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From the 9/17/2021 release of VAERS data:

Found 711,579 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 299 out of 7,116

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VAERS ID: 1577135 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 200/100 mmHg, Elevated
CDC Split Type: PHJNJFOC20210825510

Write-up: Elevated BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096080] concerned an 81 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 17:25, the patient experienced elevated blood pressure. On 02-AUG-2021, laboratory data included: Blood pressure (NR: not provided) 200/100 mmHg, elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210825510-covid-19 vaccine ad26.cov2.s -Elevated BP. 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: 1577136 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/110 mmHg
CDC Split Type: PHJNJFOC20210825516

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095981] concerned a 53 year old female patient of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 15:31, the patient experienced elevated BP (Blood Pressure). Laboratory data included: Blood pressure (NR: not provided) 180/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210825516-COVID-19 VACCINE AD26.COV2.S-Elevated blood pressure. 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: 1577137 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 200/100 mmHg, Elevated
CDC Split Type: PHJNJFOC20210825555

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096092] concerned a 39 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: unknown) dose was not reported, frequency time 1 total was administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, at 20:25 hours, the patient''s blood pressure (BP) was elevated and measurements were 200/100 mmHg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure (BP). This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210825555-covid-19 vaccine ad26.cov2.s -Elevated Blood Pressure. 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: 1577138 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 200/120 mmHg, Elevated
CDC Split Type: PHJNJFOC20210825561

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096090] concerned a 75 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 19:26, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 200/120 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210825561-Covid-19 vaccine ad26.cov2.S- Elevated BP. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1577139 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C219 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210825823

Write-up: BLOOD IN STOOL; DIARRHOEA; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300097896] concerned a 37 year old female of unknown race and ethnicity The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C219 expiry: UNKNOWN) dose was not reported, 1 total administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 12:30, the patient experienced blood in stool, diarrhoea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhoea and blood in stool was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210825823-COVID-19 VACCINE AD26.COV2.S- blood in stool. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1577140 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, elevated
CDC Split Type: PHJNJFOC20210825904

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA PH-PHFDA-300095926] concerned a 42 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, at 13:50 the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 180/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0. 20210825904-covid-19 vaccine ad26.cov2.s -elevated blood pressure. 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: 1577142 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 190/100 mmHg
CDC Split Type: PHJNJFOC20210826100

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA-PH-PHFDA-300095931] concerned a 65 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 10:25, the patient experienced elevated blood pressure of 190/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210826100-covid-19 vaccine ad26.cov2.s -Elevated BP.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: 1577143 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, ELEVATED BP
CDC Split Type: PHJNJFOC20210826235

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095934] concerned a 66 year old female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: unknown) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 14:05, the patient''s blood pressure (BP) was elevated to 180/100 mmHg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210826235-Covid-19 vaccine ad26.cov2.S- Elevated BP. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1577144 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210826362

Write-up: FAINTING; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300097340] concerned a 56 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 212C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, at 10:20 , the patient experienced fainting after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210826362-COVID-19 VACCINE AD26.COV2.S-Fainting. 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: 1577145 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, Elevated
CDC Split Type: PHJNJFOC20210826451

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095938] concerned a 52 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 10:50, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 180/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210826451-Covid-19 vaccine ad26.cov2.s-Elevated BP. 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: 1577147 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 200/130 mmHg, ELEVATED
CDC Split Type: PHJNJFOC20210828112

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095930] concerned a 56 year old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 14:16, the patient''s blood pressure was elevated to 200/130 mmHg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210828112 -Covid-19 vaccine ad26.cov2.s -Elevated Blood Pressure. 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: 1577161 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/110 mmHg, elevated
CDC Split Type: PHJNJFOC20210824252

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300096093] concerned a 47 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 20:45, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 180/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210824252-covid-19 vaccine ad26.cov2.s-Elevated blood pressure. 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: 1577162 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 190/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210825430

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096104] concerned a 57-year-old female of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 17:25, the patient diagnosed with elevated blood pressure (190/110 mmHg). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0- 20210825430-Covid-19 vaccine ad26.cov2.S- Elevated Blood Pressure. 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: 1577163 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 200/120 mmHg, elevated
CDC Split Type: PHJNJFOC20210824952

