 3 different spots where there was injury. He had an MRI this year and there was no evidence of stroke activity. The stroke was in Dec2017 and he was not cleared to return to work. Concomitant medication included clopidogrel bisulfate (PLAVIX) taken as a blood thinner, start and stop date were not reported; and other unspecified medications. The patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine) on 01Feb2021 (Lot number: EL3247); the patient had zero reactions to this shot. Earlier this year in Apr2021, the patient was diagnosed with colon cancer. In Apr2021 this year, they did a colon resection and removed 12 inches. Also in Apr2021, they referred him to an oncologist because of his examination, he had a colonoscopy. The surgeon said because this was spotted early, there was no reason for follow up treatment or chemo. The colonoscopy was done in Mar2021 and the doctor was his surgeon. He had actually been doing the colonoscopy's on him for a long time, and the spot that turned into cancer was something he, the doctor, had already been monitoring and was nothing new. It was reported that the spot was noticed way before him receiving his COVID vaccines in Feb2021. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202100999866 same report/patient, different vaccine dose/event
257	1646733-1	COVID19 (COVID19 (PFIZER-BIONTECH))	80+ years	Female	had signs of rheumatoid arthritis.; fatigue/tiredness; swelling; joint pain; can't walk; hands swollen; inflammation/very much inflammation in her breast; Back pain; weighed herself; can't sleep at night; pain in her side that went away and just went up her arm and disappeared; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 12:20 (Batch/Lot number was not reported) as dose 2, single (at the age of 84 years) for covid-19 immunisation. The patient's medical history included mastectomy from an unknown date and unknown if ongoing (many years ago, about 30 years ago), and ongoing high blood pressure which was diagnosed 6-7 years ago. Concomitant medications included spironolactone and losartan taken for high blood pressure, start and stop date were not reported. The patient received the first dose of BNT162B2 on 19Jan2021 at the age of 84 years for Covid-19 immunisation. The patient experienced fatigue/tiredness, swelling, joint pain on 14Feb2021; can't walk, hands swollen, inflammation/very much inflammation in her breast, back pain, weighed herself (weight increased), can't sleep at night and pain in her side that went away and just went up her arm and disappeared in 2021; had signs of rheumatoid arthritis on an unspecified date. The patient saw her primary care physician on 14Feb2021 for fatigue and joint pain and swelling and the HCP ordered blood work for her C-Reactive protein, it was supposed to be 3.0 and hers was 18.2 and had inflammation. She had to go on Prednisone for pain and it was 10mg three times. She experienced a lot of problems getting up in the morning and can't walk, hands swollen and can't get her shoes on and she was on Prednisone; states Prednisone relieves it and she received therapy for 4 weeks for pain and as long as she's on the Prednisone she felt good and right when she goes off of the Prednisone she's right back where she started. It was also reported that the vaccines were administered in her left arm because she had a mastectomy in her right arm and they do not like her to do anything there and that was where she had the first problem; and it just went from her right arm into her breast and she still has the blue vein from the Pfizer COVID Vaccine in her breast still; states she just had very much inflammation in her breast and pain in her side that went away and just went up her arm and disappeared; states she had swelling and stuff and it went from the side under her breast and went up that left arm and started with the other problems with swelling and feeling tired. The fatigue and tiredness and pain was kind of hard to tell if they are ongoing because she was on medication for that and still on Prednisone and was tired, can't sleep at night sometimes and when she is on the Prednisone it was really good and she can't sleep at night which might be from her back when she was real bad before taking Prednisone and she had swelling and stuff and had problems. The patient began taking prednisone on 24May2021 but that might not be the first time she took it and she was unsure. The patient also takes Gabapentin 300mg three times per day by mouth and she started it on 29Jun2021 for her back and not for the other things. The patient took regular over the counter Tylenol Extra Strength 500mg and does not know when she began taking that and was on so much stuff including opioids for when her back went out and guesses she was on Gabapentin after that time; states the Tylenol has lot AEC214, expiry date Feb2025. The patient has no name for the opioids and only took them for 5 days and then went off of them and went on the Gabapentin; states the opioids are pretty strong and then her intestines were such a mess and she got off of them and threw them away. Patient stated she was very anxious to get the Pfizer COVID Vaccine. States she just depended on her HCP and went to see the rheumatologist that was recommended along with therapy and they said she had signs of rheumatoid arthritis. Patient stated she has been very healthy and people said she can't be age 85 and she did not feel like it but the vaccine put her down. Patient stated she looked like she was age 70 until the Pfizer COVID shot and now looks like she was 90; patient just weighed herself. The outcome of the events fatigue/tiredness, joint pain, back pain was not recovered, and unknown outcome for the rest of the events.
258	1646816-1	COVID19 (COVID19 (PFIZER-BIONTECH))	65-79 years	Male	Leukaemia; Type 2 diabetes mellitus; Off label use; Acute myeloid leukemia; Dyspnoea; Mental disorder; Platelet count decreased; Haemoglobin decreased; Epistaxis; Haemorrhage; White blood cell count decreased; Pneumonia; Shortness of breath; Diabetes steroid-induced; This is a non-interventional study report from an unspecified marketing program received from a contactable consumer, information received by Pfizer from agency. (Mfr. Control No.: 21K-163-3931733-00). A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 intramuscular on 16May2021 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 72-year-old) for COVID-19 immunization; venetoclax (VENCLEXTA), oral from Jun2020 (Batch/Lot Number: 1134458) to Jun2020, at 200 mg, daily, oral from Jun2020 (Batch/Lot Number: 1134458) to Mar2021, at 2 DF, daily (Take 2 tablet(s) by mouth every day (2 in 1 D)), oral from Mar2021 (Batch/Lot Number: 1134458) and ongoing, at UNK, 1x/day, oral from Jun2020 (Batch/Lot number was not reported) to Dec2020, at 200 mg, 1x/day, oral from Dec2020 (Batch/Lot number was not reported) to Jul2021, at 100 mg, 1x/day for acute myeloid leukaemia, vitamin b12 deficiency, aortic aneurysm. Medical history included type 2 diabetes mellitus, leukaemia, acute myeloid leukaemia, white blood cell count decreased, antihistamine allergy, penicillin allergy manifested by hives, unspecified abdominal pain, calculus of kidney, calculus in bladder, malignant neoplasm of prostate, unspecified urinary incontinence, male erectile dysfunction, unspecified, parkinson's disease, ileus, unspecified, familial dysautonomia, anxiety disorder, unspecified, unspecified abnormalities of gait and mobility, allergic to dye, unspecified osteoarthritis, unspecified site, essential primary hypertension, diverticulosis of intestine, part unspecified, without perforation, vitamin d deficiency, unspecified, major depressive disorder, single episode, unspecified, mastodynia, hypertrophy of breast, adverse effect of unspecified drugs, medicaments and biologics, hydroureter, dorsalgia, unspecified, acute cystitis without hematuria, calculus of