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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 278 out of 5,069

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VAERS ID: 1398271 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
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, Fatigue, Headache, Hyperpyrexia, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Hyperpyrexia; Result Unstructured Data: Fever: 40.5 to 42 degrees Celsius
CDC Split Type: NLJNJFOC20210617421

Write-up: FEVER 40.5 TO 42 DEGREES CELSIUS; FEELING UNWELL; JOINT PAIN; COLD CHILLS; MUSCLE PAIN; FATIGUE; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority (EMEA EVHUMAN NLP, NL-LRB-00564155) concerned a 53 year old female. The patient''s weight was 59 kilograms, and height was 172 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and batch number were not reported) frequency one total, dose was not reported, 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. No concomitant medications were reported. On 01-JUN-2021, the patient experienced fever 40.5 to 42 degrees celsius, feeling unwell, joint pain, cold chills, muscle pain, fatigue and headache. On 02-JUN-2021, 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 had not recovered from fever 40.5 to 42 degrees celsius, headache, joint pain, fatigue, cold chills, muscle pain, and feeling unwell. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210617421-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: 1398275 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
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: Chills, Fatigue, Headache, Hyperpyrexia, Myalgia, SARS-CoV-2 test positive
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), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201226; Test Name: SARS-CoV-2 test positive; Result Unstructured Data: Positive; Test Date: 20210601; Test Name: Hyperpyrexia; Result Unstructured Data: Fever: 40.5 up to and including 42 degrees Celsius
CDC Split Type: NLJNJFOC20210619230

Write-up: FEVER: 40.5 UP TO AND INCLUDING 42 DEGREES CELSIUS; COLD CHILLS; MUSCLE PAIN; FATIGUE; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00565289] concerned a 53 year old female. The patient''s weight was 75 kilograms, and height was 165 centimeters. The patient''s past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD975 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 31-MAY-2021 for covid-19 immunisation. No concomitant medications were reported. On 26-DEC-2020, Laboratory data included: SARS-CoV-2 test positive (NR: not provided) Positive. On 01-JUN-2021, the patient had fever: 40.5 up to and including 42 degrees Celsius. On the same day, the patient had cold chills, muscle pain, fatigue and headache. Laboratory data included: Hyperpyrexia (NR: not provided) Fever: 40.5 up to and including 42 degrees Celsius. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever: 40.5 up to and including 42 degrees Celsius, fatigue, headache, muscle pain, and cold chills. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210619230- 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: 1398277 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
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
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Hyperpyrexia; Result Unstructured Data: Fever: 40.5 through 42 degrees Celsius
CDC Split Type: NLJNJFOC20210619367

Write-up: FEVER: 40.5 THROUGH 42 DEGREES CELSIUS; COLD CHILLS; JOINT PAIN; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00566244] concerned a 44 year old male. The patient''s weight was 76 kilograms, and height was 178 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD975 expiry: UNKNOWN)0.5 ml, 1 total dose administered on 01-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 01-JUN-2021, the patient experienced fever: 40.5 through 42 degrees Celsius, cold chills, joint pain and headache. Laboratory data included: Hyperpyrexia (NR: not provided) Fever: 40.5 through 42 degrees Celsius. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold chills on 02-JUN-2021, was recovering from fever: 40.5 through 42 degrees celsius, and had not recovered from headache, and joint pain. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 -20210619367-covid-19 vaccine ad26.cov2.s-Fever: 40.5 through 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: 1398611 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Heart rate
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CIALIS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: Heart rate; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Shortness of breath; This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included TADALAFIL (CIALIS) from 07-May-2021 to an unknown date for Erection failure. On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Shortness of breath) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2021, Heart rate: Inconclusive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided.Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Throughout the day varying moments of tightness and shortness of breath. Company comment: Based on the current available information and temporal association between the use of the product and the start date of this 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 this event, a causal relationship cannot be excluded.


VAERS ID: 1398613 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Insomnia, Pyrexia, Vertigo
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: headache; fever; Dizziness; Vertigo; Insomnia; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), VERTIGO (Vertigo), INSOMNIA (Insomnia), FATIGUE (Fatigue), HEADACHE (headache) and PYREXIA (fever) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for COVID-19 vaccination. The patient''s past 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 .). On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced INSOMNIA (Insomnia) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 02-Jun-2021, the patient experienced VERTIGO (Vertigo) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant) and PYREXIA (fever) (seriousness criterion medically significant). On 02-Jun-2021, FATIGUE (Fatigue) had not resolved. At the time of the report, DIZZINESS (Dizziness), VERTIGO (Vertigo) and INSOMNIA (Insomnia) had not resolved and HEADACHE (headache) and PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced headache and fever 1st day and now really unwell 6 days later with the above symptoms. Concomitant product usage was not provided. Treatment details were 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: 1398618 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002180 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation, Respiratory rate
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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Diabetes mellitus; Pancreatic carcinoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure measurement; Test Result: Inconclusive ; Result Unstructured Data: 130; Test Date: 20210602; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:88/52 mm[Hg]; Test Date: 20210602; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:82/51 mm[Hg]; Test Date: 20210602; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:88/51 mm[Hg]; Test Date: 20210602; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:108/53 mm[Hg]; Test Name: Body temperature; Result Unstructured Data: Decreased; Test Date: 20210602; Test Name: HR; Result Unstructured Data: Test Result:79; Test Date: 20210602; Test Name: SpO2; Result Unstructured Data: Normal; Test Date: 20210602; Test Name: SpO2; Result Unstructured Data: Normal; Test Date: 20210602; Test Name: RR; Test Result: Inconclusive ; Result Unstructured Data: Test Result:24
CDC Split Type: JPTAKEDA2021TJP035743

Write-up: Anaphylactic reaction; This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 65-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002180) for COVID-19 vaccination. Concurrent medical conditions included Pancreatic carcinoma, Diabetes mellitus and Asthma. On 01-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Jun-2021 at 7:31 PM, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criteria hospitalization and medically significant). The patient was hospitalized until 02-Jun-2021 due to ANAPHYLACTIC REACTION. The patient was treated with EPINEPHRINE for Anaphylactic reaction, at a dose of 0.3 milligram. On 02-Jun-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, Blood pressure measurement: 88/52 (Low) Test Result:88/52 mm[Hg], 82/51 (Low) Test Result:82/51 mm[Hg], 88/51 (Low) Test Result:88/51 mm[Hg] and 108/53 (Low) Test Result:108/53 mm[Hg]. On 02-Jun-2021, Heart rate: 79 (normal) Test Result:79. On 02-Jun-2021, Oxygen saturation: 97 (normal) Normal and 99 (normal) Normal. On 02-Jun-2021, Respiratory rate: 24 (Inconclusive) Test Result:24. On an unknown date, Blood pressure measurement: 130 (Inconclusive) 130. On an unknown date, Body temperature: 35.9 (Low) Decreased. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylactic reaction) to be possibly related. No concomitant medications were reported. Other treatment medications provided by the reporter included Drip infusion of normal saline solution This case, initially reported to the Moderna adverse reaction reporting site by a physician, was received by the regulatory authority. On an unknown date, body temperature before vaccination: 35.9 degrees Celsius. On 01-JUN-2021, at 19:12, the patient received the 1st dose of the vaccine. At 19:31, anaphylaxis developed. The event developed 19 minutes after the vaccination, was not sudden onset, and was rapidly progressive. There was no skin or mucosal symptom. There was a cardiovascular symptom (hypotension). There was no respiratory symptom. There was no gastrointestinal symptom. When the patient walked independently to a toilet, the patient felt poorly with cold sweat. The consciousness was clear. The patient moved to a treatment room. BP was 88/52 mmHg. SpO2 was 97%. There was no abnormal respiratory sound. There was no skin eruption. At 19:45, the patients feeling improved with bed rest, but BP was 82/51 mmHg and the patient originally had blood pressure of 130 mmHg. Thus, a diagnosis of shock vital was made. Intramuscular injection of epinephrine 0.3 mg was performed. Drip infusion of normal saline solution was started. At 19:55, BP was 88/51 mmHg. Since hypotension persisted, transportation to another hospital was decided. At 20:25, before transportation, BP was 108/53 mmHg, HR 79, SpO2 99%, and RR 24. On 02-JUN-2021, the patient was discharged from the hospital. The outcome of anaphylaxis was resolved. Follow-up investigation will be made. Company Comment: 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: 1400434 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7823 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Contusion, Fatigue, Headache
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Other ischaemic heart disease (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: BGPFIZER INC2021664186

Write-up: heart pain; large bruise at the application site; general fatigue; headaches; This is a spontaneous report from a contactable consumer. This is second case of two cases for same patient, same product, difference adverse events and dose. A 42-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EX7823, Expiration date was not reported), via intramuscular on 31May2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took (COMIRNATY Solution for injection) for covid-19 immunisation. On 01Jun2021 the patient experienced large bruise at the application site, general fatigue, heart pain, headaches. Three days before the vaccine and 4 days after the patient was taking an antihistamine. Patient did not received any treatment. On an unspecified date in 2021, the outcome of the events was recovered without treatment. Follow-up attempt completed. No expected further information. Amendment: This follow-up report is being submitted to amend previously reported Information: Amended the reported "heart pain" to LLT Cardiac Pain (PT Angina Pectoris) and upgraded the event to serious as this term is included the MedDRA Critical Preferred Terms List.


VAERS ID: 1400544 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-06-01
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eyelid function disorder, Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021639321

Write-up: This is a spontaneous report from a contactable consumer (patient''s wife), based on information received by Pfizer from BioNTech (control number: 60390), licensed party for BNT162B2 (Comirnaty). A 64-year-old male patient received the first dose of BNT162B2 (Comirnaty, solution for injection, lot# EX8680), at the age of 64, via an unknown route, on May 11, 2021, single dose, for COVID-19 immunisation. No medical history or concomitant medications provided. Since Jun 1, 2021, patient has unilateral facial paralysis (medically significant). He can''t shut his eye completely, eyelid problems (non-serious). The patient visited the doctor. He was given cortisone tablets and eye ointment. The patient has not recovered from the events.


VAERS ID: 1400551 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-06-01
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombophlebitis superficial
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021647969

Write-up: superficial vein thrombosis; This is a spontaneous report from a non-contactable consumer (patient). This is a report based on information received by Pfizer from Biontech Se (manufacturer control number 60777), license party for BNT162B2. A male patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 18May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced superficial vein thrombosis on 01Jun2021. As reported: 2 weeks ago patient received BNT vaccination after that, superficial venetrombosis. Side effect: doctor reported 2 weeks ago exactly. The gentleman was vaccinated 2 weeks ago with the 1st dose of the BioNTech vaccine. He has developed superficial vein thrombosis. He still has it at the moment. It is not serious, he was treated by the doctor. But the doctor did not know if he could get the 2nd dose. That''s why he called us. The doctor has probably already reported the side effect. The outcome was not recovered No follow-up attempts are possible, information about lot/batch number cannot be obtained.


VAERS ID: 1400696 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Loss of consciousness, Pruritus, Swelling, Swollen tongue, Tongue pruritus
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021687956

Write-up: Neck swelling; Itching of tongue; Swollen tongue; redness; Transported by ambulance, once unconscious; itching on the neck; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FI-FIMEA-20213104. A 43 years-old female patient received first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: UNKNOWN), dose 1 via intramuscular on 01Jun2021 as SINGLE dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Jun2021 the patient experienced Swollen tongue, itching on the neck and redness, itching of tongue and feeling of swelling of neck. Transported by ambulance, once unconscious. The patient was hospitalized due to these events. The outcome of the events was recovering. Follow-up attempts not possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1400942 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal distension, Back pain, Headache, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever; Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201214; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: SARS-CoV-2 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Backache; bloating; Headache; Aching all over; Abdominal bloating; Backache; This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (Abdominal bloating), the first episode of BACK PAIN (Backache), the second episode of BACK PAIN (Backache), ABDOMINAL DISTENSION (bloating) and HEADACHE (Headache) in a 30-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 and Suspected COVID-19 from 09-Dec-2020 to 28-Dec-2020. Concurrent medical conditions included Hay fever. On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced ABDOMINAL DISTENSION (Abdominal bloating) (seriousness criteria disability and medically significant), ABDOMINAL DISTENSION (bloating) (seriousness criteria disability and medically significant), HEADACHE (Headache) (seriousness criteria disability and medically significant) and MYALGIA (Aching all over). 01-Jun-2021, the patient experienced the first episode of BACK PAIN (Backache) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced the second episode of BACK PAIN (Backache) (seriousness criteria disability and medically significant). At the time of the report, ABDOMINAL DISTENSION (Abdominal bloating) had not resolved, last episode of BACK PAIN (Backache) and ABDOMINAL DISTENSION (bloating) was resolving and HEADACHE (Headache) and MYALGIA (Aching all over) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Dec-2020, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information was not provided. 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: 1400989 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 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: Medical History/Concurrent Conditions: Arrhythmia; Dust allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021633485

Write-up: Fainted after vaccination; This is a spontaneous report from a contactable consumer (patient). This 29-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: EW6126) at single dose in left arm on 01Jun2021 13:00 at age of 29-year-old for COVID-19 immunisation. Medical history included known allergies to dust, arrhythmia. Concomitant medications was none. The patient experienced fainted after vaccination on 01Jun2021 13:00 with outcome of recovered. No treatment received and event required physician office visit.


VAERS ID: 1401194 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 EY2173 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Chills, Depressed level of consciousness, Nausea, Tachycardia, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased about 140 to 110
CDC Split Type: JPPFIZER INC2021631194

Write-up: Generalised urticarial; DEPRESSED LEVEL OF CONSCIOUSNESS; Tachycardia; Blood pressure decreased about 140 to 110; Vomiting; Nausea; chills; This is a spontaneous report from a contactable physician received via COVID-19 Vaccine Adverse Event Reporting System. The patient was a non-pregnant 32-year-old female. 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. On 11May2021, the patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) intramuscular in the left arm for COVID-19 immunization. On 01Jun2021 at 09:00 (the day of vaccination), at age of 32-year-old, the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization in hospital. On 01Jun2021 (the day of vaccination), the patient experienced Generalised urticarial, Tachycardia, Depressed level of consciousness, Blood pressure decreased about 140 to 110, There were chills, nausea and Vomiting. Patient recovered quickly after receiving IV drip. The outcome of the event was recovered with treatment including IV drip. The reporter classified the events as serious (Hospitalization). Since the vaccination, the patient has not been tested for COVID-19.; 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 urticaria, depressed level of consciousness,blood pressure decreased,,tachycardia,vomiting,nausea, . 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: 1401259 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 EX3617 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Hypoaesthesia, Oxygen saturation
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Blood pressure; Result Unstructured Data: Test Result:more than 200; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210601; Test Name: Spo2; Test Result: 99 %
CDC Split Type: JPPFIZER INC2021633049

Write-up: Blood pressure more than 200; Numbness of limbs; This is a spontaneous report from a contactable consumer received via the RA, and received from a contactable other healthcare professional received from the RA. Regulatory authority report number is v21110926. The patient was a non-pregnant 70-year-old female. 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. The patient had allergies to INFLUENZA VACCINE (for immunization) with Low grade fever and Malaise. The patient had no other medical history. Body temperature before vaccination was 36.5 degrees Centigrade. The patient had no family history. On 01Jun2021 at 15:45 (the day of vaccination) the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) in the arm right as a single dose for COVID-19 immunization. On 01Jun2021 at 16:00 (as reported, also reported as more than 20 minutes after the vaccination), the patient experienced Numbness of limbs. Blood pressure was more than 200 (as reported), Spo2 99%. There was no dyspnoea. After rest for about 1 hour, although the patient was observed, there was no sign of a drop in blood pressure, the patient was transferred to another hospital (Brain surgery). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered with treatment including referral to another hospital. The reporting physician classified the event as non-serious and the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. Since the vaccination, the patient has not been tested for COVID-19.


