From the 9/23/2022 release of VAERS data:
Found 56 cases where Age is under-0.1 and Vaccine is COVID19
Government Disclaimer on use of this data
Table
Age Symptoms Count Percent .1 years Abdominal pain 1 1.79% Abdominal pain upper 1 1.79% Addison's disease 1 1.79% African trypanosomiasis 1 1.79% Agitation 1 1.79% Alanine aminotransferase 1 1.79% Amnesia 1 1.79% Appendicitis 1 1.79% Arthralgia 1 1.79% Aspartate aminotransferase 1 1.79% Asthenia 4 7.14% Asthma 1 1.79% Back pain 1 1.79% Bacterial test 1 1.79% Blepharospasm 1 1.79% Blood alkaline phosphatase 1 1.79% Blood cortisol 1 1.79% Blood creatinine 1 1.79% Blood magnesium 1 1.79% Blood phosphorus normal 1 1.79% Blood test 4 7.14% Blood test normal 1 1.79% Blood urea 1 1.79% Body temperature 1 1.79% Body temperature increased 2 3.57% Bradycardia 1 1.79% C-reactive protein 1 1.79% Cardiac disorder 1 1.79% Cardiac flutter 1 1.79% Cerebral cyst 1 1.79% Cerebral haematoma 1 1.79% Cerebral thrombosis 1 1.79% Cerebral venous sinus thrombosis 1 1.79% Cerebrovascular accident 1 1.79% Chest discomfort 1 1.79% Chest pain 2 3.57% Chest X-ray 1 1.79% Chills 7 12.5% Choking 1 1.79% Chromaturia 1 1.79% Computerised tomogram 2 3.57% Computerised tomogram normal 1 1.79% Condition aggravated 1 1.79% Congenital skin disorder 1 1.79% Cortisol decreased 1 1.79% Crying 2 3.57% CSF protein normal 1 1.79% Cyanosis 1 1.79% Decreased appetite 1 1.79% Diarrhoea 1 1.79% Disturbance in attention 1 1.79% Dizziness 9 16.07% Dyspnoea 5 8.93% Ear discomfort 1 1.79% Ear pain 1 1.79% Echocardiogram 1 1.79% Electrocardiogram 2 3.57% Electroencephalogram 1 1.79% Encephalitis 1 1.79% Erythema multiforme 1 1.79% Exposure via breast milk 10 17.86% Facial paralysis 1 1.79% Faeces discoloured 1 1.79% Fatigue 12 21.43% Feeding disorder 1 1.79% Feeling hot 2 3.57% Feeling of body temperature change 1 1.79% Foetal cardiac disorder 1 1.79% Foetal death 1 1.79% Foetal exposure during pregnancy 1 1.79% Full blood count 1 1.79% Gastritis 2 3.57% Gastrointestinal tube insertion 1 1.79% Glassy eyes 1 1.79% Groin pain 1 1.79% Guillain-Barre syndrome 1 1.79% Haematochezia 1 1.79% Haemoglobin 1 1.79% Haemorrhage neonatal 1 1.79% Headache 13 23.21% Heart rate increased 2 3.57% Hyperchlorhydria 1 1.79% Hyperhidrosis 1 1.79% Hypersomnia 1 1.79% Hypertension 1 1.79% Hypoaesthesia oral 1 1.79% Immunisation 1 1.79% Inappropriate schedule of product administration 1 1.79% Incorrect product formulation administered 1 1.79% Infantile colic 1 1.79% Infantile vomiting 3 5.36% Infant irritability 1 1.79% Influenza like illness 1 1.79% Injection site erythema 1 1.79% Injection site pruritus 1 1.79% Injection site rash 1 1.79% Intensive care 1 1.79% Interchange of vaccine products 1 1.79% Investigation 2 3.57% Irregular breathing 1 1.79% Irritability 2 3.57% Joint swelling 1 1.79% Laboratory test 1 1.79% Laryngomalacia 1 1.79% Lethargy 2 3.57% Loss of consciousness 2 3.57% Lumbar puncture 1 1.79% Lymphadenopathy 1 1.79% Lymphocyte count 1 1.79% Magnetic resonance imaging 1 1.79% Magnetic resonance imaging head 1 1.79% Malaise 1 1.79% Maternal exposure during breast feeding 1 1.79% Meningitis 1 1.79% Metabolic function test 1 1.79% Mucous stools 1 1.79% Muscle spasms 1 1.79% Muscle tightness 1 1.79% Muscle twitching 1 1.79% Myalgia 8 14.29% Nasal discomfort 1 1.79% Nausea 7 12.5% Oesophagitis 1 1.79% Off label use 5 8.93% Ophthalmological examination 1 1.79% Oropharyngeal pain 1 1.79% Oxygen saturation decreased 1 1.79% Pain 5 8.93% Pain in extremity 3 5.36% Pain of skin 1 1.79% Pallor 1 1.79% Palpitations 2 3.57% Peripheral swelling 1 1.79% Peripheral vascular disorder 1 1.79% Petit mal epilepsy 1 1.79% Pharyngeal swelling 1 1.79% Platelet count 1 1.79% Poor feeding infant 1 1.79% Product administered to patient of inappropriate age 4 7.14% Product use issue 1 1.79% Pruritus 2 3.57% Pulmonary function test 2 3.57% Pyrexia 6 10.71% Rash 2 3.57% Rash maculo-papular 1 1.79% Renal pain 1 1.79% Respiratory distress 1 1.79% Respiratory tract congestion 2 3.57% Rhinovirus infection 1 1.79% SARS-CoV-2 antibody test 1 1.79% SARS-CoV-2 test 6 10.71% Seizure 3 5.36% Sensory loss 1 1.79% Sinus congestion 1 1.79% Skin warm 1 1.79% Somnolence 2 3.57% Stool analysis 1 1.79% Suck-swallow breathing coordination disturbance 1 1.79% Swelling 1 1.79% Swelling face 1 1.79% Tachypnoea 1 1.79% Tenderness 1 1.79% Tremor 3 5.36% Ultrasound head abnormal 1 1.79% Ultrasound kidney 1 1.79% Unevaluable event 1 1.79% Urine analysis 3 5.36% Urticaria 2 3.57% Vaccination error 1 1.79% Vaccination site pain 1 1.79% Vaginal haemorrhage 1 1.79% Vertigo 3 5.36% Vision blurred 1 1.79% Vomiting 3 5.36% Weight 1 1.79% Wheezing 1 1.79% White blood cell count 1 1.79% Wrong product administered 1 1.79% total 301 537.5% TOTAL † 301 † 537.5% † Because some cases have multiple vaccinations and symptoms, a single case can account for multiple entries in this table. This is why the Total Count is greater than 56 (the number of cases found), and the Total Percent is greater than 100.
Vaccinated: 2021-09-22 Onset: 2021-09-22 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-11-11
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCJU6 / 2 - / OT Administered by: Other Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood creatinine, Blood urea, C-reactive protein, Exposure via breast milk, Haemoglobin, Lymphocyte count, Platelet count, Rash maculo-papular, SARS-CoV-2 antibody test, White blood cell count
SMQs:, Neonatal exposures via breast milk (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211009; Test Name: GPT; Result Unstructured Data: Test Result:26; Test Date: 20211009; Test Name: GOT; Result Unstructured Data: Test Result:53; Test Date: 20211009; Test Name: AP; Result Unstructured Data: Test Result:250; Test Date: 20211009; Test Name: Creatinine; Result Unstructured Data: Test Result:0.2; Test Date: 20211009; Test Name: Urea; Result Unstructured Data: Test Result:14; Test Date: 20211009; Test Name: CRP; Result Unstructured Data: Test Result:0; Test Date: 20211009; Test Name: hemoglobin; Result Unstructured Data: Test Result:9.5 g/dl; Test Date: 20211009; Test Name: Lymphocyte; Test Result: 71 %; Test Date: 20211009; Test Name: Thrombocyte; Result Unstructured Data: Test Result:460; Comments: T/ul; Test Date: 20211009; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Test Result:0.12; Test Date: 20211009; Test Name: Leukocyte; Result Unstructured Data: Test Result:7.8; Comments: T/uL
CDC Split Type: DEPFIZER INC202101327439Write-up: generalized rash similar to drug exanthema/eneralized maculopapular exanthema; a 6-week-old infant (fully breastfed); This is a spontaneous report from a contactable physician based on information received by Pfizer from Biontech [manufacturer control number: 91308, license party for Comirnaty]. This physician reported information for both mother and baby. This is the baby report. A 6-week-old female patient received BNT162B2 (COMIRNATY; lot number: SCJU6) transmammary at the age of 6-week-old on 22Sep2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient hadn''t a history of any previous allergies to specific products or any conditions indicative of an allergy. The patient didn''t receive any recent vaccines for any other conditions prior to the event being reported. The patient didn''t receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient hasn''t received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient''s mother previously received first dose of BNT162B2 (COMIRNATY, Lot number: SCUE1) on 01Sep2021 for COVID-19 immunisation and the patient experienced fever on 03Sep2021, generalized maculopapular exanthema, anaphylactic reaction and exanthema, first in the face on 04Sep2021 and exposure via breast milk on 01Sep2021. Patient''s mother received BNT162B2 (COMIRNATY) via intramuscular. A 6-week-old infant [fully breastfed] with a generalized rash similar to drug exanthema was presented. During the course of the case, it was found that the mother had been vaccinated two days earlier and the same picture appeared after the second vaccination of the infant''s mother. The event resulted in emergency room visit. Generalized maculopapular exanthema on 23Sep2021. Onset in the evening of vaccination, ongoing for 12 hours, no fever. The patient underwent lab tests included Hematology: On 09Oct2021: L: 7.8T/ul (6.3-16), Hb: 9.5 g/dl (8.2-15), T: 460 t/uL (247-550) Lymph: 71% (20-45). Clinical chemistry: On 09Oct2021: Creatinine: 0.2 (0.2-0.6), Urea: 14 (10-35), GOT: 53 (max: 69), GPT: 26 (max: 39), AP: 250 (190-715), CRP: 0, Other relevant tests: SARs-COV-2 IgG AB (09Oct2021): 0.12 (max: 0.99). The outcome of the event was recovered in Sep2021. The lot number for BNT162B2, was not provided and will be requested during follow up. Follow up (28Oct2021): New information received from the same physician included: Patient information (Gender, weight, height, historical vaccine details and lab data), product information (start date, lot number, parent route of administration), updated event and clinical course. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: Based on the current information available and considering plausible drug-event temporal association a possible contributory role of the suspect BNT162B2 for the reported events of Vaccine exposure via breast milk and Maculo-papular exanthema cannot be completely excluded. The case will be reassessed further upon receipt of additional information. 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.,Linked Report(s) : DE-PFIZER INC-202101387236 maternal case
Vaccinated: 2022-09-21 Onset: 2022-09-21 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2022-09-21
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FT9142 / 1 RL / IM Administered by: Private Purchased by: ?