ureter, thrombocytopenia, unspecified, abdominal aortic aneurysm, without rupture, deficiency of other specified b group vitamins, diabetes insipidus, alcohol user, prostate cancer, three hernia operations, intravenous contrast dye allergy manifested by breakout in hives, antiviral, antibiotic, pneumonia, unspecified urinary incontinence, penicillin allergy manifested by hives, unspecified abnormalities of mobility from an unknown date and tobacco user from an unknown date to 1987 , radical prostatectomy from 2011 to an unknown date , appendicectomy from 2013 to an unknown date. Concomitant medication(s) included azacitidine (VIDAZA) taken for acute myeloid leukaemia; aciclovir sodium (ACYCLOVIR ABBOTT VIAL) taken for antiviral treatment; levofloxacin (LEVAQUIN) taken for antibiotic therapy; metoprolol (METOPROLOL) taken for hypertension; posaconazole (POSACONAZOLE) taken for prophylaxis; allopurinol (ALLOPURINOL) taken for acute myeloid leukaemia; bicalutamide (BICALUTAMIDE) taken for prostate cancer, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for contrast media allergy, start and stop date were not reported. The patient previously took reglan [metoclopramide] and experienced sulfa [sulfacetamide sodium; sulfadiazine; sulfadimidine; sulfamerazine] and experienced drug hypersensitivity, sulfa [sulfacetamide sodium; sulfadiazine; sulfadimidine; sulfamerazine] and experienced urticaria. The past drug included antihistamine 12 hour tablet, penicillins, dye and Sulfa (Sulfonamide Antibiotics). Patient mentioned he started smoking when he was 14 years old and stopped on mid 30s, 40 years ago. Patient started drinking alcohol when he was 19 years old. Patient had three hernia operations for the past 15 years. The patient experienced pneumonia, platelet count decreased, haemoglobin decreased, epistaxis, haemorrhage, white blood cell count decreased, shortness of breath (hospitalization, medically significant) on 18May2021, type 2 diabetes mellitus, leukaemia (hospitalization, medically significant) on an unspecified date with outcome of unknown , acute myeloid leukemia, dyspnoea (hospitalization, medically significant) on 02Aug2021, mental disorder (hospitalization, medically significant) on 01Jun2021, diabetes steroid-induced (hospitalization, medically significant) on May2021, (dyspnoea) (hospitalization, medically significant) on 18May2021, off label use (hospitalization, medically significant) on an unspecified date. The patient was hospitalized for pneumonia (pneumonia) from May2021 to May2021. It was reported that On unknown dates, the patient experienced type 2 diabetes, leukaemia was getting worse, venclexta intentionally used for unlabeled indication/off label use and low white blood cell count. in May2021, the patient experienced steroid induced diabetes. on 18May2021, the patient experienced hard time breathing, low platelets, low haemoglobin, bleeding in the nose, bleeding in the arms, pneumonia and low white blood cells. On 20May2021, the low haemoglobin and bleeding in the nose resolved. On 01Jun2021, the patient experienced mind scattered. In Jul2021, the bleeding in the arms resolved. On 02Aug2021, the patient experienced shortness of breath and worsened acute myeloid leukaemia. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient was in the hospital for a couple of weeks in May2021 with pneumonia. The pneumonia mixed with leukaemia was a bad thing. The physician ordered him off of the medication for the duration of his hospital stay. His mind was scattered on 01Jun2021. He stated that developed type 2 diabetes and was supposed to resume chemo with VENCLEXTA and VIDAZA, missed dose. Two days after he received the Covid 19 vaccine he went to the emergency room. He was given two bags of platelets on 29Jul2021. The alternative etiology for the event of bleeding in the nose was reported as low haemoglobin and low white blood cells. The alternative etiology for the event of bleeding in the arms was reported as too much drugs. The alternative etiology for the event of steroid induced diabetes was reported as steroids. Primary reporter did not have the lot number information because his bottle was not the original bottle and he had the pharmacy bottle. In last May2021, Patient stated that he went to emergency room and had to hospitalized for two days. On 02Aug2021, Patient had hospitalized again due to the shortness of breath, worsened acute myeloid leukaemia and low white blood cell count. Patient stated that he was still in the hospital. Patient had a platelet transfusion yesterday due to the low white blood cell count and worsened acute myeloid leukaemia. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 16May2021 patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. The patient was treated with DAPSONE, PREDNISONE and INSULIN. On 16Jun2021, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The event of ""type 2 diabetes"" was added. On 15Jul2021, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of leukaemia was getting worse was added. On 30Jul2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, treatment drug information, laboratory/diagnostic procedures and narrative description. The events of hard time breathing, low platelets, low haemoglobin, bleeding in the nose, bleeding in the arms, low white blood cells and steroid induced diabetes were added. On 10Aug2021, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology , suspect drug information and narrative description. The events of ""shortness of breath, worsened acute myeloid leukaemia and low white blood cell count were added. Causality for Venclexta(Venetoclax): The reporter's causality for the event(s) of type 2 diabetes, venclexta intentionally used for unlabeled indication/off label use and mind scattered was not provided. the reporter's causality for the event(s) of leukemia was getting worse, hard time breathing, low platelets, low hemoglobin, bleeding in the nose, bleeding in the arms, pneumonia, low white blood cells and steroid induced diabetes with Venclexta (Venetoclax) was no reasonable possibility. Agency's opinion is that there is no reasonable possibility that the events of type 2 diabetes, leukemia was getting worse, low platelets, low hemoglobin, bleeding in the nose, bleeding in the arms, low white blood cells, venclexta intentionally used for unlabeled indication/off label use, mind scattered and steroid induced diabetes are related to Venclexta(Venetoclax). Agency's opinion is that there is a reasonable possibility that the events of hard time breathing and pneumonia are related to Venclexta (Venetoclax). The patient underwent lab tests and procedures which included haemoglobin: low on 18May2021, platelet count: low on 18May2021, ultrasound scan: pneumonia on 18May2021, ultrasound scan: pneumonia mostly cleared up on Jul2021, white blood cell count: low on 18May2021. Therapeutic measures were taken as a result of events includes two bags of platelets on 29Jul2021 and Prednisone, Insulin and Dapsone. Outcome of the events Pneumonia, dyspnoea, steroid diabetes was reported as recovering, for events acute myeloid leukemia, platelet count decreased, white blood cell count decreased it was not recovered, the events haemoglobin decreased, epistaxis, haemorrhage were recovered and unknown for events type 2 diabetes mellitus, leukaemia, mental disorder, dyspnoea and off label use. Information about lot/batch number has been requested.; Sender's Comments: Events Pneumonia, Type 2 diabetes mellitus, Acute myeloid leukaemia, Leukaemia, Dyspnoea, Platelet count decreased, Haemoglobin decreased, Epistaxis, Haemorrhage, White blood cell count decreased, Mental disorder, Shortness of breath, Off label use most likely represent intercurrent medical conditions ( Type 2 diabetes mellitus , Leukaemia )and unrelated to bnt162b2 (COMIRNATY). Also consider effect of co-suspect drug VENETOCLAX""