VAERS ID: 1401262 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 EY5420 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Oxygen saturation, Respiratory rate
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperventilation
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: BP; Result Unstructured Data: Test Result:normal; Comments: first measurement after vaccination; Test Date: 20210601; Test Name: BP; Result Unstructured Data: Test Result:80s; Comments: second measurement after vaccination; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4; Comments: before vaccination; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:normal; Comments: after vaccination; Test Date: 20210601; Test Name: SpO2; Result Unstructured Data: Test Result:normal; Comments: after vaccination; Test Date: 20210601; Test Name: Respiratory rate; Result Unstructured Data: Test Result:aggravated; Comments: after vaccination
CDC Split Type: JPPFIZER INC2021634871

Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21110639. The patient was a 22-year and 8-month-old female. Body temperature before vaccination was 36.4 degrees centigrade. The patient had no family history. Medical history included hyperventilation. Concomitant medications were not reported. 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 an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number unknown, Expiration date unknown). On 01Jun2021 at 09:50 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) at her 22-year-old intramuscularly as a single dose for COVID-19 immunisation. On 01Jun2021 at 10:00 (10 minutes after the vaccination), the patient experienced anaphylaxis. On 01Jun2021 11:30 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: On 01Jun2021 at 10:00 (10 minutes after the intramuscular injection), the patient experienced numbness of limbs and tachypnoea. The SpO2, blood pressure (BP), and body temperature were normal. Even at 10:09 (19 minutes after the vaccination), the above symptoms did not improve, BOSMIN 0.3 mg was administered intramuscularly into the left thigh. At 10:15 (25 minutes after the vaccination), LACTEC 500 ml was started at a slow speed. No improvement was obtained. Numbness of limbs became stronger. ATARAX-P (ATA-P) (25) 1 tablet (T) was administered. At 10:50 (1 hour after the vaccination), the BP was in 80s, and the respiratory rate was aggravated. At the same time, BOSMIN 0.3 mg was administered intramuscularly to the right thigh, leading to an improvement. However, at 11:05 (1 hour and 15 minutes), SOLU-CORTEF 250 + normal saline 100 ml were given by drip infusion for an hour just in case. At 11:20 (1 hour and 30 minutes), the patient had better condition temporarily and had no pyrexia. At 11:30 (1 hour and 40 minutes), her condition returned to normal. LACTEC was terminated at 13:30 (3 hours and 40 minutes after the vaccination). The patient had tended to experience hyperventilation once a year, and the symptoms were quite similar to that, but this time (illegible characters). The reporting physician classified the event as non-serious and assessed that the event was related to BNT162b2. Other possible cause(s) of the event such as any other diseases was hyperventilation syndrome. The reporting physician commented that he assessed the case as related to BNT162b2 but that was just a suspicion.


VAERS ID: 1401274 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 FA4597 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021635125

Write-up: malaise; This is a spontaneous report from a contactable physician The patient was a non-pregnant 22-years-old female (as reported). 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. The patient had no allergies to medications, food, or other products. The patient had no other medical history. On 11May2021, the patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) intramuscular in the arm left for COVID-19 immunization. On 01Jun2021 at 11:30 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) intramuscular in the arm left for COVID-19 immunization. On 01Jun2021 at 14:00 (2.5 hours after the vaccination), the patient experienced malaise. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered with treatment including Fluid replacement and Anti-inflammatory analgesic. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on temporal relationship and known safety profile, a causal association between suspect drug and the reported malaise cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1401322 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 EY5420 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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: Medical History/Concurrent Conditions: Atrial fibrillation; Gastroenteritis; Oesophageal cancer (surgery); Osteoporosis; Pancreatitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021635759

Write-up: abdominal pain; abdominal distension; This is a spontaneous report from a contactable physician received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). The patient was a non-pregnant 85-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescribed drug within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had allergy to influenza vaccine. Other medical history included Atrial fibrillative, pancreatitis, Osteoporosis, Gastroenteritis and post oesophageal cancer surgery. On 01Jun2021 04:15AM (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021), at vaccination age of 85 years, intramuscular in the left arm for COVID-19 immunization. On 01Jun2021 17:00(12 hours 45 minutes after vaccination), the patient experience abdominal pain and abdominal distension. The outcome of the event was recovered with treatment including fluid replacement and 0.2mg bosmin intramuscular. The reporter stated the events result in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: The events was considered related to suspect drug based on temporal association and known safety profile of the drug. 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: 1401329 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 EY4834 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Bradycardia, Depressed level of consciousness, Feeling abnormal
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021636246

Write-up: Consciousness clouding; Bradycardia; Feels poorly; blood pressure decreased; This is a spontaneous report from a contactable physician received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). The patient was a 29-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications 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. The patient medical history was reported as healthy without illness. On 01Jun2021 at 0:00 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021), at vaccination age of 29 years, intramuscular route of administration in arm left for COVID-19 immunization. On 01Jun2021 at 0:00 (as reported, same time after vaccination), 10 minutes after the vaccination, the patient experienced Feels poorly, consciousness clouding. No urticaria, pruritus generalised, asthma-like attack, and gastrointestinal symptoms were observed. Blood pressure decreased and bradycardia were observed. The patient kept lying on the bed with lower limb elevation. The patient was treated with normal saline drip infusion and the blood pressure increased, consciousness recovered to normal. The events resulted in Emergency room/department or urgent care. The outcome of the events was recovered with treatment including drop infusion. Since the vaccination, the patient has not been tested for COVID-19.


VAERS ID: 1401984 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Fatigue, Feeling abnormal, Headache, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Dementia (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: 20210531; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fatigue; Nausea; Foggy feeling in head; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jun-2021 and was forwarded to Moderna on 03-Jun-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy feeling in head), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) in a 35-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) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced FEELING ABNORMAL (Foggy feeling in head) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 02-Jun-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, FEELING ABNORMAL (Foggy feeling in head), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Patient is not pregnant, Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. No concomitant medication was reported. It was not reported if the patient received any corrective treatment. 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: 1403232 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hallucination
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: L-THYROXIN [LEVOTHYROXINE SODIUM]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021645035

Write-up: hallucination; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 30May2021 (at the age of 38-year-old) as 1st dose, single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (L-THYROXIN [LEVOTHYROXINE SODIUM]). The patient experienced hallucination two days after vaccination (01Jun2021). The outcome of the event was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1404054 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 - / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Haemorrhage, Limb discomfort, Pain in extremity
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021640040

Write-up: Severe lower abdominal pain and bleeding; Severe lower abdominal pain and bleeding; Very painful arms and feels very heavy when lifting / the heavy feeling of the arm; Very painful arms and feels very heavy when lifting / the heavy feeling of the arm; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old female patient received BNT162B2 (COMIRNATY) at the age of 21-years, via an unspecified route of administration, administered in left arm on 01Jun2021 at 19:15 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient concomitant medications were not reported. On 01Jun2021, the patient experienced severe lower abdominal pain and bleeding, very painful arms and feels very heavy when lifting / the heavy feeling of the arm. It was reported that very painful arms and feels very heavy when lifting / the heavy feeling of the arm has occurred immediately after vaccination / a few hours after vaccination severe lower abdominal pain and bleeding. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained


VAERS ID: 1404114 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, Fatigue, Headache, Influenza, Rhinitis allergic
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow), 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: BECONASE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021640712

Write-up: tiredness; Mild flu; headache; allergic rhinitis; Found a blood on tissue when he cleaned his nose after getting up in the morning/The blood drops came out from right nostril; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-APPCOVID-20210601103534. Safety Report Unique Identifier: GB-MHRA-ADR 25396843. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 30May2021 (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for Covid-19 immunisation. Medical history included allergic rhinitis from an unknown date and unknown if ongoing. Concomitant medication included beclometasone dipropionate (BECONASE) taken for rhinitis allergic, start and stop date were not reported. Patient has ongoing high dose systemic steroids (patient was being treated with high dose systemic steroids). Patient reported he was having headache especially in right side of his head while he got vaccinated in his right arm. Patient had mild flu and tiredness on an unspecified date. But today morning (01Jun2021) patient found a blood on tissue when he cleaned his nose after getting up in the morning. The blood drops came out from right nostril twice today at the same time when he got up in the morning. Patient was using Beconase nasal spray which he used regularly as prescribed by his GP (general practitioner) as he was an allergic rhinitis patient too. The events were reported as medically significant. Outcome of the event found a blood on tissue when he cleaned his nose after getting up in the morning. The blood drops came out from right nostril was not recovered, while for the rest of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1404118 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA LOT 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse drug reaction, Lymphadenopathy, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Painful arm; Swelling of the underarm glands; fever chills; Swelling of the underarm glands; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), ADVERSE DRUG REACTION (Swelling of the underarm glands) and PYREXIA (fever chills) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Lot 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), ADVERSE DRUG REACTION (Swelling of the underarm glands) (seriousness criterion medically significant), PYREXIA (fever chills) (seriousness criterion medically significant) and LYMPHADENOPATHY (Swelling of the underarm glands). On 04-Jun-2021, PAIN IN EXTREMITY (Painful arm) and PYREXIA (fever chills) had resolved. At the time of the report, ADVERSE DRUG REACTION (Swelling of the underarm glands) and LYMPHADENOPATHY (Swelling of the underarm glands) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not reported. The reporter stated that no treatment medication was taken for pain or swelling reduction. The flu/fever type symptoms (chills) lasted three days and the worst day was 24 hours after the vaccine was given. The patient has not tested positive for COVID-19 since receiving the vaccine. 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: 1404289 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021640676

Write-up: Vertigo; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106011055239350-M42YE, Safety Report Unique Identifier GB-MHRA-ADR 25396889 A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31May2021 (Lot Number: FA1027) as first dose single for COVID-19 immunization. Medical history included suppressed lactation. 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 vertigo (medically significant) on 01Jun2021 with outcome of recovering. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1404296 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021640588

Write-up: Blacked Out; Syncope; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106011136336720-XFAXH, Safety Report Unique Identifier GB-MHRA-ADR 25397249. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 10:57 (Lot Number: EY5456) (at the age of 30-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, not had a COVID-19 test, and unsure if patient was enrolled in clinical trial. On 01Jun2021, the patient experienced syncope and blacked out. The clinical course was reported as follows: Vaccine given at 10:57 ATRP (as reported) at 11:05 as syncopal episode. Blacked out and woke up on the floor. No preceding symptoms, no seizure activity reported, afterwards, alert and orientated, one inch superficial graze above right eye. The events were considered non serious by MHRA; Pfizer assessed the events as serious, medically significant. The outcome of the events was recovered on 01Jun2021. Report not related to possible blood clots or low platelet counts. No follow-up attempts are possible. No further information is Expected.


VAERS ID: 1404316 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-06-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 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 INC2021640467

Write-up: Dizziness; High temperature; Nausea; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106011902532690-5YEYR, Safety Report Unique Identifier GB-MHRA-ADR 25400670 . A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21May2021 (Lot Number: EW4109) as first dose, single for COVID-19 immunization. Medical history included suppressed lactation and depression. from an unknown date. Patient has not had symptoms associated with COVID-19; Patient is not enrolled in clinical trial. Concomitant medication included citalopram taken for depression, start and stop date were not reported. On 01Jun2021, the patient experienced dizziness, high temperature and nausea. The outcome of the events was not recovered. The events were considered medically significant. The patient underwent lab tests and procedures which included No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1404337 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-01
   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: Dizziness
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: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, known to lower the immune response); 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: GBMODERNATX, INC.MOD20212

Write-up: Dizziness; This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. 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 past medical history included Lactation decreased and Immunodeficiency (Taking other treatments or medicines, known to lower the immune response). Previously administered products included for an unreported indication: CONCERTA (Concerta 18mg). On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine. No relevant concomitant medications were reported. No treatment information was provided.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1404341 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   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: SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210530; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Hives; This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA (Hives) 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. On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced URTICARIA (Hives) (seriousness criterion medically significant). On 02-Jun-2021, URTICARIA (Hives) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication and treatment information were not reported. Patient has not had symptoms associated with COVID-19 Patient was not enrolled in clinical trial and not currently breastfeeding Patient has 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 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: 1404345 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Fatigue, Headache, Nausea, 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: PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Headache; Tiredness; Nausea; This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Tiredness) and NAUSEA (Nausea) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included PARACETAMOL for an unknown indication. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) and FATIGUE (Tiredness) had not resolved and NAUSEA (Nausea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. 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: 1404346 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Influenza, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Flu; Muscle ache; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), PYREXIA (Fever) and MYALGIA (Muscle ache) 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 Suspected COVID-19 from 16-Mar-2020 to 21-Mar-2020. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 02-Jun-2021, the patient experienced INFLUENZA (Flu) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, INFLUENZA (Flu) and MYALGIA (Muscle ache) was resolving and PYREXIA (Fever) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications was not provided. Patient not had a COVID-19 test, Patient is not enrolled in clinical trial and patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Treatment medication 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: 1404351 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Influenza, Influenza like illness, SARS-CoV-2 test, Vaccination site pain
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201227; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Flu like symptoms onset in the evening of 1/6 / 2021; Flu; Pain in upper left arm (vaccination site); This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms onset in the evening of 1/6 / 2021), INFLUENZA (Flu) and VACCINATION SITE PAIN (Pain in upper left arm (vaccination site)) in a 34-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 26-Dec-2020 to 05-Jan-2021. On 01-Jun-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms onset in the evening of 1/6 / 2021) (seriousness criterion medically significant), INFLUENZA (Flu) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Pain in upper left arm (vaccination site)) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Flu like symptoms, at a dose of 1000 mg every four hours. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms onset in the evening of 1/6 / 2021) was resolving and INFLUENZA (Flu) and VACCINATION SITE PAIN (Pain in upper left arm (vaccination site)) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication information was not reported. Patient was not enrolled in clinical trial. Patient has 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: 1404359 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chest crushing, Pain in extremity, Palpitations, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 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: Chest crushing; Heart racing; Abdominal pain; Fever; Foot pain; This regulatory authority case was reported by a consumer and describes the occurrence of CHEST CRUSHING (Chest crushing), PALPITATIONS (Heart racing), ABDOMINAL PAIN (Abdominal pain), PAIN IN EXTREMITY (Foot pain) and PYREXIA (Fever) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) 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 01-Jun-2021, the patient experienced PAIN IN EXTREMITY (Foot pain) (seriousness criterion medically significant). On 02-Jun-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced CHEST CRUSHING (Chest crushing) (seriousness criterion medically significant), PALPITATIONS (Heart racing) (seriousness criterion medically significant) and ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant). At the time of the report, CHEST CRUSHING (Chest crushing), PALPITATIONS (Heart racing), ABDOMINAL PAIN (Abdominal pain), PAIN IN EXTREMITY (Foot pain) and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient was not pregnant and was not currently breastfeeding. Concomitant information were not provided. Treatment information were 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. Overall seriousness assessment of the events is based on the Regulatory Authority report. No further information is expected.; 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. Overall seriousness assessment of the events is based on the Regulatory Authority report. No further information is expected.