Symptoms: Vaccination error
SMQs:, Medication errors (narrow)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:Write-up: Patient was given vaccine by error.
Vaccinated: 2021-01-10 Onset: 2021-01-10 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-01-21
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EE8493 / UNK - / - Administered by: Other Purchased by: ?
Symptoms: African trypanosomiasis, Fatigue, Hyperchlorhydria, Infantile vomiting, Malaise, Off label use, SARS-CoV-2 test
SMQs:, Neonatal disorders (narrow), Opportunistic infections (broad), COVID-19 (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIAZEPAN; ;
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210111; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021024538Write-up: very tired; had the feeling of acid in my mouth; 1-month-old female patient received; Sleeping sickness; Vomiting; Feeling unwell/being sick and feeling sick/still feel ickey; This is a spontaneous report. A contactable healthcare professional reported that a 1-month-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EE8493), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included diazepam (DIAZEPAN) for anxiety, lithium for bipolar disorder and zopiclone for sleep loss. The patient stated on 10Jan2021, "a few hours after the jab I started feeling unwell and had the feeling of acid in my mouth about 4 hrs later I was being sick and feeling sick, this went on and off till the following day, stopped being sick at around 11: 30 pm on the 11th, but continued to feel sick and still do now, however I''m able to work just taking my time, I am very tired and still feel ickey". Vomiting and sleeping sickness was also reported on 10Jan2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The outcome of "feeling unwell/being sick and feeling sick/still feel ickey" was not recovered, vomiting was recovering and other events was unknown. No follow-up attempts are possible. No further information expected.
Vaccinated: 2021-01-26 Onset: 2021-01-26 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-02-09
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ELC1768 / UNK - / - Administered by: Other Purchased by: ?
Symptoms: Dizziness, Headache, Infantile vomiting, Nausea, Product administered to patient of inappropriate age
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Neonatal disorders (narrow), Medication errors (narrow)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021084448Write-up: Dizziness; Headache; Vomiting; Nausea; A 1-month-old female patient received BNT162B2; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-APPCOVID-20210127173442, Safety Report Unique Identifier GB-MHRA-ADR 24656327. A 1-month-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Elc1768) via an unspecified route of administration at single dose on 26Jan2021 for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced dizziness, headache, vomiting, nausea on 26Jan2021. Patient did not have symptoms associated with COVID-19 and did not have a COVID-19 test. Patient is not enrolled in clinical trial. The reporter considered all events dizziness, headache, vomiting, nausea was seriousness with seriousness criteria other medically important condition. The outcome of the events dizziness, headache, vomiting, nausea was not recovered. No follow-up attempts are possible. No further information is expected.
Vaccinated: 2021-01-10 Onset: 2021-01-10 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-03-03
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / - Administered by: Other Purchased by: ?
Symptoms: Dyspnoea, Guillain-Barre syndrome, Off label use, SARS-CoV-2 test, Sensory loss, Tremor
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Demyelination (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210131; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021177714Write-up: Guillain-Barre syndrome; loss of sensation in hands and feet; breathing difficulties; wobbling; 1-month-old female patient received bnt162b2; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202102171144574100, Safety Report Unique Identifier GB-MHRA-ADR 24779509. A 1-month-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. The patient''s medical history and medications were not reported. The patient experienced guillain-barre syndrome, loss of sensation in hands and feet, breathing difficulties, wobbling on 28Jan2021. Serious criteria was reported as hospitalization. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 31Jan2021. The outcome of the events were resolving. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vaccinated: 2021-01-30 Onset: 2021-01-30 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-03-25
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / UNK - / OT Administered by: Other Purchased by: ?
Symptoms: Asthma, Dizziness, Dyspnoea, Peripheral vascular disorder, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021265813Write-up: respiratory distress; Circulatory disorder peripheral; Lightheadedness; Asthma exacerbation; Dyspnoea; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021014805, safety report unique identifier: DE-PEI-2021005250. A 43-days-old female patient received bnt162b2 (COMIRNATY), intramuscular on 30Jan2021 (Lot Number: EK9788) as SINGLE DOSE for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced circulatory disorder, lightheadedness, asthma exacerbation, dyspnea and respiratory distress on 30Jan2021. The outcome of the events not recovered. Senders comment: Asthma / feeling sick, dyspnoea, asthma exacerbation
Vaccinated: 2021-04-14 Onset: 2021-04-14 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-05-03
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM4965 / 2 - / - Administered by: Other Purchased by: ?
Symptoms: Chills, Dizziness, Headache, Inappropriate schedule of product administration, Lethargy, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Human papilloma virus infection; Irritable bowel syndrome; Lactation decreased; Strabismus (IBS diagnosed in Oct2020. Operated for strabismus in 1981. HPV operation in 2011); Surgery (operated for strabismus in 1981); Surgery (HPV operation in 2011); Suspected COVID-19; Vaccination site swelling
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021425042Write-up: Headache; first dose on 02Feb2021; second dose on 14Apr2021; first dose on 02Feb2021; second dose on 14Apr2021; Dizziness; Lethargy; Chills; Fever; This is a spontaneous report from the agency Healthcare products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202104160748543970; GB-MHRA-ADR 25149670. A contactable consumer reported that a 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 02Feb2021 (lot number: EL0739; expiry date: unknown) and second dose on 14Apr2021 (lot number: EM4965; expiry date: unknown) via unspecified routes of administration at single doses for COVID-19 immunisation. Medical history included vaccination site swelling, lactation decreased, strabismus, irritable bowel syndrome (IBS) diagnosed in Oct2020, suspected COVID-19 from 15Mar2020 to 30Mar2020, operated for strabismus in 1981, and human papilloma virus infection (HPV) which led to operation in 2021. The patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. On 14Apr2021, the patient experienced dizziness, lethargy, chills, and fever. On 15Apr2021, the patient experienced headache. The events were considered serious due to other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event lethargy and chills was recovered on 14Apr2021, while for the event dizziness, fever and headache recovering. No follow-up attempts are possible; No further information is expected.
Vaccinated: 2021-05-20 Onset: 2021-05-01 Submitted: 0000-00-00 Entered: 2021-06-07
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 - / - Administered by: Other Purchased by: ?
Symptoms: Body temperature, Myalgia, Product administered to patient of inappropriate age, Pyrexia, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Body temperature; Result Unstructured Data: Test Result:high temperature; Test Date: 20210520; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021584071Write-up: Vaginal bleeding/ Constant heavy vaginal bleeding with chunks of clot; Received the first dose of BNT162B2 at the age of 1-month-old; muscle pain; high temperature; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202105211917593750-GVQ9S, Safety Report Unique Identifier GB-MHRA-ADR 25339983. A 1-month-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: Ew4109), at the age of 1-month-old, via an unspecified route of administration on 20May2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced Vaginal bleeding/ Constant heavy vaginal bleeding with chunks of clot on 21May2021 with outcome of not recovered, muscle pain in May2021 with outcome of unknown, high temperature in May2021 with outcome of unknown. The events (vaginal bleeding, muscle pain and high temperature) were serious as medically significant. The patient underwent lab tests and procedures which included body temperature: high temperature in May2021, COVID-19 virus test: No - Negative COVID-19 test on 20May2021. No follow-up attempts are possible. No further information is expected.
Vaccinated: 2021-04-24 Onset: 2021-04-24 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-07-19
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM4965 / 1 - / OT Administered by: Other Purchased by: ?
Symptoms: Exposure via breast milk, Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Neonatal exposures via breast milk (narrow)Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021900164Write-up: blood in stool; vaccine exposure via breast milk; This is a spontaneous report from a contactable consumer (parent). This consumer reported events for both mother and fetus. This is the baby report. The maternal report is a report downloaded from the Regulatory Authority GB-MHRA-WEBCOVID-202106211313212740-NL05V. A 6-week-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM4965), transmammary on 24Apr2021 as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccine exposure via breast milk on 24Apr2021 and blood in stool on 28Apr2021. Assumed to be milk allergy but wasn''t after testing dairy free diet. The events caused congenital anomaly and were medically significant. Outcome of the blood in stool was recovered on 01Jun2021. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021774111 Maternal Case;GB-MHRA-ADR 25510477 RA;GB-MHRA-WEBCOVID-202106211313212740-NL05V RA
Vaccinated: 2021-05-05 Onset: 2021-05-05 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-09-09
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 1 - / - Administered by: Other Purchased by: ?
Symptoms: Electrocardiogram, Gastritis, Investigation, Oesophagitis, Off label use, Product use issue, Pulmonary function test
SMQs:, Gastrointestinal nonspecific inflammation (narrow), Medication errors (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:unknown result; Test Name: Clinical examination; Result Unstructured Data: Test Result:unknown result; Test Name: Laboratory values; Result Unstructured Data: Test Result:unknown result; Test Name: Lung function; Result Unstructured Data: Test Result:unknown result
CDC Split Type: DEPFIZER INC202101114360Write-up: mainly oesophagitis / mainly gastritis; mainly oesophagitis / mainly gastritis; Off label use / 5-week-old patient; Product use in unapproved population / 5-week-old patient; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100171939. A 5-week-old female patient received bnt162b2 (COMIRNATY, Lot Number: EX8679), via an unspecified route of administration on 05May2021 (at the age of 5-weeks-old) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 05May2021, the patient experienced off label use and product use in unapproved population. On 06May2021, the patient experienced mainly oesophagitis / mainly gastritis. The patient was hospitalized due to mainly oesophagitis / mainly gastritis. The patient underwent lab tests and procedures which included ECG, lung function, clinical examination, laboratory values; all were unknown results on an unspecified date. The outcome of oesophagitis and gastritis was recovered on 12May2021. The patient received bnt162b2 (COMIRNATY, lot number: FD9234), intramuscular on 16Jun2021 as dose 2, single. Relatedness Assessment: Gastritis: D. Unclassifiable. Source of assessment: HA.
Vaccinated: 2021-08-12 Onset: 2021-08-19 Days after vaccination: 7 Submitted: 0000-00-00 Entered: 2021-09-22
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7C1BSA / 1 - / OT Administered by: Other Purchased by: ?
