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From the 9/10/2021 release of VAERS data:

Found 686,636 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 346 out of 6,867

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VAERS ID: 1524096 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Axillary pain, Chills, Dizziness, Fatigue, Headache, Hyperhidrosis, Lymphadenopathy, Malaise, Nausea, Pain, Palpitations, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100929002

Write-up: faint; palpitations; feeling ill; vomiting; swollen armpit; all over body aches; No energy; Vomited; Headache; Dizziness; Nausea; Armpit pain; Chills; Sweating; Fatigue; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107210736455130-NOPEE. Safety Report Unique Identifier GB-MHRA-ADR 25684512. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 17Jul2021 (Lot Number: FD5613) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced faint, palpitations, feeling ill, vomiting, swollen armpit on an unspecified date, chills on 17Jul2021, sweating on 17Jul2021, fatigue on 17Jul2021, nausea on 18Jul2021, armpit pain on 17Jul2021, headache on 20Jul2021, dizziness on 18Jul2021, vomited on 20Jul2021. Treatment received for the events. Clinical course reported as: Started to get chills and hot sweats the evening on the vaccine. Swollen armpit. Very tired and all over body aches. Fatigue, dizziness and nausea the next couple of days followed by a bad headache on the third day. Palpitations short while in the afternoon. Vomiting and hot sweats that night. Still feeling ill on the 4th day. No energy, nausea feel faint, armpit still swollen and headache. For two nights I have had to sit up to try to sleep. Have been taking paracetamol as needed but not really helping. Have been in bed or sofa since the side effects started. Outcome of faint, palpitations, feeling ill, vomiting, swollen armpit, sweating, headache, vomited was recovering, outcome of chills was recovered on 18Jul2021, outcome of fatigue, nausea, armpit pain, dizziness not recovered, others was unknown. Patient had not tested positive for COVID-19 since having the vaccine. Case was reported as serious medically significant. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1524112 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Circulatory collapse, Feeling abnormal, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), 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: FOSTAIR; LORATADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Asthma; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934032

Write-up: hours; twice; Vomiting/ vomited; Shivering; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107211156419140-QL8RA. Safety Report Unique Identifier GB-MHRA-ADR 25685632. A 36-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 (Lot Number: FA1027) as single dose (at age of 36-years-old) for COVID-19 immunization. Medical history included lactation decreased, asthma, allergy. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medications included beclometasone dipropionate, formoterol fumarate (FOSTAIR) taken for asthma, loratadine (LORATADINE) taken for allergy. On an unspecified date patient experienced hours (reported as spaced out), twice (reported as cardiovascular collapse), on 17Jul2021 she experienced shivering and on 18Jul2021 patient experienced vomiting (vomited). Events considered serious as medically significant. It was reported that started shivering badly 12 hours after jab, lasted a few hours. Vomited twice 16-18 hours after jab. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent laboratory tests and procedures which included sars-cov-2 test: negative on an unknown date, no - negative COVID-19 test. Patient recovered on 18Jul2021 from vomiting and shivering, while recovered on unknown date from the other mentioned events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1524116 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Agitation, Axillary pain, Blood test, Chest X-ray, Chest discomfort, Chest pain, Discomfort, Gastritis erosive, Headache, Heart rate increased, Hypopnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Gastrointestinal ulceration (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Respiratory failure (narrow), 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: Allergy; Chest pain
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:No abnormality; Test Name: chest x-ray; Result Unstructured Data: Test Result:normal; Test Name: CEG; Result Unstructured Data: Test Result:Initially looks sligtly abnormal; Test Name: CEG; Result Unstructured Data: Test Result:subsequent reading was fine; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934050

Write-up: slightly abnormal; discomfort; my chest feels heavy; Breathing shallow; Armpit pain; Stomach pain; Headache; Chest pain; Heart rate increased; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number, Safety Report Unique Identifier. A female patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FD8813), via an unspecified route of administration on 17Jul2021 at single dose for COVID-19 immunisation. First fose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: not provided) was received on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history included chest pain and allergy. It was also reported that the patient had no allergy and have never been admitted to a hospital before. She haven''t had any alcohol for about a month and never smoke or take any drugs. The patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Additional medication was provided as acetylsalicylic acid (ASPIRIN) taken for chest pain on 20Jul2021. The patient experienced slightly abnormal on an unspecified date, discomfort on an unspecified date, chest feels heavy on an unspecified date, chest pain on 17Jul2021, heart rate increased on 17Jul2021, breathing shallow on 21Jul2021, armpit pain on 21Jul2021, headache on 18Jul2021 and stomach pain on 19Jul2021. The patient had a similar reaction with the first vaccine but it subsided within 24-36 hours. She have been having chest pain since having the 2nd vaccine but with more side effects that she have not experienced after my first vaccine. Her heart beats a lot faster than normal at times. At one point, it woke me up from sleep. Her chest felt heavy, especially when lying down and she get a sharp pain in my chest, arm, and stomach from time to time. She has seen a doctor at a hospital. Her CEG initially looks slightly abnormal but the subsequent reading was fine. She had a blood test and a chest x-ray. The blood test doesn''t show any abnormality and the chest x-ray looks normal. The patient was still feeling discomfort especially on her chest and her breathing felt laboured. SARS-CoV-2 test: negative No - Negative COVID-19 test. The events were serious as medically significant. Heart rate increased resolved on 20Jul2021, other events were not resolved at the time of report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1524118 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Headache, Illness, Presyncope, Pyrexia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEXOFENADINE; PREGABALIN; PROGESTERONE; QUETIAPINE; VENLAFAXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Bad mood; Lactation decreased; Mood disorder NOS; Period pains; Psychosis
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934072

Write-up: fainting; Fever; Chest pain; Chest tightness; Headache; Near fainting; Sickness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number is GB-RA-WEBCOVID-202107211331588390-WBSQN, Safety Report Unique Identifier is GB-RA-ADR 25686409. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported, Expiry date not reported), via an unspecified route of administration on 17Jul2021 (age at vaccination was 27 years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included suppressed lactation, hypersensitivity (allergy), affective disorder (mood disorder NOS), dysmenorrhoea (period pains), psychotic disorder (psychosis) and mood altered (bad mood). Concomitant medications included fexofenadine taken for hypersensitivity from 01Jan2017 to an unspecified stop date; pregabalin taken for affective disorder from 01Jan2018 to an unspecified stop date; progesterone taken for dysmenorrhoea from 01Jan2016 to an unspecified stop date; quetiapine taken for psychotic disorder from 01Jan2020 to an unspecified stop date; and venlafaxine taken for mood altered from 01Jan2017 to an unspecified stop date. The patient experienced fainting on an unspecified date with outcome of recovering, fever on 17Jul2021 with outcome of recovering, chest pain on 17Jul2021 with outcome of recovered on 17Jul2021, chest tightness on 17Jul2021 with outcome of recovered on 17Jul2021, headache on 17Jul2021 with outcome of recovered on an unspecified date, near fainting on 17Jul2021 with outcome of not recovered, and sickness on 17Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Jul2021 No - Negative COVID-19 test. The event fainting was assessed as serious, medically significant while the other events were non-serious. Additional Information: Unable to regulate temperature for five days afterwards. Sick, headache, near fainting. Chest pain and tightness on day receiving vaccine and the days afterwards. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1524249 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-07-17
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Computerised tomogram head
SMQs:, Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRONOLACTONE; TRECLIN [CLINDAMYCIN PHOSPHATE;TRETINOIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: CT Brain; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202100961818

Write-up: Palsy Bells; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202107271105495300-9LHGA. A 28-years-old non-pregnant female patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection) via an unspecified route of administration on 19Jun2021 (Batch/Lot Number: unknown) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included lactation decreased, acne from an unknown date and unknown if ongoing. Concomitant medications included spironolactone taken for acne; clindamycin phosphate, tretinoin (TRECLIN [CLINDAMYCIN PHOSPHATE; TRETINOIN]) taken for acne start and stop date were not reported. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. The patient experienced palsy bells on 17Jul2021. The patient underwent lab tests and procedures, which included CT (Computerized tomogram) brain on unknown date with unknown results. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1524267 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy
SMQs:, 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: GBPFIZER INC202100916382

Write-up: Swollen glands; This is a report received from The regulatory authority report number is GB-MHRA-YCVM-202107181254344670-ZRKAK. Safety Report Unique Identifier: GB-MHRA-ADR 25669717. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Lot Number: FD5613) as DOSE 2, single for COVID-19 vaccination. 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. The patient experienced swollen glands on 17Jul2021 with outcome of not recovered. The event was reported as serious for medically significant. Patient is not enrolled in clinical trial. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the current available information and the close drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of lymphadenopathy cannot be totally excluded.


VAERS ID: 1524402 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003605 / 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? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pre-syncope
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of SYNCOPE in a 23-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003605) for COVID-19 vaccination. The patient''s past medical history included Pre-syncope. On 17-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced SYNCOPE (seriousness criteria medically significant and life threatening). At the time of the report, SYNCOPE 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. Concomitant medications were not provided. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1524424 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood test, Body temperature, Computerised tomogram, Hyperthermia, Pyrexia, Seizure, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hypertension (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: blood test; Result Unstructured Data: Test Result:source for hyperthermia was not found; Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:38.6 Centigrade; Comments: at 21:50; Test Date: 20210717; Test Name: CT; Result Unstructured Data: Test Result:source for hyperthermia was not found
CDC Split Type: JPPFIZER INC202100923818

Write-up: body temperature raised to 38.6 degrees Centigrade/hyperthermia; generalised convulsion/convulsion; pyrexia/ body temperature raised to 38.6 degrees Centigrade; blood pressure increased; tremulousness of hands; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21120462. The patient was 79-year and 3-month-old female. Body temperature before vaccination was not reported. On 25Jun2021, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot number FA5765, and Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Jul2021 17:30 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Lot number FC3661, and Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 17Jul2021 at 21:30 (1 day after the vaccination), the patient experienced pyrexia, blood pressure increased. On an unspecified date, the outcome of the events was not recovered. The course of event was as follows: On 17Jul2021 at around 21:30 (1 day after the vaccination), the patient experienced tremulousness of hands. After that, there was generalised convulsion for about 30 seconds. On 17Jul2021 at around 21:50 (1 day after the vaccination), body temperature raised to 38.6 degrees Centigrade. Sent to hospital by ambulance. The source for hyperthermia was not found by CT and blood test. The reporter classified the event as non-serious and the causality between the event and the bnt162b2 was not reported. Reportable symptoms were reported as convulsion and others.


VAERS ID: 1524442 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Basophil count, Blood alkaline phosphatase, Blood bilirubin, Blood cadmium, Blood chloride, Blood cholesterol, Blood creatine phosphokinase, Blood creatinine, Blood lactate dehydrogenase, Blood potassium, Blood pressure measurement, Blood sodium, Blood triglycerides, Blood urea, Blood uric acid, Body temperature, C-reactive protein, Decreased appetite, Eosinophil count, Gamma-glutamyltransferase, Haematocrit, Haemoglobin, Hepatic function abnormal, Investigation, Lymphocyte count, Malaise, Monocyte count, Neutrophil count, Oxygen saturation, Platelet count, Protein total, Red blood cell count, Rhabdomyolysis, Tumour marker test, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (narrow), Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: AST(GOT); Result Unstructured Data: Test Result:151 increased U/L; Test Date: 20200626; Test Name: Hemogram Basophils; Test Result: 0 %; Test Date: 20201127; Test Name: Hemogram Basophils; Test Result: 1 %; Test Date: 20210219; Test Name: Hemogram Basophils; Test Result: 0 %; Test Date: 20210719; Test Name: Hemogram Basophils; Test Result: 1 %; Test Date: 20200626; Test Name: ALP; Result Unstructured Data: Test Result:243 U/L; Test Date: 20201127; Test Name: ALP; Result Unstructured Data: Test Result:198 U/L; Test Date: 20210219; Test Name: ALP; Result Unstructured Data: Test Result:204 U/L; Test Date: 20210719; Test Name: ALP; Result Unstructured Data: Test Result:524 increased U/L; Test Date: 20201127; Test Name: Bilirubin total; Test Result: 0.4 mg/dl; Test Date: 20210719; Test Name: Ca; Test Result: 8.6 mg/dl; Test Date: 20210719; Test Name: Cl; Result Unstructured Data: Test Result:102 mEq/l; Test Date: 20200626; Test Name: Cholesterol total; Test Result: 209 mg/dl; Test Date: 20210219; Test Name: Cholesterol total; Test Result: 199 mg/dl; Test Date: 20210719; Test Name: Cholesterol total; Test Result: 178 mg/dl; Test Date: 20210719; Test Name: CK(CPK); Result Unstructured Data: Test Result:761 increased U/L; Test Date: 20200626; Test Name: Creatinine; Result Unstructured Data: Test Result:0.99 increased mg/dl; Test Date: 20201127; Test Name: Creatinine; Result Unstructured Data: Test Result:1.15 increased mg/dl; Test Date: 20210219; Test Name: Creatinine; Result Unstructured Data: Test Result:1.04 increased mg/dl; Test Date: 20210719; Test Name: Creatinine; Result Unstructured Data: Test Result:1.21 increased mg/dl; Test Date: 20200626; Test Name: LD (LDH); Result Unstructured Data: Test Result:238 U/L; Test Date: 20201127; Test Name: LD (LDH); Result Unstructured Data: Test Result:207 U/L; Test Date: 20210219; Test Name: LD (LDH); Result Unstructured Data: Test Result:215 U/L; Test Date: 20210719; Test Name: LD (LDH); Result Unstructured Data: Test Result:761 increased U/L; Test Date: 20210719; Test Name: K; Result Unstructured Data: Test Result:4.4 mEq/l; Test Date: 20210719; Test Name: BP; Result Unstructured Data: Test Result:126/84; Test Date: 20210719; Test Name: Na; Result Unstructured Data: Test Result:136 decreased mg/dl; Test Date: 20200626; Test Name: Triglyceride; Result Unstructured Data: Test Result:179 increased mg/dl; Test Date: 20210219; Test Name: Triglyceride; Test Result: 80 mg/dl; Test Date: 20210719; Test Name: Triglyceride; Test Result: 79 mg/dl; Test Date: 20200626; Test Name: Urea nitrogen; Result Unstructured Data: Test Result:20.3 increased mg/dl; Test Date: 20201127; Test Name: Urea nitrogen; Result Unstructured Data: Test Result:22.8 increased mg/dl; Test Date: 20210219; Test Name: Urea nitrogen; Result Unstructured Data: Test Result:30.6 increased mg/dl; Test Date: 20210719; Test Name: Urea nitrogen; Result Unstructured Data: Test Result:29.4 increased mg/dl; Test Date: 20200626; Test Name: Uric acid; Test Result: 5.3 mg/dl; Test Date: 20210219; Test Name: Uric acid; Test Result: 6.3 mg/dl; Test Date: 20210719; Test Name: Uric acid; Test Result: 6.0 mg/dl; Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:35.4 Centigrade; Comments: before vaccination; Test Date: 20210719; Test Name: body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Test Date: 20201127; Test Name: CRP (Quantitative) judgement; Result Unstructured Data: Test Result:+++; Comments: normal:-; Test Date: 20210719; Test Name: CRP (Quantitative) judgement; Result Unstructured Data: Test Result:++; Comments: normal:-; Test Date: 20201127; Test Name: CRP (Quantitative) measured value; Result Unstructured Data: Test Result:5.19 increased mg/dl; Comments: normal: less than 0.3 MG/DL; Test Date: 20210719; Test Name: CRP (Quantitative) measured value; Result Unstructured Data: Test Result:3.49 increased mg/dl; Comments: normal: less than 0.3 MG/DL; Test Date: 20200626; Test Name: Hemogram Eosinophils; Test Result: 2 %; Test Date: 20201127; Test Name: Hemogram Eosinophils; Test Result: 3 %; Test Date: 20210219; Test Name: Hemogram Eosinophils; Test Result: 2 %; Test Date: 20210719; Test Name: Hemogram Eosinophils; Test Result: 2 %; Test Date: 20200626; Test Name: Gamma-GT; Result Unstructured Data: Test Result:11 U/L; Test Date: 20201127; Test Name: Gamma-GT; Result Unstructured Data: Test Result:8 U/L; Test Date: 20210219; Test Name: Gamma-GT; Result Unstructured Data: Test Result:11 U/L; Test Date: 20210719; Test Name: Gamma-GT; Result Unstructured Data: Test Result:276 U/L; Comments: normal: less than 30 U/L; Test Date: 20200626; Test Name: Haematocrit; Result Unstructured Data: Test Result:32.1 decreased %; Test Date: 20201127; Test Name: Haematocrit; Result Unstructured Data: Test Result:30.9 decreased %; Test Date: 20210219; Test Name: Haematocrit; Result Unstructured Data: Test Result:31.0 decreased %; Test Date: 20210719; Test Name: Haematocrit; Test Result: 37.4 %; Test Date: 20200626; Test Name: Haemoglobin; Result Unstructured Data: Test Result:9.9 decreased g/dl; Test Date: 20201127; Test Name: Haemoglobin; Result Unstructured Data: Test Result:9.6 decreased g/dl; Test Date: 20210219; Test Name: Haemoglobin; Result Unstructured Data: Test Result:9.7 decreased g/dl; Test Date: 20210719; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.5 decreased g/dl; Test Date: 20201127; Test Name: Neutral lobulated nuclei; Test Result: 64 %; Test Date: 20201127; Test Name: Neutral rod-shaped nucleus sphere; Test Result: 1 %; Test Date: 20200626; Test Name: Hemogram Lymphocytes; Test Result: 35 %; Test Date: 20201127; Test Name: Hemogram Lymphocytes; Test Result: 24 %; Test Date: 20210219; Test Name: Hemogram Lymphocytes; Test Result: 32 %; Test Date: 20210719; Test Name: Hemogram Lymphocytes; Result Unstructured Data: Test Result:8 decreased %; Test Date: 20200626; Test Name: Hemogram Monocytes; Result Unstructured Data: Test Result:9 increased %; Test Date: 20201127; Test Name: Hemogram Monocytes; Test Result: 7 %; Test Date: 20210219; Test Name: Hemogram Monocytes; Result Unstructured Data: Test Result:10 increased %; Test Date: 20210719; Test Name: Hemogram Monocytes; Test Result: 6 %; Test Date: 20200626; Test Name: Hemogram Neutrophils; Test Result: 54 %; Test Date: 20210219; Test Name: Hemogram Neutrophils; Test Result: 56 %; Test Date: 20210719; Test Name: Hemogram Neutrophils; Result Unstructured Data: Test Result:83 increased %; Test Date: 20210719; Test Name: SAT; Test Result: 98 %; Test Date: 20200626; Test Name: Platelet count; Result Unstructured Data: Test Result:26.8 10^4; Test Date: 20201127; Test Name: Platelet count; Result Unstructured Data: Test Result:27.2 10^4; Test Date: 20210219; Test Name: Platelet count; Result Unstructured Data: Test Result:25.6 10^4; Test Date: 20210719; Test Name: Platelet count; Result Unstructured Data: Test Result:25.3 10^4; Test Date: 20200626; Test Name: Protein total; Result Unstructured Data: Test Result:7.8 g/dl; Test Date: 20210219; Test Name: Protein total; Result Unstructured Data: Test Result:7.8 g/dl; Test Date: 20210719; Test Name: Protein total; Result Unstructured Data: Test Result:7.8 g/dl; Test Date: 20200626; Test Name: Red blood cell count; Result Unstructured Data: Test Result:380 10^4; Test Date: 20201127; Test Name: Red blood cell count; Result Unstructured Data: Test Result:358 decreased 10^4; Test Date: 20210219; Test Name: Red blood cell count; Result Unstructured Data: Test Result:354 decreased 10^4; Test Date: 20210719; Test Name: Red blood cell count; Result Unstructured Data: Test Result:396 10^4; Test Date: 20200626; Test Name: eGFR creat; Result Unstructured Data: Test Result:39.8 decreased; Comments: 90ml minute 1.73 above; Test Date: 20201127; Test Name: eGFR creat; Result Unstructured Data: Test Result:33.8 decreased; Comments: 90ml minute 1.73 above; Test Date: 20210219; Test Name: eGFR creat; Result Unstructured Data: Test Result:37.8 decreased; Comments: 90ml minute 1.73 above; Test Date: 20210719; Test Name: eGFR creat; Result Unstructured Data: Test Result:31.9 decreased; Comments: 90ml minute 1.73 above; Test Date: 20200626; Test Name: White blood cell count; Result Unstructured Data: Test Result:5.0 10^3; Test Date: 20201127; Test Name: White blood cell count; Result Unstructured Data: Test Result:4.9 10^3; Test Date: 20210219; Test Name: White blood cell count; Result Unstructured Data: Test Result:5.2 10^3; Test Date: 20210719; Test Name: White blood cell count; Result Unstructured Data: Test Result:11.3 increased 10^3; Test Date: 20200626; Test Name: ALT (GPT); Result Unstructured Data: Test Result:11 U/L; Test Date: 20201127; Test Name: ALT (GPT); Result Unstructured Data: Test Result:9 U/L; Test Date: 20210219; Test Name: ALT (GPT); Result Unstructured Data: Test Result:11 U/L; Test Date: 20210719; Test Name: ALT (GPT); Result Unstructured Data: Test Result:52 increased U/L; Test Date: 20200626; Test Name: AST(GOT); Result Unstructured Data: Test Result:18 U/L; Test Date: 20201127; Test Name: AST(GOT); Result Unstructured Data: Test Result:16 U/L; Test Date: 20210219; Test Name: AST(GOT); Result Unstructured Data: Test Result:19 U/L
CDC Split Type: JPPFIZER INC202100924706

