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From the 1/14/2022 release of VAERS data:

Found 1,031,637 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

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VAERS ID: 1974621 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7369 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Herpes zoster, Immunisation, Malaise, Nausea, 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), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: BEPFIZER INC202101762635

Write-up: This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority Regulatory number: BE-FAMHP-DHH-N2021-109745 (FAMHP). A 60 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FG7369) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, single, batch EP2166), administration date: 09Feb2021, for COVID-19 immunisation; Comirnaty (dose 2, single, batch EP2166), administration date: 02Mar2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 17Nov2021, outcome "recovering", described as "booster"; MALAISE (disability) with onset 18Nov2021, outcome "recovering", described as "Malaise"; NAUSEA (disability) with onset 18Nov2021, outcome "recovering", described as "Nausea"; HERPES ZOSTER (disability) with onset 18Nov2021, outcome "recovering", described as "Arm zona / Shingles of the arm"; CHILLS (disability) with onset 18Nov2021, outcome "recovering", described as "Shivering"; PYREXIA (disability) with onset 18Nov2021, outcome "recovering", described as "Fever"; FATIGUE (disability) with onset 18Nov2021, outcome "recovering", described as "Fatigue". Therapeutic measures were taken as a result of malaise, nausea, herpes zoster, chills, pyrexia, fatigue. Reporter Comment: Treatment: - Paracetamol - Aciclovir Evolution of the ADR: Improving Situations: Other: no error ADR time relationship: Symptomatology of fatigue and shingles still in progress ADR description: Shingles of the arm No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment: - Paracetamol - Aciclovir Evolution of the ADR: Improving Situations: Other: no error ADR time relationship: Symptomatology of fatigue and shingles still in progress ADR description: Shingles of the arm


VAERS ID: 1976604 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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: DEPFIZER INC202101762087

Write-up: Facial nerve palsy left (incomplete); 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-202100266116 (RA). A 66 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: Unknown) at the age of 66 years as dose number unknown, single for Covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: FACIAL PARALYSIS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Facial nerve palsy left (incomplete)". Clinical course: It was reported that relatedness of drug to reaction(s)/event(s) and source of assessment: RA, result of assessment was unclassifiable. No further clarification on initial privacy and vaccine used earlier, no further information on this. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1977011 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood test, Chest pain, Disturbance in attention, Dyspnoea, Feeling cold, Gait disturbance, Hallucination, Memory impairment, Migraine, Neck pain, Pain in extremity, Paraesthesia, SARS-CoV-2 test, Speech disorder, Tachycardia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROX
Current Illness: Hypothyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: blood test; Result Unstructured Data: Test Result:no anomalies; Comments: with regard to platelets, D-Dimers and troponins; Test Date: 20211122; Test Name: blood test; Result Unstructured Data: Test Result:no anomalies; Comments: with regard to platelets, D-Dimers and troponins; Test Date: 20211023; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101762278

Write-up: Paraesthesia of limbs; Dyspnea; hallucinations; Chest pain; back pain; migraines; neck pain; tachycardia; speech difficulties; pain in left leg; difficulty walking; severe difficulties in concentration; memory troubles; feeling of being cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: FR-AFSSAPS-MP20218801 (RA). A 51 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 17Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (ongoing). Concomitant medication(s) included: LEVOTHYROX taken for hypothyroidism. Past drug history included: Amoxicilline, reaction(s): "Edema Quincke''s"; Clavulanique, reaction(s): "Edema Quincke''s". The following information was reported: PARAESTHESIA (disability) with onset 17Nov2021, outcome "not recovered", described as "Paraesthesia of limbs"; DYSPNOEA (disability) with onset 17Nov2021, outcome "not recovered", described as "Dyspnea"; HALLUCINATION (medically significant) with onset 17Nov2021, outcome "not recovered", described as "hallucinations"; CHEST PAIN (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Chest pain"; BACK PAIN (non-serious) with onset 17Nov2021, outcome "not recovered", described as "back pain"; MIGRAINE (non-serious) with onset 17Nov2021, outcome "not recovered", described as "migraines"; NECK PAIN (non-serious) with onset 17Nov2021, outcome "not recovered", described as "neck pain"; TACHYCARDIA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "tachycardia"; SPEECH DISORDER (non-serious) with onset 17Nov2021, outcome "not recovered", described as "speech difficulties"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021, outcome "not recovered", described as "pain in left leg"; GAIT DISTURBANCE (non-serious) with onset 17Nov2021, outcome "not recovered", described as "difficulty walking"; DISTURBANCE IN ATTENTION (non-serious) with onset 17Nov2021, outcome "not recovered", described as "severe difficulties in concentration"; MEMORY IMPAIRMENT (non-serious) with onset 17Nov2021, outcome "not recovered", described as "memory troubles"; FEELING COLD (non-serious) with onset 17Nov2021, outcome "not recovered", described as "feeling of being cold". The patient underwent the following laboratory tests and procedures: blood test: (18Nov2021) no anomalies, notes: with regard to platelets, D-Dimers and troponins; (22Nov2021) no anomalies, notes: with regard to platelets, D-Dimers and troponins; sars-cov-2 test: (23Oct2021) negative. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1977071 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7911 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood culture, Brain natriuretic peptide, C-reactive protein decreased, Chest injury, Culture, Hyperleukocytosis, Immunisation, Inflammation, Lung disorder, Pulmonary embolism, Pyrexia, SARS-CoV-2 test, Troponin, Ultrasound Doppler
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Malignancy related conditions (narrow), Accidents and injuries (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? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Kardegic; Bisoce; Lisinopril
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendicitis; Cessation of smoking (estimated at 45-50 pack-years); Chemotherapy (Monitored Waldenstrom disease with chemotherapy); Hypertension arterial; Infarct myocardial (X 11 configuration stenting with reassuring latest coronary angiography in 2021); Stent placement; Von Waldenstrom macroglobulinaemia.
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: thoracic angiography; Result Unstructured Data: Test Result: right lower and middle lobar pulmonary embolism; Comments: with pneumopathy of the right lower lobe; Test Date: 20211122; Test Name: blood cultures; Result Unstructured Data: Test Result: no microbiology; Test Date: 20211122; Test Name: brain natriuretic peptides; Test Result: Negative; Test Date: 20211122; Test Name: C-reactive protein; Result Unstructured Data: Test Result:140 to 90 mg/l; Test Date: 20211122; Test Name: definitive culture results; Result Unstructured Data: Test Result: Unknown results; Comments: pending; Test Date: 20211122; Test Name: hyperleukocytosis; Result Unstructured Data: Test Result: from 8,000 to 1,700; Test Date: 20211125; Test Name: COVID test; Test Result: Negative; Test Date: 20211122; Test Name: troponins; Test Result: Negative; Test Date: 20211122; Test Name: Doppler ultrasound of the lower limbs; Result Unstructured Data: Test Result: did not reveal any deep vein thrombosis.
CDC Split Type: FRPFIZER INC202101762606

Write-up: Pulmonary embolism; pneumopathy of the right lower lobe; thoracic trauma without complication; hyperleukocytosis; decrease in his inflammatory syndrome; fever; C-reactive protein from 140 to 90 mg/l; Booster; This is a spontaneous report received from a contactable reporter (physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-TO20219195 (RA). A 72 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 17Nov2021 (Lot number: FG7911) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Infarct myocardial" (unspecified if ongoing), notes: X 11 configuration stenting with reassuring latest coronary angiography in 2021; "Von Waldenstrom macroglobulinaemia" (unspecified if ongoing); "Appendicitis" (unspecified if ongoing); "Stent placement" (unspecified if ongoing); "Hypertension arterial" (unspecified if ongoing); "Cessation of smoking", stop date: 2017, notes: estimated at 45-50 pack-years; "chemotherapy", stop date: 2019, notes: Monitored Waldenstrom disease with chemotherapy. Concomitant medications included: KARDEGIC; BISOCE; LISINOPRIL. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; PULMONARY EMBOLISM (hospitalization) with onset 22Nov2021, outcome "recovering", described as "Pulmonary embolism"; LUNG DISORDER (hospitalization) with onset 22Nov2021, outcome "recovering", described as "pneumopathy of the right lower lobe"; HYPERLEUKOCYTOSIS (medically significant) with onset 22Nov2021, outcome "recovering", described as "hyperleukocytosis"; INFLAMMATION (non-serious) with onset 22Nov2021, outcome "recovering", described as "decrease in his inflammatory syndrome"; CHEST INJURY (non-serious) with onset 22Nov2021, outcome "recovering", described as "thoracic trauma without complication"; PYREXIA (non-serious) with onset 22Nov2021, outcome "recovering", described as "fever"; C-REACTIVE PROTEIN DECREASED (non-serious) with onset 22Nov2021, outcome "recovering", described as "C-reactive protein from 140 to 90 mg/l". The patient was hospitalized for pulmonary embolism, lung disorder (start date: 22Nov2021, discharge date: 27Nov2021, hospitalization duration: 5 day(s)). The event "thoracic trauma without complication" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: thoracic angiography: (22Nov2021) right lower and middle lobar pulmonary embolism with pneumopathy of the right lower lobe; blood culture: (22Nov2021) no microbiology; brain natriuretic peptide: (22Nov2021) negative; C-reactive protein decreased: (22Nov2021) 140 to 90; definitive culture results: (22Nov2021) unknown results, pending; hyperleukocytosis: (22Nov2021) from 8,000 to 1,700; COVID test: (25Nov2021) negative; troponins: (22Nov2021) negative; ultrasound doppler: (22Nov2021) did not reveal any deep vein thrombosis. Therapeutic measures were taken as a result of pulmonary embolism, inflammation, chest injury, pyrexia. Additional information: The patient was discharged on 27Nov2021 with the following treatment: ELIQUIS 10 mg morning and evening for seven days, then 5 mg morning and evening; DOLIPRANE if needed; AUGMENTIN 1 g x3/day for 4 more days. Continuation of his usual treatment, a follow-up blood test on 01Dec2021 and a contrast-enhanced thoracic-abdominal-pelvic scan in six weeks. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1977189 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Heavy menstrual bleeding, Immunisation, Interchange of vaccine products, Menstruation delayed, Off label use, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Medication errors (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101768816

Write-up: bleeding; late period; Prolonged periods; Off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112081854491990-UXDYA (RA). Other Case identifier(s): GB-MHRA-ADR 26310553 (RA). A 40 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; HAEMORRHAGE (medically significant), outcome "not recovered", described as "bleeding"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 03Dec2021, outcome "not recovered", described as "Prolonged periods"; MENSTRUATION DELAYED (non-serious), outcome "unknown", described as "late period". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: Patient last menstrual period date was 06Dec2021. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Her previously like clockwork cycle has changed, late period with unusual bleeding lasting longer than before. Trying to conceive was ovulating hoping she still will be. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). Details of any relevant investigations or tests conducted: None as yet. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1977204 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness, Dyspnoea, Fatigue, Heart rate irregular, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, Palpitations, Pericarditis, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Chronic kidney disease (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (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: AMLODIPINE; CLENIL MODULITE; RAMIPRIL.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure; Breathlessness.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: COVID-19 test.
CDC Split Type: GBPFIZER INC202101770491

Write-up: Light headedness; Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); myocarditis; pericarditis; Heartbeats irregular; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112082144431360-3AD02 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26310873 (MHRA). A female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Breathlessness" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement; CLENIL MODULITE taken for dyspnoea; RAMIPRIL taken for blood pressure measurement. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 2), for COVID-19 immunisation, reaction(s): "Adverse drug reaction"; Covid-19 vaccine astrazeneca (Dose 1), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; HEART RATE IRREGULAR (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Heartbeats irregular"; DIZZINESS (medically significant), outcome "not recovered", described as "Light headedness"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: COVID-19 test. Clinical course: Had issue similar after 2nd AstraZeneca but Pfizer terrible, ended up in accident and emergency (A and E). Can get no sense help from doctor, been referred for further investigation but god knows when, is this long term, is my heart damaged for ever.Additional information: Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reaction: report relate to possible inflammation of the heart (myocarditis or pericarditis) and the symptoms did not lead to hospital, Further investigation, eventually for symptoms, when asked if any imaging carried out, answered as I wish. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1977344 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 - / 3 - / -
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Cerebrovascular accident, Feeding disorder, Hypophagia, Immunisation, Interchange of vaccine products, Off label use
SMQs:, 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), Hearing impairment (broad), Medication errors (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: AMLODIPINE; LISINOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101770251

Write-up: Palsy Bells/Left eye lid difficult closing. 4 days later face drooped badly on left side, nose and lips numb on right side.; Off label use; Interchange of vaccine products; Booster; drinking/Difficulty drinking; difficulty eating; Attended hospital as emergency as suspected stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112101342264140-MTIPL (RA). Other Case identifier(s): GB-MHRA-ADR 26318717 (RA). A 62 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VIRUS), administration date 17Nov2021 (Batch/Lot number: unknown) as single dose for immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension, start date: 01Aug2011; LISINOPRIL taken for hypertension, start date: 01Aug2011. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; HYPOPHAGIA (medically significant) with onset 2021, outcome "not recovered", described as "drinking/Difficulty drinking"; FEEDING DISORDER (medically significant) with onset 2021, outcome "not recovered", described as "difficulty eating"; BELL''S PALSY (medically significant) with onset 02Dec2021, outcome "recovering", described as "Palsy Bells/Left eye lid difficult closing. 4 days later face drooped badly on left side, nose and lips numb on right side."; CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "Attended hospital as emergency as suspected stroke". The events "off label use", "interchange of vaccine products", "booster", "drinking/difficulty drinking", "difficulty eating" and "attended hospital as emergency as suspected stroke" were evaluated at the physician office visit. The event "palsy bells/left eye lid difficult closing. 4 days later face drooped badly on left side, nose and lips numb on right side." was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of bell''s palsy.Medication is 12 Prednisolone 5mg steroids and eye ointment. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1977368 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood test, Chest X-ray, Chest pain, Decreased appetite, Dizziness, Electrocardiogram, Fatigue, Headache, Malaise, Nausea, Palpitations, Rash, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
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 Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: CXR; Result Unstructured Data: Test Result:Unknown results; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101770396

Write-up: Chest pain; Urticaria; Nausea; Arthralgia; Palpitations; Anorexia; Fatigue; Headache; General feeling of unwell; dizziness; skin rashes; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112101540580870-FLFCT. Other Case identifier(s): GB-MHRA-ADR 26319390. A 39 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FK0596) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient was not pregnant and not breastfeeding at the time of this report. The patient last menstrual date on 05Dec2021. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE;Lot Number: UNKNOWN; Route of Administration: Unspecified; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: RASH (disability, medically significant) with onset 2021, outcome "not recovered", described as "skin rashes"; ARTHRALGIA (disability, medically significant) with onset 20Nov2021, outcome "recovered with sequelae" (2021), described as "Arthralgia"; CHEST PAIN (disability, medically significant) with onset 30Nov2021, outcome "not recovered", described as "Chest pain"; URTICARIA (disability, medically significant) with onset 20Nov2021, outcome "not recovered", described as "Urticaria"; NAUSEA (disability, medically significant) with onset 20Nov2021, outcome "recovering", described as "Nausea"; DECREASED APPETITE (disability, medically significant) with onset 18Nov2021, outcome "recovering", described as "Anorexia"; FATIGUE (disability, medically significant) with onset 17Nov2021, outcome "recovering", described as "Fatigue"; HEADACHE (disability, medically significant) with onset 17Nov2021, outcome "not recovered", described as "Headache"; PALPITATIONS (disability, medically significant) with onset 20Nov2021, outcome "not recovered", described as "Palpitations"; MALAISE (disability, medically significant) with onset 2021, outcome "unknown", described as "General feeling of unwell"; DIZZINESS (disability, medically significant) with onset 2021, outcome "unknown", described as "dizziness". The events "chest pain" and "dizziness" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results; chest x-ray: unknown results; electrocardiogram: unknown results; sars-cov-2 test: no - negative covid-19 test. On 17Nov2021, the patient experienced fatigue and headache; on 18Nov2021 the patient experienced anorexia; on 20Nov2021 the patient experienced arthralgia, urticaria, nausea and palpitations; on 30Nov2021, the patient experienced chest pain; on an unknown date in 2021, the patient experienced skin rashes; all the events were reported as serious for being medically significant and causing disability. On an unknown date in 2021 the patient experienced general feeling of unwell and dizziness. It was reported that on 03Dec2021 the patient attended accident and emergency department (A&E) for chest pain and dizziness. The patient had not tested positive for COVID-19, since having the vaccine. The report was not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1977381 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deafness unilateral, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Hearing impairment (narrow), Medication errors (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: BISOPROLOL; FLECAINIDE; LIXIANA; METFORMINE ALMUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Atrial flutter; Congenital heart disease NOS (repair aged 3, failed in 2018/19); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101770073

Write-up: Off label use; Interchange of vaccine products; Booster; Deafness/went completely deaf in one ear; This is a spontaneous report received from a contactable consumer from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112101641598270-QTF9W. Other Case identifier(s): GB-MHRA-ADR 26319766. A 51-year-old male patient received BNT162B2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 51 years as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Relevant medical history included: "Atrial flutter" (unspecified if ongoing); "congenital heart condition" (unspecified if ongoing), notes: repair aged 3, failed in 2018/19; "full AFib" (unspecified if ongoing); "Type 2 diabetic", start date: 2017 (unspecified if ongoing). Patient has not had symptoms associated with COVID-19, not had a COVID-19 test, is not enrolled in clinical trial. Concomitant medications included: BISOPROLOL, start date: 01Jan2019; Flecainide, start date: 01Nov2019; LIXIANA, start date: 01Jan2019; METFORMINE ALMUS, start date: 01Jan2017. Vaccination history included: COVID-19 VACCINE (dose 1, unknown manufacturer), for COVID-19 immunisation; COVID-19 VACCINE (dose 2, unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; DEAFNESS UNILATERAL (medically significant) with onset 17Nov2021, outcome "recovering", described as "Deafness/went completely deaf in one ear". It was reported that after booster jab, went completely deaf in one ear. This persisted for around 72 hours, when it altered to hearing muffled sound. Presently hearing still affected but described as ''dull'' or ''muffled''. Gradually improving. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1978227 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Anxiety, Diarrhoea, Dizziness, Dysphonia, Dyspnoea, Face oedema, Flushing, Presyncope, Swelling, Taste disorder, Throat tightness, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Pseudomembranous colitis (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101760233

Write-up: Dizziness; Presyncope; Face oedema; Flushing; Still swollen around neck; Throat tightness; Wheezing; Vomiting; diarrhoea; Anaphylactic reaction; funny taste in her mouth; anxiety; hoarse voice; breathing struggles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-049966. A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (medically significant) with onset 17Nov2021 11:45, outcome "recovered" (2021), described as "Dizziness"; PRESYNCOPE (medically significant) with onset 17Nov2021 11:45, outcome "recovered" (2021), described as "Presyncope"; FACE OEDEMA (medically significant) with onset 17Nov2021 11:45, outcome "recovered" (2021), described as "Face oedema"; FLUSHING (medically significant) with onset 17Nov2021 11:45, outcome "recovered" (2021), described as "Flushing"; SWELLING (medically significant) with onset 17Nov2021 11:45, outcome "recovered" (2021), described as "Still swollen around neck "; THROAT TIGHTNESS (medically significant) with onset 17Nov2021 11:45, outcome "recovered" (2021), described as "Throat tightness"; WHEEZING (medically significant) with onset 17Nov2021 11:45, outcome "recovered" (2021), described as "Wheezing"; VOMITING (medically significant) with onset 17Nov2021 11:45, outcome "recovered" (2021), described as "Vomiting"; DIARRHOEA (medically significant) with onset 17Nov2021 11:45, outcome "recovered" (2021), described as "diarrhoea"; ANAPHYLACTIC REACTION (medically significant) with onset 17Nov2021 11:45, outcome "recovered" (2021), described as "Anaphylactic reaction"; TASTE DISORDER (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "funny taste in her mouth"; ANXIETY (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "anxiety"; DYSPHONIA (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "hoarse voice"; DYSPNOEA (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "breathing struggles". The events "dizziness", "presyncope", "face oedema", "flushing", "still swollen around neck ", "throat tightness", "wheezing", "vomiting", "diarrhoea" and "anaphylactic reaction" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of dizziness, presyncope, face oedema, flushing, swelling, throat tightness, wheezing, vomiting, diarrhoea, anaphylactic reaction, taste disorder, anxiety, dysphonia, dyspnoea. Patient reported that 15 minutes after vaccine administration felt dizzy and had a funny taste in her mouth. At home over the next hour developed diarrhoea and vomiting, facial swelling, wheezing, hoarse voice, throat tightness and flushed skin. Wheeze and breathing struggles resolved with 5mg neb adrenaline and 0.5mg IM adrenaline in ambulance and swollen around neck and hoarse voice on arrival to ED. Given further antihistamines and symptoms resolved completely. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1978241 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure, Chest discomfort, Eye pain, Headache, Influenza like illness, Magnetic resonance imaging heart, Musculoskeletal pain, Myocarditis, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Body temperature; Result Unstructured Data: Test Result:Pyrexia; Test Name: cardiac MRI; Result Unstructured Data: Test Result:currently awaiting a cardiac MRI
CDC Split Type: NZPFIZER INC202101760254

Write-up: Cardiac failure; Myocarditis; Chest discomfort; Eye pain; Headache; Influenza like illness; Musculoskeletal pain; Nausea; Pyrexia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority. Regulatory number: AEFI-A-050827 (RA). A 30-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st single dose), for COVID-19 immunization. The following information was reported: CARDIAC FAILURE (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Cardiac failure; MYOCARDITIS (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Myocarditis; CHEST DISCOMFORT (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Chest discomfort; EYE PAIN (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Eye pain; HEADACHE (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Headache; INFLUENZA LIKE ILLNESS (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Influenza like illness; MUSCULOSKELETAL PAIN (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Musculoskeletal pain; NAUSEA (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Nausea; PYREXIA (medically significant) with onset 17Nov2021 20:26, outcome not recovered, described as Pyrexia. The patient underwent the following laboratory tests and procedures: body temperature: (17Nov2021) pyrexia; magnetic resonance imaging heart: (unspecified date) currently awaiting a cardiac MRI. Clinical course: Reporter''s description of AEFI: Fever, headache, sore eyes and nausea started 5 hours after 2nd COVID vaccine on 17/11/21 Experiences sharp central chest pain on 20/11/21 and was brought in by ambulance for further investigations. Found to have new diagnosis heart failure with echo evidence of suspected myocarditis, currently awaiting a cardiac MRI. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1978282 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Anxiety, Burning sensation, Chills, Dizziness, Headache, Influenza like illness, Lethargy, Periorbital oedema, Pruritus, Pyrexia, Rash, Rash pruritic, Swelling, Syncope, Throat tightness, Tremor, Vaccination site pain, Vaccination site rash
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Stevens-Johnson syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101760421

