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From the 7/23/2021 release of VAERS data:

Found 506,830 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 261 out of 5,069

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VAERS ID: 1398621 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Hyperpyrexia, Malaise, Myalgia, Nausea
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? 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: 20210602; Test Name: Hyperpyrexia; Result Unstructured Data: Fever: 40.5 to 42 degrees Celsius
CDC Split Type: NLJNJFOC20210619337

Write-up: FEVER: 40.5 TO 42 DEGREES CELSIUS; FEELING UNWELL; JOINT PAIN; COLD CHILLS; MUSCLE PAIN; NAUSEA; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00565760] concerned a 53 year old female. The patient''s weight was 90 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, route of admin not reported, batch number: XD985 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 02-JUN-2021, the patient experienced fever: 40.5 to 42 degrees celsius, feeling unwell, joint pain, cold chills, muscle pain, nausea, headache. Laboratory data included: Hyperpyrexia (NR: not provided) Fever: 40.5 to 42 degrees Celsius. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold chills, and headache on 03-JUN-2021, was recovering from fever: 40.5 to 42 degrees celsius, and nausea, and had not recovered from muscle pain, feeling unwell, and joint pain. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210619337-covid-19 vaccine ad26.cov2.s-fever: 40.5 to 42 degrees Celsius. 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: 1400612 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Body temperature increased, Fatigue, Muscle discomfort, Muscle fatigue, Muscle hypertrophy, Oxygen saturation, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Date: 20210603; Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Date: 20210602; Test Name: saturation; Result Unstructured Data: Test Result:normal; Test Date: 20210603; Test Name: saturation; Result Unstructured Data: Test Result:normal
CDC Split Type: ESPFIZER INC2021676129

Write-up: Slight discomfort in the left pectoralis minor muscle; muscular hypertrophy; weakness; fatigue; muscle fatigue; pain in the puncture area; Increased body temperature of arms and legs; This is a spontaneous report from a contactable consumer (patient) or other non HCP. A male patient of an unspecified age received bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot number and Expiration date was not reported)), dose 2 via an unspecified route of administration, administered in the left arm on 02Jun2021 09:10 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Jun2021 at 22: 00hr, patient experienced pain in the puncture area, increased body temperature of arms and legs. No fever, blood pressure and saturation were normal. On 03Jun2021 at 7: 30hr, patient experienced weakness, fatigue and muscle fatigue. The patient stated that to the touch, the muscles of the extremities lacked the usual bulk. No fever, blood pressure and saturation were normal. On 03Jun2021 at 20: 00hr, patient experienced muscular hypertrophy after a short 1km walk. The patient reported that there was dramatically increased in muscle definition, above usual, like after a gym session. No fever, blood pressure and saturation were normal. On 04Jun2021 at 08: 00hr, patient experienced slight discomfort in the left pectoralis minor muscle that apparently remitted. The patient underwent lab tests and procedures which included blood pressure, saturation normal on 2jan2021 and 3 jan2021. The outcome of event fatigue and weakness were recovered On 03Jun2021, at 14:00hr. while pain in the puncture area recovered 04Jun2021 at 08: 00hr. The outcome of the events muscular hypertrophy, increased body temperature of arms and legs and muscle fatigue was unknown and slight discomfort in the left pectoralis minor muscle was recovering.


VAERS ID: 1401171 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse
SMQs:, Anaphylactic reaction (narrow), 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), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210622290

Write-up: COLLAPSE; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, IT-MINISAL02-739494] concerned a 30 year old male with unknown ethnicity and race. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD955 expiry: UNKNOWN) dose was not reported, 1 total administered on 02-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 02-JUN-2021; at 20:25, the patient had collapse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from collapse on 02-JUN-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Reaction Time: 20:25 - Sent by VigiCovid19-data sheet.; Sender''s Comments: V0 - 20210622290 - Covid-19 vaccine ad26.cov2.s - COLLAPSE. 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: 1401985 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dermal cyst
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hidradenitis suppurativa; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Skin cysts; This regulatory authority case was reported by a consumer and describes the occurrence of DERMAL CYST (Skin cysts) in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Hidradenitis suppurativa and Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced DERMAL CYST (Skin cysts) (seriousness criterion medically significant). At the time of the report, DERMAL CYST (Skin cysts) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Concomitant information were not provided. The patient reported that she had the vaccine in her right arm. Her skin is flaring very badly on the right side of her body, worse than normal. Patient has not tested positive for COVID-19 since having the vaccine. 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: 1404100 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210523; Test Name: Serology test; Result Unstructured Data: Negative; Test Date: 20210602; Test Name: Serology test; Result Unstructured Data: Negative
CDC Split Type: FRJNJFOC20210621101

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age, unspecified ethnic origin and race. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAY-2021, Laboratory data included: Serology test (NR: not provided) Negative. On 02-JUN-2021, Laboratory data included: Serology test (NR: not provided) Negative. On 02-JUN-2021, the patient experienced confirmed immunological vaccine failure. Two serological tests (unspecified) prescribed by health care professional to patient were carried out on day D + 25, then on day D + 35. They remained negative and no presence of antibodies appeared. 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 report was associated with product quality complaint: 90000182314 The suspected product quality complaint has been confirmed to be Void. evaluation/investigation performed.; Sender''s Comments: V0: 20210621101-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: 1404120 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse drug reaction, Body temperature, Chills, Cough, Dizziness, Eye pain, Headache, Malaise, Nausea, Neck pain, Pain, Polymerase chain reaction, Pyrexia, SARS-CoV-2 test, Sensitive skin, Tension headache, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Arthritis (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: SERETIDE; VENTOLIN [SALBUTAMOL SULFATE]
Current Illness: Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Temperature spikes of 88.4; Test Date: 20210603; Test Name: PCR; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210606; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: headache; dizziness; unwell; Dry cough/persistent cough; Wheezing; Sensitivity to light; Headache tension; shivering; Fever; Aching eye socket; Sensitivity to light; Neck pain; Body aches; Nausea; This regulatory authority case was reported by a consumer and describes the occurrence of EYE PAIN (Aching eye socket) and ADVERSE DRUG REACTION (Sensitivity to light) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (SERETIDE) and SALBUTAMOL SULFATE (VENTOLIN [SALBUTAMOL SULFATE]) for Asthma. On 30-May-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced NAUSEA (Nausea). On 03-Jun-2021, the patient experienced CHILLS (shivering). 03-Jun-2021, the patient experienced PYREXIA (Fever), EYE PAIN (Aching eye socket) (seriousness criterion medically significant), ADVERSE DRUG REACTION (Sensitivity to light) (seriousness criterion medically significant), NECK PAIN (Neck pain), PAIN (Body aches) and TENSION HEADACHE (Headache tension). On 04-Jun-2021, the patient experienced SENSITIVE SKIN (Sensitivity to light). On 05-Jun-2021, the patient experienced COUGH (Dry cough/persistent cough) and WHEEZING (Wheezing). On an unknown date, the patient experienced HEADACHE (headache), DIZZINESS (dizziness) and MALAISE (unwell). On 04-Jun-2021, PYREXIA (Fever) and ADVERSE DRUG REACTION (Sensitivity to light) had resolved. On 07-Jun-2021, NAUSEA (Nausea) had not resolved. At the time of the report, CHILLS (shivering), HEADACHE (headache), DIZZINESS (dizziness), MALAISE (unwell) and EYE PAIN (Aching eye socket) was resolving and NECK PAIN (Neck pain), PAIN (Body aches), COUGH (Dry cough/persistent cough), TENSION HEADACHE (Headache tension), WHEEZING (Wheezing) and SENSITIVE SKIN (Sensitivity to light) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Body temperature: (High) Temperature spikes of 88.4. On 03-Jun-2021, Polymerase chain reaction: (Negative) Negative. On 06-Jun-2021, SARS-CoV-2 test: (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient also had three lateral flow test at home and all were negative. No treatment medication 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: 1404336 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoaesthesia, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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
Allergies:
Diagnostic Lab Data: Test Date: 20210109; 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: Feeling mouth; Numbness; This regulatory authority case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness) and NAUSEA (Feeling mouth) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced HYPOAESTHESIA (Numbness) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (Feeling mouth) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA (Numbness) had not resolved and NAUSEA (Feeling mouth) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, SARS-CoV-2 test: unknown (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided by the reporter. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1404343 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Dissociation, Hyperhidrosis, Muscle spasms, Pallor, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Test Result: Negative ; Result Unstructured Data: Patient has not tested positive for COVID-19 since having the vaccine
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Stomach cramps; Colour was draining from face and felt light headed; Diarrhea; Cramps; Sweating; Pale; This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramps), DISSOCIATION (Colour was draining from face and felt light headed), DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps), HYPERHIDROSIS (Sweating) and PALLOR (Pale) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant), MUSCLE SPASMS (Cramps) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant) and PALLOR (Pale) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) (seriousness criterion medically significant) and DISSOCIATION (Colour was draining from face and felt light headed) (seriousness criterion medically significant). On 02-Jun-2021, DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweating) and PALLOR (Pale) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramps) and DISSOCIATION (Colour was draining from face and felt light headed) outcome was unknown and MUSCLE SPASMS (Cramps) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Patient has not tested positive for COVID-19 since having the vaccine. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided by the reporter. Concomitant product use was not provided by the reporter. Awoke early hours of morning feeling extremely nauseous followed by severe diarrhea and stomach cramps. Went in between hot and cold sweats. Color was draining from face and felt light headed, very poorly. Continued from no more than an hour. The following day followed loss of appetite and sore heavy arm. 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: 1404347 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Myalgia, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Painful arm; Muscle ache; Tiredness; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), MYALGIA (Muscle ache) and FATIGUE (Tiredness) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No Medical History information was reported. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm), MYALGIA (Muscle ache) and FATIGUE (Tiredness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. The treatment information was not provided. company comment Based on the current available information and temporal association between the use of the product and the start date of the 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: 1404352 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Fatigue, Hyperhidrosis, Pain in extremity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: 8 hours after vaccine; Stomachache; Excess sweating; Painful arm; Tiredness; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (8 hours after vaccine), ABDOMINAL PAIN UPPER (Stomachache), HYPERHIDROSIS (Excess sweating), PAIN IN EXTREMITY (Painful arm) and FATIGUE (Tiredness) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included PARACETAMOL from 02-Jun-2021 to an unknown date for Stomachache. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache) (seriousness criterion medically significant), HYPERHIDROSIS (Excess sweating) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced SYNCOPE (8 hours after vaccine) (seriousness criterion medically significant). At the time of the report, SYNCOPE (8 hours after vaccine), ABDOMINAL PAIN UPPER (Stomachache), HYPERHIDROSIS (Excess sweating), PAIN IN EXTREMITY (Painful arm) and FATIGUE (Tiredness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Treatment medications were not reported. The patient stated that, her sore arm gradually got worse through the day and injection sight very painful 8 hours after vaccine. She started to feel very tired, had stomach pains bad enough to take paracetamol. She felt generally awful, slept for around 8 hours waking to heavy sweating She had not tested positive for COVID-19 since having the vaccine. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1404354 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Dysmenorrhoea, Exposure during pregnancy, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: miscarriage; painful period; Exposure during Pregnancy; Vaginal bleeding; This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (miscarriage) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Jun-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding). On an unknown date, the patient experienced ABORTION SPONTANEOUS (miscarriage) (seriousness criterion medically significant), DYSMENORRHOEA (painful period) and EXPOSURE DURING PREGNANCY (Exposure during Pregnancy). The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (miscarriage) and DYSMENORRHOEA (painful period) was resolving, VAGINAL HAEMORRHAGE (Vaginal bleeding) had not resolved and EXPOSURE DURING PREGNANCY (Exposure during Pregnancy) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant product use was reported. No treatment information was provided. The patient reported that, usually she has very regular periods but her period started 6 days before expected, ~36 hours after the 1st vaccine dose (Moderna). She also believed she may have conceived this month and this may be a very early miscarriage but there''s no way to prove that. Company Comment : This is a case of product exposure during pregnancy with associated AEs for this 35-year-old female. No further information is expected.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AEs for this 35-year-old female. No further information is expected.