259	1647285-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Male	I started getting pains in stomach, pain in my intestine; I started getting pains in stomach, pain in my intestine; Diarrhoea; Exhausted and tired; I ended up having like a 101 temperature; Throwing up; Nausea; My stool turned yellow; my pee was dark; I had yellow eyes; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 31Jul2021 (Batch/Lot Number: FA6780) at 50-years-old as DOSE 1, SINGLE for COVID-19 immunisation; adalimumab (HUMIRA), via an unspecified route of administration on 08Aug2021 (Batch/Lot Number: 1146119) at DOSE NUMBER UNKNOWN, SINGLE for arthritis. Medical history included arthritis from an unknown date and unknown if ongoing. There were no concomitant medications. On unspecified dates, the patient experienced: I started getting pains in stomach, pain in my intestine (non-serious), diarrhoea (non-serious), exhausted and tired (non-serious), I ended up having like a 101 temperature (non-serious), throwing up (non-serious), nausea (non-serious), my stool turned yellow (non-serious), my pee was dark (non-serious), I had yellow eyes (non-serious); all of which required a physician office visit. The patient stated, ""I just wanted to let you guys know about the reaction possible with another drug."" Name of the medication: patient stated, ""Humira."" The patient stated, ""I think I had a reaction to it. I took my first shot (COVID vaccine) on 31Jul2021 so I waited a week and took a Humira shot 7 days later alright and then 3 days after that which was Wednesday night I started getting pains in stomach, pain in my intestine and I don't know I am 50, I had some kind of reaction then I ended up having like a 101 temperature, throwing up and then it disappeared so I don't know if taking Humira shot close to, taking Humira shot and having the COVID shot is good or bad. I talked to my doctor and he said there is, you can do it 7 days later, but I am actually had an adverse reaction to it I think."" The patient confirmed the name of the products as COVID-19 Vaccine and HUMIRA vaccine. When paraphrased, the patient stated, ""I am having diarrhea, my stool turned yellow. I am going to my doctor tomorrow to talk to him about it. It seems like I had a like, it's like it could be before that like it's like after I took it. I had no reaction to the shot whatsoever I was perfectly fine with the vaccine, but I do not know taking HUMIRA and then working and then I ask 3 different doctors if it was okay to take it. I even called this HUMIRA pharmacy and they said there is no problem, but I don't know if it just by chance if ended up with 101 fever, throwing up and nausea."" When informed about the Pfizer Medical Information Department for the concern, the patient stated, ""Well, I will call my doctor tomorrow. I am just letting you know because research article, I have called to let you know I have something weird come up so. It was weird because I had the fever and the next day it was gone. I mean the next day I was exhausted and tired, but it was gone, the fever was gone."" Anatomical site of vaccination (Pfizer covid-19 vaccine), consumer stated, ""Right"" Other medical condition, consumer stated, ""I have arthritis, that's why I take HUMIRA and that's all."" Treatment for the side effects, consumer stated, ""No, like I said when I was taking HUMIRA straight up, I never had that kind of issue, when I was taking just straight Humira."" Upon follow-up on 18Aug2021, the patient stated, ""I spoke to safety already. I had my first shot of the Pfizer COVID-19 vaccine on 31Jul2021. Couple of days later, I have noticed that on Wednesday I had pain in my intestine on Thursday night it got worst. Friday morning it was tremendous pain. I had 99.0 temperature which went to 101 and I vomited. I felt nauseous. I had chills. I had issues going to the rest room. My stool color had changed to yellow and my pee was dark. I got a COVID test done on Saturday which came back negative. I had no fever no other things. I had discomfort in my intestine, but it has subsided now. Monday, I went to see my doctor he said I was fine. I had yellow eyes. He did my blood work and liver panel with bilirubin. It all came back normal. My urine test came back normal. My color of stool is normal. I want to understand what may have caused the symptoms is it the fact that I've taken the HUMIRA shot with the vaccine. My doctor had advised me to take the HUMIRA shot seven days after the Pfizer COVID-19 vaccine, but I took it on the 8th day could that have caused me to feel this way."" The patient underwent lab tests and procedures which included blood work: normal on an unspecified date, temperature: 101 on an unspecified date, temperature: 99.0 on an unspecified date, color of stool: normal on an unspecified date, liver panel with bilirubin: normal on an unspecified date, COVID test: negative on 14Aug2021, urine test: normal on an unspecified date. The action taken in response to the events for adalimumab was not applicable. The clinical outcome of the events: stool discoloration, gastrointestinal pain, pyrexia was recovered on an unspecified date, while the clinical outcome of the other events was unknown.""
260	1648507-1	COVID19 (COVID19 (PFIZER-BIONTECH))	80+ years	Female	upset feeling digestive tract/jumping and feel gurgling; not eating right/eating little; headaches; loose phlegm in back of throat; nausea; sneezing; she has had a runny nose so she has been getting very little sleep; she has had a runny nose so she has been getting very little sleep; very unsteady the whole week; noise and mucous in the back of throat; gas and bubbling; she has all the gas and bubbling and swelling; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH EUA COVID-19 VACCINE, solution for injection, Lot number: EN5318, expiration date: May2021) via unknown route of administration on 19Feb2021 at 14:00, dose 1, single (age at vaccination: 87 years) in her arm for COVID-19 immunisation. Medical history included small intestinal bacterial overgrowth (SIBO) (she has been taking supplements to keep it under control and having fermented foods), endometrial cancer, right lung lobectomy, total hysterectomy, high potassium, edema, Mohs surgery (surgery done to her forehead recently) and blood pressure. The concomitant medication included losartan for blood pressure. Patient reported that she got the first injection a week ago today, on 19Feb at 02:00PM. She said she had no problems until Sunday and through the rest of the week. She says today is the first day she almost feels as good as she felt before getting the vaccine. She reported she has had issues in Feb2021 with upset feeling digestive tract, and not eating right (eating little), she has had nausea slightly though she never did upchuck. Patient also reported she has had headaches, sneezing, and loose phlegm in back of her throat. She said she has been gargling for that at night. She reported that she has had a runny nose so she has been getting very little sleep, she has had noise and mucous in the back of throat and noise in her digestive tract. She says she has problems with her small intestine bacteria overgrowth, also called SIBO, for which she has been taking supplements to keep it under control and having fermented foods, she puts her hand on her stomach and can feel it jumping and feel gurgling, she has been very unsteady the whole week. She says she is sorry that she took the vaccine since her immune system is totally compromised, over the years she has had 4-5 bouts of cancer, and her intestines has more bad bacteria than good bacteria, she has all the gas and bubbling and swelling because of that. The outcome of the events upset feeling digestive tract, not eating right/eating little, headache, loose phlegm in back of throat was resolving and outcome for rest of the events was unknown. No follow-up attempts are possible. No further information is expected.