Write-up: very shaky/ full body shivers; very shaky/ full body shivers; Syncope; Abdominal pain; Anxiety; Burning sensation; Dizziness/light headed; Headache; Influenza like illness; Injection site pain; Injection site rash; Lethargy; Periorbital oedema; Pruritus; Pyrexia; Rash; Rash pruritic; Swelling; Throat tightness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient. Regulatory number: AEFI-A-051762. A 51 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "SJS" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Syncope"; ABDOMINAL PAIN (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Abdominal pain"; ANXIETY (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Anxiety"; BURNING SENSATION (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Burning sensation"; DIZZINESS (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Dizziness/light headed"; HEADACHE (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Headache"; INFLUENZA LIKE ILLNESS (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Influenza like illness"; VACCINATION SITE PAIN (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Injection site pain"; VACCINATION SITE RASH (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Injection site rash"; LETHARGY (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Lethargy"; PERIORBITAL OEDEMA (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Periorbital oedema"; PRURITUS (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Pruritus"; PYREXIA (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Pyrexia"; RASH (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Rash"; RASH PRURITIC (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Rash pruritic"; SWELLING (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Swelling"; THROAT TIGHTNESS (medically significant) with onset 17Nov2021 06:00, outcome "recovering", described as "Throat tightness"; TREMOR (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "very shaky/ full body shivers". The patient reported that Have had SJS and it felt very much like another reaction flu like symptoms, excess heat and burning, rash bit and itchy, headache, raised heart rate light headed and very shaky/ full body shivers. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1979738 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-11-17
   Days after vaccination:218
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH E2246 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Anuria, COVID-19, Coronary artery bypass, Dialysis, Electrocardiogram, Physical capacity evaluation, SARS-CoV-2 test, Stenosis, Stent placement, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Other ischaemic heart disease (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atheromatosis; Chronic renal failure; COVID-19; Ischaemic heart disease; Neuropathy (Nephropathy labeled diabetic with LMV hemodialysis CKD. transplant project.); Retinopathy; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: Coronary angiography; Result Unstructured Data: Test Result:15/11; Comments: distal right occlusion not resumed or in any case saph bridge RVG diagonal occlusion II resumed by venous bypass diag subocclusion network CX, good recovery by the marginal AMID bridge + tight stenosis of the entire Common Trunk. Angioplasty success; Test Date: 202109; Test Name: oligo-anuric; Result Unstructured Data: Test Result:300cc/24h; Test Name: Quadruple coronary bypass; Result Unstructured Data: Test Result:IVA / AMIG, first marginal / AMID, diagonal / saph; Test Name: autodialysis; Result Unstructured Data: Test Result:unknown; Test Date: 202005; Test Name: ECG; Result Unstructured Data: Test Result:Normal; Test Date: 20211020; Test Name: Stress ETT; Result Unstructured Data: Test Result:below maximum (90% FMT) positive; Comments: inferolaterbasal, inferobasal and median ischemia and inferositisptobasal, apical, anteroapical, anetroseptobasal; Test Date: 20211119; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Date: 202001; Test Name: left radiocephalic FAV; Result Unstructured Data: Test Result:left radiocephalic FAV created; Test Date: 202110; Test Name: left radiocephalic FAV; Result Unstructured Data: Test Result:dilated stenosis; Test Name: stent; Result Unstructured Data: Test Result:ATL + Active Stent x 2 on TC and proximal IVA
CDC Split Type: FRPFIZER INC202101779556

Write-up: Vaccination failure; SARS-CoV-2 test positive; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority and product quality group. Regulatory number: FR-AFSSAPS-LL20217871 (AFSSAPS). A 70 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 13Apr2021 (Lot number: E2246) as dose 2, single and intramuscular, administration date 16Mar2021 (Lot number: ET3620, Expiration Date: Jun2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing); "Retinopathy" (unknown if ongoing); "Ischaemic heart disease", start date: Mar2018 (unknown if ongoing); "Type 2 diabetes mellitus" (unknown if ongoing); "Chronic renal failure" (unknown if ongoing); "Neuropathy", start date: Feb2020 (unknown if ongoing), notes: Nephropathy labeled diabetic with LMV hemodialysis CKD. transplant project.; "Atheromatosis" (unknown if ongoing). The patient''s concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant) with onset 17Nov2021, outcome "not recovered", described as "Vaccination failure"; COVID-19 (hospitalization, medically significant) with onset 17Nov2021, outcome "not recovered", described as "SARS-CoV-2 test positive". The patient underwent the following laboratory tests and procedures: angiogram: (unspecified date) 15/11, notes: distal right occlusion not resumed or in any case saph bridge RVG diagonal occlusion II resumed by venous bypass diag subocclusion network CX, good recovery by the marginal AMID bridge + tight stenosis of the entire Common Trunk. Angioplasty success; anuria: (Sep2021) 300cc/24h; coronary artery bypass: (unspecified date) iva / amig, first marginal / amid, diagonal / saph; dialysis: (unspecified date) unknown; electrocardiogram: (May2020) normal; physical capacity evaluation: (20Oct2021) below maximum (90% fmt) positive, notes: inferolaterbasal, inferobasal and median ischemia and inferositisptobasal, apical, anteroapical, anetroseptobasal; sars-cov-2 test: (19Nov2021) positive; stenosis: (Jan2020) left radiocephalic fav created; (Oct2021) dilated stenosis; stent placement: (unspecified date) atl + active stent x 2 on tc and proximal iva. Updated information: Expiration date Additional Information: (Root Parent) Description of Complaint: Drug safety QAEF (see attachment) Product quality investigation request vaccine lack of efficacy for Batch/lot number ET3620. FDA 15-day report on QAEF must be checked as NO. Reporter confirmed that it was after the 1st dose that the patient developed the symptoms. Conclusion: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID # (see File attachment in this investigation record). The complaint for adverse event/LOE of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type.The final scope was determined to be the associated lot(s) of the reported lot ET3620. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (Name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1979766 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Ophthalmic herpes zoster
SMQs:, Ocular infections (narrow), Opportunistic infections (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101762291

Write-up: Herpes zoster ophthalmic; received Comirnaty as booster on 17Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from a Regulatory Authority. Regulatory number: FR-AFSSAPS-MA20215567. A 65 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3(booster),single for covid-19 immunisation. 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; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "received Comirnaty as booster on 17Nov2021"; OPHTHALMIC HERPES ZOSTER (medically significant) with onset 25Nov2021, outcome "recovering", described as "Herpes zoster ophthalmic". The event "herpes zoster ophthalmic" was evaluated at the physician office visit. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1979830 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-11-17
   Days after vaccination:98
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Fibrin D dimer, Oxygen saturation, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Arrhythmia; Arterial hypertension; Asthma; Rheumatism; Sarcoidosis
Allergies:
Diagnostic Lab Data: Test Name: D-dimers; Result Unstructured Data: Test Result: Negative; Test Date: 20211122; Test Name: SaO2; Test Result: 85%; Comments: room air; Test Name: COVID serology: Antibody; Result Unstructured Data: Test Result: 86; Comments: unit:86 AU/m; Test Date: 20211122; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result: Positive.
CDC Split Type: FRPFIZER INC202101773495

Write-up: Vaccination failure; COVID-19 pneumonitis/COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the Regulatory Authority. The Regulatory Authority number FR-AFSSAPS-PB20217153. A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 11Aug2021 (Lot number: FA4597) as dose 2, single and administration date 09Jul2021 (Lot number: FA4597) as dose 1, single for covid-19 immunisation. Relevant medical history included Arrhythmia (unspecified if ongoing); Rheumatism (unspecified if ongoing); Sarcoidosis, start date: 2014 (unspecified if ongoing), Lofgren syndrome with episode of erythema nodosum and lymphadenopathy; Arterial hypertension (unspecified if ongoing); Asthma (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported VACCINATION FAILURE (hospitalization) with onset 17Nov2021, outcome not recovered; COVID-19 PNEUMONIA (hospitalization) with onset 17Nov2021, outcome not recovered. The patient was hospitalized for vaccination failure, covid-19 pneumonia (start date: 17Nov2021). The events vaccination failure and covid-19 pneumonitis/covid-19 confirmed by positive covid-19 test were evaluated at the emergency room visit. No immunosuppressive or immunomodulatory treatment. The patient underwent the following laboratory tests and procedures fibrin d dimer: (unspecified date) negative; oxygen saturation: (22Nov2021) 85%, room air; COVID serology: Antibody: (unspecified date) 86, unit: 86 AU/m; COVID-19 PCR test: (22Nov2021) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 pneumonia. The patient was admitted to the emergency room, put on 9L oxygen/min. Introduction of aerosolized bricanyl, terbutaline, and ipratropium + start of IV antibiotic therapy with cefotaxime 1g x 3/d. D-dimers negative. On 27Nov2021, introduction of Tocilizumab 8 mg/kg. General condition improved with oxygen therapy decreased to 9L/min. On 29Nov2021, second dose of tocilizumab 400 mg. On 30Nov2021, oxygen therapy decreased to 4L/min. In total, SarsCOV2 pneumonitis with oxygen therapy up to 11L mn in a 64 year old patient with complete vaccination regimen. Provided investigational results on 15Dec2021 for bnt162b2 included the investigation included reviewing the involved batch records, deviation investigation, and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FA4597. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, and stability. Concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root causes were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1979856 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 PCA0004 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Migraine
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: FRPFIZER INC202101774266

Write-up: Incessant migraines occurring 1 hour after the injection, duration of migraines: 8 days, nights included and not relieved by paracetamol; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the Regulatory Authority-WEB. The reporter is the patient. Regulatory number: FR-AFSSAPS-PO20215618 (RA). A 33-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 17Nov2021 (Lot number: PCA0004) at the age of 33 years as dose 1, 0.3 ml, single for covid-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (medically significant) with onset 17Nov2021, outcome "recovering", described as "Incessant migraines occurring 1 hour after the injection, duration of migraines: 8 days, nights included and not relieved by paracetamol". Therapeutic measures were taken as a result of migraine included paracetamol.


VAERS ID: 1980233 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Cough, Fatigue, Hyperhidrosis, Increased viscosity of upper respiratory secretion, Injection site mass, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (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: COVID-19 VACCINE ASTRAZENECA; FOLIC ACID; HYDROXYCHLOROQUINE; INFLUENZA VIRUS; METHOTREXATE; THYROXINE
Current Illness: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: cough; Sweating; Exhaustion; Shivering; Coughing; Thick nasal mucus; Injection site lump; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26329761) on 14-Dec-2021 and was forwarded to Moderna on 14-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COUGH (cough), INJECTION SITE MASS (Injection site lump), HYPERHIDROSIS (Sweating), FATIGUE (Exhaustion), CHILLS (Shivering), COUGH (Coughing) and INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (Thick nasal mucus) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...). Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) from 2011 to an unknown date for Hypothyroidism, HYDROXYCHLOROQUINE from 2011 to an unknown date and METHOTREXATE from 2011 to an unknown date for Rheumatoid arthritis, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 28-Feb-2021 to an unknown date, FOLIC ACID from 2011 to an unknown date and INFLUENZA VACCINE (INFLUENZA VIRUS) from 17-Nov-2021 to an unknown date for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced INJECTION SITE MASS (Injection site lump) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), COUGH (Coughing) (seriousness criterion medically significant) and INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (Thick nasal mucus) (seriousness criterion medically significant). On an unknown date, the patient experienced COUGH (cough) (seriousness criterion medically significant). On 21-Nov-2021, HYPERHIDROSIS (Sweating) and CHILLS (Shivering) had resolved. On 23-Nov-2021, FATIGUE (Exhaustion) had resolved. At the time of the report, COUGH (cough), INJECTION SITE MASS (Injection site lump), COUGH (Coughing) and INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (Thick nasal mucus) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were provided by the reporter. Patient received a full dose of Moderna. Lump at covid injection site occurred almost immediately. 24 hours after injection exhaustion, mental and physical hit, with shivering, cold but profuse sweating. The thick mucus and hacking cough came next. Nearly a month on, patient still coughs up thick mucus especially in the morning. Patient had a cough and a small lump in arm. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a female patient of an unknown age with no relevant medical history who experienced serious unexpected events of Injection site mass, Increased viscosity of upper respiratory secretion, Hyperhidrosis, Fatigue, Cough and Chills. The events occurred on the same day or one day after the third dose of mRNA-1273. At the time of the report, all the events resolved or were resolving and no further information regarding clinical course of the events was provided. Causality is confounded with concomitant use of Influenza vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event terms, onset dates and outcomes captured per Authority reporting. Event seriousness per overall case assessment by Authority. It should be noted that it was reported that the patient received COVID-19 VACCINE ASTRAZENECA prior to Company product and, therefore, Interchange of vaccine products should have been considered in this particular case.; Sender''s Comments: This case concerns a female patient of an unknown age with no relevant medical history who experienced serious unexpected events of Injection site mass, Increased viscosity of upper respiratory secretion, Hyperhidrosis, Fatigue, Cough and Chills. The events occurred on the same day or one day after the third dose of mRNA-1273. At the time of the report, all the events resolved or were resolving and no further information regarding clinical course of the events was provided. Causality is confounded with concomitant use of Influenza vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event terms, onset dates and outcomes captured per Authority reporting. Event seriousness per overall case assessment by Authority. It should be noted that it was reported that the patient received COVID-19 VACCINE ASTRAZENECA prior to Company product and, therefore, Interchange of vaccine products should have been considered in this particular case.


VAERS ID: 1983058 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain in extremity, Peripheral swelling, SARS-CoV-2 test, Skin warm
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BEZAFIBRATE; CITALOPRAM; GABAPENTIN; LANSOPRAZOL; METOCLOPRAMIDE; NAPROXEN; PARACETAMOL; URSODEOXYCHOLIC ACID; VITAMIN D [COLECALCIFEROL]
Current Illness: Primary biliary cirrhosis
Preexisting Conditions: Medical History/Concurrent Conditions: Gastroesophageal reflux disease; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Liver biopsy (Liver levels high); Prolapsed lumbar disc (L5/S1 prolapsed disc)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Painful arm; Swelling arm; Skin warm; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26331889) on 15-Dec-2021 and was forwarded to Moderna on 15-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), PERIPHERAL SWELLING (Swelling arm) and SKIN WARM (Skin warm) in a 46-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Gastroesophageal reflux disease, Prolapsed lumbar disc (L5/S1 prolapsed disc) and Liver biopsy (Liver levels high). Concurrent medical conditions included Primary biliary cirrhosis and Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). Concomitant products included METOCLOPRAMIDE from 2021 to an unknown date for Acid reflux (oesophageal), CITALOPRAM from 2015 to an unknown date for Depression worsened, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from 2019 to an unknown date for Fatigue, LANSOPRAZOLE (LANSOPRAZOL) from 2014 to an unknown date for Gastroesophageal reflux disease, BEZAFIBRATE from 2019 to an unknown date and URSODEOXYCHOLIC ACID from 2010 to an unknown date for Primary biliary cirrhosis, GABAPENTIN from 2012 to an unknown date, NAPROXEN from 2012 to an unknown date and PARACETAMOL from 2010 to an unknown date for Prolapsed lumbar disc. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant) and SKIN WARM (Skin warm) (seriousness criterion medically significant). On 27-Nov-2021, PAIN IN EXTREMITY (Painful arm), PERIPHERAL SWELLING (Swelling arm) and SKIN WARM (Skin warm) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment Medication use information was not provided by reporter. Patient was Unable to get out of bed for three days as whole body was in pain everywhere. Company Comment: This case concerns a 46 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of pain in extremity, peripheral swelling and skin warm. The events occurred on the same day 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. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 46 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of pain in extremity, peripheral swelling and skin warm. The events occurred on the same day 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. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1983218 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Burning feet syndrome, Burning sensation, Pain in extremity
SMQs:, Peripheral neuropathy (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: BENDROFLUMETHIAZIDE; INFLUENZA VIRUS; LEVOTHYROXINE; LISINOPRIL; NAPROXEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: burning sensation; Leg pain; Burning feet syndrome; This case was received via Regulatory Authority, MHRA (Reference number: GB-MHRA-ADR 26338681) on 16-Dec-2021 and was forwarded to Moderna on 16-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation), PAIN IN EXTREMITY (Leg pain) and BURNING FEET SYNDROME (Burning feet syndrome) in a 66-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 29-Oct-2021 to an unknown date for Flu prevention, BENDROFLUMETHIAZIDE, LEVOTHYROXINE, LISINOPRIL and NAPROXEN for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PAIN IN EXTREMITY (Leg pain) (seriousness criterion medically significant) and BURNING FEET SYNDROME (Burning feet syndrome) (seriousness criterion medically significant). On an unknown date, the patient experienced BURNING SENSATION (burning sensation) (seriousness criterion medically significant). At the time of the report, BURNING SENSATION (burning sensation), PAIN IN EXTREMITY (Leg pain) and BURNING FEET SYNDROME (Burning feet syndrome) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. Post vaccination patient developed leg pain around knee and burning sensation after exercising. And patient was able to walk for couple of hours post vaccination. It was reported that patient had no symptoms associated with COVID-19. Company Comment: This case concerns a 66-year-old female subject, with no medical history reported, who experienced the unexpected and serious events of Burning sensation, Pain in extremity, and Burning feet syndrome. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The events occurred the same day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 66-year-old female subject, with no medical history reported, who experienced the unexpected and serious events of Burning sensation, Pain in extremity, and Burning feet syndrome. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The events occurred the same day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1983529 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Blood test, Decreased appetite, Fatigue, Immunisation, Influenza like illness, Lip swelling, Nausea, Palpitations
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELTROXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: IEPFIZER INC202101782479

Write-up: Decreased appetite; Stomach cramps; Heart Palpations; Nausea; of note Lip swelling; some flu symptoms including fatigue; some flu symptoms including fatigue / bad flu like symptoms; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the WEB. Regulatory number: IE-HPRA-2021-087523 (HPRA). Other Case identifier(s): IE-HPRA-CVARR2021113022942 (HPRA). A 40 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH8469) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ELTROXIN taken for hypothyroidism, start date: 30Sep2010, stop date: 30Nov2021. Vaccination history included: Comirnaty (2ND DOSE, Lot number: EK9788), administration date: 13Jan2021, for COVID-19 Immunisation, reaction(s): "bad flu like symptoms", "heart palpitations"; Covid-19 vaccine (1ST DOSE, MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; DECREASED APPETITE (medically significant) with onset 26Nov2021, outcome "not recovered", described as "Decreased appetite"; ABDOMINAL PAIN UPPER (medically significant) with onset 26Nov2021, outcome "not recovered", described as "Stomach cramps"; PALPITATIONS (medically significant) with onset 26Nov2021, outcome "not recovered", described as "Heart Palpations"; NAUSEA (medically significant) with onset 26Nov2021, outcome "not recovered", described as "Nausea"; LIP SWELLING (medically significant) with onset 26Nov2021, outcome "not recovered", described as "of note Lip swelling"; FATIGUE (medically significant) with onset 26Nov2021, outcome "not recovered", described as "some flu symptoms including fatigue"; INFLUENZA LIKE ILLNESS (medically significant) with onset 26Nov2021, outcome "not recovered", described as "some flu symptoms including fatigue / bad flu like symptoms". The event "heart palpations" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results. Clinical course: The GP did blood test after heart palpitations to rule out ELTROXIN as causative factors for heart palpitations. The patient reported while the reaction experienced is not life threatening, and symptoms were long lasting and would not have had them previously felt it was worth noting. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1983536 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Electrocardiogram abnormal, Heart rate abnormal, Immunisation, Palpitations, Pericarditis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), 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? 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: Medical History/Concurrent Conditions: Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:abnormal; Comments: ECG showed abnormal heart rate. ECG irregularities.
CDC Split Type: IEPFIZER INC202101782463

Write-up: CHEST PAINS; ECG SHOWED ABNORMAL HEART RATE; ECG IRREGULARITIES; PERICARDITIS; SHORTNESS OF BREATH; HEART PALPITATIONS; booster; This is a spontaneous report received from a contactable reporter (consumer) from the regulatory authority-WEB. The reporter is the patient. Regulatory number: IE-HPRA-2021-087601 (HPRA). Other Case identifier: IE-HPRA-CVARR2021120122973 (RA). A 79 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH8469) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing). It was reported that the patient was not taking any concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 17Nov2021, outcome "unknown", described as "booster"; ELECTROCARDIOGRAM ABNORMAL (hospitalization) with onset 21Nov2021, outcome "unknown", described as "ECG IRREGULARITIES"; PERICARDITIS (hospitalization, medically significant) with onset 21Nov2021, outcome "unknown", described as "PERICARDITIS"; DYSPNOEA (hospitalization) with onset 21Nov2021, outcome "unknown", described as "SHORTNESS OF BREATH"; PALPITATIONS (hospitalization) with onset 21Nov2021, outcome "recovered", described as "HEART PALPITATIONS"; CHEST PAIN (hospitalization) with onset 21Nov2021, outcome "unknown", described as "CHEST PAINS"; HEART RATE ABNORMAL (hospitalization) with onset 21Nov2021, outcome "unknown", described as "ECG SHOWED ABNORMAL HEART RATE". The patient was hospitalized for immunisation, electrocardiogram abnormal, pericarditis, dyspnoea, palpitations (start date: 21Nov2021, discharge date: 23Nov2021, hospitalization duration: 2 days. The patient underwent the following laboratory tests and procedures: electrocardiogram (ECG): abnormal, notes: ECG showed abnormal heart rate. ECG irregularities. Clinical course: This report concerned a 79-year-old male who experienced palpitations, dyspnoea, chest pain, heart rate abnormal, electrocardiogram abnormal and pericarditis following vaccination with Comirnaty for COVID-19 immunisation. On 17/Nov/2021, the patient was vaccinated with the booster dose of Comirnaty (batch number: FH8469). Within 72 hours following vaccination, on 21/Nov/2021, the patient experienced heart palpitations, shortness of breath and chest pains. The patient was hospitalised where electrocardiogram showed abnormal heart rate. The patient was discharged after 36 hours and further tests were arranged as an outpatient. The duration of the reaction was reported as 48 hours. The patient reported that the cardiologist believes that the ECG irregularities and the pericarditis was directly related to the vaccine. At the time of reporting, the patient''s outcome was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1983553 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Immunisation, Insomnia, Interchange of vaccine products, Nervous system disorder, Off label use, Rash, Rash pruritic, Tension
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METHOTREXATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Leukaemia (Recovering from leukaemia and a stem cell transplant); Prophylactic; Stem cell transplant (Recovering from leukaemia and a stem cell transplant)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101774322