Symptoms: Foetal cardiac disorder, Foetal death
SMQs:, Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Aucun
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101218927Write-up: The baby''s heart stopped beating; The baby''s heart stopped beating; This is a spontaneous report from a contactable consumer. This is the second of two reports. The first report is a report downloaded from the Regulatory Authority FR-AFSSAPS-LL20216048. This consumer reported information for both mother and fetus/baby. This is the fetus/baby report. A fetus patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 1 transplacental on 12Aug2021 (Lot Number: FE7C1BSA) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The mother pregnant in her 1st trimester, vaccinated on 12Aug2021 at 6 weeks pregnant. On 19Aug2021 the parent had a miscarriage (metrorrhagia presenting symptom). The baby''s heart stopped beating. Though on her follow-up visit on 10Aug2021 the heart was beating. Ultrasound on 19Aug2021: interrupted pregnancy at 9 weeks. The baby died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101166496 Maternal/baby case; Reported Cause(s) of Death: The baby''s heart stopped beating; The baby''s heart stopped beating
Vaccinated: 2021-06-12 Onset: 2021-07-29 Days after vaccination: 47 Submitted: 0000-00-00 Entered: 2021-09-24
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT Administered by: Unknown Purchased by: ?
Symptoms: Congenital skin disorder
SMQs:, Congenital, familial and genetic disorders (narrow)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213Write-up: had a lesion the size of the 5-yuan coin on the scalp; This regulatory authority case was reported by an other health care professional and describes the occurrence of CONGENITAL SKIN DISORDER (had a lesion the size of the 5-yuan coin on the scalp) in a 1-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. MEDICAL HISTORY (Parent): The mother''s past medical history included Maternal exposure during pregnancy. No Medical History information was reported. On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient experienced CONGENITAL SKIN DISORDER (had a lesion the size of the 5-yuan coin on the scalp) (seriousness criterion medically significant). At the time of the report, CONGENITAL SKIN DISORDER (had a lesion the size of the 5-yuan coin on the scalp) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Company comment- This case concerns of a 1 month old female with history of transplacental exposure with Moderna on approximately last trimester of the pregnancy of the mother ( approximately 9 days before delivery after the 2nd dose) , who developed unexpected event of Congenital Skin Disorder. The patient is under close monitoring by the physicians for any development. The risk benefit ratio of Moderna is not affected by this report. This case was linked to MOD-2021-323648, MOD-2021-323099 (Parent-Child Link). See case MOD-2021-323648,MOD-2021-323099 for details regarding the child case.; Sender''s Comments: This case concerns of a 1 month old female with history of transplacental exposure with Moderna on approximately last trimester of the pregnancy of the mother ( approximately 9 days before delivery after the 2nd dose) , who developed unexpected event of Congenital Skin Disorder. The patient is under close monitoring by the physicians for any development. The risk benefit ratio of Moderna is not affected by this report.
Vaccinated: 2021-10-05 Onset: 2021-10-01 Submitted: 0000-00-00 Entered: 2021-10-15
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / - Administered by: Other Purchased by: ?
Symptoms: Dizziness, Fatigue, Hypersomnia, SARS-CoV-2 test, Tremor, Vertigo
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (narrow), Hypoglycaemia (broad), COVID-19 (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211005; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101351548Write-up: Fatigue extreme/ extremely tired; dizziness; vertigo; very tired; shaky every couple of hours; Slept 9 hours at night, but had to lay down at 11am because of vertigo and slept until 2PM; Dizzy; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202110101439352040-DIDOJ with Safety Report Unique Identifier GB-MHRA-ADR 26057934. A 42-year-old female patient received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on 05Oct2021 (at the age of 42 years old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant and was not breastfeeding. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. Concomitant medication were not reported. On 05Oct2021, since the first day of vaccine, the patient was very tired and shaky every couple of hours until the patient ate something. On 08Oct2021, the patient started feeling occasional vertigo. On 10Oct2021, the patient was extremely tired from the morning with severe dizziness. On an unknown date in Oct2021,the patient slept 9 hours at night but had to lay down at 11am because of vertigo and slept until 2PM and was still dizzy. The events vertigo, fatigue extreme, dizziness, dizzy and slept 9 hours at night were reported as serious for being medically significant. On 05Oct2021, the patient underwent COVID-19 virus test and the result was negative. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events dizzy, slept 9 hours at night, dizziness and vertigo was recovering and while that of the event fatigue extreme was not recovered and that of the events tiredness and shakiness was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccinated: 0000-00-00 Onset: 2021-08-26 Submitted: 0000-00-00 Entered: 2021-10-21
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT Administered by: Unknown Purchased by: ?
Symptoms: Erythema multiforme
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Immature baby
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213Write-up: 4 week-old infant showed skin reactions (diagnosis: erythema multiforme) after Moderna vaccination of the mother, then inpatient treatment. Hospital required a report.; This regulatory authority case was reported by a consumer and describes the occurrence of ERYTHEMA MULTIFORME (4 week-old infant showed skin reactions (diagnosis: erythema multiforme) after Moderna vaccination of the mother, then inpatient treatment. Hospital required a report.) in a 4-week-old neonate of an unknown gender exposed to mRNA-1273 (Spikevax) , while the mother received the product for Prophylactic vaccination. MEDICAL HISTORY (Parent): The mother''s past medical history included Maternal exposure during pregnancy. MEDICAL HISTORY (Patient): Concurrent medical conditions included Immature baby. On an unknown date, the mother received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 26-Aug-2021, the neonate was diagnosed with ERYTHEMA MULTIFORME (4 week-old infant showed skin reactions (diagnosis: erythema multiforme) after Moderna vaccination of the mother, then inpatient treatment. Hospital required a report.) (seriousness criteria hospitalization and medically significant). The delivery occurred on an unknown date, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. At the time of the report, ERYTHEMA MULTIFORME (4 week-old infant showed skin reactions (diagnosis: erythema multiforme) after Moderna vaccination of the mother, then inpatient treatment. Hospital required a report.) was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. The patient was born 19 days before maternal vaccination and no history of breastfeeding is reported so exposure so exposure to the vaccine is impossible, thus the case is invalid. Mother was asked if she or the affected person had any known allergies for which the mother replied no. She was asked if she had information on risk factors or pre-existing conditions. She replied none and also told that their son was born as a pre-term infant four weeks before the scheduled due date. No concomitant medication information was provided. No treatment medication were provided. Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Translation received on 18-Oct -2021 with event reported as primary source as updated and senders comment updated.; Sender''s Comments: This RA case concerns a 4 week old pre-mature (36 weeks weeks) neonate who experienced the serious unlisted event of Erythema Multiforme 27 days after birth and 8 days after maternal vaccination with dose 1 of Spikevax. Re-challenge is not applicable as no exposure to the vaccine is documented. The history of birth 19 days before maternal vaccination remains a confounder as no transplacental exposure is impossible and exposure during breastfeeding is not reported so the case seems invalid. Benefit-risk relationship of Spikevax is not affected by this report.
Vaccinated: 2022-07-26 Onset: 2022-07-26 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2022-07-26
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FT9142 / 1 LL / IM Administered by: Private Purchased by: ?
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
SMQs:, Medication errors (narrow)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: no
Current Illness: Newborn jaundice, weight loss, heat rash on face
Preexisting Conditions: none, but had newborn jaundice : total bilirubin = 15mg/dl at 7/23/2022 11:38am, transient weight loss, all resolved
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:Write-up: The patient came to have one month physical and Hepatitis B second dose. Vitals done and opened chart by the physician, the Medical Assistant took over and gave the patient Baby covid 10 vaccine adversely, which should gave another a 3 years old baby, both scheduled back to back as first patients in the morning (clinic started at 9am)
Vaccinated: 2021-08-06 Onset: 2021-08-06 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-11-29
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214019 / UNK - / OT Administered by: Unknown Purchased by: ?
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213Write-up: SECOND DOSE OF VACCINE ON AUG 06: URTICARIA AND ITCHING; SECOND DOSE OF VACCINE ON AUG 06: URTICARIA AND ITCHING; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-808214) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of PRURITUS (SECOND DOSE OF VACCINE ON AUG 06: URTICARIA AND ITCHING) and URTICARIA (SECOND DOSE OF VACCINE ON AUG 06: URTICARIA AND ITCHING) in a 1-month-old female patient who received mRNA-1273 (Spikevax) (batch no. 214019) for COVID-19 immunisation. No Medical History information was reported. On 06-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 06-Aug-2021, the patient experienced PRURITUS (SECOND DOSE OF VACCINE ON AUG 06: URTICARIA AND ITCHING) (seriousness criterion hospitalization) and URTICARIA (SECOND DOSE OF VACCINE ON AUG 06: URTICARIA AND ITCHING) (seriousness criterion hospitalization). At the time of the report, PRURITUS (SECOND DOSE OF VACCINE ON AUG 06: URTICARIA AND ITCHING) and URTICARIA (SECOND DOSE OF VACCINE ON AUG 06: URTICARIA AND ITCHING) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter. Company Comment - This regulatory case concerns a 1-month-old, female patient with no reported medical history, who experienced the unexpected, serious (hospitalization) events of pruritus and urticaria. The events occurred on the same day after an unknown dose number of mRNA-1273 vaccine. The rechallenge was not applicable, as dose number was not disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Regulatory authority reported patient''s age as 1 month old, however, mRNA-1273 has not been approved for that age group. Seriousness criteria of hospitalization was captured for all reported events according to Regulatory Authority assessment, however; there was no information provided on hospitalization dates, clinical course and/or discharge summary. Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Translation document received on 19-Nov 2021-contains, translated event verbatim.; Sender''s Comments: This regulatory case concerns a 1-month-old, female patient with no reported medical history, who experienced the unexpected, serious (hospitalization) events of pruritus and urticaria. The events occurred on the same day after an unknown dose number of mRNA-1273 vaccine. The rechallenge was not applicable, as dose number was not disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Regulatory authority reported patient''s age as 1 month old, however, mRNA-1273 has not been approved for that age group. Seriousness criteria of hospitalization was captured for all reported events according to Regulatory Authority assessment, however; there was no information provided on hospitalization dates, clinical course and/or discharge summary.
Vaccinated: 2021-09-18 Onset: 2021-09-01 Submitted: 0000-00-00 Entered: 2021-12-01
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT Administered by: Other Purchased by: ?