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA] concerned a 50 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, one total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, 19:21, the patient experienced elevated BP (blood pressure). Laboratory data included: Blood pressure (NR: not provided) 200/120 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210824952- covid-19 vaccine ad26.cov2.s-Elevated BP. 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: 1577186 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Fibrin D dimer, Immune thrombocytopenia, Platelet count, Platelet factor 4, Pulmonary embolism, Thrombocytopenic purpura, Ultrasound Doppler
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: Ultrasound Doppler; Result Unstructured Data: not reported; Test Name: Fibrin D dimer; Result Unstructured Data: not reported; Test Name: Platelet count; Result Unstructured Data: not reported; Test Name: Computerised tomogram; Result Unstructured Data: not reported; Test Name: Platelet factor 4; Result Unstructured Data: not reported
CDC Split Type: PTJNJFOC20210820221

Write-up: PULMONARY THROMBOEMBOLISM; IMMUNE THROMBOCYTOPENIA; THROMBOCYTOPAENIC PURPURA; This spontaneous report was received from a physician via a Regulatory Authority [PT-INFARMED-J202108-435] and concerned a 28 year old male of unspecified race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and vaccination site not reported, batch number: XE393) 0.5 ml, administered on 22-JUL-2021 for covid-19 immunization. No concomitant medications were reported. On 02-AUG-2021, the patient experienced pulmonary thromboembolism, immune thrombocytopenia, and thrombocytopaenic purpura. The patient was hospitalized on an unspecified date. The following diagnostic tests were done: ultrasound doppler, fibrin D dimer, platelet factor 4, computerized tomogram, and platelet count; results not provided for all tests. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pulmonary thromboembolism, immune thrombocytopenia, and thrombocytopaenic purpura. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0:This spontaneous report was received from a physician via [PT-INFARMED-J202108-435] and concerns a 28- year -old male of unspecified race who experienced pulmonary thromboembolism, immune thrombocytopenia, and thrombocytopenic purpura 11 days post vaccination. The patient''s weight, height, and medical history were not reported. No concomitant medications were reported. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome, the low platelet count and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.


VAERS ID: 1577336 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Bradyphrenia, Confusional state, Fatigue, Inappropriate schedule of product administration, Memory impairment, Mental impairment, Off label use
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Medication errors (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: HYDROXYZINE BLUEFISH; Metynor
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to antibiotics; Allergy to nuts; Fruit allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101008852

Write-up: Dose1 on 21Jun2021, dose 2 on 02Aug2021; Dose1 on 21Jun2021, dose 2 on 02Aug2021; Had difficulty perform actions in several steps and difficult to think clearly; Confusion; Memory problems; In addition to joint pain and fatigue; In addition to joint pain and fatigue; Still experiencing some brain fog; This is a spontaneous report from a contactable consumer or other non hcp. A 44-year-old non pregnant female patient received bnt162b2 (COMIRNATY COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 02Aug2021 13:30 (age at vaccination was 44 years) non pregnant at the time of vaccination (Batch/Lot Number: FF3318) as dose 2, single for covid-19 immunization. Medical history included drug hypersensitivity to antibiotics, food allergy to certain nuts, berries, and fruits. The patient had not received any other vaccine within 4 weeks. Patient received no treatment for the event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Concomitant medications included hydroxyzine hydrochloride (HYDROXYZINE BLUEFISH) taken for an unspecified indication, start and stop date were not reported; methylphenidate hydrochloride (METYNOR) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in left arm on 21Jun2021, 04:30 PM, (Batch/Lot Number: FD4555) as dose 1, single for covid-19 immunization. On 02Aug2021, 17:00 after receiving the second dose of vaccination the patient experienced had difficulty perform actions in several steps and difficult to think clearly, confusion, memory problems, in addition to joint pain and fatigue, still experiencing some brain fog, patient took dose1 on 21jun2021 and dose 2 on 02aug2021 which led to inappropriate schedule of product administration. The outcome of the event inappropriate schedule of product administration was unknown and other events was recovering. No Follow-up attempts are possible. No further information is expected.