VAERS ID: 1404363 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, Headache, Nausea
SMQs:, Acute pancreatitis (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRAMADOL
Current Illness: Nerve pain
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Nausea; Fatigue; Diarrhea; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), FATIGUE (Fatigue), DIARRHOEA (Diarrhea) and HEADACHE (Headache) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Nerve pain. Concomitant products included TRAMADOL from 06-May-2021 to an unknown date for Nerve pain. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) had not resolved and DIARRHOEA (Diarrhea) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, 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: 1404373 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cold sweat, Headache, 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), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERETIDE
Current Illness: Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Next day generally feeling rubbish; Feverish; Nausea; Fever; Cold sweats; Headache; Muscle ache; This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (Next day generally feeling rubbish), COLD SWEAT (Cold sweats), HEADACHE (Headache), MYALGIA (Muscle ache), PYREXIA (Feverish), PYREXIA (Fever) and NAUSEA (Nausea) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (SERETIDE) for Asthma. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced COLD SWEAT (Cold sweats) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (Next day generally feeling rubbish) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). On 03-Jun-2021, MYALGIA (Muscle ache) had resolved. At the time of the report, MALAISE (Next day generally feeling rubbish), PYREXIA (Feverish), PYREXIA (Fever) and NAUSEA (Nausea) had not resolved, COLD SWEAT (Cold sweats) outcome was unknown and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. After vaccine (received 8.30am) the patient reported that her arm started aching and that she had a sore head. That night, she was feverish which disturbed her sleep and she reported cold sweats. The next day she reported she was "generally feeling rubbish" and that her arm was not as sore. The next day, she reported waking up feeling very nauseous, which came in waves with hot flushes. She stated that her head still felt sore, though not as bad. She went in to work but was sent home after an hour. No treatment information was reported. It was reported that patient has not tested positive for COVID-19 since having the vaccine. 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: 1404374 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Illness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; PARACETAMOL
Current Illness: Neck pain
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Sickness; Dizzy spells/dizziness; Tired all the time/tiredness; muscle pain; This regulatory authority case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), DIZZINESS (Dizzy spells/dizziness), FATIGUE (Tired all the time/tiredness) and MYALGIA (muscle pain) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Neck pain. Concomitant products included IBUPROFEN and PARACETAMOL for Neck pain. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced FATIGUE (Tired all the time/tiredness) (seriousness criterion medically significant) and MYALGIA (muscle pain) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced DIZZINESS (Dizzy spells/dizziness) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant). At the time of the report, ILLNESS (Sickness) and DIZZINESS (Dizzy spells/dizziness) had not resolved and FATIGUE (Tired all the time/tiredness) and MYALGIA (muscle pain) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Treatment information was not reported. The patient did not have symptoms associated with COVID-19. Not had a COVID-19 test. The patient was not enrolled in clinical trial. The patient was not currently breastfeeding. The patient did not tested positive for COVID-19 since having the vaccine. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1404376 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Episcleritis, Eye pain, Headache, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Scleral disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: eye pain; blurred vision; headache; Episcleritis; This regulatory authority case was reported by a consumer and describes the occurrence of EPISCLERITIS (Episcleritis), EYE PAIN (eye pain), VISION BLURRED (blurred vision) and HEADACHE (headache) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced EPISCLERITIS (Episcleritis) (seriousness criterion medically significant). On an unknown date, the patient experienced EYE PAIN (eye pain) (seriousness criterion medically significant), VISION BLURRED (blurred vision) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). At the time of the report, EPISCLERITIS (Episcleritis) had not resolved and EYE PAIN (eye pain), VISION BLURRED (blurred vision) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1404381 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: OMEPRAZOLE
Current Illness: Esophageal acid reflux
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Headache; Fever; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache) and PYREXIA (Fever) in a 31-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Esophageal acid reflux. Concomitant products included OMEPRAZOLE for Esophageal acid reflux. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm) and PYREXIA (Fever) was resolving and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No laboratory data was provided. No treatment information was 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: 1404394 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Ear pain, Headache, Nasopharyngitis, Oropharyngeal pain, Pyrexia, Rhinorrhoea, Sinus headache, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: SUDAFED
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: runny nose; cough; cold symptoms; headache; pain at the injection site the following day; Ear pain; Sinus headache; Feverish; Sore throat; This regulatory authority case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), COUGH (cough), NASOPHARYNGITIS (cold symptoms), EAR PAIN (Ear pain), OROPHARYNGEAL PAIN (Sore throat), SINUS HEADACHE (Sinus headache), HEADACHE (headache), PYREXIA (Feverish) and VACCINATION SITE PAIN (pain at the injection site the following day) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Suspected COVID-19 since 02-Jun-2021. Concomitant products included PHENYLEPHRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED) for Cold. On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced SINUS HEADACHE (Sinus headache) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced EAR PAIN (Ear pain) (seriousness criterion medically significant). On an unknown date, the patient experienced RHINORRHOEA (runny nose) (seriousness criterion medically significant), COUGH (cough) (seriousness criterion medically significant), NASOPHARYNGITIS (cold symptoms) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant) and VACCINATION SITE PAIN (pain at the injection site the following day) (seriousness criterion medically significant). The patient was treated with PARACETAMOL at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL (COVONIA [DEXTROMETHORPHAN HYDROBROMIDE;MENTHOL]) for Cough, at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (runny nose), COUGH (cough), NASOPHARYNGITIS (cold symptoms), HEADACHE (headache) and VACCINATION SITE PAIN (pain at the injection site the following day) outcome was unknown and EAR PAIN (Ear pain), OROPHARYNGEAL PAIN (Sore throat), SINUS HEADACHE (Sinus headache) and PYREXIA (Feverish) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient developed pain at the injection site the following day, difficult to use her arm as very weak and painful to lift. Around the 3rd day after vaccination, patient developed a headache and became very hot and sweaty particularly at night. The patient had a severely sore throat causing pain when swallowing and felt like a buildup of phlegm blocking. Patient has not tested positive for COVID-19 since having the vaccine. 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: 1404397 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Headache; This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. 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: 1404404 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Pruritus, SARS-CoV-2 test, Skin warm
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (broad), Arthritis (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: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201031; 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: Joint ache; Itchy skin; Skin warm; Dizzy spells; This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (Itchy skin), ARTHRALGIA (Joint ache), DIZZINESS (Dizzy spells) and SKIN WARM (Skin warm) in a 35-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Suspected COVID-19 from 30-Oct-2020 to 01-Nov-2020. On 02-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced DIZZINESS (Dizzy spells) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced PRURITUS (Itchy skin) (seriousness criterion medically significant) and SKIN WARM (Skin warm) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced ARTHRALGIA (Joint ache) (seriousness criterion medically significant). On 06-Jun-2021, SKIN WARM (Skin warm) had resolved. At the time of the report, PRURITUS (Itchy skin) and ARTHRALGIA (Joint ache) had not resolved and DIZZINESS (Dizzy spells) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2020, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. The concomitant medications were not provided. The treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1404428 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Cough, Dizziness, Ear pain, Fatigue, Lymphadenopathy, Nausea, Oropharyngeal pain, Pruritus
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESOGESTREL; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Dry cough; Earache; Nausea; Joint ache; Localised itching; Fatigue; Swollen glands; Sore throat; Dizziness; This regulatory authority case was reported by a consumer and describes the occurrence of EAR PAIN (Earache), OROPHARYNGEAL PAIN (Sore throat), PRURITUS (Localised itching), COUGH (Dry cough), DIZZINESS (Dizziness), NAUSEA (Nausea), LYMPHADENOPATHY (Swollen glands), ARTHRALGIA (Joint ache) and FATIGUE (Fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included SERTRALINE for Anxiety depression, DESOGESTREL for Contraception. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced PRURITUS (Localised itching) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced EAR PAIN (Earache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and ARTHRALGIA (Joint ache) (seriousness criterion medically significant). On 05-Jun-2021, the patient experienced COUGH (Dry cough) (seriousness criterion medically significant). On 03-Jun-2021, PRURITUS (Localised itching) had resolved. On 05-Jun-2021, NAUSEA (Nausea) had resolved. On 06-Jun-2021, COUGH (Dry cough) had resolved. On 07-Jun-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. At the time of the report, EAR PAIN (Earache), DIZZINESS (Dizziness) and FATIGUE (Fatigue) was resolving and LYMPHADENOPATHY (Swollen glands) and ARTHRALGIA (Joint ache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Lab data includes Lateral flow test conducted on 6/6/21 which showed negative result. Concomitant medication sertraline was started on 2011. Treatment medication were not reported/unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness captured as per Regulatory Authority assessment in Source Document; 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. Events seriousness captured as per Regulatory Authority assessment in Source Document


VAERS ID: 1404438 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Intermenstrual bleeding, Postmenopausal haemorrhage, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (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: CITANEST [PRILOCAINE HYDROCHLORIDE]
Current Illness: Anxiety
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: menstrual bleeding; Spotting menstrual; This regulatory authority case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (menstrual bleeding) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Anxiety. Concomitant products included PRILOCAINE HYDROCHLORIDE (CITANEST [PRILOCAINE HYDROCHLORIDE]) from 01-Feb-2021 to an unknown date for Anxiety. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced INTERMENSTRUAL BLEEDING (Spotting menstrual). On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (menstrual bleeding) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (menstrual bleeding) outcome was unknown and INTERMENSTRUAL BLEEDING (Spotting menstrual) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. The patient had on and off menstrual bleeding from spotting to light. She was not currently breastfeeding. The patient has not tested positive for COVID-19 since having the vaccine. Treatment information was not provided. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the 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: 1404455 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Cyst, Fatigue, Laboratory test
SMQs:, Retroperitoneal fibrosis (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 Name: tests; Result Unstructured Data: Test Result:a small cyst
CDC Split Type: GBPFIZER INC2021641125

Write-up: cyst; Patient received her second vaccination on the morning of 2 June 2021. By 2pm, she was not well enough to continue working. She was experiencing severe back pain and extreme tiredness.; extreme tiredness; This is a spontaneous report from a contactable consumer. This consumer reported that an adult female patient received BNT162B2 (COMIRNATY), dose 2 intramuscular on 02Jun2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in May2021 via intramuscular for COVID-19 immunisation. The patient received her second vaccination in the morning of 02Jun2021. By 2 pm on 02Jun2021, she was not well enough to continue working. She was experiencing severe back pain and extreme tiredness. The reporter heard from the patient this morning that she went to A&E last night on 02Jun2021 and some tests were run. She was admitted to hospital and was still waiting for more tests to be performed. She was discharged from hospital on 03Jun2021. The test results showed a small cyst but the hospital advised that it was not big enough to operate and it should be ok. Pain continues. The patient did not think it''s related to the vaccine. The outcome of the event back pain was not recovered. The outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1404542 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021646421

Write-up: Fainted after vaccination; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 18 year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 02Jun2021 (Lot Number: EW6126) at 17:30 as single dose for COVID-19 immunisation. Age at vaccination was 18 years old. The patient was not pregnant. There were no medical history and no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications within 2 weeks of vaccination. The patient fainted after vaccination on 02Jun2021 at 17:30. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient was given O2 therapy and recovered from the event on an unspecified date in Jun2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1404911 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 INC2021643915

Write-up: Cerebral haemorrhage; This is a spontaneous report received from a contactable physician via a Pfizer sales representative. The patient was a 74-year-old female. On 02Jun2021 (the day of vaccination), the patient received the single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified route of administration for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 02Jun2021 (after the vaccination), the patient experienced Cerebral haemorrhage. The outcome of the event was unknown. Reporter considered that the event was non-serious and the Causality between the suspect drug and event was probably related. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Lacking any reported alternative explanation and considering the close temporal association, a contributory role of BNT162B2 vaccine for the mentioned cerebral haemorrhage 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: 1404933 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cerebral haemorrhage, Investigation, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation paroxysmal; Normal pressure hydrocephalus
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: test; Result Unstructured Data: Test Result:cerebral haemorrhage was found
CDC Split Type: JPPFIZER INC2021673324

Write-up: Weakness; Vomiting; Cerebral haemorrhage; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. An 83-year-old male received BNT162B2 (COMIRNATY) on 26May2021, as first single dose, for COVID-19 immunisation. Medical history included normal pressure hydrocephalus and atrial fibrillation paroxysmal. Concomitant medications were not reported. On 26May2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 02Jun2021 (7 days after the vaccination), the patient experienced vomiting, on 03Jun2021 (8 days after the vaccination), the patient experienced weakness, and on an unspecified date in 2021, the patient experienced cerebral haemorrhage. On 07Jun2021 (12 days after the vaccination), the patient was admitted to the hospital. The outcome of the events was unknown. The course of the events was as follows: on 26May2021, the patient received the first dose of COMIRNATY. On 02Jun2021, the patient experienced vomiting. On 03Jun2021, the patient experienced weakness. The patient was treated with intravenous infusion. Reportedly, the patient underwent test at another hospital and cerebral haemorrhage was found. The patient was admitted to the hospital. At the time of this report (09Jun2021), the patient was admitted to ICU. The reporting physician classified cerebral haemorrhage as serious (life-threatening) and assessed that the event was possibly related to BNT162b2. Seriousness criteria and causality assessment for vomiting and weakness were not provided. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information currently available, a possible contribution of the suspect drug administration to the reported events cannot be excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1404936 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Blood test, Body temperature, Computerised tomogram, Cyanosis, Interstitial lung disease, Oxygen saturation, Oxygen saturation decreased, Pyrexia
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Biochemistry test of blood; Result Unstructured Data: Test Result:SP-D 622.0; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:39.3 Centigrade; Test Date: 20210603; Test Name: CT; Result Unstructured Data: Test Result:severe pneumonia; Comments: consisted predominantly of ground-glass opacity on both lungs; Test Date: 20210603; Test Name: Oxygen saturation; Test Result: 50 %; Comments: at around 21:30; Test Date: 20210603; Test Name: Oxygen saturation; Test Result: 47 %; Comments: when paramedics arrived; in room air; Test Date: 20210603; Test Name: Oxygen saturation; Test Result: 90 %; Comments: on arrival
CDC Split Type: JPPFIZER INC2021674728

Write-up: cyanosis; SpO2 was 50%; Acute respiratory distress syndrome; Interstitial pneumonia; pyrexia of 39.3 degrees; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21112484. An 83-year and 4-month-old female patient received first dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on 01Jun2021 at 14:30 (Batch/Lot Number: EW4811; Expiration Date: 31Jul2021) (at the age of 83-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Body temperature before vaccination was 36.5 degrees centigrade. Family history was not reported. On 01Jun2021 at 14:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY). On 03Jun2021 at around 21:30 (2 days 7 hours after the vaccination), the patient experienced acute respiratory distress syndrome and interstitial pneumonia. On 04Jun2021 (3 days after the vaccination), the patient was admitted to the hospital. As of 08Jun2021 (7 days after the vaccination), the outcome of the events was not recovered. The course of the event was as follows: on 01Jun2021(the day of vaccination), the patient received the vaccine. On 02Jun2021 (1 day after the vaccination), the patient had pyrexia of 39.3 degrees centigrade. On 03Jun2021 at around 21:30 (2 days 7 hours after the vaccination), the patient''s daughter got home and noticed that the patient had cyanosis and measured oxygen saturation. Since SpO2 was 50%, ambulance was requested. When paramedics arrived, SpO2 was 47% (in room air). The patient was placed on reservoir mask at O2 10 L/min while transferred to the reporting hospital. On arrival, SpO2 was around 90% with reservoir mask. CT revealed severe pneumonia that consisted predominantly of ground-glass opacity on both lungs, for which administration of ZOSYN (antibiotic) was initiated. It was changed to nasal high flow (FiO2 0.7-0.9). From 04Jun2021 to 07Jun2021, steroid pulse therapy (mPSL 1g/day) was performed. Biochemistry test of blood showed SP-D 622.0; thus, it was diagnosed as acute respiratory distress syndrome accompanied by interstitial pneumonia. At the time of this report, the patient was placed under observation with nasal high flow (FiO2 0.7). The reporting physician classified the events as serious (life-threatening and hosp) and assessed that the events were related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: it was severe pneumonia occurred 2 days after the vaccination; thus, causality between the event and the vaccination could not be denied.


VAERS ID: 1404957 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Conjunctival haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Conjunctival 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: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021649939

Write-up: yesterday I was vaccinated and later my left eye spilled, I am hypertensive; This is a spontaneous report from a contactable consumer received from Medical Information Team. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was reported as unknown) unknown dose via an unspecified route of administration on 02Jun2021 as a single dose ( at the age of 53-years-old) for covid-19 immunization. Medical history included hypertension and concomitant medications were not reported. It was reported that, on 02Jun2021, the patient was vaccinated and later his left eye spilled. The outcome of the event was unknown. Information about batch/lot number had been requested.


VAERS ID: 1405128 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-06-02
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 1 RA / -

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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLEGRA
Current Illness: Pollen allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021687321

Write-up: Bell''s palsy. Left half of the face paralyzed; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ex6537) dose 1 via an unspecified route of administration in right arm on 09May2021 (at the age of 54-years-old) as single dose for COVID-19 immunization. Medical history included ongoing pollen allergy (during spring). Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for pollen. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine, was not diagnosed with covid-19 prior to vaccination and had not been tested for covid-19 post-vaccination. On 02Jun2021 at 10:00, the patient experienced Bell''s palsy, left half of the face paralyzed. The adverse event resulted in a physician office visit. The patient received treatment for Bell''s palsy in the form of cortisone (CORTISONE). The outcome of the event was recovering.