261	1649851-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Male	Groin pain; Intense cramping; Significant slowdown of GI tract/ constipation/ leaving a trail of stool in intestines; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 12Apr2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medications included over the counter (OTC) allergy medications, from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 10:00, the patient experienced significant slowdown of GI tract (constipation), leaving a trail of stool in intestines. He also had intense cramping and pain in the groin area which required ER visit to rule out obstruction. He further clarified that he was prescribed with laxative to address. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of significant slowdown of GI tract (constipation), intense cramping and pain in the groin area which included treatment with CT to rule out obstruction, prescribed laxative. The clinical outcome of the events groin pain, intense cramping and significant slowdown of GI tract/ constipation was resolving at the time of report. No follow-up attempts are needed. No further information is expected. .
262	1652413-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Female	could not stay awake; fever; fatigue, tiredness; arm got sore; other muscle pain; gastro symptoms started, unusual feeling in intestines, excess pooping; chills; strange taste in mouth; excess saliva; numbness in lower half of face and lips; slight twinge in heart area; sinus disorder; itching under left side of tongue in thin line from base to tip, might be a nerve; gastro symptoms started, unusual feeling in intestines, excess pooping; dizziness; lower back pain; both sides, feels like tenderness in kidneys; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EQ0182) via an unspecified route of administration in the left arm on 21May2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine, genetically cholesterol high, and the patient was allergic to sulfonamides (sulfa drugs), contrast media allergy (contrast for CT scans), eggs, the patient had multiple chemical sensitivity and smoke sensitivity. Concomitant medications included erenumab (AIMOVIG) 140 mg, monthly injection from an unknown date taken for unknown indication. The patient previously took aminobenzoic acid (PABA) for unknown indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0171) via an unspecified route of administration in the left arm on 30Apr2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021, the patient experienced strange taste in mouth and excess saliva after 10 minutes of vaccination, numbness in lower half of face and lips and slight twinge in heart area after 25 minutes of vaccination, sinus disorder after 30 minutes of vaccination, itching under left side of tongue in thin line from base to tip, might be a nerve and arm got sore after 45 minutes of vaccination, gastro symptoms started unusual feeling and excess pooping after one hour of vaccination, fatigue, tiredness after 2 hours of vaccination, chills after 5 hours of vaccination, dizziness after 8 hours of vaccination, fatigue and tiredness after 9 hours of vaccination, lower back pain, both sides, feels like tenderness in kidneys after 12 hours of vaccination, severe fatigue, tiredness, arm soreness/pain, other muscle pain, got about 8 hours sleep, felt better after 15 hours of vaccination, arm soreness, fatigue, tiredness after 24 hours of vaccination. The patient experienced severe fatigue, tiredness, fever, could not stay awake after 25 to 29 hours of vaccination and patient got about 8 hours sleep and was still really tired. The patient stated that she had severe fatigue, tiredness, fever, could not stay awake even after 54 hours of vaccination. The gastro issues was there until day 5. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event sinus disorder which included sinus clearing and drainage on 21May2021 after 30 minutes of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events strange taste in mouth, excess saliva, numbness in lower half of face and lips, slight twinge in heart area, sinus disorder, itching under left side of tongue in thin line from base to tip, might be a nerve, arm got sore, gastro symptoms started, unusual feeling in intestines, excess pooping, chills, dizziness, lower back pain, both sides, feels like tenderness in kidneys, other muscle pain, fever, could not stay awake was unknown at the time of this report. The clinical outcome of the event fatigue, tiredness was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
263	1652785-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Male	Within 2 hours of receiving the 2nd dose of the covid vaccine I began to have intense stomach pain in my intestines / At times it feels like needles inside my intestines stabbing me internally.; I have had indigestion and pain in my abdomen and stomach for 1 month straight.; I have had indigestion and pain in my abdomen and stomach for 1 month straight.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 15May2021 at 12:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included buprenorphine hydrochloride 8.6mg, naloxone hydrochloride 2.1mg (ZUBSOLV) and ibuprofen 400mg (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 17Apr2021 at 12:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 14:00, Within 2 hours of receiving the 2nd dose of the COVID vaccine the patient began to have intense stomach pain in the intestines. The patient had indigestion and pain in abdomen and stomach for 1 month straight. ""The pain comes and goes. At times it feels like needles inside my intestines stabbing me internally. I am in horrible pain every day"". The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events intense stomach pain in the intestines, indigestion and pain in abdomen and stomach for 1 month straight was not recovered at the time of this report. The lot number for BNT162b2, were not provided and will be requested during follow up.""
264	1653568-1	COVID19 (COVID19 (MODERNA))	60-64 years	Female	I received my vaccine at Pharmacy, not my doctors office. As expected, my arm was sore so my husband said I needed to massage it. As soon as I did, I felt a flush down my left arm to my fingertips, then down the left side of my body. Within less then an hour I had what felt like a swollen ball of fire in my descending colon which required using a heat pad on my abdomen. This continued for the rest of the day/ evening until I finally justwent to bed. As soon as I laid down, I experienced what felt like a burning raise up through my colon and intestines and up into my stomach until it reached my diaphragm. Also down to my rectum. It felt like I was going to explode on both ends at once (meaning vomit and have explosive diarrhea , then suddenly I started having sharp pains to my heart. It felt like shocks. This continued until I finally fell asleep. Over the next few days my arm was sore as expected but nothing else until the morning of the 26th when I woke to feeling extreme itching sensation under my skin at the site of my vaccine. My skin didn?t itch, it was inside my arm. I told my husband it felt like something was eating my arm from the inside out. This has continued to today with a large red area on my upper arm along with a hard welt and the area is hot. This evening I started breaking out in a rash on the other arm near my armpit and trunk junction which is spreading up over my shoulder.