VAERS ID: 1579335 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site rash, SARS-CoV-2 test
SMQs:, Hypersensitivity (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: VENLAFAXINE
Current Illness: Anxiety
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Rash at site of injection; This case was received via United Kingdom MHRA (Reference number: 25748677) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Rash at site of injection) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Anxiety. Concomitant products included VENLAFAXINE for Anxiety. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced INJECTION SITE RASH (Rash at site of injection) (seriousness criterion medically significant). At the time of the report, INJECTION SITE RASH (Rash at site of injection) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. 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: 1579337 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Ear pain, Fatigue, Headache, 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: CETIRIZINE
Current Illness: Seasonal allergy; Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fatigue; Dizziness; Fever; Nausea; Ear ache; Headache; Chills; This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PYREXIA (Fever), NAUSEA (Nausea), EAR PAIN (Ear ache), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 since 02-Aug-2021 and Seasonal allergy. Concomitant products included CETIRIZINE from 10-May-2021 to 24-Jul-2021 for Hay fever. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), EAR PAIN (Ear ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizziness), PYREXIA (Fever), NAUSEA (Nausea), EAR PAIN (Ear ache), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. Treatment information was not provided by reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However patient?s concomitant use of cetirizine and history of hay fever could be a confounding factor for the events.; 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. However patient?s concomitant use of cetirizine and history of hay fever could be a confounding factor for the events.


VAERS ID: 1579353 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Insomnia, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
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: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Pain; Impossible to sleep; Fever; This case was received via Regulatory Authority(Reference number: ADR 25753019) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Pain), PYREXIA (Fever) and INSOMNIA (Impossible to sleep) in a 33-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. Concomitant products included IBUPROFEN from 11-Jul-2021 to 12-Jul-2021 for Period pains. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Pain) (seriousness criterion medically significant) and INSOMNIA (Impossible to sleep) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Fever, at an unspecified dose and frequency. On 04-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, PAIN (Pain) and INSOMNIA (Impossible to sleep) outcome was unknown. 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. Patient not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. Patient had temperature of 39, with fever. Muscle aches all over. Heart rate of 130 bpm. Paracetamol helped a little although at its worst, it was impossible to sleep and in a lot of pain. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. 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: 1579375 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, Feeling hot, Headache, Maternal exposure during pregnancy, Myalgia, Nausea, Pain in extremity, Peripheral swelling, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Maternal exposure during pregnancy; Headache; Swollen arm; Painful arm; Vomiting; Nausea; Diarrhea; Muscle ache; Feeling hot; Tiredness; This case was received via regulatory authority(Reference number: ADR 25758924) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Painful arm), FEELING HOT (Feeling hot), VOMITING (Vomiting), NAUSEA (Nausea), DIARRHOEA (Diarrhea), MYALGIA (Muscle ache), FATIGUE (Tiredness), HEADACHE (Headache) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Pregnancy. Concomitant products included FOLIC ACID for Folic acid supplementation. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Aug-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced FEELING HOT (Feeling hot) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Painful arm), FEELING HOT (Feeling hot), NAUSEA (Nausea), MYALGIA (Muscle ache), FATIGUE (Tiredness) and HEADACHE (Headache) had not resolved, VOMITING (Vomiting) and DIARRHOEA (Diarrhea) was resolving and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial Patient was exposed to the medicine Second-trimester(13-28 weeks). No treatment information was provided. Company Comment: This is a case of product exposure during pregnancy with associated AEs of PERIPHERAL SWELLING , PAIN IN EXTREMITY, FEELING HOT, VOMITING, NAUSEA, FATIGUE, DIARRHOEA, MYALGIA and HEADACHE . 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. Further information will not be received as it is a regulatory authority report. Event seriousness assessed as per Regulatory Authority reporting. However, the SD does not present any evidence of seriousness from a clinical or regulatory standpoint.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AEs of PERIPHERAL SWELLING , PAIN IN EXTREMITY, FEELING HOT, VOMITING, NAUSEA, FATIGUE, DIARRHOEA, MYALGIA and HEADACHE . 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. Further information will not be received as it is a regulatory authority report. Event seriousness assessed as per Regulatory Authority reporting. However, the SD does not present any evidence of seriousness from a clinical or regulatory standpoint.