Write-up: MY NERVOUS SYSTEM FEELS ON EDGE MAKING IT DIFFICULT TO RELAX; INCAPACITATES ME AS I AM EXHAUSTED AND NEED TO BE ABLE TO SLEEP TO ENHANCE MY OVERALL RECOVERY; SEVERE INSOMNIA / WITH A SLEEPING TABLET GET ABOUT SIX HOURS SLEEP WHICH IS NOT ENOUGH; FACIAL SKIN RASH / FACIAL RASH RED SPOTS IN GROUPS AND ALSO SINGLE SPOTS WHICH ARE SLIGHTLY SORE AND IT HY; INCAPACITATES ME AS I AM EXHAUSTED AND NEED TO BE ABLE TO SLEEP TO ENHANCE MY OVERALL RECOVERY; MY NERVOUS SYSTEM FEELS ON EDGE MAKING IT DIFFICULT TO RELAX; FACIAL RASH RED SPOTS IN GROUPS AND ALSO SINGLE SPOTS WHICH ARE SLIGHTLY SORE AND IT HY; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from the WEB. The reporter is the patient. Regulatory number: IE-HPRA-2021-087774 (HPRA). Other Case identifier(s): IE-HPRA-CVARR2021120523052 (HPRA). A 61-year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH8469) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Leukaemia" (unspecified if ongoing), notes: Recovering from leukaemia and a stem cell transplant; "Stem cell transplant" (unspecified if ongoing), notes: Recovering from leukaemia and a stem cell transplant; "Prophylactic" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE taken for prophylaxis, start date: 05Nov2021. Vaccination history included: Vaxzevria (Batch/lot number ANV6514, Dosage text First dose, Pharmaceutical form (Dosage form) Suspension for injection), administration date: 12Mar2021, for COVID-19 immunisation; Covid-19 vaccine (dose 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (disability) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 17Nov2021, outcome "unknown", described as "Booster"; NERVOUS SYSTEM DISORDER (non-serious), TENSION (disability) all with onset 19Nov2021, outcome "not recovered" and all described as "MY NERVOUS SYSTEM FEELS ON EDGE MAKING IT DIFFICULT TO RELAX"; FATIGUE (disability), ASTHENIA (disability) all with onset 19Nov2021, outcome "not recovered" and all described as "INCAPACITATES ME AS I AM EXHAUSTED AND NEED TO BE ABLE TO SLEEP TO ENHANCE MY OVERALL RECOVERY"; INSOMNIA (disability) with onset 19Nov2021, outcome "not recovered", described as "SEVERE INSOMNIA / WITH A SLEEPING TABLET GET ABOUT SIX HOURS SLEEP WHICH IS NOT ENOUGH"; RASH (disability) with onset 19Nov2021, outcome "not recovered", described as "FACIAL SKIN RASH / FACIAL RASH RED SPOTS IN GROUPS AND ALSO SINGLE SPOTS WHICH ARE SLIGHTLY SORE AND IT HY"; RASH PRURITIC (non-serious) with onset 19Nov2021, outcome "not recovered", described as "FACIAL RASH RED SPOTS IN GROUPS AND ALSO SINGLE SPOTS WHICH ARE SLIGHTLY SORE AND IT HY". Therapeutic measures were taken as a result of insomnia, rash, rash pruritic. Clinical Course: Patient received the treatment for sleeping tablets for insomnia. Oral antibiotics for rash. Antibiotics no names or dosage reported for these medications. Patient reports it incapacitates them as they were exhausted and need to be able to sleep to enhance their overall recovery. Without a sleeping tablet they can only manage about three hours sleep and they are normally able to sleep for eight hours. With a sleeping tablet they get about six hours sleep which is not enough. According to patient reaction was not serious but extremely unpleasant and they are not happy having to take more medication to treat it. They report they have not had Covid, and the problems started after their Pfizer booster jab. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : IE-HPRA-2021-087782


VAERS ID: 1983599 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Diastolic hypertension, Echocardiogram, Electrocardiogram ambulatory, Headache, Lymphadenitis, Lymphadenopathy, Pharyngeal oedema, Systolic hypertension, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
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 Name: blood pressure; Result Unstructured Data: Test Result:unknown results; Test Name: echocardiogram; Result Unstructured Data: Test Result:unknown results; Test Name: 24h Holter; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101777474

Write-up: severe systolic / diastolic hypertension; severe systolic / diastolic hypertension; throat edema; severe headache; neck lymph node inflammation; swollen lymph node; vomiting; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority-WEB. Regulatory number: IT-MINISAL02-818492 (MINISAL02). A 37 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DIASTOLIC HYPERTENSION (disability), SYSTOLIC HYPERTENSION (disability) all with onset 17Nov2021, outcome "not recovered" and all described as "severe systolic / diastolic hypertension"; PHARYNGEAL OEDEMA (disability) with onset 17Nov2021, outcome "not recovered", described as "throat edema"; HEADACHE (disability) with onset 17Nov2021, outcome "not recovered", described as "severe headache"; LYMPHADENITIS (disability) with onset 17Nov2021, outcome "not recovered", described as "neck lymph node inflammation"; LYMPHADENOPATHY (disability) with onset 17Nov2021, outcome "not recovered", described as "swollen lymph node"; VOMITING (disability) with onset 17Nov2021, outcome "not recovered", described as "vomiting". The events "severe systolic / diastolic hypertension", "severe systolic / diastolic hypertension", "throat edema", "severe headache", "neck lymph node inflammation", "swollen lymph node" and "vomiting" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: unknown results; echocardiogram: unknown results; electrocardiogram ambulatory: unknown results. Therapeutic measures were taken as a result of headache, diastolic hypertension, systolic hypertension, vomiting with treatment Captopril 25mg; pharyngeal oedema with treatment 2 mg of bentelan and 20 guttae zirtec; lymphadenitis, lymphadenopathy with treatment ibuprofen morning and evening and 20 guttae zirtec for 5 days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1985373 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-13
Onset:2021-11-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Myoclonus, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (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: ATPFIZER INC202101809610

Write-up: Chills; Paresthesia in extremities; Myoclonia, finger twitching; Headache; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB. Regulatory number: AT-BASGAGES-2021-064964. A 42 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 13Nov2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Chills"; HEADACHE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Headache recurrent"; PARAESTHESIA (medically significant) with onset 18Nov2021, outcome "recovering", described as "Paresthesia in extremities"; MYOCLONUS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Myoclonia, finger twitching". On 05Dec, the patient still constant complainted. Headache recurring. Updated on 14Dec2021: Myoclonia refered to finger twitching. Paraesthesias were in slight improvement since last week. If symptoms do not resolve, the physician will refer patient to neurologist and follow up with any findings. Relatedness of drug to reaction(s)/event (s) Source of assessment Health Care Professional. Method of assessment WHO Assessment. Result of Assessment Probable/Likely (Headache recurrent) (Paraesthesia of limbs). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1985528 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-09
Onset:2021-11-17
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Chest pain, Clumsiness, Dizziness, Facial paralysis, Fatigue, Headache, Heart rate increased, Insomnia, Lymph node pain, Lymphadenopathy, Pain in extremity, Palpitations
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hearing impairment (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: PERINDOPRIL; PANTOPRAZOLE; TADALAFIL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101790006

Write-up: Facial paralysis; Abdominal pain; Chest pain; Clumsiness; Dizziness; Fatigue; Headache; Heart rate increased; Insomnia; Lymph node pain; Lymphadenopathy; Pain in extremity; Palpitations; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 679053 Agency Regulatory Authority. A 45 year-old male patient received bnt162b2 (COMIRNATY), administration date 09Nov2021 (Batch/Lot number: unknown) as dose 2, signle for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: PERINDOPRIL; PANTOPRAZOLE; TADALAFIL. Vaccination history included: Comirnaty (first dose), administration date: 19Oct2021, for COVID-19 immunisation. The following information was reported: FACIAL PARALYSIS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Facial paralysis"; ABDOMINAL PAIN (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Abdominal pain"; CHEST PAIN (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Chest pain"; CLUMSINESS (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Clumsiness"; DIZZINESS (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Dizziness"; FATIGUE (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Fatigue"; HEADACHE (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Headache"; HEART RATE INCREASED (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Heart rate increased"; INSOMNIA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Insomnia"; LYMPH NODE PAIN (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Lymph node pain"; LYMPHADENOPATHY (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Lymphadenopathy"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Pain in extremity"; PALPITATIONS (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Palpitations". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1985577 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Chills, Electrocardiogram, Myocarditis, Troponin T, Troponin T increased
SMQs:, Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APOHEALTH IBUPROFEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:unknown results; Test Date: 20211117; Test Name: Troponin T; Result Unstructured Data: Test Result:increased
CDC Split Type: AUPFIZER INC202101790354

Write-up: Myocarditis; Chest pain; Chills; Troponin T increased; This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: 680386 (TGA). A 13-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication included: APOHEALTH IBUPROFEN. The following information was reported: MYOCARDITIS (medically significant) with onset 17Nov2021, outcome "recovered", described as "Myocarditis"; CHEST PAIN (medically significant) with onset 17Nov2021, outcome "recovered", described as "Chest pain"; CHILLS (non-serious) with onset 17Nov2021, outcome "recovered", described as "Chills"; TROPONIN T INCREASED (non-serious) with onset 17Nov2021, outcome "recovered", described as "Troponin T increased". The patient underwent the following laboratory tests and procedures: electrocardiogram: (17Nov2021) unknown results; troponin t: (17Nov2021) increased. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1986070 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-02
Onset:2021-11-17
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Sjogren's syndrome
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Lacrimal disorders (narrow), Immune-mediated/autoimmune disorders (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: Syndrome sicca
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101808665

Write-up: Syndrome sicca; Disease aggravation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-LY202112803 (RA). A 45-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 02Nov2021 (Lot number: FG7387) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Syndrome sicca", start date: 2014 (ongoing). The patient''s concomitant medications were not reported. The following information was reported: SJOGREN''S SYNDROME (medically significant) with onset 17Nov2021, outcome "recovered" (25Nov2021), described as "Syndrome sicca"; CONDITION AGGRAVATED (non-serious) with onset 17Nov2021, outcome "recovered" (25Nov2021), described as "Disease aggravation". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1986216 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Bell's palsy, Headache
SMQs:, Guillain-Barre syndrome (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ACICLOVIR; AZATHIOPRINE; CO-CODAMOL; PREDNISOLON [PREDNISOLONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s disease; Eczema
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101788825

Write-up: Paralysis in one side of face; Severe pain in back of head; Feeling of total lack of energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-EYC 00268811 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26320922 (MHRA). A 41 year-old male patient received bnt162b2 (COMIRNATY), parenteral, administration date 10Nov2021 (Lot number: FK0596) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Crohn''s disease" (unknown if ongoing); "Eczema" (unknown if ongoing); have been taking medication for both conditions. Concomitant medication(s) included: ACICLOVIR; AZATHIOPRINE; CO-CODAMOL; PREDNISOLON [PREDNISOLONE]. The following information was reported: BELL''S PALSY (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Paralysis in one side of face"; ASTHENIA (disability, medically significant) with onset 17Nov2021, outcome "not recovered", described as "Feeling of total lack of energy"; HEADACHE (disability, medically significant) with onset 22Nov2021, outcome "not recovered", described as "Severe pain in back of head". Therapeutic measures were taken as a result of bell''s palsy, asthenia, headache. Contacted general practitioner (GP) on 22Nov2021 who prescribed antibiotic for ear infection. Taken to accidents and emergencies (A&E), diagnosed with Bells Palsy. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1986227 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest discomfort, Crohn's disease, Diarrhoea, Fatigue, Headache, Immunisation, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Gastrointestinal premalignant disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SALAZOPYRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Crohn''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101796934

Write-up: I suffer with crohn''s and it triggered a flare up; Fatigue; Aching muscles; Diarrhoea; Aching joints/Sore joints; Headache; Chest discomfort/A bad chest; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-EYC 00268995. Other Case identifier(s): GB-MHRA-ADR 26328627. A 71 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Crohn''s disease" (unspecified if ongoing); "COPD" (unspecified if ongoing). Concomitant medication(s) included: SALAZOPYRIN taken for crohn''s disease; STEROID taken for Chronic obstructive pulmonary disease and BLOOD PRESSURE MEDICATION taken for an unknown indication. Vaccination history included: COVID-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; COVID-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "Booster"; CROHN''S DISEASE (medically significant) with onset 17Nov2021, outcome "recovering", described as "I suffer with crohn''s and it triggered a flare up"; FATIGUE (medically significant) with onset 17Nov2021, outcome "recovering", described as "Fatigue"; MYALGIA (medically significant) with onset 17Nov2021, outcome "recovering", described as "Aching muscles"; DIARRHOEA (medically significant) with onset 17Nov2021, outcome "recovering", described as "Diarrhoea"; ARTHRALGIA (medically significant) with onset 17Nov2021, outcome "recovering", described as "Aching joints/Sore joints"; HEADACHE (medically significant) with onset 17Nov2021, outcome "recovering", described as "Headache"; CHEST DISCOMFORT (medically significant) with onset 17Nov2021, outcome "recovering", described as "Chest discomfort/A bad chest". Clinical course: Patient got those symptoms was not so good aching, sore joints ,aching muscles, headache fatigue. She suffered with crohnes and it triggered a flare up and a bad chest. It is now the 13Dec2021 had it done on the 17Nov2021 it is not as bad now they were having some good days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1986667 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation
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: Medical History/Concurrent Conditions: Multiple sclerosis (Multiple Sclerosis (MS) diagnosed 1989. Stable)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101796660

Write-up: Fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112141728569980-SKTZG. Other Case identifier(s): GB-MHRA-ADR 26334106. A 61 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing), notes: Multiple Sclerosis (MS) diagnosed 1989. Stable, no disease modifying drugs prescribed since diagnosis. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation, reaction(s): "Fatigue". The following information was reported: FATIGUE (medically significant) with onset 19Nov2021, outcome "recovered with sequelae", described as "Fatigue"; IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster". Severe MS related fatigue following the booster vaccination. It was very similar to the reaction that patient reported here following her second dose. Very, very tired and unable to do things she normally does. This time it lasted approx. 2 weeks vs 2 months for the second dose. No other MS symptoms appeared and she received no treatment other than rest until she was mostly able to function again. She still get fatigue that is unusual for her, from time to time, but it is no longer continuous. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1987220 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (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: Allergic rhinitis (Allergic rhinitis)
Preexisting Conditions: Comments: Allergic rhinitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRJNJFOC20211249951

Write-up: TINNITUS; This spontaneous report received from a consumer by a Regulatory Authority (regulatory authority, HR-HALMED-300052859) on 22-DEC-2021 concerned a 29 year old. The patient''s weight was 60 kilograms, and height was not reported. The patient''s concurrent conditions included: allergic rhinitis, and other pre-existing medical conditions included: Allergic rhinitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 0.5 ml, (dose number in series was 1), frequency time was 01 day administered on 2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 17-NOV-2021, the patient experienced tinnitus (ear ringing) (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus. This report was serious (Other Medically Important Condition).


VAERS ID: 1987285 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1005A / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Chest pain, Headache, Immunisation, Oropharyngeal pain, Quality of life decreased, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Epilepsy; Hairy cell leukaemia (Diagnosis 05/2012)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101785724

Write-up: This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: IT-MINISAL02-819271 (MINISAL02). A 53 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 17Nov2021 09:29 (Lot number: 1F1005A, Expiration Date: 31Mar2022) as dose 3 (booster), 0.3 ml single for COVID-19 immunisation. Relevant medical history included: "Hairy cell leukaemia" (unknown if ongoing), notes: Diagnosis 05/2012; "Depression" (unknown if ongoing); "Epilepsy" (unknown if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, SINGLE, Batch No:EW6327, Expiry date: 31Jul2021, Anatomical location: Left deltoid, Route of administration: Intramuscular), administration date: 30Apr2021, for COVID-19 immunisation; Comirnaty (DOSE 2, SINGLE, 0.45mL, Batch/Lot number: FA4598, Expiry date: 31Aug2021 , Anatomical location: Left deltoid, Route of administration: Intramuscular), administration date: 21May2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; ARTHRALGIA (medically significant) with onset 18Nov2021, outcome "recovering", described as "Arthralgia"; SEIZURE (medically significant) with onset 18Nov2021, outcome "recovering", described as "Convulsions"; ASTHENIA (medically significant) with onset 18Nov2021, outcome "recovering", described as "Weakness"; OROPHARYNGEAL PAIN (medically significant) with onset 18Nov2021, outcome "recovering", described as "Sore throat"; HEADACHE (medically significant) with onset 18Nov2021, outcome "recovering", described as "Headache"; CHEST PAIN (medically significant) with onset 18Nov2021, outcome "recovering", described as "Pain chest"; QUALITY OF LIFE DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Reduced quality of life (no further info)". Reporter Comment: Other relevant medical information: May2012 diagnosis of hairy cell leukemia, epilepsy, depression Other Drugs taken: none No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Reporter comment: Other relevant medical information: May2012 diagnosis of hairy cell leukemia, epilepsy, depression Other Drugs taken: none


VAERS ID: 1987689 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-11-17
   Days after vaccination:212
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: PTPFIZER INC202101808398

Write-up: Drug ineffective; SARS-CoV-2 infection; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202111-2360 (RA). A 91 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Apr2021 (Lot number: ER7812) as dose 1, 0.3ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 17Nov2021, outcome "unknown", described as "SARS-CoV-2 infection". Additional information included: The reporter''s assessment of the causal relationship of the [Drug Ineffective, COVID-19] with the suspect product was: Source of assessment: Reporter, Method of assessment: Unknown, Result of Assessment: Possible. Case was not serious and complete vaccination schedule was not known. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1987712 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-11-17
   Days after vaccination:103
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Test Date: 20211117; Test Name: Covid-19 PCR; Test Result: Positive
CDC Split Type: PTPFIZER INC202101826271

Write-up: Drug ineffective; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-1898 (INFARMED). A 38 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 06Aug2021 (Lot number: FG4442) as dose 2, 0.3 ml single and intramuscular, administration date 09Jul2021 (Lot number: FE1573) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 17Nov2021, outcome "recovered" (2021), described as "Drug ineffective"; COVID-19 (medically significant) with onset 17Nov2021, outcome "recovered" (2021), described as "Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Reporter Comment: Other information- POSITIVE CASE WIFE Onset of symptoms on 16Nov2021 - Cough, nasal obstruction, tiredness, diarrhea Covid PCR Test + on 17Nov2021 No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information- POSITIVE CASE WIFE Onset of symptoms on 16Nov2021 - Cough, nasal obstruction, tiredness, diarrhea Covid PCR Test + on 17Nov2021


VAERS ID: 1987757 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-11-17
   Days after vaccination:90
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004670 / 1 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 2: FJ8372 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad), 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: Common cold
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20214

Write-up: Cardiac muscle inflammation; This case was received via regulatory authority (Reference number: SE-MPA-2021-094740) on 10-Dec-2021 and was forwarded to Moderna on 10-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDITIS (Cardiac muscle inflammation) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004670) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) concentrate for solution for injection for an unknown indication. Concurrent medical conditions included Common cold. On 19-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Nov-2021, the patient started TOZINAMERAN (COMIRNATY) (unknown route) Dose 2. On 17-Nov-2021, the patient experienced MYOCARDITIS (Cardiac muscle inflammation) (seriousness criterion hospitalization). At the time of the report, MYOCARDITIS (Cardiac muscle inflammation) was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No Concomitant medication provided. No treatment medication reported. Company comment: This case concerns an 18-year-old male patient, with no relevant medical history, who experienced the serious expected event of Myocarditis which lead to hospitalization. The patient had 2 different Covid-19 vaccines, first dose was mRNA 1273 Covid-19 vaccine, 78 days after, received second dose using the Comirnaty Covid-19 vaccine. The event occurred 2 months after the mRNA 1273 vaccine, and 13 days after the Comirnaty vaccine. Information on clinical course or diagnostics were not provided. The strong temporal relation of the event to the Comirnaty vaccine remains as a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns an 18-year-old male patient, with no relevant medical history, who experienced the serious expected event of Myocarditis which led to hospitalization. The patient had 2 different Covid-19 vaccines, first dose was mRNA 1273 Covid-19 vaccine, 78 days after, received second dose using the Comirnaty Covid-19 vaccine. The event occurred 2 months after the mRNA 1273 vaccine, and 13 days after the Comirnaty vaccine. Information on clinical course or diagnostics were not provided. The strong temporal relation of the event to the Comirnaty vaccine remains as a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 1987836 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Amnesia, Blood pressure measurement, Blood test, Body temperature, Coma scale, Computerised tomogram head, Heart rate, Magnetic resonance imaging head, Oxygen saturation, Respiratory rate, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Blood pressure; Result Unstructured Data: Test Result:141/72 mmHg; Test Date: 20211117; Test Name: Blood test; Result Unstructured Data: Test Result:normal; Test Date: 20211117; Test Name: Body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Test Date: 20211117; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:E4V5M6; Test Date: 20211117; Test Name: Brain CT; Result Unstructured Data: Test Result:normal, no skull internal bleeding; Test Date: 20211117; Test Name: Pulse rate; Result Unstructured Data: Test Result:72 {beats}/min; Test Date: 20211119; Test Name: Magnetic resonance imaging brain; Result Unstructured Data: Test Result:normal; Test Date: 20211117; Test Name: Oxygen saturation; Test Result: 100 %; Test Date: 20211117; Test Name: Respiratory rate; Result Unstructured Data: Test Result:18 {breaths}/min
CDC Split Type: TWPFIZER INC202101854414

Write-up: SYNCOPE; 8 hours of memory was blank; This is a spontaneous report received from non-contactable healthcare professional from License Party(BioNTech SE) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100013811 (RA). Other Case identifier(s): TW-Fosun-2021FOS006814 (Fosun). This is a spontaneous report received from a non-contactable HCP received via RA. The regulatory authority report number is TW-TFDA-TVS-1100013811. A 37-year-old male patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 17-Nov-2021 via intramuscular at an unknown dose with unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history was not reported. Concomitant medications and past product were not reported. The patient experienced Syncope on 17-Nov-2021. At 19:30 of 17-Nov-2021, due to sudden lost awareness and fainting, the patient was taken to the emergency of hospital, in the emergency, the life signs showed: blood pressure: 141/72 mmHg; pulse rate: 72 times/min; body temperature: 37.2 �C; Respiratory Rate: 18 times/min; Glasgow Coma Scale : E4V5M6; blood oxygen concentration: 100%. The patient had no memory since 2 pm of 17-Nov-2021 until 3 am (8 hours of memory was blank). Brain CT, blood test and lab data were normal, no skull internal bleeding. On 18-Nov-2021, due to stable condition, the patient was discharged. On 19-Nov-2021, Brain Magnetic Resonance Imaging (MRI) was normal. Syncope met the seriousness criterion of Other Medically Important Condition. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was recovering. The patient was discharged on 18-Nov-2021. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. The reporter and BioNTech SE both considered Relatedness of drug to the event Syncope was Possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE.