265	1653848-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Female	7/30- 1st jab! 7/31- RA flare-ups in both hands (all digits) & @ the site of previous injuries: R torn rotator cuff, hips, knees, wrists, ribs, neck; Site of injection is warm & swollen; Overall warmth; No concept of time; Malaise; Strange taste in mouth/smell; Face/tongue numbness; Eyes are sensitive to light; Heart feels floppy. 8/1- new symptoms only Glands swollen in neck affecting tinnitus & breathing; Thyroid bit feels attacked; Chest feels heavier; Pressure at the base of skull; Chills/sweating. +Soreness & overall warmth at site reduced. 8/2- ER for tests. <Sent paperwork to you on 8/12 in large, manila envelope> 8/3- Profuse sweating; Vision foggy; R shoulder fatigue; Pins & needles in R hand; Difficulty breathing w/exertion. +Face not numb; Bad flavor reduced; Headache intermittent; Heart feels less floppy; Throat is mostly open; More energy. 8/7- Feeling more normal than not; Urine is warm. 8/8- Unexplained retching; Woozy; No food allowed. 8/9- Intense pains in intestines (most intense where my appendix used to be); Confined to bed; No food allowed. 8/10-Retching returns. 8/12- Food/drinks are SPICY! 8/15- Huge, painful belly bloating from gas build up from any food. Belly is hot to the touch upper R quadrant (gall bladder). 8/16- Numbness in L hand (4th & 5th digit) up to mid forearm. 8/18- Muscle tightness in back & RA flare-up in hands has returned. +Belly heat has diminished. 8/19- Vibrating, tingling senation from feet to hips (after cleaning the turtle tank for an hour) which eventually spread all over my body; Numbness in face (jaw); Lack of coordination of left hand (fingers/thumb); Bursts of rapid heart rate, but not an increase in blood pressure; Panic!; Distress! <Nearly called the ambulance to take me to the hospital> I feel weak, tired, & disinclined to eat. I try to force myself to eat at least 1 ""meal"" a day. 8/20-8/21- Pooping nothing but bile""
266	1655088-1	COVID19 (COVID19 (PFIZER-BIONTECH))	60-64 years	Male	Blood clots/thrombosis/blood clot to the intestine; His sodium went low; He was dizzy with memory loss; He was dizzy with memory loss; Not able to walk; His spleen is damaged completely/spleen damage from the blood clots; Fatigue; nausea worse after eating; Not feeling good; Stomach pain; This is a spontaneous report from a contactable consumer. This consumer (patient's daughter) reported for her father (patient). A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8735, and Expiration date: Unknown), via an unspecified route of administration, administered in arm on 03May2021 10:00 (at the age of 62-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included blood pressure high (from two or three years) and diabetes (from two years). The patient had no family medical history relevant to adverse event. There were no concomitant medications. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8735, and Expiration date: Unknown), administered in arm on 12Apr2021 09:30 AM (at the age of 62-year-old) for COVID-19 immunization (no reactions after first dose). The caller was a consumer called on behalf of her father who received both doses of the Pfizer COVID19 vaccine in the US. The first dose was received on 12Apr2021 while the second dose was on 03May2021. Her father was on a vacation here but not a citizen. The caller reported her father started in May2021 with stomach pain, fatigue, (sometimes nauseated, worse after eating food) nausea worse after eating, and he always complained like not feeling good. The caller reported that her father returned to India. The caller stated, on 16Jul2021, all of the sudden he was dizzy with memory loss, not able to walk, his sodium went low, and he went to the emergency room in India and was admitted to hospital on 16Jul2021 and ""he is still in the hospital today"". Mentioned he had thrombosis. On 16Jul2021, the also experienced blood clots/thrombosis/blood clot to the intestine. The patient was admitted to hospital and the doctor said he had blood clotting and it was going to all organs in his body. Reported he had pain in his stomach and all kinds of symptoms. Added ""his spleen is damaged completely / spleen damage from the blood clots"" and there were blood clots, and they are reaching everywhere including his stomach and his lung and the intestine also. The caller reported that they have many test reports, and she did not know where to send them. She did not have the results in front of her but stated she had a CT Scan, CBD, and chest X-rays. Stated the caller was just calling for any kind of recommendation. The caller wanted to know if this was a side effect with the vaccine and if we have recommendations. On an unspecified date in 2021, the patient underwent lab tests and procedures which included bile duct stone (CBD): unknown results, chest X-ray: unknown, and CT Scan: unknown results, and thrombosis: unknown results. Investigation assessment not provided. The outcome of the events was unknown. Follow-Up (24Aug2021): Follow-up attempts are completed. No further information is expected.""
267	1655844-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Male	I don't believe this is related to the shot, but it is a hard-to-diagnose health issue that arose at the time of having my second vaccination and has persisted since. Soon after the second shot, I developed gastrointestinal issues that were similar to gastritis or an infection both in the upper and lower parts of my stomach/intestines. It became unignorable by April 3rd and I went for a general check-up with a doctor who took blood tests and felt around my stomach. Blood tests came back all clear and he wasn't concerned however a week or so later the pain was fairly strong and I went to a urgent care. They did a urine test which came back fine but recommended me to a GI specialist. The GI specialist has done a breath test for bacteria that came back negative, he also did a colonoscopy that showed no obvious issues beyond irritation and he took a biopsy and ordered blood tests for celiac and gluten intolerance that we are awaiting results for. The pain is less bad but still present to this day and we are yet to come to a diagnosis. Again, I don't believe this is linked to the vaccine but thought it was mentioned anyway as it is a new medical event since having the shot.
268	1656180-1	COVID19 (COVID19 (MODERNA))	50-59 years	Female	Red Rash immediately, 6 months out has traveled Outside of right arm to elbow , presently lower right lower arm. CT reveals enlarged lymph nodes across the intestines, right arm neurological nerve pain in right arm. E R visit for right and left flank pain lasted 3 weeks. Presently still have right arm nerve problems under a ORtho specialist.
269	1657017-1	COVID19 (COVID19 (PFIZER-BIONTECH))	80+ years	Male	A bilateral subdural brain hemorrhage leading to a 6 mm midline shift of the brain. Symptoms started on Thursday, August 5 with a headache and led to an urgent care, emergency room, and hospital admission on Saturday, August 7 (admitted overnight, August 8). The presenting symptom moved from a headache to confusion and the feeling of needing to vomit with no result. When transported between hospitals there was erratic behavior and loss of consciousness. There was no known drooping of the face, loss of ability in the limbs or other stroke type symptoms. Once admitted the subdural hemorrhage was drained with the result being that the bleed was ""old"". This was not an active bleed or one that continued. The determination of age of the blood/bleed origination was 3 to 4 months prior to symptom onset. A series of small issues elongated the hospital stay included aspiration pneumonia, a closed loop small intestine blockage, thrombus of the forearm, and pneumothorax.""
270	1657997-1	COVID19 (COVID19 (PFIZER-BIONTECH))	30-39 years	Female	Lasting several days: Distended abdomen; slowed or improper motility in intestines; tenderness below sternum; very loud stomach gurgles Lasting about 3 months: Loose stools, loud stomach gurgles, occasional tenderness on surface of abdomen, burping
272	1661189-1	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	Female	Severe pain in the stomach; Increase in heart rate; her arm ""hurt like hell""; Scared to death of COVID; Heartburn; Tired; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 06Aug2021 as dose 1, single for covid-19 immunisation. Medical history included covid-19 virus from Mar2021 to an unknown date. The patient's concomitant medications were not reported. On unknown date in Aug2021, the patient experienced scared to death of covid; heartburn; tired; her arm ""hurt like hell""; On 09Aug2021, increase in heart rate; On 12Aug2021, severe pain in the stomach. The patient underwent lab tests and procedures which included heart rate: 106 on 09Aug2021 increase in heart rate and that it was 106 bmp at rest, sars-cov-2 test: had the covid 19 virus on Mar2021 she previously had the COVID 19 virus in March2021. It was reported that stated that she was looking for some information on the Pfizer COVID 19 vaccination and the symptoms she has experienced since her first dose. She stated that she previously had the COVID 19 virus in Mar2021. She stated that she is healthy and has no underlying conditions. She stated that she waited for 3-4 months after having COVID because she had antibodies. She stated that she's an elementary school teacher for younger children and she wanted to be fully vaccinated before school started back in September. She stated that she was ""scared to death of COVID and did not think she will make it if she gets it again"". Once she had her first dose she states that she was fine with the regular side effects and knew what to expect. She mentioned that her arm ""hurt like hell"" and that she was tied but that wasn't a problem because she was used to being tired. She got it on the 6th which was a Friday and on the 9th she reported having an increase in heart rate and that it was 106 bmp at rest. She reports that it was the same on the 10th. Elevated heart rate went away and she states that she figured her body was just making antibodies. She then reported on the 12th she began having severe pain in the stomach and it felt like bubbles and somewhat like heartburn. She stated that on the 13th it got worse and then started to level out on the 14th. On the 16th,17th,18th and today the 19th its gradually gotten better but still at a moderate level. She compares it to inflammation of the intestines and/or esophagus and that she was ""beside herself"". She relays that she spoke with her doctor and they asked if it could possible be something she ate that caused these symptoms. She stated that she had not had any foods that were out of the ordinary for her and had no tried any new foods or experimented with anything she provided an example of, ""like, spicy Indian food or anything like that"". The clinical outcome of event increase in heart rate was recovered on unknown date in Aug2021; outcome of severe pain in the stomach was recovering; while other events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.""