VAERS ID: 1579418 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Body temperature increased, Fatigue, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:unknown results; Test Date: 20210803; Test Name: Body temperature; Result Unstructured Data: Test Result:37 Centigrade; Comments: Maximum
CDC Split Type: CZPFIZER INC202100995903

Write-up: Tired; Maximum body temperature had been 37 Centigrades; Loss of consciousness; This is a spontaneous report received from a contactable consumer (parent). This reporter reported similar events for their 2 daughters. This case refers to one of the 2 daughters. A 14-years-old female patient received BNT162b2 (COMIRNATY) via an unspecified route of administration, on 02Aug2021 around 16:40, at the age of 14 years old, as 1st single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 02Aug2021, after vaccination withy BNT162b2, the patient was seated in the waiting room. After about 5 minutes after, the patient lost consciousness and sat helplessly in her seat. She was moved on a bed with help of medical staff and others, where the nurse lifted her legs and the patient started to respond after a few moments. At that moment she had no idea what had happened and where she was. Her blood pressure was measured, she received a cold compress for her forehead and she was taken to the next room. There her blood pressure was measured and the cold compress on her head was changed repeatedly and she received water to drink. After a while, the patient sat down with the nurse''s assistance. They stayed there for approximately 35 minutes. Subsequently, the patient was recommended to eat "sweets", replenish energy, adhere to drinking regimen, and rest during the day. On 03Aug2021, the patient was tired but already without any visible problems. Maximum body temperature had been 37 Centigrades. In the meantime they were asked if the patient had eaten and drank something sweet half an hour before the vaccination. It is said to be needed before vaccination. Unfortunately, the reporter did not know that and had not registered it anywhere. The patient had her last meals and drinks around 14:00, therefore, it was possible that it was related to the mentioned conditions and vaccination. However, the reporter could not assess that. The lot number for BNT162b2 was not provided and will be requested during follow-up; Sender''s Comments: Linked Report(s) : CZ-PFIZER INC-202100997286 Same reporter, different patient (sibling), same product, similar events


VAERS ID: 1579534 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992480

Write-up: Swollen lymph nodes; pain in the armpit and left side of the chest; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021035503830-A6UXC. Safety Report Unique Identifier GB-MHRA-ADR 25740045. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FD8813), via an unspecified route of administration on 31Jul2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 02Aug2021, the patient had swollen lymph nodes under the arm and there was pain in the armpit and left side of the chest. The events were reported as serious medically significant. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1579570 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Influenza, Monoparesis, Myalgia, Pyrexia, Rash, SARS-CoV-2 test, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: No relevant medical history was provided.
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: Left arm paresis; Flu symptoms; Headache; Fever; Fatigue; Blurred vision; Myalgia; Rash; This case was received (Reference number: ADR 25761478) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MONOPARESIS (Left arm paresis), INFLUENZA (Flu symptoms), HEADACHE (Headache), PYREXIA (Fever), FATIGUE (Fatigue), VISION BLURRED (Blurred vision), MYALGIA (Myalgia) and RASH (Rash) in a 36-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No relevant medical history was provided. Concomitant products included PARACETAMOL for an unknown indication. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced MONOPARESIS (Left arm paresis) (seriousness criterion medically significant), INFLUENZA (Flu symptoms) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), VISION BLURRED (Blurred vision) (seriousness criterion medically significant), MYALGIA (Myalgia) (seriousness criterion medically significant) and RASH (Rash) (seriousness criterion medically significant). On 04-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, MONOPARESIS (Left arm paresis), INFLUENZA (Flu symptoms), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Myalgia) was resolving, VISION BLURRED (Blurred vision) had resolved and RASH (Rash) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient received paracetamol for headache and fever. 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: 1579856 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004221 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Coma scale, Depressed level of consciousness, Heart rate, Oxygen saturation, Presyncope
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: House dust allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Vasovagal reaction (Feels poorly due to vasovagal reaction after blood sampling and injection)
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Blood pressure 95/65 mmHg decreased; Test Date: 20210802; Test Name: Body temperature; Result Unstructured Data: 36.2 degree Celsius; Test Date: 20210802; Test Name: Glasgow Coma Scale; Result Unstructured Data: Glasgow Coma Scale E3V5M6; Test Date: 20210802; Test Name: Pulse rate; Result Unstructured Data: Pulse rate 63; Test Date: 20210802; Test Name: Oxygen saturation; Result Unstructured Data: oxygen saturation 97 percent
CDC Split Type: JPTAKEDA2021TJP071820