VAERS ID: 1987839 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-23
Onset:2021-11-17
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Test Name: blood test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: TWPFIZER INC202101854411

Write-up: CHEST PAIN; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from License Party (BioNTech SE) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100013815 (Regulatory Authority). Other Case identifier(s): TW-Fosun-2021FOS006827 . This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100013815. A 31-year-old female patient started to receive a dose of Tozinameran (COMIRNATY) (batch number was not reported) on 23-Oct-2021 via unknown route at an unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history was not reported. Concomitant medications and past product were not reported. The patient experienced chest pain on 17-Nov-2021. At 08:54 of 17-Nov-2021, the patient suffered from intermittent chest pain without diaphoresis and shortness of breath (SOB) after the BNT vaccination. AlPrazolam Oral was given, physician saw blood test, and the patient could be discharged. Chest pain met the seriousness criterion of Hospitalisation. At the time of the report, the outcome of the event was recovering. The patient was discharged on an unknown date. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. The reporter and BioNTech SE both considered Relatedness of drug to the event chest pain was Possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE


VAERS ID: 1987856 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-29
Onset:2021-11-17
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood pressure measurement, Body temperature, Brain natriuretic peptide, C-reactive protein, Coma scale, Dyspnoea, Heart rate, Nausea, Oxygen saturation, Respiratory rate, Troponin I, Vomiting, White blood cell count
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Creatinine; Test Result: 0.73 mg/dl; Test Date: 20211117; Test Name: Blood pressure; Result Unstructured Data: Test Result:85/61 mmHg; Test Date: 20211117; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20211117; Test Name: Brain natriuretic peptide; Result Unstructured Data: Test Result:18.0 pg/mL; Test Date: 20211117; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:E4V5M6; Test Date: 20211117; Test Name: C-reactive protein; Result Unstructured Data: Test Result:1.61 mg/l; Test Date: 20211117; Test Name: Heart rate; Result Unstructured Data: Test Result:107; Comments: Units: {beats}/min; Test Date: 20211117; Test Name: O2 saturation; Test Result: 100 %; Test Date: 20211117; Test Name: Respiratory rate; Result Unstructured Data: Test Result:18; Comments: Units: {breaths}/min; Test Date: 20211117; Test Name: Troponin I; Result Unstructured Data: Test Result:0.0096 ng/ml; Test Date: 20211117; Test Name: White blood cells; Result Unstructured Data: Test Result:8.76 x10 3/mm3
CDC Split Type: TWPFIZER INC202101842314

Write-up: VOMIT; DIFFICULTY BREATHING; NAUSEA; This is a spontaneous report received from a non-contactable healthcare professional from Regulatory Authority, via License Party (BioNTech SE). Regulatory number: TW-TFDA-TVS-1100014540 (RA). Other Case identifier: TW-Fosun-2021FOS006883 (Fosun). This is a spontaneous report received from a non-contactable HCP received via RA. The regulatory authority report number is TW-TFDA-TVS-1100014540. A 27-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number was not reported) on 29-Oct-2021 via intramuscular at 0.3 ml with unspecified dosing frequency for COVID-19 immunization. No Medical history and adverse reaction medication history were reported. Concomitant medication and past product were not reported. The patient experienced vomit, difficulty breathing and nausea on 17-Nov-2021. On 29-Oct-2021, the patient received the inoculation of BNT vaccine. On 17-Nov-2021, the patient came to the hospital for emergency treatment, mainly complained that she couldn''t breathe and spit. The physician was diagnosed with sudden onset of dyspnea, nausea and vomiting once, no chest pain or cold sweating. After the doctor''s diagnosis, medical advice was given (needle) Diphenhydramine 1 AMP, AQ DEST 20 ml St IVP and Sodium Chloride 0.9% 500 ml St IVD. Life signs: Glasgow coma scale (GCS): E4V5M6; Blood pressure (BP): 85/61 mmHg; Heart Rate (HR): 107 times/min; Respiratory rate (RR): 18 times/min; Body temperature (BT): 36.5 degree celsius; O2 saturation (SPO2): 100%; White blood cells (WBC): 8.76x1000/UL; Brain natriuretic peptide (BNP): 18.0pg/ml; (Tropo-i): 0.0096 ng/ml; C-reactive protein (CRP): (quantification): 1.61 mg/L; Creatinine: 0.73 mg/dl. After the diagnosis, the patient''s condition was stabilized and adjusted. The physician notified the vaccine of adverse reactions. Vomit, difficulty breathing, and nausea met the seriousness criterion of Other Medically Important Condition. At the time of the report, the outcomes of the events were unknown. Initial report was received on 15-Dec-2021. Follow-up closed; no further information is possible. Causality Assessments Vomiting, Difficulty breathing, Nausea Per Reporter = Possible Per Company (BioNTech SE) = Possible? Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 1987887 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN ACA5778 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Deafness unilateral, Fatigue, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hearing impairment (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: Comments: None
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: Body temperature; Result Unstructured Data: 38.7 C.
CDC Split Type: HRJNJFOC20211255650

Write-up: CHRONIC FATIGUE LASTING 7 DAYS STILL FEELING TIRED; FEVER UP TO 38.7�C; HEARING PROBLEMS IN THE LEFT EAR; This spontaneous report received from a physician by a Regulatory Authority (EVHUMAN Vaccines, HR-HALMED-300052919) on 24-DEC-2021 and concerned a 39 year old male of unspecified race and ethnicity. The patient''s weight was 85 kilograms, and height was not reported. The patient''s pre-existing medical conditions included: None. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: ACA5778 expiry: UNKNOWN)0.5 ml, dose number in series was 1, administered 1 in days on 16-NOV-2021 for covid-19 vaccination. The duration of drug administered was 1 days. No concomitant medications were reported. On NOV-2021, Laboratory data included: Body temperature (NR: 36 - 37) 38.7 C. On 17-NOV-2021, the patient experienced chronic fatigue lasting 7 days still feeling tired, fever up to 38.7�c, and hearing problems in the left ear (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hearing problems in the left ear, had not recovered from chronic fatigue lasting 7 days still feeling tired, and the outcome of fever up to 38.7�c was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1987952 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain upper, Liver function test, Muscular weakness, Nausea, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic hepatitis B
Allergies:
Diagnostic Lab Data: Test Date: 20211127; Test Name: Liver function tests; Result Unstructured Data: Test Result:1000
CDC Split Type: TWPFIZER INC202101855187

Write-up: NAUSEA; VOMIT; STOMACHACHE; SYNCOPE; LIMB WEAKNESS; ABDOMINAL PAIN; ABDOMINAL FULLNESS; This is a spontaneous report received from a non-contactable healthcare professional from Regulatory Authority, via License Party (BioNTech SE). Regulatory number: TW-TFDA-TVS-1100014703. Other Case identifier: TW-Fosun-2021FOS007024. This is a spontaneous report received from a non-contactable HCP received. The regulatory authority report number is TW-TFDA-TVS-1100014703. A 40-year-old male patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 16-Nov-2021 via unknown route as dose 2, single for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history included a previous history of chronic hepatitis B. Concomitant medication and past product were not reported. The patient experienced nausea, vomit, stomachache, syncope, limb weakness, abdominal pain, and abdominal fullness on 17-Nov-2021. On 16-Nov-2021, the patient received 2nd dose of BNT vaccine. On 17-Nov-2021, the patient had abdominal pain and abdominal fullness for days. Nausea, vomit, stomachache, syncope, and limb weakness were also reported. The patient had taken medicine for treatment. Abdominal pain and abdominal symptoms were relived during follow-up. In the night of 27-Nov-2021, the patient went to the emergency for medical treatment, the patient had been hospitalized, and the liver index rose to 1000. Nausea, vomit, stomachache, syncope, limb weakness, abdominal pain and abdominal fullness met the seriousness criterion of hospitalisation. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed; no further information is possible. Causality Assessments: Nausea, Vomiting, Stomachache, Syncope, Weakness of limbs, Abdominal pain, Abdominal fullness Per Reporter was Possible, Per Company (BioNTech SE) was Possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE.


VAERS ID: 1987957 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hemiparesis
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101848539

Write-up: DIZZINESS; WEAKNESS OF LEFT SIDE OF THE LIMBS; This is a spontaneous report received from non-contactable healthcare professional from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100013743 Disease Control. Other Case identifier: TW-Fosun-2021FOS007034. This is a spontaneous report received from a non-contactable HCP received via Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100013743. A 60-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number was not reported) on 10-Nov-2021 via intramuscular at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history was not reported. Concomitant medication and past product were not reported. The patient experienced dizziness, weakness of left side of the limbs on 17-Nov-2021. On 17-Nov-2021, the patient went to the emergency room of a hospital due to dizziness and weakness of left side of the limbs after vaccination. The patient was arranged for hospitalization. Dizziness, weakness of left side of the limbs met the seriousness criterion of Hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1988016 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Chest X-ray, Computerised tomogram head, Electrocardiogram, Interchange of vaccine products, Muscular weakness, Off label use
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (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), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Medication errors (broad)

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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Nasal sinus cancer; Pituitary tumour
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Chest X-ray; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20211119; Test Name: Brain CT; Result Unstructured Data: Test Result:no intracranial haemorrhage (ICH); Comments: no intracranial haemorrhage (ICH),hypodense lesion at right internal capsule and corona radiata, calcification over bilateral basal ganglion; Test Date: 20211119; Test Name: EKG; Result Unstructured Data: Test Result:sinus rhythm (SR)
CDC Split Type: TWPFIZER INC202101855496

Write-up: LEFT LIMB WEAKNESS; STROKE; OFF LABEL USE; INTERCHANGE OF VACCINE PRODUCTS; This is a spontaneous report received from non-contactable reporter (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100013963. Other Case identifier(s): TW-Fosun-2021FOS007146. This is a spontaneous report received from a non-contactable HCP received via a regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100013963. A 58-year-old female patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 17Nov2021 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history includes diabetes, pituitary tumors and sinus cancer. Concomitant medication was not reported, past product included one dose of AstraZeneca COVID-19 vaccine received on an unknown date(interchange of vaccine products, off label use). The patient experienced left limb weakness and stroke on 18Nov2021. On an unknown date, the patient was given first dose of AstraZeneca COVID-19 vaccine. It was reported that the AZ vaccine caused blood plug. On 18Nov2021, the patient was found left limb weakness, left face was skewed and the speech was not clear. On 19Nov2021, the patient was sent to the emergency department for treatment. The Brain CT results showed: No Intracranial haemorrhage (ICH), hypodense lesion at right internal capsule and corona radiata, calcification over bilateral basal ganglion; 12 Lead Electrocardiogram (EKG): Sinus rhythm (SR); chest X-ray: no abnormalities. Stroke was suspected, and the patient was given normal saline (N / S) 500ml 1bot IVD, Bokey 3TAB, STROCAINE 1TAB ST PO. Later, the patient was admitted to the hospital for detailed inspection by the physician assessment. On 22Nov2021, the patient was receiving high medical treatment in hospital. Left limb weakness and stroke met the seriousness criterion of Hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15Dec2021. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. The reporter and BioNTech SE considered the causal relationship between vaccine and events Weakness of limbs, Stroke, Interchange of vaccine products, Off label use was possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1988018 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Chest X-ray, Coma scale, Computerised tomogram head, Dizziness, Electrocardiogram, Fall, Physical examination
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Old L''T rib, L''T clavicle fracture; Test Date: 20211117; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:E2V2M4; Test Date: 20211117; Test Name: Brain CT; Result Unstructured Data: Test Result:L''T frontal subdural hematoma, contusion; Comments: hemorrhage, falx Subdural hematoma; Test Date: 20211117; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:sinus rhythm, multiple ventricular premature; Comments: complexes, V4-V6 ST-segment depression; Test Date: 20211117; Test Name: Physical examination; Result Unstructured Data: Test Result:pupil to light reaction: right eye = 3.0mm (p),; Comments: left eye = 3.0mm (p), muscle strength: right upper limbs / lower extremity = 4/4 points, left upper limbs / lower extremity = 4/4 points
CDC Split Type: TWPFIZER INC202101841887

Write-up: DIZZINESS; FALLING DOWN; TRANSIENT CONSCIOUSNESS DISTURBANCE; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from License Party (BioNTech SE) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100013981. Other Case identifier(s): TW-Fosun-2021FOS007159. This is a spontaneous report received from a non-contactable HCP received via a regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100013981. A 63-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number was not reported) on 17-Nov-2021 via unknown route at an unknown dose with unspecified dosing frequency for COVID-19 immunization. The patient had no medical history. Concomitant medications and past product were not reported. The patient experienced dizziness, falling down and transient consciousness disturbance on 17-Nov-2021. At around 6pm of 17-Nov-2021, the patient experienced dizziness, then fell down, and the patient was found sitting on the ground with unclear consciousness. The patient was sent to the emergency of hospital for treatment, The test results showed: Brain CT: L''T frontal subdural hematoma(SDH), contusion hemorrhage, falx Subdural hematoma(SDH), Chest x-ray(CXR): Old L''T rib, L''T clavicle fracture(FX). The patient was recommended to transfer to another hospital. 12 lead electrocardiogram(EKG): sinus rhythm(SR), multiple ventricular premature complexes (VPC), V4-V6 ST-segment depression(STD), Glasgow coma scale(GCS): E2V2M4, pupil to light reaction: right eye = 3.0mm (p), left eye = 3.0mm (p), muscle strength: right upper limbs / lower extremity = 4/4 points, left upper limbs / lower extremity = 4/4 points. The counterpart of the patient: 1) check awareness, pupil reaction, limb muscle strength, if GCS was less than 8 points, followed up brain CT; 2) 3 days later, followed up brain CT and used 16Fr foley catheter, the patient needed to enter the care unit to continued care. On 18-Nov-2021, the patient was transferred to the ward. On 24-Nov-2021, the patient was still hospitalized. Dizziness, falling down and transient consciousness disturbance met the seriousness criterion of Hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1988043 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood creatinine, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, C-reactive protein, Coma scale, Fatigue, Fibrin D dimer, Generalised oedema, Haemoglobin, Heart rate, International normalised ratio, Muscular weakness, Oxygen saturation, Pain assessment, Platelet count, Prothrombin time, Red blood cell count, Respiratory distress, Respiratory rate, Troponin I, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: GPT; Result Unstructured Data: Test Result:37 IU/l; Test Date: 20211125; Test Name: Glutamic-oxaloacetic transferase; Result Unstructured Data: Test Result:23 IU/l; Test Date: 20211125; Test Name: CPK; Result Unstructured Data: Test Result:88 IU/l; Test Date: 20211125; Test Name: CK-MB; Result Unstructured Data: Test Result:1.0 ng/ml; Test Date: 20211125; Test Name: Creatinine; Test Result: 0.58 mg/dl; Test Date: 20211125; Test Name: K; Result Unstructured Data: Test Result:3.8 mmol/L; Test Date: 20211125; Test Name: BP; Result Unstructured Data: Test Result:155/92 mmHg; Test Date: 20211125; Test Name: Sodium; Result Unstructured Data: Test Result:139.0 mmol/L; Test Date: 20211125; Test Name: Blood urea nitrogen; Test Result: 12.6 mg/dl; Test Date: 20211125; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20211125; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:E4V5M6; Test Date: 20211125; Test Name: C-reactive protein; Result Unstructured Data: Test Result:4.23 mg/l; Test Date: 20211125; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:0.41 ug/ml; Test Date: 20211125; Test Name: Hemoglobin; Result Unstructured Data: Test Result:12.6 g/dl; Test Date: 20211125; Test Name: Heart rate; Result Unstructured Data: Test Result:72; Comments: Units:{beats}/min; Test Date: 20211125; Test Name: INR; Result Unstructured Data: Test Result:0.92; Test Date: 20211125; Test Name: Oxygen saturation; Test Result: 94 %; Test Date: 20211125; Test Name: Pain scale; Result Unstructured Data: Test Result:0 points; Test Date: 20211125; Test Name: Platelet count; Result Unstructured Data: Test Result:325 x10 3/mm3; Test Date: 20211125; Test Name: Prothrombin time; Test Result: 26.9 s; Test Date: 20211125; Test Name: Prothrombin time; Test Result: 26.5 s; Test Date: 20211125; Test Name: Red blood cell count; Result Unstructured Data: Test Result:5.58 10*6/uL; Test Date: 20211125; Test Name: Respiratory rate; Result Unstructured Data: Test Result:20; Comments: Units:{breaths}/min; Test Date: 20211125; Test Name: Troponin I; Result Unstructured Data: Test Result:0.003 ng/ml; Test Date: 20211125; Test Name: WBC; Result Unstructured Data: Test Result:5.52 x10 3/mm3
CDC Split Type: TWPFIZER INC202101854845

Write-up: MILD BREATHING DISTRESS (92-94%); TIRED; SWOLLEN LIMBS (THE BODY WAS SWOLLEN); LIMBS WEAKNESS (THE WHOLE BODY WAS WEAK); This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014414 (Regulatory Authority). Other Case identifier(s): TW-Fosun-2021FOS007205 (RA). A 52 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: GENERALISED OEDEMA (hospitalization) with onset 17Nov2021, outcome "not recovered", described as "SWOLLEN LIMBS (THE BODY WAS SWOLLEN)"; MUSCULAR WEAKNESS (hospitalization) with onset 17Nov2021, outcome "not recovered", described as "LIMBS WEAKNESS (THE WHOLE BODY WAS WEAK)"; RESPIRATORY DISTRESS (hospitalization) with onset 25Nov2021, outcome "not recovered", described as "MILD BREATHING DISTRESS (92-94%)"; FATIGUE (hospitalization) with onset 25Nov2021, outcome "not recovered", described as "TIRED". The patient was hospitalized for generalised oedema, muscular weakness, respiratory distress, fatigue (start date: 25Nov2021, discharge date: 2021). The events "swollen limbs (the body was swollen)" and "limbs weakness (the whole body was weak)" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: (25Nov2021) 37 IU/l; aspartate aminotransferase: (25Nov2021) 23 IU/l; blood creatine phosphokinase: (25Nov2021) 88 IU/l; blood creatine phosphokinase mb: (25Nov2021) 1.0 ng/ml; blood creatinine: (25Nov2021) 0.58 mg/dl; blood potassium: (25Nov2021) 3.8 mmol/L; blood pressure measurement: (25Nov2021) 155/92 mmHg; blood sodium: (25Nov2021) 139.0 mmol/L; blood urea: (25Nov2021) 12.6 mg/dl; body temperature: (25Nov2021) 36.4 Centigrade; coma scale: (25Nov2021) e4v5m6; c-reactive protein: (25Nov2021) 4.23 mg/l; fibrin d dimer: (25Nov2021) 0.41 ug/ml; haemoglobin: (25Nov2021) 12.6 g/dl; heart rate: (25Nov2021) 72, notes: Units:{beats}/min; international normalised ratio: (25Nov2021) 0.92; oxygen saturation: (25Nov2021) 94 %; pain assessment: (25Nov2021) 0 points; platelet count: (25Nov2021) 325 x10 3/mm3; prothrombin time: (25Nov2021) 26.9 seconds; (25Nov2021) 26.5 seconds; red blood cell count: (25Nov2021) 5.58 10*6/uL; respiratory rate: (25Nov2021) 20, notes: Units:{breaths}/min; troponin i: (25Nov2021) 0.003 ng/ml; white blood cell count: (25Nov2021) 5.52 x10 3/mm3. Therapeutic measures were taken as a result of generalised oedema, muscular weakness, respiratory distress, fatigue. Treatments of "Sodium chloride (Sodium Chloride 0.9% 500ml / Bag) 500 ml st IVD 1 day Chlorzoxazone 150mg + acetaminophen 250mg + caffeine 20mg + Thiamine 7.7mg (Soma Compound / CAP) 1 cap PO Q8H 3 days, Bromelain 20000 Unit + L-Cysteine Ysteine 20 mg (Broen-C Compound / Tab) 1 Tab PO Q8H 3 days" were prescribed. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1988046 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-11
Onset:2021-11-17
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest pain, Cough, Dizziness, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8 Centigrade
CDC Split Type: TWPFIZER INC202101855173

Write-up: SKIN RASH (NON-INJECTION SITE); FEVER; CHEST PAIN; DIZZINESS; COUGH; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party (BioNTech) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014059. Other Case identifier(s): TW-Fosun-2021FOS007208. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100014059. A 22-year-old male patient started to receive the 2nd dose of TOZUBANERAN (COMIRNATY) (batch number was not reported) on 11-Nov-2021 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history was not reported. Concomitant medication and past product were not reported. The patient experienced fever, dizziness, cough on 17-Nov-2021, experienced skin rash (non-injection site) on 23-Nov-2021, experienced chest pain on an unknown date. On 17-Nov-2021, the patient experienced dizziness, cough and fever up to 37.8 Centigrade. The patient took antipyretics for the fever. On the same day, the patient went to the emergency room of the hospital due to no improvement of the symptoms. The patient was administrated medication of normal saline (N/S) at 500 ml, keto injection (Inj.) of 30 mg/ml at 1 ml, diphenhydramine at 30 mg at 1 ml, medicine injection (Inj.) at 40 mg, cefin 1000 injection (Inj.) at 1 gm, promeran injection (Inj.) of 3.84 mg/ml at 2 ml, fadin injection (Inj.) of 10 mg/ml at 2 ml via needle (injection). The patient was admitted to hospital and the ventilator was recommended to apply. On 23-Nov-2021, the patient was discharged. On 24-Nov-2021, the symptoms of urticarial had resumed half. On 01-Dec-2021, the symptoms of urticaria improved. The patient still took medicine and experienced a side effect of stomach pain. It was reported that "continuous reciprocation treatment". Fever, skin rash (non-injection site), chest pain, dizziness, cough met the seriousness criterion of Hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of dizziness, cough and fever were unknown. The outcomes of the other events were recovering. The patient was discharged on 23-Nov-2021. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1989975 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-08
Onset:2021-11-17
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214015 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20214