273	1661561-1	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	Unknown	developing weakness on my back; developing mucous in the back; severe breathing, like shortness of breath; pains underneath my chest or the heart; pain on my back; This is a spontaneous report received from a contactable consumer (Patient). This 71-year-old patient reported for own-self. A 71-year-old patient with unspecified gender received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered on Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history includes Large intestine benign neoplasm, Visual impairment and vision problems after an accident from an unspecified date to unknown date and concomitant medications were not reported. In Mar2021, after the vaccination, the patient experienced pain underneath his chest or the heart. Patient had pain on his back and had severe breathing, like shortness of breath and developing weakness over back. Patient is also experiencing mucous development over the back but patient cough it out and blow out from his nose. right now, patient is feeling like there is mucous coming into his back. Also, weakness over the back. Its almost 3 weeks now and patient scared to take the second dose. The events assessed as non-serious. The patient lab data includes blood test with unknown results on an unspecified date. The outcome of the events was unknown. No follow-up attempts possible. No further information expected. Follow-up (PRD/SRD (17May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
274	1665630-1	COVID19 (COVID19 (MODERNA))	80+ years	Male	a lot of physical problem; intestines are going crazy; gained 15 pounds in weight/gained in 15 pound; he woke up with face and ears looking like he had sun burn, and then his hands; and he had not been in the sun because it was February. It was sore and scaly and irritable/ Sores in hand and scalp, face and hand looks like sun burn/knuckles and hand; It was sore and scaly and irritable; lost a lot of muscles; oozing; It was sore and scaly and irritable; experienced severe water retention; my bowels are a mess; my skin is burning; I had sores on my knuckles; This spontaneous case was reported by a consumer and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (a lot of physical problem), ABDOMINAL DISCOMFORT (intestines are going crazy), WEIGHT INCREASED (gained 15 pounds in weight/gained in 15 pound), RASH ERYTHEMATOUS (he woke up with face and ears looking like he had sun burn, and then his hands; and he had not been in the sun because it was February. It was sore and scaly and irritable/ Sores in hand and scalp, face and hand looks like sun burn/knuckles and hand) and SKIN IRRITATION (It was sore and scaly and irritable) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (a lot of physical problem), ABDOMINAL DISCOMFORT (intestines are going crazy), WEIGHT INCREASED (gained 15 pounds in weight/gained in 15 pound), RASH ERYTHEMATOUS (he woke up with face and ears looking like he had sun burn, and then his hands; and he had not been in the sun because it was February. It was sore and scaly and irritable/ Sores in hand and scalp, face and hand looks like sun burn/knuckles and hand), SKIN IRRITATION (It was sore and scaly and irritable), MUSCLE ATROPHY (lost a lot of muscles), SKIN WEEPING (oozing), SKIN EXFOLIATION (It was sore and scaly and irritable), FLUID RETENTION (experienced severe water retention), ABDOMINAL DISCOMFORT (my bowels are a mess), SKIN BURNING SENSATION (my skin is burning) and MYALGIA (I had sores on my knuckles). At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (a lot of physical problem), ABDOMINAL DISCOMFORT (intestines are going crazy), WEIGHT INCREASED (gained 15 pounds in weight/gained in 15 pound), RASH ERYTHEMATOUS (he woke up with face and ears looking like he had sun burn, and then his hands; and he had not been in the sun because it was February. It was sore and scaly and irritable/ Sores in hand and scalp, face and hand looks like sun burn/knuckles and hand), SKIN IRRITATION (It was sore and scaly and irritable), MUSCLE ATROPHY (lost a lot of muscles), SKIN WEEPING (oozing), SKIN EXFOLIATION (It was sore and scaly and irritable), FLUID RETENTION (experienced severe water retention), ABDOMINAL DISCOMFORT (my bowels are a mess), SKIN BURNING SENSATION (my skin is burning) and MYALGIA (I had sores on my knuckles) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: everything seems fine (normal) everything seems fine. On an unknown date, Ultrasound scan: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication included Diuretics (unspecified). After the second dose, the patient woke up with face and ears looking like had sun burn, and then his hands; and he had not been in the sun because it was February. It was sore and scaly and irritable. The patient used a cream to use (he does not remember the name), it gets better and then it comes back, like he got sun burnt again, it can't seem to heal up. The cream makes it better, but it doesn't clear it up. He lost a lot of muscles. After the second Moderna COVID-19 injection I gained 15 pounds, experienced severe water retention,"" my bowels are a mess"", my skin is burning. I had sores on my knuckles. The patient was given a steroid shot because in his knuckles and hand, he had huge sores, that was oozing, and the steroid shot helped. The patient had done some blood work (unspecified) and everything seems fine. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: follow-up received contains no new information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.""
275	1670654-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Female	Intense abdominal pain resulting in multiple doctor and hospital visits. Symptoms began 9 days after second dose. In 6 weeks, I was admitted to the hospital for 4 days. There is still no diagnosis for the chronic inflammation with ulcers in my large intestine. There is still intense pain throughout entire abdomen.