Write-up: Depressed level of consciousness; Vasovagal reaction; This case was received aug-2021. This case, reported by a vaccine recipient (other than a physician), was received by via Moderna''s adverse reaction reporting site (TASK0020666) Depressed level of consciousness was assessed as serious by the MAH. The patient had past medical history of feels poorly due to vasovagal reaction after blood sampling and injection. A patient with Allergy (house dust). On an unknown date, body temperature before vaccination: 36.2 degrees Celsius. On 02-Aug-2021, at 14:08, the patient received the 1st dose of this vaccine. The vaccination was performed in a supine position in consideration of the patients past medical history of vasovagal reaction. There were no symptoms immediately after the vaccination. After a few minutes, the patient was moved to a sitting position for follow-up. At 14:15, feels poorly developed. Cold sweat, pallor facial, blood pressure decreased (95/65 mmHg), pulse rate 63, oxygen saturation 97% on room air (RA), and consciousness Glasgow Coma Scale (GCS): E3V5M6. There was no skin eruption. There was no wheezing. The patient''s symptoms rapidly improved by taking a supine position and leg elevation. At 14:45, the patient walked home on his/her own. The patient received the diagnosis of vasovagal reaction. The outcome of vasovagal reaction (feels poorly, cold sweat, pallor facial, blood pressure decreased, pulse rate fell) and depressed level of consciousness was recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The patient received the diagnosis of vasovagal reaction based on his/her past medical history and the clinical course of the symptoms. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; 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: 1579899 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004229 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NORETHISTERONE; ETHINYLESTRADIOL
Current Illness: Allergic rhinitis; Allergy to animal (Allergy to crustaceans)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP072403

Write-up: Anaphylaxis (itching of skin, pressure sensation in throat, respiratory discomfort, numbness in limbs, feeling of weakness, pyrexia, eczema with redness in neck, dyspnea); This case was received via Regulatory Authority (Reference number: 2021TJP072403) on 05-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the RA (Ref, v21122434. Anaphylaxis was assessed as serious by the RA. A patient with allergy to crustaceans, Allergic rhinitis, Under treatment with pill (norethisterone, ethinylestradiol). On an unknown date, body temperature before the vaccination: 36.3 degrees Celsius. On 02-Aug-2021, at around 09:30, the patient received the 1st dose of the vaccine. There was no problem during observation of 30 minutes. On 02-Aug-2021, at around 10:10, on the way home in a car, the patient noticed itching of skin, pressure sensation in throat, respiratory discomfort, numbness in limbs, and feeling of weakness. Around 11:20, the patient visited a hospital. Body temperature was 37.3 degrees Celsius, blood pressure was 144/70, percutaneous oxygen saturation (SpO2) was 99%, and pulse was 96/min. Based on eczema with redness in neck and dyspnea, the patient was diagnosed with anaphylaxis due to the vaccination. The patient received 0.3 mL of adrenaline intramuscularly and infusion of 500 mL of lactate Ringer solution and 500 mL of hydrocortisone sodium succinate. Subsequently, itching and dyspnea improved, and the patient returned home. The outcome of anaphylaxis (itching of skin, pressure sensation in throat, respiratory discomfort, numbness in limbs, feeling of weakness, eczema with redness in neck, dyspnea) was unknown. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. 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. Patient?s medical history of allergy to crustaceans and allergic rhinitis, could be potentially confounders for the event.; 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. Patient?s medical history of allergy to crustaceans and allergic rhinitis, could be potentially confounders for the event.