Symptoms: Bacterial test, Blood test, Chromaturia, Exposure via breast milk, Stool analysis, Ultrasound kidney, Weight
SMQs:, Rhabdomyolysis/myopathy (broad), Neonatal exposures via breast milk (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: cytobacterioligical urine exam; Result Unstructured Data: Test Result:sterile; Test Date: 20210926; Test Name: blood test; Result Unstructured Data: Test Result:normal; Test Date: 20210926; Test Name: stool; Result Unstructured Data: Test Result:normal; Test Date: 20210926; Test Name: renal echo; Result Unstructured Data: Test Result:normal; Test Date: 20210815; Test Name: weight; Test Result: 3.080 kg; Test Date: 20210926; Test Name: weight; Test Result: 5 kg
CDC Split Type: FRPFIZER INC202101651821Write-up: dark coloration of the urine; Vaccine exposure via breast milk; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the Regulatory Agency (RA)-WEB (Regulatory authority number: FR-AFSSAPS-LY202112503). A 5-week-old patient was exposed to bnt162b2 (COMIRNATY), transmammary (mother''s route: intramuscular), administration date 18Sep2021 (Lot number: Unknown) as dose 2, single (received at the age of 5-weeks-old) for covid-19 immunization. The mother of the patient was 32-year-old. The mother''s relevant medical history included: "pregnancy" (unspecified if ongoing), notes: G1P1; "delivery" (unspecified if ongoing), notes: at 40 amenorrhea weeks + 4 days; "breastfeeding" (unspecified if ongoing). The patient''s relevant medical history and concomitant medications were not reported. The mother''s vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunisation. The following information was reported: CHROMATURIA with onset Sep2021, outcome "unknown", described as "dark coloration of the urine"; EXPOSURE VIA BREAST MILK with onset 18Sep2021, outcome "unknown", described as "Vaccine exposure via breast milk". The patient was hospitalized for chromaturia (start date: 26Sep2021, discharge date: 27Sep2021, hospitalization duration: 1 day(s)). The clinical course was reported as follows: On 11Aug2021: delivery at 40 amenorrhea weeks + 4 days. Weight when leaving the maternity hospital. On 15Aug2021: 3.080 kg - exclusive breastfeeding. On 18Sep2021: Dose 2 COMIRNATY. On 26Sep2021: hospitalization for hematuria (weight of 5 kg). Diagnosis of hematuria ruled out. A dark coloration of the urine is retained on a lack of intake. Normal blood test, normal renal echo, sterile ECBU (cytobacterioligical urine exam), normal stool. The mother stopped breastfeeding. They returned home on 27Sep2021 with 1st age milk. Doctors talked about the role of the vaccine in lowering lactation. The patient underwent the following laboratory tests and procedures: cytobacterioligical urine exam: (26Sep2021) sterile; blood test: (26Sep2021) normal; stool: (26Sep2021) normal; renal echo: (26Sep2021) normal. Therapeutic measures were taken as a result of chromaturia. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101590457 maternal case
Vaccinated: 2021-11-24 Onset: 2021-11-25 Days after vaccination: 1 Submitted: 0000-00-00 Entered: 2021-12-08
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT Administered by: Unknown Purchased by: ?
Symptoms: Fatigue, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213Write-up: tiredness; Muscle pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26256298) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26256298) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) and FATIGUE (tiredness) in a 1-month-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 24-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (tiredness) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle pain) had not resolved and FATIGUE (tiredness) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant product was not provided by the reporter Aches, Stabbing muscle pain was provided Treatment product was not provided by the reporter; Sender''s Comments: This is a regulatory case concerning a female patient of unknown age with no reported medical history, who experienced the serious (medically significant) events myalgia and fatigue, one day after receiving the third dose of mRNA-1273. Events seriousness (MS) captured as per Regulatory Authority assessment in Source Document. Age reported on the SD was 1 month, which is unlikely. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Vaccinated: 2021-11-30 Onset: 2021-12-01 Days after vaccination: 1 Submitted: 0000-00-00 Entered: 2021-12-15
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004737 / 3 - / OT Administered by: Unknown Purchased by: ?
Symptoms: Headache, Myalgia, Pyrexia, Tenderness
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214Write-up: Fever; Muscle ache; Headache; Tenderness; This case was received via Regulatory Agency RA (Reference number: GB-MHRA-ADR 26277464) on 02-Dec-2021 and was forwarded to Moderna on 02-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Muscle ache), HEADACHE (Headache) and TENDERNESS (Tenderness) in a 1-month-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004737) for an unknown indication. No Medical History information was reported. On 30-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and TENDERNESS (Tenderness) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), MYALGIA (Muscle ache), HEADACHE (Headache) and TENDERNESS (Tenderness) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant and treatment medication was reported by patient. Patient has not tested positive for COVID-19 since having the vaccine. Company comment: This regulatory authority case concerns a female patient with no relevant medical history who experienced serious unexpected events of pyrexia, myalgia, headache, tenderness.. The events occurred approximately 1 day after the third dose of the mRNA-1273 . No further details regarding clinical course were provided. At the time of the report, the events were resolving. Rechallenge was not applicable since the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable. The regulatory authority assessed the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a female patient with no relevant medical history who experienced serious unexpected events of pyrexia, myalgia, headache, tenderness.. The events occurred approximately 1 day after the third dose of the mRNA-1273 . No further details regarding clinical course were provided. At the time of the report, the events were resolving. Rechallenge was not applicable since the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable. The regulatory authority assessed the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Vaccinated: 2021-10-01 Onset: 2021-10-01 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-12-24
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / - PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / - RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / - Administered by: Other Purchased by: ?
Symptoms: Blood test, Crying, Disturbance in attention, Exposure via breast milk, Irregular breathing, Seizure, Urine analysis
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Neonatal exposures via breast milk (narrow), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Reflux esophagitis
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: blood tests; Test Result: Negative ; Test Date: 2021; Test Name: urine tests; Test Result: Negative
CDC Split Type: NZPFIZER INC202101806688Write-up: Exposure via breast milk; was not focused; breathing again but irregularly; unusually pitched sporadic cry; Seizure/rigid and jerking/ his lips to be blue, eyes rolled back and frothing at the mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the parent. An infant male patient was exposed to bnt162b2 (COMIRNATY), transmammary, administration date Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), administration date Oct2021 (Batch/Lot number: unknown) at the age of 6 weeks as dose number unknown, single for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), administration date Oct2021 (Batch/Lot number: unknown) for immunisation; rotavirus vaccine (ROTAVIRUS VACCINE), administration date Oct2021 (Batch/Lot number: unknown) for immunization. Relevant medical history included: "reflux" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 2021, outcome "recovered" (2021), described as "Seizure/rigid and jerking/ his lips to be blue, eyes rolled back and frothing at the mouth"; EXPOSURE VIA BREAST MILK (medically significant) with onset Oct2021, outcome "unknown", described as "Exposure via breast milk"; DISTURBANCE IN ATTENTION (non-serious) with onset 2021, outcome "recovered" (2021), described as "was not focused"; IRREGULAR BREATHING (non-serious) with onset 2021, outcome "recovered" (2021), described as "breathing again but irregularly"; CRYING (non-serious) with onset 2021, outcome "recovered" (2021), described as "unusually pitched sporadic cry". The events "seizure/rigid and jerking/ his lips to be blue, eyes rolled back and frothing at the mouth", "exposure via breast milk", "was not focused", "breathing again but irregularly" and "unusually pitched sporadic cry" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) negative; urine analysis: (2021) negative. Clinical course: 3 days after her 1st vaccination, the patient had a seizure. He was breastfed. Approx 6: 20 Am that morning the mother awoke to him make a strange noise. She picked him out of his bassinet noting he was completely rigid and jerking. She turned on the light and noted his lips to be blue, eyes rolled back and frothing at the mouth. He had a history of reflux so she wondered if he was choking so administered some back blows and tried to clear the froth. After 2 minutes the jerking stopped, where he then started breathing again but irregularly, was not focused and had an unusually pitched sporadic cry. This odd behaviour lasted approx 40 minutes until he returned to his usual again. She had already called an ambulance and was taken to ED and spent 2 days for observation. Of note, on the same day the mother got her covid vaccine son had his 6 week immunisations including dtap, pneumococcal and rota virus. In hospital he had blood tests and urine tests that were negative. Nor at any time was he febrile, thus a febrile convulsion was ruled out. So the doctors at the hospital said his likely seizure was a result of a reaction to her vaccine, his vaccinations, a random one off event or perhaps the preclude to an epileptic diagnosis - impossible to tell with a one off event. Their instructions were to observe him and hope it doesn''t happen again. We didn''t report this as there were so many possibilities of what had caused the even he has been his normal happy self since with no causes of concern. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : NZ-PFIZER INC-202101760454 same reporter/patient/product, different events/doses.
Vaccinated: 0000-00-00 Onset: 0000-00-00 Submitted: 0000-00-00 Entered: 2021-12-29
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT Administered by: Unknown Purchased by: ?
Symptoms: Faeces discoloured, Foetal exposure during pregnancy, Gastritis, Mucous stools, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Noninfectious diarrhoea (broad), Hypoglycaemia (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214Write-up: sleepy; Greenish stool; Mucous stools; Gastritis; Foetal exposure during pregnancy; This case was initially received via Regulatory Authority (Reference number: GB-MHRA-ADR 26339555) on 16-Dec-2021. The most recent information was received on 17-Dec-2021 and was forwarded to Moderna on 17-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), FAECES DISCOLOURED (Greenish stool), MUCOUS STOOLS (Mucous stools), GASTRITIS (Gastritis) and FOETAL EXPOSURE DURING PREGNANCY (Foetal exposure during pregnancy) in a 1-month-old male infant exposed to mRNA-1273 (Moderna CoviD-19 Vaccine) , while the mother received the product for an unknown indication. Concomitant product exposures included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On an unknown date, the mother received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the infant was diagnosed with SOMNOLENCE (sleepy) (seriousness criterion medically significant), FAECES DISCOLOURED (Greenish stool) (seriousness criterion medically significant), MUCOUS STOOLS (Mucous stools) (seriousness criterion medically significant), GASTRITIS (Gastritis) (seriousness criterion medically significant) and FOETAL EXPOSURE DURING PREGNANCY (Foetal exposure during pregnancy) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, SOMNOLENCE (sleepy) had not resolved, FAECES DISCOLOURED (Greenish stool), MUCOUS STOOLS (Mucous stools) and FOETAL EXPOSURE DURING PREGNANCY (Foetal exposure during pregnancy) outcome was unknown and GASTRITIS (Gastritis) was resolving. No Treatment information was reported. Green mucus baby poo. Sleepy baby. Breastfeeding. Gastritis. Patient was not enrolled in clinical trial. Child was exposed to the medicine: Second trimester (13-28 weeks). Patient was exposed to the medicine Second trimester (13-28 weeks). Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Company Comment - This case concerns a 1 month old male infant patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of somnolence, faeces discolored, mucous stools, gastritis and foetal exposure during pregnancy. The child and patient were exposed to the vaccine in the second trimester of the pregnancy. The events occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Significant follow up received on 17-DEC-2021: events added, seriousness and action taken updated.; Sender''s Comments: This case concerns a 1 month old male infant patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of somnolence, faeces discolored, mucous stools, gastritis and foetal exposure during pregnancy. The child and patient were exposed to the vaccine in the second trimester of the pregnancy. The events occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Vaccinated: 2021-12-16 Onset: 2021-12-16 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2022-01-20
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / - Administered by: Other Purchased by: ?