276	1673088-1	COVID19 (COVID19 (MODERNA))	65-79 years	Male	dehydration; turning on his autoimmune system to where his body is fighting itself. He states his body is fighting his intestines; lost 15 pounds; diarrhea for over 2 months; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (dehydration) and AUTOIMMUNE DISORDER (turning on his autoimmune system to where his body is fighting itself. He states his body is fighting his intestines) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Colonoscopy on 12-Aug-2021. Concurrent medical conditions included Autoimmune disorder. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced DIARRHOEA (diarrhea for over 2 months). On an unknown date, the patient experienced DEHYDRATION (dehydration) (seriousness criterion hospitalization), AUTOIMMUNE DISORDER (turning on his autoimmune system to where his body is fighting itself. He states his body is fighting his intestines) (seriousness criterion medically significant) and WEIGHT DECREASED (lost 15 pounds). At the time of the report, DEHYDRATION (dehydration), AUTOIMMUNE DISORDER (turning on his autoimmune system to where his body is fighting itself. He states his body is fighting his intestines), DIARRHOEA (diarrhea for over 2 months) and WEIGHT DECREASED (lost 15 pounds) outcome was unknown. The doctors were thinking that it caused by the shot, turning on his autoimmune system to where his body is fighting itself. Patient states that his body is fighting his intestines. Patient called to report this that he has been hospitalized 4 times for dehydration; one time he was there for 6 days. Concomitant medications was not provided by the reporter. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
277	1673124-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Male	intestinal cramps in the large intestine that has been persistent for over 2 months that gets worse when I eat; debilitating pain; lost 20 lbs; This is a spontaneous report from contactable consumer (patient) via the Regulatory Authority. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left on 08Apr2021 13:30 (lot numbers: EW0150 also reported as EN6205; expiry date: unknown) at the age of 51-years-old, as dose 1, single, for COVID-19 immunisation. Medical history included reactive arthritis from food poisoning. The patient had no known allergies. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a Public Health Clinic/Veterans Administration facility. Concomitant medications included ibuprofen, acetaminophen, and gabapentin, and more (unspecified). On 24Apr2021, the patient experienced intestinal cramps in the large intestine that has been persistent for over 2 months that gets worse when he eats. It manifests in the corners of the intestine and can cause debilitating pain. He had a weekend of ""normal"" reactions then intestines started cramping 2 weeks after that. He had lost 20 lbs since April and shows no signs of slowing down. The patient did not receive treatment for the events. The events resulted in: Doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since vaccination. Outcome of the event lost 20 lbs was unknown, while for the other events was not recovered.""
278	1673316-1	COVID19 (COVID19 (PFIZER-BIONTECH))	40-49 years	Female	having a Ulcerative colitis flare up; I got my booster yesterday; Headache; Diarrhea; Achiness; terrible stomach pain; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN0171) via intramuscular, administered in Arm Left on 18Aug2021 10:20 (at the age of 44-year-old) as dose 3, single for covid-19 immunisation. Medical history included colitis ulcerative (she was first diagnosed with Ulcerative Colitis in 2015) and hypothyroidism from an unspecified date. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6202) via an unspecified route of administration on 01Mar2021 as dose 1, single for covid-19 immunisation and received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6200) via an unspecified route of administration on 22Mar2021 as dose 2, single for covid-19 immunisation. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for hypothyroidism. On 18Aug2021 10:40 the patient experienced having a Ulcerative colitis flare up, Consumer stated that in the past diagnosed with Ulcerative Colitis and she did not have any issues or any side effects with her first or second dose. It was just with yesterday you know after her shot she had a slight headache and achiness and then this morning she just had really a terrible stomach pain. she was experiencing now a flare up of Ulcerative colitis. It was like combining of her intestines like heading (Not clarified) so it was just like a flare up of the Ulcerative Colitis. Consumer stated that Ulcerative Colitis it has been many years. she would say for 7 to 8 years ago. She states two months ago she was taking a medication called Canasa and her getting up for you right now. It was like a suppository. Consumer stated, she has not taking anything currently but that was the medicine she was prescribed in the past. Consumer stated, she called Gastroenterologist to and left a msg for the nurse and she trying to get a call back from the doctors. It was just really bad stomach pain about 07:45 this morning and then like, she had some Diarrhoea and then it some of side (Not Clarified). The way the doctor explains before happened this like the ulcer and ulcerative colitis with burns of like your Intestinal lining. The adverse events terrible stomach pain, Diarrhoea was result in visit to emergency room/ Physician Office Visit. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
279	1673861-1	COVID19 (COVID19 (PFIZER-BIONTECH))	50-59 years	Male	I felt dizzy, the lights and furniture were swinging/spinning. I felt my brain physically rolled/moved inside my head.; I felt dizzy, the lights and furniture were swinging/spinning./ I felt my brain physically rolled/moved inside my head.; My mouth seemed num/tongue was not following his brain; My jaw was slow. Just not normal.; But the adverse effects on 04/21 night really worries me.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Apr2021 at 11:15 (at the age of 57-year -old) as a single dose for COVID-19 immunisation. Medical history included colon (Unspecified disorder of intestine). The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 02:00, first time ever, at night in bed after midnight, when the patient moved the head felt dizzy, the lights and furniture were swinging/spinning. The patient felt that the brain physically rolled/moved inside the head. The patient woke his wife (multiple times) and his mouth seemed num. This occurred multiple times. The patient tried multiple times to see if it was his illusion (The patient really wished it was). The patient tested multiple times; it was really true (The patient was an engineer). In the early morning, when the patient made a phone call, he still felt that the tongue was not following his brain. The patient jaw was slow. Just not normal. The patient got the second shot on 19Apr2021, this side effect occurred at the night of 21Apr2021. The patient had relatively severe adverse effect on the first night 19Apr2021 after the second shot ""(but it was fine I guess)"", but the adverse effects on 21Apr2021 night really worries. The patient didn't have much feeling on the first shot though. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events head felt dizzy, the lights and furniture were swinging/spinning, brain physically rolled/moved inside the head, mouth seemed num, tongue was not following brain and jaw slow were unknown at the time of this report No follow-up attempts are needed; information about lot/batch number cannot be obtained.""
280	1677202-1	COVID19 (COVID19 (MODERNA))	60-64 years	Female	Just a very sore arm for a while, lasted of couple a weeks; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (just a very sore arm for a while, lasted of couple a weeks) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced MYALGIA (just a very sore arm for a while, lasted of couple a weeks). At the time of the report, MYALGIA (just a very sore arm for a while, lasted of couple a weeks) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high (High) High- Before vaccination. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Patient said that last summer went to ER because a problem with intestines and that white blood cells high (before vaccination) so was taking medication for that. Patient did not take medication to treat symptoms. No Concomitant medications were provided.
281	1681729-1	COVID19 (COVID19 (PFIZER-BIONTECH))	Unknown	Unknown	I still have throat discomfort and a very recent endoscopy confirmed my entire esophagus, stomach, and small intestine are still inflamed, but I am feeling much better than before the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history included covid-19 from Jan2021 to Jan2021, pneumonia from 2021, throat swelling from 2021, neck swelling from 2021, pain from 2021. Concomitant medications were not reported. It was reported that, patient wanted to thank Pfizer directly for offering the Covid-19 vaccine, and share patients unique experience how it helped me within ONLY 24 hours which patient actually captured on video! These were the only email addresses patient could find so patient hope this routes to the appropriate party. Patient was diagnosed with Covid-19 in Jan2021 which developed into several symptoms, including pneumonia and constant throat and neck swelling which resulted in pain 24/7. Considered a long-hauler, many of my symptoms lasted 4 months UNTIL patient received the first dose of the Pfizer COVID vaccine. Patient had been to several doctors, ENT, pulmonologist, cardiologist, speech Therapist, gastro, and even paid for a 30 minute consult, Silent Reflux was the diagnosis for patient constant throat/neck pain and swelling. Patient would periodically make videos for patient family to provide them updates on patient health, and wanted to share patient condition right before patient left patients home to get first dose of the Pfizer Covid vaccine, and then 24 hours after that first dose. Since these were made for patient family please excuse the loving gestures. Patient truly blessed and thankful it has helped!!! patient still have throat discomfort and a very recent endoscopy confirmed patient entire esophagus, stomach, and small intestine are still inflamed, but patient feeling much better than before the vaccine. The patient underwent lab tests and procedures which included endoscopy: inflamed (entire esophagus, stomach, and small intestine are still inflamed) on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
282	1685585-1	COVID19 (COVID19 (MODERNA))	50-59 years	Female	I start sweating all over like had fever but I didn't. I was vomiting. Had really bad back and stomach pain. I went to the ER. They did an ultrasound, CT scan, and a chest x-ray. They said I had inflamed small intestines.