Write-up: This case was received via regulatory authority Reference number: DE-PEI-202100227288) on 20-Dec-2021 and was forwarded to Moderna on 20-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (2x collapsed, emergency room, dismissed without findings) in a 54-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214015) for COVID-19 vaccination. No Medical History information was reported. On 08-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced SYNCOPE (2x collapsed, emergency room, dismissed without findings) (seriousness criteria hospitalization and medically significant). On 18-Nov-2021, SYNCOPE (2x collapsed, emergency room, dismissed without findings) was resolving. No concomitant medication information was mentioned by reporter The preexisting condition were included Hypertension for 2 times, collapsesed 1 at evening, 1 at morning in emergency room. The laboratory data were done in emergency room that included ECG, CT skull and blood counts without any finding and and patient got discharge. No treatment medication information was mentioned by reporter This is a regulatory case concerning a 54-year-old male patient with no reported relevant medical history, who experienced the serious unexpected event of Syncope. The event occurred approximately 10 days after the third dose of mRNA-1273 vaccine administration. The event was assessed as related, per temporal association with the product administration. The rechallenge was not applicable since the event occurred after the third dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 54-year-old male patient with no reported relevant medical history, who experienced the serious unexpected event of Syncope. The event occurred approximately 10 days after the third dose of mRNA-1273 vaccine administration. The event was assessed as related, per temporal association with the product administration. The rechallenge was not applicable since the event occurred after the third dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1990184 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCVD1 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Guttate psoriasis, Immunisation, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), 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? 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: Guttate psoriasis (a single attack several years ago.)
Allergies:
Diagnostic Lab Data: Test Date: 20200627; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101799712

Write-up: diffuse guttate psoriasis all over body, diagnosed by GP. Rash benign and well tolerated.; Rash benign and well tolerated.; booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority. Regulatory number: FR-AFSSAPS-LY202113044 (AFSSAPS). A 73 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 17Nov2021 (Lot number: SCVD1) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Guttate psoriasis" (not ongoing), notes: a single attack several years ago. The patient''s concomitant medications were not reported. The patient had no history of COVID-19. Vaccination history included: Comirnaty (first dose; Left arm, Intramuscular injection, Lot #: EW9127), administration date: 14Apr2021, for covid-19 immunisation; Comirnaty (dose second: Left arm, Intramuscular injection, Lot No: EX7823), administration date: 09May2021, for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; GUTTATE PSORIASIS (medically significant) with onset 20Nov2021, outcome "recovering", described as "diffuse guttate psoriasis all over body, diagnosed by GP. Rash benign and well tolerated."; RASH (medically significant) with onset 20Nov2021, outcome "recovering", described as "Rash benign and well tolerated.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Jun2020) negative. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1990976 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-03
Onset:2021-11-17
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Painful respiration, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Other ischaemic heart disease (narrow), Chronic kidney disease (broad), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRPFIZER INC202101803900

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 20-year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 03Nov2021 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant) with onset 17Nov2021 20:00, outcome "not recovered", described as "reached out to my doctor today and they suspect it is Pericarditis."; ANGINA PECTORIS (medically significant), PAINFUL RESPIRATION (medically significant) all with onset 17Nov2021 20:00, outcome "not recovered" and all described as "I felt intense, sharp pain at heart area, after that I feel pain on daily basis when breathing deeply". The events "reached out to my doctor today and they suspect it is pericarditis.", "I felt intense, sharp pain at heart area, after that I feel pain on daily basis when breathing deeply" and "I felt intense, sharp pain at heart area, after that I feel pain on daily basis when breathing deeply" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pericarditis, angina pectoris, painful respiration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that 2 weeks after getting the vaccine, he felt intense, sharp pain at heart area, after that he felt pain on daily basis when breathing deeply, especially when lying down. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient had not been tested for covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1991085 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-28
Onset:2021-11-17
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8021 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Joint hyperextension, Loss of consciousness, Postictal state, Salivary hypersecretion, 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), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain injury (Treatment : Risperidone 2 mg, 1/4 tablet every 24 hours.); Muscular dystrophy (Treatment : Risperidone 2 mg, 1/4 tablet every 24 hours.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC202101822137

Write-up: Afebrile convulsion; Loss of consciousness of 1 minute; Hyperextension; Sialorrhea; Postictal period; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 18226-12 (COFEPRIS). A 13 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Oct2021 (Lot number: FH8021, Expiration Date: 01Jan2022) at the age of 13 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Muscular dystrophy" (unspecified if ongoing), notes: Treatment : Risperidone 2 mg, 1/4 tablet every 24 hours.; "sequelae of brain injury" (unspecified if ongoing), notes: Treatment : Risperidone 2 mg, 1/4 tablet every 24 hours. The patient''s concomitant medications were not reported. The following information was reported: SEIZURE (hospitalization) with onset 17Nov2021 00:30, outcome "unknown", described as "Afebrile convulsion"; LOSS OF CONSCIOUSNESS (hospitalization) with onset 17Nov2021 00:30, outcome "unknown", described as "Loss of consciousness of 1 minute"; JOINT HYPEREXTENSION (hospitalization) with onset 17Nov2021 00:30, outcome "unknown", described as "Hyperextension"; SALIVARY HYPERSECRETION (hospitalization) with onset 17Nov2021 00:30, outcome "unknown", described as "Sialorrhea"; POSTICTAL STATE (hospitalization) with onset 17Nov2021 00:30, outcome "unknown", described as "Postictal period". Therapeutic measures were taken as a result of seizure, loss of consciousness, joint hyperextension, salivary hypersecretion, postictal state. The clinical course was reported as follows: "Postictal period of 10 to 15 minutes unconscious. Treatment administered: Phenytoin 500 mg in 500 cc of physiological solution 0.9% for 1 hour." ESAVI Type was serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1991094 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1620 / 3 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Diarrhoea, Headache, Immunisation, Myalgia, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Body temperature; Result Unstructured Data: Test Result:greater than or equal to 38 Centigrade; Comments: Fever; Test Date: 20211117; Test Name: SARS Covid AR test; Test Result: Negative
CDC Split Type: MXPFIZER INC202101822780

Write-up: received third (booster) dose; received third (booster) dose; Fever greater than or equal to 38 Celsius degrees; Headache; Adynamia; Chills; diarrhea; Myalgia; Arthralgia; This is a spontaneous report received from a non-contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: 18254-12 (RA). A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Nov2021 (Lot number: FJ1620) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 , MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (Dose 2 , MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "received third (booster) dose"; PYREXIA (medically significant) with onset 17Nov2021, outcome "unknown", described as "Fever greater than or equal to 38 Celsius degrees"; HEADACHE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Headache"; ASTHENIA (medically significant) with onset 17Nov2021, outcome "unknown", described as "Adynamia"; CHILLS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Chills"; DIARRHOEA (medically significant) with onset 17Nov2021, outcome "unknown", described as "diarrhea"; MYALGIA (medically significant) with onset 17Nov2021, outcome "unknown", described as "Myalgia"; ARTHRALGIA (medically significant) with onset 17Nov2021, outcome "unknown", described as "Arthralgia". The events "fever greater than or equal to 38 celsius degrees", "headache", "adynamia", "chills", "diarrhea", "myalgia" and "arthralgia" were evaluated at the physician office visit. The patient went to respiratory unit for suspicion of sars cov 2 with negative "AR" test. The patient underwent the following laboratory tests and procedures: body temperature: (17Nov2021) greater than or equal to 38, notes: Fever; sars-cov-2 test: (17Nov2021) negative. Therapeutic measures were taken as a result of pyrexia, headache, asthenia, chills, diarrhoea, myalgia, arthralgia and included Ketorolac. Solution for injection. Each vial or ampoule contains: ketorolac-tromethamine 30 mg. Package with 3 ampoules or 3 ampoules of 1 ml. 1 ampoule(s) diclofenac solution for injection each ampoule contains: diclofenac sodium 75 mg package with 2 ampoules with 3 ml. 1 ampoule. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1991307 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-11-17
   Days after vaccination:209
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202101799573

Write-up: COVID-19; Drug ineffective; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202111-2374 (RA). A 94 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Apr2021 (Lot number: ER9470, Expiration Date: 31Jul2021) as dose 1, 0.3ml, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (hospitalization) with onset 17Nov2021, outcome "unknown", described as "COVID-19"; DRUG INEFFECTIVE (hospitalization) with onset 17Nov2021, outcome "unknown", described as "Drug ineffective". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) positive, notes: positive Iu international unit(s). The adverse reaction (ADR) appeared about 7 months after the first dose of the suspected drug. At the time of notification, the disease lasted 12 days, but it''s most recent evolution was unknown. There was no reference to the administration of 2nd dose. There was no suspicion of interaction between medications or medication error. Adverse reactions to other medicinal products were unknown. The reporter''s assessment of the causal relationship of the events with the suspect product bnt162b2 was possible. Conclusion from PGS division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ER9470. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1991310 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-11-17
   Days after vaccination:293
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Test Date: 20211118; Test Name: Covid PCR test +; Test Result: Positive
CDC Split Type: PTPFIZER INC202101826250

Write-up: Drug ineffective; Drug ineffective; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-1897. A 48 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 28Jan2021 (Lot number: EL1484) as dose 2 0.3 ml, single and intramuscular, administration date 07Jan2021 (Lot number: EJ6797) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 17Nov2021, outcome "recovered" and all described as "Drug ineffective". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive. It was unknown if therapeutic measures were taken as a result of covid-19, vaccination failure. The adverse reaction (ADR) had the approximate duration of unknown. Treatment of adverse reaction with unknown. Reporter Comment: Other information-Onset of symptoms on 17Nov2021: Cough, nasal obstruction, odynophagia, headache, chest pain, dyspnea, ageusia, anosmia and diarrhea Covid PCR test + on 18Nov2021 No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information-Onset of symptoms on 17Nov2021: Cough, nasal obstruction, odynophagia, headache, chest pain, dyspnea, ageusia, anosmia and diarrhea Covid PCR test + on 18Nov2021


VAERS ID: 1991433 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-11-17
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Electrocardiogram, Myalgia, Myocarditis, SARS-CoV-2 test, Troponin I
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211019; Test Name: CK; Result Unstructured Data: Test Result:661 IU/l; Test Date: 20211019; Test Name: CK-MB; Result Unstructured Data: Test Result:27.78 IU/l; Test Date: 20211019; Test Name: CK-MB; Result Unstructured Data: Test Result:60.37 IU/l; Test Date: 20211019; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:had no abnormal discovery; Test Date: 20211019; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20211018; Test Name: Cardiac troponin I; Result Unstructured Data: Test Result:more than 16000; Test Date: 20211029; Test Name: Troponin I; Result Unstructured Data: Test Result:had decreased to 407; Test Date: 20211019; Test Name: Troponin I; Result Unstructured Data: Test Result:7363.2 ng/L; Test Date: 20211019; Test Name: Troponin I; Result Unstructured Data: Test Result:16653.6 ng/L
CDC Split Type: TWPFIZER INC202101832529

Write-up: MUSCLE ACHE; MYOCARDITIS (MYOCARDITIS); This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party (BioNTech) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014278. Other Case identifier(s): TW-Fosun-2021FOS006809. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100014278. A 15-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: unknown) on 24-Sep-2021 via intramuscular at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history was not reported. Concomitant medications and past product were not reported. The patient experienced myocarditis on 17-Nov-2021, muscle ache on 19-Nov-2021. On 24-Sep-2021, the patient received the first agent BNT vaccine, there was no symptom after inoculation, and there were no symptoms such as body discomfort, gasping and chest tightness. On 17-Nov-2021, there was a symptom of the body was not suitable for breath and chest tightness. Then the patient went to a clinic due to the symptoms had not improved. On 18-Nov-2021, the patient began to breathe abnormal, the big mouth breathing, the patient went to the hospital, due to troponin-I increased to more than 16000 and the value of myocarditis was still rising. The patient had been hospitalized. On 19-Nov-2021, the patient''s COVID-19 polymerase chain reaction (PCR) test was negative, troponin-I was 7363.2 ng/L, creatine phosphokinase MB (CK-MB) was 27.78 U/L; after 3 hours, the results showed that troponin-I was 16653.6 ng/L, creatine phosphokinase MB (CK-MB) was 60.37 U/L, creatine kinase (CK) was 661 U/L and the doctor had notified the vaccine adverse event, and the relevant diagnostic information was uploaded. The patient experienced muscle ache and myocarditis, due to the symptoms were not improvement, the patient suspected to have a severe adverse reaction of myocarditis after vaccination COVID-19 BNT vaccine, and the electrocardiogram had no abnormal discovery, and prescribed painkiller medicines. the doctor diagnosed the symptoms of myocarditis. On 26-Nov-2021, the patient was hospitalization At 29-Nov-2021 09:12, according to telephone follow-up, the patient was hospitalization, and life sigh was stable, clear consciousness, troponin-I had decreased to 407, and the attending doctor said that the patient would be discharged from the hospital if the patient''s condition was stable in these two days. On 30-Nov-2021, the patient had been discharged from the hospital, and the symptoms returned to normal in a week. Muscle ache and myocarditis met the seriousness criterion of Caused Hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Drug: Comirnaty Causality Assessments: Muscle ache;Myocarditis Per Reporter= Possible Per Company (BioNTech) = Possible


VAERS ID: 1991550 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-11-17
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Skin rashes (non-injection site); This regulatory authority case was reported by an other health care professional and describes the occurrence of RASH (Skin rashes (non-injection site)) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. Concurrent medical conditions included Diabetes. On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, the patient experienced RASH (Skin rashes (non-injection site)) (seriousness criterion medically significant). At the time of the report, RASH (Skin rashes (non-injection site)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. On 26-Oct-2021, the patient received the second dose of Moderna vaccine and later on 27-Oct-2021, he had intractable skin itching with tiny rash, distribution, bil arms, bi legs and neck truck. On 17-Nov-2021, he came to the outpatient department of the hospital for treatment. The physiological measurement information was as follow: BW: 62.4 kg, height: 158.9 centimeters, BMI: 24.71. On same day, laboratory test done were as follow: WBC 6.31 x1000/uL. GPT(ALT) =8 IU/L; CRP (quantification) = 2.02 mg/L; Creatinine=0.95 mg/dL. IgE=82.2 IU/mL. Upon examination, he had stable conditions and was permitted to be discharged from the hospital. Discharge medication (oral medicines) included, Xyzal 1 Tab QDHS 7 days in total, Trand 250mg/Cap) 1 Cap TID 3 days in total, Mycomb cream BID SKIN 1 tube in total. On 19-Nov-2021, he came to the outpatient department of the hospital for treatment, with chief complaint of improved itching skin rash. The physiological measurement information was as follow: Systolic pressure: 129 mmHg, diastolic pressure: 78 mmHg, pulse: 106 beats per minute. As the relevance to adverse reactions of COVID-19 vaccine cannot be excluded, the physician reported adverse reactions of the vaccine. The follow-up care was as follows, on 7-Dec-2021, he reported that the skin symptom was relieved. The case was closed. Company Comment: This is a regulatory authority case concerning a 67-year-old, male patient with unknown medical history, who experienced the unexpected serious (medically significant) events of rash. The event occurred approximately 1 day after the second dose of mRNA 1273 vaccine. Around 20 days later he presented to the outpatient department, several lab data were performed and discharged with oral treatment. Rash was resolved. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 67-year-old, male patient with unknown medical history, who experienced the unexpected serious (medically significant) events of rash. The event occurred approximately 1 day after the second dose of mRNA 1273 vaccine. Around 20 days later he presented to the outpatient department, several lab data were performed and discharged with oral treatment. Rash was resolved. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 1992001 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-11
Onset:2021-11-17
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0161 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Cardiovascular disorder, Diarrhoea, Diplopia, Dizziness, Fear of death, Headache, Pulmonary pain, Renal pain
SMQs:, Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Ocular motility disorders (broad), 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: ATPFIZER INC202101809744

Write-up: Headache; with the left eye seen double until the afternoon; Renal pain; Circulatory disorders; Heart problems; Pulmonary pain/lung pain attack; Fear of death/scared of death; Diarrhea; Lightheadedness; 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 patient. Regulatory number: AT-BASGAGES-2021-064998. A 69 year-old female patient received bnt162b2 (COMIRNATY), administration date 11Nov2021 (Lot number: FH0161) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DIPLOPIA (medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "with the left eye seen double until the afternoon"; DIARRHOEA (medically significant) with onset 17Nov2021, outcome "recovered" (2021), described as "Diarrhea"; RENAL PAIN (medically significant) with onset 17Nov2021, outcome "recovered" (2021), described as "Renal pain"; HEADACHE (medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Headache"; CARDIOVASCULAR DISORDER (medically significant) with onset 17Nov2021, outcome "recovered" (2021), described as "Circulatory disorders"; CARDIAC DISORDER (medically significant) with onset 17Nov2021, outcome "recovered" (2021), described as "Heart problems"; PULMONARY PAIN (medically significant) with onset 17Nov2021, outcome "recovered" (2021), described as "Pulmonary pain/lung pain attack"; FEAR OF DEATH (medically significant) with onset 17Nov2021, outcome "recovered" (2021), described as "Fear of death/scared of death"; DIZZINESS (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "Lightheadedness". On 14Dec2021, the patient said that he did not call the emergency as she was not sure that he could make out of the bed to the door as she was with lung pain attack that lasted for 30 min for which he even scared of death. On the next day, she could make it to the door and seeing double with left eye until the afternoon and had a headache. The patient confirmed that she was not going to doctor till next day for a blood draw, because she was not to the doctor in so long, to see if she had antibodies and at least the whole thing has done something. The patient did not have any previous illness and was not to the doctor in the last 10 years. She stated that her mother died 2 weeks after the vaccination and was completely healthy in the last few years.


VAERS ID: 1993184 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Chest pain, Dizziness, Electrocardiogram, Extrasystoles, Headache, Investigation, Palpitations
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Other ischaemic heart disease (narrow), Vestibular disorders (broad), Hypokalaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Non-smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: electrocardiography; Result Unstructured Data: Test Result:squeezing pain; Test Name: Cooper test; Result Unstructured Data: Test Result:approximately 3000 meters
CDC Split Type: FIPFIZER INC202101810345

Write-up: Dizziness; Cardiac pain; Extrasystoles; Headache; squeezing chest pain; palpitations; 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 patient. Regulatory number: FI-FIMEA-20217450 (RA). A 34 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 12Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "mild asthma" (ongoing); "non-smoker" (ongoing). The patient''s concomitant medications were not reported. The following information was reported: DIZZINESS (hospitalization) with onset 17Nov2021, outcome "unknown", described as "Dizziness"; ANGINA PECTORIS (hospitalization) with onset 17Nov2021, outcome "unknown", described as "Cardiac pain"; EXTRASYSTOLES (hospitalization) with onset 17Nov2021, outcome "unknown", described as "Extrasystoles"; HEADACHE (hospitalization) with onset 17Nov2021, outcome "unknown", described as "Headache"; CHEST PAIN (non-serious), outcome "unknown", described as "squeezing chest pain"; PALPITATIONS (non-serious), outcome "unknown", described as "palpitations". The events "dizziness", "cardiac pain", "extrasystoles", "headache", "squeezing chest pain" and "palpitations" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: squeezing pain; investigation: approximately 3000 meters. Therapeutic measures were taken as a result of dizziness, angina pectoris, extrasystoles, headache, chest pain, palpitations. The patient had been involved in competitive sports since childhood. No history of cardiac symptoms. The patient is aware of his limits in terms of sports endurance and recovery.The patient took a 3-day break from sports after experiencing the squeezing pain. The symptoms began after returning to exercise. The patient was now stable, but the heart did not appeared to be beating normally. The doctor had not ventured an opinion and the local health care centre did not mention the squeezing pain in the description of symptoms before electrocardiography. The patient had received beta-blockers for the symptoms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1993378 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCVD1 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Blood pressure measurement, Cerebral infarction, Computerised tomogram head, Infarction, Ischaemic stroke, Magnetic resonance imaging head, Modified Rankin score, NIH stroke scale
SMQs:, Myocardial infarction (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BIPRETERAX [INDAPAMIDE;PERINDOPRIL ARGININE]; ATORVASTATINE [ATORVASTATIN]
Current Illness: Arterial hypertension; Dyslipidaemia; Gout
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:196/105; Test Date: 20211118; Test Name: control brain CT; Result Unstructured Data: Test Result:found the ischemic lesion in the left superficial; Comments: found the ischemic lesion in the left superficial sylvian territory with the appearance of secondary bleeding; Test Name: Brain MRI; Result Unstructured Data: Test Result:found a cerebral infarction. Visible thrombus.; Comments: found a cerebral infarction. Visible thrombus.; Test Name: Rankin score; Result Unstructured Data: Test Result:1; Test Name: NIHSS; Result Unstructured Data: Test Result:3
CDC Split Type: FRPFIZER INC202101809545