Symptoms: Asthenia, Chills, Fatigue, Feeling hot, Headache, Immunisation, Interchange of vaccine products, Lymphadenopathy, Myalgia, Off label use, Somnolence, Swelling, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CANDESARTAN; INDAPAMIDE; MOMETASONE FUROATE; SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Perennial rhinitis (Taking Mometasone nasal spray regularly for perennial rhinitis and have done for decades.); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200019449Write-up: swelling; felt hot; slept more but well; Primary immunisation: ASTRAZENECA; Booster: COMIRNATY; Primary immunisation: ASTRAZENECA; Booster: COMIRNATY; Primary immunisation: ASTRAZENECA; Booster: COMIRNATY; Injection site pain; Tiredness; Headache; Muscle pain; Chills/Shivering; Enlarged lymph nodes (excl infective); Feeling of total lack of energy; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201051053182570-XNYON. Other Case identifier: GB-MHRA-ADR 26438241. A 47 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Dec2021 14:00 (Batch/Lot number: unknown) at the age of 47 days as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "Perennial rhinitis" (unspecified if ongoing), notes: Taking Mometasone nasal spray regularly for perennial rhinitis and have done for decades. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medications included: CANDESARTAN taken for hypertension; INDAPAMIDE taken for hypertension; MOMETASONE FUROATE taken for rhinitis perennial; SIMVASTATIN. Past drug history included: Mometasone for Perennial rhinitis, notes: Taking Mometasone nasal spray regularly for perennial rhinitis and have done for decades. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 2), administration date: Jun2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 1), administration date: Apr2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 16Dec2021, outcome "unknown" and all described as "Primary immunisation: ASTRAZENECA; Booster: COMIRNATY"; SWELLING (medically significant), outcome "recovered", described as "swelling"; VACCINATION SITE PAIN (medically significant) with onset 16Dec2021, outcome "recovered" (21Dec2021), described as "Injection site pain"; FATIGUE (medically significant) with onset 16Dec2021, outcome "recovered" (18Dec2021), described as "Tiredness"; HEADACHE (medically significant) with onset 16Dec2021, outcome "recovered" (18Dec2021), described as "Headache"; MYALGIA (medically significant) with onset 16Dec2021, outcome "recovered" (18Dec2021), described as "Muscle pain"; CHILLS (medically significant) with onset 16Dec2021, outcome "recovered" (18Dec2021), described as "Chills/Shivering"; LYMPHADENOPATHY (medically significant) with onset 16Dec2021, outcome "recovered" (18Dec2021), described as "Enlarged lymph nodes (excl infective)"; ASTHENIA (medically significant) with onset 16Dec2021, outcome "recovered" (18Dec2021), described as "Feeling of total lack of energy"; FEELING HOT (medically significant), outcome "unknown", described as "felt hot."; SOMNOLENCE (medically significant), outcome "unknown", described as "slept more but well". Therapeutic measures were taken as a result of vaccination site pain, headache, myalgia. The clinical course was reported as follows: the patient received vaccination approximately 14:00. He experienced injection site pain started within hours and lasted approximately five days. It was mild. All other symptoms were concurrent, starting together and ending together. These started after approximately six hours and faded about 36 hours after onset; he found his normal activities a lot harder and if he had had nothing to do that day he would have spent most of it in bed. The patient took paracetamol and ibuprofen. He slept more but well. The patient found he was shivering despite being dressed warmly, under a duvet and with the heating on. He also felt hot because he was hot. He found a slight swelling in both armpits. Two days after the vaccination all symptoms had gone, with the exception of the injection site pain. No relevant investigations or tests were conducted for the patient. The patient had not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This report is not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccinated: 2021-12-09 Onset: 2021-12-09 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2022-01-21
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 2 - / OT Administered by: Other Purchased by: ?
Symptoms: Exposure via breast milk, Fatigue, Infantile colic, Infantile vomiting, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal exposures via breast milk (narrow), Neonatal disorders (narrow)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202200032651Write-up: a breastfeeding mother who has been vaccinated and whose child seems to have reacted; Fatigue; Nausea; Vomiting; Colic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the WEB. The reporter is the parent. Regulatory number: BE-FAMHP-DHH-N2021-111633 (FAMHP). A 1 month-old female patient was exposed to bnt162b2 (COMIRNATY), transmammary (mother''s route: intramuscular), administration date 09Dec2021 (Lot number: FH8469) as dose 2, single for covid-19 immunisation. The mother of the patient was 30 year-old. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: EXPOSURE VIA BREAST MILK (disability) with onset 09Dec2021, outcome "recovered" (10Dec2021), described as "a breastfeeding mother who has been vaccinated and whose child seems to have reacted"; FATIGUE (disability) with onset 09Dec2021, outcome "recovered" (10Dec2021), described as "Fatigue"; NAUSEA (disability) with onset 09Dec2021, outcome "recovered" (10Dec2021), described as "Nausea"; INFANTILE VOMITING (disability) with onset 09Dec2021, outcome "recovered" (10Dec2021), described as "Vomiting"; INFANTILE COLIC (disability) with onset 09Dec2021, outcome "recovered" (10Dec2021), described as "Colic". Clinical information: The reporter was a breastfeeding mother who has been vaccinated and my newborn seems to have reacted to it. She didn''t experience any side effects. Reporter Comment: Treatment: Unknown. Evolution of the ADR: Healing: 1 day. ADR description: Colic all night following the injection. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment: Unknown Evolution of the ADR: Healing: 1 day ADR description: Colic all night following the injection Follow-up information: I am a breastfeeding mother who has been vaccinated and my newborn seems to have reacted to it. I didn''t experience any side effects; Sender''s Comments: Linked Report(s) : BE-PFIZER INC-202200085413 mother case
Vaccinated: 2021-08-17 Onset: 2021-08-17 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2022-01-25
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5029 / 2 - / OT Administered by: Other Purchased by: ?
Symptoms: Agitation, Diarrhoea, Exposure via breast milk, Infant irritability
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Neonatal exposures via breast milk (narrow), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202200053117Write-up: diarrhea; irritability; excessive agitation especially at night; Vaccine exposure via breast milk; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). A 7 week-old patient was exposed to bnt162b2 (COMIRNATY), transmammary, administration date 17Aug2021 (Lot number: FC5029, Expiration Date: 11Sep2021) at the age of 7 week-old, as dose 2, single for covid-19 immunisation. The mother''s relevant medical history included: "breast feeding" (unspecified if ongoing). The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, Transmammary, Batch/LOT number: FE6029; Expiration date: 31Jul2021), administration date: 26Jul2021, when the patient was 4 weeks old, for covid-19 immunisation, reaction(s): "Irritability", "agitation", "large appetite", "Exposure via breast milk". The child experienced Vaccine exposure via breast milk on 17Aug2021. On 18Aug2021 and 19Aug2021, child had irritability, excessive agitation especially at night, diarrhoea. The child''s symptoms didn''t require medication or a visit to the doctor or hospitalisation. The child had similar symptoms before mother''s vaccination. The outcome of events was recovered.; Sender''s Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely 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.,Linked Report(s) : PL-PFIZER INC-202200053115 mother case, 2nd dose;PL-PFIZER INC-202200053116 child case, 1st dose;PL-PFIZER INC-202200045442 mother case 1st dose
Vaccinated: 2021-12-06 Onset: 2021-12-07 Days after vaccination: 1 Submitted: 0000-00-00 Entered: 2022-02-18
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT Administered by: Unknown Purchased by: ?
Symptoms: Influenza like illness
SMQs:Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient was allergic to pencil, diclofenac, aminexilyn, cross allergy, nickel, bee, chlorine, milk, shower room, hair products and ibuprofen. Patient had concurrent conditions of asthma.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20224Write-up: headache, muscle aches, fatigue, crib like ailments.Eyes burn, puncture pain.. heat and cold, breathing problems; This case was received via the regulatory authority (Reference number: DE-PEI-202200048987) on 09-Feb-2022 and was forwarded to Moderna on 09-Feb-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (headache, muscle aches, fatigue, crib like ailments.Eyes burn, puncture pain.. heat and cold, breathing problems) in a 52-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Patient was allergic to pencil, diclofenac, aminexilyn, cross allergy, nickel, bee, chlorine, milk, shower room, hair products and ibuprofen. Patient had concurrent conditions of asthma. On 06-Dec-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 13-Jan-2022, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (headache, muscle aches, fatigue, crib like ailments.Eyes burn, puncture pain.. heat and cold, breathing problems) (seriousness criterion hospitalization). At the time of the report, INFLUENZA LIKE ILLNESS (headache, muscle aches, fatigue, crib like ailments.Eyes burn, puncture pain. heat and cold, breathing problems) had resolved with sequelae. Concomitant medications was not provided by the reporter. Patient''s information on risk factor or pre-existing conditions included crib similar complaints, crib similar complaints, headache, stomach pain, sweating, freezing, tiredness, stinging pains, 30 Jul 1970. Treatment information was not provided. Company comment: This case concerns a 52-year-old female patient with medical history of various allergies and asthma, who experienced serious, unexpected INFLUENZA LIKE ILLNESS (headache, muscle aches, fatigue, crib like ailments, eyes burn, puncture pain, heat and cold, breathing problems) and was hospitalized. The event of INFLUENZA LIKE ILLNESS occurred in compatible temporal relationship, one day after the patient received a dose of mRNA-1273. Treatment and diagnostic information was not provided., and outcome had resolved with sequelae. The reporter did not provide causality assessment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2022: Translation received on 15-Feb-2022, wherein sender''s comments updated.; Reporter''s Comments: Are you or the person concerned aware of allergies? If yes, which one? Astma, pencil, dicklofenag, aminaxil yn, cross allergy, nickel, bee, chlorine, milk, shower room, hair products, ibuprofen, information on risk factors or pre-existing conditions crib similar complaints... headache, stomach pain, sweating, freezing, tiredness, stinging pains/30.07.1970; Sender''s Comments: This case concerns a 52-year-old female patient with medical history of various allergies and asthma, who experienced serious, unexpected INFLUENZA LIKE ILLNESS (headache, muscle aches, fatigue, crib like ailments, eyes burn, puncture pain, heat and cold, breathing problems) and was hospitalized. The event of INFLUENZA LIKE ILLNESS occurred in compatible temporal relationship, one day after the patient received a dose of mRNA-1273. Treatment and diagnostic information was not provided., and outcome had resolved with sequelae. The reporter did not provide causality assessment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Vaccinated: 2022-01-12 Onset: 2022-01-12 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2022-03-22
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT Administered by: Other Purchased by: ?