283	1692242-1	COVID19 (COVID19 (PFIZER-BIONTECH))	80+ years	Female	swelling in both legs and feet; congestive heart failure; Crohn's flare up/Crohn's acting up; height shrunk; Dizziness; eye sight was not focusing together with Humira 40mg; This is a solicited report based on the information received by Pfizer. (MFR Control No. # 21K-163-3995267-00). A contactable physician and consumer reported that an 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202, expiry date: 26Feb2021) via intramuscular on 26Feb2021 (at the age of 83-year-old) as dose 2, single for COVID-19 vaccination; Adalimumab (HUMIRA, Solution for injection in pre-filled pen, lot number: 1141161) from 2019 and ongoing at 40 mg via Subcutaneous for moderate to severe rheumatoid arthritis and celecoxib via an unknow route on an unknown date at an unknown dose and frequency for osteoarthritis. The patient medical history included thyroid, diuretic, supplement, overactive bladder, small intestine, general pain, arthritis, all were ongoing, congestive heart failure from 2017, non-smoker, abstains from alcohol, low iron levels. The patient had no known allergies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications included levothyroxine for thyroid, furosemide for diuretic, potassium chloride for unknown indication, cobamamide (VITAMIN B12) for supplement, oxybutynin for overactive bladder, budesonide for small intestine, acetaminophen for general pain and arthritis. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: BM9809, expiration date: Jun2021) via intramuscular on 05Feb2021 (at the age of 83-year-old) as dose 1, single for COVID-19 vaccination. On unknown date in 2021, the patient experienced height shrunk and dizziness and the patient experienced eye sight was not focusing together with Humira 40mg. In Mar2021, the patient experienced Crohn's flare up/Crohn's acting up. In Jul2021, the patient experienced congestive heart failure. On 01Jul2021, the patient experienced swelling in both legs and feet. Pfizer covid-19 vaccine and Celecoxib were also considered suspect. The patient went to the emergency room and diagnosed with congestive heart failure and she believed this was related to Humira. In 2021, her eye sight had worsened and was advised to get new glasses. In Mar2021, her Crohn's disease flared up really bad after Covid 19 vaccine and felt extreme fatigue and loose stools, diarrhea. Her Crohn's had been acting up. She took Pepto Bismol and an over the counter anti diarrheal to help with her symptoms. She was concerned about weight loss, lost 10 lbs due to excessive diarrhea and was very upset. She gained 3 lbs in a week which in turn made her feel a lot better. Weight loss was improved and she weighed 101 lbs. In Jun2021, she had weight loss, her appetite went down, and felt very tired. In Jul2021, due to swelling in both legs and feet she went to emergency room and had electrocardiogram which had shown she had congestive heart failure. She was not hospitalized and had taken furosemide, wore compression stockings and had been advised to walk around. On unknown date in 2021, Her height had shrunken as she used to be sixty five inches tall. Outcome of the events of Crohn's disease, Body height decreased was unknown and other events was not recovered. The causality of the events of cardiac failure congestive, peripheral swelling, vision blurred, body height decreased, dizziness and Crohn's disease with respect to the suspect bnt162b2 was not related as per reporter (Drug/Vaccine). The causality of the events of cardiac failure congestive, peripheral swelling, vision blurred, body height decreased, dizziness with respect to the co-suspect Humira was not assessable per reporter and no reasonable possibility as per manufacturer; and for the event of Crohn's disease was no reasonable possibility per reporter and no reasonable possibility as per manufacturer. The causality of the events of peripheral swelling, vision blurred, body height decreased, dizziness and Crohn's disease with respect to the co-suspect celecoxib was not related as per reporter and for the event of cardiac failure congestive was Probable as per reporter. No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Congestive heart failure, Crohn's disease, body height decreased, dizziness, peripheral swelling and vision blurred cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
284	1694501-1	COVID19 (COVID19 (PFIZER-BIONTECH))	18-29 years	Female	Had a small bug in Early/Mid August that involved a lot of fatigue, nausea, dizziness, and diarrhea. May be unrelated, but unsure. On 8/27/2021, I went to the bathroom and had a bit of diarrhea. After I had gone, I looked in the bowl and saw a lot of blood. I called my father's girlfriend who is a nurse and she said it was likely just an internal hemorrhoid. Later that evening I felt extremely dizzy and like I was going to faint so I went to an Urgent Care and they told me to go to the ER. At the ER they did a CT scan and found that there was inflammation in the lower intestine but were unsure of the cause. I still had blood coming out every time I went to the bathroom, even if I was just peeing. The ER doctor put me on two antibiotics (cipro and metronidazole). Over the next week or so, I felt extremely fatigued and continued to have diarrhea. I went to see a doctor and he put me on a different antibiotic (bactrim). He also did a blood test (all levels were normal), and a stool sample (they found high levels of yeast) Symptoms cleared up and diarrhea lessened. After about 5 days, doctor took me off the bactrim and put me on Diflucan for the yeast. I have an appointment with a GI doctor on Thursday 9/16 to follow up on things.
285	1707335-1	COVID19 (COVID19 (MODERNA))	Unknown	Female	her elbows came out; felt tired/ experienced chronic fatigue; achy all over; Fibromyalgia; More problems breathing; Problems with her intestines; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Fibromyalgia), DYSPNOEA (More problems breathing), GASTROINTESTINAL DISORDER (Problems with her intestines), FATIGUE (felt tired/ experienced chronic fatigue) and MYALGIA (achy all over) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immunocompromised and Asthma (, she had problems with her lungs (sister has asthma but after second dose experienced more problems breathing). Sister also had problems with her intestines. ). In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. In January 2021, the patient experienced FIBROMYALGIA (Fibromyalgia), DYSPNOEA (More problems breathing) and GASTROINTESTINAL DISORDER (Problems with her intestines). On an unknown date, the patient experienced FATIGUE (felt tired/ experienced chronic fatigue), MYALGIA (achy all over) and JOINT DISLOCATION (her elbows came out). At the time of the report, FIBROMYALGIA (Fibromyalgia), DYSPNOEA (More problems breathing), GASTROINTESTINAL DISORDER (Problems with her intestines), FATIGUE (felt tired/ experienced chronic fatigue), MYALGIA (achy all over) and JOINT DISLOCATION (her elbows came out) outcome was unknown. Sister was concerned about receiving full third dose and not half, as Moderna submitted FDA approval for 50 mcg dose now. she was worried that whether this dose will create any problem or not Concomitant medication use was unknown Treatment information was unknown Reporter did not allow further contact

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