VAERS ID: 1404389 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-06-01
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, C-reactive protein, Fibrin D dimer, Lung opacity, Platelet count, Platelet factor 4, Pulmonary embolism, Respiratory failure, SARS-CoV-2 test, White blood cell count
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AZATHIOPRINE; FLUOXETIN; OLANZAPINE; PREGABALIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Asthma; Crohn''s disease; Depression; Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: CT PA; Result Unstructured Data: Test Result:Pulmonary embolism; Test Name: CRP; Result Unstructured Data: Test Result:raised CRP ($g300); Test Date: 20210603; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:D-dimer was greater than 4000; Test Date: 20210603; Test Name: platelet count; Result Unstructured Data: Test Result:Unknown; Test Name: Platelet factor 4; Result Unstructured Data: Test Result:Anti-PF4 antibodies were not identified; Test Date: 20210603; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: WBC; Result Unstructured Data: Test Result:Unknown
CDC Split Type: GBPFIZER INC2021657877

Write-up: ground glass changes; Respiratory failure; Pulmonary embolus; This is a spontaneous report from a contactable physician received from the RA. The regulatory authority report number is GB-MHRA-WEBCOVID-202106051613464660-TKWPU, Safety Report Unique Identifier GB-MHRA-ADR 25426111. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown), via an unspecified route of administration on 28Apr2021 as first dose, single for COVID-19 immunisation. Medical history included depression, anxiety, asthma, Crohn''s disease and non-tobacco user. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications included azathioprine, olanzapine, pregabalin all for an unspecified indication, start and stop date were not reported; fluoxetine hydrochloride (FLUOXETIN) taken for depression, start and stop date were not reported. He previously took Heparin. The patient experienced pulmonary embolus on 01Jun2021; respiratory failure on 03Jun2021. Patient presented with 3/7 acute SOB on background of general decline last 4/52. CT PA showed unilateral ground glass changes and multiple small pulmonary emboli. Admitted to ICU for HFNO, eventually requiring intubation and ventilation due to oxygen requirements. Pyrexic with raised inflammatory markers. Currently still intubated and ventilated. The events were reported as serious medically significant, hospitalization and life threatening. The patient underwent lab tests and procedures which included fibrin d dimer: d-dimer was greater than 4000 on 03Jun2021, platelet factor 4: anti-pf4 antibodies were not identified on unknown date, sars-cov-2 test: no - negative covid-19 test on 03Jun2021, angiogram: pulmonary embolism on 03Jun2021, platelet count: unknown on 03Jun2021, Bloods - raised CRP ($g300) and WBC (unknown) on unspecified date. The outcome of ground glass changes was recovering; for other events was not recovered. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.


VAERS ID: 1404392 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-01
   Days after vaccination:4
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, Diarrhoea, Illness, Pyrexia
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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Diarrhea; Sickness; Fever; Stomach pain; This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea), ILLNESS (Sickness) and PYREXIA (Fever) in a 33-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 02-Jun-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) and DIARRHOEA (Diarrhea) had not resolved and ILLNESS (Sickness) and PYREXIA (Fever) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was 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.; 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: 1404399 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-01
   Days after vaccination:8
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: SARS-CoV-2 test, Urticaria, Vaccination site erythema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BECLOMETHASONE [BECLOMETASONE]; VENLAFAXINE
Current Illness: Mixed anxiety and depressive disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210506; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: red splotches; Hives; This regulatory authority case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red splotches) and URTICARIA (Hives) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Mixed anxiety and depressive disorder. Concomitant products included BECLOMETHASONE [BECLOMETASONE] and VENLAFAXINE for Mixed anxiety and depressive disorder. On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced URTICARIA (Hives) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red splotches) (seriousness criterion medically significant). On 05-Jun-2021, URTICARIA (Hives) was resolving. At the time of the report, VACCINATION SITE ERYTHEMA (red splotches) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient experienced red splotches on skin, not generally itchy (less than 5 times has it felt itchy) appeared suddenly and started spreading really quickly. Called GP and submitted photos. Antihistamines were given as treatment. 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: 1404400 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   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: Migraine, 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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Migraine; Muscle pain; This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) and MYALGIA (Muscle pain) in a 36-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 01-Jun-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). On 04-Jun-2021, MYALGIA (Muscle pain) had resolved. At the time of the report, MIGRAINE (Migraine) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Conomitant product usage were not provided. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.


VAERS ID: 1404410 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
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: COVID-19, Heavy menstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: POSITIVE
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Heavy periods; SARS-CoV-2 infection; This regulatory authority case was reported by a consumer and describes the occurrence of COVID-19 (SARS-CoV-2 infection) and HEAVY MENSTRUAL BLEEDING (Heavy periods) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 since 31-May-2021. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant). On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant). At the time of the report, COVID-19 (SARS-CoV-2 infection) and HEAVY MENSTRUAL BLEEDING (Heavy periods) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, SARS-CoV-2 test: positive (Positive) POSITIVE. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant drugs were reported. No treatment information was reported. Causality for the event COVID-19 is not applicable. Very limited information regarding the event Heavy menstrual bleeding has been provided at this time. No further information is expected in this regulatory report case.; Sender''s Comments: Causality for the event COVID-19 is not applicable. Very limited information regarding the event Heavy menstrual bleeding has been provided at this time. No further information is expected in this regulatory report case.


VAERS ID: 1404440 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-06-01
   Days after vaccination:17
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: Rheumatoid arthritis
SMQs:, Arthritis (narrow), Immune-mediated/autoimmune disorders (narrow)

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

Write-up: Arthritis rheumatoid; This regulatory authority case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Arthritis rheumatoid) in a 45-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced RHEUMATOID ARTHRITIS (Arthritis rheumatoid) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Arthritis rheumatoid) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. The patient has a history of a negative COVID-19 test on an unspecified date. No treatment details reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time.


VAERS ID: 1404771 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 EY4834 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Dyspnoea, Eyelid function disorder, Heart rate increased, Oxygen saturation, Pulse abnormal, Somnolence
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypoglycaemia (broad), Dehydration (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: MENESIT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylactic shock due to adverse food reaction; Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: BP; Result Unstructured Data: Test Result:124/72; Comments: 15:30; Test Date: 20210601; Test Name: BP; Result Unstructured Data: Test Result:170/88; Comments: 15:43; Test Date: 20210601; Test Name: BP; Result Unstructured Data: Test Result:134/73; Comments: 15:45; Test Date: 20210601; Test Name: BP; Result Unstructured Data: Test Result:122/62; Comments: 16:00; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210601; Test Name: spo2; Test Result: 98 %; Comments: 15:30; Test Date: 20210601; Test Name: spo2; Test Result: 98 %; Comments: 16:10; Test Date: 20210601; Test Name: pulse; Result Unstructured Data: Test Result:82; Comments: 15:30; Test Date: 20210601; Test Name: pulse; Result Unstructured Data: Test Result:108; Comments: 15:43; Test Date: 20210601; Test Name: pulse; Result Unstructured Data: Test Result:113; Comments: 15:45; Test Date: 20210601; Test Name: pulse; Result Unstructured Data: Test Result:102; Comments: 16:00
CDC Split Type: JPPFIZER INC2021635543

Write-up: BP was 170/88; P was equal to 108; Sleepiness; Dyspnoea; Difficult to open eyes; This is a spontaneous report. The patient was an 81-year-old and 4 months non-pregnant female patient. Body temperature before vaccination was 36.7 degrees Centigrade. The patient''s family history was not reported. Patient''s 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, etc.) included Anaphylactic shock caused by using Flomox, yam and taro. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Menesit within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 01Jun2021 (at the age of 81-years-old) at 15:15 (the day of vaccination) (as reported), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) via intramuscular, administered in arm left at single dose for COVID-19 immunization. Event onset date was reported as: 01Jun2021 at 15:30. On 01Jun2021, Event outcome was reported as recovered. The course of the event was as follows: From the beginning, the patient experienced sleepiness and dyspnoea. Difficult to open eyes. SpO2 was 98%, BP was 124/72, P was 82. At 15:35, with ensure venous access, infusion of physio35 500ml was provided. At 15:40, Bosmin vis intramuscular injection was provided with adding 1.65 mg of Decadron in the bottle. At 15:43, BP was 170/88, P was equal to 108. Loosen the drip drop speed. At 15:45, BP was 134/73, P was equal to 113. At 16:00, BP was 122/62, P was equal to 102. At 16:10, dyspnea disappeared and SpO2 was 98%. The event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered with treatment including Adrenaline injection and intravenous treatment. Since the vaccination, the patient has not been tested for COVID-19. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as related. Other possible cause of the event such as any other diseases was not provided. Reporter''s comment: Anaphylactic shock caused by using Flomox, yam and taro.


VAERS ID: 1404780 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-01
   Days after vaccination:8
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: Anaemia
SMQs:, Haematopoietic erythropenia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021636370

Write-up: severe Anaemia; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A 90-year-old male patient received bnt162b2 (COMIRNATY, lot number and expiry date unknown), via an unspecified route of administration on 24May2021 as an unknown dose number, as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Jun2021, the patient was hospitalized for severe anaemia. The event was found after using the product. The outcome of the event was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1404787 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 FA7338 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Dermatitis allergic, Heart rate, Oxygen saturation
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Contrast media allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: BP; Result Unstructured Data: Test Result:120/86; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: before consultation; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination; Test Date: 20210601; Test Name: P; Result Unstructured Data: Test Result:78; Test Date: 20210601; Test Name: SpO2; Result Unstructured Data: Test Result:97
CDC Split Type: JPPFIZER INC2021636678

Write-up: Dermatitis allergic; Anaphylaxis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21110809. The patient was a 79-year and 2-month-old female. Body temperature before consultation was 35.6 degrees centigrade. Body temperature before vaccination was 36.0 degrees centigrade. Family history was not reported. Medical history included prior contrast media allergy (on a medical record). The patient was currently receiving treatment or medication for hypertension and other unspecified conditions and the doctor treating her for the diseases told her that she could have the vaccine. The patient had had no fever nor got sick in the last month. There were no parts of her body that were not feeling well on the vaccination day. The patient had never had a convulsion (seizure). The patient had never experienced severe allergic symptoms (such as anaphylaxis) to medications or foods. The patient had never been sick after receiving a vaccine. The patient was not pregnant nor breastfeeding. The patient had received no vaccines within the last two weeks. On 01Jun2021 at 11:14 (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 at 0.3 mL as a single dose for COVID-19 immunization. On 01Jun2021 at 11:25 (11 minutes after the vaccination), the patient experienced anaphylaxis and dermatitis allergic. On 01Jun2021 (the day of the vaccination), the outcome of the event was recovered. The course of the event was as follows: On 01Jun2021 at 11:14, the condition of the patient was as usual and the patient received the first vaccination. Having a history of contrast media allergy, the patient was placed under observation for 30 minutes. Eleven minutes after the vaccination, the patient had redness of palms. The patient had no rash or wheezing. At 11:30, BOSMIN 0.3 mL was inhaled and antiallergic drug was taken orally. At 11:40, after the inhalation, the patient had floating feeling; however, redness of palms immediately improved. After the onset of the symptoms, the patient was placed under observation for 60 minutes and then returned home. At the time of returning home, blood pressure was 120/86, pulse rate was 78, and SpO2 was 97. The reporting physician classified the events as non-serious 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: Against erythema of fingers suggestive of immediate reaction, inhalation of BOSMIN was considered effective treatment.


VAERS ID: 1404854 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OLMESARTAN OD; LOXOPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s disease; Hyperlipidaemia; Inclusion body myositis (As for Inclusion body myositis, Only outpatient treatment, No interventional treatment.)
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021638762

Write-up: left Facial palsy/The patient''s left face was unable to move, the corner of the left mouth was drooling, and the left eye cannot be closed at all.; This is a spontaneous report from a contactable Physician received via Medical Information Team and the Pharmaceuticals and the Regulatory Authority. Regulatory authority report number is v21111243 The patient was 77 years old female. On 24May2021, the patient received 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. The details of the reaction was reported as follow: On 24May2021, the first dose of vaccination performed. 10 days after the first vaccination (that was, yesterday) (actually they thought it was 8 days later), left Facial palsy occurred. Additional information received was as follows: The patient was 77-year and 3 month-old female. Body temperature before the vaccination was 36.5 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included that Inclusion body myositis, Hyperlipidaemia, Hashimoto''s disease. As for Inclusion body myositis, Only outpatient treatment, No interventional treatment. In addition, regular oral administration of Olmesartan OD 15mg, oral administration of Loxoprofen 60mg. On 24May2021 (the day of vaccinations), the patient received the first dose of bnt162b2(COMIRNATY intramuscular injection, Lot number: EY0779, expiration date: 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Clinical course of the event was reported as follows: On 01Jun2021(8 days after vaccination), An acquaintance pointed out that the movement of the patient''s left face was abnormal On 02Jun2021(9 days after vaccination), The patient''s left face was unable to move, the corner of the left mouth was drooling, and the left eye cannot be closed at all. On 02Jun2021(9 days after vaccination), The patient went to hospital, the event was identified as left Facial palsy. According to Bell''s palsy as the standard, the patient took steroid by oral (Decrease from 30mg) and prescribed Valaciclovir 1000mg/2x The event term was reported as Facial palsy. The onset day of the events was 01Jun2021(8 day after vaccination). Outcome of events was not recovered on 02Jun2021. The causality between the event and the vaccine was Unassessable. Other possible cause of the event such as any other diseases was included that it was indistinguishable from the usual Bell''s palsy. The reporter''s comment was that It was difficult to judge whether it was the direct effect of the vaccine or Bell''s palsy.


VAERS ID: 1404859 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Feeling hot, Heart rate, Vision blurred, Vital signs measurement
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: KT; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210601; Test Name: KT; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: 10 minutes after the vaccination; Test Date: 20210601; Test Name: HR; Result Unstructured Data: Test Result:60; Test Date: 20210601; Test Name: Vital Sign; Result Unstructured Data: Test Result:104/60
CDC Split Type: JPPFIZER INC2021639087

Write-up: Hazy vision; feeling hot; This is a spontaneous report from a contactable Physician received from Medical Devices Agency. The patient was an 86-year and 2-month-old male. Body temperature before vaccination was 36.3 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 01Jun2021 at 11:10 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jun2021 at 11:25, the patient experienced adverse events. On 01Jun2021 (the same day after the vaccination), the outcome of the event was recovered. The course of the event was follows: On 01Jun2021 at 11:25 (the day of vaccination), about 10 minutes after vaccination, the patient experienced Hazy vision and feeling hot. Vital Sign 104/60, HR 60, KT 36.4 degree Centigrade. There were no issues that require special attention, but just in case, Adrenaline 0.3g was injected in the thigh. The reporting Physician classified the event as non-serious and assessed the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting Physician commented as follows: Although it is considered to be no problem at all, but I reported it because there was a person who complained of subjective symptoms for the first time in the 100 inoculations. Therapeutic measures were taken as a result of the events and included Adrenaline. The outcome of the events was recovered on 01Jun2021.


VAERS ID: 1404885 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 FA2453 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Nausea, Oxygen saturation, Pruritus, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreasing; Comments: after vaccination; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210601; Test Name: SpO2; Result Unstructured Data: Test Result:improved to 96; Comments: after vaccination
CDC Split Type: JPPFIZER INC2021641996

Write-up: Anaphylaxis; itchy symptoms; urticaria; Queasy; vomiting; blood pressure was decreasing; This is a spontaneous report from a contactable physician received from the agency. Regulatory authority report number is v21110943. The patient was a 28-year-old female. Body temperature before vaccination was 36.3 degrees centigrade. Family history and concomitant medications were not reported. On 11May2021 at unknown time (the day of the first vaccination), the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number unknown, Expiration date unknown); she experienced urticaria from 13May2021 to 14May2021. On 01Jun2021 at 14:00 (the day of the second vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a second single dose for COVID-19 immunisation. Patient age at vaccination was 28 years old. On 01Jun2021 at 14:10 (10 minutes after the vaccination), the patient experienced anaphylaxis. On 01Jun2021 (the day of the second vaccination), the patient was admitted to another hospital. As of the reporting date, the outcome of the event was not provided. The course of the event was as follows: On 11May2021 (the day of the first vaccination), the patient received a BNT162b2 vaccine for the coronavirus. From 13May2021 to 14May2021 (2 to 3 days after the first vaccination), the patient experienced urticaria at night. On 14May2021 (3 days after the first vaccination), an antiallergic drug was prescribed by the dermatologist. Around 25May2021 (14 days after the vaccination), the symptom improved. On 01Jun2021 at 14:00 (the day of the second vaccination), the patient was vaccinated; several minutes later (at 14:10), she experienced itchy symptoms and urticaria and took 1 tablet of mequitazine. However, itching did not improve, and when a route was about to be secured before the symptoms was aggravated, the patient felt worse and moved by herself to a stretcher. Hydrocortisone sodium succinate (SOLU-CORTEF) was given by drip infusion. Queasy and vomiting were also present, and oxygen (5L) was administered. After this, the blood pressure was decreasing, and epinephrine (BOSMIN) 0.2 (illegible unit) was therefore injected into the thigh intramuscularly. The SpO2 improved to 96. It became possible to measure the blood pressure, and the patient was transported by ambulance to another hospital. The reporting physician classified the event as serious (hospitalization) and assessed that the event was related to BNT162b2. It was not reported whether there was other possible cause of the event such as any other diseases.


VAERS ID: 1404890 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 FA7338 / 1 - / -

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? 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: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:219/108 mmHg; Comments: after the vaccination; Test Date: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:220/125 mmHg; Comments: at 15:15; Test Date: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:189/109 mmHg; Comments: at 15:40; Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: Before vaccination; Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: at 15:15; Test Date: 20210601; Test Name: pulse rate; Result Unstructured Data: Test Result:84 to 85; Comments: after the vaccination; Test Date: 20210601; Test Name: pulse rate; Result Unstructured Data: Test Result:85/min; Comments: at 15:15; Test Date: 20210601; Test Name: SpO2; Result Unstructured Data: Test Result:93 to 97 %; Comments: after the vaccination; Test Date: 20210601; Test Name: SpO2; Test Result: 98 %; Comments: at 15:15
CDC Split Type: JPPFIZER INC2021642062

Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician and pharmacist received from the Regulatory Authority. Regulatory authority report number is v21110910 and v21111516. The patient was a 79-year and 5-month-old female. Body temperature before vaccination was 35.9 degrees Centigrade. The family history was not reported. Medical history and concomitant medications were not reported. 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 01Jun2021 at 14:20 (the day of vaccination), at age of 79-year-old 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 01Jun2021 at 14:22 (2 minutes after the vaccination), the patient experienced anaphylaxis. On 01Jun2021 (the day of the vaccination), the outcome of the event was recovering. The patient experienced cold sweat, cough, and ill complexion. The blood pressure was 219/108 (mmHg), the pulse rate was 84 to 85, and the SpO2 was 93 to 97%. Although the symptoms improved with bed rest, the patient had irritating sensation of the throat, and she orally took an antiallergic drug at 14:40 (30 minutes after vaccination, as reported, pending clarification), and she was transferred to the nearby hospital. The course of the event was also reported as follows: On 01Jun2021 at 14:20, the patient felt pharynx strange sensation of, cold sweat, and numbness in left hand. On 01Jun2021 at 14:22, the patient called to the emergency room of the reporter''s hospital. On 01Jun2021 at 14:40, the patient took XYZAL, and pharynx strange sensation of and numbness were relieved. On 01Jun2021 at 15:15, the patient was emergency transported to the reporter''s hospital. The patient was able to walk by own. Body temperature was 35.6 degrees Centigrade, HR was 85/min, blood pressure was 220/125 mmHg, SpO2 was 98%. On 01Jun2021 at 15:40, blood pressure was 189/109 mmHg. The patient had a mild cough at the time of arrival to the hospital, but symptoms were generally recovering. After observing the patient until 16:00, the decision was made to send her home. The reporting pharmacist classified the event as non-serious and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1404894 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 FA2453 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021642163

Write-up: Right peripheral facial palsy/right facial palsy; This is a spontaneous report from a contactable physician received via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES). The patient was a non-pregnant 75-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or the same day of the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unknown medications within 2 weeks of vaccination. Other medical history included history of arrhythmia and ongoing hypertension. The patient has no known allergies. On 01Jun2021 at 12:15 (the day of vaccination) at the age of 75-year-old, the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) intramuscular at left arm for COVID-19 immunization. On 01Jun2021 at 19:00 (the day of vaccination), the patient experienced right peripheral facial palsy. The outcome of the event was unknown with treatment including take medicine against the herpes virus that causes paralysis of the facial nerve. The reporter stated the event result in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Additional information received on 04Jun2021 from the same contactable physician received from the regulatory authority. Regulatory authority report number is v21111339. New information added as follows: Body temperature before vaccination was 36.1 degrees Centigrade. On 01Jun2021 after 12:15 (the day of vaccination), the patient experienced right facial palsy(as the source reported). On unknown day (the source not provided), the outcome of the event was unknown(the source not provided). The course of the event was as follows: On 01Jun2021 at 12:15,the COMIRNATY(FA2453) was vaccinated at left arm. On the same day, when watched TV at around 19:00 in the evening, felt that right field of vision became dark and right eyelid down. Speaking of this, remembered that when went home after the vaccination, drove the right eyelid up while driving. Before going to bed on the same day, when (the patient) was brushing teeth, water started to flow down from the corner of right mouth. On 02Jun, the condition of the right face was still not good, so went to this hospital for medical treatment. Diagnosed as right peripheral facial palsy. At 13:50, there was no cerebral infarction in the head and inner ear canal.No neoplastic lesions were found in the inner ear canal and cerebellar pons angle. The reporting physician classified the event as serious (risk of disability) and assessed that the event was related to bnt162b2. Other possible cause(s) of the event such as any other diseases were diabetes mellitus and hypertension. The reporting physician commented as follows: Symptoms developed on the same day of vaccination. There was the basic disease of diabetes mellitus and hypertension.Because of vaccination, herpes virus activated immune responsiveness. Prevaccination Screening Questionnaire for COVID-19 vaccine as follows: The patient was currently treated (with medications, etc.) for disease of arrhythmia and hypertension. The patient had been told by treating physician of the above disease that it is OK for herself to receive this vaccination The patient chosen "no" in these questions included as follows: "Have you been sick or had a fever in the past month", " feeling sick today", " have you ever had convulsions (seizures)","have you ever had severe allergic reactions (anaphylaxis, etc.) to a medication or food? Causative medication/food" ," have you ever been sick after receiving vaccination", " are you possibly pregnant (e.g. late period) or are you currently breast-feeding", " have you received any other vaccines in the past two weeks" ," do you have any questions about this vaccination".; Sender''s Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1404901 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Tremor
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypersensitivity (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: JPPFIZER INC2021642922

Write-up: Anaphylactic reaction; dyspnoea; cough; tremulousness; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21111089. The patient was a 74-year and 7-month-old female. Family history was not reported. There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status); however, details were not provided. On 01Jun2021 at 11:45 at the age of 74-year-old (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jun2021 at 11:45 (immediately after the vaccination), the patient experienced anaphylactic reaction. Immediately after the vaccination, the patient complained of dyspnoea, cough, and tremulousness. The symptoms was improving with intramuscular injection of BOSMIN 0.3 mL and infusion of REPLAS 200 mL and SOLU-CORTEF 200 mg. The outcome of the event was recovering. The reporting physician classified the event as serious (medically significant) and assessed that the event was related to BNT162b2. Other possible cause of the event such as any other diseases was not provided. The reporting physician commented that it was anaphylactic reaction.


VAERS ID: 1404913 (history)  
Form: Version 2.0  
Age: 101.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure measurement, Body temperature, Hypotension, Pallor, Pulse absent, Shock
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vasovagal reaction
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: blood pressure; Result Unstructured Data: Test Result:low; Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021644107

Write-up: shock; Consciousness disturbed; Pulse impalpable; Pallor facial; low blood pressure; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21110911. The patient was a 101-year male. Body temperature before vaccination was 36.7 degrees Centigrade on 01Jun2021. The patient received antihypertensive drugs within 1 month of vaccination. On 01Jun2021, at 11:21, the patient received the first dose of BNT162B2 (COMIRNATY, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Medical history included vasovagal reaction. On 01Jun2021, at 11:35 (14 minutes after the vaccination), the patient experienced consciousness disturbed, shock, pallor facial, pulse impalpable. The course of the event was as follows: Fourteen minutes after the vaccination, the patient''s family claimed that he or she tried to get the patients attention, but the patient did not respond. For the patient''s consciousness disturbed, pallor facial, pulse impalpable, it was interpreted as a state of shock. The patient was treated with recumbent position with lower extremities elevated and vital statistics etc. were carried out. It was reported his breathing was stable. The patient''s level of consciousness improved afterwards, and due to low blood pressure, route keep (as reported),the patient was transferred to the emergency room. The outcome of events was unknown. The reporting physician classified the event the causality between the event and BNT162B2 as un-assessable. Other possible cause(s) of the event such as any other diseases was Vascular vagal neurological reflex.


VAERS ID: 1405009 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
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, Body temperature, Chills, Fatigue, Headache, Hyperpyrexia, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Body temperature; Result Unstructured Data: Fever 40.5 to 42 degrees Celsius
CDC Split Type: NLJNJFOC20210623131

Write-up: FEVER 40.5 TO 42 DEGREES CELSIUS; COLD CHILLS; FATIGUE; HEADACHE; REACTION AT OR AROUND THE INJECTION SITE REDNESS; REACTION AT OR AROUND THE INJECTION SITE PAIN; MUSCLE PAIN; REACTION AT OR AROUND THE INJECTION SITE SWELLING, ONSET WITHIN ONE WEEK OF THE VACCINATION; INFLAMMATION REACTION AT THE REACTION (INJECTION) SITE REDNESS, PAIN, SWELLING, ONSET WITHIN ONE WEEK AFTER THE VACCINATION; FEELING UNWELL; JOINT PAIN; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00566515] concerned a 22 year old male with unknown ethnicity and race. The patient''s weight was 72 kilograms, and height was 190 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: 21C10-02 expiry: UNKNOWN) dose was not reported, 1 total administered on 01-JUN-2021 for covid-19 immunisation. Drug start period was 6 (Hours). No concomitant medications were reported. On 01-JUN-2021, the patient experienced inflammation reaction at the reaction (injection) site redness, pain, swelling, onset within one week after the vaccination, feeling unwell, joint pain, reaction at or around the injection site redness, reaction at or around the injection site pain, muscle pain, reaction at or around the injection site swelling, onset within one week of the vaccination, headache. On 02-JUN-2021, the patient experienced fever 40.5 to 42 degrees celsius, cold chills, fatigue. Laboratory data included: Body temperature (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 fever 40.5 to 42 degrees celsius, and cold chills on 02-JUN-2021, and feeling unwell on 03-JUN-2021, was recovering from reaction at or around the injection site redness, reaction at or around the injection site pain, reaction at or around the injection site swelling, onset within one week of the vaccination, inflammation reaction at the reaction (injection) site redness, pain, swelling, onset within one week after the vaccination, fatigue, and headache, and had not recovered from muscle pain, and joint pain. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210623131-COVID-19 vaccine ad26.cov2.s - FEVER 40.5 TO 42 DEGREE 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: 1405125 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 FA8016 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Asthenia, Chills, Cold sweat, Diarrhoea, Nausea, Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021641430

Write-up: fainting due to pain; pain; severe stomach pain and diarrhea; severe stomach pain and diarrhea; cold sweat; nausea; chills; asthenic; This is a spontaneous report from a contactable consumer reporting about herself. A 60-year-old non-pregnant female patient received BNT162B2 (COMIRNATY), 2nd dose via an unspecified route of administration, administered in Arm Left on 01Jun2021 15:45 (Lot Number: FA8016, expiration date not provided) as a single dose for covid-19 immunisation (age at vaccination 60 years). Historical vaccines included 1st dose of BNT162B2 via an unspecified route at age of 60 years old (batch/lot number EW4815) in left arm for Covid-19 immunisation on 21Apr2021 but no other vaccinations within 4 weeks. She had no medical history and no known allergy. Patient was not pregnant at time of vaccination. There were no concomitant medications. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient experienced fainting due to pain, severe stomach pain and diarrhea, cold sweat, nausea, chills, asthenic, all on 01Jun2021 22:45. After approximately 7 hours the patient got severe stomach pain and diarrhoea, cold sweat and nausea. Fainted due to pain. Wokes up and had chills for 30 minutes. Took a shower and went to bed. Woke up the day after (02Jun2021) and was mainly asthenic. No treatment received for all events. The outcome of the asthenic was not recovered, the other events was recovered on 02Jun2021. Follow-up (11Jun2021): Follow-up attempts completed. No further information expected.


VAERS ID: 1408045 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 EW0216 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Crying, Depression, Emotional disorder, Fatigue, Haemorrhage, Heavy menstrual bleeding, Hot flush, Insomnia, Menstrual disorder, Muscle spasms, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Depression (excl suicide and self injury) (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Intra-uterine contraceptive device insertion; Knee replacement; Osteoarthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: fever; Result Unstructured Data: Test Result:99.8 Fahrenheit; Comments: vs normal 97.5
CDC Split Type: CAPFIZER INC2021649038

Write-up: bleeding with clotting; fever; inability to regulate emotional response; joint pain particularly in small digits; insomnia; my period started out of the blue. 8 day early and heavy with clotting; my period started out of the blue. 8 day early and heavy with clotting; extreme depression; extreme Fatigue; hormone shift: crying; hot flashes; cramps; This a spontaneous report from a contactable female consumer (patient) regarding product BNT162B2. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 01Jun2021 14:45 (Lot Number: EW0216) as 1st single dose at the age of 43-years-old for covid-19 immunization. Medical history included osteoarthritis, total knee replacement (TKR) left, intrauterine device (IUD). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Event started on 01Jun2021 15:15. Within the first hour, the patient started experiencing an extreme hormone shift: crying, hot flahses, depression, fatigue, cramps. Approx. 12h after vaccination, her period started out of the blue. 8 days early and heavy with clotting. Benchmark: The patient had an IUD and typical barely spot, was regular to the hour as to starting. Day 2 (02Jun2021): extreme depression and bleeding with clotting. Day 3: (now as the patient report this, 03Jun2021). Continued bleeding with clotting, hot flashes, fever (99.8F vs normal 97.5F), inability to regulate emotional responses, extreme fatigue and depression (none of which are ever experienced on an ongoing basis). Joint pain particularly in smaller digits. Fatigue but insomnia. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered.


VAERS ID: 1408046 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-01
   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 UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Bradycardia, SARS-CoV-2 test, Ultrasound scan abnormal
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Malignancy related therapeutic and diagnostic 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:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:unknown result; Test Name: tested for COVID-19; Result Unstructured Data: Test Result:unknown result; Test Name: Heart ultrasound; Result Unstructured Data: Test Result:47; Comments: before 2nd dose; Test Name: Heart ultrasound; Result Unstructured Data: Test Result:37; Comments: after 2nd dose
CDC Split Type: CAPFIZER INC2021649042

Write-up: Heart ultrasound reading was 47 before and after 2nd dose was 37; This is a spontaneous report received from a contactable consumer (patient) male of 92 years old regarding product BNT162B2. A 92-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28May2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. 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. Heart ultrasound reading was 47 before and after 2nd dose was 37 on 01Jun2021. The reporter wonder if this related to study out of Israel called myocarditis. The patient''s hospitalization was prolonged as a result of the event. The patient underwent lab tests and procedures which included blood test. Since the vaccination, the patient has been tested for COVID-19. Outcome of the event was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1408062 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
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, Chills, Drug ineffective, Malaise, Pyrexia, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: COVID test; Result Unstructured Data: Test Result:Positive
CDC Split Type: COPFIZER INC2021677951

Write-up: A COVID test was performed and was positive; A COVID test was performed and was positive; Very sick; Fever/fever went up and down; Chills; This is a spontaneous report from a contactable consumer (the patient) via the Medical information team. A 69-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Jun2021 as a single dose and first dose via an unspecified route of administration on an unspecified date (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) as a single dose, both for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient reported adverse events after the application of the second dose of the COVID-19 Pfizer vaccine, patient referred that he did not have any situation after the first dose. It was reported that "on the next days (Friday 04Jun2021 and Saturday 05Jun2021) he had fever, patient used for the symptoms acetaminophen and Advil, as well as "little lemon" (as reported). The patient informed that he was going to be hospitalized, but he said no, because the fever went up and down, and on an unspecified date in Jun2021, had chills. The patient referred that the night before the time of reporting, 08Jun2021 he was very sick and on the day of reporting, 09Jun2021 in the morning, approximately at 05:00 a COVID test was performed and was positive. The patient asked why this was happened. On 09Jun2021, the patient underwent lab tests and procedures which included COVID test: positive. The event fever was treated with acetaminophen and Advil, as well as "little lemon" (as reported). The outcome of events was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1408097 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-06-01
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Fatigue, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: SARS-CoV-2 IgG antibodies; Result Unstructured Data: Test Result:Positive; Comments: Method used:.; Test Date: 20210601; Test Name: nasopharyngeal swab RT PCR; Test Result: Positive
CDC Split Type: ESPFIZER INC2021676911

Write-up: RT PCR positive; RT PCR positive; After three days with a high fever and low oxygen saturation in the blood, very tired and in bed; After three days with a high fever and low oxygen saturation in the blood, very tired and in bed; After three days with a high fever and low oxygen saturation in the blood, very tired and in bed; This is a spontaneous case reported by a contactable physician Regulatory Authority (ES-PFIZERINC-GRACE00285292). A 92-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection), second dose via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ER9470), as a single dose, first dose via an unspecified route of administration on 03Mar2021 (Batch/Lot Number: EP9578), as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was reported that 92-year-old woman, confined in her home, but without pathologies that are not of geriatric origin. Cared for by her daughters and cared for by external assistants. Monitored regularly and without symptoms compatible with COVID-19. "At the end of May2021, one of the external assistants, of CONFIDENTIAL nationality, was infected with a traceable transmission: a brother-in-law (infected) to whom her son has infected, although we cannot go any further back". But it was very likely that it was due to a family outbreak of possible origin imported from CONFIDENTIAL. This assistant infected the patient because almost simultaneously with the appearance of the assistant''s symptoms, she begins to develop symptoms that are clearly compatible with COVID-19. On the instructions of an expert family member, a Reverse transcription polymerase chain reaction (RT PCR) was performed immediately on 01Jun2021, using a nasopharyngeal swab and with a positive result. RT PCR assay: (Manufacturer and trademark of the RT PCR kit: Abbott, Manufacturer and model of the thermal cycler used: Alinity from Abbott, cycle threshold value (CT Value): 12.3). After three days in Jun2021, with high fever and low blood oxygen saturation, very tired and in bed, the patient was recovering satisfactorily and there has been no need for hospital admission. The physician requested information as per "your opinion", was it a failure of the batch of the vaccine. Could it be due to errors in vaccination logistics, such as breaking the cold chain of conservation, injection of inadequate doses. Could it be due to an infection with a variant (possibly imported from PRIVACY) that avoids the antibodies that we know the vaccine has generated in this case. To resolve this doubt, "I suggest that, if possible, a genomic sequencing of SARS-CoV-2 be carried out in order to eliminate the fact that the infection is due to a variant that eludes the immunity of your vaccine". There was also the possibility, with a very low probability, that the IgG antibodies generated by the vaccine are not protectors and blockers of the strain with which it has been infected (REDACTED). They are due to the fact that "I have studied the incidence of "vaccine breaktrough" provided and it seemed to me an unlikely enough case to bring it to your attention. Waiting on your prompt response." The patient underwent lab tests and procedures which included Sars-Cov-2 antibody test: positive on 13Apr2021, method used: . The outcome of the events was reported as RT PCR positive (Vaccination failure) was reported as unknown and outcome for all other events was reported as resolving.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Fatigue, Pyrexia, Low oxygen saturation and the suspect drug BNT162b2.


VAERS ID: 1408313 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fainting
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021640658

Write-up: This is a spontaneous report from a contactable healthcare professional received from the Regulatory Agency. A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date were not reported), via an unspecified route of administration on 01Jun2021 (at the age of 29-years) as single dose for COVID-19 immunisation. Medical history included fainting. 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. The patient''s concomitant medications were not reported. The patient experienced syncope on 01Jun2021 with outcome of recovered on 01Jun2021. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1408314 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Disturbance in attention, Feeling abnormal, Headache, Pain in extremity
SMQs:, Dementia (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021640697

Write-up: Arm very painful, varying between strong throbbing and sharp pains; Headache, generally very fuzzy; Headache; Concentration loss; This is a spontaneous report from a contactable consumer received from the regulatory authority, report number is GB-MHRA-APPCOVID-20210601220523, Safety Report Unique Identifier GB-MHRA-ADR 25401756. A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included lactation decreased. She has not had symptoms associated with COVID-19, not had a COVID-19 test, not enrolled in clinical trial, not pregnant, and not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced arm very painful on an unspecified date; headache and concentration loss on 01Jun2021. Case narrative: Headache, generally very fuzzy and unable to concentrate. Arm very painful, varying between strong throbbing and sharp pains. No relevant investigations or tests conducted. The outcome of headache and concentration loss was not recovered while outcome of other events was unknown. Case was reported as medically significant by health authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1408462 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Cardiac flutter, Dizziness, Feeling abnormal, Palpitations, SARS-CoV-2 test, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Tachyarrhythmia terms, nonspecific (narrow), Vestibular 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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201112; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021640529

Write-up: Heart fluttering; Fluttering heart had gone from a light flutter to more of a heavy throb; Light-headed; feeling is not overly unpleasant but do feel a little out of the room; Blurred vision/ blurry vision; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106011457184160-45AD9, Safety Report Unique Identifier GB-MHRA-ADR 25398776. A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 (Lot number was not reported) (at the age of 29-years-old) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included suspected COVID-19 from 11Nov2020 to 30Nov2020, and headache from an unknown date and unknown if ongoing. Patient was not enrolled in clinical trial. Concomitant medication included paracetamol taken for headache from 29May2021 to 29May2021. On 01Jun2021, the patient experienced heart fluttering, light-headed, and blurred vision/ blurry vision. The clinical course was also reported as follows: Not described as severe but definitely noticeable. On 01Jun2021, fluttering heart had gone from a light flutter to more of a heavy throb, deep breaths seemed to calm it down. Light headed felt related to the heart flutter, feeling was not overly unpleasant but do feel a little out of the room with the light headedness. Blurry vision was more of a struggle to focus, when moving his eyes it took a while for vision to settle and see clearly. The events were considered non serious by MHRA; Pfizer assessed the event heart fluttering medically significant and the rest of the events were non serious. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 12Nov2020, Yes - Positive COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the evets was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1408486 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Dizziness, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular 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: Comments: Take 10mg of citalopram daily 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; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021640726

Write-up: Light-headed/ was very lightheaded/ light headedness; This is a spontaneous report from a contactable consumer received from the Regulatory Authority; the Regulatory Authority report number is GB-MHRA-WEBCOVID-202106011742378300-GMZW7 and the Safety Report Unique Identifier is GB-MHRA-ADR 25400090. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Jun2021 (batch/lot number: EW3143) at 33 years old as 1ST DOSE, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. The patient previously took citalopram for an unspecified indication. The patient experienced light-headed on 01 Jun2021. It was reported that the patient was very lightheaded about 1 hour after vaccine. He never experienced light headedness before, so he was certain that it was a vaccine related effect. Outcome of the event "light-headed/ was very lightheaded/ light headedness" was recovering. The event was reported as medically significant. The patient has not tested positive for COVID-19 since having the vaccine; patient tested no - negative for COVID-19 virus test on an unknown date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408503 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Feeling hot, Paraesthesia, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021640774

Write-up: arm and hand were also a little tingly; faint after a few minutes of driving; Near fainting; felt extremely hot; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority, report number is GB-MHRA-WEBCOVID-202106011903282250-LGT6Q, Safety Report Unique Identifier GB-MHRA-ADR 25400823. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 01Jun2021 (at the age of 34 years old) as 1st dose, single dose for COVID-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19 and 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 faint after a few minutes of driving, near fainting, felt extremely hot on an 01Jun2021 and arm and hand were also a little tingly on an unspecified date. It was reported that the patient left the center after waiting for 15 minutes and felt extremely hot and faint after a few minutes of driving. She had to pull over very quickly. Her arm and hand were also a little tingly. The reporter assessed all events as non-serious. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events faint after a few minutes of driving, near fainting was recovered on 01Jun2021 while the outcome of all other events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1408505 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   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, Headache, 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: LUCETTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative
CDC Split Type: GBPFIZER INC2021640651

Write-up: Shivers; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106011923558370-YHSLG. Safety Report Unique Identifier is GB-MHRA-ADR 25400916. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 31May2021 (lot number and expiry date: unknown) as 1st 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. Concomitant medication included drospirenone, ethinylestradiol (LUCETTE) taken for an unspecified indication, start and stop date were not reported. The patient experienced shivers and headache on 01Jun2021. The events were considered serious due to other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1408506 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Blood pressure measurement, Blood pressure systolic increased, Head injury, Heart rate, Joint injury, Oxygen saturation, Respiratory rate, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Hypertension (narrow), 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: Medical History/Concurrent Conditions: Faint (Previous faint when receiving vaccines as a young man - had not advised staff despite); Comments: Previous faint when recieving vaccines as a young man - had not advised staff despite being asked. 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: Test Name: blood pressure; Result Unstructured Data: Test Result:139/81 mmHg; Test Name: pulse; Result Unstructured Data: Test Result:77 bpm; Test Name: SpO2 on air; Test Result: 99 %; Test Name: respiration; Result Unstructured Data: Test Result:12 rpm
CDC Split Type: GBPFIZER INC2021640345

Write-up: blood pressure of 139/81 mmHg; Syncope; hit head and right knee; hit head and right knee; This is a spontaneous report from a contactable healthcare professional received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106011927513670-G9DET, Safety report unique identifier GB-MHRA-ADR 25400941. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW3143), via an unspecified route of administration on 01Jun2021 (at the age of 33 years old) as 1st dose, single dose for COVID-19 immunization. Medical history included syncope from an unknown date and unknown if ongoing. The patient had previous faint when receiving vaccines as a young man - had not advised staff despite. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced syncope, hit head and right knee on 01Jun2021 and blood pressure of 139/81 mmHg on an unspecified date. It was reported that a few moments after sitting in waiting area post vaccination, the patient fainted. He hit head and right knee. The reporter assessed all events as non-serious. The patient underwent lab tests and procedures which included blood pressure: 139/81 mmHg, pulse (P): 77 bpm, SpO2 on air: 99 %, respiration (R): 12 rpm, all on unspecified dates. The outcome of the event syncope was recovered on 01Jun2021 while the outcome of all other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408511 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   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: SARS-CoV-2 test, Vaccination site movement impairment, Vaccination site pain
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Injury
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021640471

Write-up: Difficult to lift arm due to pain Hard to operate gears and handbrake in car due to pain; pain/Intense pain at injection site and upper arm extending down to elbow; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106012044357120-VRYYU.Safety Report Unique Identifier (GB-MHRA-ADR 25401414). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31May2021 (Batch/Lot Number: EW3143) as 1st dose, single dose for COVID-19 immunisation. Medical history included injury from an unknown date and unknown if ongoing. No other medication or injury. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient had no concomitant medications. The patient experienced pain on 01Jun2021. The clinical course was reported as follows: intense pain at injection site and upper arm extending down to elbow. Difficult to lift arm due to pain. Hard to operate gears and handbrake in car due to pain. The event was reported as serious (disabling and 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. The outcome of the pain was not recovered while for the other event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408519 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-06-01
   Days after vaccination:10
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: Haemorrhage, Vaginal 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: Irregular periods (irregular bleeding/bleeding at a mid-point between periods); Lactation decreased; Poor sucking reflex; Suspected COVID-19; Therapeutic embolisation; Comments: Since having a coil fitted in 2018 i have sometimes had irregular bleeding, I had a few tests, scans etc but nothing was conclusive. Otherwise, there would be no other reason for me to be bleeding at a mid-point between periods. 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 INC2021640305

Write-up: This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. A 37-year-old female non-pregnant patient received bnt162b2, via unspecified route of administration on 22May2021 (batch/lot number and expiry date unknown) as 1st dose, single for covid-19 immunization. Medical history included menstruation irregular, lactation decreased, poor sucking reflex, suspected covid-19 from 20Apr2020 to 01May2020. The patient since having a coil fitted in 2018, the patient sometimes had irregular bleeding. The patient had a few tests, scans etc., but nothing was conclusive, otherwise, there would be no other reason for her to be bleeding at a mid-point between periods. The patient not had a COVID-19 test, not enrolled in clinical trial, not currently breastfeeding. The patient''s concomitant medications were not reported. On 01Jun2021, the patient experienced bleeding (medically significant) and bleeding vaginal. The patient informed that her period started the day before having the vaccine (21May2021), so to be bleeding at 11 days after the start of her regular period showed (01Jun2021) that it was irregular bleeding. The bleeding was fairly heavy, although not painful. The patient logging the symptoms on the day they had appeared, so the patient was not sure yet when or how they will be resolved. The patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.


VAERS ID: 1408526 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chest pain, Musculoskeletal chest pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; IBUPROFEN; LUCETTE; PARACETAMOL; PROPRANOLOL; SERTRALINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 Test
CDC Split Type: GBPFIZER INC2021640403

Write-up: Stomach pain; Chest pain/stabbing pain in sternum; pain/left side of my rib cage; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106012321180490-DY74T, Safety Report Unique Identifier is GB-MHRA-ADR 25401905. A 23-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 01Jun2021 (Lot number was not reported) as second dose, single for covid-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medications included amitriptyline, ibuprofen; drospirenone, ethinylestradiol (LUCETTE); paracetamol, propranolol and sertraline. On unspecified date in Jun2021, the patient experienced stomach pain, chest pain/stabbing pain in sternum and pain/left side of rib cage. "Around 3-4 hours after having the vaccine (Jun2021), I started getting stabbing pains in my sternum and slightly to the left of my chest which has progressed down to my stomach area and up the left side of my rib cage." 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 01Jun2021. 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: 1408540 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular 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: Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210515; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021649245

Write-up: Dizzy spells; dizzy; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number: GB-MHRA-WEBCOVID-202106020823372060-VK2WY. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 25403015. A female patient of an unspecified age received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 1 via an unspecified route of administration on 01Jun2021 (Batch/Lot Number: Not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced dizzy spells on 01Jun2021 the day she had the vaccine and dizzy 20 hours after (Jun2021). The events were assessed as serious: medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 15May2021. Patient has not tested positive for COVID-19 since having the vaccine. No other relevant investigations or tests conducted. The outcome of dizzy spells was recovering while outcome of dizzy was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1408547 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hypothermia, Nausea, Nucleic acid test, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Fever; Lactation decreased; Nucleic acid test (no active signs of AOSD; weaning off prednisolone)
Allergies:
Diagnostic Lab Data: Test Name: Temperature; Result Unstructured Data: Test Result:very (v) low temperature/v low (34); Test Name: Temperature; Result Unstructured Data: Test Result:mild fever (38); Test Name: NADIAs; Result Unstructured Data: Test Result:no active signs of AOSD; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021640621

Write-up: Hypothermia; Feverish/Fever; Nauseous; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106020854309260-3YPVM, Safety Report Unique Identifier: GB-MHRA-ADR 25402865. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31May2021 (lot number: not known) at 2nd dose, single for COVID-19 immunisation. Medical history included lactation decreased, fever , nucleic acid test (NADIAs) which showed no active signs of AOSD. The patient is weaning off prednisolone. 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 previously took prednisolone. The patient experienced fever on an unspecified date; and hypothermia, feverish, and nauseous on 01Jun2021. Clinical course reported: the main unusual side effect was an intermittent very (v) low temperature that the thermometer cannot record. It oscillated between v low (34) and a mild fever (38). The low temperature caused more concern. 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 the events nauseous was recovered on an unspecified date; and hypothermia and feverish was not recovered. Regulatory authority assessed the events as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1408549 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-01
   Days after vaccination:3
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: Pain in extremity, SARS-CoV-2 test
SMQs:, 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: IBUPROFEN; NAPROXEN; SERTRALINE
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 INC2021649131

Write-up: Leg pain; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106020903473150-IJJSF. A 30-year-old patient of an unspecified gender received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 29May2021 (Lot number was not reported) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included ibuprofen, naproxen, and sertraline. The patient experienced leg pain (medically significant) on 01Jun2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test was no - negative COVID-19 test on an un specified date. Patient has not tested positive for COVID-19 since having the vaccine No follow-up attempts are possible, information about batch/lot number cannot be obtained.


VAERS ID: 1408571 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Abdominal pain upper, Feeling drunk, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 virus test negative; Hay fever; Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210526; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021649739

Write-up: Stomach cramps; Intoxication/ like she was highly intoxicated/ she was swaying and appeared very drunk; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority; the Regulatory Authority report number is GB-MHRA-WEBCOVID-202106021125574850-QQFNP and the Safety Report Unique Identifier is GB-MHRA-ADR 25404332. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Jun2021 (batch/lot number: ew3143) at 33 years old as 1ST DOSE, SINGLE for COVID-19 immunization. The patient''s medical history included lactation decreased and hay fever, both from an unknown date. The patient was suspected COVID-19 from 25May2021; patient tested no - negative for COVID-19 virus test on 26May2021. The patient was not enrolled in clinical trial. Patient was not pregnant and not currently breastfeeding. Concomitant medication included cetirizine (CETIRIZINE) taken for hay fever from 01Apr2021 to an unspecified stop date. On 01Jun2021, two (2) hours after vaccination, the patient experienced intoxication reported as an hour period that was like she was highly intoxicated. She was swaying and appeared very drunk, this subsided after approximately one (1) hour later. The patient also experienced stomach cramps on an unspecified date. The patient recovered from the event "intoxication/ like she was highly intoxicated/ she was swaying and appeared very drunk" on 01Jun2021. Outcome of stomach cramps was unknown. 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 possible. No further information is expected.


VAERS ID: 1408575 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Pruritus, Rhinorrhoea, Seasonal allergy
SMQs:, Anaphylactic reaction (broad), Conjunctival disorders (narrow), Hypersensitivity (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 INC2021649055

Write-up: Itching; Runny nose; Hay fever; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106021139475190-ECHE9. Safety Report Unique Identifier: GB-MHRA-ADR 25404444. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 (Batch/Lot number was not reported) at the age of 33 years old, single dose, for Covid-19 immunisation. Medical history included lactation decreased. 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 was not enrolled in clinical trial. Patient was not pregnant at the time of vaccination. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced runny nose, and hay fever on 01Jun2021; itching on 02Jun2021. The events were reported as medically significant. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1408577 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hyperhidrosis, Investigation, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: Observation; Result Unstructured Data: Test Result:within normal range
CDC Split Type: GBPFIZER INC2021649185

Write-up: sweaty; passed out; Syncope; This is a spontaneous report from a contactable physician received from the regulatory authority, report number is GB-MHRA-WEBCOVID-202106021153152400-Z5NHN. Safety Report Unique Identifier is GB-MHRA-ADR 25404472. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EY5456), via an unspecified route of administration on 01Jun2021 as first dose, single dose for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19, she has not had a COVID-19 test, and she was not enrolled in clinical trial. She was not pregnant and was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced sweaty and passed out on Jun2021; and syncope on 02Jun2021. The events were reported as non-serious. The clinical course was reported as follows: Had vaccine and felt sweaty. Stood up to have fresh air but passed out very briefly. Put in recovery position. Recovered ok and observed for 30minutes. All observation within normal range. Discharged home on Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. This report does not relate to possible blood clots or low platelet counts. The events sweaty and passed out recovered on Jun2021. The outcome of syncope was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408621 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Dysmenorrhoea, Menstruation delayed, Premenstrual pain
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649472

Write-up: cramps/period cramps; my period is also a day late now; Premenstrual cramps; This is a spontaneous report from a contactable pharmacist (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106021427245140-OBL0N. Safety Report Unique Identifier GB-MHRA-ADR 25405827. A 24-year-old female patient (not pregnant, not currently breastfeeding) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ew3143), via an unspecified route of administration on 01Jun2021 as first dose, single for COVID-19 immunization. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. The patient experienced premenstrual cramps on 01Jun2021. On unspecified date, she informed she had period cramps and she usually don''t get cramps (painful, it felt like contractions). They were so bad that she couldn''t get up at all for an hour and her period was also a day late now and she can''t be pregnant. The evens were reported as serious-disability. The outcome of premenstrual cramps was not recovered; for other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408636 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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, Dyspnoea, Electrocardiogram, Feeling hot, Formication, Head discomfort, Heart rate increased, Vertigo
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Leg pain; Poor peripheral circulation
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:Unknown Result
CDC Split Type: GBPFIZER INC2021649513

Write-up: Heart rate high/rising heartbeat/heart was beating extremely fast; Head pressure/feeling pressure and heat in my head.; Formication/feeling vibration in my left hand; Felt faint/seeing black circles; Head spinning; Breath shortness/difficulty with breathing; feeling pressure and heat in my head.; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106021521237410-8XNQX, Safety Report Unique Identifier GB-MHRA-ADR 25406474. A 29-year-old female patient (age at vaccination: 29-year-old, not pregnant, not currently breastfeeding) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 01Jun2021 as first dose, single for COVID-19 immunisation. Medical history included poor peripheral circulation, decreased lactation and leg pain. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient had no concomitant medications. On 01Jun2021, the patient experienced rising heartbeat/heart rate high also informed of heart was beating extremely fast, started feeling vibration in the left hand (formication), head was spinning, started feeling pressure (head pressure) and heat in her head, started seeing black circles (felt faint) and had difficulty with breathing (breathshortness). The events were reported as serious medically significant. The patient underwent procedure which included electrocardiogram: unknown result on an unspecified date. The outcome of formication was not recovered; for felt faint, breath shortness was recovered; for other events was recovering. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1408640 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Cold sweat, Dizziness, Face injury, Facial pain, Fall, Head injury, Lip injury, Lip swelling, Loss of consciousness, Pain in extremity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Glaucoma (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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 INC2021649475

Write-up: Fainting; Loss of consciousness; regained consciousness; cut his bottom lip; feeling dizzy; fell flat on his face; The patient sustained injuries to his face; cut his bottom lip; The patient sustained injuries to his face; cut his bottom lip; The patient sustained injuries to his face; cut his bottom lip; pain to the left side of his face and his left hand; The patient sustained injuries to his face; cut his bottom lip; This is a spontaneous report from a contactable pharmacist received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106021529593550-SD5GR, Safety Report Unique Identifier GB-MHRA-ADR 25406462. A 32-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Jun2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced fainting on 01Jun2021 with outcome of recovered, loss of consciousness on 01Jun2021 with outcome of recovered, regained consciousness (cold sweat) on 01Jun2021 with outcome of recovered, cut his bottom lip (lip swelling) on 01Jun2021 with outcome of recovered, feeling dizzy on 01Jun2021 with outcome of unknown, fell flat on his face on 01Jun2021 with outcome of unknown, the patient sustained injuries to his face; cut his bottom lip on 01Jun2021 with outcome of unknown, pain to the left side of his face and his left hand on 01Jun2021 with outcome of unknown. The clinical course was reported as follows: Patient had received his Pfizer vaccine and was in the waiting room. After around 10 minutes he got up to get a glass of water he lost consciousness and fell flat on his face. The patient sustained injuries to his face; cut his bottom lip, and lacerated his forehead, complained of pain to the left side of his face and his left hand. The patient regained consciousness quite quickly and was transferred to the recovery area. Complained of feeling dizzy therefore laid semi-recumbent. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained.


VAERS ID: 1408643 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-06-01
   Days after vaccination:10
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, Dehydration, Fatigue, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Dehydration (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: Clinical trial participant; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021649498

Write-up: dehydrated arm; arm still sore; tired / drained; Weakness; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106021544102680-RAVB9. Safety Report Unique Identifier GB-MHRA-ADR 25406467. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22May2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included suppressed lactation, clinical trial participant. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced dehydrated arm (medically significant) on an unspecified date with outcome of recovering, weakness (medically significant) on 01Jun2021 with outcome of not recovered, arm still sore (medically significant) on an unspecified date with outcome of unknown, tired / drained (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24May2021 No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. The clinical course was reported as follows: feeling weak tired / drained dehydrated arm still sore (nothing else has changed out of routine) No follow-up attempts are possible; information about lot/batch number cannot be obtained. .


VAERS ID: 1408673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   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: Axillary pain, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARITHROMYCIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped); Tonsillitis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 2021; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:not tested positive; Comments: since having the vaccine
CDC Split Type: GBPFIZER INC2021649541

Write-up: Swollen glands; Armpit pain; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106021559117860-Q8GGJ. A 30-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 31May2021 (Lot Number: EY5456) as single dose for COVID-19 immunisation. Medical history included suspected COVID-19 from 29Dec2020 (Unsure when symptoms stopped) and tonsillitis. Patient is not enrolled in clinical trial. Concomitant medication included clarithromycin taken for tonsillitis from 27May2021 to 01Jun2021. The patient experienced swollen glands and armpit pain; both on 01Jun2021 with outcome of not recovered. The patient had positive COVID-19 virus test on unspecified date. Patient has not tested positive for COVID-19 on unspecified date in 2021 since having the vaccine. The case has been considered serious due to seriousness criterion of other medically important condition. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408676 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Chest pain, Confusional state, Dizziness, Feeling abnormal, Heart rate, Heart rate abnormal, Nausea, Tachycardia, Visual impairment
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (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: CERAZETTE [DESOGESTREL]; LEMSIP COLD & FLU [CAFFEINE;PARACETAMOL;PHENYLEPHRINE HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: heart rate; Result Unstructured Data: Test Result:124 bpm; Test Date: 20210601; Test Name: heart rate; Result Unstructured Data: Test Result:dropping to 64; Test Date: 20210601; Test Name: heart rate; Result Unstructured Data: Test Result:elevating like the flick of a switch; Test Date: 20210601; Test Name: heart rate; Result Unstructured Data: Test Result:record and my normal heart rate is 54bpm
CDC Split Type: GBPFIZER INC2021649495

Write-up: dizzy spells; nausea; Tachycardia; Dizzy; Light-headed; Nauseous; Chest pain; Confusion; Heart rate abnormal; feel faint; vision felt strange; felt like she was very drunk; This is a spontaneous report from a contactable consumer received from the Regulatory authority report number is [GB-MHRA-WEBCOVID-202106021621220130-ZBTFG], Safety Report Unique Identifier [GB-MHRA-ADR 25406832]. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 01Jun2021 (Lot/batch number and expiry date not reported) at 1st dose, single for COVID-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing, suspected COVID-19 from 09Mar2020 to an unknown date (Unsure when symptoms stopped) and contraception from an unknown date and unknown if ongoing. Concomitant medications included desogestrel (CERAZETTE [DESOGESTREL]) taken for contraception, start and stop date were not reported; caffeine, paracetamol, phenylephrine hydrochloride (LEMSIP COLD & FLU [CAFFEINE;PARACETAMOL;PHENYLEPHRINE HYDROCHLORIDE]) taken for an unspecified indication from 07Mar2021 to an unspecified stop date. The patient experienced dizzy spells and nausea on an unspecified date; tachycardia, dizzy, light-headed, nauseous, confusion, chest pain, heart rate abnormal, vision felt strange, feel faint and felt like she was very drunk on 01Jun2021. The patient underwent lab tests and procedures which included heart rate: 124 bpm , heart rate: dropping to 64, heart rate: elevating like the flick of a switch, heart rate: record and her normal heart rate is 54bpm , all on 01Jun2021. The outcome of the events ''dizzy spells'', ''nausea'', ''light-headed'' was not recovered; events ''tachycardia'' and ''dizzy'' was recovered with sequelae on 01Jun2021; event ''nauseous'' was recovered on'' 01Jun2021; events ''feel faint'', ''vision felt strange'' and ''felt like she was very drunk'' was unknown; outcome of the other events was recovering. The clinical course was reported as follows: 5 minutes after having her vaccine, she began to feel faint, dizzy and nauseous, her vision felt strange and it felt like she was very drunk. Then by 10 minutes after the vaccine it was even worse, her heart felt like it was dropping through the floor, and going up through the roof, she was able to record and her normal heart rate is 54bpm, it was elevating to over 124 bpm then dropping to 64, then elevating like the flick of a switch. She was extremely dizzy by this point and felt like the blood was being drained out of her. The nurses were great however and found her somewhere safe to lie down, and had her feet elevated. They wanted to send her into hospital but there was no spaces available to be seen for the next two hours. They also discussed calling an ambulance but she asked them not too because they were very busy. So her partner had to call her doctor and talk to him about what we could do. Her heart rate now is still not back to normal, she is still suffering from dizzy spells and nausea too. Patient has not tested positive for COVID-19 since having the vaccine. Additional information: Not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1408679 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Fatigue, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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; Ventricular ectopics
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649296

Write-up: Ache; Tiredness; Vomiting; Feverish; This is a spontaneous report from a contactable consumer received from the Regulatory authority report number is [GB-MHRA-WEBCOVID-202106021641512010-L8H5Q], Safety Report Unique Identifier [GB-MHRA-ADR 25406872]. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 (Lot/batch number and expiry date were not reported) as 1st dose, single for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing, Suspected COVID-19 from 17Mar2020 to 28Mar2020 and ventricular ectopics from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced vomiting, feverish and tiredness on 01Jun2021; ache on 02Jun2021. The outcome of the event ''vomiting'' was recovered on 02Jun2021 and outcome of the other events was not recovered. Additional information: Not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about Batch/Lot Number cannot be obtained.


VAERS ID: 1408687 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-01
   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: Anxiety, Fatigue, Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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: PROZAC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649054

Write-up: tingling in hands and feet; Tingling; Numbness/numbness feeling in legs and fingers; Tiredness/feeling totally fatigued; Anxiety/anxious; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106021714065490-DMTOM, Safety Report Unique Identifier GB-MHRA-ADR 25407211. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 28May2021 (lot number and expiry date: unknown) as 1st dose, single for COVID-19 immunisation. Medical history included lactation decreased and anxiety. 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. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for anxiety, start and stop date were not reported. On 01Jun2021, the patient experienced tingling, numbness/numbness feeling in legs and fingers, tiredness, and anxiety. On unspecified date, the patient experienced tingling in hands and feet. Additional information: Tingling in hands and feet, alternates between hands and feet, numbness feeling in legs and fingers, feeling totally fatigued and anxious not knowing why she had these symptoms. Patient was waiting for a general practitioner (GP) appointment. The events were considered serious due to other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event tingling in hands and feet was unknown, while for the remaining 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: 1408689 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-02
Onset:2021-06-01
   Days after vaccination:30
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: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC2021649189

Write-up: Neck rash; This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-WEBCOVID-202106021728473670-FTFYY, Safety Report Unique Identifier GB-MHRA-ADR 25407218. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW3143), via an unspecified route of administration on 02May2021 as 1st dose, single dose for COVID-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19 and 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 neck rash on 01Jun2021. The reporter assessed the event as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408698 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Illness, Motion sickness, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), 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 INC2021649549

Write-up: Fainting; Sea sickness; started being sick; felt light headed; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106021836060740-BTBAT. Safety Report Unique Identifier GB-MHRA-ADR 25407663. 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 was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not pregnant. The patient''s concomitant medications were not reported. The patient experienced felt light headed on an unspecified date in Jun2021 with outcome of recovering, fainting on 02Jun2021 with outcome of recovering, sea sickness on 02Jun2021 with outcome of recovering, started being sick on an unspecified date in Jun2021 with outcome of unknown, all reported as medically significant. Clinical course reported as follow: Felt light headed, fainted in parked vehicle, started being sick when came round. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408711 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   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: Fatigue, Feeling abnormal, Influenza, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 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 INC2021649111

Write-up: Painful arm; felt run down; Swelling arm; Stiffness/arm started feeling stiff; flu symptoms; Spaced out; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106021953568110-NCO3Q, Safety Report Unique Identifier is GB-MHRA-ADR 25408052. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 31May2021 at 18:30, as first dose, single dose for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. She was not pregnant and not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced spaced out on an unspecified date in 2021; flu symptoms on Jun2021; painful arm and felt run down on 02Jun2021 at 00:30; swelling arm on 02Jun2021; and stiffness on 01Jun2021 at 06:30. The events were reported as serious, with seriousness criteria of other medically important condition. The clinical course was reported as follows: The patient received her jab at 18:30 on 31May21. Her arm started feeling stiff about 12 hours after her jab. After about 30 hours, she woke up in the night with very painful arm, which would not settle, has been painful for about 20 hours but was lessening. Have felt run down for the same amount of time since arm became painful. But not full flu symptoms. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent COVID-19 virus test on an unspecified date which resulted negative (No - Negative COVID-19 test). The outcome of event spaced out was recovered on an unspecified date in 2021. The outcome of events flu symptoms and swelling arm was recovered on Jun2021. The outcome of event "felt run down" was unknown, while outcome of the remaining events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1408712 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 FA1027 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Vaccination site pain
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021649152

Write-up: Injection site pain; This is a spontaneous report from a contactable consumer, received from theregulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106021956040820-EZNGK, Safety Report Unique Identifier GB-MHRA-ADR 25408044. A 21-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 01Jun2021 (at the age of 21-years-old) (Batch/Lot Number: FA1027) as a single dose for COVID-19 immunization. Medical history included suppressed lactation. The patient has not had symptoms associated with COVID-19, was not enrolled in a clinical trial, was not pregnant, and was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced injection site pain on 01Jun2021. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on an unspecified date. The patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event was not recovered. The case was reported as serious (medically significant). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408713 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-01
   Days after vaccination:3
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: Blood urine present, Renal pain, SARS-CoV-2 test, Urinary tract infection, Urine analysis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage 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: Sertraline
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; decreased lactation.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test; Test Name: Urine Sample; Result Unstructured Data: Test Result: Unknown Results.
CDC Split Type: GBPFIZER INC2021649096

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number is GB-MHRA-WEBCOVID-202106021957381830-2GUMX). A 34-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# not reported), via an unspecified route of administration, on May 29, 2021, single dose, for COVID-19 immunisation. Medical history included decreased lactation and anxiety. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in a clinical trial. Patient is not pregnant and not currently breastfeeding. Concomitant medication included sertraline taken for anxiety. On Jun 1, 2021, patient experienced kidney pain, urinary tract infection and blood in urine. Medically significant events. The patient underwent lab tests and procedures, which included COVID-19 virus test was No - Negative COVID-19 test and urine sample, with unknown results both on an unspecified date. Outcome of the urinary tract infection: recovering; while of the remaining events were unknown. The clinical course was reported as follows: Strong symptoms of UTI blood in urine and kidney pain. Patient has not tested positive for COVID-19 since the vaccination. No follow-up attempts are possible. Information about batch number cannot be obtained.


VAERS ID: 1408721 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: LYMECYCLINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne; COVID-19; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210104; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021649274

Write-up: Stomachache; Fever; Nauseous; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106022022348930-PKYKQ, Safety Report Unique Identifier GB-MHRA-ADR 25408307. A female patient of an unspecified age received b BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ey5456), via an unspecified route of administration on 01Jun2021 15:30 as 1st dose, single dose for COVID-19 immunization. Medical history included suspected COVID-19 from 28Dec2020 to 10Jan2021, acne from an unknown date and unknown if ongoing and COVID-19 from 04Jan2021 to an unknown date. Patient is not enrolled in clinical trial. Concomitant medications included lymecycline taken for acne from 20Mar2021 to an unspecified stop date. The patient experienced nauseous on 01Jun2021 18:00, stomachache and fever on 02Jun2021. It was reported that the patient got the jab around 3:30 PM, started feeling nauseous since 6 PM until next day. She had an episode of very bad stomachache in the afternoon the following day. Had a high fever in the afternoon day following the jab. The reporter assessed all events 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: positive (yes/positive COVID-19 test) on 04Jan2021. The outcome of the event nauseous was not recovered while the outcome of all other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408733 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-01
   Days after vaccination:5
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: Pain, Paraesthesia, Renal pain, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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: Comments: Patient has not had symptoms associated with COVID-19 Unsure if patient is enrolled in clinical trial Planing to be participate in a study
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021649283

Write-up: radiating; pin / needles; Kidney pain; This is a spontaneous report from a contactable consumer received from the Regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106022121331530-NWUN0, Safety Report Unique Identifier GB-MHRA-ADR 25408648. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also COVID-19 MRNA VACCINE BIONTECH, lot EW3143), via an unspecified route of administration on 27May2021 as first dose, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Jun2021, the patient informed that kidneys on both sides were aching. It was radiating/affecting the legs and felt pin/needles in lower legs (calves) and left ankle on unspecified date. The events were reported as serious medically significant. The patient underwent laboratory test Sars-cov-2 test: No - Negative COVID-19 test. The outcome of kidney pain was not recovered; for other events was recovering. No follow up attempts are possible. No further information is expected.


VAERS ID: 1408753 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   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: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-CODAMOL; COLCHICINE; NAPROXEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Erythema; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649146

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the The regulatory authority report number is GB-MHRA-WEBCOVID-202106022321358340-7QMV6. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 31May2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included lactation decreased and erythema. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant and is not currently breastfeeding. Concomitant medications included codeine phosphate, paracetamol (CO-CODAMOL), colchicine, and naproxen all taken for erythema. The patient experienced swollen lymph nodes (medically significant) on 01Jun2021 with outcome of not recovered. 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: 1408755 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021649463

Write-up: Rash/Extensive localized hot rash in arm which had vaccine; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106030015356830-DV2QL, Safety Report Unique Identifier GB-MHRA-ADR 25408985. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW3143), via an unspecified route of administration, administered in the arm on 01Jun2021 as 1st dose, single dose for COVID-19 immunization. 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 rash/extensive localized hot rash in arm which had vaccine on 01Jun2021. The reporter assessed the event 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 the event was not recovered. This report does not relate to possible blood clots or low platelet counts. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1408774 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-06-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021657242

Write-up: SARS-CoV-2 infection / COVID-19 respiratory infection / COVID-19 virus test positive; SARS-CoV-2 infection / COVID-19 respiratory infection / COVID-19 virus test positive; This is a spontaneous report from a contactable healthcare professional received from the The regulatory authority report number is GB-MHRA-WEBCOVID-202106041246016680-IEGO3. Safety Report Unique Identifier: GB-MHRA-ADR 25420381. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01May2021 (Batch/Lot Number: Not known) as 1ST DOSE, SINGLE 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. Patient was not enrolled in clinical trial. Patient was not pregnant at the time of vaccination. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient was normally fit and well. The patient experienced sars-cov-2 infection/covid-19 respiratory infection, she developed covid-19 symptoms and tested positive for covid-19 virus test on 01Jun2021 following the first dose of the vaccine. The patient underwent lab tests which included COVID-19 virus test: yes - positive covid-19 test on 01Jun2021. Outcome of the events was not recovered. Information about lot/batch number cannot be obtained. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1408789 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-01
   Days after vaccination:4
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: Lip swelling, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Hives; Lip swelling; This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and LIP SWELLING (Lip swelling) in a 35-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 28-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced LIP SWELLING (Lip swelling) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced URTICARIA (Hives) (seriousness criterion medically significant). At the time of the report, URTICARIA (Hives) and LIP SWELLING (Lip swelling) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not provided. No treatment medications were 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: 1408796 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-01
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021677609

Write-up: Bell''s palsy; This is a spontaneous report from a contactable physician received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106081505233400-EGEKP. Safety Report Unique Identifier GB-MHRA-ADR 25438569. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW4109), via an unspecified route of administration on 20May2021 as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. On 01Jun2021, the patient experienced bell''s palsy. The outcome of the event was not recovered. Additional information: Reaction Does your report relate to possible blood clots or low platelet counts? If yes, we will ask you additional questions at the end of this report: "No" No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408818 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Suspected COVID-19; Comments: Patient is not enrolled in clinical trial Patient is not pregnant, Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20201222; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021640786

Write-up: Fainting; This is a solicited report from the RA from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202106012117352480-EJK1K, Safety Report Unique Identifier GB-MHRA-ADR 25401530. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 01Jun2021 at the age of 34-year-old as single dose for covid-19 vaccination. Medical history included suspected covid-19 from 22Dec2020 to 03Jan2021. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. Patient last menstrual period was 19May2021. The patient''s concomitant medications were not reported. The patient experienced fainting on 01Jun2021. This event was reported as non-serious by RA. Additional information: This medication is only taken when a severe migraine occurs (unspecified). The patient underwent lab tests and procedures which included COVID-19 virus test: positive covid-19 test on 22Dec2020. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was recovered on 01Jun2021. The reporter''s assessment of the causal relationship of the event 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: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.


VAERS ID: 1409062 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Altered state of consciousness, Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Chills, Depressed level of consciousness, Heart rate, Nausea, Tachycardia, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Blood pressure; Result Unstructured Data: Test Result:140s-110s; Comments: Blood pressure dropped; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210601; Test Name: HR; Result Unstructured Data: Test Result:120
CDC Split Type: JPPFIZER INC2021643133

Write-up: Anaphylaxis; Consciousness disturbance transient; decreased consciousness level; Tachycardia; systemic urticaria; Chills; Nausea; Vomiting; blood pressure slightly decreased from about 140s to about 110s; This is a spontaneous report from a contactable physician received from the Regulatory Authority, report number is v21111204. A 32-year and 2-month-old female patient received second dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on 01Jun2021 at 09:48 (Lot Number: EY2173; Expiration Date: 31Aug2021) (at the age of 32-year-old) as single dose for COVID-19 immunisation. Body temperature before vaccination was 36.5 degrees Centigrade. The patient previously received first dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation and experienced vaccination site pruritus. On 01Jun2021 at 09:48 (the day of vaccination), the patient received the second dose of BNT162B2 (COMIRNATY). On 01Jun2021 at 10:00 (12 minutes after the vaccination), the patient experienced anaphylaxis, consciousness disturbance transient, tachycardia, urticaria. On 01Jun2021, the patient was admitted to the hospital. On 02Jun2021, the outcome of the events was recovered. The course of the event was as follows: 12 minutes after the second inoculation, it was confirmed that allergic symptoms (Brighton classification grade 2-3), systemic urticaria, tachycardia (HR120), decreased blood pressure (from 140 to 110), decreased consciousness level (1), and blood pressure slightly decreased from about 140s to about 110s. The symptoms of chills, nausea and vomiting improved rapidly after infusion. In order to observe the situation, the patient was hospitalized and discharged after recovery. After recovery, atrial frequency was also confirmed and external follow-up was decided. The reporting physician classified the event as serious (hospitalization from 01Jun2021 to 02Jun2021) 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: the patient said that after the first vaccination, there was pruritus at the vaccination site.


VAERS ID: 1409065 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021643171

Write-up: Anaphylaxis/pharynx strange sensation of and feeling difficulty in breathing; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21111252. The patient was a 20-year and 6-month-old female. Body temperature before vaccination was 36.0 degrees Centigrade. No information on medical history or concomitant medications was provided. It was uncertain if the patient had a relevant family history. On 11May2021, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization and afterwards she experienced pyrexia, palpitations and malaise. On 01Jun2021 at 13:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY4834, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jun2021 at 13:40 (10 minutes after the vaccination), the patient experienced anaphylaxis. On 01Jun2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: on 01Jun2021, during the observation after the vaccination, the patient complained of pharynx strange sensation of and feeling difficulty in breathing. Blood pressure decreased or rash was not recognized. These symptoms were determined to be anaphylaxis, and adrenaline 0.3 mg was intramuscularly administered. Thirty minutes later, the symptoms disappeared and the patient returned home. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1409083 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Blood pressure measurement, Body temperature, Drug eruption, Urticaria, Vital signs measurement
SMQs:, Severe cutaneous adverse reactions (broad), 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: Medical History/Concurrent Conditions: Anesthesia procedure; Fracture; Urticaria
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210601; Test Name: vital sign; Result Unstructured Data: Test Result:normal
CDC Split Type: JPPFIZER INC2021644419

Write-up: Drug eruption; urticaria began to appear on the back; This is a spontaneous report from the contactable physician received from the regulatory authority report number is v21110933. The patient was 67-year and 2-month-old female. Body temperature before the vaccination was 36.5 degrees Centigrade. The patient had none family history. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included usually, when the physical condition was not good, urticaria may also appeared, but it all subsided naturally. On 10Mar2021, after a general Anesthesia procedure due to fracture, mild urticaria appeared, but it subsided naturally. The causal relationship with anesthetics was unknown. On 01Jun2021 at 15:45 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY Intramuscular injection, Lot number: EY5420, expiration date: 31Aug2021) via an unspecified route of administration at a single dose (at the age of 67-years-old) for COVID-19 immunization. Event onset date was reported on 01Jun2021 at 15:50. Clinical course of the event was reported as follows: On 01Jun2021 at 15:45 (same day of vaccination), first dose of vaccination (COMIRNATY intramuscular injection Pfizer) performed. No special rash before injection. Five (5) minutes after the injection, (around 15:50) urticaria began to appear on the back, then spread to the abdomen and upper arms, but there were no systemic reactions such as wheezing and dyspnoea, Blood pressure and vital signs were also normal. Symptoms improved after oral administration of Bilanoa and infusion of Solu-cortef (250). The event term was reported as drug eruption. The reporter classified the event as non-serious and assessed the causality between the event and the vaccine as related. There was no other possible cause of the events such as any other diseases. On 01Jun2021 (same day of vaccination), the outcome of the events was recovering. The reporter commented as follows: it seemed that there was a causal relationship, and the symptoms were recovering after treatment.


VAERS ID: 1409091 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial (was being treated); COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:152/106 stable; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before the vaccinations; Test Date: 20210601; Test Name: SpO2; Test Result: 88 %; Test Date: 202102; Test Name: COVID-19; Test Result: Positive
CDC Split Type: JPPFIZER INC2021645172

Write-up: SpO2 decreased (88%); wheezing; vomited up what she ate in the morning; Blood pressure decreased and could not be measured.; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21110995. The patient was 27-year old female. Body temperature before the vaccinations was 36.0 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included Pyrexia after influenza vaccine vaccination, Asthma bronchial was being treated, and On February 2021 COVID-19 positive. On 01Jun2021 at 10:30 (the day of vaccinations), the patient received the first dose of bnt162b2(COMIRNATY Intramuscular injection, Lot number: FA2453, expiration date: 31Aug2021). And the event onset date was reported as 01Jun2021 at 10:45. Clinical course of the event was reported as follows: On 01Jun2021 at 10:30 (the day of vaccinations), vaccination performed. On 01Jun2021 at 10:45 (the day of vaccinations), the patient experienced wheezing appeared about 15 minutes after the vaccination. SpO2 decreased (88%), and the patient vomited up what she ate in the morning. Blood pressure decreased and could not be measured. Temporary use of Meptin inhalation, blood pressure recovered to 152/106, stable. The wheezing also disappeared and the patient returned home. The outcome of the events wheezing and blood pressure decreased and could not be measured was recovered on an unspecified date. The reporter assessed the causality between the event and the vaccines as unassessable.


VAERS ID: 1409100 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Asthma, Auscultation, Body temperature, Cough, Electrocardiogram, Heart rate, Pollakiuria, Tachycardia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (under treatment); Cough
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210601; Test Name: ECG; Result Unstructured Data: Test Result:sinus tachycardia; Test Date: 20210601; Test Name: PR; Result Unstructured Data: Test Result:80; Test Date: 20210601; Test Name: PR; Result Unstructured Data: Test Result:130; Test Date: 20210601; Test Name: auscultation; Result Unstructured Data: Test Result:No abnormalities
CDC Split Type: JPPFIZER INC2021646017

Write-up: Asthmatic attack; Tachycardia; Cough worsened; Anxiety; FREQUENCY URINARY; This is a spontaneous report from the a contactable other-hcp received from the Regulatory Authority. The Regulatory authority report number is v21111034. The patient was a 45-year and 9-month female. Body temperature before the vaccinations was 36.6 centigrade. Patient''s history according to the vaccine screening questionnaire included asthma, under treatment, and cough symptoms. Concomitant medications were not reported. On 01Jun2021 at 10:45 (the day of vaccination), the patient received the first single dose of bnt162b2(COMIRNATY Intramuscular injection, Lot number: FA7338, expiration date:30Sep2021) at the age of 45-year-old for COVID-19 immunisation. On 01Jun2021 at 10:45 (the day of vaccination), the patient experienced Asthmatic attack and Tachycardia (as reported). Clinical course of the event was reported as follows: Cough worsened after vaccination, inhalation of MEPTIN. Cough disappeared, but palpitations consciously, PR130. No abnormalities on auscultation, no skin abnormalities, ECG sinus tachycardia. After resting for 30 minutes, the symptoms disappeared and PR80 returned home. The reporter classified the event as non-serious and assessed the causality between the event and the vaccines as unassessable. Other possible cause of the event such as any other diseases was anxiety. The reporter concluded as follows: Anxiety and FREQUENCY URINARY caused by vaccination. On 01Jun2021 (the day of vaccination), the outcome of event was recovered.


VAERS ID: 1409104 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 FA4597 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Cerebral haemorrhage, Computerised tomogram head, Depressed level of consciousness, Dysarthria, Paresis, Sensory disturbance, Thalamus haemorrhage
SMQs:, Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), 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), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:146/110; Comments: 9:26 pm; Test Date: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:140/90; Comments: 9:00 pm; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:35.3 Centigrade; Comments: before vaccination; Test Date: 20210601; Test Name: Head CT; Result Unstructured Data: Test Result:Left thalamus haemorrhage
CDC Split Type: JPPFIZER INC2021646286

Write-up: When the emergency team arrived home (9:00 pm), blood pressure was 140/90, when they came to the hospital (9:26 pm) blood pressure was 146/110; Left thalamus haemorrhage; Intra-cerebral haemorrhage; Dysarthria; Right paresis; consciousness level JCSII-10; Sensory disturbance; This is a spontaneous report from a contactable physician received via regulatory authority and from another contactable physician received from the agency. Regulatory authority report number is v21111591. The patient was a 68-year and 0-month-old male. Body temperature before vaccination was 35.3 degrees Centigrade on 01Jun2021. The patient had no family history. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included that hypertension. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received antihypertensive drugs 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. On 01Jun2021 at 11:00 (the day of vaccination, at the age of 68-year-old), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) intramuscular in the Arm Left as a single dose for COVID-19 immunisation. On 01Jun2021 at 18:00 (7 hours after the vaccination), the patient experienced Intra-cerebral haemorrhage. On 01Jun2021 (the day of vaccination), the patient was admitted to the hospital. On 03Jun2021 (2 days after the vaccination), the outcome of the event was not recovered. The course of the event was as follows: On 01Jun2021 at around 18:00 (7 hours after the vaccination), the patient experienced sudden dysarthria and right paresis, then the patient was transported to hospital by emergency. At the time of admission, the consciousness level JCSII-10, right paresis and sensory disturbance appeared, and computed tomography (CT) showed left thalamus haemorrhage, the patient was hospitalized. When the emergency team arrived home (9:00 pm), blood pressure was 140/90, when they came to the hospital (9:26 pm) blood pressure was 146/110. The reporting physician classified the event as serious (hospitalization, Disability) and stated the events result in emergency room/department or urgent care, Hospitalization and Disability or permanent damage. The outcome of the events was not recovered with treatment including blood pressure control, drug treatment. The causality between the event and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was Hypertension. The reporting physician commented as follows: The relationship with vaccination was unknown. Since the vaccination, the patient has not been tested for COVID-19.


VAERS ID: 1409108 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Body temperature, Hypersensitivity, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021646565

Write-up: itching and mild rash appeared on the extremities; itching and mild rash appeared on the extremities; allergic reaction; This is a spontaneous report from a contactable physician received from The regulatory authority report number is v21111095. The patient was a 65-year-old female. Body temperature before vaccination was 36.3 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 01Jun2021 at 16:00 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) at the age of 65-year-old via an unspecified route of administration as a single dose for COVID-19 immunization. The event onset date was reported as 01Jun2021 at 17:00 (as reported) (1 hours after the vaccination). The course of the event was as follows: Approximately 30 minutes after the vaccination (as reported), itching and mild rash appeared on the extremities. There was no blood pressure decreased and normal breathing sound. It was considered that the allergic reaction was caused by the vaccination, and the antihistamine was injected. The symptoms were recovering after 15 minutes of treatment. On 01Jun2021 (the same day of vaccination), the outcome of the events was recovering. The reporter 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 reporter commented as follows: It was believed to be a mild allergic reaction caused by vaccination.


VAERS ID: 1409110 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dysphonia, Feeling abnormal, Infarction, Magnetic resonance imaging, Muscular weakness, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Test Date: 20210601; Test Name: MRI; Result Unstructured Data: Test Result:new Infarction
CDC Split Type: JPPFIZER INC2021646698

Write-up: infarction; Slight temperature; felt poorly; Muscular weakness; Dysphonia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21111110. The patient was a 86-year and 5-month female. Body temperature before the vaccinations was 36.7 centigrade. Patient''s history according to the vaccine screening questionnaire was none. Concomitant medications were not reported. On 01Jun2021 at 15:00 (the day of vaccination), the patient received the first single dose of bnt162b2(COMIRNATY Intramuscular injection, Lot number: EY5420, expiration date:31Aug2021) at the age of 86-year-old for COVID-19 immunisation. Adverse event onset date was on 01Jun2021. (as reported). Clinical course of the event was reported as follows: Before the vaccination on 01Jun2021, the patient experienced Neurological disorder on right upper arm. After the vaccination, the patient experienced Slight temperature and felt poorly. After 22:00, the patient visit the hospital. During the examination, the patient experienced Muscular weakness of right upper arm, Dysphonia. MRI confirmed new Infarction. On an unspecific date, the outcome of events was unknown. The reporter classification of seriousness of the event was not provided and the reporter assessed the causality between the event and the vaccines as related. Other possible cause of the event such as any other diseases was Cerebral infarction.


VAERS ID: 1409115 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   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: Blood pressure increased, Blood pressure measurement, Body temperature, Chills, Dizziness, Respiratory rate
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:215/104 mmHg; Comments: at 14:10; Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: at 14:10; Test Date: 20210601; Test Name: respiratory rate; Result Unstructured Data: Test Result:20; Comments: beats/minute at 14:10
CDC Split Type: JPPFIZER INC2021646819

Write-up: The blood pressure was 215/104 mmHg; chills; light-headed feeling; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21111021. The patient was an 86-year-old female. Body temperature before vaccination was not provided. The family history and medical history were not provided. On 01Jun2021 at 14:05 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jun2021 at 14:10 (5 minutes after the vaccination), the patient experienced chills and light-headed feeling. On 02Jun2021 (one day after the vaccination), the outcome of the events was recovered. The course of the event was as follows: On 01Jun2021 at 14:10 (5 minutes after vaccination), the patient experienced chills and light-headed feeling. The blood pressure was 215/104 mmHg, the body temperature was 36.2 degrees Celsius, and the respiratory rate was 20 /minute. On 02Jun2021 (one day after the vaccination), the symptoms disappeared. The reporting physician classified the event as non-serious and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. Information on the lot/batch number has been requested.


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