Symptoms: Addison's disease, Asthenia, Blood cortisol, Chest discomfort, Computerised tomogram, Cortisol decreased, Investigation, Magnetic resonance imaging head, Palpitations, Vertigo
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (narrow), Immune-mediated/autoimmune disorders (narrow)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220112; Test Name: Cortisol; Result Unstructured Data: Test Result:low; Test Date: 20220112; Test Name: Computerized tomography; Result Unstructured Data: Test Result:did not find special exceptions; Test Date: 20220210; Test Name: Investigation; Result Unstructured Data: Test Result:no problem; Test Date: 20220112; Test Name: Magnetic resonance imaging brain; Result Unstructured Data: Test Result:did not find special exceptions
CDC Split Type: TWPFIZER INC202200428551Write-up: GENERAL WEAKNESS; PALPITATION; CHEST TIGHTNESS; VERTIGO SYMPTOM; CORTISOL WAS LOW; SUSPECTED VACCINE-INDUCED AUTOIMMUNE ADRENAL INSUFFICIENCY; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party (BioNTech SE) and Regulatory Authority. Other Case identifier(s): TW-Fosun-2022FOS002663 (RA). This is a spontaneous report received from a non-contactable HCP received via the Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1110001738. A 45-year-old male patient started to receive 3rd dose of Tozinameran (COMIRNATY) (batch number: unknown) on 12-Jan-2022 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. The 1st and 2nd doses of the vaccine were received on an unknown date. Medical history, concomitant medications, and past products were not reported. The patient experienced general weakness, palpitation, chest tightness and vertigo symptom, cortisol was low, suspected vaccine-induced autoimmune adrenal insufficiency on 12-Jan-2022. On 12-Jan-2022, the patient received a COV_BIONTECH-BOOSTER and experienced general weakness, palpitation, chest tightness, vertigo symptom. Computed tomography (CT) and brain magnetic resonance imaging (MRI) did not find special exceptions. The patient was found that cortisol was low, suspected vaccine-induced autoimmune adrenal insufficiency. On 28-Jan-2022, the patient fainted and visited the doctor. On 30-Jan-2022, the patient fainted and went to an emergency room for diagnosis. On 08-Feb-2022, the patient''s condition was not good, and the patient was hospitalized for other detailed inspections. On 10-Feb-2022, the patient had no problem with heart examination. On 11-Feb-2022, the patient was discharged. General weakness, palpitation, chest tightness, vertigo symptom, cortisol was low, suspected vaccine-induced autoimmune adrenal insufficiency met the seriousness criterion of caused hospitalisation. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of g the events were recovering. The patient was discharged on 11-Feb-2022. Initial report was received on 09-Mar-2022. Follow-up closed, no further information is possible. Causality Assessments: Events Weakness generalized, Palpitation, Chest tightness, Vertigo, Cortisol low, Autoimmune adrenal insufficiency with drug Comirnaty was reported as Possible as Per Reporter and Per Company (BioNTech SE) Comirnaty is under agreement with BioNTech SE.
Vaccinated: 2021-08-03 Onset: 0000-00-00 Submitted: 0000-00-00 Entered: 2022-05-26
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / UNK - / OT Administered by: Other Purchased by: ?
Symptoms: Exposure via breast milk, Haemorrhage neonatal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neonatal exposures via breast milk (narrow), Neonatal disorders (narrow)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202200749154Write-up: Unexpected infant bleeding; Vaccine exposure via breast milk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority -WEB. The reporter is the parent. A 10-month-old patient was exposed to BNT162b2 (COMIRNATY), administration details for the mother: on 03Aug2021 as dose number unknown, single (Lot number: FE8244) for covid-19 immunization. The patient''s and the mother''s relevant medical history and concomitant medications were not reported. The following information was reported: HAEMORRHAGE NEONATAL (medically significant), outcome "unknown", described as "Unexpected infant bleeding"; EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown", described as "Vaccine exposure via breast milk". Follow-up (23May2022): The initial case was missing the following minimum criteria: [Patient]. Upon receipt of follow-up information on [23May2022], this case now contains all required information to be considered valid. This is a spontaneous follow-up report, Updated information included: Date of birth and new information about the breastfeeding condition of the patient updated. No follow-up attempts are possible. No further information is expected.
Vaccinated: 2022-02-08 Onset: 2022-02-08 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2022-06-17
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FB8967 / 3 - / OT Administered by: Other Purchased by: ?
Symptoms: CSF protein normal, Cardiac disorder, Cerebral venous sinus thrombosis, Echocardiogram, Electrocardiogram, Electroencephalogram, Encephalitis, Loss of consciousness, Lumbar puncture, Magnetic resonance imaging, Meningitis, Ophthalmological examination, Pulmonary function test, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: neuronal antibodies in the CSF and serum; Result Unstructured Data: Test Result:normal; Test Name: heart echo; Result Unstructured Data: Test Result:normal; Test Name: ECG; Result Unstructured Data: Test Result:normal; Test Name: EEG; Result Unstructured Data: Test Result:normal; Test Name: lumbar puncture; Result Unstructured Data: Test Result:normal; Test Name: MRI of skull; Result Unstructured Data: Test Result:normal; Test Name: ophthalmological consultation; Result Unstructured Data: Test Result:normal; Test Name: lung function test; Result Unstructured Data: Test Result:normal
CDC Split Type: DEPFIZER INC202200825774Write-up: unclear loss of consciousness; Sinus vein thrombosis; encephalitis; meningitis; seizure; cardiac cause; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: DE-PEI-202200116238. A 6-year-old female patient received BNT162b2 (COMIRNATY), on 08Feb2022 as dose 3 (booster), single (Lot number: FB8967) at the age of 6 weeks intramuscular for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE), administration date: 15Jun2021, for Prophylactic vaccination; comirnaty (DOSE 2, SINGLE), administration date: 27Jul2021, for Prophylactic vaccination, reaction(s): "Groggy", "fatigue", "exhaustion", "Inappropriate schedule of vaccine administered". The following information was reported: LOSS OF CONSCIOUSNESS (hospitalization, medically significant) with onset 08Feb2022, outcome "not recovered", described as "unclear loss of consciousness"; CEREBRAL VENOUS SINUS THROMBOSIS (medically significant), outcome "unknown", described as "Sinus vein thrombosis"; ENCEPHALITIS (medically significant), outcome "unknown"; MENINGITIS (medically significant), outcome "unknown"; SEIZURE (medically significant), outcome "unknown"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "cardiac cause". The patient underwent the following laboratory tests and procedures: CSF protein normal: normal; Echocardiogram: normal; Electrocardiogram: normal; Electroencephalogram: normal; Lumbar puncture: normal; Magnetic resonance imaging: normal; Ophthalmological examination: normal; Pulmonary function test: normal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202200842712 Original Case : 202200825774 (same patient, same reporter, same drug, different dose numbers and different events);
Vaccinated: 2021-03-18 Onset: 2021-03-19 Days after vaccination: 1 Submitted: 0000-00-00 Entered: 2021-07-01
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8727 / 1 RA / - Administered by: Work Purchased by: ?
Symptoms: Chills, Ear pain, Fatigue, Headache, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021318241Write-up: Massive headache; TIREDNESS; Muscle pain; fever; ears ache; nausea; chills; This is a spontaneous report from a contactable consumer, the patient. A 55-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8727), via an unspecified route of administration in the right arm on 18Mar2021 at 12:30 (at the age of 55-year-old) as single dose for COVID-19 immunisation. Medical history was not reported. The patient has allergies to codeine. Concomitant medications were not reported. Prior to the 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 19Mar2020, the patient experienced massive headache that she couldnt get out of bed for 2 days, tiredness, muscle pain, chills, fever, ears ache, nausea for 5 days most lasted 3 to 4 days. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the reported events massive headache, tiredness, muscle pain, chills, fever, ears ache and nausea was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Vaccinated: 2021-01-06 Onset: 2021-01-14 Days after vaccination: 8 Submitted: 0000-00-00 Entered: 2021-01-18
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / 1 RA / IM Administered by: Private Purchased by: ?
Symptoms: Headache, Nausea, Pain in extremity, Pain of skin, Skin warm
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: none
Preexisting Conditions: none
Allergies: None
Diagnostic Lab Data: NONE
CDC Split Type:Write-up: Day after vaccines arm sore, warm to touch and painful to touch. 01/07/2021 Right now on and off Headaches and nauseas for a long period of time. this starts on 1/15/2021
Vaccinated: 2021-01-27 Onset: 2021-02-04 Days after vaccination: 8 Submitted: 0000-00-00 Entered: 2021-02-10
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM Administered by: Senior Living Purchased by: ?
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vit d Multi vit Baby Aspirin Paxil 10mg Fish oil Vit c
Current Illness:
Preexisting Conditions:
Allergies: Nka
Diagnostic Lab Data:
CDC Split Type:Write-up: I have a large red rash just below the injection site, not really painful but it does itch often.
Vaccinated: 2021-02-14 Onset: 2021-02-14 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-02-14
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030M20A / 2 LA / IM Administered by: Public Purchased by: ?
Symptoms: Incorrect product formulation administered
SMQs:, Medication errors (narrow)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:Write-up: RN at car side obtained pt history and pt reports having completed questionnaire prior to arrival today. Pt reported to RN that he had not received previous dose of vaccine. Moderna vaccine administered to left arm w/o incident. When logging the Moderna vaccination the RN noted that the patient had previously received a dose of Pfizer. The companies were notified of event and the VAERS report was completed. The pt had the event explained to them and was asked if they needed any additional assistance or observation, the pt declined and wanted to return home. Pt is given company contact details and advised if any adverse reactions to go to hospital or contact 911.
Vaccinated: 2021-02-05 Onset: 2021-02-06 Days after vaccination: 1 Submitted: 0000-00-00 Entered: 2021-02-22
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 028L20A / 2 RA / SYR Administered by: Work Purchased by: ?
Symptoms: Chills, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Benadryl, Tylenol
Current Illness:
Preexisting Conditions: asthma
Allergies: peanut allergy
Diagnostic Lab Data:
CDC Split Type:Write-up: Nausea, fever, chills, body aches 48 hours
Vaccinated: 2021-02-24 Onset: 2021-02-24 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-02-28
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ENV201 / 1 LA / IM Administered by: Public Purchased by: ?