Write-up: Rhabdomyolysis; Hepatic function disorder; Malaise; Appetite impaired; This is a spontaneous report from a contactable physician from the Regulatory Authority. Regulatory authority number was v21120578. A 91-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Jul2021 15:00 (Batch/Lot Number: EY0573; Expiration Date: 30Sep2021) (at the age of 91-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Body temperature before vaccination was 35.4 degrees Centigrade. The patient had no medical history. Nothing special on patient''s family history. The patient''s concomitant medications were not reported. On 17Jul2021, the patient experienced rhabdomyolysis, hepatic function disorder, malaise, and appetite impaired. The course of the event was as follows: From 17Jul2021 (1 day after vaccination), Malaise and Appetite impaired appeared. On 19Jul2021 (3 days after vaccination), the patient visited the hospital. At the time of consultation, BT: 35.7 degrees centigrade, SAT:98%, BP:126-84. On the same day (19Jul2021), Performed blood sampling and got the attached blood sampling result. The reporter classified the event as serious (medically significant) and assessed that the causality between the event and BNT162B2 as related. There was no other possible cause of the event such as any other diseases. On 26Jun2020, White blood cell count:5.0 (4.0-8.0 10^3); Red blood cell count:380(380-500 10^4); Haemoglobin:9.9 decreased (12.0-16.0 G/DL); Haematocrit:32.1 decreased(36.0-48.0%); Hemogram Neutrophils:54 (45-47%); Hemogram Lymphocytes:35 (20-45%); Hemogram Monocytes:9 increased (2-8%); Hemogram Eosinophils:2 (0-6%); Hemogram Basophils:0(0-3%); Platelet count:26.8 (12.0-40.0 10^4); Protein total:7.8 (6.7-8.3 G/DL); Urea nitrogen:20.3 increased (8.0-20.0 MG/DL); Uric acid:5.3 (2.0-7.0 MG/DL); Creatinine:0.99 increased (0.50-0.86 MG/DL);Cholesterol total:209 (130-220 MG/DL); Triglyceride:179 increased (30-149 MG/DL); ALP:243 (38-113 U/L); AST(GOT): 18(8-38 U/L); ALT (GPT):11 (4-44 U/L); LD (LDH):238 (120-245 U/L);Gamma-GT:11(less than 30 U/L); eGFR creat:39.8 decreased (90ml minute 1.73 above). On 27Nov2020, White blood cell count:4.9 (4.0-8.0 10^3); Red blood cell count:358 decreased (380-500 10^4); Haemoglobin:9.6 decreased (12.0-16.0 G/DL); Haematocrit:30.9 decreased(36.0-48.0%); Neutral rod-shaped nucleus sphere:1(0-6%); Neutral lobulated nuclei:64 (45-68%); Hemogram Lymphocytes:24 (20-45%); Hemogram Monocytes:7 (2-8%); Hemogram Eosinophils:3 (0-6%); Hemogram Basophils:1(0-3%);Platelet count:27.2 (12.0-40.0 10^4); CRP (Quantitative) judgement :+++ (-); CRP (Quantitative) measured value:5.19 increased (less than 0.3 MG/DL); Urea nitrogen:22.8 increased (8.0-20.0 MG/DL); Creatinine:1.15 increased (0.50-0.86 MG/DL);ALP:198 (38-113 U/L); AST(GOT):16 (8-38 U/L); ALT (GPT):9 (4-44 U/L);LD (LDH):207 (120-245 U/L);Gamma-GT:8 (less than 30 U/L); Bilirubin total:0.4 (0.2-1.2 MG/DL); eGFR creat:33.8 decreased(90ml minute 1.73 above). On 19Feb2021, White blood cell count:5.2(4.0-8.0 10^3); Red blood cell count:354 decreased (380-500 10^4); Haemoglobin:9.7 decreased (12.0-16.0 G/DL); Haematocrit:31.0 decreased (36.0-48.0%); Hemogram Neutrophils:56 (45-47%); Hemogram Lymphocytes:32 (20-45%); Hemogram Monocytes:10 increased (2-8%); Hemogram Eosinophils:2 (0-6%); Hemogram Basophils:0(0-3%); Platelet count:25.6 (12.0-40.0 10^4); Protein total:7.8(6.7-8.3 G/DL); Urea nitrogen:30.6 increased(8.0-20.0 MG/DL); Uric acid:6.3(2.0-7.0 MG/DL); Creatinine:1.04 increased(0.50-0.86 MG/DL); Cholesterol total:199 (130-220 MG/DL);Triglyceride:80 (30-149 MG/DL); ALP:204 (38-113 U/L); AST(GOT):19 (8-38 U/L); ALT (GPT):11 (4-44 U/L); LD (LDH):215 (120-245 U/L);Gamma-GT:11(less than 30 U/L);eGFR creat:37.8 decreased (90ml minute 1.73 above). On 19Jul2021, White blood cell count:11.3 increased (4.0-8.0 10^3); Red blood cell count:396 (380-500 10^4); Haemoglobin:11.5 decreased(12.0-16.0 G/DL); Haematocrit:37.4 (36.0-48.0%); Hemogram Neutrophils:83 increased (45-47%); Hemogram Lymphocytes:8 decreased (20-45%); Hemogram Monocytes:6 (2-8%); Hemogram Eosinophils:2 (0-6%); Hemogram Basophils:1 (0-3%); Platelet count:25.3 (12.0-40.0 10^4); CRP (Quantitative) judgement :++ (-); CRP (Quantitative) measured value:3.49 increased(less than 0.3 MG/DL); Protein total:7.8(6.7-8.3 G/DL); Urea nitrogen:29.4 increased(8.0-20.0 MG/DL); Uric acid:6.0(2.0-7.0 MG/DL); Creatinine:1.21 increased(0.50-0.86 MG/DL); Cholesterol total:178 (130-220 MG/DL);Triglyceride:79 (30-149 MG/DL); Na:136 decreased(137-147 MG/DL); K:4.4(3.5-5.0 MEQ/L);Cl:102(98-108 MEQ/L); Ca:8.6(8.4-10.2 MG/DL); ALP:524 increased (38-113 U/L); AST(GOT):151 increased (8-38 U/L); ALT (GPT):52 increased (4-44 U/L); LD (LDH):761 increased (120-245 U/L);Gamma-GT:276(less than 30 U/L); CK(CPK): 761 increased(40-170 U/L); eGFR creat:31.9 decreased(90ml minute 1.73 above). The outcome of the events was unknown.


VAERS ID: 1524446 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure decreased, Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Heart rate increased, Hot flush, Loss of consciousness, Oxygen saturation, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased; Comments: 15:17; Test Date: 20210717; Test Name: Blood pressure; Result Unstructured Data: Test Result:144/96; Comments: 15:32; Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210717; Test Name: Pulse rate; Result Unstructured Data: Test Result:124; Comments: 15:17; Test Date: 20210717; Test Name: Pulse rate; Result Unstructured Data: Test Result:106; Comments: 15:24; Test Date: 20210717; Test Name: Pulse rate; Result Unstructured Data: Test Result:99; Comments: 15:32; Test Date: 20210717; Test Name: SpO2; Test Result: 95 %; Comments: 15:17; Test Date: 20210717; Test Name: SpO2; Test Result: 97 %; Comments: 15:24
CDC Split Type: JPPFIZER INC202100924853

Write-up: Anaphylactic shock; Loss of consciousness; Wheezing; Generalized hot flush; Blood pressure decreased; P 124; BP 144/96; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number. The patient was a 46-year and 10-month-old female. Body temperature before vaccination was 36.8 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 17Jul2021 at 15:01 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FC8736, Expiration date 30Sep2021) via an unspecified route of administration as DOSE 1, SINGLE for covid-19 immunisation. On 17Jul2021 at 15:17 (16 minutes after the vaccination), the patient experienced Anaphylactic shock. On unspecified date, the patient was admitted to the hospital. On 18Jul2021 (1 day after the vaccination), the outcome of the event was recovered. The course of the event was as follows: At 15:01, the patient received vaccination. At 15:17, Suddenly wheezing and generalized hot flush appeared. Blood pressure decreased and Loss of consciousness were admitted (Blood pressure could not be measured and P 124, SpO2 was 95%) and Anaphylactic shock was diagnosed. At 15:19, Epipen Intramuscular injection. At 15:24 The radial artery was palpable. P 106, SpO2 97% (O2 10L Mask). At 15:32, BP 144/96, P 99. Consciousness level recovered. At 15:40, Transported to Hospital Emergently. The reporting physician classified the event as serious (Hospitalization) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1524474 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Autonomic nervous system imbalance, Blood pressure measurement, Body temperature, Dizziness, Laryngeal oedema, Oropharyngeal discomfort, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), 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: Medical History/Concurrent Conditions: Asplenia syndrome; Dextrocardia; Fontan procedure; Univentricular heart
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: blood pressure; Result Unstructured Data: Test Result:110s; Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210717; Test Name: SpO2; Test Result: 95 %
CDC Split Type: JPPFIZER INC202100926610

Write-up: Suspected mild laryngeal oedema; Pharynx strange sensation of; Giddiness; abdomen strange feeling of; Autonomic nervous system imbalance; This is a spontaneous report from a contactable nurse received from the Regulatory authority report number is v21120613. An 18-year-old (also reported as 18-year and 9-month-old) female patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on 17Jul2021 15:44 (Batch/lot number: EY0573; Expiration date: 30Sep2021), at age 18 years old, as dose 1, single, for COVID-19 immunisation. Relevant medical history included right ventricular single ventricle, asplenia syndrome, dextrocardia, and fontan procedure from unspecified dates, not reported if ongoing or not. Concomitant medications were not reported. The patient previously took acetylsalicylic acid (BAYASPIRIN) and warfarin both after the fontan procedure. Body temperature before vaccination on 17Jul2021 was 36.7 degrees Centigrade. On 17Jul2021 at 15:54 (10 minutes after the vaccination), the patient experienced suspected mild laryngeal oedema. The course of the event was as follows: After the vaccination, the patient experienced pharynx strange sensation of. There was no dyspnoea and rash. Blood pressure was in the 110s on 17Jul2021. There was no arrhythmia. SpO2 ws 95%. The patient experienced giddiness and abdomen strange feeling of on 17Jul2021. It was suspected as mild laryngeal oedema and autonomic nervous system imbalance. On 17Jul2021 (the day of vaccination), the outcome of the events was not reported. The reporting nurse classified the events as non-serious and assessed that the event was related to BNT162B2.


VAERS ID: 1524562 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation
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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: BP; Result Unstructured Data: Test Result: 78/39 mmHg; Comments: at 14:03; Test Date: 20210717; Test Name: BP; Result Unstructured Data: Test Result: 94/61 mmHg; Comments: at 14:10; Test Date: 20210717; Test Name: BP; Result Unstructured Data: Test Result: 108/67 mmHg; Comments: at 14:30; Test Date: 20210717; Test Name: BP; Result Unstructured Data: Test Result: 117/65 mmHg; Comments: at 14:55; Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.5 Centigrade; Comments: Before vaccination; Test Date: 20210717; Test Name: HR; Result Unstructured Data: Test Result: 52; Comments: bpm, at 14:03; Test Date: 20210717; Test Name: HR; Result Unstructured Data: Test Result: 76; Comments: bpm, at 14:10; Test Date: 20210717; Test Name: HR; Result Unstructured Data: Test Result: 75; Comments: bpm, at 14:30; Test Date: 20210717; Test Name: HR; Result Unstructured Data: Test Result: 78; Comments: bpm, at 14:55; Test Date: 20210717; Test Name: SAT; Test Result: 97%; Comments: at 14:03; Test Date: 20210717; Test Name: SAT; Test Result: 99%; Comments: at 14:30; Test Date: 20210717; Test Name: SAT; Test Result: 98%; Comments: at 14:55.
CDC Split Type: JPPFIZER INC202100967389

Write-up: Anaphylactic shock; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21120495. A 60-year-old male patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EY3860, Expiration date: 31Aug2021), at the age of 60 years old, on 17Jul2021 at 13:50 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.5 degrees Centigrade. Medical history was none. There were no points to be considered on the vaccine screening questionnaire. The patient had no relevant family history. The patient''s concomitant medications were not reported. On 17Jul2021 at 13:50 (the day of vaccination), the patient received the first dose of BNT162b2. On 17Jul2021 at 14:00 (10 minutes after the vaccination), the patient experienced anaphylactic shock. On 17Jul2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: On 17Jul2021 at 14:00, feels poorly and pallor facial were noted, then he lost consciousness, and collapsed to the floor. On 17Jul2021 at 14:03, blood pressure (BP) was 78/39 mmHg, heart rate (HR) was 52 bpm, oxygen saturation percutaneous (SAT) was 97%. Epinephrine (BOSMIN) 0.5 mg was intramuscularly administered. Intravenous (IV) route was secured to administer calcium chloride dihydrate; maltose; potassium (POTACOL) 250 mL and fluid replacement therapy was started. On 17Jul2021 at 14:10, BP was 94/61 mmHg, HR was 76 bpm. The patient''s consciousness became clear. On 17Jul2021 at 14:30, BP was 108/67 mmHg, HR was 75 bpm and SAT was 99%. On 17Jul2021 at 14:55, BP was 117/65 mmHg, HR was 78 bpm and SAT was 98%. The reporting physician classified the event as serious (other medically significant condition) 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: Although respiratory symptoms were rarely seen, decreased blood pressure, decreased HR and loss of consciousness appeared, and he was in a state of shock. Therefore, this case was reported as anaphylactic shock. No follow-up attempts are possible. No further information is expected. Reporter''s Comments: Although respiratory symptoms were rarely seen, decreased blood pressure, decreased HR, loss of consciousness appeared, and he was in a state of shock. Therefore, this case was reported as anaphylactic shock.