Write-up: Ischemic stroke; left temporal insular cerebral infarction; left posterior superficial sylvian infarction; sudden aphasia with a slight deficit in the right lower limb.; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Agency-WEB. Regulatory number: FR-AFSSAPS-TO20219033 . A 72-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 15Nov2021 (Lot number: SCVD1) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Gout" (ongoing); "Arterial hypertension" (ongoing); "Dyslipidaemia" (ongoing). Concomitant medication(s) included: BIPRETERAX [INDAPAMIDE; PERINDOPRIL ARGININE]; ATORVASTATINE [ATORVASTATIN]. The following information was reported: ISCHAEMIC STROKE (hospitalization) with onset 17Nov2021, outcome "recovered with sequelae" (01Dec2021), described as "Ischemic stroke"; CEREBRAL INFARCTION (hospitalization) with onset 17Nov2021, outcome "unknown", described as "left temporal insular cerebral infarction"; INFARCTION (hospitalization) with onset 17Nov2021, outcome "unknown", described as "left posterior superficial sylvian infarction"; APHASIA (hospitalization) with onset 17Nov2021, outcome "unknown", described as "sudden aphasia with a slight deficit in the right lower limb.". The patient was hospitalized for ischaemic stroke, cerebral infarction, infarction, aphasia (start date: 17Nov2021, discharge date: 01Dec2021, hospitalization duration: 14 day(s)). The patient underwent the following laboratory tests and procedures: blood pressure measurement: (unspecified date) 196/105; computerised tomogram head: (18Nov2021) found the ischemic lesion in the left superficial, notes: found the ischemic lesion in the left superficial sylvian territory with the appearance of secondary bleeding; magnetic resonance imaging head: (unspecified date) found a cerebral infarction. visible thrombus., notes found a cerebral infarction. Visible thrombus; modified ranking score: (unspecified date) 1; nih stroke scale: (unspecified date) 3. Therapeutic measures were taken as a result of ischaemic stroke, cerebral infarction, infarction. Patient administrated with LOXEN 20mg and treated with actilyse started at 18:30 i.e., 2h45 after the onset of symptoms. Additional information: Patient considered to be at risk of developing a severe form of COVID-19 disease. It was reported that, 2 days after vaccination, the patient presents with sudden aphasia with a slight deficit in the right lower limb. After a call to the (emergency medical service), he was transferred to the hospital for ischemic stroke. Hospitalization from 17Nov2021 to 01Dec2021 for management of a left temporal insular cerebral infarction and left posterior superficial sylvian infarction, having benefited from a fibrinolytic treatment in the acute phase. In total: Left posterior superficial insular and sylvic infarction, the origin of which is assumed to be cardioembolic, without having any certainty, having benefited in the acute phase from a fibrinolytic treatment by ACTILYSE, resulting in haemorrhagic softening in the heart infarction. Severe mixed aphasia persisted, with no other signs of focusing. The patient has not tested for Covid. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1993469 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blister, Breast pain, Burning sensation, Chest pain, Dyspnoea, Fatigue, Headache, Heart rate, Herpes zoster, Immunisation, Interchange of vaccine products, Lymphadenopathy, Malaise, Off label use, Pain, Palpitations, Pruritus, Pyrexia, Rash, SARS-CoV-2 test, Tachycardia
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Lipodystrophy (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (broad), 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:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Breast conserving surgery (Lumpectomy); Chronic fatigue; Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)); Radiotherapy (left breast has been treated with radiotherapy therefore already the nerve endings are highly sensitive, 15 sessions)
Allergies:
Diagnostic Lab Data: Test Name: Racing heart (tachycardia); Result Unstructured Data: Test Result:increased; Comments: increased; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101805733

Write-up: Fatigue / unusual tiredness / Chronic fatigue; Chest pain; Fever; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Lymphadenopathy / swollen glands in right armpit; Headache; Malaise; Pruritus; Pain; Breast pain; Back pain; Burning sensation; rash; blisters; Shingles; received the 1st and 2nd of COVID-19 VACCINE ASTRAZENECA and 3rd of BNT162B2; received the 1st and 2nd of COVID-19 VACCINE ASTRAZENECA and 3rd of BNT162B2; received the 1st and 2nd of COVID-19 VACCINE ASTRAZENECA and 3rd of BNT162B2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112141026534550-MM2WQ (RA). Other Case identifier(s): GB-MHRA-ADR 26331312 (RA). A 71 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: Unknown) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Radiotherapy", start date: 2015 (unspecified if ongoing), notes: left breast has been treated with radiotherapy therefore already the nerve endings are highly sensitive, 15 sessions; "Breast conserving surgery", start date: 2015 (unspecified if ongoing), notes: Lumpectomy; "Suspected COVID-19", start date: 01Mar2020 (ongoing); "Neoplasm" (unspecified if ongoing), notes: Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy); "Fatigue" (unknown if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca, administration date: 14Feb2021, for COVID-19 immunization, reaction(s): "Herpes zoster / Shingles"; Covid-19 vaccine astrazeneca, for COVID-19 immunization, reaction(s): "Herpes zoster / Shingles". The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "received the 1st and 2nd of COVID-19 VACCINE ASTRAZENECA and 3rd of BNT162B2"; RASH (medically significant), outcome "recovering", described as "rash"; BLISTER (medically significant), outcome "unknown", described as "blisters"; HERPES ZOSTER (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Shingles"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue / unusual tiredness / Chronic fatigue"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; PYREXIA (medically significant), outcome "unknown", described as "Fever"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; LYMPHADENOPATHY (medically significant), outcome "unknown", described as "Lymphadenopathy / swollen glands in right armpit"; HEADACHE (medically significant), outcome "unknown", described as "Headache"; MALAISE (medically significant), outcome "unknown", described as "Malaise"; PRURITUS (medically significant), outcome "unknown", described as "Pruritus"; PAIN (medically significant), outcome "unknown", described as "Pain"; BREAST PAIN (medically significant), outcome "unknown", described as "Breast pain"; BACK PAIN (medically significant), outcome "unknown", described as "Back pain"; BURNING SENSATION (medically significant), outcome "unknown", described as "Burning sensation". The patient underwent the following laboratory tests and procedures: heart rate: increased, notes: increased; sars-cov-2 test: no - negative covid-19 test. Therapeutic measures were taken as a result of breast pain. Addition information: It was reported that: swollen glands in right armpit from day 1, fever, headache and general malaise. From third day severe itching and pain throughout body but especially on left breast, chest side and back where severe rash and blisters appeared all around also chest pains around heart area. My left breast has been treated with radiotherapy in 2015 therefore already the nerve endings are highly sensitive as it is but after 4 weeks with Pfizer booster still excruciating burning pain and sensitive to touch. I had milder shingles outbreak on same side with earlier double AstraZeneca vaccines but nothing as painful an outbreak as Pfizer booster. left breast has been treated with radiotherapy therefore already the nerve endings are highly sensitive, 15 sessions. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was related to possible inflammation of the heart (myocarditis or pericarditis). The diagnosis was not made by a medical professional. There were not blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1993489 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FKO596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Cough, Disease recurrence, Dyspnoea, Fatigue, Immunisation, Interchange of vaccine products, Off label use, Pericarditis, Productive cough, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (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: Pericarditis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101805824

Write-up: chest tightness; productive cough; Fatigue/unusual tiredness; Chest pain; Shortness of breath; dry barky cough/spasmodic cough; Pericarditis; Pericarditis; Off label use; Interchange of vaccine product; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112141924196180-USFPO. Other Case identifier(s): GB-MHRA-ADR 26334796. A 74 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FKO596) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "severe pericarditis", start date: 1999 (unspecified if ongoing). Patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURE UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURE UNKNOWN), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine product"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; PERICARDITIS (medically significant), DISEASE RECURRENCE (medically significant) all with onset 24Nov2021, outcome "not recovered" and all described as "Pericarditis"; CHEST DISCOMFORT (non-serious), outcome "not recovered", described as "chest tightness"; PRODUCTIVE COUGH (non-serious), outcome "not recovered", described as "productive cough"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (non-serious), outcome "unknown", described as "Chest pain"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; COUGH (non-serious), outcome "unknown", described as "dry barky cough/spasmodic cough". 1 week after booster, patient developed dry barky cough with chest tightness. Then a productive cough occurred. This lasted 2 weeks and then settled to episodic chest tightness with shortness of breath and spasmodic cough. This was exactly the same as during his recovery process from severe pericarditis in 1999. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. His report related to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1993669 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, Dyspnoea, Immunisation, Influenza like illness, Interchange of vaccine products, Malaise, Off label use, Rhinorrhoea, SARS-CoV-2 test, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Medication errors (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE; ESTRADIOL; FELODIPINE; GLUCOSAMINE; PREMARIN; CONJUGATED OESTROGENS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; BP raised; Eczema (Slight eczema on hands and feet, treated with hydrocortisone / betnovate); Facial swelling (linked to ACE inhibitor and antibiotic interaction after using Piz Buin suncream); Hay fever; Hysterectomy; Suspected COVID-19 (Unsure when symptoms stopped); Vaginal pain
Allergies:
Diagnostic Lab Data: Test Date: 202003; Test Name: Antibody Test; Test Result: Positive ; Test Date: 20200930; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101813633

Write-up: runny nose; shortness of breath; flu-like Symptom; Facial swelling; Malaise; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112152027321700-PCKW1. Other Case identifier(s): GB-MHRA-ADR 26344347. A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Swelling face" (unspecified if ongoing), notes: linked to ACE inhibitor and antibiotic interaction, after using Piz Buin suncream requiring steroid treatment; "Seasonal allergy" (unspecified if ongoing); "Eczema" (unspecified if ongoing), notes: Slight eczema on hands and feet, treated with hydrocortisone / betnovate; "Suspected COVID-19", start date: 16Mar2020 (unspecified if ongoing), notes: Unsure when symptoms stopped; "Allergy" (unspecified if ongoing); "Vaginal pain" (unspecified if ongoing); "Hysterectomy" (unspecified if ongoing); "BP raised" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE taken for hypersensitivity; ESTRADIOL taken for vulvovaginal pain; FELODIPINE taken for blood pressure increased; GLUCOSAMINE; PREMARIN taken for hysterectomy; CONJUGATED OESTROGENS and VITAMIN D. Past drug history included: Nickel. It was reported that Other allergies / sensitivities includes Nickel, Aloe Vera, Hayfever (more or less all year round), Wine (sulphite intolerance - causes facial reddening), Covid 19 infection Mar2020 (confirmed by subsequent antibody test): only symptoms identified at the time slight runny nose and occasional hot flashes plus pinprick rash on foot but followed later by shortness of breath (when exercising / singing) for the rest of the year.Vaccination history included: Covid-19 vaccine astrazeneca (Batch/lot number : AB0013 , Dose 1), administration date: 27Feb2021, for COVID-19 immunisation, reaction(s): "leg rash", "Facial swelling"; Covid-19 vaccine astrazeneca (Batch/lot number: PV46687 , Dose 2), administration date: 18May2021, for COVID-19 immunisation, reaction(s): "Rash on leg", "Leg pain".It was reported that after first vaccination followed by delayed reaction which was not identified at the time because of time lag. GP suggested leg rash due to subcutaneous bleeding - referred to consultant because of ongoing leg pain particularly at night, however this had resolved by time of appointment in October; suggested caused by vaccine and no further action required.Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; RHINORRHOEA (medically significant), outcome "recovering", described as "runny nose"; DYSPNOEA (medically significant), outcome "recovering", described as "shortness of breath"; MALAISE (medically significant) with onset 29Nov2021, outcome "recovered" (11Dec2021), described as "Malaise"; SWELLING FACE (medically significant) with onset 04Dec2021, outcome "recovered" (09Dec2021), described as "Facial swelling"; INFLUENZA LIKE ILLNESS (medically significant), outcome "unknown", described as "flu-like Symptom". The events "runny nose", "shortness of breath", "malaise", "facial swelling" and "flu-like symptom" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: antibody test: (Mar2020) positive; sars-cov-2 test: (30Sep2020) positive, notes: Yes - Positive COVID-19 test. Therapeutic measures were taken as a result of swelling face, influenza like illness. Treated in A and E with Prednisolone (5 days). No leg symptoms to date. It was reported that the report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1993674 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Fatigue, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: 20211215; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101805821

Write-up: aching heaviness; Fatigue; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112152055549790-XGXNX (RA). Other Case identifier(s): GB-MHRA-ADR 26341175 (RA). A 63 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH3220) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (disability) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 17Nov2021, outcome "unknown", described as "Booster"; DISCOMFORT (disability), outcome "recovering", described as "aching heaviness"; FATIGUE (disability) with onset 17Nov2021, outcome "not recovered", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Dec2021) negative, notes: No - Negative COVID-19 test. Clinical course: Also still experiencing aching heaviness in both calves. Prior to booster patient could run up over 100 steps, now can only walk up them usually stopping twice. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report not related to possible inflammation of the heart. No relevant investigations or tests conducted. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1994134 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-06
Onset:2021-11-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: GRMODERNATX, INC.MOD20214

Write-up: Transient ischaemic stroke; This regulatory authority case was reported by a consumer and describes the occurrence of ISCHAEMIC STROKE (Transient ischaemic stroke) in a 37-year-old female patient who received mRNA-1273 for COVID-19 vaccination. No Medical History information was reported. On 06-Nov-2021, the patient received dose of mRNA-1273 (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced ISCHAEMIC STROKE (Transient ischaemic stroke) (seriousness criteria disability and medically significant). At the time of the report, ISCHAEMIC STROKE (Transient ischaemic stroke) was resolving. The action taken with mRNA-1273 (Unknown) was unknown. No concomitant product was provided. No treatment information was provided. This is a regulatory case concerning a 37-year-old female patient with no medical history reported, who experienced the unexpected serious event of ischaemic stroke. The event occurred approximately 11 days after the received dose of mRNA � 1273 vaccine. Event caused disability for the patient but at the time of report ischaemic stroke was resolving. The rechallenge is unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 37-year-old female patient with no medical history reported, who experienced the unexpected serious event of ischaemic stroke. The event occurred approximately 11 days after the received dose of mRNA � 1273 vaccine. Event caused disability for the patient but at the time of report ischaemic stroke was resolving. The rechallenge is unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1994261 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Chest pain, Electrocardiogram, Emergency care examination, Heart rate, Immunisation, Neck pain, Oxygen saturation, Pain, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Arthritis (broad), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: blood pressure; Result Unstructured Data: Test Result: 150/80 mmHg; Test Date: 2021; Test Name: blood chemistry test; Result Unstructured Data: Test Result: unknown results; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result: unknown results; Test Date: 2021; Test Name: ER examination; Result Unstructured Data: Test Result: General examination; Comments: patient alert, oriented, collaborating, no pathological findings at chest auscultation; Test Date: 2021; Test Name: heart rate; Result Unstructured Data: Test Result: 105 b/m; Test Date: 2021; Test Name: saturation; Test Result: 98%.
CDC Split Type: ITPFIZER INC202101817215

Write-up: Acute pericarditis; Chest pain radiating to the neck; Chest pain radiating to the neck; Chest pain radiating to the neck; booster, Dose Number (3); This is a non-interventional study report from the Regulatory Authority. The Regulatory Authority number IT-MINISAL02-820942. A 29 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 17Nov2021 08:52 (Lot number: FF2382, Expiration Date: 31Dec2021) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Past drug history included Contraceptives, reaction(s) high values of homocysteine. The patient was taking a contraceptive until a month ago, of which she did not remember the name, then suspended for high values of homocysteine. Vaccination history included Comirnaty (Dose 2, Single, Administration time: 15:14, lot number: EJ6136, Expiration date:30Apr2021, Anatomical location: left arm), administration date: 26Jan2021, for COVID-19 vaccination; Comirnaty (Dose 1, Single, Administration time: 15:52, lot number: EL1484, Expiration date:30Apr2021, Anatomical location: left arm), administration date: 05Jan2021, for COVID-19 vaccination. The following information was reported IMMUNISATION (hospitalization) with onset 17Nov2021 08:52, outcome unknown, described as booster, Dose Number (3); PERICARDITIS (hospitalization) with onset 23Nov2021, outcome not recovered; CHEST PAIN (hospitalization), PAIN (hospitalization), NECK PAIN (hospitalization) all with onset 23Nov2021, outcome not recovered. The patient was hospitalized for immunisation, pericarditis, chest pain, pain, and neck pain (start date: 2021). The events acute pericarditis, chest pain radiating to the neck, chest pain radiating to the neck, and chest pain radiating to the neck were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) 150/80 mmHg; blood test: (2021) unknown results; electrocardiogram (2021) unknown results; emergency care examination (2021) general examination, notes: patient alert, oriented, collaborating, no pathological findings at chest auscultation; heart rate: (2021) 105 b/m; oxygen saturation: (2021) 98 %. Therapeutic measures were taken with pantoprazole (2 vials) in 100 ml saline; FLECTADOL 1 g in 250 ml saline, for the reported events. It was recommended to have Acetylsalicylic acid 500 mg 3 tablets per day for 10 days, pantoprazole 40 mg (1 tablet in the morning for 3 weeks), Cefixime 400 mg (1 tablet per day for 10 days). The reporter''s assessment of the causal relationship of the acute pericarditis and chest pain radiating to the neck with the suspect product(s) bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The suspected Adverse Drug Reaction (ADR) was observed as part of the analysis of adverse drugs reactions in Emergency room. The patient received the 1 dose of vaccine on 05Jan2021, 15:52, lot EL1484, expiration 30Apr2021, left arm; the 2 dose on 26Jan2021, 15:14, lot EJ6136, expiration 30Apr2021, left arm. No follow-up attempts are possible. No further information is expected. The suspected Adverse Drug Reaction (ADR) was observed as part of the analysis of adverse drugs reactions in Emergency room. The patient received the 1 dose of vaccine on 05Jan2021, 15:52, lot EL1484, expiration 30Apr2021, left arm; the 2 dose on 26Jan2021, 15:14, lot EJ6136, expiration 30Apr2021, left arm. Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of events pericarditis, chest pain, neck pain, and irradiating pain cannot be totally excluded.


VAERS ID: 1994267 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-28
Onset:2021-11-17
   Days after vaccination:81
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Gastroenteritis, Investigation, Magnetic resonance imaging, Myocarditis, Troponin
SMQs:, Cardiomyopathy (broad), Noninfectious diarrhoea (broad), 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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: CPK; Result Unstructured Data: Test Result:high; Test Date: 20211117; Test Name: investigations; Result Unstructured Data: Test Result:diagnosis of Perimiocarditis; Test Date: 20211117; Test Name: MRI; Result Unstructured Data: Test Result:prescribed; Test Date: 20211117; Test Name: troponin; Result Unstructured Data: Test Result:high
CDC Split Type: ITPFIZER INC202101817357

Write-up: Acute myocarditis; gastroenteritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the WEB. Regulatory number: IT-MINISAL02-821533 (MINISAL02). A 16 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 28Aug2021 16:14 (Lot number: FG6273) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose, time: 16:00, deltoid left, lot# FF4213), administration date: 23Jul2021, for Covid-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization) with onset 17Nov2021, outcome "recovering", described as "Acute myocarditis"; GASTROENTERITIS (hospitalization) with onset 17Nov2021, outcome "unknown", described as "gastroenteritis". The events "acute myocarditis" and "gastroenteritis" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood creatine phosphokinase: (17Nov2021) high; investigation: (17Nov2021) diagnosis of perimiocarditis; magnetic resonance imaging: (17Nov2021) prescribed; troponin: (17Nov2021) high. Clinical course: "the adverse reaction results from covid vaccine administration (I believe). The reaction continues to this day." On 15Dec2021 the patient''s GP is contacted who communicates that he visited the patient on 17Nov2021 and was diagnosed with gastroenteritis; the patient presented with chest pain. In the afternoon the symptoms did not cease and therefore he was accompanied to the emergency room where he was detained for investigations with the diagnosis of Perimyocarditis with high troponin and CPK values. Discharged with diagnosis of acute myocarditis, the GP prescribed a cardiac MRI.".


VAERS ID: 1994409 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1014A / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Immunisation, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Medical History/Concurrent Conditions: Candidiasis genital; Menopause; Tobacco abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101846502

Write-up: Vaccination failure; Vaccination failure; Advese drug reaction to the 3rd dose.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-2129. A 57 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: 1F1014A) as dose 3 (booster), 0.3 ml single, intramuscular, administration date 07Mar2021 (Lot number: ET1831, Expiration Date: 30Jun2021) as dose 2, single and intramuscular, administration date 13Feb2021 (Lot number: EM6950) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Symptom/Complaint of Menopause", start date: 03May2021 (unspecified if ongoing); "Female genital candidiasis", start date: 03May2021 (unspecified if ongoing); "Tobacco abuse", start date: 28Jun2018 (unspecified if ongoing). There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Advese drug reaction to the 3rd dose."; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Dec2021, outcome "recovered" (19Dec2021) and all described as "Vaccination failure". It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Conclusion from Regulatory Authority division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5788211 (see File attachment in this investigation record)The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ''ET1831''. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The Regulatory Authority process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause were identified as the complaint was not confirmed. Reporter Comment: Concomitant medication Comirnaty 13Feb2021 Lot EM6950, Comirnaty 07Mar2021 Lot:ET1831. Other information: Symptom/ Complaint of Menopause 03May2021 Female genital candidiasis 03May2021 Tobacco abuse 28Jun2018 No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Concomitant medication Comirnaty 13Feb2021 Lot EM6950, Comirnaty 07Mar2021 Lot:ET1831. Other information: Symptom/ Complaint of Menopause 03May2021 Female genital candidiasis 03May2021 Tobacco abuse 28Jun2018


VAERS ID: 1994415 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-11-17
   Days after vaccination:119
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE393 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Vaccination failure
SMQs:, Lack of efficacy/effect (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: Medical History/Concurrent Conditions: Acne; Cardiovascular disease, unspecified; Neurological impairment; Overweight; Tobacco abuse; Uncomplicated hypertension; Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20211259089

Write-up: This spontaneous report received from a health care professional by a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202112-913) on 28-DEC-2021 and concerned a 28-year-old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: neurological impairment, uncomplicated hypertension, cardiovascular disease, unspecified, overweight, tobacco abuse, and acne. The patient received covid-19 vaccine (Dose number in series was 1) (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 21-JUL-2021 for covid-19 immunisation. Drug start period was 119 days. No concomitant medications were reported. On 17-NOV-2021, the patient experienced vaccination failure. The action taken with covid-19 vaccine was not applicable. The patient recovered from vaccination failure on 29-NOV-2021. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Reporter''s Comments: Other information: T83 OVERWEIGHT 2019 P17 TOBACCO ABUSE 2018 N99 NEUROLOGICAL SYSTEM DISEASE OTHER 2015 K86 HYPERTENSION UNCOMPLICATED 2013 S96 ACNE 2013 K99 DISEASE OF THE CIRCULATORY SYSTEM OTHER.


VAERS ID: 1996231 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1021A / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Immunisation
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101816989

Write-up: Arrhythmia; booster; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) from the regulatory authority. Regulatory number: DE-PEI-CADR2021202267. Other Case identifier: DE-CADRPEI-2021202267, DE-PEI-202100227368. A 73-year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: 1F1021A) as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "arterial hypertension" (unknown if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1. Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2. Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; ARRHYTHMIA (hospitalization, medically significant) with onset 18Nov2021, outcome "not recovered", described as "Arrhythmia". Therapeutic measures were taken as a result of arrhythmia. This report is serious - hospitalization. English summary (full translation available upon request). Sender Comment: Information on risk factors or previous illnesses: arterial hypertension / currently in intensive care unit PRIVACY intubated / ventilated, moderate catecholamine requirement. First attempt to wake up frustrated, therefore currently post-resuscitation management with cooling of the body temperature. Neurological outcome currently questionable. If you have any questions, phone doctor''s room: PRIVACY Relatedness: Comirnaty / Arrhythmia / RA: A. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1996232 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G040A / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Headache, Immunisation, Influenza, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (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: Medical History/Concurrent Conditions: Addison''s disease; Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101816938

Write-up: Headache; Flu symptoms; Dyspnoea; Dyspnoea; Fatigue; booster; Pyrexia; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the WEB. Regulatory number: DE-PEI-CADR2021202520 (PEI). Other Case identifier(s): DE-CADRPEI-2021202520 (PEI Webportal), DE-PEI-202100227566 (PEI). A 45 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: 1G040a) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "penicillin allergy" (unspecified if ongoing); "Addison''s disease" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1: MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2: MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HEADACHE (hospitalization) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "Headache"; INFLUENZA (hospitalization) with onset 18Nov2021, outcome "recovered" (19Nov2021), described as "Flu symptoms"; DYSPNOEA (non-serious) with onset 18Nov2021, outcome "recovering", DYSPNOEA (non-serious) with onset 18Nov2021, outcome "unknown" and all described as "Dyspnoea"; PYREXIA (non-serious) with onset 17Nov2021, outcome "recovering", described as "Pyrexia"; FATIGUE (non-serious) with onset 18Nov2021, outcome "recovering", described as "Fatigue"; IMMUNISATION (non-serious) with onset 17Nov2021, outcome "recovering", described as "booster". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1996254 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1014A / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, Cognitive disorder, Confusional state, Immunisation, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: Medical History/Concurrent Conditions: Chronic renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: C-reactive protein; Result Unstructured Data: Test Result:increased
CDC Split Type: ESPFIZER INC202101817187

Write-up: Fever; General malaise; Confusion; C-reactive protein increased; Cognitive disturbance; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: ES-AEMPS-1065315 (RA). An elderly male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: 1F1014A) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic renal failure" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, single), for COVID-19 immunisation; Comirnaty (Dose 2, single), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, disability) with onset 17Nov2021, outcome "unknown", described as "Booster"; PYREXIA (hospitalization, disability) with onset 18Nov2021, outcome "not recovered", described as "Fever"; MALAISE (hospitalization, disability) with onset 18Nov2021, outcome "not recovered", described as "General malaise"; CONFUSIONAL STATE (hospitalization, disability) with onset 18Nov2021, outcome "not recovered", described as "Confusion"; C-REACTIVE PROTEIN INCREASED (hospitalization, disability) with onset 18Nov2021, outcome "not recovered", described as "C-reactive protein increased"; COGNITIVE DISORDER (hospitalization, disability) with onset 18Nov2021, outcome "not recovered", described as "Cognitive disturbance". The patient underwent the following laboratory tests and procedures: c-reactive protein: (18Nov2021) increased. Therapeutic measures were taken as a result of pyrexia, malaise, confusional state, c-reactive protein increased, cognitive disorder.Description of the treatment followed for the adverse drug reaction: PARACETAMOL AND ANTIBIOTICS. It was stated that Have you had COVID-19? No. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1996567 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fungal infection, Immunisation, Psoriasis, SARS-CoV-2 test, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Paraplegic; Psoriasis (father had psoriasis); Spinal cord injury
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101877119

Write-up: scaly skin; fungal infection; Psoriasis; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). The reporter is the patient. A 59 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Spinal cord injury" (unspecified if ongoing); "paraplegic" (unspecified if ongoing). Family history included: "psoriasis" (unspecified if ongoing), notes: father had psoriasis. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Lot number: unknown), administration date: 13May2021, for COVID-19 immunisation, reaction(s): "scaly skin", "fungal infection"; Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; SKIN EXFOLIATION (medically significant), outcome "not recovered", described as "scaly skin"; FUNGAL INFECTION (medically significant), outcome "not recovered", described as "fungal infection"; PSORIASIS (medically significant), outcome "not recovered", described as "Psoriasis". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The report was 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.; Sender''s Comments: Linked Report(s) :-PFIZER INC-202101721573 same patient, same product, different events/dose.


VAERS ID: 2000113 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 3 - / IM
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER AFLBA602AB / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Blood thyroid stimulating hormone, Rash
SMQs:, Anaphylactic reaction (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypothyroidism (with recent changes (increased TSH).)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Thyroid stimulating hormone; Result Unstructured Data: (Test Result:Increased,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: PTGLAXOSMITHKLINEPT202126

Write-up: Rash on the neck, trunk and limbs; This case was reported by a other health professional via regulatory authority and described the occurrence of exanthema in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2021-2022 season) (batch number AFLBA602AB, expiry date unknown) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Influenza Vaccine Quadrivalent Pre-Filled Syringe Device) injection syringe for prophylaxis and TOZINAMERAN (COMIRNATY) (batch number FF2382, expiry date unknown) for prophylaxis. Concurrent medical conditions included hypothyroidism (with recent changes (increased TSH).). On 15th November 2021, the patient received Fluarix Tetra 2021-2022 season (intramuscular) .5 ml, Influenza Vaccine Quadrivalent Pre-Filled Syringe Device and the 3rd dose of COMIRNATY (intramuscular) .3 ml. On 17th November 2021, 2 days after receiving Fluarix Tetra 2021-2022 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device, the patient experienced exanthema (serious criteria other: Serious as per reporter). On 20th November 2021, the outcome of the exanthema was recovered/resolved. It was unknown if the reporter considered the exanthema to be related to Fluarix Tetra 2021-2022 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. This report is made by Agency without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: On an unknown date,patient thyroid stimulating hormone was recorded with unknown date. The age at vaccination was unknown. The duration for the event was 3 day. Time to onset for reported events exanthema was 2 days with respect to suspect COMIRNATY. It was unknown if the reporter considered the reported events exanthema to be related to COMIRNATY. Initial information was received from a other health care professional via regulatory authority on 31st December 2021: Rash on the neck, trunk and limbs


VAERS ID: 2000448 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006273 / 3 - / OT
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR V3J602V / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fall, General physical health deterioration
SMQs:, Accidents and injuries (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLVIDON; PARACETAMOL NET; BISOPROLOL SANDOZ; ESOMEPRAZOL SANDOZ [ESOMEPRAZOLE MAGNESIUM]; METFORMIN ACTAVIS; ELIQUIS; BETOLVIDON
Current Illness: Atrial fibrillation; Chronic obstructive pulmonary disease; Leg ulcer; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20214

Write-up: FALL; REDUCED GENERAL CONDITION; This case was received via Regulatory Agency (Reference number: SE-MPA-2021-095408) on 22-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of FALL (FALL) and GENERAL PHYSICAL HEALTH DETERIORATION (REDUCED GENERAL CONDITION) in a 92-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3006273) for COVID-19 vaccination. Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 4V (VAXIGRIPTETRA) for an unknown indication. The patient''s past medical history included COVID-19. Concurrent medical conditions included Type 2 diabetes mellitus, Chronic obstructive pulmonary disease, Leg ulcer and Atrial fibrillation. Concomitant products included FOLIC ACID (FOLVIDON), PARACETAMOL (PARACETAMOL NET), BISOPROLOL FUMARATE (BISOPROLOL SANDOZ), ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOL SANDOZ [ESOMEPRAZOLE MAGNESIUM]), METFORMIN HYDROCHLORIDE (METFORMIN ACTAVIS), APIXABAN (ELIQUIS) and CYANOCOBALAMIN (BETOLVIDON) for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE INACT SPLIT 4V (VAXIGRIPTETRA) (Subcutaneous) at an unspecified dose. On 17-Nov-2021, the patient experienced FALL (FALL) (seriousness criterion hospitalization) and GENERAL PHYSICAL HEALTH DETERIORATION (REDUCED GENERAL CONDITION) (seriousness criterion hospitalization). At the time of the report, FALL (FALL) was resolving and GENERAL PHYSICAL HEALTH DETERIORATION (REDUCED GENERAL CONDITION) had resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. Company comment. This regulatory authority case concerns a 92 � year � old, female patient with previous relevant medical history of Type 2 diabetes mellitus, Chronic obstructive pulmonary disease, Leg ulcer and Atrial fibrillation, who experienced the unexpected serious events of fall and general physical health deterioration. The events occurred one day after the administration of one dose (unknown dosage) of mRNA-1273 vaccine, considered as third dose of COVID-19 vaccine schedule. No information about previous vaccination schedule was provided. At the time of the report the outcome of the event fall was resolving, and the outcome of general physical health deterioration was recovered. Patient�s medical history of Type 2 diabetes mellitus, Chronic obstructive pulmonary disease, Leg ulcer and Atrial fibrillation could be confounder for the events. Case is further confounded by polypharmacy. The case was assessed as serious as per Regulatory Authority�s report due to hospitalization; however, no details on hospitalization dates and/or clinical course were provided in the source document. Co-suspect product included Influenza vaccine (VAXIGRIPTETRA), which remains as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 92 � year � old, female patient with previous relevant medical history of Type 2 diabetes mellitus, Chronic obstructive pulmonary disease, Leg ulcer and Atrial fibrillation, who experienced the unexpected serious events of fall and general physical health deterioration. The events occurred one day after the administration of one dose (unknown dosage) of mRNA-1273 vaccine, considered as third dose of COVID-19 vaccine schedule. No information about previous vaccination schedule was provided. At the time of the report the outcome of the event fall was resolving, and the outcome of general physical health deterioration was recovered. Patient�s medical history of Type 2 diabetes mellitus, Chronic obstructive pulmonary disease, Leg ulcer and Atrial fibrillation could be confounder for the events. Case is further confounded by polypharmacy. The case was assessed as serious as per Regulatory Authority�s report due to hospitalization; however, no details on hospitalization dates and/or clinical course were provided in the source document. Co-suspect product included Influenza vaccine (VAXIGRIPTETRA), which remains as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2002839 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Malaise, Nausea, Off label use, Product use issue, Pyrexia, Suppressed lactation
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Functional lactation disorders (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Breast feeding (newborn)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101827920

Write-up: Shivering; Decreased breastfeeding (on 20Nov2021 again ok); Fatigue; Nausea; Malaise; Fever; patient received bnt162b2 during breastfeeding; patient received bnt162b2 during breastfeeding; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority -WEB. Regulatory number: BE-FAMHP-DHH-N2021-110709 (FAMHP). A female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing), notes: newborn. The patient''s concomitant medications were not reported. The following information was reported: CHILLS (disability) with onset 18Nov2021, outcome "recovered" (19Nov2021), described as "Shivering"; SUPPRESSED LACTATION (disability) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "Decreased breastfeeding (on 20Nov2021 again ok)"; FATIGUE (disability) with onset 18Nov2021, outcome "recovered" (19Nov2021), described as "Fatigue"; NAUSEA (disability) with onset 18Nov2021, outcome "recovered" (19Nov2021), described as "Nausea"; MALAISE (disability) with onset 18Nov2021, outcome "recovered" (19Nov2021), described as "Malaise"; PYREXIA (disability) with onset 18Nov2021, outcome "recovered" (19Nov2021), described as "Fever". Reporter Comment: No treatment. Evolution of the adverse reactions was recovered with duration of 2 days. Adverse reaction description - Decreased breastfeeding (on 20Nov2021 back ok). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: No treatment. Evolution of the adverse reactions was recovered with duration of 2 days. Adverse reaction description - Decreased breastfeeding (on 20Nov2021 back ok).; Sender''s Comments: Linked Report(s) : BE-PFIZER INC-202101876032 baby case


VAERS ID: 2003544 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-08
Onset:2021-11-17
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Movement disorder
SMQs:, Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (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: DEPFIZER INC202101817777

Write-up: Movement disorder; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). Regulatory number: DE-PEI-CADR2021201659 (PEI). Other Case identifier(s): DE-CADRPEI-2021201659, DE-PEI-202100227364 (PEI). A 84 year-old female patient received bnt162b2 (COMIRNATY), intravenous, administration date 08Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: MOVEMENT DISORDER (hospitalization) with onset 17Nov2021, outcome "recovered with sequelae" (18Nov2021), described as "Movement disorder". Sender Comment: Are you or the person concerned known of any allergies? If yes, which? no Information on risk factors or previous illnesses No / There will be more analyses done. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2004346 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram thorax, Dyspnoea, Fibrin D dimer, Immunisation, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:bilateral pulmonary embolism (Clots); Test Name: d-dimer; Result Unstructured Data: Test Result:raised
CDC Split Type: GBPFIZER INC202101823421

Write-up: Booster; Shortness of breath/problem with breathing; Pulmonary embolism/bilateral pulmonary embolism; This is a spontaneous report received from a contactable reporter (Physician) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-EYC 00269301 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26344468 (MHRA). A 65 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history and not had known drug allergy. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, manufacturer unknown), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 17Nov2021, outcome "unknown", described as "Booster"; DYSPNOEA (hospitalization) with onset 2021, outcome "unknown", described as "Shortness of breath/problem with breathing"; PULMONARY EMBOLISM (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Pulmonary embolism/bilateral pulmonary embolism". The patient was hospitalized for immunisation, dyspnoea, pulmonary embolism (start date: 13Dec2021). The patient underwent the following laboratory tests and procedures: computerised tomogram thorax: bilateral pulmonary embolism (clots); fibrin d dimer: raised. The patient treated initially with blood thinner injection (Rivaroxaban) and now switched to tablet. Patient was fit and well. Patient was currently medically fit for discharge to home today as per medical consultant involved in care. Therapeutic measures were taken as a result of immunisation, dyspnoea, pulmonary embolism. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2004453 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Hypoaesthesia, Immunisation, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS; AMITRIPTYLINE; ATORVASTATIN; BENDROFLUMETHIAZIDE; OMEPRAZOLE; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; High cholesterol; Sciatica
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101824210

Write-up: Head pains; Numbness; Pins and needles; Received third dose of COMIRNATY vaccine; This is a spontaneous report received from a contactable consumer from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112171037326290-PGWRX. Other Case identifier(s): GB-MHRA-ADR 26350731. A 69-year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK0596) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sciatica" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation; AMITRIPTYLINE; ATORVASTATIN; BENDROFLUMETHIAZIDE; OMEPRAZOLE; PARACETAMOL. Vaccination history included: Bnt162b2 (DOSE 1, lot number: EL7834), administration date: 11Feb2021, for COVID-19 immunisation; Bnt162b2 (DOSE 2, lot number: ER1749), administration date: 21Mar2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 17Nov2021, outcome "unknown", described as "Received third dose of COMIRNATY vaccine"; HEADACHE (disability) with onset 01Dec2021, outcome "not recovered", described as "Head pains"; HYPOAESTHESIA (disability) with onset 01Dec2021, outcome "not recovered", described as "Numbness"; PARAESTHESIA (disability) with onset 01Dec2021, outcome "not recovered", described as "Pins and needles". The events "head pains", "numbness" and "pins and needles" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: COVID-19 virus test: No - Negative COVID-19 test. It was reported that after a week of side effects patient called 111 where they said it may be to do with nerves. Patient had stabbing pains in head as well as numbness and pins and needles in what was originally the left side of the face, and was now (at the time of this report) only on the right side of the face. It came and went an hour at a time, sometimes went and came back in the morning. Relevant investigations or tests conducted reported as nothing was done other than contacting 111 and being advised to contact general practitioner (GP). Worried to visit doctors as patient and her husband were shielding. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 2004556 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness unilateral, Blood test, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADCAL D3; ATORVASTATIN; CO-CODAMOL; FUROSEMIDE; GAVISCON ADVANCE [SODIUM ALGINATE]; METFORMIN; OMEPRAZOLE; RIVAROXABAN; SERTRALINE; PREDNISOLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid indigestion; Arthritis; Blood test abnormal; Calcium; Cholesterol; Depression; Diabetes; DVT of calf; Oesophageal acid reflux; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...); Temporal arteritis; Water retention
Allergies:
Diagnostic Lab Data: Test Name: Blood tests; Result Unstructured Data: Test Result:Temporal Arteritis; Comments: Temporal Arteritis
CDC Split Type: GBPFIZER INC202101823376

Write-up: BOOSTER; Interchange of vaccine products; Off label use; Blind right eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112171610371340-OPX5K (RA). Other Case identifier(s): GB-MHRA-ADR 26353217 (RA). A 71 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Temporal arteritis" (unspecified if ongoing); "Blood test abnormal" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...; "Giant cell arteritis" (unspecified if ongoing); "Depression" (unspecified if ongoing); "DVT of calf" (unspecified if ongoing); "Oesophageal acid reflux" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Acid indigestion" (unspecified if ongoing); "Water retention" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Calcium" (unspecified if ongoing). Concomitant medication(s) included: ADCAL D3 taken for blood calcium; ATORVASTATIN taken for blood cholesterol; CO-CODAMOL taken for arthritis; FUROSEMIDE taken for fluid retention; GAVISCON ADVANCE [SODIUM ALGINATE] taken for dyspepsia; METFORMIN taken for diabetes mellitus; OMEPRAZOLE taken for gastrooesophageal reflux disease; RIVAROXABAN taken for deep vein thrombosis; SERTRALINE taken for depression; PREDNISOLONE taken for giant cell arteritis. Vaccination history included: Covid-19 vaccine (DOSE number unknown ; Manufacturer: UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE number unknown; Manufacturer: UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "BOOSTER"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; BLINDNESS UNILATERAL (disability, medically significant) with onset 17Nov2021, outcome "not recovered", described as "Blind right eye". The patient underwent the following laboratory tests and procedures: blood test: temporal arteritis, notes: Temporal Arteritis. Clinical course: The patient had problem with right eye started immediately after injection with vast quantity of flowters across vision, then a lot of vision gone with darkness, new glasses which been tested did not work for right eye anymore. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report does not relate 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.


VAERS ID: 2004725 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea, Immunisation, Menstrual disorder, SARS-CoV-2 test
SMQs:, Fertility disorders (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: BISOPROLOL FUMARATE; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart block
Allergies:
Diagnostic Lab Data: Test Date: 20211216; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101823211

Write-up: Menstrual disorder; No menstruation; The patient received third (booster) dose.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112180752387040-IJAER (RA). Other Case identifier(s): GB-MHRA-ADR 26356716 (RA). A 40 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart block" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation, administration date 13Oct2021; BISOPROLOL FUMARATE taken for atrioventricular block, start date: 01Jun2016; RAMIPRIL taken for atrioventricular block, start date: 01Jun2016. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN; Route of administration: unspecified.), for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN; Route of administration: unspecified.), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "The patient received third (booster) dose."; MENSTRUAL DISORDER (medically significant) with onset 12Dec2021, outcome "not recovered", described as "Menstrual disorder"; AMENORRHOEA (non-serious) with onset 12Dec2021, outcome "unknown", described as "No menstruation". No menstruation since having the booster inoculation. Now at 30 days since end of last period. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had no symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Dec2021) no - negative covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2005166 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, SARS-CoV-2 test, Vaccination site mass, Vaccination site pain
SMQs:, Medication errors (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101828977

Write-up: Enlarged lymph nodes (excl infective); Armpit pain; Injection site lump; Injection site pain; 3rd dose has a been administered and the patient has not previously received the full primary immunization series of BNT162b2 vaccination; 3rd dose has a been administered and the patient has not previously received the full primary immunization series of BNT162b2 vaccination; 3rd dose has a been administered and the patient has not previously received the full primary immunization series of BNT162b2 vaccination; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112191726305460-XX2N5 (RA). Other Case identifier(s): GB-MHRA-ADR 26360151 (RA). A 41 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK9706) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant; Patient is not currently breastfeeding. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1; MANUFACTUERER UNKNOWN), administration date: 22Apr2021, for COVID-19 IMMUNISATION; Covid-19 vaccine astrazeneca (DOSE 2; MANUFACTUERER UNKNOWN), administration date: 23Jun2021, 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 17Nov2021, outcome "unknown" and all described as "3rd dose has a been administered and the patient has not previously received the full primary immunization series of BNT162b2 vaccination"; LYMPHADENOPATHY (medically significant) with onset 18Dec2021, outcome "not recovered", described as "Enlarged lymph nodes (excl infective)"; AXILLARY PAIN (medically significant) with onset 18Dec2021, outcome "not recovered", described as "Armpit pain"; VACCINATION SITE MASS (medically significant) with onset 18Dec2021, outcome "not recovered", described as "Injection site lump"; VACCINATION SITE PAIN (medically significant) with onset 17Dec2021, outcome "not recovered", described as "Injection site pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2007264 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-11-17
   Days after vaccination:104
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad), 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101845597

Write-up: Perimyocarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: DE-PEI-CADR2021211046. Other Case identifier(s): DE-CADRPEI-2021211046, DE-PEI-202100262917. A 24 year-old male patient received bnt162b2 (COMIRNATY), administration date 05Aug2021 (Lot number: FE6975) at the age of 24 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single; MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization) with onset 17Nov2021, outcome "recovering", described as "Perimyocarditis". Clinical Course: Relatedness of the drug to the event: Peri-myocarditis was reported as D. Unclassifiable by the regulatory authority (RA). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2007309 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCTN4 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Cyanosis, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101830545

Write-up: Syncope; acute loss of consciousness; outbreak of cold sweat; cyanosis; 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-CADR2021224970. Other Case identifier(s): DE-CADRPEI-2021224970, DE-PEI-202100278859. A 37-year-old female patient received bnt162b2 (COMIRNATY), administration date 10Nov2021 (Lot number: SCTN4) as dose number unknown, 0.3ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (hospitalization) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Syncope"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "acute loss of consciousness"; COLD SWEAT (non-serious), outcome "unknown", described as "outbreak of cold sweat"; CYANOSIS (non-serious), outcome "unknown", described as "cyanosis". Therapeutic measures were taken as a result of syncope, loss of consciousness, cold sweat, cyanosis.


VAERS ID: 2007568 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-11-17
   Days after vaccination:99
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (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: FRMODERNATX, INC.MOD20214

Write-up: Miscarriage; This case was received via Regulatory Agency (Reference number: FR-AFSSAPS-PC20215299) on 23-Dec-2021 and was forwarded to Moderna on 23-Dec-2021. This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214011) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form once a day. Last menstrual period and estimated date of delivery were not provided. On 17-Nov-2021, after starting mRNA-1273 (Spikevax), the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The delivery occurred on 17-Nov-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication information was not reported by the reporter. Treatment information was not reported by the reporter. Company comment:This RA case concerns female patient of 36 years with no relevant medical history, who experienced the unexpected event of Abortion Spontaneous. The event Abortion Spontaneous occurred 99 days days after the second dose of mRNA-1273 vaccine. Patient''s Last menstrual period and estimated date of delivery was not reported. The outcome for event Abortion spontaneous was resolved.The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority''s report due to important medical condition.; Sender''s Comments: This RA case concerns female patient of 36 years with no relevant medical history, who experienced the unexpected event of Abortion Spontaneous. The event Abortion Spontaneous occurred 99 days days after the second dose of mRNA-1273 vaccine. Patient''s Last menstrual period and estimated date of delivery was not reported. The outcome for event Abortion spontaneous was resolved.The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority''s report due to important medical condition.


VAERS ID: 2007686 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Eye pain, Feeling abnormal, Headache, Hypoaesthesia, Inappropriate schedule of product administration, Platelet count
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Medication errors (narrow), Sexual dysfunction (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:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: No significant history to note
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Bloods; Result Unstructured Data: Test Result:as per protocol; Test Date: 2021; Test Name: platelets; Result Unstructured Data: Test Result:unremarkable
CDC Split Type: GBPFIZER INC202101839097

Write-up: Numbness facial/left hand side of face numbness; Inappropriate schedule of vaccine administered; headache; numbness; pain behind left eye with it; Left side off mouth felt different/Left eye felt different; This is a spontaneous report received from contactable reporter(s) (Other HCPs) from the Regulatory Agency-WEB. Regulatory number: GB-MHRA-WEBCOVID-202112161037543540-9CTQN. Other Case identifier(s): GB-MHRA-ADR 26343371. A 35 year-old male patient received bnt162b2 (COMIRNATY,Solution for injection), administration date 17Nov2021 (Lot number: FK0596) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. No significant history to note. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. There were no concomitant medications. Currently on no medications or no medications recently. Vaccination history included: Comirnaty (Dose 1), administration date: 23Sep2021, for COVID-19 Immunization. The following information was reported: HYPOAESTHESIA (medically significant) with onset 17Nov2021, outcome "unknown", described as "Numbness facial/left hand side of face numbness"; HEADACHE (medically significant) with onset 2021, outcome "not recovered", described as "headache"; HYPOAESTHESIA (medically significant) with onset 2021, outcome "not recovered", described as "numbness"; EYE PAIN (medically significant) with onset 2021, outcome "unknown", described as "pain behind left eye with it"; FEELING ABNORMAL (medically significant) with onset 2021, outcome "unknown", described as "Left side off mouth felt different/Left eye felt different"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "numbness facial/left hand side of face numbness", "headache", "numbness", "pain behind left eye with it" and "left side off mouth felt different/left eye felt different" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) as per protocol; platelet count: (2021) unremarkable. Clinical course: Patient presented to GP after receiving second Pfizer Covid19 vaccination. One hour later patient experienced left hand side of face numbness. Had headache and pain behind left eye with it. Left side off mouth felt different. Able to close eyes fully. Left eye felt different. Facial movements normal. No drooping off eye lid etc. Send to Emergency department - Bloods as per protocol, platelets unremarkable, reassured and home. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reaction: Does your report relate to possible blood clots or low platelet counts? If yes, we will ask you additional questions at the end of this report: "No". Does your report relate to possible myocarditis or pericarditis? If yes, we will ask you additional questions at the end of this report: "No". Suspect Reactions: Please provide details of any relevant investigations or tests conducted: "As above". No follow-up attempts are needed. No further information is expected.


VAERS ID: 2007867 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Retroperitoneal fibrosis (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101829280

Write-up: Low back pain/Severe back pain; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112200023283800-VR1RN. Other Case identifier(s): GB-MHRA-ADR 26360978. A 36 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Primary Immunization series complete but unknown manufacturer, ), for COVID-19 immunisation; Covid-19 vaccine (Dose 2; Primary Immunization series complete but unknown manufacturer, ), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; BACK PAIN (medically significant) with onset 16Dec2021, outcome "recovered" (17Dec2021), described as "Low back pain/Severe back pain". Therapeutic measures were taken as a result of back pain. The clinical course was reported as follows: Patient last menstrual period date: 24-NOV-2021. Patient had not symptoms associated with COVID-19 or had not a COVID-19 test. Severe back pain but pain was relieved after taking ibuprofen but kicks again after 3 hours from taking the ibuprofen, so I just have to kill the pain with pain killers. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2008006 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8649 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abscess, Arthralgia, Cough, Gingival recession, Immunisation, Loose tooth, Mass, Oropharyngeal pain, Pain in jaw, Pneumonia, Productive cough, SARS-CoV-2 test, Toothache
SMQs:, Anaphylactic reaction (broad), Gingival disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101839138

Write-up: Abscess; Loose tooth; Chronic sore throat; Chronic cough; Jaw pain; Phlegm; Aching joints; Tooth pain; Booster; pneumonia; cough; rock hard lump below one tooth; gums receded; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The Regulatory Authority number GB-MHRA-WEBCOVID-202112201133547410-LWBYC, other case identifier(s) GB-MHRA-ADR 26363216. A 54 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH8649) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose 1), administration date: 25Feb2021, for Covid-19 immunisation; Bnt162b2 (Dose 2), administration date: 14May2021, for Covid-19 immunisation; Pneumonia vaccination, administration date: 2018, for pneumonia. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome unknown; PNEUMONIA (medically significant) with onset 2021, outcome not recovered; COUGH (medically significant) with onset 2021, outcome not recovered; ARTHRALGIA (medically significant) with onset 19Nov2021, outcome recovered with sequelae (17Dec2021); TOOTHACHE (medically significant) with onset 19Nov2021, outcome recovering; COUGH (medically significant) with onset 20Nov2021, outcome recovering; PAIN IN JAW (medically significant) with onset 20Nov2021, outcome recovered with sequelae (15Dec2021); PRODUCTIVE COUGH (medically significant) with onset 20Nov2021, outcome recovering; OROPHARYNGEAL PAIN (medically significant) with onset 22Nov2021, outcome recovering; LOOSE TOOTH (medically significant) with onset 23Nov2021, outcome not recovered; ABSCESS (medically significant) with onset 24Nov2021, outcome not recovered; MASS (medically significant) with onset 2021, outcome unknown; GINGIVAL RECESSION (medically significant) with onset 2021, outcome unknown. The patient underwent the following laboratory tests and procedures sars-cov-2 test negative, No - Negative COVID-19 test. Patient has not had symptoms associated with COVID-19. Severe jaw ache with gums receded, teeth loose along right lower jaw. Abscess now on lower jaw, rock hard lump below one tooth. Gums now seem to be better, most teeth now not loose. It went as quick as it arrived. Gut wrenching cough like when I had pneumonia with lots of phlem off of chest. Not brown as with pneumonia. Did have pneumonia vaccination in 2018 so perhaps stopped it getting hold. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2009550 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-11-17
   Days after vaccination:232
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1749 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Maternal exposure during breast feeding
SMQs:, Neonatal exposures via breast milk (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101846085

Write-up: Maternal exposure during breast feeding; booster; MHRA YELLOW CARD VACCINE MONITOR This is a solicited report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from a Regulatory Authority for a sponsored program. Regulatory number: GB-MHRA-YCVM-202103282143367450. Other Case identifier(s): GB-MHRA-ADR 26372243. A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: ER1749) as dose 2, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number 1, Batch/lot number: EL0141), administration date: 18Jan2021, for COVID-19 Immunization. The following information was reported: MATERNAL EXPOSURE DURING BREAST FEEDING (medically significant), outcome "unknown", described as "Maternal exposure during breast feeding"; IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "booster". Clinical course: On 17Nov2021 patient experienced muscle ache and outcome of event reported as recovered on 18Nov2021. Patient last menstrual period date was reported as 31Oct2020. Patient has not had symptoms associated with COVID-19. Patient did not have a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The reporters assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 2009663 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-01
Onset:2021-11-17
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Angina pectoris, Pain, Pericarditis, Skin discolouration, Ultrasound scan, X-ray
SMQs:, Systemic lupus erythematosus (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Baby asprin
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Ultra sounds and X-rays
CDC Split Type:

Write-up: Pericarditis, stabbing heart and body pains. Purple/black circles on my body. Head feels like it?s leaking on left side only.


VAERS ID: 2009781 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (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: Test Date: 202112; Test Name: COVID-19 virus test; Test Result: Positive; Comments: confirmed as COVID-19 with mutant strain of L452R.
CDC Split Type: HKPFIZER INC202101884536

Write-up: This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2021FOS007482. This is a spontaneous report received from a non-contactable HCP received via Department of Health (DH). The regulatory authority report number is not applicable. As of 0:00 am, 20-Dec-2021, DH announced that five additional confirmed cases of COVID-19 after Comirnaty vaccination. This report was split for 1 of 5 patients that confirmed COVID-19 after Comirnaty vaccination. A 78-year-old male patient receive 1st and 2nd dose of Tozinameran (COMIRNATY) (lot number: unknown) on 11-Mar-2021 and 07-Apr-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. The patient had received 3rd doses of (COMIRNATY) (lot number: unknown) on 17-Nov-2021. Medical history, concomitant medication(s) and past product were not reported. On 19-Dec-2021, he arrived via flight. In December 2021, the patient tested positive. He was asymptomatic and confirmed as COVID-19 with mutant strain of L452R. The adverse event ''confirmed case of COVID-19/imported case with mutant strain of L452R'' and ''received 3rd dose of Tozinameran (COMIRNATY) on 17/11/2021. The first two dose was given Tozinameran (COMIRNATY) on 11/03/2021 and 07/04/2021'' were considered as Important Medical Event. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 21-Dec-2021. This case was split from AER (master case No.2021FOS007464) due to same reporter/product, different event/patient. Follow-up closed; no further information is possible. Causality Assessments. Asymptomatic COVID-19, Vaccination failure, Booster. Per Reporter = Possible. Per Company (BioNTech SE) = Possible.


VAERS ID: 2009920 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Vertigo
SMQs:, Vestibular 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: ATPFIZER INC202101859219

Write-up: vertigo / Rotatory vertigo; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: AT-BASGAGES-2021-063770 Regulatory Authority. A 69 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single, manufacturer unknown), for covid-19 immunisation; Covid-19 vaccine (dose 2, single, manufacturer unknown), for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; VERTIGO (medically significant) with onset 18Nov2021, outcome "not recovered", described as "vertigo / Rotatory vertigo". It was not possible for the patient to drive the car, otherwise it would inevitably have resulted in a disaster. Otherwise, no impairments. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2011514 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Immunisation, Interchange of vaccine products, Menstrual disorder, Off label use, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Medication errors (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: DESOGESTREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Oral contraception
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101846308

Write-up: menstrual cycle; Menstrual flow excessive; Off-Label Use; BOOSTER; INTERCHANGE OF VACCINE PRODUCT; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from The Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112211141458420-SG1TG (MHRA). Other Case identifier(s): GB-MHRA-ADR 26370683 (MHRA). A female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Oral contraception" (unspecified if ongoing). Concomitant medication(s) included: DESOGESTREL taken for oral contraception. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), administration date: 24Feb2021, for COVID-19 immunization; Covid-19 vaccine astrazeneca (DOSE 2, Menstrual disorder- 10Sep2021 , Outcome- Not recovered/Not resolved), administration date: 12May2021, for COVID-19 immunization, reaction(s): "Menstrual disorder". The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off-Label Use"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "BOOSTER"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "INTERCHANGE OF VACCINE PRODUCT"; MENSTRUAL DISORDER (medically significant), outcome "unknown", described as "menstrual cycle"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Menstrual flow excessive". Patient has had a consistent menstrual cycle for a number of years, there have been no changes to their contraceptive pill (desogestrel). The patient takes this as recommended. No issues reported with this. Patient tracks their menstrual cycle regularly. Prolonged Menstrual bleeding first occurred in September 2021. This began again having received the Pfizer vaccine booster in November. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. The outcome of the event menstrual disorder was unknown and for heavy menstrual bleeding was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2011904 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Interchange of vaccine products, Off label use, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Medication errors (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: NEBIVOLOL; TELMISARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test/COVID PCR test; Test Result: Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101852436

Write-up: off label use; Interchange of vaccine products; Booster; Fatigue; Pins and needles; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) Regulatory number: GB-MHRA-WEBCOVID-202112221158061440-ZPXVZ. Other Case identifier: GB-MHRA-ADR 26377722. A 42-year-old male patient received BNT162B2 (COMIRNATY) (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Concomitant medications included: NEBIVOLOL taken for hypertension, start date: Sep2020; TELMISARTAN taken for hypertension, start date: Sep2020. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; FATIGUE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Fatigue"; PARAESTHESIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Pins and needles". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: symptoms of fatigue and pins and needles in the thigh started soon after having the booster. These are new symptoms which occurred after the booster. Did not have these during the first two vaccines. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2015240 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-11-17
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (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? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: so far no symptoms
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101859596

Write-up: pulmonary embolism on the left; This is a spontaneous report received from a contactable reporter(s) (Physician) from the WEB. Regulatory number: CZ-CZSUKL-21013363 (CZSUKL). A 52 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 29Jun2021 (Lot number: FD6840) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. So far asymptomatic patient. Vaccination history included: Comirnaty (Dose:1, batch/lot number FA4598, route of administration: intramuscular), administration date: 18May2021, for Covid-19 immunisation. The following information was reported: PULMONARY EMBOLISM (hospitalization, medically significant) with onset 17Nov2021, outcome "unknown", described as "pulmonary embolism on the left". The patient was hospitalized for pulmonary embolism (start date: 17Nov2021, discharge date: 23Nov2021, hospitalization duration: 6 day(s)). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2015271 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-11-17
   Days after vaccination:264
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Suspected COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: DEPFIZER INC202101865855

Write-up: Drug ineffective; Suspected COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB and product quality group. Regulatory number: DE-PEI-202100279409. A 37 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 26Feb2021 (Lot number: EY6789) at the age of 36 years as dose 2, single and intramuscular, administration date 05Feb2021 (Lot number: EK9788) as dose 1, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Drug ineffective"; SUSPECTED COVID-19 (medically significant) with onset 17Nov2021, outcome "unknown", described as "Suspected COVID-19". Sender''s Comment: Initials: PRIVAC. Relatedness of drug to reaction(s)/event(s). Source of assessment: RA; Result of Assessment: Indeterminate. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2015282 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SDEJ8 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Encephalitis, Hemianopia, Immunisation, Interchange of vaccine products, Lumbar puncture, Magnetic resonance imaging, Off label use, Visual field tests
SMQs:, Noninfectious encephalitis (narrow), Optic nerve disorders (broad), Medication errors (broad), 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CSF; Result Unstructured Data: Test Result:unknown results; Test Name: eMRI; Result Unstructured Data: Test Result:unknown results; Test Name: ophthalmological perimetry; Result Unstructured Data: Test Result:unknown results
CDC Split Type: DEPFIZER INC202101859999

Write-up: acute hemianopia in suspected acute diss. Encephaltis diss.; off label use; interchange of vaccine products; booster; pathogen-induced meningoencephalitis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: DE-PEI-202100281895 Regulatory Authority. A male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: SDEJ8) as dose 2 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen (1st dose), for covid-19 immunisation. The following information was reported: OFF LABEL USE (hospitalization, medically significant) with onset 17Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant) with onset 17Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (hospitalization, medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; HEMIANOPIA (hospitalization, medically significant) with onset 23Nov2021, outcome "not recovered", described as "acute hemianopia in suspected acute diss. Encephaltis diss."; ENCEPHALITIS (medically significant), outcome "unknown", described as "pathogen-induced meningoencephalitis". The patient underwent the following laboratory tests and procedures: lumbar puncture: unknown results; magnetic resonance imaging: unknown results; visual field tests: unknown results. Clinical information: Diagnosis: ophthalmological perimetry, eMRI, lumbar puncture , visual, sensory and motor evoked potentials. Exclusion: Ischaemia, space-occupying lesion, pathogen-induced meningoencephalitis. Relatedness of drug to all reactions/events Source of assessment: Regulatory Authority Result of Assessment: unclassifiable


VAERS ID: 2015283 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCTD6 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Immunisation
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101860014

Write-up: booster; Anaphylactic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The Regulatory Authority number DE-PEI-202100282742. A 50 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: SCTD6) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included Comirnaty (dose 1), administration date: 13Jan2021, for covid-19 immunisation; Comirnaty (dose 2), administration date: 03Feb2021, for covid-19 immunisation. The following information was reported IMMUNISATION (medically significant), outcome unknown; ANAPHYLACTIC REACTION (medically significant) with onset 17Nov2021, outcome unknown. One on 13Jan2021 and the patient got the second vaccination with Comirnaty BioNTech on 03Feb2021. Relatedness of drug to event included Anaphylactic reaction. Source of assessment, Result of Assessment Indeterminate. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2015436 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 15024A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial flutter
SMQs:, Supraventricular tachyarrhythmias (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac ablation; Cold allergy; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101859811

Write-up: Persistent atrial flutter with the need for cardioversion; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the RA. Regulatory number: DE-PEI-CADR2021214728. Other Case identifier(s): DE-CADRPEI-2021214728 (PEI Webportal), DE-PEI-202100266912. A 73 year-old male patient received bnt162b2 (COMIRNATY), administration date 10Nov2021 (Lot number: 15024A) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Cold urticaria/cold allergy" (unspecified if ongoing); "Cardiac ablation/Ablation for atrial fibrillation" (unspecified if ongoing); "atrial fibrillation" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: ATRIAL FLUTTER (hospitalization) with onset 17Nov2021, outcome "recovered" (25Nov2021), described as "Persistent atrial flutter with the need for cardioversion". Therapeutic measures were taken as a result of atrial flutter including drug therapy that did not help. It was reported that cardioversion would have to be performed. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? Cold allergy Information on risk factors or previous illnesses: Ablation for atrial fibrillation and hypertension, but medically adjusted. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2015837 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Interchange of vaccine products, Migraine with aura, Neck pain, Off label use, Pain, Rash erythematous, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BEZALIP-MONO; CODEINE; PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: High cholesterol; Knee pain; Migraine
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101857926

Write-up: This is a spontaneous report received from a contactable reporter (Consumer) from Regulatory Authority (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112231655047160-7XSM9 (RA). Other Case identifier: GB-MHRA-ADR 26386622 (RA). A 68-year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FA4751) at the age of 68 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "High cholesterol", "Knee pain", and "Migraine". Concomitant medications included: INFLUENZA VIRUS taken for influenza immunisation, administration date 02Nov2021; BEZALIP-MONO taken for blood cholesterol increased; CODEINE taken for arthralgia; PROPRANOLOL taken for migraine. Vaccination history included: Covid-19 vaccine astrazeneca (Dose-1,), administration date: 13Feb2021 and (Dose-2), administration date: 24Apr2021, for COVID-19 immunisation. The following information was reported: RASH ERYTHEMATOUS (disability) with onset 17Nov2021, outcome "recovered" (19Nov2021), described as "Rash"; MIGRAINE WITH AURA (disability) with onset 18Nov2021, outcome "recovered with sequelae" (19Nov2021), described as "Migraine"; HEADACHE (disability) with onset 19Nov2021, outcome "not recovered", described as "Headache"; PAIN (disability), outcome "unknown", described as "pain was 10/10"; NECK PAIN (disability), outcome "unknown", described as "headaches (coming from the back of my head/neck)". Clinical course: a bright red rash appeared all over my chest and around my back. This lasted about 2 -3 days. Within a few hours I had my first visual aura type migraine, then 3 more followed within 24 hours. The pain was 10/10. Since then, I have suffered with headaches (coming from the back of my head/neck). Nothing seems to get rid of them. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2015843 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, COVID-19, Cough, Drug ineffective, Immunisation, Presyncope, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Medical History/Concurrent Conditions: Heartbeats irregular
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101856524

Write-up: Near fainting; Coughing; Stomach pain; BOOSTER; Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112231859255840-Z6VNL. Other Case identifier(s): GB-MHRA-ADR 26387302. A 32 year-old female patient received bnt162b2 (COMIRNATY), administration date 21Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heartbeats irregular" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Flecainide acetate for Heartbeats irregular. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 17Nov2021, outcome "recovered" (28Nov2021), described as "Drug ineffective"; COVID-19 (medically significant) with onset 17Nov2021, outcome "recovered" (28Nov2021), described as "COVID-19"; IMMUNISATION (medically significant) with onset 21Dec2021, described as "BOOSTER"; ABDOMINAL PAIN UPPER (medically significant) with onset 22Dec2021, outcome "not recovered", described as "Stomach pain"; PRESYNCOPE (medically significant) with onset 23Dec2021, outcome "recovering", described as "Near fainting"; COUGH (medically significant) with onset 22Dec2021, outcome "not recovered", described as "Coughing". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) yes - positive covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2016556 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
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: PHPFIZER INC202101844644

Write-up: Anaphylactic Shock; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300127643. A 15 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: PCB0002) at the age of 15 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC SHOCK (life threatening) with onset 17Nov2021 12:51, outcome "recovered" (17Nov2021 08:21), described as "Anaphylactic Shock". Clinical Course: Event stop date: 17-NOV-2021 08:21 No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.


VAERS ID: 2016695 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1014A / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Blood disorder, Lymphatic disorder, Tachycardia
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Dehydration (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: PTPFIZER INC202101838871

Write-up: Arrhythmia; blood / disorder; lymphatic/ disorder; Nocturnal Tachycardia; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. Regulatory number: PT-INFARMED-E202112-1102 (RA). A 52 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 10Nov2021 (Lot number: 1F1014A) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: TACHYCARDIA (medically significant) with onset 17Nov2021, outcome "unknown", described as "Nocturnal Tachycardia"; ARRHYTHMIA (medically significant), outcome "unknown", described as "Arrhythmia"; BLOOD DISORDER (non-serious), outcome "unknown", described as "blood / disorder"; LYMPHATIC DISORDER (non-serious), outcome "unknown", described as "lymphatic/ disorder". Therapeutic measures were not taken as a result of tachycardia. Clinical course: The adverse reaction involved blood, lymphatic and cardiovascular (arrythmia) disease. Observation at hospital was required. Specific treatment for adverse reaction included sedoxil but it was not taken. Medication Error was not applicable. A protuberance on armpit happened after 2nd dose of Comirnat, lot FG7898 on 02Dec2021. The reporter''s assessment of the causal relationship of the [Nocturnal Tachycardia] with the suspect product per Notifier was probable. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : PT-PFIZER INC-202101863518 Same patient and drug, different dose and events


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