Symptoms: Joint swelling, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Dose 1 Pfizer-BiONTech COVID-19 Vaccine
Current Illness: None
Preexisting Conditions: None
Allergies: sulfa based products
Diagnostic Lab Data: none
CDC Split Type:Write-up: I am a 74 year old male in good health with NO prior reactions to the annual flu, pneumonia, or shingles vaccinations. Because of a scheduled prostate biopsy in early April 2021, I wanted to complete the vaccination for COVID-19 in advance of this procedure. Within 5 mins of receiving the vaccination shot in my left arm, my left elbow and forearm began to swell into a large ball shape near the elbow joint. At the same time, my left hand became noticeably swollen as well. Fortunately, I did not experience trouble breathing or have any numbness in my fingers at that time. The observation staff nurses took me to a separate room to check my blood pressure and heart rate which were both in the normal range.
Vaccinated: 2021-02-12 Onset: 2021-02-26 Days after vaccination: 14 Submitted: 0000-00-00 Entered: 2021-03-02
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / - Administered by: Public Purchased by: ?
Symptoms: Unevaluable event
SMQs:Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:Write-up: Was scheduled before 4 day grace period and was sent away when we tried to get 2nd Dose on 02/26/21 at same facility
Vaccinated: 2021-02-04 Onset: 2021-02-05 Days after vaccination: 1 Submitted: 0000-00-00 Entered: 2021-03-17
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / IM Administered by: Other Purchased by: ?
Symptoms: Arthralgia, Dizziness, Myalgia, Nausea, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:Write-up: Dizziness, Myalgia, Arthralgia & NauseaVomiting Narrative:
Vaccinated: 2021-03-18 Onset: 2021-03-17 Submitted: 0000-00-00 Entered: 2021-03-18
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 1 LA / IM Administered by: Other Purchased by: ?
Symptoms: Hypertension, Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:Write-up: SkinRash, UrticariaPruritus & HYPERtension Narrative:
Vaccinated: 1958-04-03 Onset: 2021-04-03 Days after vaccination: 23011 Submitted: 0000-00-00 Entered: 2021-04-12
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8732 / UNK LA / IM Administered by: Public Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Feeding disorder, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Calcium, vitamin D, women''s multi vitamin
Current Illness: knee pain
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:Write-up: Within 40 minutes I began to feel weak, followed by nausea and severe headaches. A few hours later acute abdominal pain that left me doubled over and lasted for 8 hours and 40 hours of stomach pain that left me unable to eat.
Vaccinated: 2021-04-15 Onset: 2021-04-15 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-04-16
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8735 / 1 LA / ID Administered by: Private Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:Write-up: Age of 15 yrs.
Vaccinated: 2021-04-19 Onset: 2021-04-19 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-04-21
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM Administered by: Pharmacy Purchased by: ?
Symptoms: Blood magnesium, Blood phosphorus normal, Full blood count, Headache, Hypoaesthesia oral, Metabolic function test, Muscle spasms, Muscle twitching, Pain
SMQs:, Dyskinesia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Bloodwork from the hospital was Basic Metabolic panel CBC Differential Magnesium Phosphorus 4-20-21 I was not given a copy of the results the doctor simply told me everything looked fine.
CDC Split Type:Write-up: Was given the injection and within the first five minutes had severe headache and body pain. Numbness in lips. Was taken back after the 15 minute window and checked for swelling in throat or mouth. Non visible. Waited another 30 minutes and then was released because there was no swelling in the throat. On the drive home, starting around 7pm the front right side of my tongue started to twitch painfully. Occasionally the back right would also spasm. Continued nonstop. I called a 24 hour nurse hotline around 11:45pm. The nurse told me to make sure I was hydrated and to schedule an appointment the next day. The next morning I called and set up another nurses appointment and she encouraged me to set up an appointment on "doctor on demand". I had an appointment with a doctor from Doctor on Demand and she told me to immediately go to the ER as this could be a sign of blood clotting. I was driven to the ER were they did some blood tests and said to come back if it persisted past the 72 hour mark. It is now 4/21/21 and I am still experiencing the tongue twitch, numb lips, headache, bodyaches.
Vaccinated: 2021-05-22 Onset: 2021-05-23 Days after vaccination: 1 Submitted: 0000-00-00 Entered: 2021-05-27
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / UNK LA / SYR Administered by: Other Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia, Pain, Tremor, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: The ALT was a little high two years ago.
Allergies: None
Diagnostic Lab Data: Haven''t Yet
CDC Split Type:Write-up: Day 1 (May 22, Sat) Almost No Symptom Day 2 (May 23, Sun) Mild muscle pain Day 3 (May 24, Mon) Severe chills, shaking, body aches - Symptoms start at midnight Day 4 (May 25, Tue) Mild Body ache, Severe Headache Day 5 (May 26, Wed) Mild headache, tiredness - Worked Day 6 (May 27, Thu) Severe dizziness, vertigo - Symptoms begin the night before
Vaccinated: 2021-03-05 Onset: 2021-03-05 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-06-18
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 042L20A / 1 LA / SYR COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036A21A / 2 LA / SYR Administered by: Public Purchased by: ?
Symptoms: Back pain, Chest pain, Groin pain, Laboratory test, Pain, Pain in extremity, Pyrexia, Renal pain, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Osteonecrosis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)Life Threatening? Yes
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:Write-up: Back and body ache, legs groin chest, kidneys, throw up and fever. Went to emergency, Doctors took many many test
Vaccinated: 0000-00-00 Onset: 2021-01-09 Submitted: 0000-00-00 Entered: 2021-01-18
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EC 3248 / 2 LA / IM Administered by: Private Purchased by: ?
Symptoms: Appendicitis, Computerised tomogram, Fatigue, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amlodipine Atorvast
Current Illness: None
Preexisting Conditions: None
Allergies: Penicillin
Diagnostic Lab Data: CT 1/16/2021
CDC Split Type:Write-up: Arm soreness Fatigue Appendicitis (unclear if directly related to vaccine but need to report to determine if increased risk due to vaccine)
Vaccinated: 1940-03-09 Onset: 2021-07-27 Days after vaccination: 29725 Submitted: 0000-00-00 Entered: 2021-07-29
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / - Administered by: Private Purchased by: ?
Symptoms: Dyspnoea, Fatigue
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:Write-up: shortness of breath, fatigue
Vaccinated: 2021-08-06 Onset: 2021-08-06 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-08-06
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / IM Administered by: Public Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Pallor, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma
Allergies: Turkey, iodine, seafood, and Advil
Diagnostic Lab Data: 11:15 AM- VITAL SIGNS: PULSE-96, SATURATION-99%, R- 20 / MIN, B / P- 90/60, DTX- 100
CDC Split Type:Write-up: 22 year old female patient presents with dizziness and blurry vision 5 minutes after vaccination. Pale and sweaty from head to toe.
Vaccinated: 2021-02-18 Onset: 2021-08-13 Days after vaccination: 176 Submitted: 0000-00-00 Entered: 2021-08-21
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ENG201 / 2 RA / IM Administered by: Other Purchased by: ?
Symptoms: Body temperature increased, Chest X-ray, Dizziness, Ear discomfort, Fatigue, Headache, Nasal discomfort, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test, Sinus congestion
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methotrexate, benlysta (belimumab), levothyroxine, Atorvastatin, hydroxychloaquine, pantoprazole, metoprolol, FOLIC ACID, vitamins D3, losartan, cyclobenzaprine
Current Illness:
Preexisting Conditions: LUPUS, SYSTEMIC SCLEROSIS, SYNDROME, HASHIMOTOS THYROIDITIS (hypo)
Allergies: Imuran, penicillin, erythromycin, Flagyl, peanuts, pollen, formaldehyde
Diagnostic Lab Data: Exam, Chest xray, covid19 test
CDC Split Type:Write-up: Fatigue, 99.3 temp, sore throat, chest and sinus congestion, left earplugged, dizziness, sores in nostrils, headache
Vaccinated: 2021-05-27 Onset: 2021-05-27 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-08-23
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 008C21A / 1 LA / OT Administered by: Unknown Purchased by: ?
Symptoms: Chills, Feeling of body temperature change, Headache, Muscle tightness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212Write-up: "he felt hot, then felt cold"; "tight muscles in his neck"; "it hurt really bad"; chills; "super bad headache"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jun-2021 and was forwarded to Moderna on 03-Jun-2021. This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE ("he felt hot, then felt cold"), MUSCLE TIGHTNESS ("tight muscles in his neck"), MYALGIA ("it hurt really bad"), CHILLS (chills) and HEADACHE ("super bad headache") in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE ("he felt hot, then felt cold"), MUSCLE TIGHTNESS ("tight muscles in his neck"), MYALGIA ("it hurt really bad"), CHILLS (chills) and HEADACHE ("super bad headache"). The patient was treated with IBUPROFEN at a dose of 200mg. On 27-May-2021, FEELING OF BODY TEMPERATURE CHANGE ("he felt hot, then felt cold"), MUSCLE TIGHTNESS ("tight muscles in his neck"), MYALGIA ("it hurt really bad"), CHILLS (chills) and HEADACHE ("super bad headache") had resolved. 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 concomitant medications were provided.
Vaccinated: 2021-07-28 Onset: 2021-07-28 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2021-09-03
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004671 / N/A AR / OT Administered by: School Purchased by: ?
Symptoms: Asthenia, Blood test, Cardiac flutter, Cerebrovascular accident, Chest pain, Dizziness, Dyspnoea, Heart rate increased, Palpitations, Pharyngeal swelling, Rash, Swelling face, Urine analysis
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Diazepam, Clonazepam, Ketazolam, Cetix
Current Illness: allergies and conversive crisis
Preexisting Conditions: conversive crisis
Allergies: Acestilisteine
Diagnostic Lab Data: blood and pee 29/7/2021
CDC Split Type:Write-up: Chest pain; Shortness of breath; Feelings of having a fast-beating, fluttering, or pounding heart; Injection on the mussle; Difficulty breathing; Swelling of your face and throat; A fast heartbeat; A bad rash all over your body Dizziness and weakness; Stroke indicatores
Vaccinated: 2021-09-08 Onset: 2021-09-12 Days after vaccination: 4 Submitted: 0000-00-00 Entered: 2021-09-14
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 1 LA / SYR Administered by: Unknown Purchased by: ?