VAERS ID: 1524564 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Oxygen saturation
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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Blood pressure; Result Unstructured Data: Test Result:95/56; Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210717; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202100967481

Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21120915. A 30-year and 6-month-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EY0573, Expiration date: 30Sep2021), at the age of 30-year and 6-month-old, on 17Jul2021 at 10:40 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.3 degrees centigrade. Medical history was none. The patient had no particular family history. There were no points to be considered on the vaccine screening questionnaire. The patient''s concomitant medications were not reported. On 17Jul2021 at 10:40 (the day of vaccination), the patient received the first dose of BNT162B2. On 17Jul2021 at 10:50 (10 minutes after the vaccination), the patient experienced anaphylaxis. On 17Jul2021 (on the same day of after the vaccination), the outcome of the event was recovered. The course of the event was as follows: On 17Jul2021 at 10:40, the patient received BNT162B2. At around 10:50, during the follow-up after the vaccination, feeling queasy appeared, followed by complaint of abdominal pain. The patient was in a state of consciousness clouding and transferred to a bed. Blood pressure was 95/56 and SpO2 was 98%. Intravenous infusion of sodium chloride (PHYSIOLOGICAL SALINE) was initiated. At 11:10, rash of both eyelids appeared, followed by a complained of dyspnoea, for which adrenaline 0.3 mg was intramuscularly injected. 15 minutes later, consciousness clouding and dyspnoea persisted, for which adrenaline 0.3 mg was intramuscularly injected again. Dyspnoea alleviated but the patient was transported to another hospital as a precaution, where the patient was followed-up. On the same day, the patient returned home. 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: Considering the symptoms, it was considered as anaphylaxis due to COVID vaccine.; Reporter''s Comments: Considering the symptoms, it was considered as anaphylaxis due to COVID vaccine.


VAERS ID: 1525252 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acne, Influenza, Influenza like illness, Menstrual disorder, Muscle spasms, SARS-CoV-2 test
SMQs:, Dystonia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN; FLUOXETINE; LUCETTE; YASMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative; Result Unstructured Data: Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: flu like symptoms; acne; cramps; Menstruation abnormal; Flu symptoms; This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS, ACNE, MUSCLE SPASMS, MENSTRUAL DISORDER, and INFLUENZA in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Acne and Lactation decreased. Concomitant products included LUCETTE from 01-Jan-2015 to an unknown date for Birth control, YASMIN for Birth control pill, FLUOXETINE from 01-Jan-2015 to an unknown date for Obsessive-compulsive disorder, ASPIRIN for an unknown indication. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced INFLUENZA (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced MENSTRUAL DISORDER (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (seriousness criterion medically significant), ACNE (seriousness criterion medically significant) and MUSCLE SPASMS (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Muscle ache, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS, ACNE, MUSCLE SPASMS, and MENSTRUAL DISORDER had not resolved and INFLUENZA was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient on the contraceptive pill Yasmin. The day of getting the second Moderna jab patient went off the pill for the 7 day "break" in the contraceptive pill cycle were supposed to have a period. However, the patient had no menstrual bleeding and not had the usual mild cramps and acne, the patient usually get when the menstruating either. It is now the 26th of July 2021, had not yet resumed taking Yasmin tablets, and the patient still had any menstrual bleeding. The patient particularly worried about this as patient''s sister had also receive the first dose of the vaccine, after which she began having very abnormal, heavy menstrual bleeding even though the patient had just finished period a few days before having the jab. About the day after the patient had the second Moderna jab, I started having the usual flu like symptoms. On the third day after. I had muscle aches so bad in my legs I could not sleep even though I had taken paracetamol and aspirin. I am not as in as much pain now but I still have bad headaches and muscle aches in my legs. I also have a sharp pain in my right arm (which was not the arm I had any of the jabs in). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1525256 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-17
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Hypersensitivity, Rash, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Lactation decreased
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.MOD20212

Write-up: swelling; allergy; Armpit pain; Rash on legs & arms; This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (swelling), HYPERSENSITIVITY (allergy), RASH (Rash on legs & arms) and AXILLARY PAIN (Armpit pain) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced RASH (Rash on legs & arms) (seriousness criterion medically significant). On 27-Jul-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING (swelling) (seriousness criterion medically significant) and HYPERSENSITIVITY (allergy) (seriousness criterion medically significant). The patient was treated with CHLORPHENAMINE MALEATE at an unspecified dose and frequency. On 24-Jul-2021, RASH (Rash on legs & arms) had resolved. At the time of the report, SWELLING (swelling) and HYPERSENSITIVITY (allergy) was resolving and AXILLARY PAIN (Armpit pain) had not resolved. 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. No concomitant medication has been reported. Very limited information regarding the events has been provided at this time. Further information can''t be requested and is not expected.; Sender''s Comments: Very limited information regarding the events has been provided at this time. Further information can''t be requested and is not expected.


VAERS ID: 1525267 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoaesthesia, Loss of consciousness, Vaccination site erythema
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), 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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: Fainting with a moment of complete unconsciousness, shortly after the arm where I performed the vaccine (which has a red spot all around) went numb and stiffened without being able to move it; Fainting with a moment of complete unconsciousness, shortly after the arm where I performed the vaccine (which has a red spot all around) went numb and stiffened without being able to move it; Fainting with a moment of complete unconsciousness, shortly after the arm where I performed the vaccine (which has a red spot all around) went numb and stiffened without being able to move it; This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS. unable to move it.) in a 27-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Fainting with a moment of complete unconsciousness, shortly after the arm where I performed the vaccine (which has a red spot all around) went numb and stiffened without being able to move it.) (Seriousness criterion medically significant), HYPOAESTHESIA (Fainting with moment of complete unconsciousness, shortly after the arm where I performed the vaccine (which has a red spot all around it) went numb and stiffened without being able to move it.) and VACCINATION SITE ERYTHEMA (Fainting with a moment of complete unconsciousness, shortly after the arm where I ran the vaccine (which has a red spot all around it) went numb and stiffened without being able to move it.). At the time of the report, LOSS OF CONSCIOUSNESS (Fainting with a moment of complete unconsciousness, shortly after the arm where I administered the vaccine (which has a red spot all around) went numb and stiff without being able to move it.), HYPOAESTHESIA (Fainting with a moment of complete unconsciousness, shortly after the arm where I performed the vaccine (which has a red spot all around it) went numb and stiffened without being able to move it.) And VACCINATION SITE ERYTHEMA (Fainting with a moment of complete unconsciousness, shortly after the arm where I ran the vaccine (which has a red spot all around it) went numb and stiffened without being able to move it.) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1525416 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-07-17
   Days after vaccination:169
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chest pain, Cough, Nasopharyngitis, Oropharyngeal pain, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: 20210720; Test Name: SARS-CoV-2 PCR test; Test Result: Positive.
CDC Split Type: ATPFIZER INC202100949279

Write-up: Vaccination failure; SARS-CoV-2 PCR test positive; Pain pharynx; Dry cough; Common cold; Chest ache; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-37862. A 53-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: EJ6134; Expiration Date: 30Apr2021), dose 2 via an unspecified route of administration on 29Jan2021 and dose 1 via an unspecified route of administration on 08Jan2021 (Batch/Lot Number: EJ6796; Expiration Date: 30Apr2021) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination and sars-cov-2 pcr test positive on 20Jul2021 and pain pharynx, dry cough, common cold, and chest ache on 17Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test with result positive on 20Jul2021. The outcome of the events were reported as unknown. Product Quality Complaint: Conclusion: The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, 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 EJ6796 and EJ6134. 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. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root causes were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.


VAERS ID: 1525443 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       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: AUPFIZER INC202100964083

Write-up: This is a spontaneous report from a contactable other healthcare professional, via the regulatory authority (report number: 590992). A 43-year-old female patient received BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On Jul 17, 2021, after the vaccination, patient experienced Bell''s palsy; with outcome of not recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1526480 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-17
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7959 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
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: 20210723; Test Name: antigen test; Result Unstructured Data: Test Result:positive
CDC Split Type: ESPFIZER INC202100952367

Write-up: Positive COVID (confirmed by antigen test); Positive COVID (confirmed by antigen test); COVID symptoms; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). An 18-year-old male patient received BNT162B2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: FD7959, expiry date: unknown), via an unspecified route of administration on 07Jul2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced positive covid (confirmed by antigen test), on 23Jul2021 and covid symptoms on 17Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 23Jul2021. The outcome of the events was unknown.


VAERS ID: 1526785 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache
SMQs:, Arthritis (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: LABETALOL HYDROCHLORIDE; PREGNACARE ORIGINAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER;CY
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100934229

Write-up: Fatigue; Aching joints; Headache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-EYC 00256632, Safety Report Unique Identifier is GB-MHRA-ADR 25678682. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), parenteral on 16Jul2021 as dose number unknown, single for COVID-19 immunization. The patient''s medical history was not reported. Concomitant medications included labetalol hydrochloride; ascorbic acid, betacarotene, biotin, calcium pantothenate, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, magnesium, nicotinamide, phytomenadione, pyridoxine hydrochloride, riboflavin, selenium, thiamine mononitrate, tocopheryl acid succinate, zinc (PREGNACARE ORIGINAL). On 17Jul2021, the patient experienced fatigue, aching joints, and headache. The events were reported as serious per other medically important condition. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1526801 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cellulitis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100945407

Write-up: This is a spontaneous report from two contactable consumers, downloaded via the regulatory authority (number: GB-MHRA-WEBCOVID-202107191232006130-DKENQ; safety report unique identifier: GB-MHRA-ADR 25672442). A patient, of an unspecified age and gender, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, lot# FD8813, expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location, on Jul 16, 2021, single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19, nor had a COVID-19 test. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, lot# unknown, expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location, on an unspecified date, single dose, for COVID-19 immunization. On Jul 17, 2021, patient experienced cellulitis; with outcome of resolving. No follow-up attempts possible. No further information expected.


VAERS ID: 1526809 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-07-17
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling hot, Rash, Rash pruritic, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
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 INC202100928831

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202107201114449450-8W2BO; safety report unique identifier: GB-MHRA-ADR 25679614). A female patient, of an unspecified age, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# ET8885), via an unspecified route of administration, on Jun 24, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in a clinical trial. The patient experienced itch, hot-to-touch (unspecified date); and rash all over (Jul 17, 2021). The patient reported to have rash all over body. Itchy and hot-to-touch. The event reported serious (medically significant). Patient had a telephone appointment with a doctor. The patient underwent lab tests and procedures, which included SARS-CoV-2 test: No - Negative COVID-19 test result on an unknown date. The patient has not recovered from rash (all over) and hot-to-touch; while outcome of itchy unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1526856 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye disorder, Eye pain, Headache
SMQs:, Glaucoma (broad), Corneal disorders (broad), Retinal 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: GBPFIZER INC202100934306

Write-up: Headache; Difficult to open eye; Eye pain/Eyelid pain; This is a spontaneous report from a contactable consumer (patient) received from The regulatory authority report number is GB-MHRA-WEBCOVID-202107211014224720-YAX47 and Safety Report Unique Identifier GB-MHRA-ADR 25685141. A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 14Jul2021 as dose 1, single for COVID-19 immunisation. Medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. On 17Jul2021, he had pain behind his eye and on eye lid. On unknown date, the patient had difficulty to open his eye causing headache. The events were reported as serious medically significant. The outcome of eye pain was not recovered; for other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1526861 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-17
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Fatigue, Headache, Heavy menstrual bleeding, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IMPLANON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100934147

Write-up: Headache; Fatigue; Faint; Menstruation lasting a lot longer; menstrual cramps; Menstrual flow excessive; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number is GB-RA-WEBCOVID-202107211030208830-CKX2P, Safety Report Unique Identifier is GB-RA-ADR 25685248. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jun2021 (Lot Number: FA1027, Expiry date not reported) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included suppressed lactation, and contraception (birth control), from an unknown date and unknown if ongoing. Concomitant medication included etonogestrel (IMPLANON) taken for contraception from 21Aug2016 to an unspecified stop date. Patient had not had symptoms associated with COVID-19. Patient had not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. The patient experienced menstrual cramps on an unspecified date with outcome of unknown, menstrual flow excessive on 17Jul2021 with outcome of not recovered, headache on an unspecified date with outcome of unknown, fatigue on an unspecified date with outcome of unknown, faint on an unspecified date with outcome of unknown, and menstruation lasting a lot longer on an unspecified date with outcome of unknown. The events were reported as serious, medically significant by the health authority. Additional Information: Severe menstrual cramps, Excessive bleeding, Passing large clots, Menstruation lasting a lot longer, Headaches, Fatigued/Faint. All of the above are very unusual for me to have during usual menstruation. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1526866 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Lethargy, Myalgia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (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: AMITRIPTYLINE HYDROCHLORIDE; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pain relief
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934120

Write-up: headache; Giddiness; tiredness; Pain in upper arm near injection site; painful muscle; Lethargy; Headache dull; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202107211101578600-SKZRD, Safety Report Unique Identifier GB-MHRA-ADR 25685426. A 38-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 2020 as dose 2, single for COVID-19 immunization. Medical history included lactation decreased and pain relief. Patient has not had symptoms associated with COVID-19. Patient is not pregnant; Patient is not currently breastfeeding. Concomitant medications included amitriptyline hydrochloride taken for pain relief and paracetamol taken for pain relief from 2021. On 17Jul2021, patient experienced lethargy and headache dull. On an unspecified date, the patient experienced headache, giddiness, tiredness, pain in upper arm near injection site and painful muscle. The clinical course was reported as follows: Extreme tiredness and lethargy started 12 hours after vaccine given, getting worse 48 hours later, not improved yet. Headache- mild, dull, started about 12 hours after, resolved after 48 hours. Pain in upper arm near injection site, very painful muscle in upper arm, started immediately after vaccine given, most painful 24 hours after, staring to feel less painful 72 hours later. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient had COVID-19 Virus test (Unknown date): no - negative covid-19 test. The case is serious (medically significant). The outcome for the events lethargy, headache, giddiness and tiredness was not recovered; outcome for headache dull was recovered pm 19Jul2021; outcome for pain in upper arm near injection site and painful muscle was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1526890 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Feeling hot, Headache, Neck pain
SMQs:, Arthritis (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: GBPFIZER INC202100934498

Write-up: headache; Neck pain; Pain radiating up into shoulder; feeling extremely hot during the night; This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-WEBCOVID-202107211417161200-61RFD, Safety Report Unique Identifier GB-MHRA-ADR 25686837. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration, administered in arm left on 17Jul2021 (at the age of 37 years old) as DOSE 2, SINGLE for COVID-19 immunization. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient''s concomitant medications were not reported. On 17Jul2021, the patient experienced headache, neck pain, pain radiating up into shoulder, and feeling extremely hot during the night. The events were medically significant. Outcome of the headache and neck pain was recovering while of the remaining events was unknown. The clinical course was reported as follows: Pain radiating up into shoulder, neck and head on the same site as the injection site (left upper arm). Associated systems feeling extremely hot during the night with painful headache. Neck pain-associated headache subsided after 2 days. Neck pain persists but slightly milder that on the first day of the symptoms presenting. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible, Information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1526945 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Illness, 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: NAPROXEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934385

Write-up: Sickness; Fatigue; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number [GB-RA-WEBCOVID-202107211806483220-DU4HP], Safety Report Unique Identifier [GB-RA-ADR 25688457]. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. Concomitant medication included naproxen taken for arthritis, start and stop date were not reported. The patient experienced sickness on 18Jul2021 and fatigue on 17Jul2021. The events were assessed as serious (disability, medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 16Jul2021. The outcome of the events was not recovered. Additional information: Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained


VAERS ID: 1526951 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Heavy menstrual bleeding, Migraine
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: ISOPROPANOL; SERTRALINE; ZOLMITRIPTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Lactation decreased; Migraine; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100934270

Write-up: My period was much heavier than usual; Migraine; headache; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107211851005080-WH8EQ. Safety Report Unique Identifier GB-MHRA-ADR 25688848. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 (at the age of 41 years) (Batch/Lot Number: FD8813) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included lactation decreased, suspected COVID-19 from 02Mar2020 to 25Apr2020, depression and migraine. Not had a COVID-19 test. Patient is not pregnant, Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medications included isopropanol taken for migraine from 16Mar2015; sertraline taken for depression from 01Jan2015; zolmitriptan taken for migraine from May2017. On 17Jul2021, the patient had a migraine headache around an hour after the vaccine which stayed on and off for around 4 days. The patient''s period was much heavier than usual on an unspecified date. The events were assessed as serious (medically significant). The outcome of the event migraine was not recovered, while unknown for the rest of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1526952 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-07-17
   Days after vaccination:115
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood test, Chills, Fatigue, Headache, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (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: LISINOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:unknown result; Comments: during first bout; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934274

Write-up: muscle ache; Chills; Muscle pain; Headache; Fatigue; Pain joint; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202107211858332300-XHZDS], Safety Report Unique Identifier [GB-MHRA-ADR 25688853]. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Mar2021 (Batch/Lot number was Not known) as dose 2, single for COVID-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medications included lisinopril taken for blood pressure, start and stop date were not reported. The patient experienced muscle ache on an unspecified date; chills, muscle pain, headache, fatigue and pain joint on 17Jul2021. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test and blood tests during first bout: unknown result, both on an unknown date. Therapeutic measures were taken as a result of muscle ache, chills and muscle pain. The outcome of the event ''muscle ache'' was recovering and outcome of the other events was not recovered. The clinical course was reported as follows: First bout was 2 weeks after 2nd vaccination lasted 3 weeks. This is the second bout which started 17Jul2021 and ongoing, spoke to clinical pharmacist and was told paracetamol and Ibuprofen as they seem to ease the chills and muscle ache. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional Information: Patient has not had symptoms associated with COVID-19. No follow-up at tempts are possible; information about Lot/Batch number cannot be obtained.


VAERS ID: 1526955 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100934325

Write-up: Tiredness; Fainting; Dizzy spells; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number [GB-MHRA-WEBCOVID-202107211915261040-HPYLI], Safety Report Unique Identifier [GB-MHRA-ADR 25688865]. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Lot/batch Number: Fd5613) as dose 2, single for COVID-19 immunisation. Medical history included pregnancy from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced tiredness on an unspecified date; fainting and dizzy spells/got of bed and got dizzy on 17Jul2021. The events were assessed as serious (medically significant). The outcome of the event ''tiredness'' was unknown and outcome of the other events ''fainting'' and ''dizzy spells/got of bed and got dizzy'' was recovered on 17Jul2021. The clinical course was reported as follows: Got of bed and got dizzy, then fainted. Was dizzy on/off all day. Patient was not enrolled in clinical trial. Additional information: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1526963 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy
SMQs:, 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: GBPFIZER INC202100934322

Write-up: Lymphadenopathy; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number: GB-MHRA-WEBCOVID-202107212025039270-EYHWU, Safety Report Unique Identifier: GB-MHRA-ADR 25689263. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 15Jul2021 (Lot Number: FF3319) as single dose for COVID-19 Immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced lymphadenopathy on 17Jul2021 further reported as large sausage shape/sized swelling of axillary lymph node chain unilaterally (same side as vaccination). The event was considered serious: medically significant. The outcome of lymphadenopathy was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1526995 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934353

Write-up: Chest pain; Fever; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number: GB-MHRA-WEBCOVID-202107212319444720-BBHG2, Safety Report Unique Identifier: GB-MHRA-ADR 25689793. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced fever on 17Jul2021 and chest pain on 18Jul2021. The events were considered serious: 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: No - Negative COVID-19 test on 21Jul2021. The patient recovered from fever on 18Jul2021 and from chest pain on 19Jul2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1527022 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, SARS-CoV-2 test
SMQs:, 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 Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: Negative.
CDC Split Type: GBPFIZER INC202100941379

Write-up: Fatigue; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107221009449520-LYPDT. Safety Report Unique Identifier (GB-MHRA-ADR 25691494). A 30-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Lot number was not reported) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. On 17Jul2021 patient experienced fatigue. Event considered serious as medically significant. The patient underwent laboratory tests and procedures which included sars-cov-2 test: no - negative covid-19 test- Negative on unknown date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient recovered from the event on 18Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1527044 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Malaise, Musculoskeletal stiffness, Pain in extremity, Pyrexia, SARS-CoV-2 test, Sinusitis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fatigue (Suspected COVID-19); Lactation decreased; Loss of smell (Suspected COVID-19); Loss of taste (Suspected COVID-19); Suspected COVID-19 (Contact with traveler who tested pos. on next day. Symptoms: loss of taste/smell; fatigue)
Allergies:
Diagnostic Lab Data: Test Name: Lateral flow x2; Test Result: Negative ; Comments: Lateral flow x2; Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever
CDC Split Type: GBPFIZER INC202100941358

Write-up: Sinusitis; Sore arm; Stiffness/limb stiffness; Feverish; Feeling uncomfortable/unwell; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107221608305670-DGFTM, Safety Report Unique Identifier GB-MHRA-ADR 25693887. A 26-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 17Jul2021 (Batch/Lot Number: FE3380), at the age of 26 years old, as 1st single dose, for COVID-19 immunisation. Medical history included decreased lactation, suspected COVID-19 (with symptoms of loss of taste and smell, and fatigue) from 11Mar2020 to 10Jun2020 due to having had contact with a traveler who had tested positive on the following day. Otherwise there were no relevant medical conditions to report. The patient was usually fit and healthy with no illness of any kind for the 18 months prior to BNT162b2 vaccination. The patient was not pregnant and was not currently breastfeeding. The patient was not enrolled in any clinical trial. The patient''s concomitant medications were not reported. The patient stated that she got home from jab, and a couple of hours after having the vaccine on 17Jul2021, she had sore arm and stiffness that developed into feverish temperatures and feeling uncomfortable. She was struck with sinusitis the following day (18Jul2021) and had not recovered after 5 days. She stated she had not been ill, not even with just a cold, for 18 months before having the jab. She had not suffered from sinusitis before or anything similar. At the time of the reporting she had to take the day off work and possibly the day after as well as unable to drive or concentrate at work due to feeling so unwell. She was not tested at the time but she suspected that she had had COVID-19 in Mar2020 (reported as from 11Mar2020 to 10Jun2020) after being in contact with a traveler who tested positive the following day. She added that herself and several colleagues suffered loss of taste and smell and fatigue that were not listed as symptoms at that time so she had carried on as usual. She was wondering if this had contributed to her severe reaction to the vaccine. Treatment due to the events included ibuprofen from 17Jul2021 for fever, paracetamol/caffeine (PANADOL) from 18Jul2021 for sinusitis, paracetamol from 17Jul2021 for fever, and phenylephrine HCl/pseudoephedrine HCl (SUDAFED) from 18Jul2021 for sinusitis. The patient has not tested positive for COVID-19 since having the vaccine, a COVID-19 test (lateral flow x2) on an unspecified was negative. The patient had not recovered from the events except from sinusitis and fever from which she was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1527059 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anal incontinence, Headache, SARS-CoV-2 test
SMQs:, Noninfectious diarrhoea (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 Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100941424

Write-up: lost control of bowel; Headache; This is a spontaneous report from a contactable consumer, received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202107222206210320-NHV8B, Safety Report Unique Identifier GB-MHRA-ADR 25695941. A 39-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on 16Jul2021 (Batch/Lot Number: FC9001) as single dose for COVID-19 immunization. The patient'' s medical history and concomitant medications were not reported. The patient has not tested positive for COVID-19 since having the vaccine. The patient has not had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. On 17Jul2021 the patient experienced headache and, on an unknown date, he lost control of bowel. They were reported as "severe reaction and lost control of bowel". Both the events were assessed as medically significant. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on an unspecified date. The event Headache resolved on 18Jul2021, whereas the outcome of the event lost control of bowel was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1527123 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was reported. Patient has not had symptoms associated with COVID-19 and Not had a COVID-19 test.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Tinnitus; This regulatory authority case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 33-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No medical history was reported. Patient has not had symptoms associated with COVID-19 and Not had a COVID-19 test. On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form(s). On 17-Jul-2021, the patient experienced TINNITUS (Tinnitus) (seriousness criterion medically significant). At the time of the report, TINNITUS (Tinnitus) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. It was reported that patient developed Tonal tinnitus, mild constant high pitch, way more present during periods of quiet noise. Started 24h after vaccine shot. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Treatment information was not provided.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time


VAERS ID: 1527267 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Maternal exposure during pregnancy, Pain in extremity, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Cardiac ablation (Heart ablation because of supraventricular tachycardia in 2020); Heart murmur; Miscarriage (Miscarriage in May 2021); Supraventricular tachycardia (Heart ablation because of supraventricular tachycardia in 2020)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100941944

Write-up: Painful arm; Fatigue; Maternal exposure during pregnancy/ Patient last menstrual period date: 21-JUN-2021; This is a solicited report from a contactable other HCP and a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202107211511433740-TE7FJ and Safety Report Unique Identifier GB-MHRA-ADR 25687205. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD5613), via an unspecified route of administration on 17Jul2021, at the age of 26-year-old, as dose 2, single for COVID-19 immunisation. Medical history included ongoing pregnancy (Estimated due date: 28Mar2022), Miscarriage in May2021, Heart ablation because of supraventricular tachycardia in 2020, Asthma, Heart murmur. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient previously received first dose of BNT162B2 (Lot Number: ET8885) on 05Jun2021, at the age of 26-year-old, for COVID-19 immunization and experienced painful arm. The patient experienced painful arm (medically significant) and fatigue (medically significant), both on 17Jul2021 with outcome of recovered on 19Jul2021. The patient was pregnant while receiving BNT162B2. Patient last menstrual period date was 21Jun2021. The patient experienced maternal exposure during pregnancy on 17Jul2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test. Patient is not enrolled in clinical trial. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Painful arm and Fatigue and suspect drug BNT162B2 cannot be excluded.


VAERS ID: 1527696 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9909 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal tenderness, Blood test, Body temperature, Computerised tomogram, Decreased appetite, Diarrhoea, General physical health deterioration, Inflammation, Loss of consciousness, Malaise, Pyrexia, Secondary adrenocortical insufficiency, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: blood sampling; Result Unstructured Data: Test Result:no decrease in blood pressure; Comments: no decrease in blood pressure, and no obvious findings of adrenal insufficiency such as low Na, Hyperkalemia, Eosinophilia, and Hypoglycaemia were observed.; Test Date: 20210717; Test Name: blood test; Result Unstructured Data: Test Result:increased inflammatory response; Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before the vaccination; Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:39.0 Centigrade; Comments: around 03:00; Test Date: 202104; Test Name: ct; Result Unstructured Data: Test Result:unknown results; Test Date: 20210717; Test Name: ct; Result Unstructured Data: Test Result:no obvious changes; Comments: no obvious changes in the abdominal pelvic cavity compared to the previous imaging in Apr2021.
CDC Split Type: JPPFIZER INC202100935458

Write-up: loss of appetite; the consciousness was slightly unclear; Vomiting/ mild vomiting; diarrhea; malaise; pyrexia 39.0 Centigrade; the general condition was poor; Mild tenderness in the epigastric region; increased inflammatory response on blood tests; Hypophyseal accessory renal cortical dysfunction/the possibility of adrenal insufficiency; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21120751. A 67-year-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Jul2021 14:10 (Lot Number: FC9909; Expiration Date: 30Sep2021) as single dose (at age of 67-years-old) for covid-19 immunisation. Medical history included Lung cancer during chemotherapy. Patient received concomitant medications, no further details provided. On 17Jul2021 07:30 patient experienced consciousness was slightly unclear, on 17Jul2021 03:00 patient experienced vomiting/ mild vomiting, diarrhea, malaise, pyrexia 39.0 Centigrade, on 17Jul2021 the general condition was poor, she also experienced mild tenderness in the epigastric region, increased inflammatory response on blood tests and hypophyseal accessory renal cortical dysfunction/ possibility of adrenal insufficiency, on 18Jul2021 patient experienced loss of appetite. The patient was hospitalized for the events from 17Jul2021 to 20Jul2021. Patient recovered from the events on 20Jul2021. The clinical course was as follows: The patient was a 67-year and 10-month-old female. Body temperature before vaccination was 36.5 degrees Centigrade. The patient had no family history. 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 that Underlying disease: Lung cancer during chemotherapy. On 16Jul2021 at 14:10 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Lot number FC9909, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 17Jul2021 around 03:00 (1 day after the vaccination), the patient experienced Vomiting, Diarrhea, Malaise, Pyrexia. On 17Jul2021 (1 day after the vaccination), the patient was admitted to the hospital and discharged on 20Jul2021. On 20Jul2021 (4 days after the vaccination), the outcome of the event was recovered. The course of the event was as follows: On 16Jul2021 second vaccination of the new coronavirus infection vaccine. After vaccination, there was no particular abnormality. On 17Jul2021 from around 03:00 vomiting, diarrhea, malaise, and pyrexia (39.0 Centigrade) were observed. Since no improvement, on the same day 07:30 am, emergency outpatient visit. Because the consciousness was slightly unclear at the time of admission and the general condition was poor, the possibility of adrenal insufficiency was also taken into consideration. Because stress and vomiting continued, the patient can''t take Cortril orally in the morning, Hydrocortisone (steroid) intravenous drip of 100 mg after blood sampling. There was no decrease in blood pressure, and no obvious findings of adrenal insufficiency such as low Na, Hyperkalemia, Eosinophilia, and Hypoglycaemia were observed. Mild tenderness in the epigastric region and increased inflammatory response on blood tests. Computerised tomogram (CT) showed no obvious changes in the abdominal pelvic cavity compared to the previous imaging in Apr2021. The patient was hospitalized on the same day and was observed with fluid replacement. On the day of admission, the next day, mild vomiting and loss of appetite were observed, but after the third day, the condition improving and the patient was discharged from the hospital on 20Jul2021. The reporting physician classified the event as serious (hospitalized from 17Jul2021 to 20Jul2021) and assessed that the event was related to bnt162b2. Other possible cause(s) of the event such as any other diseases was Hypophyseal accessory renal cortical dysfunction. The reporting physician commented as follows: Post-vaccination side reactions were considered from the findings and timing of vaccination. No obvious findings of adrenal insufficiency were found from blood pressure findings or blood test findings at the time of visit, but it was considered that the adrenal glands were stressed by adverse reactions after vaccination.


VAERS ID: 1527698 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Magnetic resonance imaging, Speech disorder, Thalamus haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: MRI; Result Unstructured Data: Test Result:Left thalamus haemorrhage
CDC Split Type: JPPFIZER INC202100935461

Write-up: Left thalamus haemorrhage; Difficulty of talking; This is a spontaneous report from a contactable nurse (patient) received from the Agency. The regulatory authority report number is v21120755. A 76-year-old female patient received BNT162B2 (COMIRNATY; solution for injection; lot number: EY0583; expiration date: 31Oct2021), via an unspecified route of administration on 16Jul2021 (at the age of 76-years-old) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On unspecified date, the patient previously received the first dose of BNT162B2 (COMIRNATY; lot number: EY5422; expiration date: 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 16Jul2021 (the day of vaccination), the patient received the second dose of BNT162B2. On 17Jul2021 around 10:00 (1 day after vaccination), the patient was aware of the difficulty of talking, when the patient consulted with her family doctor and was transported via an ambulance. MRI showed left thalamus haemorrhage. The patient was hospitalized. The outcome of the events was unknown. The reporting nurse classified the event as serious (hospitalized from 17Jul2021 and likely disability) and the causality between the event and BNT162B2 as unassessable.


VAERS ID: 1527728 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Facial paralysis, Viral infection
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100936100

Write-up: Facial palsy/right facial palsy; Other possible cause(s) of the event such as any other diseases included viral infection etc.; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21120945. The patient was an 85-year and 10-month-old male. On 16Jul2021 at 15:30 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY0583, Expiration date 31Oct2021) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees Centigrade. 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). The patient medical history was none. The patient concomitant medications were not reported. On 17Jul2021 at 09:00 (1 day after the vaccination), the patient experienced facial palsy. The course of the event was as follows: Right facial palsy. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases included viral infection etc. The patient underwent lab tests and procedures which included body temperature: 36.4 centigrade on 16Jul2021 before vaccination. On 20Jul2021 (4 days after the vaccination), the outcome of the event was not recovered The reporting physician commented as follows: It was a short period of time after vaccination, the causality with the vaccine was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1527928 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Chills, Epistaxis, Facial bones fracture, Fatigue, Interchange of vaccine products, Lip injury, Loose tooth, Malaise, Myalgia, Nausea, SARS-CoV-2 test positive, Syncope, Vaccination site inflammation, Vaccination site pain, Vaccination site warmth
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (disease symptoms: little); Fruit allergy (allergy: Cherries)
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: body temperature increased; Result Unstructured Data: Test Result:37.5-38 Centigrade; Comments: Fever: 37.5 to 38 degrees Celsius; Test Date: 20210331; Test Name: coronavirus, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC202100936083

Write-up: Passed out (been unconscious) broken nose and nosebleed. Broken lips and loose teeth.; Passed out (been unconscious) broken nose and nosebleed. Broken lips and loose teeth.; Passed out (been unconscious) broken nose and nosebleed. Broken lips and loose teeth.; Passed out (been unconscious) broken nose and nosebleed. Broken lips and loose teeth.; Passed out (been unconscious) broken nose and nosebleed. Broken lips and loose teeth.; Malaise; Myalgia; Fever: 37.5 to 38 degrees Celsius; Fatigue; Nausea; Chills; interchange of vaccine products; Inflammatory reaction at the reaction site: heat, pain; Inflammatory reaction at the reaction site: warmth; Reaction at or around the injection site: pain; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency -WEB, regulatory authority number NL-LRB-00630941. A 65-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FF0688), dose 2 via an unspecified route of administration on 17Jul2021 (at the age of 65-year-old) as single dose for covid-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA, manufacture, Batch/Lot Number: unknown), dose 1 via an unspecified route of administration on 27Apr2021, at single dose for covid-19 immunisation. Medical history included previous covid-19 infection (disease symptoms: little) from 31Mar2021 to an unknown date, allergy: Cherries. There were no concomitant medications. After received covid-19 vaccine astrazeneca injection fluid on 27Apr2021, the patient experienced fever, myalgia, dizziness, nausea. After received bnt162b2, the patient experienced inflammatory reaction at the reaction site: heat, pain/ warmth on 17Jul2021, passed out (been unconscious) broken nose and nosebleed; broken lips and loose teeth, malaise, myalgia, fever: 37.5 to 38 degrees celsius, fatigue, nausea, chills on 19Jul2021. The patient underwent lab tests and procedures which included body temperature increased: Fever: 37.5 to 38 degrees Celsius on 19Jul2021, coronavirus, confirmed with test positive on 31Mar2021. The outcome of events inflammatory reaction at the reaction site: heat, pain/ warmth, Passed out (been unconscious), malaise, myalgia, fever: 37.5 to 38 degrees celsius, nausea, was recovered on 19Jul2021, chills was recovered on an unspecified date, fatigue was recovering, the rest of events was unknown. Confounding factors reported as allergy: Cherries. Sender Comment: Since the nature of the reported reaction does not imply seriousness according to one of the agencycritera, the report was considered as non-serious by the Pharmacovigilance Centre. Case Summary and Reporter''s Comments Text-- BioNTech/Pfizer vaccine (Comirnaty) -- Past drug therapy: yes ADRs: Elevation (fever), muscle pain, dizzy and nauseous Date: 27Apr2021.


VAERS ID: 1527929 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Echocardiogram, Electrocardiogram, Myocarditis, Troponin
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: Test Name: Troponin; Result Unstructured Data: 22867; Test Name: Echocardiography; Result Unstructured Data: No abnormalities; Test Name: ECG; Result Unstructured Data: diffuse ST elevations
CDC Split Type: NLJNJFOC20210801687

Write-up: PERI-MYOCARDITIS; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00630946] concerned a 21 year old male of unknown race and ethnicity. The patient''s weight was 83 kilograms, and height was 178 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 dosage forms, 1 total, administered on 14-JUL-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The patient received 3-Methylmethcathinone (3 MMC) (route of admin, and batch number were not reported) administered on 16-JUL-2021 for Drug abuse. No concomitant medications were reported. On 17-JUL-2021, the patient experienced peri-myocarditis, and was hospitalized (date unspecified). Laboratory data (dates unspecified) included: and Troponin (NR: not provided) which result was 22867, Electrocardiogram (NR: not provided) with diffuse ST elevations, consistent with peri-myocarditis, and Echocardiography (NR: not provided) with no abnormalities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from peri-myocarditis. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: V0: 20210801687- covid-19 vaccine ad26.cov2.s-peri-myocarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1527945 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-17
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3064 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202100939982

Write-up: BLEEDING; This is a spontaneous report from a contactable other healthcare professional, downloaded from the Regulatory Authority EudraVigilance-WEB, Regulatory authority number: NO-NOMAADVRE-FHI-2021-U827nj. A 35-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in the left arm on 08Jul2021 at 12:20 (Batch/Lot Number: FE3064) as dose 1, single for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced bleeding on 17Jul2021. The outcome of the event was not resolved. The case was considered serious. The Regulatory Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as not assessed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Reporters qualification: Other (NOS).


VAERS ID: 1528058 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214002 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acne, Hypersensitivity, Pain in extremity, Pruritus, Pyrexia, Rash, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTMODERNATX, INC.MOD20212

Write-up: Pimples all over the body; a lot of itching; the site where the vaccine was administered was warm; the site where the vaccine was administered was very red; rashes all over body; slight pain in the arm; started to have a allergic reaction stronger in the course of time; slight pain in the arm; I also had fever the day after; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slight pain in the arm), HYPERSENSITIVITY (started to have a allergic reaction stronger in the course of time), ACNE (Pimples all over the body), PRURITUS (a lot of itching), PYREXIA (I also had fever the day after), VACCINATION SITE WARMTH (the site where the vaccine was administered was warm), VACCINATION SITE ERYTHEMA (the site where the vaccine was administered was very red), RASH (rashes all over body) and VACCINATION SITE PAIN (slight pain in the arm) in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214002) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced PAIN IN EXTREMITY (slight pain in the arm) (seriousness criterion hospitalization) and PYREXIA (I also had fever the day after) (seriousness criterion hospitalization). On 23-Jul-2021, the patient experienced HYPERSENSITIVITY (started to have a allergic reaction stronger in the course of time) (seriousness criterion hospitalization). On an unknown date, the patient experienced ACNE (Pimples all over the body) (seriousness criterion hospitalization), PRURITUS (a lot of itching) (seriousness criterion hospitalization), VACCINATION SITE WARMTH (the site where the vaccine was administered was warm) (seriousness criterion hospitalization), VACCINATION SITE ERYTHEMA (the site where the vaccine was administered was very red) (seriousness criterion hospitalization), RASH (rashes all over body) (seriousness criterion hospitalization) and VACCINATION SITE PAIN (slight pain in the arm) (seriousness criterion hospitalization). The patient was treated with CORTISONE (intravenous) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (slight pain in the arm), HYPERSENSITIVITY (started to have a allergic reaction stronger in the course of time), ACNE (Pimples all over the body), PRURITUS (a lot of itching), PYREXIA (I also had fever the day after), VACCINATION SITE WARMTH (the site where the vaccine was administered was warm), VACCINATION SITE ERYTHEMA (the site where the vaccine was administered was very red), RASH (rashes all over body) and VACCINATION SITE PAIN (slight pain in the arm) outcome was unknown. Concomitant medications were not provided. Treatment medication included an anti-allergy medication and cortisone. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. In a conservative manner the event translated differently as pimples and rash are kept.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. In a conservative manner the event translated differently as pimples and rash are kept.


VAERS ID: 1528073 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Heart rate, Nausea, Palpitations
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: heart rate; Result Unstructured Data: Test Result:120 beats per minute
CDC Split Type: SEPFIZER INC202100940038

Write-up: Heart pounding; Chest pressure; Nausea; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-063013. A 33-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 17Jul2021 (Batch/Lot Number: FE6208) (at the age of 33 years) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included asthma from 1988 and ongoing. The patient''s concomitant medications were not reported. The patient previously took acetylsalicylic acid and experienced dyspnoea. The patient experienced heart pounding, chest pressure, nausea, all on 17Jul2021, with seriousness of hospitalization (from 18Jul2021). Patient sought hospital care next day. The patient underwent lab tests and procedures which included heart rate: 120 beats per minute on 17Jul2021. The outcome of event heart pounding was recovered while for other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1528479 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Malaise, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: BEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA, MALAISE, CHILLS and MYALGIA in a 39-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 17-Jul-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced PYREXIA (seriousness criterion disability), MALAISE (seriousness criterion disability), CHILLS (seriousness criterion disability) and MYALGIA (seriousness criterion disability). The patient was treated with PARACETAMOL for Adverse event following immunisation, at an unspecified dose and frequency. On 18-Jul-2021, PYREXIA, MALAISE, CHILLS and MYALGIA was resolving. No concomitant medication were provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1529491 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-17
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Appendicitis, Diabetes mellitus inadequate control, Diarrhoea, Malaise, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type I diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100964492

Write-up: Appendicitis; could not control her blood sugar; General malaise; Stomach pain type griping; An episode of vomiting and diarrhea; An episode of vomiting and diarrhea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 08Jul2021 (Batch/Lot Number: FE3065) as dose 1, single for covid-19 immunisation. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. The patients'' concomitant medications were not reported. On 17Jul2021, 9 days after first shot of the vaccine, the patient had an episode of diarrhea and vomiting. The patient has type 1 diabetes mellitus and when she could not control her blood sugar she went to emergency room and there, they told her that despite having no symptoms, just general malaise/feeling unwell and stomach pain type griping like cramps with pain, she had appendicitis. The outcome of the events was unknown.


VAERS ID: 1529629 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: computerised tomography scan brain; Result Unstructured Data: Test Result:no abnormality
CDC Split Type: FRPFIZER INC202100967090

Write-up: Left peripheral facial paralysis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-TS20213160 Safety Report Unique Identifier FR-AFSSAPS-2021098758 received via regulatory authority. A 14-years-old female patient received first dose of bnt162b2 (COMIRNATY, COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: FE7010; Expiration Date: not reported) via an intramuscularly administered on 16Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 17Jul2021, On day 1 of the injection (24 hours after the first dose of Comirnaty), in the middle of the day, the patient experienced sudden appearance of a left peripheral facial paralysis. The patient was hospitalized for facial paralysis from 17Jul2021 to 18Jul2021. The patient visited to the emergency room where she underwent lab tests and procedures which included computerized tomogram head: no abnormality on 17Jul2021. Therapeutic measures were taken as a result of left peripheral facial paralysis with prednisone and aciclovir. Viral serologies in progress. The clinical outcome of event was not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1529633 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-17
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Swelling face
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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100950594

Write-up: giant hives; swollen face; This is a spontaneous report from a contactable consumer via portal. A 50-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in Arm Left on 30Jun2021 14:00 (Batch/Lot Number: Unknown) as dose 2, single (at the age of 49 years) for covid-19 immunisation. The patient has no medical history. Patient has no known allergy and no past drug history. The patient''s concomitant medications were not reported. The patient received the first dose of COMIRNATY (Batch/Lot Number: Unknown) in May2021 at 14:00 in the left arm for Covid-19 immunisation. The patient experienced giant hives and swollen face on 17Jul2021 04:00. Treatment for the events included cortisone. The outcome of the events was unknown. The adverse event resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.


VAERS ID: 1529639 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Folliculitis, Haemorrhage, Hypoaesthesia, Loss of consciousness, Pain in extremity, Pain of skin, Palpitations, Peripheral swelling, Presyncope, Pruritus, Psoriasis, Rash, SARS-CoV-2 test, Skin haemorrhage, Skin irritation, Skin swelling, Somnolence, Syncope, Vaccination site hypoaesthesia, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (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), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), 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: Medical History/Concurrent Conditions: Folliculitis; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100943565

Write-up: palpitations; passing out; folliculitis; fainting; bleeding; Pain in and around injection site with mild numbness to injected arm; Pain in and around injection site with mild numbness to injected; Very drowsy; Scalp bleeding; Scalp pain; Scalp rash; Psoriasis of scalp; Scalp folliculitis; Scalp tenderness; Scalp swelling; Itchy scalp; Scalp irritation; Felt faint; Near fainting; Heart pounding; Painful arm; Swollen arm; Numbness of limbs; This is a spontaneous report from a contactable consumer or other non hcp received from. The regulatory authority report number is GB-MHRA-APPCOVID-202107250133242410-3GCBL. A 25-year-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: FD5613), via an unspecified route of administration, administered in Arm on 17Jul2021as DOSE 2, SINGLE for covid-19 immunization. Medical history included folliculitis, suppressed lactation. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 17Jul2021 the patient experienced palpitations, passing out, folliculitis, fainting, bleeding, felt faint, near fainting, heart pounding, painful arm, swollen arm and numbness of limbs. Scalp rash, scalp swelling, scalp irritation, itchy scalp on 20Jul2021. Patient also experienced psoriasis of scalp, scalp folliculitis, scalp pain and scalp tenderness on 21Jul2021 and scalp bleeding on 22Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. Clinical course: fainting and passing out and feeling light-headed. Sore, bleeding and aggravated scalp (presenting similar to Folliculitis but no infection present - confirmed by medical professional). Pain in and around injection site with mild numbness to injected arm. Very drowsy. Heart palpitations frequent. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The events were assessed as serious. Outcome of event Felt faint, near fainting, heart pounding, scalp rash, scalp swelling, psoriasis of scalp, scalp folliculitis, scalp bleeding, scalp irritation, scalp pain, itchy scalp, scalp tenderness was not recovered. Outcome of Painful arm recovered on 24Jul2021.Outcome of Swollen arm was recovered on 22Jul2021. Outcome of numbness of limbs was recovered on 23Jul2021.Outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1529669 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure management, Chest pain, Diarrhoea, Heart rate, Muscle twitching, Neck pain, Pain in extremity, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Dyskinesia (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), 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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Irritable bowel syndrome; Rib injury
Allergies:
Diagnostic Lab Data: Test Name: slightly raised BP; Result Unstructured Data: Test Result:Unknown Results; Comments: Unknown Results; Test Name: checked heart - normal; Result Unstructured Data: Test Result:Unknown Results; Comments: Unknown Results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100941327

Write-up: Neck pain; Palpitations; Chest pain; Diarrhea; Twitching of limbs; Pain in arm; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107221328581300-IW40D, safety report unique identifier is GB-MHRA-ADR 25692714. A 44-year-old male patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Lot Number: FD8813) via an unspecified route of administration on 17Jul2021 as dose1, single for COVID-19 immunisation. The patient medical history included irritable bowel syndrome and chest injury from an unknown date and unknown if ongoing. Concomitant medication included paracetamol taken for chest injury from 11Jul2021 to 14Jul2021. Patient had no symptoms associated with COVID-19 and did not do a COVID-19 test. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 17Jul2021, the patient had pain in arm. On 18Jul2021, the patient had twitching of limbs, Twitching left foot for 1 hour and diarrhea. On 19Jul2021 the patient had chest pain (like cramp) between left shoulder and nipple for 72 hours and the patient had unexpected heart palpitations (three times post vaccine). On 22Jul2021, the patient had experienced Neck pain, left sided behind ear and descending. The events were considered as medically significant. The events outcome was resolved for diarrhea, palpitations, muscle twitching and pain in arm on an unknown date in 2021. Outcome of the events chest pain and neck pain was not resolved. The lab tests included heart rate and blood pressure results were unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1529801 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Breast mass, Fatigue, Maternal exposure during breast feeding, Nausea, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal exposures via breast milk (narrow), Arthritis (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: CITALOPRAM
Current Illness: Anxiety
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: lump in armpit; Maternal exposure during breast feeding; Breast lump; Fatigue; Aching joints; Nausea; This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (lump in armpit), BREAST MASS (Breast lump), FATIGUE (Fatigue), ARTHRALGIA (Aching joints), NAUSEA (Nausea) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 28-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 from 15-Jun-2021 to 22-Jun-2021. Concurrent medical conditions included Anxiety. Concomitant products included CITALOPRAM from 26-Jun-2021 to an unknown date for Anxiety. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced NAUSEA (Nausea). On 18-Jul-2021, the patient experienced FATIGUE (Fatigue) and ARTHRALGIA (Aching joints). On 25-Jul-2021, the patient experienced BREAST MASS (Breast lump). On an unknown date, the patient experienced SWELLING (lump in armpit) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). On 19-Jul-2021, FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved. On 20-Jul-2021, ARTHRALGIA (Aching joints) had resolved. At the time of the report, SWELLING (lump in armpit) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown and BREAST MASS (Breast lump) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Company Comment: This is a case of product exposure during breastfeeding with associated AEs of swelling, breast mass, fatigue, arthralgia and nausea for this 28-years-old female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Causality for the product exposure during breastfeeding is not applicable. This case was linked to MOD-2021-274093 (Parent-Child Link). See case MOD-2021-274093 for details regarding the child case.; Sender''s Comments: This is a case of product exposure during breastfeeding with associated AEs of swelling, breast mass, fatigue, arthralgia and nausea for this 28-years-old female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Causality for the product exposure during breastfeeding is not applicable.


VAERS ID: 1530217 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Blood pressure systolic, Body temperature, Cold sweat, Coma scale, Erythema, Heart rate, Heart rate increased, Oropharyngeal discomfort, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREDONINE [PREDNISOLONE ACETATE]; TALION [BEPOTASTINE BESILATE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: blood pressure; Result Unstructured Data: Test Result:188/109; Test Date: 20210717; Test Name: sBP; Result Unstructured Data: Test Result:140; Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: before vaccination; Test Date: 20210717; Test Name: GCS; Result Unstructured Data: Test Result:0; Test Date: 20210717; Test Name: HR; Result Unstructured Data: Test Result:72; Test Date: 20210717; Test Name: HR; Result Unstructured Data: Test Result:104; Test Date: 20210717; Test Name: SPO2; Test Result: 98 %; Test Date: 20210717; Test Name: SPO2; Test Result: 95 %
CDC Split Type: JPPFIZER INC202100943943

Write-up: Anaphylaxis/mild anaphylaxis s/o; BP was 188/107; HR was 104; throat strange sensation of; mild redness of the forearm; skin wetting; This is a spontaneous report received from a contactable physician via regulatory authority. Regulatory authority report number is v21120882. The patient was a 71-year-old female. Body temperature before vaccination (17Jul2021) was 35.9 degrees Centigrade. The patient''s medical history was not reported. The patient''s concomitant medications included prednisolone acetate (PREDONINE) oral and bepotastine besilate (TALION), both from unspecified date. The patient had a past drug history, details were as follows: At the time (date not specified) of first dose of the vaccination with bnt162b2 (COMIRNATY) for COVID-19 immunisation, the patient had rash, and was being prescribed PREDONINE and TALION. On 17Jul2021 at 09:55 (the day of vaccination) (at the age of 71-year-old), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FD0889, Expiration date 30Sep2021) via an unspecified route of administration as dose 2, single for COVID-19 immunization. On 17Jul2021 at 10:15 (the same day of vaccination), the patient experienced anaphylaxis. On 17Jul2021 (the same day of vaccination), the outcome of the event was recovering. The course of the event was as follows: the patient complained of throat strange sensation of, mild redness of the forearm and skin wetting. GCS was 0, HR was 104, BP was 188/109, SPO2 was 98%, BT was 35.9, general good. Able to converse. The patient complained of no respiratory symptoms, light-headed feeling and gastrointestinal symptoms. At 10:20, the patient was taking oral PREDONINE that was prescribed from previous doctor. At 10:35, re-took vital signs, HR was 72, sBP was 140, SPO2 was 95%, redness of the forearm was recovering and no symptom. General state was good, the patient was instructed to see her previous physician and it was judged that she was able to go home. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. The outcome of the events was resolving. The reporting physician commented as follows (reporter''s comment): mild anaphylaxis suspected of (s/o).; Reporter''s Comments: Mild anaphylaxis suspected of (s/o)


VAERS ID: 1530222 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Computerised tomogram, Endoscopy upper gastrointestinal tract, Haematemesis, Pneumatosis intestinalis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Haematemesis; Sigmoid volvulus (performed reduction); Urinary tract infection (hospitalized again for Urinary tract infection)
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210717; Test Name: CT; Result Unstructured Data: Test Result:Had Pneumatosis coli; Comments: from the night on 17Jul2021; Test Name: Gastrocamera; Result Unstructured Data: Test Result:there was no Haemorrhage; Comments: before vaccination, specific date not provided
CDC Split Type: JPPFIZER INC202100944049

Write-up: tarry-like Haematemesis/haematemesis; Had Pneumatosis coli; This is a spontaneous report from a contactable pharmacist from the Agency Regulatory Authority. Regulatory authority number was v21121387. The patient was a 91 years and 7 months old female. Body temperature before vaccination was 36.5 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: From 07Jun2021 to 19Jun2021, when vomiting, blood was also mixed. Concomitant medications were not reported. The patient visited the reporter''s hospital. Had Sigmoid volvulus and performed reduction. Gastrocamera was also performed, but there was no Haemorrhage. The patient was hospitalized for observation. From 20Jun2021 to 06Jul2021, the patient was hospitalized again for Urinary tract infection. On 15Jul2021 at 15:00 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FC8736, Expiration date 30Sep2021) via an unspecified route of administration as a single dose (at 91 years old) for COVID-19 immunization. On 17Jul2021 (2 days after vaccination), the patient experienced Haematemesis. On 21Jul2021 (6 days after vaccination), the outcome of the events was recovered. The course of the events was as follows: From the night on 17Jul2021(2 days after vaccination), It was said had tarry-like Haematemesis. CT: Had Pneumatosis coli. Until 20Jul2021 (5 days after vaccination), had Haematemesis. Since it was not fresh blood Haematemesis, description of observation. After 21Jul2021 (6 days after vaccination), no Haematemesis or Stool tarry. The reporter classified the events as non-serious and assessed that the causality between the events and BNT162B2 as unrelated. Other possible cause(s) of the events such as any other diseases included: There was a description that blood was mixed in the vomit and excreta from before. The reporting physician commented as follows: Since the patient might had blood in the vomit and excreta before vaccination, it seemed that there was no causal relationship due to vaccination.; Sender''s Comments: Based on the information currently available, the reported events are likely intercurrent and not related to BNT162B2.


VAERS ID: 1530383 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN #XD974 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Eosinophil count, Serology test, Therapy non-responder
SMQs:, Lack of efficacy/effect (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: Blood cholesterol abnormal (Usual medication: For cholesterol, but started after the JCV.); Eosinophil count increased (Since the beginning of the year that was disregarded by the doctor before vaccination and was being studied.); Mite allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: IgM; Result Unstructured Data: NEGATIVE, IgM value- 0,23; Test Date: 20210717; Test Name: IgG; Result Unstructured Data: NEGATIVE, IgG value- 0,37; Test Date: 20210730; Test Name: Serology test; Result Unstructured Data: NEGATIVE; Test Name: Eosinophil count; Result Unstructured Data: High eosinophils
CDC Split Type: PTJNJFOC20210801315

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 53 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included high eosinophils, abnormal cholesterol (usual medication, but started after the vaccine) and mites allergy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: XD974 and expiry: unknown) dose was not reported, 1 total administered at left arm on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the patient had confirmed immunological vaccine failure. Laboratory data included: Patient was submitted to a Serological test (30 days after vaccine) on 17-07-2021 with a negative result (IgG - 0,37 and IgM - 0,23) and the doctor told her to repeat the test 15 days later. On 30-JUL-2021, Serological test (43 days after vaccine) was also negative. On unspecified date Eosinophil count (Result: high), since the beginning of the year. This information was disregarded by the doctor before vaccination against covid-19 and was being studied. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210801323. This report was associated with product quality complaint: 90000187924.; Sender''s Comments: V0: 20210801315-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1530401 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Malaise, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: SEPFIZER INC202100949118

Write-up: General feeling of illness; Heart palpitations; Pain in the chest; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-063698. A 22-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 2021 as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The reported suspect adverse events were pain in the chest and heart palpitations in 2021 and general feeling of illness on 17Jul2021. The report was assessed as serious, life threatening. The outcome of malaise was not recovered while for the remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1531347 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202100963554

Write-up: Pericarditis; chest pain; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 588857. A 21-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis and chest pain on 17Jul2021. Onset Time in Days: 1 days. 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: 1532346 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination site lymphadenopathy
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100949064

Write-up: Vaccination site lymphadenopathy/Swollen lymph nodes in the right armpit (arm where the vaccine was received); This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency-WEB, regulatory authority number ES-AEMPS-948806. A 42-year-old non-pregnant female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in Arm Right on 16Jul2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included paracetamol taken for an unspecified indication, start and stop date were not reported. The patient experienced vaccination site lymphadenopathy/swollen lymph nodes in the right armpit (medically significant) on 17Jul2021 with outcome of not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1532369 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1435 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Subcutaneous abscess
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (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: ZOELY; TARDYFERON; ACFOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Contraception; Polycystic ovary
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100949120

Write-up: Numbness in face; Abscess in the lobe of the left ear; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is ES-AEMPS-951121. A non-pregnant 33-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: FC1435), intramuscular in left arm, on 17Jul2021 (at the age of 33 years), as dose 1, single, for COVID-19 immunization. The patient''s medical history included polycystic ovary, contraceptive, and anaemia. The patient''s concomitant medications included estradiol/ nomegestrol acetate (ZOELY) for polycystic ovary and as contraceptive from 16Jun2017, ferrous sulfate (TARDYFERON) for anaemia from 03Jul2021, and folic acid (ACFOL) from 03Jul2021. On 17Jul2021, the patient experienced abscess in the lobe of the left ear. On 20Jul2021, the patient experienced numbness in face. Therapeutic measures were taken as a result of the events including amoxicillin 875 every 8 hours. The events were considered serious as medically significant. The patient had not recovered from "Numbness in face". The patient was recovering from the other event. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1532422 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1248 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram pulmonary, Blood pressure measurement, Chest pain, Computerised tomogram, Fibrin D dimer
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NOCERTONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endocarditis (in childhood); Migraine with aura (treated with Nocertone)
Allergies:
Diagnostic Lab Data: Test Name: Pulmonary angiogram; Result Unstructured Data: Test Result:Nothing to report; Comments: Nothing to report. No pulmonary embolism nor pneumomediastinum; Test Name: Blood pressure; Result Unstructured Data: Test Result:137/81 mmHg; Test Name: Lung CT scan; Result Unstructured Data: Test Result:Unknown; Test Name: D-dimer level; Result Unstructured Data: Test Result:679 ng/ml
CDC Split Type: FRPFIZER INC202100949315

Write-up: Chest pain; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency-WEB, regulatory authority number FR-AFSSAPS-CN20212393. A 33-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right on 16Jul2021 (Lot Number: FE1248) as DOSE 2, SINGLE for covid-19 immunization. Medical history included migraine with aura from an unknown date treated with Nocertone and endocarditis from an unknown date in childhood. Concomitant medication included oxetorone fumarate (NOCERTONE) taken for migraine with aura, start and stop date were not reported. The patient experienced chest pain on 17Jul2021. At 20 hour after vaccination, chest pain (D-dimer level at 679 ng/mL) requiring Emergency Room care and lung computerised tomogram (CT) scan. Emergency department report from 17Jul2021: Anamnesis: Patient referred for chest pain since morning, awakened by pain in the chest without favourably-evolving radiation, then new episode of chest pain which does not subside. Examinations: - Blood Pressure normal at 137/81 mmHg, rest of clinical exam normal - Heightened pain during breathing - D-dimer level at 679 ng/mL (N <500 ng/mL) - Pulmonary angiogram: Nothing to report. No pulmonary embolism nor pneumomediastinum. SUMMARY: chest pain with no biological or electrical evidence of cardiac aetiology, no scanographic evidence of pulmonary aetiology. Possible vaccine response. No history of COVID-19 and no history of PCR test. The outcome of event was not recovered. Chest pain reported as medically significant from health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1532583 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, Condition aggravated, Dermatomyositis, Diarrhoea, Electric shock sensation, Faeces discoloured, Insomnia, Pain, SARS-CoV-2 antibody test
SMQs:, Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Immune-mediated/autoimmune disorders (narrow), 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: PROPRANOLOL
Current Illness: Dermatomyositis (treated with Propranolol, anti-Mi2 antibodies had been found positive)
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; COVID-19 (positive serology on 23Oct2020); Diffuse pain
Allergies:
Diagnostic Lab Data: Test Name: anti-Mi2 antibodies; Test Result: Positive ; Test Date: 20201023; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202100949132

Write-up: yellow-orange diarrhea; yellow-orange diarrhea; violent shocks in limbs; insomnia/prevent her from sleeping; pains; Dermatomyositis; Aggravation of existing disorder; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority FR-AFSSAPS-RN20212345 via the Regulatory Authority portal number 20210720061739444. A 55-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in the left arm on 17Jul2021 (Lot Number: FE2296, Expiry date unknown) as dose 1, single for COVID-19 immunization. Medical history included asthma from an unknown date, COVID-19 from an unknown date in 2020 with a positive serology on 23Oct2020 with symptoms of long COVID in the aftermath (as reported) with diagnosis of dermatomyositis on an unknown date and ongoing which is treated with Propranolol. The diagnosis of the dermatomyositis was when she had diffuse pain and her anti-Mi2 antibodies had been found positive. The pain has then improved. On 17Jul2021, 15 minutes after the vaccination, the patient presented with violent shocks in limbs causing insomnia. Since 17Jul2021, she still has these pains that prevent her from sleeping. It was also reported that on 17Jul2021, the patient had aggravation of existing disorder of dermatomyositis. The patient also presented with yellow-orange diarrhea since 19Jul2021. The outcome of the events was not recovered. The events yellow-orange diarrhea and aggravation of existing disorder of dermatomyositis were reported with a seriousness of disability. No follow-up attempts possible. No further information expected.


VAERS ID: 1532691 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Axillary pain, Body temperature, Dizziness, Eating disorder, Fatigue, Feeling abnormal, Headache, Inappropriate schedule of product administration, Muscle spasms, Oropharyngeal pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: Body Temperature; Result Unstructured Data: Test Result:38.6 Centigrade; Test Date: 20210126; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100934278

Write-up: Reluctance to eat; Sore throat; Painful armpit; Headaches; Dizziness; Stomach pains; Sharp cramp; Tired legs; joint pain; painful arm; feeling like they''re full of lactic acid; High temperature (38.6 Celsius); 2nd dose is outside of the 19-42 day vaccination window; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202107211530481150-IWNOQ, Safety Report Unique Identifier is GB-MHRA-ADR 25687395. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD8813, Expiry date not reported), via an unspecified route of administration on 17Jul2021 (age at vaccination was 34 years) as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation, and suspected covid-19 from 26Jan2021 to an unknown date (unsure when symptoms stopped). None are applicable. Patient tested positive for covid 19 on 26th January 2021 and had very mild symptoms. Patient gave birth in December 2019, was the last medical treatment. She had no conditions and did not take any medication or supplements. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22May2021 as dose 1, single for COVID-19 immunisation dizziness, breast pain female, stomach pain, headache, and stiff neck. The patient experienced joint pain on an unspecified date with outcome of not recovered, painful arm on an unspecified date with outcome of not recovered, high temperature (38.6 Celsius) on 18Jul2021 with outcome of recovered on 19Jul2021, reluctance to eat on an unspecified date with outcome of unknown, sore throat on an unspecified date with outcome of unknown, painful armpit on an unspecified date with outcome of unknown, headaches on an unspecified date with outcome of unknown, dizziness on an unspecified date with outcome of unknown, stomach pains on an unspecified date with outcome of unknown, sharp cramp on an unspecified date with outcome of unknown tired leg on an unspecified date with outcome of unknown, and 2nd dose is outside of the 19-42 day vaccination window on 17Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Jan2021 Yes - Positive COVID-19 test , body temperature: 38.6 centigrade on an unspecified date. The events were assessed as serious, medically significant by the health authority. Narrative case summary and further information: Case Narrative: Painful arm and armpit, Joint pain on the left side of my body (same side as vaccine), Headaches, Dizziness, Stomach pains, Sharp cramp like pains that lasted for days, Tired legs, feeling like they''re full of lactic acid, Sore throat, Temperature with a high of 38.6 Celsius, Reluctance to eat, not nauseous but off food. In case this is relevant. I tested positive got covid on 26th January 2021, 4 months before my first vaccine. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1532698 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, 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 INC202100941555

Write-up: bleeding; cramps; Menstruation abnormal; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202107220638316430-RZSNV, Safety Report Unique Identifier is GB-MHRA-ADR 25691939. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Jul2021 (Batch/Lot number and expiry date were not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history was not reported. It was unsure if patient had symptoms associated with COVID-19. Concomitant medications were not reported. The patient experienced bleeding on 17Jul2021, cramps on 17Jul2021 and menstruation abnormal on 17Jul2021. Period or bleeding and cramps began 2 days after, almost 2 weeks before her period was due. Bleeding had gone on more than 11 days and hadn''t stopped yet. Normal periods for her were only 3 days. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on unknown date. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event menstruation abnormal was unknown. The outcome of events cramps and bleeding was not recovered. All the events were reported as serious-medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1532721 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Body temperature, Chest pain, Dry throat, Dyspnoea, Eye pain, Fatigue, Headache, Nausea, Ocular hyperaemia, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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 Name: temperature; Result Unstructured Data: Test Result:High; Test Date: 20210721; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100941687

Write-up: high temperature; stomachache; Headache; Dry throat; Eyes red; Sore eyes; Difficulty breathing; Tiredness; Nausea; Pain injection site; Chest pain; This is a spontaneous report from a contactable consumer received from the RA. The regulatory authority report number is GB-MHRA-WEBCOVID-202107221015518470-RTFNQ. Safety Report Unique Identifier [GB-MHRA-ADR 25691542]. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 17Jul2021 (Batch/Lot Number: FD5613) (at the age of 27-years-old) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient had no concomitant medications. No medication taken apart from Covid vaccine dose 1. Patient has not had symptoms associated with COVID-19. The patient experienced chest pain and pain injection site on 17Jul2021; tiredness, sore eyes, difficulty breathing and nausea on 18Jul2021, eyes red on 19Jul2021, headache and dry throat on 20Jul2021; high temperature and stomachache on an unspecified date. The events were reported as serious (other medically important condition). The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 21Jul2021, No - Negative COVID-19 test. The clinical course was reported as follows: feeling ok the day of the vaccine however noticed some chest pain on the left side appearing and disappearing rapidly. Severe pain on the injection side during night after vaccine. Extreme tiredness and tired eyes / red eyes experienced from the day after the vaccine and still ongoing 5 days later. Severe headache started 2 days after vaccine and stopped within a day (as reported). Dry throat started 3 days after vaccine and still experienced 5 days after. 1 g of paracetamol taken 3 times a day from the day after the vaccine until 5 days later with no effect on headache, dry throat or tiredness. Light nausea and stomachache experienced during the day. No fever or high temperature experienced (as reported). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of pain injection site was recovered with sequela on 18Jul2021, of the event chest pain was recovered with sequela on 19Jul2021, of the event headache was recovered with sequela on 22Jul2021. The outcome of high temperature and stomachache was recovering while not recovered for the other events. No Follow-up attempts are possible. No further information is expected.


VAERS ID: 1532727 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Bradycardia, Electrocardiogram, Exercise tolerance decreased, Loss of consciousness, Muscular weakness, SARS-CoV-2 test, Sinus tachycardia, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown Results; Test Name: ECG; Result Unstructured Data: Test Result:Sinus bradycardia; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100941633

Write-up: sinus tachycardia; reduced exercise tolerance; Loss of consciousness; Muscle weakness; Blurred vision; Bradycardia; This is a spontaneous report from a contactable physician. This is a report received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107221047445580-WF6T0, Safety Report Unique Identification Number: GB-MHRA-ADR 25691569. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 17Jul2021 (Lot number: not reported) as second dose, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. On 17Jul2021, the patient experienced bradycardia. On 18Jul2021, the patient experienced muscle weakness and blurred vision. On unspecified date, the patient experienced sinus tachycardia, reduced exercise tolerance, loss of consciousness. The patient underwent lab tests and procedures which included blood test: unknown results on unspecified date; electrocardiogram (ECG): sinus bradycardia on unspecified date and covid-19 virus test: no - negative COVID-19 test on unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Unsure if patient is enrolled in clinical trial. Outcome of the events sinus tachycardia, reduced exercise tolerance, loss of consciousness was unknown. Outcome of the events bradycardia, muscle weakness and blurred vision was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1532854 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms started)
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100942912

Write-up: Explosive diarrhea; Fatigue extreme; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107231025081160-PDTOI, Safety Report Unique Identifier GB-MHRA-ADR 25698193. A 22-year-old female (not pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number Fc9001), via an unspecified route of administration, on 16Jul2021 at single dose for COVID-19 immunisation. Relevant medical history included lactation decreased, and suspected COVID-19 from an unknown date to 20Jun2021 (COVID-19 virus test was done on 09Jun2021 and resulted positive). Patient is not enrolled in clinical trial and she is not currently breastfeeding . No relevant concomitant medications were provided. On 17Jul2021, the patient had fatigue extreme. On 18Jul2021, the patient had explosive diarrhea. Both events were assessed serious as medically significant by Health Authority (HA). The patient had not recovered from the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1532879 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-07-17
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Contraceptive cap, Intermenstrual bleeding, Pulmonary embolism, SARS-CoV-2 test, Ultrasound pelvis, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, venous (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 Name: blood tests; Result Unstructured Data: Test Result:Unknown results; Test Name: Dutch test; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201222; Test Name: COVID-19 virus test; Test Result: Positive ; Test Name: pelvic scan; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202100943351

Write-up: vaginal spotting; Pulmonary embolism; Spotting between menses; This is a spontaneous report from a contactable consumer (patient). This report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107231157146470-UWEP6. Safety Report Unique Identifier GB-MHRA-ADR 25698370. A female patient of an unspecified age received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH) via an unspecified route of administration on 28May2021 as dose 1, single for covid-19 immunisation. Medical history included suspected covid-19 from 16Dec2020 to an unknown date (Unsure when symptoms stopped). The patient''s concomitant medications were not reported. The patient experienced vaginal spotting in between menses on an unspecified date, Pulmonary embolism on an unspecified date, spotting between menses on 17Jul2021. She had suffered from clots during menses. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 22Dec2020, Dutch test: unknown results, pelvic scan: unknown results, blood tests: unknown results. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the events vaginal spotting and Pulmonary embolism was unknown, of the event spotting between menses was not recovered. This report was serious with seriousness criteria of medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1532957 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-07-17
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Heavy menstrual bleeding, Menstruation delayed, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100943536

Write-up: Late period; heavier bleeding; bleeding; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number , Safety Report Unique Identifier. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Jun2021 as single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient had not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced bleeding in 2021 with outcome of unknown, late period on 17Jul2021 with outcome of recovered on 23Jul2021, heavier bleeding in 2021 with outcome of unknown. The patient had late period which had never been late before & heavier bleeding. The case was reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unspecified date. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1532979 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Myalgia, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Eosinophilic pneumonia (broad), Tachyarrhythmia terms, nonspecific (narrow), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100943433

Write-up: Heart fluttering; Muscle ache; Painful arm; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107232042366770-5GXA0, Safety Report Unique Identifier is GB-MHRA-ADR 25702225 . A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Jul2021 (Lot number was not reported) at single dose for COVID-19 immunisation (37-year-old at vaccination). Medical history included Lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 for COVID-19 immunisation on unknown date. The patient experienced heart fluttering (cardiac flutter) (medically significant) on 19Jul2021 with outcome of not recovered , muscle ache (myalgia) (medically significant) on 17Jul2021 with outcome of recovered on 21Jul2021, painful arm (pain in extremity) (medically significant) on 17Jul2021 with outcome of recovered on 22Jul2021. The patient underwent COVID-19 virus test: negative on unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1533036 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-17
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Breast pain, Lymphadenopathy, Musculoskeletal chest pain, Pain, Pain in extremity
SMQs:, Lipodystrophy (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: CEFUROXIME; LYMECYCLINE; MELATONIN; NALTREXONE; RIFAMPICIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency; Lactation decreased; Lyme disease; Poor sleep; 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 INC202100942914

Write-up: pain; Shooting pains down left arm and across her breast; Shooting pains down left arm and across her breast; pain radiating over rib cage to my back; pain radiating over left shoulder blade/ stabbing pain in her shoulder; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202107240959411450-DIN2R, Safety Report Unique Identifier GB-MHRA-ADR 25702785. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, as dose 1, single on 03Jul2021 for COVID-19 immunization. Medical history included lactation decreased, immunodeficiency, lyme disease, and poor sleep. Patient is not pregnant nor currently breastfeeding. Concomitant medications included cefuroxime taken for lyme disease from 26Apr202; lymecycline taken for lyme disease from 26Apr2021 to 18Jul2021; melatonin taken for poor sleep from 28Feb2021; naltrexone taken for lyme disease from 28Feb2021; and rifampicin taken for lyme disease from 26Apr2021. The patient experienced swollen lymph nodes on 17Jul2021 and pain on an unspecified date. Additional information was reported as follows: very swollen lymph nodes developed under the left armpit and in left breast. Whole area became extremely painful, inflamed, swollen, hot and tender. Shooting pains down left arm and across her breast. Vaccine was given in left arm. Was given a physical exam by doctor to rule out any other issues and she believes it''s a delayed reaction to the vaccine. Have also had pain radiating across from left breast over rib cage to my back / left shoulder blade and stabbing pain in her shoulder. The events were considered medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient has not recovered from the event, swollen lymph nodes and outcome of the remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1533056 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-17
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Confusional state, Dizziness, Electrocardiogram, Gait disturbance, Headache, Hypoaesthesia, Muscle twitching, SARS-CoV-2 test, Visual impairment
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure test; Result Unstructured Data: Test Result:Unknown result; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown result; Test Name: ECG; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210718; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100942891

Write-up: headache; Muscle twitching; Abnormal vision; Mental confusion/confusion; Difficulty in walking; Body numbness/whole body and face becoming numb; Dizziness/felt faint/dizzy; 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-202107241141157900-JVA5Z. Safety Report Unique Identifier GB-MHRA-ADR 25703117. A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jul2021 (Batch/Lot Number: fe1510) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. On 17Jul2021 (also reported as "6 days ago"), the patient felt faint and light headed, slowly each day symptoms have increased where I cannot even stand up without feeling dizzy, whole body and face becoming numb sometimes, confusion, difficulty walking on 18Jul2021; abnormal vision on 21Jul2021; muscle twitching on 23Jul2021; and headache on an unspecified date. The patient was hospitalized due to the events. Lab data includes blood tests, blood pressure test, ECG with unknown results on an unspecified date; and COVID-19 virus test: No - Negative COVID-19 test on 18Jul2021. The outcome of the event headache was unknown, while not recovered for the rest of the events. No follow-up attempts are possible. No further information is expected


VAERS ID: 1533097 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Migraine, SARS-CoV-2 antibody test
SMQs:, 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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Result Unstructured Data: Test Result:Negative
CDC Split Type: GBPFIZER INC202100942965

Write-up: Migraine; Exhaustion due to exposure; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202107241641012180-ORZTS, Safety Report Unique Identifier is GB-MHRA-ADR 25703242. A 35-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 16Jul2021 (Lot number and expiry date not reported) as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation (lactation decreased). Patient had not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant, Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. Historical vaccine included of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1 single for COVID-19 immunisation. The patient experienced exhaustion due to exposure on 17Jul2021 with outcome of recovering, and migraine on 21Jul2021 with outcome of recovered on 22Jul2021. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: negative on an unspecified date. The events were reported a serious, medically significant. Narrative case summary and further information: Case narrative: Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1533145 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 3003608 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heart rate, Heart rate increased, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: high heart rate; Result Unstructured Data: Test Result:high; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100943382

Write-up: Heart rate high; suspected covid-19; This is a spontaneous report from a contactable consumer. This is a report, received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107242002555900-IB2IR, Safety Report Unique Identifier GB-MHRA-ADR 25703370. A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number 3003608), via an unspecified route of administration, on 17Jul2021 (at the age of 47-year-old) at single dose for COVID-19 immunisation. No relevant medical history was provided. Patient is not enrolled in clinical trial. No relevant concomitant medications were provided. On 17Jul2021, the patient experienced heart rate high (medically significant). It was reported suspected COVID-19 from 17Jul2021. On unknown date, COVID-19 test was done and resulted negative. The patient had recovered from increased heart rate on 18Jul2021 while the outcome of suspected COVID-19 was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1533164 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-17
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Cough, Fatigue, Headache, Hot flush, Malaise, Nasal congestion, Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100943348

Write-up: This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107242143270660-8UHXK. Safety Report Unique Identifier GB-MHRA-ADR 25703489. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Jul2021 (Batch/Lot Number: FD5613) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Lactation decreased, suspected COVID-19 from 21Jul2021 and ongoing. Patient is not pregnant,Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient had developed cold-like symptoms: blocked nose, runny nose, coughing, headaches, fatigue and hot flushes and she had also realized, lost her sense of taste and smell. The patient was currently working from home (a office based role) and had to take numerous breaks throughout work day to take a nap as she often felt too unwell to carry out work tasks. The patient experienced fatigue on an unspecified date with outcome of recovering, unwell on 17Jul2021, which is just over a week afterward with outcome of recovering, hot flushes on an unspecified date with outcome of recovering, runny nose on an unspecified date with outcome of recovering, cold symptoms on 18Jul2021 with outcome of not recovered, loss of taste on 22Jul2021 with outcome of not recovered, loss of smell on 21Jul2021 with outcome of not recovered , hot flush on 19Jul2021 with outcome of not recovered, coughing on 21Jul2021 with outcome of not recovered. Events were Medically Significant. The patient underwent lab tests and procedures which included COVID-19 virus test: on 21Jul2021, No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event blocked nose was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1533174 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Dizziness postural, Muscular weakness, Musculoskeletal stiffness, Nausea, Peripheral coldness, Piloerection, SARS-CoV-2 test, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (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: PROPRANOLOL; QUETIAPINE; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100943039

Write-up: goosebumps; body shaking and going stiff; dizzy; Nauseous; coldness go down the arm, then down the legs; Shaking; Light-headed; Dizzy on standing; Muscle weakness; Chills; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number: GB-MHRA-WEBCOVID-202107242242497040-DFDSA, Safety Report Unique Identifier: GB-MHRA-ADR 25703536. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient was 44-years-old at the time of vaccination. Medical history included lactation decreased, suspected covid-19 from 08Feb2020 to 01May2020. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included propranolol, quetiapine, and sertraline. On 17Jul2021, once patient had the injection, she felt coldness go down the arm, then down the legs and she started shaking. She tried to stand but she felt light-headed and dizzy. She also had muscle weakness, and chills on 17Jul2021. She then had goosebumps on arms and legs on an unspecified date. She laid on the bed with her whole body shaking and going stiff. Her legs felt like jelly and she couldn''t stand. She experienced dizzy and was nauseous on an unspecified date. The events were considered serious: medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. There were no other relevant investigations or tests conducted. The outcome of nauseous, dizzy and goose bumps was recovering, body going stiff was unknown, while the other events recovered on 17Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1533332 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F08813 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Hypoaesthesia, Inappropriate schedule of product administration, Migraine, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100968466

Write-up: mild diarrhea; vomited; numbness in right arm and face; Migraine; Dose 1: 21May2021; Dose 2: 17Jul2021; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: F08813), via an unspecified route of administration, administered in Arm Left on 17Jul2021 15:15 at 26 years old as dose 2 , single for covid-19 immunization. The patient''s medical history was not reported. The patient did not receive any other medications the within 2 weeks of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 (Lot number: E78885) on 21May2021 04:30 pm on the Left Arm for covid-19 immunization. The patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. On 19Jul2021 15:15, 48 hours after, the patient developed migraine starting with numbness in right arm and face. On 19Jul2021 19:15, 4 hours after migraine started the patient vomited. On 20Jul2021 03:15, 12 hours after start of migraine, patient had mild diarrhea. No treatment was given. Dose 1: 21May2021; Dose 2: 17Jul2021. The reporter considered the event numbness in right arm and face as medically significant. The outcome of the events was recovered.


VAERS ID: 1533337 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Headache, Inappropriate schedule of product administration, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ANUSOL [BISMUTH OXIDE;MYROXYLON BALSAMUM VAR. PEREIRAE BALSAM;ZINC OXIDE]; DESLORATADINE; ENANTYUM; IBUPROFEN; RENNIE [CALCIUM CARBONATE;MAGNESIUM CARBONATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Dust allergy; Glandular fever (On his early 30''s, severe.); Haemorrhoids; Heartburn; Hepatitis symptom; Jaundice; Joint pain; Piles; Seasonal allergic rhinitis; Tension headache
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976345

Write-up: Dose 1 on 28May2021 and Dose 2 on 17Jul2021; Chest pain; Muscle ache; Headache; This is a solicited report from the monitoring program from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). This is the second of 2 reports, the first has regulatory authority report number GB-MHRA-YCVM-202105271248009900-OJZOI, Safety Report Unique Identifier GB-MHRA-ADR 25382603. A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot Number: FC9001) dose 2 via an unspecified route of administration on 17Jul2021 (at the age of 35-year-old) as single dose for COVID-19 vaccination. Medical history included mild seasonal allergic rhinitis and dust mite allergy, Haemorrhoids, Tension headache, Joint pain, Heartburn, Piles and Allergic rhinitis. On his early 30''s he had a severe glandular fever, associated with jaundice and other hepatitis symptoms. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medications included bismuth oxide, myroxylon balsamum var. pereirae balsam, zinc oxide (ANUSOL) taken for piles, start and stop date were not reported; desloratadine taken for rhinitis allergic, start and stop date were not reported; dexketoprofen trometamol (ENANTYUM) taken for tension headache, start and stop date were not reported; ibuprofen taken for joint pain, start and stop date were not reported; calcium carbonate, magnesium carbonate (RENNIE) taken for heartburn, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW3143), on 28May2021 for COVID-19 vaccination and experienced arm discomfort from 28May2021 to 30May2021, tiredness from 28May2021 to 30May2021, chills from 28May2021 to 29May2021 and tinnitus from 20Jun2021 and not recovered. The patient was received second dose on 17Jul2021. The patient experienced chest pain on 18Jul2021, headache on 17Jul2021, muscle ache on 18Jul2021. The case was reported as serious due to other medically important condition. The outcome of the event chest pain was not recovered; of the events headache and muscle ache was recovering. Patient was not enrolled in clinical trial. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1533511 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dermatitis bullous
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100944826

Write-up: Following a second Pfizer vaccination for COVID carried out on 16Jul2021, raised stinging blisters were found all over the body for 36 hours.; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the -WEB, regulatory authority number IT-MINISAL02-759127. A 34-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection) via intramuscular on 16Jul2021 (Batch/Lot Number: FF0680) as DOSE 2, 0.3 ml SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 17Jul2021, following the second dose of Pfizer on 16Jul2021, the appearance of raised stinging blisters all over the body for 36 hours - Impact on quality of life (6/10). The outcome of event was recovering.


VAERS ID: 1533536 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7959 / 2 - / OT

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: ITPFIZER INC202100948559

Write-up: SUSPECTED ACUTE PERICARDITIS; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-759812. A 52-year-old female patient received BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: FD7959; Expiration Date: 31Oct2021), dose 2 intramuscularly on 13Jul2021 19:09 as dose 2, 0.3 ML, single for COVID-19 immunization.The patient medical history and concomitant medications were not reported. Historical vaccine includes BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: FC1526; Expiration Date: 30Sep2021), dose 1 intramuscularly on 08Jun2021 as dose 1, single for COVID-19 immunization. It was reported that the patient experienced suspected acute pericarditis on 17Jul2021.Outcome of the event was reported as Unknown at this time of the report. No follow-up attempts possible. No further information expected.


VAERS ID: 1533552 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: 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? 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 INC202100947662

Write-up: Fainting for a few seconds following second administration of Pfizer; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB. A 41-year-old male patient received bnt162b2 (COMIRNATY Solution for injection Batch/Lot Number was not reported), via intramuscularly in arm left on 17Jul2021 as dose 2, 30 ug single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Jul2021, the patient experienced fainting for a few seconds following second administration of Pfizer (blackout). The clinical outcome of the event was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1533616 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-07-17
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100948396

Write-up: Discomfort; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was a female and age were not confirmed, lot number was not confirmed. On 26Jun2021, the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number not confirmed) via an unspecified route of administration as a single dose for COVID-19 immunization. Reaction was reported as follows: The patient received the first vaccination on 26Jun2021, and planned to accepted the second vaccination on 17Jul2021, but the patient was hospitalized and accepted surgery because she felt discomfort in the morning of that day. And after that, the patient was discharged from hospital for the body became to recovering. The patient asked the doctor about the second dose vaccination and was told that it was ok to vaccinate according to the physical condition and vaccination period had exceeded three weeks, the answer seemed a bit perfunctory and the patient was worried about it. It was about 5 weeks from the first inoculation, but does the immune effect get well? The outcome of the event was recovering. Therapeutic measures were taken as a result of discomfort. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1533627 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Blood pressure systolic decreased, Body temperature, Physical deconditioning
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), 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? 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: 20210717; Test Name: Blood pressure; Result Unstructured Data: Test Result:60 mmHg; Comments: at 13:27; Test Date: 20210717; Test Name: Blood pressure; Result Unstructured Data: Test Result:100 - 70 mmHg; Comments: After intravenous drip infusion of SOLU-MEDROL 125 mg, BOSMIN 0.1 mg; Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before the vaccinations
CDC Split Type: JPPFIZER INC202100951722

Write-up: Anaphylaxis; Physical deconditioning; systolic blood pressure decreased to 60 mmHg on palpation; Blood pressure decreased/his blood pressure decreased considerably; This is a spontaneous report from a contactable physician received from the Regulatory Authoriity. Regulatory authority report number is v21121139. This 35-year-old and 5-month-old male patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number: FA7812, Expiration date: 30Sep2021), via intramuscular, on 17Jul2021 at 13:21 (at the age of 35-year-old and 5-month) at single dose for COVID-19 immunisation. On 17Jul2021 (before vaccination), body temperature was 36.6 Centigrade. The patient did not have a relevant medical history and family history. No relevant concomitant medications were provided. On 17Jul2021 at 13:27 (6 minutes after the vaccination), the patient experienced anaphylaxis, physical deconditioning, blood pressure decreased, his systolic blood pressure decreased to 60 mmHg on palpation. After securing vascular access, an intravenous drip infusion of methylprednisolone sodium succinate (SOLU-MEDROL) 125 mg and epinephrine (BOSMIN) 0.1 mg was performed and his blood pressure increased to 100 - 70 mmHg. Ambulance was requested, and the patient was transferred to privacy hospital. The patient presented no dermatological/mucosal symptoms nor respiratory/gastrointestinal symptoms. The events were reported serious as medically significant by Health Authority (HA). The patient had recovered from the events on 17Jul2021. The reporter classified the event ''anaphylaxis'' as serious (medically significant) and assessed the causality between the event and the vaccines as related. There is no other possible cause of the event such as any other diseases. The reporter''s comments: Given that the symptom appeared in a short time after vaccination and his blood pressure decreased considerably, it was highly likely that the patient developed anaphylaxis. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1535701 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site reaction, Malaise, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), 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? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210807763

Write-up: REACTION AT THE INJECTION SITE; COLD CHILLS; JOINT PAIN; FEELING UNWELL; MUSCLE PAIN; FEVER; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, BE-FAMHP-DHH-N2021-101979] concerned a 20 year old female of unspecified race and ethnicity. The patient''s weight was 63 kilograms, and height was 171 centimeters. 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: 21C14-02 expiry: UNKNOWN) dose was not reported, 1 total administered on 16-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-JUL-2021, the patient experienced reaction at the injection site, cold chills, joint pain, feeling unwell, muscle pain, fever, headache, fatigue, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from reaction at the injection site, cold chills, joint pain, feeling unwell, muscle pain, fever, headache, fatigue, and nausea on 18-JUL-2021. This report was serious (Disability Or Permanent Damage).; Sender''s Comments: V0: 20210807763-COVID-19 VACCINE AD26.COV2.S-reaction at the injection site. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210807763-COVID-19 VACCINE AD26.COV2.S-cold chills, joint pain, feeling unwell, muscle pain, fever, headache, fatigue, and nausea. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1535751 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Musculoskeletal chest pain, Nausea, Vertigo
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210814528

Write-up: BREATH SHORTNESS; VERTIGO; INTERCOSTAL PAIN; NAUSEA; This spontaneous report received from a pharmacist via a Regulatory Authority (EMEA EVHUMAN NLP, FR-AFSSAPS-BR20212945) concerned a 57 year old female. The patient''s weight was 58 kilograms, and height was 160 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C14-03, expiry: unknown) 1 dosage forms, 1 total administered on 16-JUL-2021 for covid-19 vaccination. Drug start period was 1 day. Drug last period was 1 day. No concomitant medications were reported. On 17-JUL-2021, the patient experienced breath shortness, vertigo, intercostal pain and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from breath shortness, nausea, vertigo, and intercostal pain. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210814528- covid-19 vaccine ad26.cov2.s -BREATH SHORTNESS,VERTIGO ,INTERCOSTAL PAIN. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210814528- covid-19 vaccine ad26.cov2.s -NAUSEA. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1535755 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

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: FRJNJFOC20210808727

Write-up: CEREBROVASCULAR ACCIDENT; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, FR-AFSSAPS-LL20215116] concerned a 74 year old male of unknown race and ethnicity. The patient''s weight was 57.8 kilograms, and height was 167 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) 1 dosage forms,1 total, administered on 16-JUL-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 17-JUL-2021, the patient experienced cerebrovascular accident, and was hospitalized (date and days unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cerebrovascular accident. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210808727-covid-19 vaccine ad26.cov2.s-cerebrovascular accident. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1537761 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9095 / UNK RA / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Heart rate irregular, Hypertension, Hypoaesthesia, Neck pain, Pain, Retching
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Sexual dysfunction (broad)

Life Threatening? Yes
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: BRPFIZER INC202100977389

Write-up: diarrhea; numbness all over arm; high blood pressure; retching; severe pain in the body and neck; severe pain in the body and neck; strong heartbeat, felt heart in throat; This is a spontaneous report from a contactable consumer, reporting for herself, received through regulatory authority. A 42-year-old female patient received bnt162b2 (COMIRNATY; Lot Number: FA9095), via an unspecified route of administration in the right arm on 17Jul2021 at 14:00 at a single dose for covid-19 immunisation. The patient history was not reported. There were no concomitant medications. On 17Jul2021, the patient experienced diarrhea, numbness all over arm, high blood pressure, retching, severe pain in the body and neck, and strong heartbeat, felt heart in throat, which was serious for disability (permanent damage) and life-threatening (immediate risk of death due to the event). The patient described the events as things never had in life, but its been since vaccination. Therapeutic measures were unknown. The clinical outcome of the events was not recovered. There was no COVID-19 prior to or post vaccination. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1537833 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Depressed level of consciousness, Generalised tonic-clonic seizure, Oxygen saturation
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: blood pressure; Result Unstructured Data: Test Result:120/80 mmHg; Test Date: 20210717; Test Name: Oxygen saturation; Test Result: 97 %
CDC Split Type: CYPFIZER INC202100965916

Write-up: Consciousness decreased; tonic-clonic seizures; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number CY-CYPPVPR-19072KK1. A 26-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: UNKNOWN), via intramuscular route of administration on 17Jul2021 13:00 (Age at vaccination: 26-years-old) as dose number unknown, 0.3 ml single for covid-19 immunization. No medical history and no concomitant medications were not reported. On 17Jul2021 13:05 patient experienced consciousness decreased, tonic-clonic seizures. The patient underwent lab tests and procedures which included blood pressure measurement: 120/80 mmhg on 17Jul2021, oxygen saturation: 97 percent on 17Jul2021. The outcome for the events was resolved on 17-JUL-2021 13:10. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.


VAERS ID: 1537892 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-07-17
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100979076

Write-up: peripheral facial palsy on the left; 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-202100148176. A 38-years-old male patient received bnt162b2 (COMIRNATY, solution for injection; Batch/Lot number: Not reported) via intramuscular on 09Jun2021 at the age of (at the age of 38-years-old) as second dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 17Jul2021, the patient experienced peripheral facial palsy on the left. The outcome of the event was not recovered. Drug-reaction / Event Matrix : Relatedness of drug to reaction/event Source of assessment Result of Assessment: D. Unclassifiable No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1537896 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-17
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Cerebral venous sinus thrombosis, Fibrin D dimer, Magnetic resonance imaging head
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (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: Test Name: venous MR angiography; Result Unstructured Data: Test Result:Sinus vein thrombosis; Comments: supported by; Test Name: D-dimers; Result Unstructured Data: Test Result:increased; Comments: in the laboratory; Test Name: MRI head; Result Unstructured Data: Test Result:Sinus vein thrombosis; Comments: supported by
CDC Split Type: DEPFIZER INC202100987755

Write-up: Thrombosis of venous sinuses; This is a spontaneous report from a non contactable consumer or other non health professional downloaded from the regulatory authority-WEB DE-PEI-202100148316. A 19-years-old female patient received BNT162b2 (COMIRNATY, solution for injection, Lot Number: Unknown), via an intramuscular route on 08Jul2021 (at the age of 19-years) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Jul2021, the patient experienced thrombosis of venous sinuses. The patient underwent lab tests and procedures which included MRI head, venous MR angiography shows sinus vein thrombosis supported by, increased D-dimers in the laboratory. The outcome of event was not recovered. Sender Comment: Sinus vein thrombosis supported by MRI head, venous MR angiography, increased D-dimers in the laboratory. A cerebral mass, bleeding and cerebral infarction were excluded. Batch/lot number: [UNK] (UNKNOWN) Relatedness of drug to reaction(s)/event(s) Cerebral venous sinus thrombosis assessed by Agency as B. Indeterminate. No follow-up attempts possible. No further information expected. Batch/Lot numbers can not be obtained.


VAERS ID: 1538114 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Constipation, Gastrointestinal pain, Headache, Hot flush, Nausea, Paraesthesia, Reactogenicity event
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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: Menopause
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100954701

Write-up: Reactogenicity event; Nausea with blocking sensation of the stomach; intestinal pain with diffusion in the back with high constipation; intestinal pain with diffusion in the back with high constipation; exacerbated hot flashes; headache; tingling in the fingers, legs and feet; pain in the left knee bent even when lying down; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LL20214892. A 45-years-old female patient received bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: FE2296), via an unspecified route of administration on 15Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included ongoing menopause. The patient''s concomitant medications were not reported. On 17Jul2021, the patient experienced reactogenicity event, nausea with blocking sensation of the stomach, intestinal pain with diffusion in the back with high constipation, intestinal pain with diffusion in the back with high constipation, exacerbated hot flashes, headache, tingling in the fingers, legs and feet, pain in the left knee bent even when lying down. The outcome of the events was not recovered. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1538219 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Insomnia, 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: Rheumatoid arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101018488

Write-up: excruciating pain, lack of sleep and since severe pain put on cortisone/arthritis attacks; lack of sleep; This is a spontaneous report from a contactable pharmacist. This is the second of two reports. The first report is a report downloaded from the regularly authority - FR-AFSSAPS-RS20212418. A 73-year-old female patient received the second dose of BNT162B2 (COMIRNATY; lot number: FE2296), intramuscular on 14Jul2021 (at an unspecified age) at dose 2, single for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. It was not informed if the patient has COVID-19 history. The patient''s concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (COMIRNATY) received on Jun2021 for COVID-19 immunisation and experienced exacerbation of the polyarthritis crisis. From the first injection, reaction ++ but bearable (rheumatoid arthritis flare up). On 17Jul2021 and 18Jul2021, the patient experienced excruciating pain, and lack of sleep. Due to the severe pain, the patient was put on cortisone. The patient experienced arthritis attacks after the first and second BNT162B2 (COMIRNATY) injections. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-AFSSAPS-RS20212418 AFSSAPS


VAERS ID: 1538244 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-07-17
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Menstruation delayed, Pregnancy test
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: Test Name: Pregnancy test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100956582

Write-up: Late period - never had a late period, tested and I am not pregnant.; This is a spontaneous report from a contactable consumer. This report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-EYC 00256981. Safety Report Unique Identifier GB-MHRA-ADR 25702780. This consumer reported that the 27-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, Lot Number was not reported), via an parenteral on 23Jun2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 17Jul2021 the patient had late period, and she never had a late period, tested and she was not pregnant. the patient stated that, I will be contacting my doctor if I miss my second period and I will log it on here. The patient underwent lab tests and procedures which included pregnancy test was negative on an unknown date. The event was reported as eventually medically significant. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1538293 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Headache, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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:
CDC Split Type: GBPFIZER INC202100943605

Write-up: nauseous; Dizziness; Shortness of breath; Headache; Nausea; This is a spontaneous report from a contactable consumer received from . The regulatory authority report number is GB-MHRA-WEBCOVID-202107242039580620-Y9QY0. Safety Report Unique Identifier GB-MHRA-ADR 25703423. A 40-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: FD8813), dose 2 via an unspecified route of administration on 15Jul2021 as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No medical issues Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient experienced nauseous on an unspecified date. On 17Jul2021, the patient experienced dizziness, shortness of breath, headache, nausea. Had a suffocating feeling two days after Pfizer. Could not breathe and went to A&E where his blood pressure and heart beat were fine and was let go home. Ever since then he have had dizziness, headaches and feeling nauseous and tired. Seven days now and no signs of it getting better. He was a fit individual with no known underlying issues so it was worrying. Having blood tests next week. The outcome of the event nausea occured on an unspecified date was reported as unknown and outcome of all the other events was reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1538510 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Vertigo
SMQs:, Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100956802

Write-up: Vertigo; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number {GB-MHRA-WEBCOVID-202107260912010670-JP3CE} Safety Report Unique Identifier {GB-MHRA-ADR 25705525}. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2, via an unspecified route of administration on 16Jul2021 (Batch/lot number: Not Known, Expiration Date: not reported), as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for covid-19 immunisation. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. On 17Jul2021 patient experienced vertigo. The event was considered serious as other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The outcome of the 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: 1538910 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity, Oedema, Oral discomfort, Oropharyngeal discomfort, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: JPPFIZER INC202100952164

Write-up: Allergy reaction; lip and pharynx strange sensation of; lip and pharynx strange sensation of; oedema; itching; This is a spontaneous report from a contactable physician received from the Regulatory Authority . Regulatory authority report number is v21120888. A 51-year and 10-month-old female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN; Lot number and expiry date not reported), via an unspecified route of administration on 17Jul2021 09:00 (at the age of 51-years-old) as dose 1, single for COVID-19 immunization. The patient''s medical history was not reported. The patient had no family history. The patient''s concomitant medications were not reported. On 17Jul2021 at 11:30, the patient experienced allergic reaction, lip and pharynx strange sensation of, edema and itching. The course of the event was as follows: On 17Jul2021 at 9:00 (the day of vaccination), the patient received the first dose of the COVID-19 vaccine at the upper record facility. The patient was asymptomatic after 15 minutes observation and went home. Afterwards, the patient ate at the restaurant. After eating, the patient felt lip and pharynx strange sensation of, oedema and itching, and visited the hospital. Although the patient''s condition was stable, The patient was diagnosed with allergy reaction and after receiving intravenous steroid, MEYLON Infusion the symptoms improved and the patient went home. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. Other possible causes of the event such as any other diseases was eating out after vaccination, the possibility of allergy caused by food. On 17Jul2021 (the day of vaccination), the outcome of the event was recovering. The reporting physician commented as follows: Patients with no known history of allergy were considered to have had an allergic reaction approximately two hours after vaccination. The administration of the second dose of vaccine hopes to be discontinued.


VAERS ID: 1538952 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Feeling abnormal, Heart rate, Oxygen saturation
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Hypertension (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: ZACRAS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: BP; Result Unstructured Data: Test Result:177/82; Comments: at 17:08; Test Date: 20210717; Test Name: BP; Result Unstructured Data: Test Result:123/75; Comments: at 17:13; Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210717; Test Name: P; Result Unstructured Data: Test Result:70; Comments: at 17:08; Test Date: 20210717; Test Name: P; Result Unstructured Data: Test Result:63; Comments: at 17:13; Test Date: 20210717; Test Name: SpO2; Test Result: 97 %; Comments: at 17:08
CDC Split Type: JPPFIZER INC202100954075

Write-up: BP: 177/82; Feels poorly; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21121181. A 54-year-old ("54-year and 7-month-old") female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 17Jul2021 17:00 (Lot Number: EY0583; Expiration Date: 31Oct2021) as single dose (at the age of 54-years-old) for COVID-19 immunization. Medical history included hypertension. Concomitant medication included amlodipine besilate, azilsartan (ZACRAS) taken for hypertension, start and stop date were not reported. On 17Jul2021 at 17:00 (the same day after the vaccination), the patient experienced Feels poorly. The course of the event was as follows: After vaccination, the patient complained of Feels poorly. The symptom improved during course observation. At 17:08 BP: 177/82, P 70 SpO2 97%. At 17:13 BP: 123/75, P 63. The patient experienced BP: 177/82 on 17Jul2021 17:08 and feels poorly on 17Jul2021. The patient underwent lab tests and procedures which included blood pressure measurement: 177/82 on 17Jul2021 (at 17:08), blood pressure measurement: 123/75 on 17Jul2021 (at 17:13), body temperature: 36.4 centigrade on 17Jul2021 (before vaccination), heart rate: 70 on 17Jul2021 (at 17:08), heart rate: 63 on 17Jul2021 (at 17:13), oxygen saturation: 97 % on 17Jul2021 (at 17:08). On 17Jul2021 (the same day after the vaccination), the outcome of the event Feels poorly was recovered. The event BP: 177/82 was recovered on 17Jul2021 17:13. 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.


VAERS ID: 1539009 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-17
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RHEUMATREX [METHOTREXATE]; SMYRAF; AZILVA; ALFAROL; ADALAT; CELECOX; NEUROTROPIN [RABBIT VACCINIA EXTRACT]; FOLIAMIN [FOLIC ACID]; PARIET
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100965457

Write-up: Cerebral infarction; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 78-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 02Jul2021, at the age of 78-years-old, (Batch/Lot number was not reported) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis. Concomitant medications included methotrexate (RHEUMATREX) taken for rheumatoid arthritis, start and stop date were not reported; peficitinib hydrobromide (SMYRAF) taken for an unspecified indication, start and stop date were not reported; azilsartan (AZILVA) taken for an unspecified indication, start and stop date were not reported; alfacalcidol (ALFAROL) taken for an unspecified indication, start and stop date were not reported; nifedipine (ADALAT) taken for an unspecified indication, start and stop date were not reported; celecoxib (CELECOX) taken for an unspecified indication, start and stop date were not reported; rabbit vaccinia extract (NEUROTROPIN) taken for an unspecified indication, start and stop date were not reported; folic acid (FOLIAMIN) taken for an unspecified indication, start and stop date were not reported; rabeprazole sodium (PARIET) taken for an unspecified indication, start and stop date were not reported. The patient experienced cerebral infarction on 17Jul2021. The patient was hospitalized for cerebral infarction (cerebral infarction) from 17Jul2021 to an unknown date. The outcome of the event was unknown. The reporting physician classified the event as serious (Hospitalized) and assessed that the event was possibly related to BNT162b2. Information regarding lot/batch number was requested.; Sender''s Comments: Based on a temporal association, a contributory role of BNT162B2 to the event cerebral infarction cannot be completely excluded. However, the concomitant medications of azilsartan and nifedipine indicated preexisting cardiovascular risk factors that confounded the causality assessment. 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: 1539169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-07-17
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8889 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Foramen ovale patent
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202100954824

Write-up: BRAIN INFARCTION; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number NO-NOMAADVRE-FHI-2021-U95mep. A 40-years-old female patient received BNT162B2 (COMIRANTY; Solution for injection; Batch/Lot Number: FC8889), dose 1 intramuscular on 28May2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history foramen ovale patent included, which was identified during examination of the patient after the adverse event (/Jul2021). Concomitant medication was not reported. On 17Jul2021, the patient developed brain infarction. The reporter comments that 1/4 of the population have patent foramen ovale and that it rarely causes brain infarction. The case was considered to be serious. The outcome of the event was recovering. assessed the causal relationship between BNT162B2 (CO-MIRNATY) and all the reported events as Possible. No follow-up attempts possible. No further information expected.


VAERS ID: 1539973 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic thrombosis
SMQs:, Embolic and thrombotic events, arterial (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: Comments: Hypertension treated by Candesartan. Active smoking .History of Covid-19: Unknown. History of PCR test : Yes, negative on 22/07/2021 .Unknown allergic history
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210814918

Write-up: AORTA THROMBOSIS; This spontaneous report received from a pharmacist via a Regulatory Authority (EMEA EVHUMAN NLP, FR-AFSSAPS-CN20212460) concerned a 60 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Hypertension treated by Candesartan, active smoking, unknown history of Covid-19, history of PCR test, negative on 22-JUL-2021,unknown allergic history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C14-03, expiry: unknown) 1 dosage forms, 1 total administered on 02-JUL-2021 for covid-19 vaccination. Drug start period was 16 days. Drug last period was 16 days. No concomitant medications were reported. On 17-JUL-2021, the patient experienced aorta thrombosis and was hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aorta thrombosis. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender''s Comments: V0: 20210814918-COVID-19 VACCINE AD26.COV2.S-aorta thrombosis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1541178 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-07-17
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Cardio-respiratory arrest, Computerised tomogram head, Magnetic resonance imaging heart, Myocarditis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Coronary angiography; Result Unstructured Data: Test Result:normal; Test Name: brain CT scan; Result Unstructured Data: Test Result:normal; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:semi-recurrent myocarditis
CDC Split Type: FRPFIZER INC202100987878

Write-up: Cardio-respiratory arrest; Myocarditis; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority number FR-AFSSAPS-BX20216956. A 56-year-old male patient received the second dose of bnt162b2 (COMIRNATY), via intramuscular on 13May2021 (lot number: FA4598) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not provided. No history of Covid. The patient previously received the first dose of bnt162b2 (COMIRNATY), on Apr2021 as single dose for COVID-19 immunisation. It was reported 2 months after dose 2, patient experienced cardiopulmonary arrest resuscitated by external electric shock on 17Jul2021 (life-threatening and hospitalization), myocarditis on 17Jul2021 (hospitalization). Lab data included on unspecified date coronary angiography was normal; brain CT (computed tomography) scan was normal; cardiac MRI (magnetic resonance imaging): semi-recurrent myocarditis. Therapeutic measures were taken as a result of cardiopulmonary arrest. Outcome of events was recovering. Note: Imputation made without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable procedures of compensation. No follow-up attempts are possible, no further information is expected.


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