VAERS ID: 1406238 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperpyrexia, Injection site pain, Malaise, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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? 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: Disease risk factor
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Hyperpyrexia; Result Unstructured Data: Fever 40.5 up to and including 42 degrees Celsius
CDC Split Type: NLJNJFOC20210623176

Write-up: COLD CHILL; FEELING UNWELL; JOINT PAIN; HEADACHE; FATIGUE; MUSCLE PAIN; NAUSEA; FEVER 40.5 UP TO AND INCLUDING 42 DEGREES CELSIUS; REACTION AT OR AROUND THE INJECTION SITE PAIN; This spontaneous report received from a consumer via a Regulatory Authority [NLP, NL-LRB-00566771] concerned a 54 year old male. The patient''s weight was 89 kilograms, and height was 182 centimeters. The patient''s past medical history included disease risk factor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD985 expiry: UNKNOWN) 0.5 ml, 1 total administered on 02-JUN-2021 for covid-19 immunisation. The drug start period was 8 hours. No concomitant medications were reported. On 02-JUN-2021, the patient experienced reaction at or around the injection site pain. On 03-JUN-2021, the patient experienced fever 40.5 up to and including 42 degrees Celsius, feeling unwell, joint pain, headache, fatigue, muscle pain and nausea. Laboratory data included hyperpyrexia (NR: not provided) (fever 40.5 up to and including 42 degrees Celsius). On an unspecified date, the patient experienced cold chill. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cold chill, and had not recovered from headache, fatigue, reaction at or around the injection site pain, feeling unwell, muscle pain, nausea, fever 40.5 up to and including 42 degrees celsius, and joint pain. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210623176-COVID-19 VACCINE AD26.COV2.S-FEVER 40.5 UP TO AND INCLUDING 42 DEGREES CELSIUS . 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: 1406239 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Hyperpyrexia, Injection site haematoma, Injection site inflammation, Injection site pain, Injection site swelling, Malaise, Myalgia, SARS-CoV-2 test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEXOFENADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201217; Test Name: SARS-CoV-2 test positive; Result Unstructured Data: Positive; Test Date: 20210602; Test Name: Hyperpyrexia; Result Unstructured Data: Fever: 40.5 to 42 degrees Celsius
CDC Split Type: NLJNJFOC20210623104

Write-up: FEVER: 40.5 TO 42 DEGREES CELSIUS; REACTION AT OR AROUND THE INJECTION SITE: BRUISE; INFLAMMATION REACTION AT THE INJECTION SITE: PAIN, SWELLING, ONSET WITHIN A WEEK OF THE VACCINATION; FEELING UNWELL; REACTION AT OR AROUND THE INJECTION SITE: SWELLING, ONSET WITHIN A WEEK OF THE VACCINATION; REACTION AT OR AROUND THE INJECTION SITE: PAIN; MUSCLE PAIN; FATIGUE; COLD CHILLS; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00568175] concerned a 45-year-old female patient of unspecified race and ethnic origin. The patient''s weight was 81 kilograms, and height was 168 centimeters. The patient''s had past medical included covid-19 on 17-DEC-2020 which was confirmed by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown, expiry date: unknown) 0.5 ml, 1 total, administered on 02-JUN-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medication included fexofenadine 120 mg film-coated tablet. On an unspecified date, the patient experienced fever of 40.5 to 42 degrees Celsius. On 02-JUN-2021, the patient experienced cold chills, and fatigue. On 03-JUN-2021, the patient experienced reaction at or around the injection site: bruise, inflammation reaction at the injection site: pain, swelling (reported as onset within a week of the vaccination), felt unwell, had muscle pain, reaction at or around the injection site: swelling (reported as onset within a week of the vaccination), and reaction at or around the injection site: pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold chills on 03-JUN-2021, was recovering from fever: 40.5 to 42 degrees Celsius, feeling unwell, and muscle pain, and had not recovered from reaction at or around the injection site: swelling, onset within a week of the vaccination, reaction at or around the injection site: pain, reaction at or around the injection site: bruise, inflammation reaction at the injection site: pain, swelling, onset within a week of the vaccination, and fatigue. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210623104-COVID-19 VACCINE AD26.COV2.S-fever: 40.5 to 42 degrees Celsius. 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: 1408339 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse drug reaction
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: shoulder pain for 4 days, headache 5 days, vomiting once, weakness one day; This regulatory authority case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (shoulder pain for 4 days, headache 5 days, vomiting once, weakness one day) in a 35-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) 1 dosage form. On 02-Jun-2021, the patient experienced ADVERSE DRUG REACTION (shoulder pain for 4 days, headache 5 days, vomiting once, weakness one day) (seriousness criterion medically significant). On 07-Jun-2021, ADVERSE DRUG REACTION (shoulder pain for 4 days, headache 5 days, vomiting once, weakness one day) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) was unknown. Concomitant product use was not provided by the reporter. No treatment information was 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: 1408572 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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: CO-AMOXICLAV [AMOXICILLIN;CLAVULANATE POTASSIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Infection
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021649157

Write-up: sudden menstrual bleeding, heavy; sudden menstrual bleeding, heavy, and painful; Vaginal bleeding; This is a spontaneous report from a contactable consumer or other non hcp received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number: GB-MHRA-WEBCOVID-202106021126136900-5F0BJ; Safety Report Unique Identifier: GB-MHRA-ADR 25404267. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 31May2021 (batch/lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. Medical history included infection. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included amoxicillin, clavulanate potassium (CO-AMOXICLAV [AMOXICILLIN; CLAVULANATE POTASSIUM]) taken for infection from 14Apr2021 to 21Apr2021. The patient experienced sudden menstrual bleeding, heavy, and painful on an unspecified date. The patient experienced vaginal bleeding on 02Jun2021. The events were assessed as 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 an unspecified date. The outcome of vaginal bleeding was not recovered, while sudden menstrual bleeding, heavy, and painful was unknown. No follow-up attempts are possible; information about lot/batch number cannot be requested.


VAERS ID: 1408574 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649715

Write-up: Bleeding menstrual heavy; This is a spontaneous report from a contactable consumer received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106021137135190-KXVWX, and Safety Report Unique Identifier is GB-MHRA-ADR 25404340. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 (Lot/batch number was not reported) as 1st dose, single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant and not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced bleeding menstrual heavy on 02Jun2021 with outcome of recovering. The event was assessed as serious, other medically important condition by the health authority. 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.


VAERS ID: 1408576 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Nausea, Off label use, Pain, Product use issue
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649216

Write-up: ongoing breast feeding; ongoing breast feeding; Nausea; Chills; Tiredness; Dizziness; Ache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106021152589140-ICNOU. Safety Report Unique Identifier GB-MHRA-ADR 25404482. This consumer reported information for both the mother and baby. This is the maternal report. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 (Lot/batch number was not reported) as 1st dose, single dose for COVID-19 immunisation. Medical history included ongoing breast feeding. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. The patient''s concomitant medications were not reported. On 02Jun2021, the patient experienced nausea, chills, tiredness, dizziness and ache. The events were assessed as serious (medically significant) by health authority. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events ''nausea, chills, tiredness, dizziness and ache'' was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1408587 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epilepsy, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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 INC2021649258

Write-up: Seizure; Epilepsy; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Agency; the Regulatory Authority report number is GB-MHRA-WEBCOVID-202106021246540880-WXHNG and the Safety Report Unique Identifier is GB-MHRA-ADR 25404828. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Jun2021 (batch/lot number: EW3143) at 31 years old as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported and not disclosed by the patient. On 02Jun2021, the patient experienced seizure. It was reported that the patient appeared to have seizure following vaccination in waiting area, eyes rolled back, and body became stiff which lasted approximately 20 seconds. It was unknown if this was epilepsy. 999 was called. Outcome of the event seizure was recovering. Outcome of epilepsy was unknown. This report does not relate to possible blood clots or low platelet counts. The events were reported as medically significant. The patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1408677 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Feeling hot, SARS-CoV-2 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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC2021649386

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202106021624201430-53NBN; safety report unique identifier: GB-MHRA-ADR 25406791). A 34-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on May 29, 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. It was reported the patient became extremely tired while walking the dog around 13:00, (4 days after the vaccination, Jun 2, 2021). Had a fine night sleep. Reported that it is a lot warmer than it has been, so this could be the cause (he thought he''d mention it in case it''s useful). The events assessed serious (medically significant). Patient has not tested positive for COVID-19 since the vaccination. Lab data includes COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of tiredness was not recovered; while unknown for the other event. No follow-up attempts are possible. Information about the batch number cannot be obtained.


VAERS ID: 1408680 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Chest pain, Cold sweat, Nausea, Pain assessment
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Pain; Result Unstructured Data: Test Result:8/10
CDC Split Type: GBPFIZER INC2021649081

Write-up: chest pain; Acute chest pain; pain in the centre of the chest and radiating through to the upper back; Nausea; Cold sweat; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number GB-MHRA-WEBCOVID-202106021644191080-XO2L1, Safety report unique identifier: GB-MHRA-ADR 25406929. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Jun2021 (batch/lot number and exp date not reported) as SINGLE DOSE for COVID-19 immunisation. Medical history included lactation decreased. Unsure if patient has had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication included sertraline from 22Mar2021. On 02Jun2021, 9 hours after receiving the vaccine, patient experienced severe acute chest pain in the centre of the chest and radiating through to the upper back. Pain was rated 8/10. It was accompanied by severe nausea and cold sweats. Pain lasted approximately 1 hour, then became a dull ache for the next 2 to 3 hours. Phoned Agency 24 after experiencing acute pain for about 20 mins, but she didn''t speak to an advisor until about 45 mins of pain. They arranged for paramedics to attend and review. However, the paramedics phoned the patient approximately 3 hours later, asked for an update on condition, and agreed with the patient not to attend since symptoms had subsided. They advised the patient to phone 999 or go to A&E if it happened again. The patient experienced chest pain on an unspecified date. The events were assessed as serious: medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient recovered from acute chest pain and pain in the centre of the chest and radiating through to the upper back on 02Jun2021, nausea and cold sweats recovered on 2021 while chest pain recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1408692 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649583

Write-up: it very hard to stay awake; Tiredness; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106021738463430-JUNCN, Safety Report Unique Identifier GB-MHRA-ADR 25407309. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW3143), via an unspecified route of administration on 01Jun2021 as 1st dose, single dose for COVID-19 immunization. Medical history included suspected COVID-19 from 31Mar2020 to 24Apr2020. The patient had not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced tiredness on 02Jun2021 and it very hard to stay awake on an unspecified date. It was reported that approximately 24 hours later, incredible tiredness set in, found it very hard to stay awake. The reporter assessed all events as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event tiredness was recovered while the outcome of all other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408700 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649364

Write-up: sweaty; Syncope/faint; This is a spontaneous report from a contactable physician received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106021842018370-XBFM0, Safety Report Unique Identifier GB-MHRA-ADR 25407702. A 31-year-old male patient (age at vaccination: 31-year-old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ET8885), via an unspecified route of administration on 02Jun2021 as first dose, single, for COVID-19 immunisation. The patient''s medical history included had previous faint (for immunization) with yellow fever vaccination. Patient has 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. On 02Jun2021, after first Pfizer vaccine, patient was walking to the exit door towards the waiting/observation area then he felt hot sweaty and faint (syncope). Immediately helped to the floor and lain prone with legs raised in the air. No LOC (loss of consciousness). Mobilized onto wheeled stretcher, observed for 40 mins, given water and general, driving and safety netting advice. The outcome of sweaty was recovered on unspecified date; for syncope was recovered on 02Jun2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408705 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Lethargy, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (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:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative.
CDC Split Type: GBPFIZER INC2021649407

Write-up: Joint ache; Muscle ache; Lethargic; Headache; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106021906369420-OXVHR. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 25407975. A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Jun2021 (Lot Number: EY5456) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced joint ache, muscle ache, headache, all on 02Jun2021 with outcome of recovering, lethargic on 02Jun2021 with outcome of recovered on 02Jun2021. Events were reported as serious with medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test (COVID-19 virus test): no - negative on an unknown date. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. No follow up attempts are possible. No further information is expected.


VAERS ID: 1408726 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear pain, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649478

Write-up: Flu; Earache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106022042098910-6KYND, Safety Report Unique Identifier GB-MHRA-ADR 25408340. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Jun2021 as first 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; Not had a COVID-19 test; Patient is not enrolled in clinical trial. The patient experienced flu and earache on 02Jun2021. The outcome of the events was not recovered. The events were considered medically significant. 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.


VAERS ID: 1408735 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Lymphadenopathy, SARS-CoV-2 test, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (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: Positive; Comments: Yes - Positive COVID-19 test.
CDC Split Type: GBPFIZER INC2021649299

Write-up: armpit area started to ache then started to swell, very tender to touch; very tender to touch; Armpit area started to ache; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. This is a report received from the Medicines Healthcare Products Regulatory Agency. The Regulatory authority report number is (GB-MHRA-WEBCOVID-202106022133293860-MMKYY) and the Safety Report Unique Identifier is (GB-MHRA-ADR 25408644). A 31-year-old female patient (not pregnant, not currently breastfeeding) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown), via unspecified route of administration on 01Jun2021 as first dose, single for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Medical history included decreased lactation. The patient''s concomitant medications were not reported. The patient experienced armpit area started to ache, then started to swell, very tender to touch on unspecified date. On 02Jun2021, she had swollen lymph nodes. The events were reported as serious medically significant. The patient underwent laboratory test which included COVID-19 virus test: Positive on unknown date. The outcome of swelling was recovering; for lymphadenopathy was not recovered; for other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1408757 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Gait disturbance, Muscular weakness, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEXPLANON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diarrhea; Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021649437

Write-up: muscles in all parts of my body still feel weak/Muscle weakness; Walking difficulty; Diarrhea; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106030058041520-VOOML. Safety Report Unique Identifier:GB-MHRA-ADR 25409000. A 22-year-old female patient received BNT162B2 (BNT162B2), dose 1, via an unspecified route of administration on 02Jun2021 (Lot/Batch Number: ET8885) as single dose for COVID-19 immunisation. Age at vaccination: 22 years. Medical history included diarrhoea and suppressed lactation, on unknown dates and unknown if ongoing. The patient had not had symptoms associated with COVID-19, was not enrolled in clinical trial. The patient was not pregnant, not currently breastfeeding. Concomitant medication(s) included etonogestrel (NEXPLANON) taken for contraception, start and stop date were not reported. The patient had not tested positive for COVID-19 since having the vaccine. COVID-19 virus test on an unspecified date was negative. The patient experienced muscles in all parts of body felt weak/muscle weakness on 02Jun2021, walking difficulty on 02Jun2021, diarrhea on 02Jun2021. Around 3 hours after the vaccine, her muscles began to feel weak, hard to move, this affected walking particularly. After 5-6 hours, sudden defecation occurred, with no warning, no signs of needing the bathroom occurred before hand, barely even felt the incident happening, it was unlike any other case of diarrhea the patient had previously experienced in her life. Muscles in all parts of her body still felt weak, like she was lacking control. She had never experienced anything like this before and had no prior issues which might lead to this. Seriousness criterion of this report was provided as other medically important condition. The events muscle weakness and walking difficulty were not resolved. The outcome of diarrhea was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408765 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649229

Write-up: Muscle pain; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106030714467230-5MJGD. Safety Report Unique Identifier GB-MHRA-ADR 25409673. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced muscle pain on 02Jun2021 with outcome of not recovered. The event was assessed as serious (medically significant). No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1408806 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-06-02
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Periodontitis, SARS-CoV-2 test, Tooth loss
SMQs:, Lack of efficacy/effect (narrow), Oropharyngeal infections (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started and stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021692848

Write-up: Gums went soft and teeth fell out; Tooth loss; SARS-CoV-2 infection; SARS-CoV-2 infection; 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-202106121529467160-T7QNR. Safety Report Unique Identifier GB-MHRA-ADR 25466152. A 28-year-old male patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on 10May2021as 1st dose, single dose for COVID-19 immunization. Medical history included suspected COVID-19, unsure when symptoms started and stopped. The patient''s concomitant medications were not reported. On 02Jun2021 the patient experienced sars-cov-2 infection, on an unspecified date experienced gums went soft and teeth fell out, tooth loss. The patient underwent lab tests and procedures which included COVID-19 virus test: positive COVID-19 test. The patient was hospitalised. The outcome of event recovered with squeal for event sars-COV-2 infection on 10Jun2021 and for event gums went soft and teeth fell out, tooth loss was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1408811 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Migraine, SARS-CoV-2 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: BECLOMETHASONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210209; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 Test.
CDC Split Type: GBPFIZER INC2021657289

Write-up: Migraine; Headache; This is a Non-Interventional Study Report from a contactable consumer or other Non-Health Care Professional received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-YCVM-202105271741470660-JZDKY. Safety Report Unique Identifier-GB-MHRA-ADR 25425451. A 32-years-old non-pregnant female patient received first dose of fbnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ET8885, Expiration date: Unknown), via an unspecified route of administration on 02Jun2021 as 1 ST DOSE, SINGLE DOSE for Covid-19 immunisation. The patient medical history included asthma. The patient concomitant medications included Beclomethasone taken for asthma. Patient was not enrolled in clinical trial nor patient was currently breastfeeding. On 02Jun2021, the patient had experienced headache and on 04Jun2021, patient had migraine. The events were considered serious as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test which was negative on 09Feb2021. It was reported that asthma patient has not had symptoms associated with COVID-19. The outcome of event headache was recovered on 03Jun2021. Outcome of another event migraine was not recovered. No follow-up attempts are possible. No further information Is Expected.; Sender''s Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of headache,migraine. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1408816 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypermobility syndrome; Mast cell activation syndrome; Postural orthostatic tachycardia syndrome; Comments: Hypermobility Spectrum Disorder, POTS, Mast Cell Activation Syndrome Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649284

Write-up: Felt faint; Nausea; This is a solicited report from the RA from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-YCVM-202105300006485820-CCI6M, Safety Report Unique Identifier GB-MHRA-ADR 25408022. A 32-year-old female patient received BNT162B2(COVID-19 MRNA VACCINE BIONTECH),dose 1, via an unspecified route of administration on 02Jun2021 (Batch/Lot Number unknown) at single dose at the age of 32 years old for COVID-19 immunisation. Medical history included Hypermobility Spectrum Disorder from an unknown date, POTS from an unknown date, Mast Cell Activation Syndrome from an unknown date. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. Patient last menstrual period date reported as in 2011. Concomitant medication included ethinylestradiol, levonorgestrel (MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]) taken for heavy periods, start and stop date were not reported. The patient experienced felt faint and nausea on 02Jun2021.The events were serious as medically significant. The outcome of the events was recovering. 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; information about lot/batch number cannot be obtained.; Sender''s Comments: " Based on a strong temporal relationship and the known drug safety profile, the event of was considered possibly related to the suspect drug BNT162B2" The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1408820 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Limb discomfort, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 20210730)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649324

Write-up: Maternal exposure during pregnancy; Arm discomfort; YELLOW CARD VACCINE MONITOR This is a solicited report from a regulatory authority program from a contactable consumer or other non hcp received from a regulatory authority. The regulatory authority report number is GB-MHRA-YCVM-202106021131389970-CFPPL. Safety Report Unique Identifier is GB-MHRA-ADR 25409638. A 32-year-old female patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 02Jun2021 (Batch/Lot Number: not known) at single dose at the age of 32 years old for COVID-19 vaccination. Medical history included ongoing pregnancy (Estimated due date: 20210730). Patient last menstrual period date reported as 23Oct2020. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medication included folic acid (FOLIC ACID) taken for folic acid supplementation at 400 ug, start and stop date were not reported. The patient experienced maternal exposure during pregnancy on 02Jun2021, arm discomfort on 02Jun2021. The events were serious as medically significant. The outcome of the event arm discomfort was not recovered, of the other event was unknown. Patient does not think vaccination had an adverse effect on any aspect of the pregnancy. Patient was exposed to the vaccine Third-trimester (29-40 weeks). 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; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the description given in the narrative there is reasonable possibility of causal association between the events Maternal Exposure during pregnancy, Limb Discomfort and the suspect BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1408830 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
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 INC2021648134

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EW4109), via an unspecified route of administration, administered in Arm Left on 19May2021 10:15 (at age of 34-year-old) at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 02Jun2021 12:00 (14 days after receiving first dose of BNT162B2 ), the patient experienced early miscarriage around 8 weeks (as reported). The mother reported she became pregnant while taking bnt162b2. Patient last menstrual period date 31Mar2021. The outcome of the event was unknown. This consumer reported information for both mother and fetus/baby. This is a enter maternal report. A 34-year-old female patient received the first dose of bnt162b2 (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, lot# EW4109), via an unspecified route of administration, administered in Arm Left on 19May2021 10:15 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced early miscarriage around 8 weeks, 14 days after receiving 1st. affine dose (abortion spontaneous) (congenital anomaly) on 02Jun2021 12:00 with outcome of recovering. The mother reported she became pregnant while taking bnt162b2. The mother was 9 Weeks pregnant at the onset of the event. The mother was due to deliver on 07Jan2022. Additional Information: Start Date/Time: [Pfizer bioNTec] 19May2021 10:15 AM Facility where the most recent COVID-19 vaccine was administered: Doctor''s office/urgent care Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No List of any other medications the patient received within 2 weeks of vaccination: No Reported Event: Early miscarriage around 8 weeks, 14 days after receiving 1st. Affine dose Did the adverse event result in any of the following: Doctor or other healthcare professional office/clinic visit Did the adverse event result in any of the following: Emergency room/department or urgent care Prior to vaccination, was the patient diagnosed with COVID-19: No Since the vaccination, has the patient been tested for COVID-19: No Device Date: 03Jun2021


VAERS ID: 1409064 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure decreased, Blood pressure measurement, Dyspnoea, Dyspnoea exertional, Headache, Malaise, Oxygen saturation, Oxygen saturation decreased, Palpitations, Pyrexia, Status asthmaticus, Tachycardia, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial; Dermatitis atopic; Rhinitis allergic
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210602; Test Name: SpO2; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC2021643170

Write-up: Palpitations; Dyspnoea; SpO2 decreased; Wheezing; Status asthmaticus-like symptoms; Blood pressure decreased; Tachycardia; Dyspnoea exertional; Malaise; Headache; Low grade fever; Arthralgia; This is a spontaneous report from a contactable nurse (patient) received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The patient was a non-pregnant 25-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had Loxonin allergy, allergic reaction was asthmatic attack. Other medical history included Asthma bronchial, Rhinitis allergic and Dermatitis atopic. On 02Jun2021 at 14:15, the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) intramuscular in the Arm Right for COVID-19 immunization. On 02Jun2021 at 14:30 (15 minutes after the vaccination), within 5-10 minutes after the vaccination, the patient experienced Palpitation and Dyspnoea, then SpO2 decreased, Wheezing and Status asthmaticus-like symptoms. And Blood pressure decreased, Tachycardia, Dyspnoea exertional, Malaise, Headache, Low grade fever, Arthralgia. The outcome of the events was recovering with treatment including Adrenaline intramuscular / intravenous injection. The reporter classified the events as serious (Hospitalized) and stated the events result in emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on temporal association, the reported events are probably related to the BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.


VAERS ID: 1409089 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Depressed level of consciousness, Heart rate, Hypotension, Oxygen saturation, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Diabetes mellitus; Latent hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: blood pressure; Result Unstructured Data: Test Result:126/31; Test Date: 20210602; Test Name: blood pressure; Result Unstructured Data: Test Result:136/34; Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Celsius; Comments: before the vaccination; Test Date: 20210602; Test Name: HR; Result Unstructured Data: Test Result:76/min; Test Date: 20210602; Test Name: Oxygen saturation; Test Result: 95 %; Test Date: 20210602; Test Name: Oxygen saturation; Test Result: 87 %; Test Date: 20210602; Test Name: Oxygen saturation; Test Result: 97 %; Test Date: 20210602; Test Name: Oxygen saturation; Test Result: 99 %; Test Date: 20210602; Test Name: Oxygen saturation; Test Result: 95 %
CDC Split Type: JPPFIZER INC2021645109

Write-up: Depressed level of consciousness; low oxygen saturation; blood pressure 126/31, BP 136/34; This is a spontaneous report from the contactable physician received from the Agency. Regulatory authority report number is v21111244. The patient was 95-year and 6-month-old female. Body temperature before the vaccination was 36.4 degrees Celsius. 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 Diabetes mellitus, Latent hypothyroidism, Constipation. sitagliptin phosphate hydrate (GLACTIV) 75mg, Levothyroxine sodium hydrate (THYRADIN-S) 25ug, Sennoside granules 0.4g was under taking. On 02Jun2021 at 14:08 (at the age of 95 years old) (the day of vaccination), the patient received the second dose of BNT162B2 ( COMIRNATY Intramuscular injection, Lot number: EY2173, expiration date: 31Aug2021) via an unspecified route of administration as second dose, single dose for COVID-19 immunisation. Event onset date was reported on 02Jun2021 at 14:20. Clinical course of the event was reported as follows: On 02Jun2021 at 14:08 (same day of vaccination), vaccination performed. SpO2 was 95% after vaccination. 10 minutes later SpO2 was 87%. Looked pale and Complexion ill. At this time, although the patient opened eyes, she did not respond to the call (usually reply with it was really annoying or go over there). Immediately moved by a wheelchair, SpO2 decreased to 87%, Started to use mask for oxygen infusion 3L/min. No Stenosis sound was found on auscultation, no skin red rash. SpO2 was 97%, blood pressure 126/31, oxygen volume decreased to 1.5L/min, SpO2 was 99%, BP 136/34, HR 76/min. The patient can reply and move the body. On 02Jun2021 at 14:30 (same day of vaccination), oxygen infusion ended, SpO2 was 95%, returned to the usual level, and ended the treatment at 14:33. The event term was reported as low oxygen saturation, Depressed level of consciousness. The reporter classified the event as non-serious and assessed the causality between the event and the vaccine as related. The other possible cause of the events such as any other diseases was the patient was a 95-year-old elderly who had been in a wheelchair for 1 hour. It cannot be said that there was no possibility of symptoms caused by this. However, there was no problem at all if she sit for such a long time. On 02Jun2021 (same day of vaccination), the outcome of the event low oxygen saturation, Depressed level of consciousness was recovered, for ''blood pressure 126/31, BP 136/34'' was unknown. The reporter commented as follows: the patient was a 95-year-old elderly. Although sitting posture cannot completely deny hypotension and Circulatory failure, the patient was not bedridden due to illness and can sit for a day. Therefore, the possibility of adverse reactions of the vaccine was higher. This cannot be judged as Circulatory failure (decreased myocardial contraction) or breathing problem. According to the impression, it was suspected to be a circulatory problem (just lying on the bed, the complexion improved).; Reporter''s Comments: the patient was a 95-year-old elderly. Although sitting posture cannot completely deny hypotension and Circulatory failure, the patient was not bedridden due to illness and can sit for a day. Therefore, the possibility of adverse reactions of the vaccine was higher. This cannot be judged as Circulatory failure (decreased myocardial contraction) or breathing problem. According to the impression, it was suspected to be a circulatory problem (just lying on the bed, the complexion improved).


VAERS ID: 1409124 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Road traffic accident
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021647363

Write-up: Traffic accident; This is a spontaneous report from a contactable consumer (patient) via medication information team. On 31May2021 (the day of vaccination), a female patient of unspecified age received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number not provided, Expiration date not provided) via an unspecified route of administration as a single dose for COVID-19 immunization. The course of the event was as follows: On 02Jun2021 (2 days after vaccination), the patient experienced Traffic accident. The second vaccination was originally scheduled on 21Jun2021, but due to traffic accident, the second vaccination could not be carried out. Hospitalization for treatment would take several months. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1409162 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021650613

Write-up: Urticaria; Itching; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21111333. A 45-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 02Jun2021 at 12:25 (Batch/Lot Number: FC3661; Expiration Date: 30Sep2021) at age of 45-year-old as single dose for covid-19 immunisation. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Body temperature before vaccination was 36.1 degrees Centigrade on 02Jun2021. Concomitant medications were not reported. On 02Jun2021 at 12:27 (2 minutes after the vaccination), the patient experienced urticaria and itching appeared on the left upper arm immediately. It subsided immediately again. Patient received predonine at 20mg IV. The symptoms were further improved. The outcome of events was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Immediately calmed down. The course of the event was as follows: After vaccination, urticaria and itching appeared on the left upper arm immediately. It subsided immediately again. (PREDONINE 20mg IV) The symptoms were further improved. 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: Immediately calmed down.; Sender''s Comments: Based on temporal association and profile of the product bnt162b2 (COMIRNATY), the causal relationship between the events and the suspect drug cannot be denied.


VAERS ID: 1409189 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Dizziness, Dysstasia, Heart rate, Hypersensitivity, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Alcohol allergy; Allergy to grains; Contrast media allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: blood pressure; Result Unstructured Data: Test Result:178-90; Comments: After vaccination; Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210602; Test Name: pulse; Result Unstructured Data: Test Result:80; Comments: After vaccination
CDC Split Type: JPPFIZER INC2021651200

Write-up: Mild allergic reaction; Urticaria; Generalised itching; blood pressure was 178-90; Giddiness / Swaying feeling; Difficulty in standing; This is a spontaneous report from a contactable physician received from the Medical Devices Agency. The patient was a 67 years old female. Body temperature before vaccination was 36.8 degrees Centigrade. Patients had allergic to Soba, contrast media allergy and alcohol allergy. On 12May2021, the patient previously received the first dose of BNT162B2 (COMIRNATY, Lot number unknown, Expiration date unknown) for COVID-19 immunization and experienced urticaria. On 02Jun2021 at 14:30 (the day of vaccination), the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31-AUG-2021) via intramuscular as a single dose for COVID-19 immunization. Patient age at vaccination was 67 years old. On 02Jun2021 at 14:35 (5 minutes after the vaccination), the patient experienced giddiness, swaying feeling, difficulty in standing, urticaria, generalised itching. On 02Jun2021 (the same day of vaccination), the outcome of the event was recovered. The course of the event was as follows: After the intramuscular injection, the patient soon stated that she had symptoms of giddiness and swaying feeling, difficulty in standing, blood pressure was 178-90, pulse was 80, and soon the patient lay in bed to infuse calcium chloride dihydrate; maltose monohydrate; potassium chloride; sodium chloride; sodium lactate (SOLULACT TMR) 500ml. About 5 minutes after that, because the patient stated that he had generalised itching, stronger neo-minophagen C1A was added. The symptoms disappeared after that. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: mild allergic reaction.


VAERS ID: 1409193 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chest discomfort, Dyspnoea, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (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: ZOLPIDEM; LUNESTA; FLUNITRAZEPAM; ETIZOLAM; NEXIUM [ESOMEPRAZOLE SODIUM]; MOSAPRIDE CITRATE; LOTRIGA; WYPAX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contrast media allergy; Dyslipidaemia; Food allergy; Reflux oesophagitis; Sleep disorder; Ventricular extrasystoles
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: BP; Result Unstructured Data: Test Result:159/51; Comments: about 30minutes after vaccine; Test Date: 20210602; Test Name: BP; Result Unstructured Data: Test Result:144/49; Comments: about 1hour after vaccine; Test Date: 20210602; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccine; Test Date: 20210602; Test Name: SpO2; Test Result: 97 %; Comments: about 30minutes after vaccine; Test Date: 20210602; Test Name: SpO2; Test Result: 96 %; Comments: about 1hour after vaccine
CDC Split Type: JPPFIZER INC2021651271

Write-up: Dyspnoea; BP 159/51; Dyspnoea with chest; This is a spontaneous report from a contactable pharmacist received from the Regulatory authority; report number is v21111294. The patient was a 78-year and 7-month-old female. Body temperature before vaccination was 36.1 degrees Centigrade. Other medical history included history of sleep disorder, reflux oesophagitis, dyslipidaemia, ventricular extrasystoles, melon allergy and coantrast agent allergy. The patient was taking Zolpidem tablets 10mg, Lunesta tablets 3mg, Flunitrazepam tablets 2mg, Etizolam tablets 1mg for sleep disorder,taking NEXIUM [ESOMEPRAZOLE SODIUM] capsule 20mg, Mosapride Citrate Tab 5mg for reflux oesophagitis, taking Lotriga capsule 2g for dyslipidaemia and taking Wypax tablets for ventricular extrasystoles treatment. On 02Jun2021 at 14:07 (the day of vaccination), the patient received the firs dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) for COVID-19 immunization. On 02Jun2021 at 14:42 (35 minutes after the vaccination), the patient experienced dyspnea, Dyspnoea with chest, BP 159/51. On 02Jun2021 (the day of vaccination, as reported), the outcome of the events were recovered. The course of the event was as follows: 30 minutes after the vaccination (as reported), the patient experienced dyspnea with chest. BP was 159/51, SpO2 was 97%. The patient had a rest in the bed and then was injected 500ml saline solution intravenous drip, polaramine of 5mg and Famotidine of 20mg Intravenous Injection. The symptoms improved after 5 minutes. BP became 144/49, and SpO2 was 96% 30minutes later. The patient left after confirmed the symptoms were not exacerbated. The reporting pharmacist classified the events as non-serious and assessed that the events were related to BNT162B2. Other possible cause of the event such as any other diseases was dyspnoea of chest due to the heart disease.


VAERS ID: 1409201 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Inflammation, Leukocytosis, Pyrexia, Renal failure, Rhabdomyolysis
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: ARIPIPRAZOLE EG; FLUVOXAMINE MALEATE; ATELEC; AKINETON [BIPERIDEN HYDROCHLORIDE]; TEGRETOL CR; MAGNESIUM OXIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Renal failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: blood test; Result Unstructured Data: Test Result: CPK=2,189u/LILLEGIBLE High ug/L; Comments: CPK=2,189u/L High; CRP=13.25mg/uL High; WBC=10260 High; BON 49.6 mg/uL High; Cr 1.93mg/uL High; eGFRcr = 27ml/min Low; Test Name: Body temperature; Result Unstructured Data: Test Result: KT=37.5 Centigrade; Comments: KT=37.5 25days before vaccination; Test Name: Body temperature; Result Unstructured Data: Test Result: KT=37.5 Centigrade; Comments: KT=37.5 12days before vaccination; Test Date: 20210531; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result: KT=38.0 at 4:00 Centigrade; Comments: KT=37.8 at 14:00.
CDC Split Type: JPPFIZER INC2021651593

Write-up: Inflammatory reaction; Leukocytosis; Renal failure aggravated; Rhabdomyolysis; pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21111376. A 82-years-old male patient (reported as 82-year and 4-month-old) received bnt162b2 (COMIRNATY, Solution for injection, Lot ), dose 2 intramuscular on 31May2021 15:30 (Batch/Lot Number: EX3617; Expiration Date: 31Aug2021) as 2ND DOSE, SINGLE for covid-19 immunisation. Body temperature before vaccination was 36.4 degrees Centigrade. The patient had no family history.Medical history included chronic kidney disease, hypertension. Concomitant medications included aripiprazole (ARIPIPRAZOLE EG) Powder (1%) 0.6g; fluvoxamine maleate (FLUVOXAMINE MALEATE) (50) /tab; cilnidipine (ATELEC) (10)/ tab; biperiden hydrochloride (AKINETON [BIPERIDEN HYDROCHLORIDE]) 0.1g taken; carbamazepine (TEGRETOL CR) (50%) 0.2g; magnesium oxide (MAGNESIUM OXIDE). The patient experienced rhabdomyolysis (1 day 20 hours after the vaccination), on 02Jun2021 11:30, pyrexia on 02Jun2021 04:00; inflammatory reaction on 02Jun2021 13:59; leukocytosis on 02Jun2021 13:59; renal failure aggravated on 02Jun2021 13:59. The patient was hospitalized for the events on 09Mar2021 (before the vaccination), the patient was admitted to the hospital. to an unknown date. The patient underwent lab tests and procedures which included blood test: cpk=2,189u/lillegible high ug/l on 02Jun2021, CPK=2,189u/L High, CRP=13.25mg/uL High, WBC=10260 High, BON 49.6 mg/uL High, Cr 1.93mg/uL High eGFRcr = 27ml/min Low, body temperature: 36.4 before vaccination centigrade on 31May2021 KT=37.5 25days before vaccination, KT=37.5 12days before vaccination , body temperature: kt=38.0 at 4:00 centigrade on 02Jun2021 KT=37.8 at 14:00. Therapeutic measures were taken as a result of rhabdomyolysis, pyrexia, inflammatory reaction, leukocytosis, renal failure aggravated. ''On 02Jun2021 (after the vaccination), the outcome of the event was unknown for the above treatment was just started'' The clinical outcome of the events was unknown. Pyrexia within the last one month: KT=37.5 (25days before vaccination); KT=37.5(12days before vaccination). The course of the event was as follows: On 31May2021 at 15:30, the patient received the second dose of COMIRNATY, Solution for injection via intramuscular. On 02Jun2021 at 04:00, pyrexia KT=38.0 appeared, and Antipyretic with ALPINY SUPPOSITORIES (200) 1p/1x. At 2:00 PM (14:00) on the same day, KT=37.8. Due to insufficient Antipyretic , blood test was done at 11:30 AM on the same day. The blood test result came at 13:59 (02Jun) , CPK=2,189u/L High, CRP=13.25mg/uL High, WBC=10260 High, High CPK level, enhanced Inflammatory reaction, Hyperleukocytosis, Condition aggravated(Renal failure chronic), BON 49.6 mg/uL High, Cr 1.93mg/uL High, eGFRcr = 27ml/min Low.Therefore, with 1000 ml / day Fluid replacement (Replas 1 Injection) and Cefon intravenous drip was started (100 ml of ISOTONIC SODIUM CHLORIDE + SBT/CPZ 100g x 2/ day). The reporting physician classified the event as serious and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was considered to be a side reaction of the community intramuscular injection Pfizer because the timing and because there was nothing else that causes the onset of the event.


VAERS ID: 1409202 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriogram, Cardiac ventriculogram left, Chest pain, Echocardiogram, Electrocardiogram, Myocardial infarction, Stress cardiomyopathy
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Coronary angiography; Result Unstructured Data: Test Result:there was no coronary artery stenosis; Test Date: 20210602; Test Name: Cardiac ventriculogram left; Result Unstructured Data: Test Result:patient was diagnosed as Tako-Tsubo cardiomyopathy; Test Date: 20210602; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:showed side wall motion abnormalities; Test Date: 20210602; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:showed ST elevated guided by I-aVl and ST depresse; Comments: showed ST elevated guided by I-aVl and ST depressed guided by III-aVF
CDC Split Type: JPPFIZER INC2021651630

Write-up: there was a high probability of Myocardial infarction; Tako-Tsubo cardiomyopathy; Chest pain; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21111408. A 71-year and 10-month-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 02Jun2021 at 15:00 (Lot Number: FA7338; Expiration Date: 30Sep2021), at the age of 71 years, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The family history of this patient was UNKNOWN. Whether patient had primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status was unknown. On 02Jun2021 at 15:15, the patient experienced there was a high probability of myocardial infarction, tako-tsubo cardiomyopathy, and chest pain. The events caused hospitalization on 02Jun2021. The clinical course was reported as follows: On 02Jun2021 at 15:00 (the day of vaccination), the patient received?the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 02Jun2021 at 15:15 (15 minutes after the vaccination), the patient experienced Chest pain. On 02Jun2021, the patient was admitted to the hospital. On 04Jun2021 (2 days after the vaccination), the outcome of the event was not recovered. The course of the event was as follows: 15 minutes after the vaccination, the patient felt chest pain and went for treatment. The electrocardiogram showed ST elevated guided by I-aVl and ST depressed guided by III-aVF. Cardiac ultrasound showed side wall motion abnormalities and it was considered that there was a high probability of Myocardial infarction. Patient was urgently transported to the hospital. Although the Coronary angiography was urgently performed, there was no coronary artery stenosis. A Cardiac ventriculogram left was also performed, and the patient was diagnosed as Tako-Tsubo cardiomyopathy. The clinical outcome of the events there was a high probability of Myocardial infarction, Tako-Tsubo cardiomyopathy, and chest pain was not recovered. The reporting physician classified the events as serious (Hospitalization from 02Jun2021) and assessed the causality between the events and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Relationship with COVID-19 vaccine could not be ruled out and it was very likely to be related.


VAERS ID: 1409213 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Eczema, Erythema, Oral mucosal erythema, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021653702

Write-up: Generalised urticaria/7-8 places wheals on waist, 7-8 places 1cm wheals on left forearm, on the back of two lower legs for one place and on the inside of two ankles; Oral redness(Pharynx); redness on right lower leg of 3-5cm and on front of two thighs/redness in back head and area covered with hair; Eczema inside of right upper arm of 5x5cm, low back and back of 5x5cm, whealslike eczema(1cm), forehead, few on front chest, 5-6 places of abdomen, front of two thighs, 3-5cm on right lower leg; Generalized pruritus; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21111412 and from contactable physician via Pfizer company representative.. The patient was a 72-year and -2month-old male. Body temperature before vaccination was 35.8degrees Centigrade. The patient didn''t have history of underlying diseases and allergies. On 01Jun2021 at 10:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY0779 Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 02Jun2021 in the morning (one day after the vaccination), the patient experienced the reported events. On 03Jun2021 (two days after the vaccination), the outcome of the event was not recovered. The course of the event was as follows: The patient experienced Eczema on the inside of right upper arm of 5x5cm, low back and back of 5x5cm, whealslike eczema(1cm), Oral redness (Pharynx), eczema on forehead, few on front chest, 5-6 places of abdomen, redness accompanied with eczema on front of two thighs, 3-5cm on right lower leg, one place on the back of two lower legs, two places on the inside of two ankles, 7-8 places wheals on waist, 7-8 places 1cm wheals on left forearm. (mentholatum-eczema ointment on the market was applied.) 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: taking AE as generalized urticaria, please do detailed research. On 01Jun2021 (the day of vaccination), the patient received bnt162b2 (COMIRNATY, Solution for injection) via intramuscular at 0.3 ml daily for COVID-19 immunization. On 02Jun2021 (one day after the vaccination), the patient experienced generalized urticarial, event outcome was unknown on 03Jun2021. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. Event name: Generalised urticarial Discovery: On 01Jun2021 at about 10:00 (the day of vaccination, Tuesday), the patient received the first dose of bnt162b2 (COMIRNATY). and planed to receive the second dose of bnt162b2 (COMIRNATY) on 23Jun2021. On 01Jun2021(one day after the vaccination, Wednesday), the patient experienced generalized pruritus and generalised urticarial symptoms. The patient said that eczema began to appear from the legs, the scope of symptoms gradually spread to the whole body, and accompanied by redness symptoms (some areas showed wheal like). Right upper arm inside 5 x 5cm / low back and back of 5 x 5 cm wheals like (about 1 cm size) / Oral redness (+) / redness in back head and area covered with hair (+) / forehead, front chest (+) / abdomen 5-6 places / front of bilateral thighs (+) / eczema in right leg, And accompanied with 3 ~ 5mg of redness (+) / 1 in the back of the leg / 2 in the medial malleolus of both legs (+) / 7 ~ 8 in the waist (+) / 7 ~ 8 about 1cm of the left forearm wheals (+) It was reported that the vaccinated patient smeared Mentholatum on the market. I''m very sorry to disturb you in your busy schedule. Please check it. current prescription: Talion OD10mg 2 tablets twice: in the morning and after dinner (5 days amount) Pfizer considered giant urticaria an Important Medical Event. Follow up information has been requested.


VAERS ID: 1409247 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Diarrhoea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: temperature; Result Unstructured Data: Test Result:40 Centigrade
CDC Split Type: MXPFIZER INC2021655836

Write-up: 40 degree temperature; vomit; diarrhea; This is a spontaneous report from a non-contactable consumer (patient''s parent) via a Pfizer-sponsored program, Corporate Web Site, social media. A 14-year-old male patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on 31May2021, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 02Jun2021, the patient experienced 40 degree temperature, vomit and diarrhea. What distress. The parent took patient to emergency room. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1409302 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Hemihyperaesthesia, Hemiparesis, International normalised ratio, Lacunar infarction, Magnetic resonance imaging, Platelet count, Prothrombin time
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

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: CHOLECALCIFEROL; ETHINYLESTRADIOL/LEVONORGESTREL
Current Illness: Endometriosis; Ex-smoker; Familial risk factor
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: MRI; Result Unstructured Data: semirecent ischemia in right central semiovale; Test Name: C-reactive protein; Result Unstructured Data: 10; Test Name: Prothrombin time; Result Unstructured Data: 10.6 S; Test Name: INR; Result Unstructured Data: 1.0; Test Name: Platelet count; Result Unstructured Data: 342 /nL
CDC Split Type: NLJNJFOC20210623220

Write-up: CEREBRAL INFARCTION MRI SHOWED SEMI-RECENT ISCHEMIA SEEN AT RIGHT SEMIOVAL CENTER; SENSITIVITY SYMPTOMS OF LEFT HALF OF THE BODY; REDUCED CONTROL OF THE LEG; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00567578] concerned a 52 year old female. The patient''s weight was 64 kilograms, and height was 165 centimeters. The patient''s concurrent conditions included familial risk factor, endometriosis and ex-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose was not reported, 1 total administered on 01-JUN-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included colecalciferol, and ethinylestradiol/levonorgestrel. On 02-JUN-2021, patient experienced sensitivity symptoms of the left half of the body which also meant reduced control of the leg. On the same day, the patient had cerebral infarction. The Magnetic resonance imaging (MRI) showed semi-recent ischemia seen at right semioval center. On unspecified date, patient was hospitalized. The number of days, patient hospitalized was not reported. Laboratory data (dates unspecified) included: C-reactive protein (NR: not provided) 10, international normalized ratio (INR) (NR: not provided) 1.0, MRI (NR: not provided) semi recent ischemia in right central semiovale, Platelet count (NR: not provided) 342 /nL, and Prothrombin time (NR: not provided) 10.6 S. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sensitivity symptoms of left half of the body, reduced control of the leg, and cerebral infarction MRI showed semi-recent ischemia seen at right semioval center. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0-20210623220-Covid 19 Vaccine- Cerebral infarction MRI showed semi-recent ischemia seen at right semioval center, sensitivity symptoms of left half of the body,reduced control of the leg. 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: 1409338 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-06-02
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: covid positive; Test Result: Positive
CDC Split Type: PHPFIZER INC2021685462

Write-up: Covid Positive; Covid Positive; This is a spontaneous report from a contactable pharmacist. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300081500. An 85-year-old female patient received bnt162b2 (COMIRNATY), unknown dose at the age of 85-year-old intramuscularly on 18May2021 (Batch/Lot Number: EY4834) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced covid positive on 02Jun2021 at 16:00. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1410654 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8889 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Abdominal rigidity, Diarrhoea, Investigation, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), 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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MAGNESIUM; CBD OIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pollen allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210517; Test Name: Rapid test; Test Result: Negative ; Comments: Nasal Swab; Test Name: COVID-19 test; Result Unstructured Data: Test Result:result not provided; Comments: after vaccination
CDC Split Type: DEPFIZER INC2021656495

Write-up: Hospitalization due to severe spasmodic pain in the upper abdomen; Hospitalization due to severe spasmodic pain in the upper abdomen; Diarrhea; This is a spontaneous report from a contactable consumer. A 38-year-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm at age of 38-year-old on 29May2021 21:30 (Lot Number: FC8889) as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Patient had pollen allergy. 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. Concomitant medications included magnesium taken for an unspecified indication, start and stop date were not reported; cannabidiol (CBD OIL) as drops taken for an unspecified indication, start and stop date were not reported and monk pepper taken for an unspecified indication, start and stop date were not reported. The patient historical vaccination included first dose of bnt162b2 (COMIRNATY), received on 17Apr2021 22:30 (Batch/Lot Number: EW8904), administered in arm left for COVID-19 immunisation. On 02Jun2021 15:00, patient experienced hospitalization due to severe spasmodic pain in the upper abdomen and hospitalization due to diarrhea. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included investigation: negative on 17May2021 nasal swab, SARS-CoV-2 test: result not provided on an unspecified date after vaccination. Therapeutic measures were taken as a result of the events included Pantoprazole, pain relievers, gastroscopy. Events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.


VAERS ID: 1411110 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D013A / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Inappropriate schedule of product administration, Insomnia, Loss of control of legs, Pain
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hereditary neuropathy with liability to pressure palsies (Diagnosed since 1997 and triggered by vaccination.)
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021693250

Write-up: Inappropriate schedule of vaccine administered; Persistent severe pain; Insomnia; Headache; Control loss of the legs; This is a spontaneous report from a contactable consumer or other non HCP. A 56-year-old male patient received second dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 1D013A; Expiration Date: unknown) via an unspecified route of administration, administered in arm right on 02Jun2021 12:30 (at the age of 56 years old) as single dose for COVID-19 immunization. Medical history included hereditary neuropathy with pressure palsies from 1997 and ongoing (diagnosed since 1997 and triggered by vaccination). The patient concomitant medications were reported as yes. Past drug allergy was reported as cortisone. Patient had previously received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EX3510; Expiration Date: unknown) via an unspecified route of administration, administered in arm right on 22Mar2021 12:30 as single dose for COVID-19 immunization. On 02Jun2021 at 01:00 patient experienced control loss of the legs, 00 persistent severe pain, insomnia and headache. On unspecified date patient had inappropriate schedule of vaccine administered. Patient had persistent severe pain and control loss of the legs, as well as insomnia and headache now over 12 days. The event control of loss of legs was serious as the event was medically significant. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient was not diagnosed with COVID-19 prior and since the vaccination. Therapeutic measures were taken as a result of control loss of the legs, persistent severe pain and headache as patient received Lyrica. The outcome for the events loss of control of legs, pain, insomnia and headache was reported as not recovered and inappropriate schedule of product administration with outcome of unknown.


VAERS ID: 1411149 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-06-02
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Immunology test, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Elisa test; Result Unstructured Data: Test Result:IgG +; Test Date: 20210413; Test Name: covid-19 antibody test; Test Result: Positive ; Test Date: 20210602; Test Name: PCR; Test Result: Positive
CDC Split Type: ESPFIZER INC2021669681

Write-up: PCR on 02Jun2021 and it tests positive; PCR on 02Jun2021 and it tests positive; This is a spontaneous report from a contactable consumer via a Pfizer Sponsor Program. A 92-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on 26Mar2021 (Lot Number: ER9470) as second dose, single and dose 1 via an unspecified route of administration on 03Mar2021 (Lot Number: EP9598) as first dose, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. 20 days after the second dose, on 13Apr2021, antibody test was positive and a quantitative immunoassay was performed, which gave IgG +. Shortly after patient was infected. Patient was ordered a PCR on 02Jun2021 and it tests positive. Patient had 4 days quite bad and had a bad time. Reporter said that event is a vaccine failure, an infection that has occurred by breaking the vaccine barriers.The outcome of the event was unknown.


VAERS ID: 1411369 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649261

Write-up: Bleeding; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106020913160430-NFRGJ, Safety Report Unique Identifier GB-MHRA-ADR 25403258 A 33-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 01Jun2021 (Lot number and expiration date not reported) as single dose for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced bleeding on 02Jun2021 with outcome of recovering. The event was assessed as non-serious by regulatory authority. Additional Information: Started a period type bleed. Other than the feel fine. 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.


VAERS ID: 1411374 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Dyspnoea, Feeling abnormal, Lethargy, Nausea, Pain, Pain of skin, Pyrexia, SARS-CoV-2 test, Sensitive skin
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (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: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Dislocation of knee (since the age of 14); Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210602; Test Name: temperature; Result Unstructured Data: Test Result:possible slight temperature
CDC Split Type: GBPFIZER INC2021649181

Write-up: nausea; breathlessness; Sensitive skin; pain on entire left side of body; painful skin to the touch; Feeling slightly dumb; Painful joints; Lethargic; Possible slight temperature; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106021135587940-6Y1CO, Safety Report Unique Identifier GB-MHRA-ADR 25404471. A 33-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 (Lot number and expiry date were not reported) as single dose for COVID-19 immunisation. Medical history included lactation decreased, multiple knee dislocations since the age of 14, and anxiety. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant at the time of the vaccination. Patient is not currently breastfeeding. Concomitant medication included sertraline taken for anxiety. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), on unspecified date for COVID-19 immunisation. The patient woke up the morning of 02Jun2021 with these side effects: pain on entire left side of body, slight nausea, sensitive and painful skin to the touch, feeling slightly dumb, painful joints, breathlessness, lethargic, and possible slight temperature. The patient had negative COVID-19 virus test on unspecified date. The outcome of the events nausea and breathlessness was recovering, for the event sensitive skin was not recovered, while for the other events was unknown. The case has been considered serious due to seriousness criterion of other medically important condition. No follow-up attempts are possible; information about lot number cannot be obtained.


VAERS ID: 1411380 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Dizziness, Heart rate, Hyperhidrosis, Investigation, Oxygen saturation, Oxygen saturation decreased, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (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: 20210602; Test Name: Pulse; Result Unstructured Data: Test Result:70; Test Date: 20210602; Test Name: examination; Result Unstructured Data: Test Result:Chest slight wheeze; Test Date: 20210602; Test Name: Oxygen saturation; Test Result: 89 %; Test Date: 20210602; Test Name: Oxygen saturation; Test Result: 99 %
CDC Split Type: GBPFIZER INC2021655448

Write-up: Acute anaphylaxis; sweating; vomiting; felt faint; oxygen saturation 89%; chest slight wheeze; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106021354556200-9IVNX, and Safety Report Unique Identifier GB-MHRA-ADR 25405656. A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (Lot Number: EW3143) as 1st dose, single for COVID-19 immunisation. Patient has no significant history, and no medication. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications were reported as none. On 02Jun2021, the patient experienced acute anaphylaxis, sweating, vomiting, felt faint, oxygen saturation 89% and chest slight wheeze. The events were assessed as serious (medically significant) by the health authority. Case narrative: Acute anaphylaxis. Patient had Pfizer vaccine, approximately 5-10 minutes later, developed sweating, then profuse vomiting, felt faint. Laid down. On examination: pulse 70, oxygen saturation 89%, chest slight wheeze. Denied any feeling of dyspnoea or face/mouth swelling. Given oxygen, saturation recovered to 99% then stabilised without oxygen. Adrenaline not given. All Symptoms resolved over 30 minutes. Advised to be observed 24 hours, use antihistamine, and call 999 if worsens/returns. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included pulse: 70, examination: chest slight wheeze, oxygen saturation: 89 % and oxygen saturation: 99 %, all on 02Jun2021. The outcome of all the events was recovered on 02Jun2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411388 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypotension, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: 20210602; Test Name: blood pressure; Result Unstructured Data: Test Result:Low
CDC Split Type: GBPFIZER INC2021649556

Write-up: Low blood pressure; Immediate fainting; Convulsion; This is a spontaneous report. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 02Jun2021 (Batch/Lot Number: EW3143) as 1st dose, single for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. No issues since measles jab 34 years ago. Rang Dr before jab and they recommend it. The patient experienced low blood pressure on 02Jun2021 with outcome of recovering; immediate fainting, convulsion on 02Jun2021 with outcome of unknown. The events were assessed as serious and medically significant. The clinical course was reported as follows: Immediate fainting and convulsion Followed by extremely low blood pressure for 3 hours, couldn''t stand without fainting. Patient has not tested positive for COVID-19 since having the vaccine. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1411393 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hypersensitivity, Hypoaesthesia, Hypoaesthesia oral, Limb discomfort, Muscle tightness, Paraesthesia, Paraesthesia oral, Syncope, Tinnitus, Tonsillar hypertrophy
SMQs:, Torsade de pointes/QT prolongation (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BECLOMETHASONE [BECLOMETASONE]; MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis (controlled by using MICROGYNON 30); Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649672

Write-up: then the right side of my face started tingling about 20-25 minutes after my vaccination; feeling dizzy and muffled sound in my right ear; Allergic reaction; muffled sound in right ear; right side of my face started tingling...then it went numb/ right had side of my body started to tingle and went numb; right side of my face started tingling...then it went numb/ right had side of my body started to tingle and went numb; Lips numb and tingling; Lips numb and tingling; Right arm felt heavy; neck feels tight; tonsils are swollen; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-2021060 21947451350-NBHPY; Safety Report Unique Identifier is GB-MHRA-ADR 25408120. A 37-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW4109), via an unspecified route of administration, administered in left arm on 02Jun2021 10:00 (37-year-old at time of vaccination) as single dose for COVID-19 immunisation. Medical history included endometriosis (controlled by using MICROGYNON 30) and lactation decreased. Concomitant medications included beclometasone (BECLOMETHASONE); ethinylestradiol/levonorgestrel (MICROGYNON) taken for endometritis. The patient experienced "then the right side of my face started tingling about 20-25 minutes after my vaccination", "feeling dizzy and muffled sound in my right ear", and allergic reaction on 02Jun2021. Events were assessed as serious with criteria of Disabling/Incapacitating and Other medically important condition. Additional information: Had her vaccination, everything went well, waited 15 mins and then was told she could leave, she felt fine so did. Then the right side of her face started tingling about 20-25 minutes after her vaccination, then it went numb. Lips numb and tingling. Then the right had side of her body started to tingle and went numb. Right arm felt heavy. Feeling dizzy and muffled sound in her right ear, numb tingly head. her neck feels tight though no breathing difficulties. her tonsils are swollen. Had her injection at 10am today in her left arm and still have the reaction now at nearly 8pm. Called emergency medical advice number at 12pm, they informed her doctor who phoned me back. Her Doctor advised her to take strong antihistamines to counter the reaction. Saw the pharmacist at the chemist who said she''s to call EMS if the reaction gets any worse. Just waiting now to see if it gets any worse. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. The outcome of "then the right side of my face started tingling about 20-25 minutes after my vaccination" and "feeling dizzy and muffled sound in my right ear" was recovering; allergic reaction was not recovered; outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411398 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; 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 INC2021649315

Write-up: Pain stomach; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106030307505600-NZJSN. A 30-year-old female patient (not pregnant, not currently breastfeeding) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration on 02Jun2021 (lot number was not known) as a single dose for COVID-19 immunisation. Medical history included lactation decreased and depression. Concomitant medication(s) included citalopram taken for depression. The patient experienced pain stomach on 02Jun2021 with outcome of not recovered; assessed as serious medically significant. Lab data included COVID-19 virus test: negative (No - Negative COVID-19 test) on an unspecified date. The patient has not had symptoms associated with COVID-19 and 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: 1411403 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, Haemorrhage, Haemorrhoidal haemorrhage, Off label use, Product use issue
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLEXANE
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Cesarean section; Postoperative bleeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655663

Write-up: nose bleed; piles bled; Bleeding; received vaccine during breast feeding; received vaccine during breast feeding; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106030818495390-BTMPZ, Safety Report Unique Identifier GB-MHRA-ADR 25410074. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Jun2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing breast feeding, caesarean section, Post-surgery bleeding. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Concomitant medication included enoxaparin sodium (CLEXANE) taken for caesarean section from 17May2021 to 26May2021. The patient received vaccine during breast feeding. The patient experienced bleeding on 03Jun2021, nose bleed and piles bled on an unspecified date. the patient was 18 days post caesarean section. Post-surgery she had a few days of bleeding and then it stopped. However, during the night following the injection she began to bleed again, more heavily than before. She also had a nose bleed and piles bled this morning. Feel a bit concerned. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of event bleeding was not recovered; nose bleed was recovered and other events was unknown. The report was considered as serious as medically significant from regulatory authority. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021665293 Mother/baby case


VAERS ID: 1411415 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655682

Write-up: Tiredness; Headache; Pain in arm; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106030915285960-QMN2I, Safety Report Unique Identifier GB-MHRA-ADR 25410745. A 25-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), (Lot Number: EW3143) the first dose via an unspecified route of administration on 02Jun2021 as single dose for COVID-19 immunization. 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 pain in arm on 02Jun2021, tiredness on 03Jun2021, headache on 03Jun2021. Patient had not tested positive for COVID-19 since having the vaccine. The events were reported as serious due to medically significant. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411426 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Cough, Increased viscosity of upper respiratory secretion, Influenza like illness, Oropharyngeal pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: FLUTICASONE PROPIONATE; RELVAR ELLIPTA [FLUTICASONE FUROATE;VILANTEROL TRIFENATATE]; TERBINAFINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Atopic rhinitis; Flu; Fungal rash; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021655743

Write-up: Sore throat; Flu like symptoms; Aching in limb; Cough; Chest tightness; Thick nasal mucus; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106030943392740-Z7HCI. Safety Report Unique Identifier GB-MHRA-ADR 25411099. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot Number: EW4109) dose 1 via an unspecified route of administration at single dose on 01Jun2021 for COVID-19 immunization. Medical history included Flu, suspected COVID-19 from 01Mar2020 to 31Mar2020, steroid therapy (taking regular steroid treatment (e.g. orally or rectally)), Atopic rhinitis, asthma, Fungal rash. Patient is not enrolled in clinical trial. Concomitant medications included fluticasone propionate taken for Atopic rhinitis, start and stop date were not reported; fluticasone furoate, vilanterol trifenatate (RELVAR ELLIPTA) taken for asthma, start and stop date were not reported; terbinafine taken for Fungal rash from 27May2021 to an unspecified stop date. Historical vaccine included Flu vaccination on 2020. Patient had not tested positive for COVID-19 since having the vaccine. The patient was feeling well and no ok prior to vaccination. All began when woke up day after vaccine. On 02Jun2021, the patient experienced Sore throat, Flu like symptoms, Aching in limb, Cough, Chest tightness and Thick nasal mucus. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 02Jun2021. The outcome of all events was not resolved. All events are serious with medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411427 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Body temperature, Chills, Fatigue, Headache, Malaise, Pain, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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 Date: 20210602; Test Name: Temperature; Result Unstructured Data: Test Result:high; Test Date: 20210603; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655385

Write-up: unwell; Upper abdominal pain; body aches/achey; feeling tired; High temperature; Shivers; Headache; Joint ache; Injection site pain; 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-202106030957033360-5E1HK, Safety Report Unique Identifier: GB-MHRA-ADR 25411096. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Jun2021 (lot number: ET8885) at 2nd dose, single for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced unwell and upper abdominal pain on an unspecified date; and high temperature, shivers, headache, joint ache, and injection site pain on 02Jun2021. Clinical course reported: injection site pain only until around 10 hours after vaccination; then shivers, body aches & high temp treated with paracetamol through night. Temperature gone by morning, just left feeling tired and achey. Mild overall but enough to feel unwell. 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 03Jun2021. The outcome of the events shiver was recovered on 02Jun2021; high temperature, headache, joint ache, and injection site pain was recovered on 03Jun2021; unwell and upper abdominal pain was recovering; and body aches/achey and feeling tired was unknown. Regulatory authority assessed the events as serious for being medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411432 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Generalised anxiety disorder; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655673

Write-up: Muscle pain; 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-MHRA-WEBCOVID-202106031044232120-PPXJ1, Safety Report Unique Identifier GB-MHRA-ADR 25411513. A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch and Lot number was provided), via an unspecified route of administration at single dose on 02Jun2021 for COVID-19 immunization. Medical history included lactation decreased and generalised anxiety disorder. Concomitant medications included sertraline (Manufacturer unknown) taken for generalised anxiety disorder from 01Jun2020. The patient experienced muscle pain on 02Jun2021, fatigue on 02Jun2021. The events were reported as serious due to medically significant. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411443 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Gout, SARS-CoV-2 test
SMQs:, Arthritis (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655357

Write-up: Gout; This is a spontaneous report from a contactable consumer. The regulatory authority report number is GB-MHRA-WEBCOVID-202106031125000670-EAA03. Safety Report Unique Identifier GB-MHRA-ADR 25411771. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE 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. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced gout on 02Jun2021 with outcome of not recovered. The event was assessed as serious (medically significant). Lab data includes COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1411451 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Gait disturbance, Joint stiffness
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655317

Write-up: Joint ache/Severe joint pain in big toe; unable to bend it or walk properly; unable to bend it or walk properly; This is a spontaneous report. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Ew3143), via an unspecified route of administration on 02Jun2021 (at the age of 34 years old) as first 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 and has not had a COVID-19 test. He was not enrolled in clinical trial. On 02Jun2021, the patient experienced joint ache, unable to bend it or walk properly. The events were reported as serious, per other medically important condition. The clinical course was reported as follows: Severe joint pain in big toe, unable to bend it or walk properly Patient has not tested positive for COVID-19 since having the vaccine. The outcome of joint ache was not recovered. The outcome of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1411468 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Fatigue, Headache, Hyperhidrosis, Malaise, Myalgia, Oxygen saturation, Pyrexia, SARS-CoV-2 test
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), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Name: oxygen saturation level; Test Result: 87 %; Test Date: 20210215; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021655722

Write-up: chills; Fever/body temperature on 02Jun2021: 39 centigrade; Fatigue; Headache; Muscle ache; Fever chills; Sweats; Unwell; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202106031439147620-AWJYZ. Safety Report Unique Identifier is GB-MHRA-ADR 25413624. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 01Jun2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included COVID-19 in Feb2021. Patient had not had symptoms associated with COVID-19 (as reported). Concomitant medications were not reported. The patient experienced chills, fever, fatigue, headache, muscle ache, fever chills, sweats and unwell all on 02Jun2021. All events were reported as medically significant. The patient underwent lab tests and procedures which included body temperature on 02Jun2021: 39 centigrade; oxygen saturation level on an unknown date: 87 %; COVID-19 virus test on 15Feb2021: yes - positive covid-19 test. The outcome of events chills, sweats and unwell was unknown; of remains events was recovering. The clinical course was reported as follows: His body temperature was 39 degrees for two mornings after vaccination and he was so unwell that he spent the entire day proceeding the vaccination in bed with chills and sweats. He had to take two days off work as was in no fit state to attempt anything other than rest. He tested positive for COVID19 in February 2021 with symptoms lasting for around 3 weeks and at its worse, oxygen saturation level of 87 percent. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411470 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Feeling drunk
SMQs:, Anticholinergic syndrome (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 INC2021655416

Write-up: Dizziness; Feeling drunk; This is a spontaneous report from a contactable consumer received from the regulatory authority, report number is GB-MHRA-WEBCOVID-202106031441350220-RQHKD. Safety Report Unique Identifier GB-MHRA-ADR 25413545. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (Batch/Lot Number: Ew3143-L690) (at the age of 26-years-old) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced dizziness and feeling drunk on 02Jun2021. The events were reported as serious (medically significant). The clinical course was reported as follows: started with a feeling of slight dizziness. Progressed to the point of feeling intoxicated. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of dizziness was recovering while not recovered for feeling drunk. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411474 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Nausea, Pain, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: CITALOPRAM; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Headache
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655287

Write-up: Fatigue; Nausea; Vomiting; localised pain around injection site developed a few hours after injection; Pain localised; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106031459186250-K82IJ. Safety Report Unique Identifier GB-MHRA-ADR 25413791. A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (Batch/Lot number was not reported) at the age of 31 years old, as single dose for Covid-19 immunisation. Medical history included depression, and headache. Patient has not had symptoms associated with COVID-19; has not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medications included citalopram taken for depression from 17Jan2021 to an unspecified stop date; paracetamol taken for headache, start and stop date were not reported. The patient experienced pain localized and localised pain around injection site which developed few hours after injection on 02Jun2021; fatigue, nausea, and vomiting on 03Jun2021. The events were reported as medically significant. Outcome of the event vaccination site pain was recovered on an unknown date; while the rest of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411475 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial bones fracture, Investigation, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Tests; Result Unstructured Data: Test Result:all tests came back negative
CDC Split Type: GBPFIZER INC2021655331

Write-up: Seizure; Fainting; Broke nose; This is a spontaneous report from a contactable pharmacist. Regulatory authority report number GGB-MHRA-WEBCOVID-202106031512308350-TSKUA, Safety Report Unique Identifier GB-MHRA-ADR 25413845. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (Batch/Lot number: Not known) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19, not had a COVID-19 test and unsure if patient was enrolled in clinical trial. On 02Jun2021, the patient experienced seizure and fainting. The clinical course was also reported as follows: Multiple seizures - non epileptic patient, passed out and broke nose. The events were considered serious, medically significant. It was reported that patient went to accident and emergency (A+E). The patient underwent lab tests and procedures which included tests (unspecified): all tests came back negative on unknown date. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events seizure and fainting was recovered on 02Jun2021, while outcome of broke nose was unknown. Report was not related to possible blood clots or low platelet counts. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411476 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN
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 INC2021655654

Write-up: fainting; Near fainting; Excess sweating/sweating; This is a spontaneous report from a contactable consumer (patient) received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202106031521168010-EERHH, Safety Report Unique Identifier GB-MHRA-ADR 25413925. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Jun2021 (at the age of 32-year-old) (Lot Number: ET8885) as 1st dose, single for covid-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial. Concomitant medication included atorvastatin taken for Familial hypercholesterolemia. The patient experienced fainting and sweating on an unspecified date; near fainting and excess sweating on 02Jun2021. Immediately after receiving the vaccine whilst sitting before being able to leave the patient began sweating profusely. The patient also then started to get the typical signs of fainting: felt very hot, vision became obscured by white spots and could hear a ringing in ears. The patient managed to control breathing and eventually this feeling passed after about ten minutes. The patient did not know if the vaccine caused this response or if the situation caused it as it was a hot day and the patient had walked to the vaccination center. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests included sars-cov-2 test: no - negative covid-19 test on unknown date. Outcome of events were recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411478 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pyrexia, SARS-CoV-2 test, Tremor, Vaccination site mass, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655563

Write-up: Injection site lump; Injection site pain; Shaking of hands; Fever; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106031532406870-M1NB9, Safety Report Unique Identifier GB-MHRA-ADR 25414451. A 19-year-old female patient received BNT162B2 (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ET8885, expiry date not reported), via an unspecified route of administration on 02Jun2021 (at the age of 19-year-old) as first dose, single 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 02Jul2021, injection site lump, injection site pain and shaking of hands 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 (No - Negative COVID-19 test) on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The patient has not recovered from injection site lump and injection site pain, recovering from fever, recovered from shaking of hands. No follow up attempts are possible. No further information is expected.


VAERS ID: 1411485 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-06-02
   Days after vaccination:152
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Pneumonitis, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DEXAMETHASONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started); Comments: Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021655270

Write-up: pneumonitis/ SARS-CoV-2 infection/ COVID-19 PCR test positive; SARS-CoV-2 infection; pneumonitis; COVID-19 PCR test positive; This is a spontaneous report from a contactable physician.This is a report received from the Regulatory Authority.The regulatory authority report number is GB-MHRA-WEBCOVID-202106031605154930-OZERK,Safety Report Unique Identifier GB-MHRA-ADR 25414304. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 (Batch/Lot Number: not known) as 2ND DOSE, SINGLE and via an unspecified route of administration in Dec2020 (Batch/Lot Number: not known) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included suspected COVID-19 (unsure when symptoms started) on an unspecified date. Patient is not enrolled in clinical trial. Concomitant medication included dexamethasone taken for an unspecified indication, start and stop date were not reported. On 02Jun2021, the patient experienced pneumonitis, SARS-CoV-2 infection, and COVID-19 PCR test positive. It was reported that patient presented on unspecified date in 2021 to hospital, had COVID pneumonitis, whole family also lateral flow positive. Patient briefly had oxygen (O2) supplementation, now off O2, and on co-amoxiclav and dexamethasone. The events were considered serious, medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: yes - positive covid-19 test on 02Jun2021. The outcome of the events was recovering at the time of report. Report not related to possible blood clots or low platelet counts. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411490 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Body temperature, Dysgeusia, Fatigue, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655739

Write-up: nausea; Body temperature; Fatigue; Loss of taste; Metalic taste in mouth; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority, report number is GB-MHRA-WEBCOVID-202106031636238190-AHQSM. A 28-year-old male patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH), dose 1 via an unspecified route of administration on 02Jun2021 as 1st dose single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea on an unspecified date, metalic taste in mouth on 02Jun2021 14:00-16:00, loss of taste on 02Jun2021 18:00, body temperature, fatigueon 03Jun2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Jun2021 No - Negative COVID-19 test. The outcome of the event nausea was unknown, the outcome of theother events was not resolved. No follow up attempts are possible; Information about lot/batch number cannot be obtained.


VAERS ID: 1411556 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Disorientation, Hyperhidrosis, Maternal exposure timing unspecified, Nausea, Paraesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypotonic-hyporesponsive episode (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655704

Write-up: nausea; Feeling faint; sweating; Disorientated; tingling; Maternal exposure during pregnancy; Anxiety; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106031819432390-8NMN7. Safety Report Unique Identifier GB-MHRA-ADR 25415402. A 32-year-old female patient (pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA5843), dose 1 via an unspecified route of administration on 02Jun2021 (at the age of 32 years old, pregnant) at single dose for COVID-19 immunisation. Medical history included pregnancy from an unknown date and not ongoing: Patient no longer pregnant at the time of reporting. The patient''s concomitant medications were not reported. The patient experienced nausea, feeling faint, Sweating, disorientated and tingling on an unspecified date; maternal exposure during pregnancy and Severe anxiety on 02Jun2021. Patient had not tested positive for COVID-19 since having the vaccine. The medicine didn''t have an adverse effect on any aspect of the pregnancy. The outcome of the event anxiety was not recovered, of the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411560 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Neck pain, Pain in extremity, Pain in jaw, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655713

Write-up: Swollen glands; Under arm pain in left arm; Swelling in armpit; Pain extending now to left side of neck/jaw; Pain extending now to left side of neck/jaw; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106031824490480-PXPKC. Safety Report Unique Identifier is GB-MHRA-ADR 25415423. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 26May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced swollen glands (medically significant) on 02Jun2021, under arm pain in left arm (medically significant) in 2021, swelling in armpit (medically significant) in 2021, pain extending now to left side of neck/jaw (medically significant) in 2021. The outcome of event swollen glands was not recovered. The outcome of other events was unknown. The clinical course was reported as follows: Under arm pain in left arm. Swelling in armpit. Pain extending now to left side of neck/jaw. Patient has not tested positive for COVID-19 since having the vaccine. Suspect Reactions. Please provide details of any relevant investigations or tests conducted: "Pharmacy advised pain relief and Gp appointment if it doesn''t subside in next few days. " No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411590 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: Flu; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655459

Write-up: Sore throat; Cough; Fatigue; Headache; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency. The regulatory authority report number is (GB-MHRA-WEBCOVID-202106032219480160-JAT6R), Safety Report Unique Identifier is (GB-MHRA-ADR 25417189). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (lot number not known) (at the age of 40-years-old) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient''s medical history included lactation decreased and flu on unspecified dates. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not pregnant and not currently breastfeeding. The patient''s concomitant medications were not reported. Historical vaccine included flu vaccine on unspecified date for immunization and reported previous reaction to flu vaccine that lasted months, never fully investigated by the GP in order to understand what happened. It was reported that immune system was depleted. On 02Jun2021, the patient experienced headache and fatigue. On 03Jun2021, the patient experienced sore throat and cough. The events were considered serious, medically significant. The outcome of all 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: 1411593 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Mastitis
SMQs:, Functional lactation 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: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655547

Write-up: mastitis; This is a spontaneous report from a contactable consumer received from the RA. The regulatory authority report number is GB-MHRA-WEBCOVID-202106032242094960-GNTXP. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on 30May2021 (batch/lot number and expiry date unknown) as 1st dose, single for covid-19 immunization. Medical history included pregnancy. The patient has not had symptoms associated with COVID-19, not had a COVID-19 test, was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced mastitis (medically significant) on 02Jun2021 with outcome of not recovered. The 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.


VAERS ID: 1411605 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Balance disorder, Chest pain
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), 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 INC2021655634

Write-up: Chest pain; Loss of balance; Back pain; This is a spontaneous report from a contactable consumer. This is a report received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202106040108233010-1AFDF, Safety Report Unique Identifier GB-MHRA-ADR 25417467. A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Jun2021 (at 21 years old of vaccination) as 1st 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. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced chest pain on 03Jun2021, back pain on 02Jun2021, loss of balance on 03Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of event Back pain was not recovered, and other events were recovering. This report was serious and with seriousness criteria of medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411631 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Limb injury
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LUSTRAL
Current Illness:
Preexisting Conditions: Comments: No relevant Medical history Reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Arm injury; This regulatory authority case was reported by a consumer and describes the occurrence of LIMB INJURY (Arm injury) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No relevant Medical history Reported. Concomitant products included SERTRALINE HYDROCHLORIDE (LUSTRAL) from 13-Jan-2021 to an unknown date for Depression. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced LIMB INJURY (Arm injury) (seriousness criterion medically significant). At the time of the report, LIMB INJURY (Arm injury) had resolved with sequelae. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The treatment medications were 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: 1411637 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021683496

Write-up: Shingles; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106091749494640-9ORP7. A 32-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown, Expiration Date: unknown), dose 1 via an unspecified route of administration on 02Jun2021 as 1st dose, single dose for covid-19 immunisation (age at vaccination: 32-years-old). The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test and was not enrolled in clinical trial. On 02Jun2021 patient experienced shingles. Hard know exactly date when shingles symptoms started but was around the same time as the vaccine. The event was considered as serious as other medically important condition. The patient was not tested positive for COVID-19 since having the vaccine. The outcome of the events was reported as not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411646 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pain in extremity, Rash
SMQs:, Anaphylactic reaction (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Headache; Sore arm; Rash; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH (Rash) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) (seriousness criterion medically significant) and RASH (Rash) (seriousness criterion medically significant). On 11-Jun-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH (Rash) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the 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: 1411651 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACYCLOVIR [ACICLOVIR]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021709882

Write-up: Shingles; This is a spontaneous report from a contactable consumer. This is a report received from a Regulatory Authority . Regulatory authority report number {GB-MHRA-WEBCOVID-202106141900150570-YI3NX} Safety Report Unique Identifier {GB-MHRA-ADR 25472509}. A 32-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and expiration date: not reported) via an unspecified route of administration on 27May2021 as single dose for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test and was not enrolled in clinical trial. Concomitant medication included acyclovir. On 02Jun2021 patient experienced shingles. Patient had standard shingles symptoms on leg. Therapeutic measures were taken as a result of shingles and included acyclovir. The outcome of the event shingles was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411702 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Adverse drug reaction
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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC2021684966

Write-up: COMMON SIDE EFFECTS; This is a spontaneous report from a non-contactable health professional via Regulatory Authority (regulatory authority report number: not provided), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS002095), license party for bnt162b2(COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. In the 24 hours ending at 00:00 on 03Jun2021, there were six cases of ambulance transfer to hospital from Community Vaccination Centres or designated general out-patient clinics of the Hospital Authority. A patient with unknown age and gender experienced common side effects after vaccination on 02Jun2021 and was sent to hospital. Common side effects were met the seriousness criterion of hospitalization. As of 00:00 on 03Jun2021, the patient was in stable condition and discharged against medical advice. At the time of the report, the outcome of the event was unknown. Initial report was received on 04Jun2021. This is one of six reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS002090 (master case), 2021FOS002092, 2021FOS002093, 2021FOS002094, 2021FOS002095 and 2021FOS002096. No further follow-up information was available. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-2021684959 same drug, same event and different patient


VAERS ID: 1411836 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Feeling abnormal, Headache, Heart rate, Nausea, Oxygen saturation, Pallor, Vomiting
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GLIMEPIRIDE; PIOGLITAZONE; PITAVASTATIN; AMLODIPINE; ESOMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Dyslipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: blood pressure; Result Unstructured Data: Test Result:126/68 mmHg; Test Date: 20210602; Test Name: pulse; Result Unstructured Data: Test Result:81; Comments: /min; Test Date: 20210602; Test Name: SPO2; Test Result: 97 %
CDC Split Type: JPPFIZER INC2021642075

Write-up: Feels poorly; Queasy; Occipital headache; Complexion ill; vomiting; This is a spontaneous report from a contactable physician received via COVID-19 Vaccine Adverse Event Reporting System. The patient was a 78-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Glimepiride 1.5mg, Pioglitazone 30mg, Pitavastatin 1mg, Amlodipine 5mg, Nexium capsules 10mg within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included diabetes mellitus, hypertension and dyslipidaemia. On 02Jun2021 at 15:30 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA5715, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. On 02Jun2021 at 15:45 (15 minutes after the vaccination), about 20 minutes after vaccination, the patient experienced Feels poorly, queasy, occipital headache. The patient also vomiting once. Although the patient was complexion ill, blood pressure was 128/68 mmHg, SPO2 was 97%, and pulse was 81/min. The reporter stated the events results in doctor or other healthcare professional office/clinic visit. The reporter stated the event results in recovered with treatment including normal saline 500ml intravenous drip and antiemetic Nauzelin orally taken. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Base on the information provided, events nausea, vomiting, feeling poorly and occipital headache are possibly related to suspect product. due to plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1411843 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, 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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALFACALCIDOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Blood pressure; Result Unstructured Data: Test Result:129/ 73 mmHg; Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210602; Test Name: Pulse rate; Result Unstructured Data: Test Result:64; Comments: /min; Test Date: 20210602; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC2021650861

Write-up: suspicion of anaphylaxis; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES) and received from the Regulatory authority report number is v2111793.? A 66-year-old (reported as 66-year and 9-month-old) non-pregnant female patient received the first dose of BNT162b2 (COMIRNATY), via an intramuscular route of administration, administered in left arm on 02Jun2021 16:00 (Batch/Lot Number: EY0779; Expiration Date: 31Aug2021) (at the age of 66-years-old) as 1st dose, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included the patient received alfacalcidol within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included osteoporosis. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Body temperature before vaccination was 36.6 degrees Centigrade. On 02Jun2021 at 16:00 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. On 02Jun2021 at 16:15 the patient experienced adverse events. On 02Jun2021 at 16:20 (20 minutes after the vaccination), the patient experienced suspicion of anaphylaxis. On 02Jun2021 after the vaccination, the patient was admitted to the hospital for a day. On 03Jun2021 (1 days after the vaccination), the outcome of the event was recovered. The clinical course of the adverse events was following: 20 minutes after vaccination, the patient experienced pharynx strange sensation of. It was also found that pharynx redness of, oropharyngeal swelling, upper limb and trunk redness. The outcome of the event was recovered with adrenaline injection treatment. The reporter classified the event(s) as serious (hospitalization for 1 day) and stated the event(s) result in hospitalization. Since the vaccination, the patient had not been tested for COVID-19. The course of the event was as follows: On 02Jun2021 at 16:20, the patient complained feeling strange. (irritating feeling in the pharynx, fuzzy head feeling, feeling hot, skin itching, nape and trunk temporary redness. Blood pressure: 129/ 73 mmHg, pulse rate: 64/min, SpO2: 98%). On 02Jun2021 at 16:40, the reporter assessed symptoms as suspicion of anaphylaxis because pharynx redness of, oropharyngeal swelling and skin symptoms had continued. The patient was intramuscularly injected Adrenaline injection 0.5 ml. On 02Jun2021 at 16:55, the patient was emergently moved to the hospital. The physician classified the event as serious (medically significant) and assessed it as related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: There were skin and mucous membrane symptoms, and although not respiratory symptoms, there was a persistent feeling of irritation in the throat, therefore, the event was decided to suspect anaphylaxis.


VAERS ID: 1411846 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dysarthria, Paresis, Pyrexia, Thalamus haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dialysis (Maintenance dialysis); Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: JPPFIZER INC2021651612

Write-up: left thalamus haemorrhage; Paresis of the right upper and lower limbs; Inarticulateness; Pyrexia at 38.0 degrees Centigrade; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21111381. The patient was a 72-year-old male. On 01Jun2021 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified route of administration as 2ND DOSE, SINGLE (at the age of 72 years) for COVID-19 immunization. Date of first dose of vaccination of BNT162B2 for COVID-19 immunization was not reported. On 02Jun2021 at about 03:00 (1 day after vaccination), there was paresis of the right upper and lower limbs, Inarticulateness and pyrexia at 38.0 degrees Centigrade. The same day at 15:00, patient visited and was hospitalized due to left thalamus hemorrhage. On 02Jun2021 (1 day after the vaccination), the patient was admitted to the hospital. Unspecified treatment was received for events paresis of the right upper and lower limbs, Inarticulateness, left thalamus hemorrhage and pyrexia. The reporting physician classified the event as serious (Hospitalization from 02Jun2021) and assessed that the event was related to BNT162b2. Other possible cause(s) of the event such as any other diseases were maintenance dialysis and hypertension. Information on the lot/batch number has been requested.


VAERS ID: 1411850 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Cough, Erythema, Pruritus
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021651866

Write-up: Anaphylaxis; Violent cough/ Barking-like cough; itching and redness appeared on face, neck, precordial; itching and redness appeared on face, neck, precordial; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21111642. The patient was a 42-year and 7-month-old female. Body temperature before vaccination was 36.2 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). On 02Jun2021 at 13:40(the day of the vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 02Jun2021 at 13:50 (10minutes after the vaccination), the patient experienced Anaphylaxis On 02Jun2021(the day of the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 02Jun2021 at around 13:40, the patient received the second dose of COMIRNATY vaccination. At around 13:50, the patient experienced violent cough, complicated with barking-like cough. Fluid replacement and Intravenous injection of SAXIZON 200mg were given, symptoms did not improve, itching and redness appeared on face, neck, precordial. Get the Inhalation of Bisolvon, Intravenous injection of STRONGER NEO-MINOPHAGEN C , cough and skin symptoms were recovering, barking-like cough continued, the patient was given 0.3ml of BOSMIN via intramuscular injection, during this period, No consciousness disturbance or blood pressure decreased or fraction of oxygen decreased were founded. As the above symptoms continued, the patient was transported to a PRIVACY Hospital. The reporting physician classified the event as serious(Hospitalized from 02Jun2021) and the causality between the event and bnt162b2 as related. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1411862 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Asthma, Blood pressure measurement, Body temperature, Chest discomfort, Cough, Heart rate, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Eosinophilic pneumonia (broad), 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: Medical History/Concurrent Conditions: Asthma; Hashimoto''s disease; Hypertension; Oral allergy syndrome; Tracheal stenosis; WPW syndrome (Appointment check)
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: BP; Result Unstructured Data: Test Result:129/91; Test Date: 20210602; Test Name: body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Comments: before vaccination; Test Date: 20210602; Test Name: Heart rate; Result Unstructured Data: Test Result:90; Test Date: 20210602; Test Name: SPO2; Test Result: 95 %; Test Date: 20210602; Test Name: SPO2; Result Unstructured Data: Test Result:97~98 %
CDC Split Type: JPPFIZER INC2021653090

Write-up: becomes Level 3 (Collaboration); Asthmatic attack; dry cough; chest discomfort; This is a spontaneous report from a contactable physician (patient) received from the Regulatory authority report number is v21111474. The patient was a 49-year-old male. Body temperature before vaccination was 35.7 degrees Centigrade. Other medical history included Asthma, Hashimoto''s disease, hypertension, and the patient was taking medicine orally. The patient made an appointment for WPW syndrome. The patient had oral allergy with soymilk and had Tracheal stenosis. The patient had a headache due to influenza vaccination. On 02Jun2021 at 14:25 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a first dose, single dose for COVID-19 immunization (at the age of 49 years old). The patient experienced adverse events on 02Jun2021. The course of the event was follows: On 02Jun2021 about 14:30 (within 5 minutes after vaccination), the patient experienced dry cough and chest discomfort. Without wheezing. Even after 30 minutes, it did not improve so that the patient reported it. In the monitor (self-taking), Oxygen saturation (SPO2) was 95 percentage and Heart rate was 90s. The patient inhaled Meptin (self-taking) twice, slightly improved in 3 minutes. Blood pressure was 129/91. Oxygen saturation was 97~98 percentage. After 30 minutes, the symptoms disappeared The patient experienced Asthmatic attack. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2 On 02Jun2021 (the day of vaccination), the outcome of the event was recovered. The physician commented as follows: Can intermittent cough be minor symptoms? In this case, it became Level 3 (Collaboration). No other organ symptoms. This report was reported to the Asthmatic.; Reporter''s Comments: Can intermittent cough be minor symptoms? In this case, it became Level 3 (Collaboration). No other organ symptoms. This report was reported to the Asthmatic.


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