Symptoms: Blood test, Body temperature increased, Condition aggravated, Decreased appetite, Exposure via breast milk, Fatigue, Feeling hot, Heart rate increased, Irritability, Respiratory tract congestion, Rhinovirus infection, Tachypnoea, Urine analysis
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Neonatal exposures via breast milk (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: Rhinovirus
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:Write-up: Patient is an exclusively breastfed newborn. He has had rhinovirus symptoms since 9/5 which consisted of minor congestion. That has been the only symptom and never got worse. When I woke him up on the morning of 9/12, he was very tired and hardly ate. He slept through his next feeding. Around 3:00 he started getting fussy but still would not eat well. His congestion was not any worse than it had been. He remained irritable. I fed him around 7:30. He didn?t eat well again but I put him down to bed after. Around 11:00pm, his heart rate monitor went off because his heart rate spiked. When we got him out of bed, he felt so warm. He had rapid breathing and seemed to be struggling. His under the arm temperature was 100.8 on one arm and 100.9 on the other arm. I called the exchange and they said to bring him to the ER. When I brought him in, they swabbed him and sent blood and urine in. His rectal temperature was 100.8 at the hospital. The only thing that came back positive was for rhinovirus. As I was processing everything, I realized that the progression of symptoms were the exact progression of symptoms I had from the covid vaccine. I asked the ER doctor if that could have any relation and if it could be noted in the file since he had the same symptoms for a whole week and everything else came out of nowhere and so fast. The ER doctor said it absolutely could not have anything to do with that and quickly dismissed me. Prior to talking to the doctor, I mentioned it to the nurse and she said it could be but they don?t have enough research on the effect on a nursing newborn. They gave him Tylenol at 2:00 am. When he was discharged around 3:30 am, he went to bed as soon as we got home. At 10:00am when he woke up and I fed him, his underarm temperature was 98.6 with no other medicine given to him besides at the hospital at 2:00am. He was smiling and back to his normal self with just the minor congestion. He has remained this way ever since. I was disappointed the doctor dismissed it so quickly and did not want to consider it. My pediatrician?s office recommended me reporting it here.
Vaccinated: 2021-09-12 Onset: 2021-09-13 Days after vaccination: 1 Submitted: 0000-00-00 Entered: 2021-09-25
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / IM Administered by: Unknown Purchased by: ?
Symptoms: Bradycardia, Cerebral cyst, Cerebral haematoma, Cerebral thrombosis, Choking, Cyanosis, Exposure via breast milk, Gastrointestinal tube insertion, Intensive care, Lethargy, Oxygen saturation decreased, Poor feeding infant, Suck-swallow breathing coordination disturbance, Ultrasound head abnormal
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal exposures via breast milk (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: multivitamin
Current Illness:
Preexisting Conditions:
Allergies: NKDA
Diagnostic Lab Data: Head ultrasound.
CDC Split Type:Write-up: Mother of infant received 2nd dose of Pfizer 9/21. Mother actively breast feeding infant. 24 hours after mother receiving 2nd vaccination, infant had significant bradycardia (drop in heart rate), desaturation ( low oxygen in the blood causing infant to turn blue). Infant was a previous 31 weeker adjusted to 36 weeks and discharge was pending at time mother received 2nd vaccination. After the initial episode, infant required a feeding tube due to feeding difficulties and lethargy. Infant was monitored in NICU with continued episodes of feeding difficulties associated with choking, inability to coordinate suck/swallow/breath, and bradycardic events. Head ultrasound was completed to show multiple cysts/hematomas (blood clots) present on the brain that were not present prior to vaccination. Infant was transferred to higher level of care for neurological evaluation. Due to absence of hematomas prior to vaccination and no evidence of head trauma, and the known vaccination side effects of potential blood clots; this shall be considered an adverse event.
Vaccinated: 2009-09-28 Onset: 2021-10-02 Days after vaccination: 4387 Submitted: 0000-00-00 Entered: 2021-10-08
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO185 / 2 LA / SYR Administered by: Private Purchased by: ?
Symptoms: Amnesia, Blepharospasm, Blood test normal, Computerised tomogram normal, Facial paralysis, Glassy eyes, Headache, Loss of consciousness, Petit mal epilepsy, Seizure, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Viral cold
Preexisting Conditions: None
Allergies: Penicillin
Diagnostic Lab Data: CT scan on 10/3/21 normal blood work came back normal as well.
CDC Split Type:Write-up: Seizure around 10:30, Started experience left eye twitching, along with absence seizure, followed with her mouth going unintentionally to the right. Glaze eyes and after getting conscious she didn?t have any recollection of what had happened. Follows with a very sever headache and vomiting.
Vaccinated: 2021-12-28 Onset: 2021-12-29 Days after vaccination: 1 Submitted: 0000-00-00 Entered: 2022-01-13
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM Administered by: Pharmacy Purchased by: ?
Symptoms: Maternal exposure during breast feeding
SMQs:, Neonatal exposures via breast milk (narrow)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin d
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:Write-up: I received the COVID 19 vaccine on 12/28/21. I breast feed my daughter. She started to get a couple hives within 24 hours and then worsen until the rash was all over her body. She became fussy and stopped wanting to nurse and a started having dry diapers so I took her to the ER on 12/31/21 related to this. ER recommended Tylenol and were unsure of what caused the rash and said it could be cradle cap. And we were discharged home. Thankfully over the next 24 hours her rash and fussiness resolved without any intervention. I met with her Pediatrician 1/13/22 and showed him pictures of her rash. He said it was either an allergic reaction to something or a viral rash.
Vaccinated: 2020-12-30 Onset: 2021-07-01 Days after vaccination: 183 Submitted: 0000-00-00 Entered: 2022-02-12
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / OT Administered by: Unknown Purchased by: ?
Symptoms: Laryngomalacia
SMQs:, Congenital, familial and genetic disorders (narrow)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20200Write-up: Laryngomalacia; This spontaneous case was reported by a consumer and describes the occurrence of LARYNGOMALACIA (Laryngomalacia) in a 1-month-old male infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): The mother''s past medical history included Hypertension, Maternal exposure during pregnancy and Ultrasound abdomen on 23-Oct-2020. No Medical History information was reported. On 30-Dec-2020, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The mother''s last menstrual period was on 25-Aug-2020 and the estimated date of delivery was 13-Jun-2021. In July 2021, the infant was diagnosed with LARYNGOMALACIA (Laryngomalacia) (seriousness criterion medically significant). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the eighteenth week of the pregnancy. The vaginal delivery occurred on 09-Jun-2021, which was reported as Full-term. For neonate 1, the birth weight was 108472 grams (239lbs 3oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. The fetal weight was 3827 grams with length as 53.34 and head circumference as 34.8. At the time of the report, LARYNGOMALACIA (Laryngomalacia) 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. No concomitant medications reported. No Treatment medications was provided by the reporter. The patient''s mother had normal ultrasound on 23-Oct-2020, 15-Jan-2021, 19-Mar-2021 and 13-May-2021. On 20-Mar-2021, the patient glucose for one hour. The patient''s mother gestation period was 39. Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. This case was linked to MOD-2021-272273 (Parent-Child Link). See case MOD-2021-272273 for details regarding the Parent case. Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2021: No specific follow-up information recorded. On 01-Aug-2021: Follow up information was received: The additional reporter (Physician) and pregnancy outcome report added.; Sender''s Comments: This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Vaccinated: 2021-12-07 Onset: 2021-12-07 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2022-03-17
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0809 / 1 LA / OT Administered by: Unknown Purchased by: ?
Symptoms: Crying, Exposure via breast milk, Irritability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Neonatal exposures via breast milk (narrow), Hypoglycaemia (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101761084Write-up: the baby was fussy all day yesterday and today; Crying; she had a baby and is currently breastfeeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 5 week-old female patient was exposed to bnt162b2 (BNT162B2), transplacental administered in arm left, administration date 07Dec2021 (Lot number: FD0809) as dose 1, single for covid-19 immunisation. The mother''s relevant medical history included: "C Section" (unspecified if ongoing), notes: Mode of delivery (e.g. natural birth [i.e., vaginal delivery without medication or anesthesia], cesarean section: C Section; "Full term live birth" (unspecified if ongoing), notes: Pregnancy outcome: check one: Full term live birth. The mother was 1 weeks pregnant at the event onset. The mother is expected to deliver one baby(s). The mother''s concomitant medications were not reported. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious) with onset 07Dec2021, outcome "not recovered", described as "she had a baby and is currently breastfeeding"; IRRITABILITY (non-serious) with onset 08Dec2021, outcome "not recovered", described as "the baby was fussy all day yesterday and today"; CRYING (non-serious) with onset 08Dec2021, outcome "not recovered", described as "Crying". The baby was delivered live birth(unspecified), via cesarean route. Additional Context: Caller reported having her first dose of the vaccine on 07Dec2021. Caller reported on 08Dec2021 having itchiness on her hands and feet. She had a baby on (#) and was currently a breastfeeding; the baby was fussy all day yesterday and today. Caller asked her HCP about the reaction and for treatment recommendations; her HCP recommended she call Pfizer. While reporting for herself, she mentioned she just had a daughter on (#) and she was breastfeeding. She confirmed she was breastfeeding after she received the vaccine. This report was to capture information about her daughter. She normally does not get vaccines but got it because of her daughter. She then asked if you can pass antibodies through breast milk. She was breastfeeding her daughter. Since then, her daughter has been extremely fussy. She was crying all day yesterday and today. She then stated she cries all the time anyway. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101758869 maternal/child case
Vaccinated: 2022-03-14 Onset: 2022-03-15 Days after vaccination: 1 Submitted: 0000-00-00 Entered: 2022-03-22
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027L2A / 1 LA / IM Administered by: Pharmacy Purchased by: ?
Symptoms: Dyspnoea, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
Extended hospital stay? No
Previous Vaccinations: H1N1, difficulty with speech, word finding, ataxic gait for days
Other Medications: Multivitamins, liposomal C, Melatonin, Armour Thyroid, Venlafexine. Bactrim
Current Illness: Bladder infection,, on day 2 of treatment.
Preexisting Conditions: Asthma, fibromyalgia, Hypothyroidism, Obesity, Osteoarthritis, Osteopenia, GERD
Allergies: Inderal Gluten
Diagnostic Lab Data:
CDC Split Type:Write-up: Restricted breathing, difficulty taking deep breath,, expiratory wheezing, shortness of breath
Vaccinated: 2022-04-28 Onset: 2022-04-28 Days after vaccination: 0 Submitted: 0000-00-00 Entered: 2022-05-19
Vaccination / Manufacturer Lot / Dose Site / Route COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FM9992 / 3 LA / IM Administered by: Other Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Pain
SMQs:Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:Write-up: Headache BODY ACHES, CHILLS, FATIGUE Narrative:
