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From the 10/15/2021 release of VAERS data:

Found 800,916 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 244 out of 8,010

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VAERS ID: 1729155 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Colitis ulcerative, Dysuria, Fatigue, Heavy menstrual bleeding, Myalgia, Rectal haemorrhage, Renal pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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: MESALAZINE
Current Illness: Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis))
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic diarrhoea; Chronic fatigue; Colitis; Epstein Barr virus positive mucocutaneous ulcer (Epstein bar virus reactivation); Iron deficiency (low iron); Lyme disease (chronic Lyme)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: ulcerative colitis; severe back pain around kidneys and pain urinating day after vaccine; fatigue; painful urinating; body aches; Rectal bleeding; Kidney pain; Heavy periods; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25929279) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding), COLITIS ULCERATIVE (ulcerative colitis), BACK PAIN (severe back pain around kidneys and pain urinating day after vaccine), HEAVY MENSTRUAL BLEEDING (Heavy periods), RENAL PAIN (Kidney pain) and FATIGUE (fatigue) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Chronic fatigue, Chronic diarrhoea, Colitis, Lyme disease (chronic Lyme), Epstein Barr virus positive mucocutaneous ulcer (Epstein bar virus reactivation) and Iron deficiency (low iron). Concurrent medical conditions included Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)). Concomitant products included MESALAZINE for Autoimmune colitis. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant). On 10-Sep-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant) and RENAL PAIN (Kidney pain) (seriousness criterion medically significant). On an unknown date, the patient experienced COLITIS ULCERATIVE (ulcerative colitis) (seriousness criterion medically significant), BACK PAIN (severe back pain around kidneys and pain urinating day after vaccine) (seriousness criterion medically significant), FATIGUE (fatigue) (seriousness criterion medically significant), DYSURIA (painful urinating) and MYALGIA (body aches). On 11-Sep-2021, HEAVY MENSTRUAL BLEEDING (Heavy periods) had resolved. At the time of the report, RECTAL HAEMORRHAGE (Rectal bleeding) had not resolved, COLITIS ULCERATIVE (ulcerative colitis), BACK PAIN (severe back pain around kidneys and pain urinating day after vaccine), RENAL PAIN (Kidney pain) and FATIGUE (fatigue) had resolved and DYSURIA (painful urinating) and MYALGIA (body aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was reported. Reported that Long term colitis Also diagnosed with chronic Lyme, Epstein bar virus reactivation and chronic fatigue, low iron. Up and down with inflammatory symptoms over last few years Reported that severe back pain around kidneys and pain urinating day after vaccine, with extreme fatigue and body aches. Next day a flare of known ulcerative colitis occurred, main symptoms rectal bleeding. Was also on patient''s period which was heavier than normal. Company Comment: This case concerns a 33-year-old, female patient with previous relevant medical history of chronic fatigue, chronic diarrhoea, colitis, Lyme disease (chronic Lyme), Inflammatory bowel disease, who experienced the unexpected events of fatigue, renal pain, back pain, heavy menstrual bleeding, rectal haemorrhage and colitis ulcerative. The events occurred between 3 and 4 days after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The medical history of chronic fatigue, chronic diarrhoea, colitis, Lyme disease (chronic Lyme), Inflammatory bowel disease, remains a confounder for fatigue, rectal haemorrhage and colitis ulcerative. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 33-year-old, female patient with previous relevant medical history of chronic fatigue, chronic diarrhoea, colitis, Lyme disease (chronic Lyme), Inflammatory bowel disease, who experienced the unexpected events of fatigue, renal pain, back pain, heavy menstrual bleeding, rectal haemorrhage and colitis ulcerative. The events occurred between 3 and 4 days after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The medical history of chronic fatigue, chronic diarrhoea, colitis, Lyme disease (chronic Lyme), Inflammatory bowel disease, remains a confounder for fatigue, rectal haemorrhage and colitis ulcerative. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1729174 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angioedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Angioedema; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25937431) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANGIOEDEMA (Angioedema) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (Angioedema) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Patient suffered angioedema of her lips following the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Treatment product was not provided by the reporter. Company comment: This case concerns a 29-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Angioedema. The event occurred approximately 1 day after the second dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge was unknown since no information about the first dose was disclosed. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) in not affected by this report.; Sender''s Comments: This case concerns a 29-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Angioedema. The event occurred approximately 1 day after the second dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge was unknown since no information about the first dose was disclosed. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) in not affected by this report.


VAERS ID: 1729552 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-09-08
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Multiple injuries, Pleural thickening, Pulmonary embolism, Respiratory failure
SMQs:, Anaphylactic reaction (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, venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? Yes
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: ITPFIZER INC202101228464

Write-up: multiple subpleuric thicknesses; politrauma; hypoxemic respiratory insufficiency; pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-785977. A 49-year-old female patient received first dose of bnt162b2 (COMIRNATY; solution for injection), via intramuscular route, administered in right arm on 17Aug2021 (Lot Number: FG4686; Expiration Date: 30Nov2021) at 12:05 hours as 0.3 mL, single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 08Sep2021, the patient experienced hypoxemic respiratory insufficiency due to pulmonary embolism. On an unspecified date, the patient experienced multiple subpleuric thicknesses in results of polytrauma. All events considered as life-threatening. The clinical outcome of the events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1729587 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure measurement, Body temperature, Feeling abnormal, Hyperhidrosis, Hypotension, Nausea, Pallor, Presyncope
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: ROSUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylactic shock (at about 50-year-old)
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: Blood pressure; Result Unstructured Data: Test Result:systolic blood pressure decreased to 58 mmHg; Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101177954

Write-up: feels poorly; queasy; pallor facial; sweaty on the face; Anaphylactic shock; systolic blood pressure decreased to 58 mmHg/ vagal reflex hypotension; vagal reflex; This is a spontaneous report from a contactable physician (vaccinator) received from the Regulatory Authority (RA). Regulatory authority report number is v21127361. A 59-years-old male patient received bnt162b2 (COMIRNATY Solution for injection), via an unspecified route of administration on 08Sep2021 11:30 (Batch/Lot Number: FG0978; Expiration Date: 30Nov2021) as DOSE 1, SINGLE (59-year and 0-month-old age at vaccination) for covid-19 immunisation. Medical history included anaphylactic shock from 2012 to 2012 at about 50-year-old. Concomitant medication included rosuvastatin (ROSUVASTATIN) unknown route and dose, taken for hypercholesterolaemia, start and stop date were not reported. The patient previously took atorvastatin in 1992 for hypercholesterolaemia. The patient had hypercholesterolaemia since about 30-year-old and took oral atorvastatin at that time. Body temperature before vaccination was 36.4 degrees Centigrade on 08Sep2021. The patient had no family history. The patient was transported to hospital by ambulance at about 50-year-old, due to anaphylactic shock caused by unknown reason, but the details were unknown. The patient had hypercholesterolaemia since about 30-year-old and took oral atorvastatin at that time. "At this reporting time, the patient was taking oral Rosuvastatin 5mg". On 08Sep2021 at 11:30 (the day of vaccination), the patient received the first dose of BNT162b2. The course of the event was as follows: About 5 minutes after the vaccination, the patient claimed of feels poorly, queasy. Blood pressure was measured, systolic blood pressure decreased to 58 mmHg on 08Sep2021 and the patient experienced pallor facial as well as sweaty on the face on 08Sep2021. The reporting physician (vaccinator) classified the event as non-serious and assessed that the event was related to BNT162b2. Other possible cause of the event such as any other diseases was vagal reflex hypotension, which could not be completely denied. The reporting physician (vaccinator) commented as follows: Since the patient had a medical history of anaphylactic shock, it was considered as anaphylactic shock this time too. However, about 10 minutes after intramuscular injection of catecholamine 0.3 mg, blood pressure increased, and the symptoms mostly recovered. So the possibility of vasovagal reflex could not be completely denied. The patient underwent lab tests and procedures which included blood pressure: systolic blood pressure decreased to 58 mmhg on 08Sep2021, body temperature: 36.4 centigrade on 08Sep2021 Before vaccination. Outcome of the events was recovered on 08Sep2021 (the same day of the vaccination).


VAERS ID: 1729594 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fear of injection, Hypersensitivity, Neurosis, Oropharyngeal discomfort, Stress, Vital signs measurement
SMQs:, Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (Allergy in childhood, now recovered.)
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination; Test Date: 20210908; Test Name: Vital signs; Result Unstructured Data: Test Result:did not become unstable
CDC Split Type: JPPFIZER INC202101179906

Write-up: Mild Allergic reaction; Pharynx strange sensation of; Stress reaction; Fear of injection; Neurosis; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126253. A 22-year and 8-month-old male patient received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration on 08Sep2021 at 13:52 (Batch/Lot Number: FF2782; Expiration Date: 30Nov2021, at age 22-year and 8-month-old at vaccination) as a single dose for COVID-19 immunisation. Medical history included hypersensitivity (allergy in childhood which was now recovered). Concomitant medications were not reported. Body temperature before vaccination on 08Sep2021 was 36.9 degrees Centigrade. On 08Sep2021 at 13:52 (the day of vaccination), the patient received the first dose of BNT162B2. On 08Sep2021 at 14:30 (38 minutes after the vaccination), the patient experienced strange sensation of pharynx appeared. There were no other symptoms of anaphylaxis or dyspnoea. The patient was judged to have a very mild allergic reaction, and FAMOTIDINE and POLARAMINE (1A) were administered by IV. His vital signs did not become unstable during observation. The symptom improved after the IV treatment. On 08Sep2021 (the day of vaccination), the outcome of the event was recovered. The reporting physician classified the event as non-serious and assessed the causality between the event and BNT162B2 as unassessable. Other possible cause of the event such as any other disease was reported as neurosis. The reporting physician commented that the patient''s fear of injection was strong. The event also lacked an anaphylactic-like reaction, however he suspected an allergy, but the event could also be a stress reaction. The outcome of the events mild allergic reaction with strange sensation of pharynx and possible stress reaction, fear of injection and neurosis was recovered on 08Sep2021.


VAERS ID: 1729606 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5357 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? 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 Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101183875

Write-up: Loss of consciousness; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126316. A 19-year and 10-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection; Lot number: FF5357, Expiration date: 30Nov2021) via an unspecified route of administration on 08Sep2021 16:25 (at the age of 19-year and 10-month-old), as dose 1, single for COVID-19 immunisation. Patient has no relevant medical history. The patient''s concomitant medications were not reported. The patient experienced loss of consciousness on 08Sep2021 16:26. The patient underwent lab tests and procedures which included body temperature: 36.5 centigrade on 08Sep2021 before vaccination. The course of the event was as follows: After corona virus vaccination, the patient sat on a chair, and lost consciousness for few seconds. Immediately, consciousness was regained. Event was assessed as serious (medically significant). The outcome of event was recovered on 08Sep2021. The reporting physician classified the event as serious and assessed that the causality between the event and bnt162b2 as unassessable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1729612 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
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 Date: 20210907; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 degrees Centigrade; Comments: Before vaccination; Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: Test Result:39.2 degrees Centigrade; Comments: from the morning; pyrexia; Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: Test Result:40.2 degrees Centigrade; Comments: at noon; pyrexia; Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 degrees Centigrade; Comments: 17:20
CDC Split Type: JPPFIZER INC202101183980

Write-up: pyrexia of 40.2/ 39.2/ degrees Centigrade; chills/shivering; This is a spontaneous report from a contactable physician (vaccinator) received from the regulatory authority, regulatory authority report number is v21126317. A 17-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 07Sep2021 14:30 (Lot Number: FE8162; Expiration Date: 30Nov2021) (at the age of 17 years old) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were reported as none. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Body temperature before vaccination was 36.6 degrees Centigrade on 07Sep2021. On 08Sep2021 in the morning (1 day after the vaccination), the patient experienced pyrexia of body temperature (B.T.) 40.2 degrees Centigrade. The course of the event was as follows: On 07Sep2021, the patient received the 2nd dose of the vaccination. On 08Sep2021 from the morning, the patient experienced pyrexia of B.T. 39.2 degrees Centigrade, chills, and shivering. The patient took oral paracetamol (CALONAL 300) once, but pyrexia was not gone. On 08Sep2021 at noon, B.T. 40.2 degrees Centigrade. On 08Sep2021, thereafter, the patient visited the hospital for consultation. IV drip of calcium chloride dihydrate;potassium chloride;sodium chloride;sodium lactate (SOLULACT 250) was administrated, and 1 piece of suppository of diclofenac Na 25mg was inserted through the anus. On 08Sep2021 at 17:20, B.T. decreased to 37.1 degrees Centigrade, and the patient went home. The events were reported as serious (medically significant). On 08Sep2021 (1 day after the vaccination), the outcome of the events was recovering. The reporting physician (vaccinator) classified the events as serious and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician (vaccinator) commented as follows: Pyrexia and chills were side reactions caused by the 2nd dose of Pfizer novel coronavirus vaccination. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1729616 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Auscultation, Body temperature, Oxygen saturation, Vital signs measurement
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XYZAL; ROSUVASTATIN; PARIET
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (B. Asthma - The last attack was a half year ago - Slightly heard at the end of respiration); Lipids abnormal (Nature of treatment: (Xyzal Tablets, rosuvastatin, PARIET)); Reflux oesophagitis (Nature of treatment: (Xyzal Tablets, rosuvastatin, PARIET)); Rhinitis allergic (Nature of treatment: (Xyzal Tablets, rosuvastatin, PARIET)); Wheezing (Due to asthma, pre-vaccination wheezing was noted at the end of respiration.)
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: auscultation; Result Unstructured Data: Test Result:prominent aggravation of wheezing was noted; Test Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 degrees Centigrade; Comments: before vaccination; Test Date: 20210908; Test Name: SpO2; Test Result: 98 %; Comments: RA; Test Date: 20210908; Test Name: vitals; Result Unstructured Data: Test Result:normal
CDC Split Type: JPPFIZER INC202101184068

Write-up: mild asthmatic attack; This is a spontaneous report received from The regulatory authority report number is v21126340. A contactable physician reported that a 52-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection), intramuscularly, on 08Sep2021 at 14:05 (Lot Number: FH0151; Expiration Date: 31Dec2021) (at the age of 52 years old) as dose 1, single for COVID-19 immunisation. Medical history included asthma (the last attack was a half year ago - slightly heard at the end of respiration); rhinitis allergic, lipids abnormal, reflux oesophagitis (nature of treatment: Xyzal tablets, rosuvastatin, Pariet); due to asthma, wheezing (pre-vaccination wheezing was noted at the end of respiration). The patient had not been sick or had a fever in the past month. The patient had not any parts of body that are not feeling well today. The patient had not experienced convulsions (seizures). The patient never had severed allergic reactions (anaphylaxis, etc.) to a medication or food. Concomitant medications included levocetirizine dihydrochloride (XYZAL) taken for rhinitis allergic, start and stop date were not reported; rosuvastatin taken for lipids abnormal, start and stop date were not reported; rabeprazole sodium (PARIET) taken for reflux oesophagitis, start and stop date were not reported. The patient had not received any other vaccines in the past two weeks. The patient experienced mild asthmatic attack. The event onset date was reported as 08Sep2021 at 14:35 (30 minutes after vaccination). The course of the event was as follows. Body temperature before vaccination was 36.4 degrees centigrade. On 08Sep2021 at 14:05 (the day of vaccination), the patient received the first dose of Pfizer''s COVID-19 vaccine, BNT162B2 (COMIRNATY). About 30 minutes after the vaccination, the patient experienced symptoms of wheezing and cough. No skin eruption, no gastrointestinal symptoms, vitals were normal, and SpO2 was 98% RA. Pre-vaccination auscultation was performed, and prominent aggravation of wheezing was noted after vaccination. It was regarded as a mild asthmatic attack, combination of procaterol (MEPTIN) 0.3 mL (30 micrograms) + normal saline 10 mL were administered twice as treatment for the events. Wheezing improved. The patient was observed for 2 hours and went home. The patient underwent lab tests and procedures on 08Sep2021 which included body temperature: 36.4 degrees centigrade (before vaccination); SpO2: 98% RA; vitals: normal; auscultation: prominent aggravation of wheezing was noted. The regulatory authority classified the events as non-serious (as reported) and assessed that the events were related to BNT162B2. There was no other possible cause of the events such as any other diseases. On 08Sep2021, the outcome of the events was recovering. The reporting physician commented as follows: It was considered related to the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1729626 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Cough, Erythema, Feeling hot, Heart rate, Nausea, Oropharyngeal discomfort, Oxygen saturation, Pruritus
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: blood pressure; Result Unstructured Data: Test Result:142/90; Comments: after vaccination; Test Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210908; Test Name: Pulse; Result Unstructured Data: Test Result:65; Comments: after vaccination; Test Date: 20210908; Test Name: Spo2; Test Result: 98 %; Comments: after vaccination
CDC Split Type: JPPFIZER INC202101185047

Write-up: Anaphylaxis/Brighton classification level 2-3; Feeling of blocked throat; redness and feeling hot of both hands; redness and feeling hot of both hands; generalized itching; dry cough/cough occurred again; Queasy; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21126279. A 51-years and 9-months-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FE8162, Expiration date 30Nov2021) via an unspecified route of administration on 08Sep2021 at 15:21 (at the age of 51-years old) as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.6 degrees Centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 08Sep2021 at 15:21 (the day of vaccination), the patient received bnt162b2. On 08Sep2021 at 15:26 (5minutes after the vaccination), the patient experienced Anaphylaxis. The course of the event was as follows: Five minutes after vaccination, the patient experienced redness and feeling hot of both hands, generalized itching, and dry cough so received BOSMIN0.3ml subcutaneous injection and started to receive intravenous drip of STRONGER NEO-MINOPHAGEN C and Neurotropin special order + PSS(Physiologic Saline Solution)100ml. At that time, Spo298%, Pulse65, blood pressure 142/90, After that, Queasy and Feeling of blocked throat occurred. Cough was recovering for a time, 43minutes after vaccination, cough occurred again, so the patient started to receive intravenous drip of PREDONINE 30mg and PSS100ml. After that, the symptoms were relieved. Prednisolone (5)4T, Allelock (5) 2T/2x5 days were additionally prescribed, and the patient went home with her family. Brighton classification level 2-3. On 08Sep2021 (the day of the vaccination), the outcome of the event was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: I prescribed oral steroids for the patient and gave her an introduction letter to visit the outpatient department if the symptoms worsened. And then she went home.


VAERS ID: 1729633 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Allergic reaction to excipient, Anaphylactic reaction, Auscultation, Blood pressure increased, Blood pressure measurement, Blood test, Heart rate, Oropharyngeal discomfort, Oxygen saturation, Pharyngeal swelling, Physical deconditioning, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Shellfish allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: auscultation; Result Unstructured Data: Test Result:without stridor audible; Test Date: 20210908; Test Name: Bp; Result Unstructured Data: Test Result:186/106; Comments: at 10:36 prior to EPIPEN administration; Test Date: 20210908; Test Name: Bp; Result Unstructured Data: Test Result:185/115; Comments: at 10:40; Test Date: 20210908; Test Name: Bp; Result Unstructured Data: Test Result:171/110; Comments: at 10:43; Test Date: 20210908; Test Name: Bp; Result Unstructured Data: Test Result:152/103; Comments: at 10:44; Test Date: 20210908; Test Name: Bp; Result Unstructured Data: Test Result:162/114; Comments: at 10:55; Test Date: 20210908; Test Name: Bp; Result Unstructured Data: Test Result:143/84; Comments: at 11:02; Test Date: 20210908; Test Name: Blood collection (biochemical/ hematological).; Result Unstructured Data: Test Result:no abnormal results; Comments: 10:43; Test Date: 20210908; Test Name: HR; Result Unstructured Data: Test Result:84; Comments: at 10:44; Test Date: 20210908; Test Name: SpO2; Test Result: 95 %; Test Date: 20210908; Test Name: SpO2; Test Result: 98 %; Comments: at 10:40; Test Date: 20210908; Test Name: SpO2; Test Result: 98 %; Comments: at 10:43
CDC Split Type: JPPFIZER INC202101185770

Write-up: Anaphylaxis; Bp 185/115; possibly an allergy due to PEG; Pharynx strange sensation of; swelling of throat and tongue; swelling of throat and tongue; physical deconditioning; This is a spontaneous report from a contactable pharmacist received from a regulatory authority. Regulatory authority report number is v21127579. The patient was a 55-year-old female. Patient''s history (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) as follows: allergy to shrimp, oyster, and crab. No medical checkup was performed. BP 186/106 (in 30 minutes after vaccination, prior to EPIPEN administration). On 08Sep2021 at 10:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: FF2782, Expiration date: 30Nov2021) via an unspecified route of administration as a single dose (at the age of 55-years-old) for COVID-19 immunization. On 08Sep2021 at 10:15 (15 minutes after the vaccination), the patient experienced Anaphylaxis. The course of the event was as follows: 15 minutes after the vaccination, the patient complained of pharynx strange sensation of and swelling of throat and tongue. SpO2 95%. No R difficulty (respiratory difficulty) was present, without stridor audible at an auscultation. At 10:36, Bp 186/106. At 10:40, Bp 185/115. SpO2 98%. The physician established a diagnosis of anaphylaxis, and EPIPEN intramuscular injection was administered. At 10:43, Bp 171/110. SpO2 98%. Blood collection (biochemical/ hematological). Fluid infusion with SOLULACT + FAMOTIDINE 20mg was initiated. At 10:44, Bp 152/103. HR 84. At 10:50, NS 100mL + POLARAMINE 5mg was administered. At 10:55, Bp 162/114. The symptoms abated. At 11:02, Bp 143/84. At 11:30, NS 100mL + DECADRON 6.6mg was administered. At 12:00, physical deconditioning abated. On 09Sep2021 (1 day after the vaccination), the outcome of the event was recovering. The reporting pharmacist classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting pharmacist commented as follows: The event is possibly an allergy due to PEG as the patient was female, but sufficient information consistent with the definition of anaphylaxis case was not obtained from the records by the physician and the nurse. The symptom was classified into level 4 of Brighton Classification as the event could not be judged to be consistent with the definition of the symptom. Causal relationship between the event and vaccination could not be ruled out given the onset in 15 to 30 minutes after the administration and the no abnormal results of the blood collection data.; Reporter''s Comments: Summary of reporter comment: The event is possibly an allergy due to PEG but sufficient information consistent with the definition of anaphylaxis case wasn''t obtained from the records. The symptom was classified into level 4 Brighton Classification as event couldn''t be judged to be consistent with definition of the symptom. Causal relationship between events and vaccination couldn''t be ruled out given the onset in 15-30 min after admin and no abnormal results of blood collection data.


VAERS ID: 1729676 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0349 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Computerised tomogram, Contusion, Disease recurrence, Fall, Heart rate, Loss of consciousness, Oxygen saturation, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vasovagal reaction
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: BP; Result Unstructured Data: Test Result:100/59; Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210908; Test Name: CT; Result Unstructured Data: Test Result:unknown result; Test Date: 20210908; Test Name: HR; Result Unstructured Data: Test Result:53; Test Date: 20210908; Test Name: SpO2; Result Unstructured Data: Test Result:99
CDC Split Type: JPPFIZER INC202101192598

Write-up: Loss of consciousness; Weakness; The patient fell forward and had Contusion on the right head; The patient fell forward and had Contusion on the right head; Vasovagal reflex; Vasovagal reflex; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126444. A 23-year and 10-month-old female patient received bnt162b2 (COMIRNATY), first dose via an unspecified route of administration on 08Sep2021 13:42 (Batch/Lot Number: FD0349; Expiration Date: 31Oct2021) as DOSE 1, SINGLE for covid-19 immunisation, at the age at vaccination of 23-year and 10-month-old. Medical history included Vasovagal reflex. The patient''s family history was unknown. The patient''s concomitant medications were not reported. The patient experienced loss of consciousness, weakness, the patient fell forward and had contusion on the right head, vasovagal reflex, all on 08Sep2021 13:47 (5 minutes after the vaccination), with outcome of recovered on 08Sep2021 (the day of vaccination). The patient underwent lab tests which included blood pressure measurement: 100/59, body temperature: 36.6 centigrade before vaccination, computerised tomogram: unknown result, heart rate: 53, oxygen saturation: 99, all on 08Sep2021. Clinical courses: About 5 minutes after the first vaccination, the patient experienced Loss of consciousness and Weakness. The patient fell forward and had Contusion on the right head. When lie down on the bed, BP 100/59, HR 53, SpO2 99. There was a recovery of Loss of consciousness only on the bed rest, and the patient returned home alone. Just in case, the patient was requested a CT from the PRIVACY hospital emergency center. The reporting physician classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was the patient with the med history of Vasovagal reflex. The reporting physician commented as follows: There was a high possibility of Vasovagal reflex from the course. All events result in emergency room visit.


VAERS ID: 1729677 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC202101192684

Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician via a Pfizer sales representative. The patient was an 18-year-old female. On 08Sep2021 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified route of administration for COVID-19 immunization at the age of 18-years. Medical history and concomitant medications were not reported. On 08Sep2021(after the vaccination), the patient experienced anaphylaxis. Because blood pressure decreased was observed, epinephrine (BOSMIN) was administered. After that, the patient was transported to another hospital and hospitalized for one night just in case. At that point, the patient almost recovered. The patient was discharged from the hospital on the following day (09Sep2021). The outcome was recovered on 09Sep2021. The reporter considered that the events were non-serious and the causality between the suspect drug and events was possibly related. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: The event anaphylaxis was considered related to suspect drug based on strong temporal association and known safety profile of the drug.


VAERS ID: 1729686 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5357 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Arthralgia, Blood pressure measurement, Body temperature, Feeling cold, Heart rate, Neck pain, Oxygen saturation, Pruritus, Rash, Tremor, Vaccination site pain
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Skin irritation
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210908; Test Name: pulse rate; Result Unstructured Data: Test Result:normal; Test Date: 20210908; Test Name: spo2; Result Unstructured Data: Test Result:normal
CDC Split Type: JPPFIZER INC202101193817

Write-up: Anaphylaxis; Pain at the vaccination site; feeling cold from Left shoulder to upper limb developed/feeling cold in whole body; Rash appeared on the upper left arm; itching; Tremulousness in left hand/Tremulousness in both hands and neck developed to the whole body; pain developed from left neck to shoulder; pain developed from left neck to shoulder; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21126479. A 43-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 08Sep2021 09:15 (Lot Number: FF5357; Expiration Date: 30Nov2021) at age of 43-years-old female as DOSE 1, SINGLE for covid-19 immunisation . Medical history included skin irritated by Drip infusion. The patient''s concomitant medications were not reported. The patient experienced anaphylaxis on 08Sep2021 09:20. The course of the event was as follows: At 9:15, within a short time after vaccination, Pain at the vaccination site appeared, feeling cold from Left shoulder to upper limb developed. Rash appeared on the upper left arm, itching, and feeling cold in whole body developed. Blood pressure, pulse rate, and spo2 were normal. Adrenaline 0.3 ml was injected intramuscularly. After that, Tremulousness in left hand, pain developed from left neck to shoulder, and Adrenaline was added. Tremulousness in both hands and neck developed to the whole body. Adrenaline was added. DIAZEPAM 4mg was taken orally. From about 12:10, Symptoms improved. At 12:40, the patient Return home. The outcome of events was recovered on 08Sep2021. Body temperature before vaccination was 36.5 degrees Centigrade. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Mild Anaphylaxis


VAERS ID: 1729730 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005286 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; This case was received via Pharmaceutical company (Reference number: 2021TJP091791) on 09-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This case, initially reported to the regulatory authority by a (physician), was received via the regulatory authority (Ref, v21126272). On an unknown date, body temperature before the vaccination: 36.2 degrees Celsius. On 08-Sep-2021, at 13:30, the patient received the 1st dose of the vaccine. At 13:30, Anaphylaxis developed. The patient experienced hot flash, coldness, and difficulty breathing. Subsequently, decreased blood pressure was noted, and the patient was rushed to a hospital. After the transportation, vital signs were stabilized without any treatments. Thereafter, the symptoms were resolving. The outcome of anaphylaxis was reported as resolving. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 34-year-old, male patient with no previous relevant medical history, who experienced the expected serious event of Anaphylactic reaction. The event occurred on the same day, immediately after the first dose of COVID-19 Vaccine Moderna was given. The patient recovered during the same day without any medical treatment. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of COVID-19 Vaccine Moderna is not affected by this report.


VAERS ID: 1730669 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angioedema, Pyrexia, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOELY
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: IT-MINISAL02-783834) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ANGIOEDEMA, RASH, VOMITING and PYREXIA in a 22-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 immunisation. Concomitant products included ESTRADIOL, NOMEGESTROL ACETATE (ZOELY) for Birth control pill. On 07-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 08-Sep-2021, the patient experienced ANGIOEDEMA (seriousness criterion medically significant), RASH (seriousness criterion medically significant), VOMITING (seriousness criterion medically significant) and PYREXIA (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA , RASH, VOMITING and PYREXIA had not resolved. No treatment medication was reported. Company comment: This case concerns a 22-year-old, female patient with no relevant medical history, who experienced the unexpected events of angioedema, rash, vomiting, and pyrexia. The events occurred approximately 2 days after the first dose of Spikevax . The rechallenge was not applicable, as the event happened after the first dose. The events was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 22-year-old, female patient with no relevant medical history, who experienced the unexpected events of angioedema, rash, vomiting, and pyrexia. The events occurred approximately 2 days after the first dose of Spikevax . The rechallenge was not applicable, as the event happened after the first dose. The events was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1730683 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / 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? 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: PHMODERNATX, INC.MOD20213

Write-up: Fainting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Sep-2021 and was forwarded to Moderna on 18-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Fainting) in a 25-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 939894) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 08-Sep-2021 at 10:43 AM, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). On 08-Sep-2021 at 11:20 AM, SYNCOPE (Fainting) had resolved. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. Treatment information not reported. Company Comment: This case concerns a 25-year-old female patient with no relevant medical history, who experienced the unexpected event Syncope.The event occurred on the same day at a reported time 10 43 with a duration of 37 minutes, after Unknown dose of Spikevax. The rechallenge was unknown as there''s no information available about the dose number. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 25-year-old female patient with no relevant medical history, who experienced the unexpected event Syncope.The event occurred on the same day at a reported time 10 43 with a duration of 37 minutes,after Unknown dose of Spikevax. The rechallenge was unknown as there''s no information available about the dose number. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1730816 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: S?ncope; This case was received (Reference number: ES-AEMPS-997563) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (S?ncope) in a 29-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product MIRABEGRON (BETMIGA) for Hyperactive bladder. No Medical History information was reported. On 06-Sep-2021, the patient started MIRABEGRON (BETMIGA) (Oral) 50 milligram once a day. On 08-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced SYNCOPE (S?ncope) (seriousness criterion medically significant). At the time of the report, SYNCOPE (S?ncope) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive). mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 08-Sep-2021. No Treatment informations were reported. Company Comment: This case concerns a 29-year-old, female subject, who is taking co-suspect product that included non-company product MIRABEGRON (BETMIGA) for Hyperactive bladder who experienced the serious unexpected event of Syncope. The event occurred on the same day after first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. However, the mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 08-Sep-2021. The co-suspect drug remains confounders as this medication was started on 06Sep2021 and withdrawn on 08Sep2021. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 29-year-old, female subject, who is taking co-suspect product that included non-company product MIRABEGRON (BETMIGA) for Hyperactive bladder who experienced the serious unexpected event of Syncope. The event occurred on the same day after first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. However, the mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 08-Sep-2021. The co-suspect drug remains confounders as this medication was started on 06Sep2021 and withdrawn on 08Sep2021. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1732688 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-09-08
   Days after vaccination:212
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alopecia, COVID-19, Condition aggravated, Headache, Pyrexia, SARS-CoV-2 test, Vaccination failure, Vaccination site pain
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210910; Test Name: PCR test; Result Unstructured Data: Test Result:Unkown result
CDC Split Type: ESPFIZER INC202101191895

Write-up: Headache; Fever; Vaccination site pain; Hair loss greater than usual; Hair loss greater than usual; COVID-19 antigen test positive; COVID-19 antigen test positive; This is a spontaneous report received from a contactable other hcp. A female patient of an unspecified age received 1st dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EM0477; Expiration Date: 30Apr2021), via an unspecified route of administration on 18Jan2021, as Dose 1,single and dose 2 of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL8723; Expiration Date: 31May2021), via an unspecified route of administration on 08Feb2021 as Dose 2,single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced covid-19 antigen test positive on 08Sep2021, sars-cov-2 infection on an unspecified date, headache, fever, vaccination site pain and hair loss greater than usual on an unspecified date. No therapeutic measures were taken as a result of events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Sep2021 and sars-cov-2 test: unkown result on 10Sep2021. The outcome of the events was unknown. Upon followup received on 15 sep2021 from product quality complaint team regarding consumer''s complaint about Comirnaty (BNT162N2), lot: EM0477, expiration date: 30Apr2021 and lot: EL8723, expiration date: 31May2021,Investigational report conclusion from Puurs division was as follows: 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 5595397 and 5693567. The complaint for a cardiac arrest after vaccination of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type.No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. The NTM process determined that a regulatory notification was required.No root cause or CAPA were identified as the complaint was not confirmed. Follow up attempts are completed. No further information is expected.; Sender''s Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure cannot be ruled out.


VAERS ID: 1732912 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), 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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101214750

Write-up: Maternal exposure during pregnancy; Miscarriage; This is a spontaneous report from a contactable consumer. This is a report downloaded from a regulatory authority-WEB, Regulatory authority number GB-MHRA-WEBCOVID-202109100955404850-8ULLC. Safety Report unique Identifier GB-MHRA-ADR 25922890.This consumer reported information for both mother and fetus. This is a maternal report. A 37-year-old female pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on 08Sep2021 (Batch/Lot number was not reported) (at the age of 37-years-old) as dose 1, single for COVID-19 immunization. Medical history included pregnancy from an unknown date. Patient no longer pregnant at the time of reporting, Folic acid supplementation from an unknown date. Concomitant medication included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. Patient did not had symptoms associated with COVID-19, did not had a COVID-19 test. Patient is not currently breastfeeding. The patient experienced miscarriage on 08Sep2021, maternal exposure during pregnancy on an unspecified date. The mother reported she became pregnant while taking bnt162b2. The event miscarriage was serous medically significant. The outcome the event miscarriage was recovered on 09Sep2021 and maternal exposure during pregnancy was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1732920 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Lymphadenopathy, SARS-CoV-2 test
SMQs:, 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: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101191623

Write-up: Swollen area in armpit; Armpit pain; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109101650116800-VY3OD and Safety Report Unique Identifier GB-MHRA-ADR 25924995. A 31-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot Number: FF2153), dose 2 via an unspecified route of administration on 08Sep2021 (at the dose of vaccination 31Years old) as single dose for COVID-19 immunisation. Medical history included immunodeficiency from an unknown date and unknown if ongoing (taking other treatments or medicines, not listed above, known to lower the immune response and I) on an unspecified date. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The patient concomitant medications were not reported. The patient has not tested positive for COVID-19 since having the vaccine. The patient is not enrolled in clinical trial. The patient experienced armpit pain on 08Sep2021. Swollen area in armpit along with tender beats. The event was medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Aug2021 Yes - Positive COVID-19 test. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1732939 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-09-08
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Electroencephalogram, SARS-CoV-2 test, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210325; Test Name: EEG; Result Unstructured Data: Test Result:UNKNOWN; Comments: UNKNOWN; Test Date: 20210325; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101196569

Write-up: Seizures; This is a spontaneous report from a contactable consumer or other non healthcare professional received from the Regulatory AUTHORITY (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109120720563270-XHKNI. Safety Report Unique Identifier GB-MHRA-ADR 25929091. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 27Aug2021, as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunisation. On 08Sep2021, 12 days after second dose, the patient experienced seizures. patient experienced seizures for the first time. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included electroencephalogram: unknown on 25Mar2021, SARS-CoV-2 test: positive on 25Mar2021. The clinical outcome of the event was resolving. Suspect Reactions Please provide details of any relevant investigations or tests conducted: "EEG" No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1732951 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Fatigue, Hypoaesthesia, Insomnia, Lymphadenopathy, Musculoskeletal chest pain, Pyrexia, SARS-CoV-2 test, Skin irritation, Tenderness
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (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 INC202101196570

Write-up: Fatigue; High temperature; Insomnia; Numbness; Rib pain; Swollen lymph nodes; Tenderness; Armpit pain; Shoulder pain; Skin irritation; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109121030362730-CFFUU and Safety Report Unique Identifier GB-MHRA-ADR 25929003. A 30-years-old non-pregnant female patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Batch/lot number: not known) via an unspecified route of administration on 08Sep2021 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for COVID-19 immunization. The patient experienced skin irritation on 08Sep2021; swollen lymph nodes, tenderness, armpit pain, shoulder pain on 09Sep2021; insomnia, numbness, rib pain on 10Sep2021; fatigue, high temperature on 11Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (No- Negative COVID-19 test) on an unspecified date. The events were medically significant. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733059 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Myalgia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101205377

Write-up: Joint ache; Aching muscles; Fainting; Headache; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109131345073550-JPGT7 with Safety Report Unique Identifier GB-MHRA-ADR 25931926. An 18-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153) via an unspecified route of administration on 08Sep2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19 and not had a COVID test. The patient was not enrolled in clinical trial. The patient was not pregnant and was not breastfeeding at the time of report. Concomitant medications were not reported. On 08Sep2021, a few minutes after receiving the vaccine, the patient experienced fainting and 12 hours after receiving the vaccine had headache. On 09Sep2021, 24 hours after receiving the vaccine, the patient had joint ache and aching muscles. The patient had not tested positive for COVID-19 since the vaccination. The clinical outcome of the event fainting was recovered on 08Sep2021; joint ache on 09Sep2021 after duration of 1 day; headache on 10Sep2021, after the duration of 2 days while that of outcome for aching muscles was unknown at the time of this report. The events, fainting, joint ache and headache were reported as serious for being medically significant. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1733384 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-08
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hypoaesthesia, Migraine, Pain in extremity, Prothrombin level, Pyrexia, Ultrasound Doppler
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? Yes
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: Test Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:37.1; Test Name: prothrombin; Result Unstructured Data: Test Result:no results reported; Test Name: doppler; Result Unstructured Data: Test Result:no results reported
CDC Split Type: ITPFIZER INC202101228419

Write-up: very strong migraines; Fever 37.1 for days; severe pain in the left leg; numbness; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB IT-MINISAL02-785853. A 29-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 30Aug2021 as DOSE 1, single for covid-19 immunisation . The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced very strong migraines , fever 37.1 for days, severe pain in the left leg, numbness on 08Sep2021 with outcome of not recovered. Impact on quality of life (9/10). Specialist visits. Seriousness criteria reported as life threatening. The patient underwent lab tests and procedures which included prothrombin level and ultrasound doppler: no results reported. Information on the lot/batch number has been requested.


VAERS ID: 1733391 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Chest pain, Cough, Dyspnoea, Laboratory test, Movement disorder, Pericarditis, Pyrexia, Respiration abnormal, Tachycardia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
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:
Allergies:
Diagnostic Lab Data: Test Name: tests; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101228470

Write-up: acute pericarditis; fever; severe chest pain; burning in the arm; shortness of breath; wheezing; tachycardia; inability to move; cough; restricted breathing; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB [IT-MINISAL02-786872]. A 27-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Batch/Lot Number: FG7387) via intramuscular at single dose in left arm on 06Sep2021 for covid-19 immunisation. The first dose was via intramuscular in left deltoid on 09Aug2021 14:46 (Batch Number: FG4493) and no adverse reaction. Medical history and concomitant medications were not reported. On 08Sep2021, the patient experienced acute pericarditis (life threatening), fever (life threatening), severe chest pain, burning in the arm, shortness of breath, wheezing, tachycardia, inability to move, cough and restricted breathing. The events required emergency room visit and physician office visit. There were days of continuous cardiology visits, tests, lung visits, trips to the emergency room. Impact on quality of life was 10/10. The outcome of events was not recovered. Reporter''s comments: I was healthy as fish Sender''s comments: 09Aug2021 at 14:46 first dose of Comirnaty vaccine (batch FG4493) in the left deltoid. Clinical documentation required Batch/lot number (2nd dose): FG7387 Reaction/event as reported: After the second dose of the pfizer vaccine: acute pericarditis, severe chest pain, burning in the arm, shortness of breath, wheezing, inability to move, tachycardia, fever, coughing, restricted breathing; Reporter''s Comments: I was healthy as fish


VAERS ID: 1733426 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2018 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Drug eruption, Erythema, Heart rate, Pruritus
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Thrombocytosis; Urticaria
Preexisting Conditions: Medical History/Concurrent Conditions: Cough; Hepatic disease
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: blood pressure; Result Unstructured Data: Test Result:181/98; Test Date: 20210909; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210909; Test Name: pulse; Result Unstructured Data: Test Result:63
CDC Split Type: JPPFIZER INC202101184602

Write-up: Measured blood pressure was 181/98; suspicion of Drug eruption.; redness appeared; Generalised itching; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21126315. A 52-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 08Sep2021 at 12:23 (Batch/Lot Number: FF2018; Expiration Date: 31Dec2021) as dose 1, single (at the age of 52-years-old) for Covid-19 immunisation. Medical history included (20-30 years ago) history of liver disease, coughing disease and the patient was in observation due to ongoing thrombocytosis and urticaria (would be confirmed, as reported). The patient was being treated in a department. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.5 degrees Centigrade. On 08Sep2021 at 12:23 (the day of vaccination), the patient experienced suspicion of Drug eruption. The course of the event was as follows: ''25 minutes after the vaccination'' (as source reported), on the same upper arm different from the left forearm on which urticaria originally existed, redness appeared and generalised itching developed. The patient was laid on the bed. Measured blood pressure was 181/98, pulse was 63. After administration of POLARAMINE 1T, course observation was performed. On 08Sep2021 at 12:50 (27 minutes after the vaccination) symptoms newly developed were alleviated, and the patient was instructed to visit a medical institution on the same day. Therapeutic measures were taken as a result of the events. The outcome of the events resolved. The reporting physician classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was in treatment for Urticaria. The reporting physician commented as follows: Causality with the vaccination was high, but a final decision should be made considering treatment hereafter at a medical institution. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1733431 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
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:
CDC Split Type: JPPFIZER INC202101191236

Write-up: Generalised urticaria; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution . The patient was a 17-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Medical history was none. On 06Sep2021 at unspecified time at 17 years (the day of vaccination), the patient received ?the first single dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration at unspecified administration site for COVID-19 immunisation at another hospital. On 08Sep2021 at an unspecified time (2 days after the vaccination), the patient experienced generalised urticaria. The event resulted in the reporting physician''s office visit. The outcome of the event was recovered with treatment including intravenous drip of steroid and oral administration of an antihistamine receptor antagonist. Since the vaccination, the patient has not been tested for COVID-19. The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported event Urticaria 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: 1733437 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-09-08
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Magnetic resonance imaging head
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AZILVA; AMLODIPINE TOWA; TARLIGE
Current Illness: Hypertension; Peripheral neuropathic pain; Putamen haemorrhage
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: Head MRI; Result Unstructured Data: Test Result:cerebral hemorrhage
CDC Split Type: JPPFIZER INC202101192058

Write-up: Cerebral haemorrhage; This is a report from a Non-Interventional Study Source for Protocol from two investigators of the study. A 49-year-old male subject received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FF4204, expiration date 31Oct2021), dose 2 intramuscular, administered in deltoid left on 20Aug2021 16:24 as 0.3 ml, single dose for covid-19 immunisation. Medical history included putamen haemorrhage in the left from 27Aug2019 and ongoing, hypertension from 2019 and ongoing, peripheral neuropathic pain from 29May2020 and ongoing. The subject had no history of allergy. The subject did not receive any other vaccines. SARS-CoV-2 pathogen test was not performed. The subject did not develop COVID-19. Concomitant medications included (AZILVA, tablet, 20 mg) taken for hypertension from 17Dec2019 and ongoing, amlodipine besilate (AMLODIPINE TOWA, Orodispersible tablet, 2.5 mg) taken for hypertension from 17Dec2019 to ongoing, and mirogabalin besilate (TARLIGE, tablet, 5 mg) taken orally for peripheral neuropathic pain from 17Jul2020 to ongoing. The subject previously received first dose of BNT162b2 (COMIRNATY, Lot# EY0583, expiration date 31Oct2021) 0.3 mL intramuscularly in deltoid left as a single dose for COVID-19 immunization On 30Jul2021 at 16:29 at the age of 49 years. The subject did not experience adverse event on previous vaccination. On 08Sep2021 (19 days after the second vaccination), the subject experienced cerebral haemorrhage. The event did not require emergency room and resulted in medical institution visit and hospitalization from 10Sep2021 to 13Sep2021. Lab data on 10Sep2021 showed that Head MRI: Cerebral haemorrhage. The course of the event was as follows: From around 08Sep2021, the subject had right hemiplegia aggravation and dysphagia. On 10Sep2021, the subject visited neurosurgery department of the reporting hospital. Based on head MRI, diagnosis of cerebral haemorrhage was made and the subject was admitted to the hospital. On 13Sep2021, the subject was discharged from hospital since no aggravation in condition was noted. The outcome of event was recovering. The investigator classified the event as serious (hospitalization). The investigator considered that there was no reasonable possibility that the serious adverse event was related to the study drug or concomitant medications. Another investigator also reported that the severity of the event cerebral haemorrhage was moderate and treatment was required, considered that the event was related to the study drug.; Sender''s Comments: Based on temporal association, the reported event Cerebral haemorrhage is possibly related to BNT162B2. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 1733441 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Eyelid oedema, Hyperventilation, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: VACTERL syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: blood pressure; Result Unstructured Data: Test Result:No decreased; Test Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210908; Test Name: Spo2; Result Unstructured Data: Test Result:No decreased
CDC Split Type: JPPFIZER INC202101192484

Write-up: heavy breathing; Eyelid oedema; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126480. A 19-years and 11-months-old female patient received BNT162B2 (COMIRNATY) dose 2 via an unspecified route of administration on 08Sep2021 15:15 (Lot Number: FF9942; Expiration Date: 30Nov2021) as dose 2, single (at the age of 19 years old) for covid-19 immunisation. Body temperature before vaccination was 36.8 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included VACTERL association. The patient''s concomitant medications were not reported. The patient previously took modacin and experienced rash. The event onset date was reported as 08Sep20212021 at 15:40. On 08Sep2021 (the day of the vaccination), the outcome of the events was recovered. The course of the event was as follows: Approximately 30 minutes after vaccination, the patient experienced Eyelid oedema and heavy breathing. No Spo2 decreased, no rash, no blood pressure decreased. The patient received intravenous drip with DEXART 2 mg and symptoms were recovering. The reporting physician classified the event as non-serious but causality was not provided. There was no other possible cause of the event such as any other diseases. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1733470 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure increased, Blood pressure measurement, Body temperature, Feeding disorder, Headache, Nausea, Oxygen saturation, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: Blood pressure; Result Unstructured Data: Test Result:158/100 mmHg; Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Test Date: 20210909; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210909; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202101201609

Write-up: Feeling queasy; Unable to eat; Blood pressure:158/100; Headache; Arthralgia; Pyrexia (37.5 and 38 degrees Centigrade); This is a spontaneous report received from a contactable physician via a Pfizer sales representative. A 52-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on 08Sep2021, at the age of 52 years old, as 2nd single dose for COVID-19 immunisation. Medical history included hypertension, and dyslipidaemia. The patient''s concomitant medications were not reported. The patient had received the 1st dose of BNT162b2 on 18Aug2021. During the night of 08Sep2021, the patient experienced pyrexia of 37.5 degrees Centigrade. On 09Sep2021, pyrexia was of 38 degrees Centigrade, and headache and arthralgia appeared. From noon of the same day, the patient was unable to eat due to feeling queasy. And when the patient visited the hospital, the patient''s blood pressure was 158/100 mmHg and SpO2 was 98%. So he was admitted to hospital. On 10Sep2021, the patient was discharged. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Pyrexia,headache,nausea, Arthralgia,unable to eat and blood pressure increased cannot be totally excluded.The impact of this report 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: 1733515 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005691 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction
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: Comments: No medical history was provided
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; This case was received via Regulatory Authority (Reference number: 2021TJP092543) on 11-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the regulatory authority (Ref,v21127796). Anaphylaxis was assessed as serious by the regulatory authority. On an unknown date, the patient received the 1st dose of this vaccine. On 08-Sep-2021, at 13:23, the patient received the 2nd dose of this vaccine. At 13:30, anaphylaxis developed. Pruritus in the throat and cough developed but were resolving spontaneously. The outcome of anaphylaxis was reported as resolving. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 58-year-old, female patient with no relevant medical history, who experienced the expected event of Anaphylaxis. The event occurred on the same day after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the event as possible. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1733516 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005286 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neuropathy peripheral, Vaccination site erythema, Vaccination site swelling
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Peripheral nerve disorder (radial nerve disorder); Redness and swelling at the vaccination site; Redness and swelling at the vaccination site; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP093662) on 13-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This case, reported by a physician, was received by Takeda Pharmaceutical Company Limited via Moderna''s adverse reaction reporting site (TASK0021704). Peripheral nerve disorder (radial nerve disorder) was assessed as serious by the MAH. On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 08-Sep-2021, at 11:30, the patient received the 1st dose of the vaccine. At 11:50, after 15 minutes of observation, the patient suddenly noticed the symptom. The patient had a localized pale redness and swelling of about 10 cm in diameter at the vaccination site (right). Peripheral nerve disorder (radial nerve disorder) associated with acute and transient swelling at the vaccination site developed, and the patient had a nerve pain mainly in the radial nerve region from the forearm to the fingers distal to the elbow joint. The patient was unable to move the right upper arm due to severe hypersensitivity and nerve pain that made the patient jump when touched. On 13-Sep-2021, the symptoms were confirmed as resolved. The outcome of redness and swelling at the vaccination site and peripheral nerve disorder (radial nerve disorder) was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Company comment- This case refers to a 36-year-old female patient with no known medical history who experienced the unexpected event of Neuropathy Peripheral on the same day after receiving the first dose of COVID-19 Vaccine Moderna. The reporter assessed the event as related to COVID-19 Vaccine Moderna. The benefit-risk relationship of COVID-19 Vaccine Moderna is not affected by this report.; Reporter''s Comments: The patient experienced acute and transient radial nerve disorder with localized swelling at the vaccination site. The symptoms resolved on the following day accompanying disappearance of the acute reaction. The patient was able to work as usual from 11-Sep-2021 without problems at work.; Sender''s Comments: This case refers to a 36-year-old female patient with no known medical history who experienced the unexpected event of Neuropathy Peripheral on the same day after receiving the first dose of COVID-19 Vaccine Moderna. The reporter assessed the event as related to COVID-19 Vaccine Moderna. The benefit-risk relationship of COVID-19 Vaccine Moderna is not affected by this report.


VAERS ID: 1736417 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002538 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Female sex hormone level, Postmenopausal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Absence of menstruation (Had her last menstrual bleed 2 years ago.); Early menopause (Newly discovered by her physician that her hormone levels indicate early menopause.); Postmenopause (Had her last menstrual bleed 2 years ago.)
Allergies:
Diagnostic Lab Data: Test Name: Female sex hormone level; Result Unstructured Data: Levels indicate early menopause.
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00049616) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE in a 42-year-old female patient who received mRNA-1273 (batch no. 3002538) for Vaccination. The patient''s past medical history included Early menopause (Newly discovered by her physician that her hormone levels indicate early menopause.), Postmenopause (Had her last menstrual bleed 2 years ago.) and Absence of menstruation (Had her last menstrual bleed 2 years ago.). On 07-Sep-2021 at 7:40 AM, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Female sex hormone level: early menopause (abnormal) Levels indicate early menopause.. The action taken with mRNA-1273 (Intramuscular) was unknown. The concomitant medications were not reported. The treatment information was not provided. The latency for Postmenopausal Bleeding was reported to be less than 24 hours. Company Comment : This case concerns a 41 year-old, male with a history of Early menopause and Absence of menstruation , who experienced the unexpected event of postmenopausal haemorrhage. The event occurred approximately 2 days after the first dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since only information about the first dose was disclosed The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. Events were classified as serious by regulatory authority (seriousness criteria: medically important condition). However, as per medical criteria none of the events was serious. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received on 22-SEP-2021 contain no new information.; Sender''s Comments: This case concerns a 41 year-old, male with a history of Early menopause and Absence of menstruation , who experienced the unexpected event of postmenopausal haemorrhage. The event occurred approximately 2 days after the first dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since only information about the first dose was disclosed The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. Events were classified as serious by regulatory authority (seriousness criteria: medically important condition). However, as per medical criteria none of the events was serious.


VAERS ID: 1737928 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-08
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F036A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Platelet count, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? Yes
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: Adiposity; Contraception NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: Thrombocytes; Result Unstructured Data: Test Result:129; Comments: 129 /ul
CDC Split Type: DEPFIZER INC202101228469

Write-up: Lung embolism; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number DE-PEI-202100190500. A 16-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 02Sep2021 (Batch/Lot Number: 1F036A) as single dose for COVID-19 immunisation (age at vaccination was 16-year-old). Medical history included contraception and adiposity. The patient''s concomitant medications were not reported. The patient experienced lung embolism (pulmonary embolism) (hospitalization, life threatening) on 08Sep2021 with outcome of not recovered. On 08Sep2021 the patient experienced lung embolism. Thrombocytes 129 /?l on 11Sep2021. Outcome of the event was not resolved for lung embolism. This case was reported as serious with seriousness criteria: hospitalized and life-threatening. Relatedness Assessment: Lung embolism: D. Unclassifiable. Source of assessment: Agency No follow-up attempts possible. No further information expected.


VAERS ID: 1738709 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-09-08
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Menstruation irregular, Polymenorrhoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Fertility 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: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101209571

Write-up: shortness of breath; Period has become irregular; Menstruation frequent; This is a spontaneous report from a contactable consumer (patient) downloaded from the RA, regulatory authority number GB-MHRA-WEBCOVID-202109091857322270-UMQ5A; Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25919733. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 07Aug2021 (Batch/Lot Number: Fe3380) as DOSE 1, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test, Patient is not pregnant at the time of vaccination and Patient is not currently breastfeeding. The patient experienced menstruation frequent on 08Sep2021, shortness of breath and period has become irregular on an unspecified date. The patient have experienced shortness of breath for several weeks. This has affected her running routine. Period has become irregular, and she would be very regular, every 28 days and now arriving every two weeks. When asked about details of any relevant investigations or tests conducted, it was reported that just arranged a doc appointment. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of shortness of breath was reported as not recovered and other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738710 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-08
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Formication, Menstruation irregular, Pain, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), 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: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101209554

Write-up: pins and needles; sharp and sore; sometimes like something is crawling on my skin; Irregular periods; This is a spontaneous report from a contactable consumer or other non hcp (Patient) downloaded from the Agency Regulatory Authority-WEB, regulatory authority number GB-MHRA-WEBCOVID-202109092318400470-U8GXQ.Safety Report Unique Identifier GB-MHRA-ADR 25921271. A 37-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration on 04Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162b2, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing (Taking regular medicines for rheumatoid arthritis or other types of arthritis except osteoarthr). Concomitant medication included codeine phosphate, paracetamol (KAPAKE) taken for rheumatoid arthritis from 04Sep2021 to an unspecified stop date. Kapak for pain the pill. Unsure if patient has had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 08Sep2021, the patient experienced irregular periods. On an unspecified date, the patient experienced pins and needles, sharp and sore and sometimes like something is crawling on my skin. Patient stated that period started 4 days after the shot, patient was on the pill so did not had a period until patient stop the pill for my pill free week, patient was not due for 3 weeks, also patient had pins and needles in my feet and hands, sometimes sharp and sore, sometimes like something was crawling on my skin. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date (No - Negative COVID-19 test). The outcome of the event irregular periods was not recovered, event pins and needles was recovered on an unspecified date and event sharp and sore and sometimes like something was crawling on my skin was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738775 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-08
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Adenovirus infection, Bone formation test, C-reactive protein, Cytomegalovirus infection, Epstein-Barr virus infection, HIV test, Hepatitis B virus test, Hepatitis C virus test, Immunoglobulins, Liver function test, Pain, Rash, SARS-CoV-2 test, Still's disease, Synovitis
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (narrow), 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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: bone profile; Result Unstructured Data: Test Result:Unknown results; Test Name: CRP; Result Unstructured Data: Test Result:Unknown results; Test Name: CMV; Result Unstructured Data: Test Result:Unknown results; Test Name: EBV; Result Unstructured Data: Test Result:Unknown results; Test Name: HepB/C; Result Unstructured Data: Test Result:Unknown results; Test Name: HepB/C; Result Unstructured Data: Test Result:Unknown results; Test Name: HIV; Result Unstructured Data: Test Result:Unknown results; Test Name: serum immunoglobulins; Result Unstructured Data: Test Result:Unknown results; Test Name: lfts; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210831; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211503

Write-up: synovitis; aches/ pains; AOSD; AAV; Rash; This is a spontaneous report from a contactable pharmacist. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109140953534410-FBUKO. Safety Report Unique Identifier GB-MHRA-ADR 25937922. A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. Unsure if patient has 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. Concomitant medications included allopurinol; amitriptyline; mirtazapine; propranolol; thiamine; all start date and stop date were not provided taken for unspecified indication. On 08Sep2021, patient experienced rash. On an unspecified date, the patient experienced ongoing active synovitis. The patient was seen by rheumatology in hospital- symptoms rash, aches and pains, less likely, but consider AOSD and AAV (Adenovirus infection). Patient started ibuprofen and prednisolone. On an unspecified date the patient underwent lab tests and procedures which included serum immunoglobulins- bone formation test: unknown results, c-reactive protein: unknown results, cytomegalovirus infection: unknown results, epstein-barr virus infection: unknown results, hepatitis b virus test: unknown results, hepatitis c virus test: unknown results, HIV test: unknown results, immunoglobulins: unknown results, liver function test: unknown results. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Aug2021 (No - Negative COVID-19 test). Therapeutic measures were taken as a result of synovitis, rash, aches/ pains, AOSD, AAV. The outcome of rash was recovering. The outcome of synovitis was not recovered. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738783 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Dizziness, Motion sickness, SARS-CoV-2 test, Suspected COVID-19, Vertigo
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (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: Medical History/Concurrent Conditions: Vertigo
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211457

Write-up: Severe dizziness; Motion sick; Losing balance, Spinning around.; Suspected COVID-19; Vertigo; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109141107335600-SVT0F. Safety Report Unique Identifier GB-MHRA-ADR 25938286. A 36-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF2153) via an unspecified route of administration on 07Sep2021 as dose 1, single for COVID-19 immunization. Medical history included vertigo from an unknown date and unknown if ongoing. He had a similar occasion in the past with vertigo like symptoms reported to his GP year and a half ago. The patient''s concomitant medications were not reported. The patient experienced suspected COVID-19 and vertigo on 08Sep2021, severe dizziness, motion sick, losing balance and spinning around on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Sep2021 No - Negative COVID-19 test. Additional information: severe dizziness vertigo like symptoms motion sick. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of vertigo was not recovered and outcome of other events was unknown. No follow-up attempts are needed; No further information is expected.


VAERS ID: 1738785 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dysphonia, Influenza, Migraine
SMQs:, Anaphylactic reaction (broad), Parkinson-like events (broad), Infective pneumonia (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: GBPFIZER INC202101211325

Write-up: Dry cough; Flu; Hoarse voice; Migraine type headaches; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202109141128582330-DV3H1, Safety Report Unique Identifier GB-MHRA-ADR 25938321. A 29-year-old patient of an unknown gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fe8087), via an unspecified route of administration on 07Sep2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not enrolled in clinical trial. On 08Sep2021, the patient experienced flu, hoarse voice, and migraine type headaches. On 10Sep2021, the patient experienced dry cough. All the events were reported as serious for causing disability and being medically significant. The patient is waiting on COVID test due to increase of symptoms and seemed to be getting worse rather than better. Adverse reaction did not occur as a result of an exposure during pregnancy (as reported). It was reported that the patient was still suffering from all these symptoms. The clinical outcome of the events was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738833 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Depressed mood, Influenza, Limb discomfort, Nightmare, SARS-CoV-2 test, Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Depression (excl suicide and self injury) (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211427

Write-up: had vaccine on day 7; Arm discomfort; Nightmare; Mood depression; Flu symptoms; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109141853160250-ESCZT, Safety Report Unique Identifier GB-MHRA-ADR 25940642. A 33-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Sep2021 as dose 2, single for COVID-19 immunization. Medical history included clinical trial participant. Cconcomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced had vaccine on day 7 (reported as Status epilepticus), on 08Sep2021, patient had arm discomfort, nightmare, mood depression, flu symptoms. It was reported that patient had vaccine on day 7, then played badminton no problem on same evening, then slept and problems started - sleeping an entire day has recovered from all symptoms. The patient underwent lab tests which included SARS-CoV-2 test: Negative (No - Negative COVID-19 test) on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of event Status epilepticus was recovered on unspecified date and other events recovered on 09Sep2021. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1738913 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-28
Onset:2021-09-08
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Illness, Nausea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217740

Write-up: sick; Breathlessness; nauseus; This is a spontaneous report from a contactable Consumer or other non-health care professional. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID 202109151938164540-UFR78. Safety Report Unique Identifier GB-MHRA-ADR 25947944. A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration on 28Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received historical vaccine, first dose of BNT162B2 as dose 1, single for COVID-19 immunization on an unspecified date. 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 patient experienced breathlessness on 12Sep2021, nauseus on 08Sep2021, sick on 13Sep2021. The events considered as medically significant. Patient started being nauseus from wednesday 08Sep2021. Being sick monday 13Sep2021. Breathlessness now remains. The details of any relevant investigations or tests conducted includes none, GP not available and urgent care sent him packing twice. On 11Sep202, the patient underwent lab tests and procedures which included sars-cov-2 test (no - negative COVID-19 test). The outcome of the event breathlessness recovered on 15Sep2021, while the events nauseus and sick was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1738980 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-09-08
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhage, Oropharyngeal pain, Peripheral swelling, SARS-CoV-2 test, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Bleeding; Swelling; Swollen arm; Sore throat; This case was received via RA (Reference number: GB-MHRA-ADR 25958547) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding), SWELLING (Swelling), PERIPHERAL SWELLING (Swollen arm) and OROPHARYNGEAL PAIN (Sore throat) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 01-Jun-2021. In July 2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant). On 09-Sep-2021, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant). On 10-Sep-2021, PERIPHERAL SWELLING (Swollen arm) had resolved. At the time of the report, HAEMORRHAGE (Bleeding) had not resolved and SWELLING (Swelling) and OROPHARYNGEAL PAIN (Sore throat) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant product use was mentioned. Treatment included antibiotics from urgent care following swollen arm, armpit, throat and face. Company Comment: This case concerns a 37 year-old female patient with history of COVID-19 (01Jun2021), who experienced the unexpected events of Haemorrhage, Swelling, Peripheral swelling, and Oropharyngeal pain. The events occurred 1-2 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event coding and seriousness criteria of Medically significant maintained for consistency with RA report, however source documents did not include additional information supporting the seriousness criteria.; Sender''s Comments: This case concerns a 37 year-old female patient with history of COVID-19 (01Jun2021), who experienced the unexpected events of Haemorrhage, Swelling, Peripheral swelling, and Oropharyngeal pain. The events occurred 1-2 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event coding and seriousness criteria of Medically significant maintained for consistency with RA report, however source documents did not include additional information supporting the seriousness criteria.


VAERS ID: 1739023 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-08
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dry mouth, Fatigue, Heart rate increased, Loss of personal independence in daily activities, Myalgia, Pain, Panic attack, Pyrexia, Respiratory rate increased, SARS-CoV-2 test, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201002; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Shaking; High temperature; dry mouth; breathing was rapid; heart rate was thumping; pain; Unable to attend work the next day; Panic attacks; Panic attack; Fever; Muscle ache; Fatigue; This case was received via Regulatory Authority RA (Reference number: GB-MHRA-ADR 25965266) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PANIC ATTACK (Panic attacks), PANIC ATTACK (Panic attack), TREMOR (Shaking), PYREXIA (High temperature), PYREXIA (Fever), MYALGIA (Muscle ache) and FATIGUE (Fatigue) in a 27-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suspected COVID-19 from 01-Oct-2020 to 10-Oct-2020. In 2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced PANIC ATTACK (Panic attack) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced PANIC ATTACK (Panic attacks) (seriousness criterion medically significant), TREMOR (Shaking) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), DRY MOUTH (dry mouth), RESPIRATORY RATE INCREASED (breathing was rapid), HEART RATE INCREASED (heart rate was thumping), PAIN (pain) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to attend work the next day). On 08-Sep-2021, PANIC ATTACK (Panic attack) had resolved. On 09-Sep-2021, PYREXIA (Fever) had resolved. On 13-Sep-2021, MYALGIA (Muscle ache) had resolved. At the time of the report, PANIC ATTACK (Panic attacks), TREMOR (Shaking) and PYREXIA (High temperature) had resolved, FATIGUE (Fatigue) was resolving and DRY MOUTH (dry mouth), RESPIRATORY RATE INCREASED (breathing was rapid), HEART RATE INCREASED (heart rate was thumping), PAIN (pain) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to attend work the next day) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2020, SARS-CoV-2 test: yes - positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.; Sender''s Comments: This case concerns a 27-year-old, male, who experienced the unexpected events of PYREXIA, MYALGIA, FATIGUE, PANIC ATTACK and TREMOR. The event occurred after the most recent dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1739343 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-08
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, 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: ITMODERNATX, INC.MOD20213

Write-up: This case was initially received (Reference number: IT-MINISAL02-783174) on 17-Sep-2021. The most recent information was received on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of BELL''S PALSY (Paralisi di Bell dx) in a 31-year-old male patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. No Medical History information was reported. On 04-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 08-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced BELL''S PALSY (Paralisi di Bell dx) (seriousness criterion medically significant). At the time of the report, BELL''S PALSY (Paralisi di Bell dx) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information was provided. On 08-SEP-2021, Patient had an office visit. Bell''s Palsy was on right-hand side. This case concerns a 31-year-old male patient with no relevant medical history, who experienced the unexpected event of Bell''s palsy .The event occurred 4 days after administration unknown dose of Spikevax. The rechallenge was unknown as there''s no information available about the dose number. The events is consistent with the current understanding of the mechanism of action of the vaccine The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translated document received on 22 Sep 2021 was updated with event details. On 21-Sep-2021: Follow-up received: The event seriousness and listedness updated.; Sender''s Comments: This case concerns a 31-year-old male patient with no relevant medical history, who experienced the unexpected event of Bell''s palsy .The event occurred 4 days after administration unknown dose of Spikevax. The rechallenge was unknown as there''s no information available about the dose number. The events is consistent with the current understanding of the mechanism of action of the vaccine The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1739378 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dysphoria, Loss of consciousness, Presyncope, Pulse abnormal, Respiratory arrest
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 (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202101192882

Write-up: Loss of consciousness; Respiratory arrest; Vasovagal reflex; Pulse weak; Dysphoria; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126551. The patient was a 34-year-old male. (age at first dose of vaccination) Body temperature before vaccination was 36.5 centigrade. There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) as follows: Before the vaccination the patient said that the patient experienced Loss of consciousness when receiving influenza vaccine. On 08Sep2021 at 19:03 (the day of vaccination), the patient received the first dose of bnt162b2 (comirnaty, solution for injection, Lot number FG0978, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 08Sep2021 at 19:08 (the day of vaccination), the patient experienced Vasovagal reflex. On 08Sep2021 (the day of the vaccination), the outcome of the event was recovered. The course of the event was as follows: 5 minutes after vaccination, the patient felt Dysphoria, let the patient Lie down and rest. The patient experienced Loss of consciousness, Pulse weak and Respiratory arrest. Let the patient to put head down and feet up. About a minute later, the patient recovered. After recovered let the patient to the hospital for a medical examination. The reporter classified the event as non-serious and assessed that the event was unrelated to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporter commented as follows: Due to had the Relevant Med History, It is necessary to take measures such as lying injection and so on. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: Based on plausible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported events 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: 1739411 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Body temperature, Chest X-ray, Chest discomfort, Electrocardiogram, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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 Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210908; Test Name: Chest X-ray; Result Unstructured Data: Test Result:nothing abnormal; Test Date: 20210908; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:negative T wave in leads V1 to V3
CDC Split Type: JPPFIZER INC202101199229

Write-up: Feelings of weakness in left elbow and left wrist; left front Chest pressure sensation; Left Axillary pain; This is a spontaneous report from a Physician received from the Regulatory authority report number is v21126575. The patient was a 35-year and 10-month-male (Age at Vaccination). On 08Sep2021 at 17:25 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Lot number FG0978, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.8 degrees Centigrade. The patient had no family history. The patient had no medical history. Concomitant medications were not reported. On 08Sep2021 at 17:30 (5 minutes after vaccination), the patient experienced in the upper left arm, left front Chest pressure sensation and Feelings of weakness in left elbow and left wrist appeared. Left Axillary pain appeared. Chest x-ray showed nothing abnormal. Electrocardiogram showed negative T wave in leads V1 to V3. Symptoms were strong on the ulnar side and there was no problem with the injection site. Instructed to call this hospital if there was a change and the patient went home. On 13Sep2021 (5 days after vaccination), the outcome of the event was unknown. The reporter classified the event as serious (can lead to Disability) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Reporting because the patient had never experienced these symptoms.


VAERS ID: 1739470 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-09-08
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Gaze palsy, Presyncope
SMQs:, Anticholinergic syndrome (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Rolling of the eyes; Vasovagal reflex; This case was received via Regulatory Authority (Reference number: 2021TJP093732) on 13-Sep-2021 and was forwarded to Moderna on 25-Sep-2021. This case, reported by a physician, was received by company via Moderna''s adverse reaction reporting site (TASK0021716), and reported to the Regulatory Authority by a physician, was received via the agency (Ref, v21126673). Rolling of the eyes was assessed as serious by the agency On 11-Aug-2021, the patient received the 1st dose of this vaccine. On 08-Sep-2021, at 11:54, the patient received the 2nd dose of this vaccine. At 12:03, vasovagal reflex developed. Rolling of the eyes and vomiting were noted once. The patient recovered with leg elevation in a first-aid room. The patient was followed up for 30 minutes and returned home without any particular exacerbation. The outcome of vasovagal reflex and rolling of the eyes was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 24-year-old male patient with no relevant medical history who experienced unexpected event of Gaze palsy. The event occurred the same day after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing will be given. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however, there was no information in the source document of seriousness from a clinical or regulatory standpoint.


VAERS ID: 1740633 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-08
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: ATJNJFOC20210951161

Write-up: Perimyocarditis; This spontaneous report received from a physician via Regulatory Authority (AT-BASGAGES-2021-044287) on 27-SEP-2021 concerned a 54 year old male of an unspecified race and ethnic origin The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE393 expiry: unknown) 1 dosage forms, with frequency time 1 total administered on 03-SEP-2021 for covid-19 vaccination. No concomitant medications were reported. On 08-SEP-2021, the patient experienced perimyocarditis, and was hospitalized (date unspecified). Treatment with Covid-19 vaccine ad26.cov2.s was withdrawn on 03-SEP-2021. The outcome of perimyocarditis was not reported. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1740736 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-08
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pericarditis
SMQs:, Systemic lupus erythematosus (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101213674

Write-up: Pericarditis; This is a spontaneous report from a contactable health professional via the Regulatory Authority. Regulatory authority report number is 621312. A 31-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis on 08Sep2021 with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742012 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Fatigue, Hot flush, Major depression, Menstruation irregular
SMQs:, Psychosis and psychotic disorders (broad), Depression (excl suicide and self injury) (narrow), Fertility 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:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101205808

Write-up: Severe menstrual cramps lasting a week so far; Major depression; Missed menstrual cycle (not pregnant); Hot flashes; Fatigued; This is a spontaneous report received from a contactable other health professional (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 03Sep2021 14:00 (batch/lot number not reported), at age 22 years old, as dose 1, single, for COVID-19 immunisation, at a pharmacy or drug store. The patient was not pregnant at the time of vaccination. The patient has no medical history, past drug history and known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive other medications/concomitant medications within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 08Sep2021 06:00, 4 days and 16 hours after the first vaccination, the patient experienced severe menstrual cramps lasting a week so far, major depression, missed menstrual cycle (not pregnant), hot flashes and was fatigued. The events resulted to emergency room visit. The patient was not given treatment for the events. The outcome of the events was not resolved. The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the currently available information the possibility of causal association between the event menstrual cramps, major depression and the suspect drug BNT162B2 cannot be ruled out. 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: 1742887 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Hypersensitivity, Skin reaction, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101202536

Write-up: Allergic reaction with generalized skin rash with itchy wheals and angioedema.; Allergic reaction with generalized skin rash with itchy wheals and angioedema.; Allergic reaction with generalized skin rash with itchy wheals and angioedema.; Allergic reaction with generalized skin rash with itchy wheals and angioedema.; This is a spontaneous report from a contactable other healthcare professional downloaded from the regulatory authority-WEB IT-MINISAL02-782981 received via regulatory authority. A 31-Years old female received bnt162b2 (Comirnaty , Formulation: Solution for injection, Batch/Lot number : FG7387, Expiration Date: 30Nov2021) dose 2, 0.3Ml , Via an Intramuscular route of administration, administered in left arm on 07Sep2021 at 13:47pm as a single dose for COVID-19 immunisation. Patient medical history and concomitant medication were not reported. Historical vaccine include bnt162b2 (Comirnaty , Formulation: Solution for injection, Batch/Lot number : Not reported) dose 1, Via an unspecified route of administration on 12Aug2021 as a single dose for COVID-19 immunisation. Patient experienced Allergic reaction with generalized skin rash with itchy wheals and angioedema on 8Sep2021. Treatment received for the event include (antihistamines + cortisone ) Self-administration of trimeton 1 vial intramuscular + prednisone 25 mg orally. Outcome of the event was Recovered with Sequel.


VAERS ID: 1742898 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hyperpyrexia, Muscle spasms
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: ITPFIZER INC202101208425

Write-up: Muscle spasms in the left upper, lower limbs and hyperpyrexia (38 C); Muscle spasms in the left upper, lower limbs and hyperpyrexia (38 C); This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority-WEB IT-MINISAL02-783665 received via regulatory authority. A 12-year-old male patient received bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot Number: FG7387; Expiration Date: 30Nov2021), via intramuscular, administered in arm right on 07Sep2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 08Sep2021, the patient experienced muscle spasms in the left upper, lower limbs and hyperpyrexia (38 c). The patient was treated with paracetamol 500mg as a therapeutic measure of muscle spasms in the left upper, lower limbs and hyperpyrexia (38 c). On 08Sep2021, the patient underwent lab tests and procedures which included body temperature: 38 centigrade. Seriousness of the event hyperpyrexia (38 C) was reported as medically significant. It was reported that, on 09Sep2021, the patient recovered from muscle spasms in the left upper, lower limbs and hyperpyrexia (38 C). No follow-up attempts possible. No further information expected.


VAERS ID: 1742965 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Pain in extremity
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101223061

Write-up: The same day pain in the arm; the next morning fainting with loss of consciousness, muscle stiffness, no convulsions; muscle stiffness; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-785310. A 13-years-old male patient received BNT162B2 (COMIRNATY solution for injection lot number: FG3739) via intramuscular, administered in Arm Left on 08Sep2021 16:40 9at the age of 13 years as dose 1 single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Sep2021 the patient experienced the same day pain in the arm, the next morning fainting with loss of consciousness, muscle stiffness, no convulsions, muscle stiffness. The outcome of events was recovered in 09Sep2021. Reported Dosage of Comirnaty vaccine: 1DF, cyclical. No follow-up attempts possible. No further information expected.


VAERS ID: 1743207 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005286 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neuropathy peripheral, Vaccination site erythema, Vaccination site swelling
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Peripheral nerve disorder; Light redness and swelling of about 10 cm in diameter at the vaccination site; Light redness and swelling of about 10 cm in diameter at the vaccination site; This case was received via Pharmaceutical Company (Reference number: 2021TJP094118) on 14-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the Regulatory Authority (Ref, v21127810). Peripheral nerve disorder was assessed as serious by the Regulatory Authority. On an unknown date, body temperature before vaccination: 36.5 degrees Celsius. On 08-Sep-2021, at 11:30, the patient received the 1st dose of this vaccine. At 11:50, the patient experienced peripheral nerve disorder. The heaviness of the vaccination site gradually occurred. The patient also gradually had myalgia-like heaviness from the elbow joint to the forearm. The symptom gradually changed to neuralgia-like hypersensitivity and sharp pain, and the patient was unable to move the right upper limb. Around 12:40, the patient was examined by a physician. The right upper arm was already limp because of neurogenic pain. Light redness and mild swelling of about 10 cm in diameter was noted at the vaccination site. Tenderness was not prominent. Sensory sensitivity and neuralgia, which made the patent jump when touched, were noted from the forearm below the elbow joint to the fingers, mainly in the radial nerve region. The patient was unable to move the fingers due to symptoms from the forearm to the fingers in combination with associated somatic pain. The patient was advised to seek medical attention. The symptoms slightly improved once the patient returned home, so the patient took acetaminophen at home and rested in bed. The patient realized the reduction of the symptom in about 2 hours, and the patient waited and saw how things would go. After the patient took acetaminophen again after dinner, the symptoms were relieved, and the patient became able to move the right hand fingers. Therefore, the patient did not take further measures. On 09-Sep-2021, sensory sensitivity and neuralgia disappeared. On 13-Sep-2021, recovery of symptoms was confirmed. The outcome of peripheral nerve disorder, and light redness and swelling of about 10 cm in diameter at the vaccination site was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: It is possible that acute inflammatory changes or swelling in the muscle occurred as a local reaction at the vaccination site spread to the radial nerve in the upper arm, and acute transient neuropathy mainly centered on the radial nerve region below the elbow joint occurred. The neurological symptoms seemed to disappear with the disappearance of the reaction.; Sender''s Comments: This case concerns a 36-year-old, female patient with no relevant medical history, who experienced the unexpected event of peripheral neuropathy. The event occurred approximately 20 minutes after the first dose of Moderna COVID-19 Vaccine. The rechallenge was unknown since no information about the second dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per information provided in source document.


VAERS ID: 1743219 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005693 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Hyperventilation, Hypoaesthesia, Pyrexia, Seizure
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (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: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: body temperature; Test Result: Inconclusive ; Result Unstructured Data: 36.4 degrees Celsius
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Pyrexia; Convulsion; Difficulty breathing; Hyperpnoea; Numbness in hands and feet; This case was received via Pharmaceutical Company(Reference number: JP-TAKEDA-2021TJP095722) on 16-Sep-2021 and was forwarded to Company on 28-Sep-2021. This case, reported by a physician, was received by Pharmaceutical Company via Company adverse reaction reporting site (TASK0021743). Convulsion was assessed as serious by the Regulatory Authority. On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 08-Sep-2021, at 09:56, the patient received the 1st dose of the vaccine. At 19:40, after the vaccination, the patient experienced pyrexia and convulsion while working as usual. The patient lay down due to worsening of difficulty breathing. Hyperpnea and difficulty breathing persisted, and numbness in hands and feet developed; thus, emergency call was made. The patient was taken to an emergency hospital. On 09-Sep-2021, resolution of the symptoms was confirmed. The outcome of pyrexia, convulsion, difficulty breathing, hyperpnea, and numbness in hands and feet was reported as resolved. Follow-up investigation will be made. Company Comment: This case concerns a 26-year-old male patient with relevant medical history of Asthma , who experienced the unexpected serious events of Seizure, Hyperventilation, Hypoaesthesia, Dyspnoea ,Pyrexia .The events occurred approximately 1 day after the first dose of Spikevax. The rechallenge is unknown since the events occurred after the first dose and no details were provided about the second dose. The benefit-risk relationship of Spikevax is not affected by this report.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 26-year-old male patient with relevant medical history of Asthma , who experienced the unexpected serious events of Seizure, Hyperventilation, Hypoaesthesia, Dyspnoea ,Pyrexia .The events occurred approximately 1 day after the first dose of Spikevax. The rechallenge is unknown since the events occurred after the first dose and no details were provided about the second dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1744267 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-09-08
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Muscle twitching, Neuropathy peripheral, Paraesthesia, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test positive
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: SARS-CoV-2 S-protein level; Result Unstructured Data: Test Result:30 756
CDC Split Type: ZAPFIZER INC202101204510

Write-up: Muscle twitching.; Paraesthesia; Peripheral neuropathy; Headache; Fatigue; Dizziness; SARS-CoV-2 S-protein level came back at 30 756 (normal being <50); This is a spontaneous report from a contactable physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: Unknown) via an unspecified route of administration on 23Jul2021 as a single dose for COVID-19 immunization. Medical history included COVID-19 on an unspecified date and unspecified if ongoing. Concomitant medications were not reported. On an unspecified date, the patient experienced muscle twitching, paraesthesia, peripheral neuropathy, headache, fatigue, dizziness and on 08Sep2021, the patient experienced SARS-CoV-2 S-protein level came back at 30 756 (normal being <50). The events muscle twitching and paraesthesia were reported as serious for disability. The clinical outcomes of the events muscle twitching, paraesthesia, peripheral neuropathy, headache, fatigue, dizziness were recovered/resolved on an unspecified date and the clinical outcome of the event SARS-CoV-2 S-protein level came back at 30 756 (normal being <50) was unknown. No follow-up attempts are possible; information about lot number cannot be obtained.; Sender''s Comments: Based on the information provided, a contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: Unknown) to the reported events Muscle twitching, paresthesia, and peripheral neuropathy can''t be excluded. This case will be reassessed should additional information becomes available.


VAERS ID: 1744856 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-08
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: AUPFIZER INC202101213465

Write-up: Anaphylactic reaction; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 620564. A 35-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction on 08Sep2021. The outcome of the event was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1744886 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG9019 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Ear pain, Fatigue, Headache, Incorrect route of product administration, Malaise, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: fever; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: BEPFIZER INC202101215653

Write-up: Fever; Feeling unwell; Shivering; Fatigue; Nausea; Headache; Earache all day (including night).; inappriopriate route of vaccination; This is a spontaneous report from a contactable consumer or non health professional downloaded from the regulatory authority-WEB BE-FAMHP-DHH-N2021-106515. Narrative: [BE-FAMHP-DHH-N2021-106515] Spontaneous COVID-19 report received by the regulatory authorities on 09Sep2021. This female patient was vaccinated on 08Sep2021 with Comirnaty (second dose administered). Concomitant drug(s): Dafalgan Reported ADR''s: Fever Malaise Shivering Fatigue Nausea Headache Ear pain Reportercomment: Treatment - Unknown Evolution of the adverse drug reaction - No improvement Situations - Incorrect route of administration: adverse drug reaction description - Headache and earache all day long (also at night). Fatigue all day long. Chills now and then, but a fever of 38 degrees Sendercomment: CaseSummary. Stop date of events is: 09Sep2021 with outcome ''not recovered''. Batch/lot number: FG9019 No follow-up attempts possible. No further information expected. ; Reporter''s Comments: Treatment - Unknown Evolution of the adverse drug reaction - No improvement Situations - Incorrect route of administration: adverse drug reaction description - Headache and earache all day long (also at night). Fatigue all day long. Chills now and then, but a fever of 38 degrees


VAERS ID: 1744889 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH VBBF7EE468C5641 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cardiovascular disorder, Chills, Fatigue, Malaise, Myalgia, Pyrexia, Thrombophlebitis, Ultrasound Doppler
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: venous doppler; Result Unstructured Data: Test Result:thrombophlebitis left leg
CDC Split Type: BEPFIZER INC202101215680

Write-up: thrombophlebitis left leg; Fatigue; Myalgia; Malaise; Fever; Arthralgia; Shivering; Cardiovascular disorder; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number BE-FAMHP-DHH-N2021-106521 A 13-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Sep2021 (Lot Number: Vbbf7ee468c56416) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced thrombophlebitis left leg, fatigue, myalgia, malaise, fever, arthralgia, shivering and cardiovascular disorder on 08Sep2021. The outcome of events was unknown. The patient underwent lab tests and procedures which included venous doppler: thrombophlebitis left leg on 10Sep2021. The event thrombophlebitis left leg was reported as medically significant form health authority. Reporter''s comments: Treatment - Evolution of the ADR - Examinations - venous doppler scheduled for 10Sep2021 ADR description - thrombophlebitis left leg. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: Treatment - Evolution of the ADR - Examinations - venous doppler scheduled for 10Sep2021 ADR description - thrombophlebitis left leg


VAERS ID: 1746502 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-09-08
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acne, Constipation, Diarrhoea, Dysmenorrhoea, Muscle spasms, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: FLUOXETINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191528

Write-up: acne; constipation; cramps; diarrhea; Pain menstrual; This is a spontaneous report from a contactable consumer or other non-HCP. This is a report received from the Regulatory Authority; report number GB-MHRA-APPCOVID-20210910093802, Safety Report Unique Identifier GB-MHRA-ADR 25922837. A 34-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number FA1027 and Expiry date was not reported), via an unspecified route of administration on 15Jun2021 as DOSE NUMBER UNKNOWN, single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included depression from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medications included fluoxetine (FLUOXETINE) taken for depression from 01May2019 to an unspecified stop date. Clinical course of events includes; third period after vaccine and still having effects - very reactive acne and painful cramps. This period has so far been very painful with diarrhea and now constipation with very painful sharp stomach and perineum pain (latter has never happened before) lasting about 30 mins at a time. On an unspecified date the patient experienced acne, constipation, cramps, diarrhea, on 08Sep2021 patient experienced pain menstrual. The patient underwent lab tests and procedures which included sars-cov-2 test negative on an unspecified date, no-negative COVID-19 test. Outcome of the events pain menstrual was not recovered, diarrhea was unknown, and rest of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1746524 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Bone pain, Fatigue, Feeling abnormal, Headache, Insomnia, Limb discomfort, Malaise, Nausea, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Osteonecrosis (broad), Tendinopathies and ligament 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: CERELLE; IBUPROFEN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Irregular periods; Pain
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101190611

Write-up: Severe headaches; Fatigue; Nausea; Weakness; feeling abnormal; Feeling unwell; Severe Bone pain; Difficulty sleeping; Pain in arm; arm heavy; Hand pain; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number, GB-MHRA-WEBCOVID-202109091513303030-3UGOU, Safety Report Unique Identifier of GB-MHRA-ADR 25918559. An 18-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ff8222) via an unspecified route of administration on 08Sep2021 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history included irregular periods and pain. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient was not pregnant at the time of vaccination and was currently not breastfeeding. Concomitant medications included desogestrel (CERELLE) for irregular periods, ibuprofen for pain and paracetamol for pain. On 07Sep2021, the patient underwent COVID-19 virus test and the result was negative. On 08Sep2021, the patient experienced feeling abnormal, feeling unwell, severe bone pain, difficulty sleeping, pain in arm, arm heavy and hand pain. On 09Sep2021, the patient experienced severe headache, fatigue, nausea and weakness. All events were reported as serious for being medically significant. The clinical course was reported as follows: The patient started experiencing pain in the bones of some fingers soon after the vaccine. A few hours later, the patients arm became painful, heavy and was difficult in sleeping. The next day patient experienced severe headaches, severe pain in bones including whole hands, fatigue and weakness which was due to the pain and random times of nausea. The patients arm pain had slightly gotten better. The patient was not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event feeling abnormal, pain in arm, nausea and feeling unwell was resolving. The clinical outcome of the event severe bone pain, hand pain, severe headache, fatigue, weakness was not resolved. The clinical outcome of the event difficulty sleeping and arm heavy was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1746679 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Menstrual disorder, Muscle spasms, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (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 INC202101225113

Write-up: bleeding; cramps; Menstruation abnormal; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202109161057496600-WXCAN, Safety Report Unique Identifier GB-MHRA-ADR 25953804. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: not reported), via an unspecified route of administration on 03Sep2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced bleeding and cramps on an unspecified date, menstruation abnormal on 08Sep2021. The events were reported as medically significant. The clinical course was reported as she got her first shot on September 3 and got her period early and she has not stopped bleeding for over 8 days now. Usually, her flow lasts 2 to 4 days at most. She had cramps every day since she got her period early. She cant imagine what the impact was going to be after the second shot. The patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (no- negative covid-19 test) on an unspecified date. The outcome of the events was not recovered. No follow-up attempts were possible. No further information was expected. Information about lot/batch number cannot be obtained.


VAERS ID: 1746700 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acne, Anxiety, Axillary pain, Blood pressure measurement, Blood test, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Dysmenorrhoea, Heavy menstrual bleeding, Hypertension, Investigation, Mood swings, Pain, Premenstrual syndrome, Throat tightness, Vaccination site mass, Vitamin B complex deficiency
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypertension (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (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: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Test Name: blood parameter; Result Unstructured Data: Test Result:normal; Test Name: TSH level; Result Unstructured Data: Test Result:High; Test Name: vitamin B; Result Unstructured Data: Test Result:Low
CDC Split Type: GBPFIZER INC202101225283

Write-up: general aching; anxiety; TSH level: high; vitamin B: Low; Period pains; Heavy periods; Acne; Mood swings; Prolonged periods; severe PMS; Blood pressure high; Throat tightness; Vaccination site lump; Armpit pain; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number [GB-MHRA-WEBCOVID-202109161155317880-DGPDN], Safety Report Unique Identifier [GB-MHRA-ADR 25952208]. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Sep2021 (Lot Number: FE3380) at dose 2, single for COVID-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing, suspected COVID-19 from 01Jun2020 to 01Jul2020. Concomitant medications included sertraline taken for anxiety from 08Feb2018 to an unspecified stop date. The patient previously took sertraline for anxiety; and first dose of BNT162B2 on an unknown date for COVID-19 immunisation and experienced Throat tightness. The patient experienced blood pressure high and throat tightness on 09Sep2021; mood swings, severe PMS and prolonged periods on 10Sep2021; period pains and heavy periods on 12Sep2021; vaccination site lump and armpit pain on 08Sep2021; acne on 11Sep2021; and general aching, anxiety on an unspecified date. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included blood pressure measurement: high, TSH level: high, blood parameters: Normal, vitamin B: Low, all on an unknown date. The outcome of the events ''TSH level: high'' and ''vitamin B: Low'' was unknown and outcome of the other events was not recovered. The clinical course was reported as follows: Heavy painful early period with severe PMS like acne, mood swings, general aching, anxiety. Throat tightness appeared after 1st dose but she didn''t really link it. It got worse recently. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional Information: Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1746726 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, SARS-CoV-2 test
SMQs:, 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 Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101224886

Write-up: Head pain; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161340467600-0ED82. Safety Report Unique Identifier GB-MHRA-ADR 25952871. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on 07Sep2021 as dose 2, single for COVID-19 immunisation. The patient previously received first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took pregabalin for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. The patient experienced head pain (disability, medically significant) on 08Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (no-negative COVID-19 test) on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The clinical outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746761 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness, Electrocardiogram, Nausea, Paraesthesia, X-ray
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:Unknown; Test Name: X ray; Result Unstructured Data: Test Result:Unknown
CDC Split Type: GBPFIZER INC202101224827

Write-up: Felt light headed; Nauseous; Tingling; Chest pain; This is a spontaneous report from a contactable pharmacist received from the regulatory authority . The regulatory authority report number is GB-MHRA-WEBCOVID-202109161632476780-ZFHXX, Safety Report Unique Identifier GB-MHRA-ADR 25954115. A 52-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FE3380), via an unspecified route of administration on 08Sep2021 (at the age of 52-years-old) as dose 2, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19 and not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Unsure if patient was enrolled in clinical trial. Historical vaccine included that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On 08Sep2021, initially lips tingled within first 15mins and she developed quite severe chest pains. On an unspecified date, patient felt lightheaded and nauseous. First responder arrived on scene. Ambulance called and took her to hospital. Tingling spread to whole body. No explanation for the cause of the chest pain. Chest still feels sore on left side and left arm tingles sometimes. The patient underwent lab tests and procedures which included electrocardiogram and x-ray: unknown on an unspecified date. The reporter considered the events as serious (medically significant). The outcome of events tingling, chest pain was recovering and for dizziness and nausea was unknown. The report does not relate to possible blood clots or low platelet counts. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: ECG, X rays. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1746999 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-09-08
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Rheumatoid arthritis
SMQs:, Arthritis (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101214788

Write-up: This is a spontaneous report from a contactable physician downloaded from the regulatory authority number IT-MINISAL02-784238. A 61-year-old male patient received first dose of BNT162B2 (COMIRNATY COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FF3318), via Intramuscular route of administration, in the left deltoid on 28Jul2021 (age at the time of vaccination 61-years-old), as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 08Sep2021, the patient experienced Rheumatoid arthritis exacerbation. Patient took oki and cortisone as needed for the treatment of adverse event. The outcome of the event was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1747038 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug allergy (ketoprofen); Drug allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via Medicines Agency (Reference number: IT-MINISAL02-785553) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE and ABDOMINAL PAIN in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (ketoprofen) and Drug allergy. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form in total. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) at an unspecified dose. On 08-Sep-2021, the patient experienced SYNCOPE (seriousness criterion medically significant) and ABDOMINAL PAIN (seriousness criterion medically significant). At the time of the report, SYNCOPE and ABDOMINAL PAIN had not resolved. No concomitant medication reported. No treatment medication provided. On Sep 07 2021, the patient had their second dose of the Moderna vaccine. In the night after a strong bellyache (without discharge) I fainted, cutting my lips (top and bottom) 1 cut to the eyebro, 2 blows near eye/nose. Company Comment: This case concerns a 32 year-old male with a concurrent medical condition of drug allergy, who experienced the unexpected events of Syncope and Abdominal pain. These events occurred approximately one day after the second dose of Spikevax.The event was considered related to the study drug per the reporter''s assessment. The concurrent medical condition of Drug Allergy may be a cofounder. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation received on 24-sep-21 and it included reporter''s and sender''s comments added patient details On 22-Sep-2021: Follow Up appended; Reporter''s Comments: Allergy to ketoprofen 13/09/2021 Sender''s Comments: This case concerns a 32 year-old male with a concurrent medical condition of drug allergy, who experienced the unexpected events of Syncope and Abdominal pain. These events occurred approximately one day after the second dose of Spikevax.The event was considered related to the study drug per the reporter''s assessment. The concurrent medical condition of Drug Allergy may be a cofounder. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1747327 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004224 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Echocardiogram, Interchange of vaccine products, Myocarditis, N-terminal prohormone brain natriuretic peptide, Troponin
SMQs:, Cardiomyopathy (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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: COMIRNATY
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: NT-proBNP; Result Unstructured Data: 2246; Test Date: 20210908; Test Name: Troponin; Result Unstructured Data: 3932 - 4109; Test Date: 20210908; Test Name: Echocardiogram; Result Unstructured Data: Ejection fraction ca 40 %,
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: Interchange of vaccine products; This case was received via a regulatory authority (Reference number: NO-NOMAADVRE-E2B_00050078) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS in a 20-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004224) for Revaccination with different COVID-19 vaccine. The occurrence of additional non-serious events is detailed below. Previously administered products included for Vaccination: COMIRNATY. Concomitant products included TOZINAMERAN (COMIRNATY) for Vaccination. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, MYOCARDITIS outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, Echocardiogram: 40 percent Ejection fraction ca 40 %. On 08-Sep-2021, N-terminal prohormone brain natriuretic peptide: 2246 2246. On 08-Sep-2021, Troponin: 3537 (High) 3932 - 4109. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered MYOCARDITIS to be possibly related. No further causality assessment was provided for INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 08 Sep 2021 patient had undergone Echocardiogram and the result was Ejection fraction ca 40 %. Concomitant medications was not provided by the reporter. Treatment information was not provided. Company Comment: This case concerns a 20 years old male whose medical history was not provided. The patient received a dose of Cominarty vaccine on an unknown date. On 06-Sep-2021 the patient received Moderna product as second dose (Revaccination with different COVID-19 vaccine). The date for Cominarty product administration is unknown. 3 days after Moderna product administration the patient experienced the serious (as per IME and hospitalization) listed AESI event of Myocarditis. The rechallenge is not applicable as per further doses are not expected. There is no reporter?s causality provided (nevertheless, translation is pending for further case assessment). The product Cominarty is a confounder/co-suspect for the event Myocarditis. The event outcome was unknown at the time of the report. The benefit-risk relationship of Moderna nMRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 20 years old male whose medical history was not provided. The patient received a dose of Cominarty vaccine on an unknown date. On 06-Sep-2021 the patient received Moderna product as second dose (Revaccination with different COVID-19 vaccine). The date for Cominarty product administration is unknown. 3 days after Moderna product administration the patient experienced the serious (as per IME and hospitalization) listed AESI event of Myocarditis. The rechallenge is not applicable as per further doses are not expected. There is no reporter?s causality provided (nevertheless, translation is pending for further case assessment). The product Cominarty is a confounder/co-suspect for the event Myocarditis. The event outcome was unknown at the time of the report. The benefit-risk relationship of Moderna nMRNA-1273 is not affected by this report.


VAERS ID: 1747436 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-08
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: SE-MPA-2021-083051) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS in a 19-year-old male patient who received mRNA-1273 for COVID-19 vaccination. No Medical History information was reported. On 30-Aug-2021, the patient received second dose of mRNA-1273 (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS was resolving. For mRNA-1273 (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case concerns a 19-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event occurred approximately 10 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation received on 27-SEP-2021: Dose number was updated.; Sender''s Comments: This case concerns a 19-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event occurred approximately 10 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1749136 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-09-08
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0575 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chorioretinal atrophy, Hypotension, Ocular vascular disorder, SARS-CoV-2 test, Vision blurred, Visual impairment
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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 Date: 20210628; Test Name: Fast Test; Test Result: Negative ; Comments: Other (Fast Test)
CDC Split Type: BRPFIZER INC202101226140

Write-up: the vaccine activated the disease angioid streaks in my eye; a blood clot in the retina; vision darkened; cloud in vision, only in the left eye; low pressure; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (COMIRNATY; Lot Number: EY0575 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 01Jul2021 14:15 (at the age of 43-years-old) at dose 1, single for covid-19 immunization. Patient had no medical history and no concomitant medications. It was unknown if the patient was allergic to any medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered at Heath Public Center. After vaccination, patient vision was darkened, after a few days, there was a cloud in vision, only in the left eye and he underwent some tests and it was found that the vaccine activated the disease angioid streaks in eye on 08Sep2021 20:00. Patient could see normally from right eye. Patient had a blood clot in the retina, was waiting for the public health center to pass the retina physician. Exception for the eye, he was in good health, had lowpressure, non-diabetic, does normal walking on 08Sep2021. Patient underwent Covid-19 Test: fast test with negative results on 28Jun2021. No treatment was given for the events. The outcome of the events was not recovered.


VAERS ID: 1749154 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Migraine
SMQs:, 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: Medical History/Concurrent Conditions: Bipolar affective disorder; Endocrine disorder; Hashimoto''s disease; Immune disorder (NOS); Major depressive disorder; Mental disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101241212

Write-up: Left-side facial and arm paralysis (Bell''''s Palsy); severe migraines; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient himself) via Regulatory Authority. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Batch/Lot number: not reported Expiration Date: Unknown) via an unspecified route of administration, in Left arm on 07Sep2021 12:30 PM as dose 1, single (at the age of 40-year-old) for covid-19 immunization. Past Medical history included Auto-Immune Disease/Mental Health Issues. Previous Diagnosis of Bi-Polar and Major Depressive Disorder, Pineal Gland Lesion, Auto-Immune Thyroid (Hashimoto''s). The patient''s concomitant medications were not reported. Patient previously took azithromycin. Patient had not received any other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. On 08Sep2021 post vaccination patient experienced Left-side facial and arm paralysis (Bell''s Palsy) for 3 days and severe migraines for 7 days post vaccine. Patient did not receive any treatment. Outcome of events was Recovering. Information on batch number will be requested


VAERS ID: 1749307 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214029 / 1 - / 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:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Miopericarditis; This case was received via the RA (Reference number: ES-AEMPS-998887) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of MYOCARDITIS in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214029) for COVID-19 vaccination. The patient''s past medical history included COVID-19 (Covid-19). On 05-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Treatment information was not provided. Company comment -This case concerns a 28-year-old male patient with no relevant medical history, who experienced serious, AESI, listed event of myocarditis. The serious event occurred after 4 days of 1st dose of Moderna COVID-19 Vaccine. The rechallenge was unknown as the date for the first dose of Moderna COVID-19 Vaccine was provided. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translated document was received on 27-Sep-2021, document had no new Information.; Sender''s Comments: This case concerns a 28-year-old male patient with no relevant medical history, who experienced serious, AESI, listed event of myocarditis. The serious event occurred after 4 days of 1st dose of Moderna COVID-19 Vaccine. The rechallenge was unknown as the date for the first dose of Moderna COVID-19 Vaccine was provided. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1751024 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Menstruation delayed, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210917; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101226838

Write-up: Painful periods; Late period; This is a spontaneous report from a contactable consumer. This report is received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109171441334130-DKUXF, Safety Report Unique Identifier GB-MHRA-ADR 25960353. A 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Sep2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant nor currently breastfeeding. The patient experienced painful periods on 12Sep2021 and late period on 08Sep2021. The events were considered medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 17Sep2021. The patient was recovering from the event, late period and not recovered from painful periods. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751369 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLINA [FOLIC ACID]; DOBETIN [CYANOCOBALAMIN]
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: IT-MINISAL02-786053) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of NAUSEA and VOMITING in a 43-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 immunisation. No medical history was provided by the reporter. Concomitant products included FOLIC ACID (FOLINA [FOLIC ACID]) and CYANOCOBALAMIN (DOBETIN [CYANOCOBALAMIN]) for an unknown indication. On 08-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 08-Sep-2021, the patient experienced NAUSEA () (seriousness criterion medically significant) and VOMITING (seriousness criterion medically significant). On 08-Sep-2021, NAUSEA and VOMITING had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications were not reported. It was reported that, 5 hours after vaccine administration, onset of nausea and vomiting. Company Comment: This case concerns a 43-year-old male subject, with no relevant medical history, who experienced the unexpected serious events of nausea and vomiting. The events occurred 5 hours after vaccine administration of the first dose of Spikevax. The rechallenge was unknown, as no information about second dose is available. The benefit-risk relationship of the vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation received on 28-Sep-21 of initial document, event verbatim was updated.; Sender''s Comments: This case concerns a 43-year-old male subject, with no relevant medical history, who experienced the unexpected serious events of nausea and vomiting. The events occurred 5 hours after vaccine administration of the first dose of Spikevax. The rechallenge was unknown, as no information about second dose is available. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1751392 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-09-08
   Days after vaccination:168
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, 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: Medical History/Concurrent Conditions: Coeliac sprue; Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: La Meridiana cluster, positive molecular swab at vaccinated patient, asymptomatic.
CDC Split Type: ITPFIZER INC202101231388

Write-up: Vaccination failure; La Meridiana cluster. Positive molecular swab at vaccinated patient. Asymptomatic; This is a spontaneous report from a contactable other Healthcare Professional downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-787204. A 87-years-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EP2166, Expiration date: 31May2021) intramuscular, administered in left arm (left shoulder) on 03Mar2021 (age at vaccination was unknown) as dose 1, 0.3 ml single and second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: ET3620, Expiration date: 30Jun2021) intramuscular, administered in left arm (left shoulder) on 24Mar2021 (age at vaccination was unknown) as dose 2, 0.3 ml single for COVID-19 immunization. The patient''s medical history included diabetes mellitus from 20May1997 and unknown if ongoing and coeliac sprue from 27Feb2002 and unknown if ongoing. The patient''s concomitant medications were not reported. On 08Sep2021, there was La Meridiana cluster, positive molecular swab at vaccinated patient, asymptomatic (vaccination failure). The patient underwent lab test which included COVID-19 PCR test: Positive (La Meridiana cluster, positive molecular swab at vaccinated patient, asymptomatic) on 08Sep2021. The information received from the Product Quality Complaint Group for Lot number: EP2166, Expiration date: 31May2021 included Conclusion: 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 EP2166. 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 Puurs 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. For Lot number: ET3620, Expiration date: 30Jun2021 included Conclusion: 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. Site 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. The outcome of the event was resolving. No follow-up attempts possible. No further information expected.


VAERS ID: 1751565 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939900 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Cough, Diarrhoea, Headache, Malaise, Myalgia, Nasopharyngitis, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (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)

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: PHMODERNATX, INC.MOD20213

Write-up: Body Malaise; Cough; cold; diarrhoea; mild fever; headache; joint pain; muscle pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of MALAISE (Body Malaise), COUGH (Cough), NASOPHARYNGITIS (cold), DIARRHOEA (diarrhoea), PYREXIA (mild fever), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a 57-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 939900) for COVID-19 vaccination. No Medical History information was reported. On 03-Sep-2021 at 9:50 AM, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 08-Sep-2021 at 4:00 AM, the patient experienced MALAISE (Body Malaise) (seriousness criterion medically significant). 08-Sep-2021 at 4:00 AM, the patient experienced COUGH (Cough) (seriousness criterion medically significant), NASOPHARYNGITIS (cold) (seriousness criterion medically significant), DIARRHOEA (diarrhoea) (seriousness criterion medically significant), PYREXIA (mild fever) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant), ARTHRALGIA (joint pain) (seriousness criterion medically significant) and MYALGIA (muscle pain) (seriousness criterion medically significant). At the time of the report, MALAISE (Body Malaise), COUGH (Cough), NASOPHARYNGITIS (cold), DIARRHOEA (diarrhoea), PYREXIA (mild fever), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had not resolved. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment was reported. This report concerns a 57 year old male patient with no relevant medical history who experienced serious unexpected events of malaise, cough, nasopharyngitis (cold), diarrhoea, pyrexia, headache, arthralgia, and myalgia. The events occurred approximately 5 days after vaccination with first dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This report concerns a 57 year old male patient with no relevant medical history who experienced serious unexpected events of malaise, cough, nasopharyngitis (cold), diarrhoea, pyrexia, headache, arthralgia, and myalgia. The events occurred approximately 5 days after vaccination with first dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1752915 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-09-08
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Cystic fibrosis; Cystic fibrosis related diabetes
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.MOD20213

Write-up: Weakness; Fever; This case was received via the RA (Reference number: GB-MHRA-ADR 25980261) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and PYREXIA (Fever) in a 35-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Vaccination. Concurrent medical conditions included Cystic fibrosis, Asthma and Cystic fibrosis related diabetes. On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHENIA (Weakness) (seriousness criterion medically significant). On 11-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, ASTHENIA (Weakness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No- Negative COVID-19 test. 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. Patient reported that the temperature reached 40 degrees Celsius. The patient had high fever, body aches, weakness, painful arm. Patient lost appetite and had never been so sick. Patient was hallucinating from the fever. 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 35-year-old male patient with a history of asthma, cystic fibrosis and diabetes, who experienced the unexpected serious events of Pyrexia (onset latency 1 day) and Asthenia (unknown latency) after the first dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as there is no information regarding the second dose. Medical history of diabetes remains a confounding factor for the event of asthenia. Seriousness is captured per event as reported by the RA. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 35-year-old male patient with a history of asthma, cystic fibrosis and diabetes, who experienced the unexpected serious events of Pyrexia (onset latency 1 day) and Asthenia (unknown latency) after the first dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as there is no information regarding the second dose. Medical history of diabetes remains a confounding factor for the event of asthenia. Seriousness is captured per event as reported by the RA. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1752971 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004729 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: PHMODERNATX, INC.MOD20213

Write-up: Blood clot, right eye; Severe headache; This regulatory authority case was reported by a physician and describes the occurrence of THROMBOSIS (Blood clot, right eye) and HEADACHE (Severe headache) in a 29-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3004729) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) .5 ml. On 08-Sep-2021, the patient experienced HEADACHE (Severe headache) (seriousness criterion medically significant). On 15-Sep-2021, the patient experienced THROMBOSIS (Blood clot, right eye) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clot, right eye) and HEADACHE (Severe headache) had resolved. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment drug information provided. No concomitant drug information provided. Company comment - This case concerns a 29 year old female patient with no relevant medical history ,who experienced the serious unexpected events of Thrombosis and Headache .The event Thrombosis occurred 8 days and Headache after 1 day following administration of first dose of Spikevax.The rechallenge was not applicable since only information about the first dose was disclosed.. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 29 year old female patient with no relevant medical history ,who experienced the serious unexpected events of Thrombosis and Headache .The event Thrombosis occurred 8 days and Headache after 1 day following administration of first dose of Spikevax.The rechallenge was not applicable since only information about the first dose was disclosed.. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1755016 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-09-08
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Menstruation delayed
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Late period; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 25949623) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Late period) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced MENSTRUATION DELAYED (Late period) (seriousness criterion medically significant). At the time of the report, MENSTRUATION DELAYED (Late period) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. It was reported that the patient''s menstrual period was due on 08-Sep-2021, however, it was late by 9 days and accompanied by extreme period pain and blood clots. The patient further reported that she used an app to track her period and it had been "correct" for 3 years. The patient has not tested positive for COVID-19 since having the vaccine. No treatment information was provided. Company comment: This case concerns a 29-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of menstruation delayed. The event occurred approximately 27 days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 29-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of menstruation delayed. The event occurred approximately 27 days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1755094 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F.F2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, Diarrhoea, Headache, Hyperhidrosis, Pain in extremity, Rash, Skin burning sensation, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), 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: Dust allergy; Hay fever (Taking daily, over the counter antihistamine for hay fever/dust allergies); Comments: No current medical treatment. Taking daily, over the counter antihistamine for hay fever/dust allergies. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: Temperature; Result Unstructured Data: Test Result:Raised
CDC Split Type: GBPFIZER INC202101233646

Write-up: sore arm; raised like a burn; Rash; raised temperature; Headache; Swelling; Sweating; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109192211369480-CJAGU; Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25966400. A 30-year-old female patient received bnt162b2 (PFIZER COVID-19 MRNA VACCINE BIONTECH, solution for injection, Batch/Lot number F.F2153) via an unspecified route of administration on 08Sep2021 (at the age of 30-years-old) as Dose 2, single for covid-19 immunization.Co-suspect drug included bcg vaccine (BCG), via an unspecified route of administration from 08Sep2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. Medical history included seasonal allergy and dust allergies (taking daily, over the counter antihistamine for hay fever/dust allergies). No current medical treatment. Concomitant medications were not reported. The patient was not currently breastfeeding. The patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not enrolled in clinical trial. On 08Sep2021, the patient experienced headache, swelling, sweating and diarrhea. On 09Sep2021, the patient experienced raised temperature. On 10Sep2021, the patient experienced rash. On an unspecified date, the patient experienced sore arm and raised like a burn. It was stated that within 24 hours of receiving the second dose of the vaccine patient experienced diarrhoea, a raised temperature, sweating as well as a headache/sore arm. Approximately 48 hours following the vaccine patient noticed a rash below the injection site (under my BCG scar). The following morning this had become raised like a burn. This continued to spread over the weekend and remained uncomfortable. The patient has not tested positive for COVID-19 since having the vaccine. The events raised temperature, rash, Headache, Swelling, Sweating,Diarrhea were reported as eventually medically significant. The patient underwent lab tests and procedures which included body temperature increased raised on 09Sep2021. The action taken in response to the event for bcg vaccine was unknown. The outcome of the event diarrhea was recovered on 09Sep2021 while the outcome of the events raised temperature and headache was recovered on 16Sep2021 and the outcome of the other events was recovering and the outcome of the events sore arm and raised like a burn was unknown.


VAERS ID: 1755148 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dyspepsia, Menstruation delayed, Pain, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), 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:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Heartburn; Loss of energy; Pins and needles; Shooting pain; Delayed period; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25983100) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pins and needles), PAIN (Shooting pain), MENSTRUATION DELAYED (Delayed period), DYSPEPSIA (Heartburn) and ASTHENIA (Loss of energy) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 since 09-Sep-2021. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced PARAESTHESIA (Pins and needles) (seriousness criterion medically significant), PAIN (Shooting pain) (seriousness criterion medically significant) and MENSTRUATION DELAYED (Delayed period) (seriousness criterion medically significant). On 09-Sep-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ASTHENIA (Loss of energy) (seriousness criterion medically significant). On 20-Sep-2021, the patient experienced DYSPEPSIA (Heartburn) (seriousness criterion medically significant). At the time of the report, PARAESTHESIA (Pins and needles), PAIN (Shooting pain), MENSTRUATION DELAYED (Delayed period), DYSPEPSIA (Heartburn) and ASTHENIA (Loss of energy) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, SARS-CoV-2 test: negative (Negative) No -Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Treatment information was not provided. Company Comment: This case concerns a 37-year-old female patient with no relevant medical history, who experienced the unexpected events of paranesthesia, pain, menstruation delayed, asthenia and dyspepsia. The events of paranesthesia, pain, menstruation delayed, asthenia and dyspepsia occurred approximately 1 day after the second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) and the event of dyspepsia occurred approximately 12 days after receiving the second dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 37-year-old female patient with no relevant medical history, who experienced the unexpected events of paranesthesia, pain, menstruation delayed, asthenia and dyspepsia. The events of paranesthesia, pain, menstruation delayed, asthenia and dyspepsia occurred approximately 1 day after the second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) and the event of dyspepsia occurred approximately 12 days after receiving the second dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1755306 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Monoplegia, Nasal congestion, Nasopharyngitis, Nausea, Pain in extremity, Paraesthesia, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was initially received (Reference number: IT-MINISAL02-785844) on 22-Sep-2021. The most recent information was received on 22-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MONOPLEGIA in a 34-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 08-Sep-2021, the patient experienced , PAIN IN EXTREMITY On an unknown date, the patient experienced NASAL CONGESTION (congestion), PARAESTHESIA (tingling in the arm), NASOPHARYNGITIS (extreme cold) and HEADACHE (headache). At the time of the report, MONOPLEGIA NASAL CONGESTION (congestion), PARAESTHESIA (tingling in the arm), NASOPHARYNGITIS (extreme cold), VOMITING (NAUSEA and HEADACHE (headache) had not resolved. Concomitant product was not provided by the reporter Lab data was provided Body Temperature Treatment product was not provided by the reporter Company comment -This case concerns a 34-year-old male patient with no relevant medical history, who experienced the unexpected serious event of Monoplegia. The event occurred 8 days after the first dose of (Spikevax). The rechallenge was not applicable as there is no information regarding the second dose. Pain in extremity, Nasal congestion, Paraesthesia, Nasopharyngitis, Vomiting, Pyrexia, Nausea, Headache are non-serious events. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up received on 23-SEP-2021 contained Significant information Lab data Body Temperature was updated; Sender''s Comments: This case concerns a 34-year-old male patient with no relevant medical history, who experienced the unexpected serious event of Monoplegia. The event occurred 8 days after the first dose of (Spikevax). The rechallenge was not applicable as there is no information regarding the second dose. Pain in extremity, Nasal congestion, Paraesthesia, Nasopharyngitis, Vomiting, Pyrexia, Nausea, Headache are non-serious events. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1755408 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004492 / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Intentional dose omission, Pyrexia, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: CARDIOASPIRINA
Current Illness: Anaphylactic reaction to drug; Contrast media allergy (contrast agent used for the CT scan); Drug allergy; Headache vasomotor; Heart failure (diagnosed before contracting the covid19); Tiredness (feels tired since she got covid19)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; COVID-19 virus test positive
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: INTENTIONALLY MISSED DOSE; pain in the arm at the injection site, stronger than before; fever; headache; tiredness; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the arm at the injection site, stronger than before) in a 74-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004492) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included COVID-19 in March 2021 and COVID-19 virus test positive in March 2021. Concurrent medical conditions included Drug allergy, Tiredness (feels tired since she got covid19), Heart failure (diagnosed before contracting the covid19), Contrast media allergy (contrast agent used for the CT scan), Anaphylactic reaction to drug and Headache vasomotor. Concomitant products included ACETYLSALICYLIC ACID (CARDIOASPIRINA) for an unknown indication. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced PYREXIA (fever), HEADACHE (headache), FATIGUE (tiredness) and VACCINATION SITE PAIN (pain in arm). On 19-Sep-2021, the patient experienced VACCINATION SITE PAIN (pain in the arm at the injection site, stronger than before) (seriousness criterion disability). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (INTENTIONALLY MISSED DOSE). On 10-Sep-2021, PYREXIA (fever), HEADACHE (headache), FATIGUE (tiredness) and VACCINATION SITE PAIN (pain in arm) had resolved. At the time of the report, VACCINATION SITE PAIN (pain in the arm at the injection site, stronger than before) was resolving and INTENTIONAL DOSE OMISSION (INTENTIONALLY MISSED DOSE) had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant medication also included beta- blockers, drugs for vasomotor headaches, and drugs for allergies. Reportedly, the patient also has several allergies to drugs. Because of COVID-19 in Mar-2021, the patient received and will receive only one vaccine injection. Around 19-Sep-2021- 20-Sep-2021, the patient reported again pain in the arm at the injection side, stronger than before was reported. The patient described the pain as "disabling pain" in the right arm and she can''t lift the arm. The pain improved slightly as the days go by. No treatment details provided. Company comment -This case concerns a 74-year-old, female patient with medical history drug allergies, who experienced the unexpected and serious event of vaccination site pain (the event is unexpected as it is retained as serious). The event occurred 12 days after the first dose of Spikevax was administered. The rechallenge was not applicable, as the events happened after the first dose. The medical history of drug allergies remains as a confounder. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case concerns a 74-year-old, female patient with medical history drug allergies, who experienced the unexpected and serious event of vaccination site pain (the event is unexpected as it is retained as serious). The event occurred 12 days after the first dose of Spikevax was administered. The rechallenge was not applicable, as the events happened after the first dose. The medical history of drug allergies remains as a confounder. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1757811 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Dysentery, Malaise, Nasopharyngitis, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: IT-MINISAL02-788534) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSENTERY in a 33-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced DYSENTERY (seriousness criterion medically significant), COUGH , NASOPHARYNGITIS , MALAISE and PYREXIA . At the time of the report, DYSENTERY , COUGH , NASOPHARYNGITIS , MALAISE and PYREXIA had not resolved. No relevant concomitant and treatment medications were reported Patient experienced Dysentery and intense vomiting, pain in arm and fever for 7 days after the first dose Patient experienced Dry cough, head cold, dysentery and high fever for 10 days after the second dose. Patient was allergic to cortisone and penicillin Company comment - This case concerns a 33-year-old, female patient with no relevant medical history, who experienced the unexpected event of Dysentry. The event occurred approximately 2 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation document received on 29-SEP-2021 included event verbatim, allergy to cortisone and penicillin narrative updated accordingly; Sender''s Comments: This case concerns a 33-year-old, female patient with no relevant medical history, who experienced the unexpected event of Dysentry. The event occurred approximately 2 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1757818 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005693 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Dyspnoea
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? Yes
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: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; Dyspnoea sense; This case was received via a regulatory authority (Reference number: 2021TJP098268) on 24-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This case, initially reported to a regulatory authority by a physician, was received via a regulatory authority (Ref, v21127636). On an unknown date, body temperature before vaccination: 36.3 degrees Celsius. On 08-Sep-2021, around 11:03, the patient received the 1st dose of this vaccine. At 11:05, dyspnoea sense and anaphylaxis developed. The patient was followed up after taking rupatadine fumarate, but the symptoms did not improve. Since the sound of airway stenosis also developed, adrenaline was also administered to the patient, and emergency was requested. The outcome of dyspnoea sense and anaphylaxis was unknown. Follow-up investigation will be made. Company Comment: This case concerns a 31-year-old, female patient with no previous relevant medical history , who experienced the expected event of Anaphylactic reaction and unexpected event dyspnea. The events occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.; Reporter''s Comments: Another factor could be anxiety.; Sender''s Comments: This case concerns a 31-year-old, female patient with no previous relevant medical history , who experienced the expected event of Anaphylactic reaction and unexpected event dyspnea. The events occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1757988 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-09-08
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Dyspnoea, Headache, Investigation, Limb discomfort, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Multiple sclerosis
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 PCR test positive; Hay fever (birch)
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: Computerised tomography scan; Result Unstructured Data: Test Result:pulmonary embolism; Test Date: 20210908; Test Name: G-value; Result Unstructured Data: Test Result:increased; Test Date: 20210301; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: DEPFIZER INC202101228958

Write-up: Pulmonary embolus; Discomfort in arm; headaches; breathing difficulties/shortness of breath under exertion; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021177311. Safety Report Unique Identifier: DE-PEI-202100186877. A 52-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Jul2021 (at unknown age) as single dose for COVID-19 immunisation. The patient''s medical history included: COVID-19 PCR test positive, Mild hay fever because of birch, ongoing Multiple sclerosis diagnosed with very slow progression. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) as single dose for COVID-19 immunisation. On 31Jul2021 a "second" vaccination with Biontech/Pfizer. After the vaccination, on unknown date: Discomfort in arm, headaches more often, but especially breathing difficulties and shortness of breath under exertion. During a visit to the lung specialist on 08Sep2021, an increased G-value was detected. In the subsequent Computed tomography scan, pulmonary embolism diagnosed with immediate admission to the emergency room and then hospitalization. Positive PCR test on 01Mar2021. Thereafter recovery with full sporting activity. This report is serious-hospitalization for Pulmonary embolus. Physician office visit for all events. The outcome of the event Pulmonary embolus was not recovered, for other events was unknown. COMIRNATY/Pulmonary embolus/PEI/D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1758043 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Headache, Hyperhidrosis, Limb discomfort, Musculoskeletal stiffness, Pain, Palpitations, Paraesthesia, Peripheral swelling, SARS-CoV-2 test, Swelling, Tachycardia, Vaccination site swelling, Visual impairment
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Arthritis (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: COVID-19 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101229195

Write-up: Tachycardia; Chest tightness/feeling of tightness in the thoracic right side; headaches; difficulty breathing; visual disturbance of the right eye; sweating; palpitations; swelling of the left arm; swelling of neck; swelling of feet; heaviness of the legs; tingling in the fingers and feet; neck stiffness; pain; extreme fatigue; This is a spontaneous report from a contactable other HCP downloaded from the Regulatory Agency-WEB, regulatory authority number FR-AFSSAPS-MP20217339. A 30-years-old female patient (Patient''s height (cm):180; Patient''s weight (kg): 108) received bnt162b2 (COMIRNATY), first dose, intramuscular, administered in Arm Left on 08Sep2021 (Batch/Lot Number: FG7387) as DOSE 1,SINGLE for covid-19 immunization, at the age at vaccination date of 30 years old. The patient''s medical history and concomitant medications were not reported. No History of COVID-19. The patient experienced tachycardia, chest tightness/feeling of tightness in the thoracic right side, headaches, difficulty breathing, visual disturbance of the right eye, sweating, palpitations, swelling of the left arm, swelling of neck, swelling of feet, heaviness of the legs, tingling in the fingers and feet, neck stiffness, pain, extreme fatigue, all medically significant on 08Sep2021 with outcome of recovered with sequelae on 09Sep2021 (reported Healing with sequelae at the time of the report). The patient underwent lab tests which included sars-cov-2 test: negative on 06Sep2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1758172 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-08
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005244 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypotension, Loss of consciousness, Pelvic pain
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Sexual dysfunction (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: Drug allergy; Nickel sensitivity.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Agency (Reference number: IT-MINISAL02-787478) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS, HYPOTENSION and PELVIC PAIN in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005244) for COVID-19 vaccination. Concurrent medical conditions included Nickel sensitivity and Drug allergy. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (seriousness criteria hospitalization and medically significant), HYPOTENSION (seriousness criterion hospitalization) and PELVIC PAIN (seriousness criterion hospitalization). At the time of the report, LOSS OF CONSCIOUSNESS, HYPOTENSION and PELVIC PAIN was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant product use was not provided. Treatment information was not provided. Company comment: This case concerns a 30-year-old, female patient with a no relevant medical history, who experienced the serious, unexpected event of Loss of consciousness, Hypotension and Pelvic pain. The events occurred after the administration of mRNA-1273. (The start date and dose sequence are unknown). The rechallenge information is unknown as we do not know what dose of the vaccine was received. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation document received on 30-OCT-2021 and contain included amoxicillin and nickel allergy added in I-narrative supplement. Sender''s Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the serious, unexpected event of Loss of consciousness, Hypotension and Pelvic pain. The events occurred after the administration of mRNA-1273. (The start date and dose sequence are unknown). The rechallenge information is unknown as we do not know what dose of the vaccine was received. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1758184 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Deep vein thrombosis, Incorrect route of product administration, Inflammation, Lymphadenopathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Drug abuse and dependence (broad), Thrombophlebitis (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
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: ITMODERNATX, INC.MOD20213

Write-up: Inappropriate route of vaccination; This case was received via European Medicines Agency (Reference number: IT-MINISAL02-788175) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS, LYMPHADENOPATHY, INFLAMMATION and PYREXIA in a 52-year-old female patient who received mRNA-1273 (batch no. 3004730) for Prevention. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Sep-2021, the patient received dose of mRNA-1273 (Intradermal) 1 dosage form. On 08-Sep-2021, the patient experienced DEEP VEIN THROMBOSIS (seriousness criteria medically significant and life threatening), LYMPHADENOPATHY (seriousness criterion life threatening), INFLAMMATION (seriousness criterion life threatening) and PYREXIA (seriousness criterion life threatening). On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). At the time of the report, DEEP VEIN THROMBOSIS, LYMPHADENOPATHY, INFLAMMATION and PYREXIA had not resolved and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. Patient medical history included Hashimoto''s thyroiditis. After vaccination patient were experienced DVT in the right gemellar vein, lymphadenomegaly in the axillary and inguinal regions Fever of 38.5 for 2 days, and also was suffered with inflammation of the ear and throat. Company Comment: This case concerns a 52 year old female with no relevant history who experienced the unlisted, serious event of Deep vein thrombosis, Lymphadenopathy, Inflammation, and Pyrexia the day after a dose of mRNA-1273. The dose number is unknown and re-challenge is unknown due to this. The benefit-risk relationship is not affected by this report. The events Inflammation, Pyrexia and Lymphadenopathy are assessed as serious by the RA; however, there is no evidence in the source documents supporting that the events were life-threatening. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translated information received on 29-Sep-2021 that contains updated Narrative. On 28-Sep-2021: Follow up received on 28-Sep-2021 that contains no new information.; Reporter''s Comments: Hashimoto''s thyroiditis; Sender''s Comments: This case concerns a 52 year old female with no relevant history who experienced the unlisted, serious event of Deep vein thrombosis, Lymphadenopathy, Inflammation, and Pyrexia the day after a dose of mRNA-1273. The dose number is unknown and re-challenge is unknown due to this. The benefit-risk relationship is not affected by this report. The events Inflammation, Pyrexia and Lymphadenopathy are assessed as serious by the RA; however, there is no evidence in the source documents supporting that the events were life-threatening.


VAERS ID: 1758201 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Feeling abnormal, Lip swelling, Oropharyngeal discomfort
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis (3 times); Food allergy (3 times)
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101228590

Write-up: Anaphylaxis-grade1; feels poorly; lower Lip swelling; Pharynx strange sensation of; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21127219. A 52-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FD0889; Expiration Date: 30Sep2021), via an unspecified route of administration on 08Sep2021 14:00 (at age of 52 years old) as single dose for COVID-19 immunisation. Medical history included Anaphylaxis-grade1 due to food allergy. The patient''s concomitant medications were not reported. The patient previously took epinephrine (EPIPEN) 3 times. The patient was a 52-year and 6-month-old female. Body temperature before vaccination was 35.7 degrees centigrade. There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status): the patient experienced 3 times Anaphylaxis-grade1 due to food allergy and received EpiPen before. On 08Sep2021 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY Intramuscular injection, Lot number FD0889, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The adverse event onset date was reported as on 08Sep2021 at 15:00 (the day of the vaccination). On 08Sep2021 (the day of the vaccination), the patient was admitted to the hospital and discharged on 09Sep2021. The course of the event was as follows: After vaccination, the patient experienced feels poorly, lower Lip swelling, Pharynx strange sensation of. But vital was normal and oxygenation was normal too. It was diagnosed as Anaphylaxis-grade1. It was not reached Anaphylactic shock. the patient was not given epinephrine but was given polaramine iv drip and was observed the progress. In order to prevent Delayed anaphylactoid reaction, the patient was given steroid iv drip and hospitalized for further treatment. The reporting physician classified the event as serious (hospitalized from 08Sep2021 to 09Sep2021) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporter commented as follows: The patient was recovering after received polaramine. It was not delayed anaphylaxis, symptoms got better and the patient discharged the next day. On 09Sep2021 (1 day after the vaccination), the outcome of the event was recovered.


VAERS ID: 1758202 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Arthralgia, Body temperature, Diarrhoea, Dysstasia, Encephalitis, Encephalopathy, Headache, Hypoaesthesia, Magnetic resonance imaging, Muscular weakness, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (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: Acute disseminated encephalomyelitis; Guillain-Barre syndrome; Myocardial infarction ((patient''s mother))
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:39s Centigrade; Comments: from the evening; Test Date: 20210911; Test Name: MRI; Result Unstructured Data: Test Result:No brain hyperimage
CDC Split Type: JPPFIZER INC202101228991

Write-up: abdominal pain; diarrhoea; could not stand; Upper limb muscle distal muscle position weakness; numbness of left arm; Encephalitis; encephalopathy; pyrexia(39s centigrade degrees); Generalised joint pain; headache; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21127225. A 30-year and 10-month-old female patient received 1st single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT number: FG0978, expiration date: 30Nov2021) via an unspecified route of administration on 08Sep2021 at 12:00 at age of 30-year and 10-month-old for COVID-19 immunisation. Medical history included Guillain-Barre syndrome and acute disseminated encephalomyelitis (ADEM). Family history included myocardial infarction (patient''s mother). Body temperature on 08Sep2021 before vaccination was 36.5 degrees centigrade. On 08Sep2021 at 20:00 (the day of the vaccination), the patient experienced encephalitis/encephalopathy. On 11Sep2021 (3 days after the vaccination), the patient was admitted to the hospital. On 17Sep2021 (9 days after the vaccination), the outcome of the events encephalitis/encephalopathy was not recovered. The course of the event was as follows: On 08Sep2021, the patient experienced pyrexia(39s centigrade degrees), generalised joint pain, headache from the evening. On 11Sep2021, in the morning, the patient experienced abdominal pain and diarrhea and was emergency transported. On the same day, the patient was observed the progress and hospitalized. After hospitalization, headache and the symptoms above got better gradually. But the patient could not stand and there was Upper limb muscle distal muscle position weakness. The patient did MRI and there was no brain hyperimage. The patient also experienced numbness of left arm. Outcome of events pyrexia, generalised joint pain, headache, abdominal pain, diarrhoea was recovering, of the other events was not recovered. The events required emergency room visit. The reporter classified the events as serious (hospitalized from 11Sep2021) and assessed that the causality between the events and bnt162b2 as unassessable. Other possible causes of the events such as any other diseases were ADEM, Guillain-Barre syndrome.


VAERS ID: 1758286 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7372 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Chills, Dyspnoea, Feeling hot, Heart rate, Inappropriate schedule of product administration, Oxygen saturation, Oxygen saturation decreased, Pallor, Stridor, Tachycardia, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Medication errors (narrow), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: Blood pressure; Result Unstructured Data: Test Result:129/85; Test Date: 20210908; Test Name: Pulse rate; Result Unstructured Data: Test Result:95; Test Date: 20210908; Test Name: Oxygen saturation; Test Result: 93 %; Comments: 12:15; Test Date: 20210908; Test Name: Oxygen saturation; Test Result: 75 %; Comments: 12:28; Test Date: 20210908; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:80-85 %; Comments: 12:27
CDC Split Type: NOPFIZER INC202101229083

Write-up: Feeling of warmth; STRIDOR; dyspnea/heavy breathing; wheezing; chills and shivering; OXYGEN SATURATION LOW; anaphylaxis; pale; TACHYCARDIA; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-U8q7rg. Safety unit identifier number: NO-NOMAADVRE-E2B_00049680. The physician reported different events for two doses. This is the first of two reports. A 21-year-old female patient received the second dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 08Sep2021 12:15 (Lot Number: FG7372) at the age of 21-year-old as Dose 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (COMIRNATY) on 07Jul2021 for Covid-19 immunisation and experienced dyspnea. The patient experienced stridor, dyspnea/heavy breathing, wheezing, low spo2, tachycardia, chills and shivering, anaphylaxis, pale on 08Sep2021 with outcome of recovered on 08Sep2021, feeling of warmth on an unspecified date with outcome of unknown, inappropriate schedule of vaccine administered on 08Sep2021 12:15 with outcome of unknown. Events were reported as serious with hospitalization (exclude event inappropriate schedule of vaccine administered). The patient underwent lab tests and procedures which included blood pressure measurement: 129/85 on 08Sep2021, heart rate: 95 on 08Sep2021, oxygen saturation: 93% (12:15), 75% (12:28), 80-85 % (12:27) all on 08Sep2021. Therapeutic measures were taken as a result of all events (exclude event inappropriate schedule of vaccine administered). Events cased patient visit emergency room. Clinical details reported as: A previous healthy 21-year-old female received the second dose of Comirnaty 08Sep2021 at 12:15. She immediately got heavy breathing. 20 mg prednisolone was given. No improvement and development of stridor and feeling of warmth. Treatment with 0.5 mg adrenalin at 12:22. The emergency number was called with code anaphylaxis. No improvement of symptoms. Still stridor and dyspnea. Chills and shivering. Not unconscious. Pale, but no cyanosis. A second dose of 0.5 mg adrenalin was given at 12:28. Still stridor and dyspnea. Oxygen saturation 75 %. A third dose of 0.5 mg adrenalin was given at 12:37. Oxygen saturation 80-85 %. The ambulance came and the woman was transported to hospital. The Agency assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible.; Sender''s Comments: Linked Report(s) : NO-PFIZER INC-202101279069 Same reporter and patient, different doses and events


VAERS ID: 1758442 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-02
Onset:2021-09-08
   Days after vaccination:129
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 2 - / -

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? 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: 20210914; Test Name: Coronavirus SARS-CoV-2 PCR; Test Result: Positive ; Comments: Swab from 13Sep
CDC Split Type: DEPFIZER INC202101237605

Write-up: COVID-19; COVID-19; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulator authority number DE-PEI-202100191393. A 49-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 02May2021 (Batch/Lot Number: EX3599) as dose 2, single; dose 1 via an unspecified route of administration on 11Apr2021 (Batch/Lot Number: EW8904) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced covid-19 on 08Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Sep2021 (Swab from 13Sep). Outcome of the event was unknown. Sender''s comments: Initials PRIVACY. Patient fell ill on 08Sep2021 with headache, cough and sore throat. Swab from 13Sep, on 14Sep2021 Coronavirus SARS-CoV-2 PCR positive. The PEI assessment for COVID-19 with the suspect product Comirnaty is B. Indeterminate. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1759852 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5110 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Diarrhoea haemorrhagic, Pain, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (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? 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 Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:39.6 Centigrade; Test Date: 20210909; Test Name: COVID PCR test; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: BRPFIZER INC202101233845

Write-up: diarrhea with blood; High fever of 39.6 degrees; body pain; vomit; This is a spontaneous report from a contactable consumer (patient). A 14-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection; lot number: Ff5110, expiration date: 31Dec2021), via an unspecified route of administration, on 06Sep2021 09:00 (at the age of 14-year-old), as dose 1, single, for COVID-19 immunisation. Patient had no medical history and no known allergies. There were no concomitant medications. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. The patient experienced high fever of 39.6 degrees Celsius, body pain, vomit, and diarrhea with blood on 08Sep2021 06:00. The symptoms lasted 10 days. The events resulted in emergency room visit. The patient was treated with antipyretic, ibuprofen and azithromycin. The patient underwent lab tests and procedures which included boy temperature: 39.6 centigrade on 08Sep2021; COVID-19 PCR nasal swab test: negative on 09Sep2021. The outcome of the evets was recovered with sequelae.


VAERS ID: 1759859 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-09-08
   Days after vaccination:138
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-1 test positive, 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? 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: 20210909; Test Name: SARS-CoV-2 PCR; Result Unstructured Data: Test Result:Positive
CDC Split Type: DEPFIZER INC202101229674

Write-up: SARS-CoV-1 test positive; SARS-CoV-1 test positive; COVID-19; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority number DE-PEI-202100189688. A 48-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration on 23Apr2021 (Batch/Lot Number: Unknown) as dose 2, single and dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: Unknown) as dose 1, single both taken for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Sep2021, the patient experienced SARS-CoV-1 test positive (medically significant) and 09Sep2021, the patient experienced SARS-CoV-1 test positive (medically significant) and on an unspecified date in 2021, experienced COVID-19. The patient underwent lab test and procedure which included SARS-CoV-2 PCR: positive on 09Sep2021. The outcome of events was unknown. Assessment in all the events: Comirnaty/ PEI: B. Indeterminate. Sender''s comment: Initials PRIVACY patient not ill. Smear from 08Sep. on 09Sep2021 Coronavirus SARS-CoV-2 PCR positive. No follow-up attempts are possible. No further information expected. No information about batch/lot number can be obtained.


VAERS ID: 1760167 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-09-08
   Days after vaccination:138
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Smear 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? 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: 20210909; Test Name: Coronavirus SARS-CoV-2 PCR positive.; Test Result: Positive ; Comments: Coronavirus SARS-CoV-2 PCR positive.; Test Date: 20210908; Test Name: COVID-19 smear test; Test Result: Positive ; Comments: Smear from 08Sep201
CDC Split Type: DEPFIZER INC202101237590

Write-up: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional downloaded from the -WEB DE-202100191321. A 48-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection; Lot number: EX3510), via an unspecified route of administration on 23Apr2021 as dose 2, single, dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: ER9480) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 08sep2021, the patient experienced drug ineffective and sars-cov-2 pcr test positive. On an unspecified date, the patient experienced covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Sep2021 Smear from 08.09. on 09.09.21 Coronavirus SARS-CoV-2 PCR positive. The outcome of events was unknown. Senders comment: Initials PRIVACY patient not ill. Smear from 08Sep. on 09Sep21 Coronavirus SARS-CoV-2 PCR positive. The assessment for all the events with the suspect product Comirnaty is B. Indeterminate.


VAERS ID: 1760168 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-09-08
   Days after vaccination:184
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2659 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive, 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: Test Date: 20210909; Test Name: Covid-19 PCR test; Test Result: Positive ; Comments: Smear from 08Sep on 09Sep21 Coronavirus SARS-CoV-2 PCR positive.
CDC Split Type: DEPFIZER INC202101237535

Write-up: Vaccination failure; Covid-19; SARS-CoV-2 PCR test positive; This is a spontaneous report from a non-contactable consumer or other non-health care professional downloaded from the regulatory authority number DE-PEI-202100191328. A 85-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EX2659) via an unspecified route of administration on 08Mar2021 as dose 2, single and bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: ER2659) via an unspecified route of administration on 13Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 08Sep2021, the patient experienced vaccination failure, covid-19 and had sars-cov-2 pcr test positive. The patient underwent lab tests and procedures which included Covid-19 PCR test result was positive on 09Sep2021 Smear from 08Sep on 09Sep21 Coronavirus SARS-CoV-2 PCR positive. Outcome of the events were unknown. Senders comment: Initials privacy patient not ill. Smear from 08Sep on 09Sep21 Coronavirus SARS-CoV-2 PCR positive. Event assessment: PEI / Comirnaty / SARS-CoV-2 PCR test positive / B. Indeterminate No follow-up attempts possible. No further information expected.


VAERS ID: 1760170 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-02
Onset:2021-09-08
   Days after vaccination:129
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Nasopharyngitis, Oropharyngeal pain, SARS-CoV-2 test, Smear test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: Test Date: 20210912; Test Name: Covid-19 PCR test; Test Result: Positive ; Comments: On 12Sep21 Coronavirus SARS-CoV-2 PCR positive.; Test Date: 20210910; Test Name: covid-19 smear test; Result Unstructured Data: Test Result:positive; Comments: Smear from 10Sep21
CDC Split Type: DEPFIZER INC202101236730

Write-up: COVID-19; COVID-19; cold; cough; sore throat; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100191344. A 43-years-old female patient received second dose of BNT162B2 (COMIRNATY; formulation: solution for injection, Batch/Lot Number: EX3599), via an unspecified route of administration on 02May2021 as single dose and first dose via an unspecified route of administration on 11Apr2021 (Batch/Lot Number: EW8904) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 08Sep2021, the patient fell ill with a cold, cough, and sore throat. The patient on 08Sep2021, experienced COVID-19 and exhibited vaccination failure. The patient underwent lab tests and procedures which included COVID-19 smear test: positive on 10Sep2021, and Covid-19 PCR test: positive on 12Sep2021, Coronavirus SARS-CoV-2 PCR positive. The clinical outcome for the events was unknown. Relatedness of drug to reaction(s)/event(s) Covid-19 B. Indeterminate No follow-up attempts possible. No further information expected.


VAERS ID: 1760175 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRW2 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Breast pain, Dyspnoea, Electrocardiogram, Fibrin D dimer, Muscle spasms, Troponin T
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Lipodystrophy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood creatine phosphokinase; Result Unstructured Data: Test Result:Normal; Test Name: Blood creatine phosphokinase MB; Result Unstructured Data: Test Result:Normal; Test Name: electrocadriogram; Result Unstructured Data: Test Result:Normal; Test Name: d-dimer; Result Unstructured Data: Test Result:Normal; Comments: D-dimer exclusion: pulmonary embolism, deep vein thrombosis; Test Name: troponin t; Result Unstructured Data: Test Result:Normal
CDC Split Type: DEPFIZER INC202101238798

Write-up: Belly ache; Breast pain; Cramps; Dyspnea; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number DE-PEI-202100191458. A 16-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, (Batch/Lot Number: SCRW2), via an unspecified route of administration on 08Sep2021 as, dose number unknown, single (at the age of 16-years-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patients admission to the hospital for further clarification and treatment. On 08Sep2021, The patient experienced belly ache, breast pain, cramps, dysponea. The patient underwent lab tests and procedures which included blood creatine phosphokinase was normal, blood creatine phosphokinase mb was normal, electrocardiogram was normal, fibrin d dimer: normal, D-dimer exclusion, pulmonary embolism, deep vein thrombosis, troponin t was normal. Assessment in all the events: Comirnaty/ Agency: B. Indeterminate. The outcome of the event cramps was recovered on 09Sep2021 and rest all other events was recovered on 08Sep2021. Sender''s comment: Patients admission to the hospital for further clarification and treatment. ECG normal, laboratory: CK + D dimers normal, Trop T and CK-MB normal D-dimer exclusion: pulmonary embolism, deep vein thrombosis No follow-up attempts are possible. No further information is expected.


VAERS ID: 1760537 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0161 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Angiogram, Arthralgia, Dyspnoea, Fibrin D dimer, Lower respiratory tract congestion, Myalgia, Oropharyngeal pain, Productive cough, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: Angioscanner; Result Unstructured Data: Test Result:segmental pulmonary embolism; Test Date: 20210909; Test Name: D-dimer; Result Unstructured Data: Test Result:880; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101239651

Write-up: Embolism pulmonary; Large bronchial congestion; thick fatty cough; shortness of breath; throat pain; abdominal pain; joint pain; muscle pain; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FR-AFSSAPS-BX20218554. A 53-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 06Sep2021 (Batch/Lot Number: FH0161) as DOSE 2, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no history of COVID-19. The patient received the first dose of bnt162b2 (COMIRNATY) on 10Aug2021 (lot: FF0688) for COVID-19 immunization. Then, the 2nd dose on 06Sep2021. The patient had joint and muscle pain, and abdominal pain and throat on 08Sep2021 (also reported as at Day 3 of dose 2). The patient also had big/large bronchial congestion, thick fatty cough, and shortness of breath on that same day but no sign of Homans. It was noted that the patient had D-dimer of 880 (unit of measure and normal range not provided) and angioscanner showed segmental pulmonary embolism (started on 08Sep2021). The patient was hospitalized in 2021 due to segmental pulmonary embolism. Outcome of the events were not recovered. "Note: this charge is made without prejudice to the investigation elements that could be carried out in the framework of legal or amicable compensation procedures. No follow-up attempts are possible. No further information is expected.


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