VAERS ID: 1579904 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004496 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Application site paraesthesia, COVID-19, Guillain-Barre syndrome, Hypoaesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP073407

Write-up: Guillain-Barre syndrome; COVID-19; Numbness in the right 4th and 5th fingers; Dysaesthesia in both ankles and wrists; This case was received via Regulatory Authority (Reference number: 2021TJP073407) on 04-Aug-2021 and was forwarded to Moderna on 14-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) and COVID-19 (COVID-19) in a 25-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004496) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced HYPOAESTHESIA (Numbness in the right 4th and 5th fingers) and APPLICATION SITE PARAESTHESIA (Dysaesthesia in both ankles and wrists). On 03-Aug-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant) and COVID-19 (COVID-19) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), COVID-19 (COVID-19), HYPOAESTHESIA (Numbness in the right 4th and 5th fingers) and APPLICATION SITE PARAESTHESIA (Dysaesthesia in both ankles and wrists) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), COVID-19 (COVID-19), HYPOAESTHESIA (Numbness in the right 4th and 5th fingers) and APPLICATION SITE PARAESTHESIA (Dysaesthesia in both ankles and wrists) to be possibly related. COVID-19 is unlikely to be related to the Moderna COVID-19 vaccine. Based on the current available information and temporal association between the use of the product and the start date of the other events - Guillian- Barre syndrome, Hypoesthesia and application site paresthesia, a causal relationship cannot be excluded.; Sender''s Comments: COVID-19 is unlikely to be related to the Moderna COVID-19 vaccine. Based on the current available information and temporal association between the use of the product and the start date of the other events - Guillian- Barre syndrome, Hypoesthesia and application site paresthesia, a causal relationship cannot be excluded.


VAERS ID: 1579979 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/110 mmHg, elevated
CDC Split Type: PHJNJFOC20210825268

Write-up: ELEVATED BP; .This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300096099] concerned a 43 year old male patient of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 20:35 hours, the patient''s blood pressure (BP) was elevated and was measured to be at 180/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210825268 -covid-19 vaccine ad26.cov2.s -Elevated Blood Pressure. Follow-up received regarding Other Information: non serious to serious. 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: 1579980 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 220/110 mmHg, ELEVATED
CDC Split Type: PHJNJFOC20210825983

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300095924] concerned a 57 year old female unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 10:38, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure 220/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20210825983-covid-19 vaccine ad26.cov2.s-Elevated Blood pressure. 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: 1582281 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Heavy menstrual bleeding
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: MISOPROSTOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202100998777

Write-up: heavy bleeding; abdominal pain; This is spontaneous report received via database from a contactable consumer A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown on 02Aug2021 at 14:30 on left arm, both doses were administered at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history was not reported. Concomitant medication included MISOPROSTOL for medically assisted miscarriage. It was reported that patient was not pregnant at time of vaccination. The patient informed she had a medically assisted miscarriage on Jul2021 with 2 doses of misoprostol. Bleeding has almost stopped by 31Jul2021. She received second dose on 02Aug2021 and since then she was experiencing heavy bleeding, a lot of clots and abdominal pain. She believed this was related to the vaccine since the first dose also has triggered heavy and painful period. At the time of the reporting events outcome was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up


VAERS ID: 1582991 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Rash pruritic
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: None
Current Illness: None
Preexisting Conditions: Rheumatic Heart Disease Eczema Allergic Rhinitis
Allergies: None
Diagnostic Lab Data: None yet
CDC Split Type:

Write-up: Itchy rashes that come and go on different areas of my body starting the evening after I got the jab. This has been going on everyday since. I seem to get more of it during night time. The pamphlet given by the healthcare worker said rashes are normal but it''s been over two weeks since and I am starting to feel concerned. I googled images of rashes and mine looks like urticaria. The rashes would disappear after a few hours. Then another would appear on a different spot on my body.


VAERS ID: 1583543 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7221 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chronic spontaneous urticaria, Disease recurrence
SMQs:, Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUOXETINE; BILASTINE
Current Illness: Chronic spontaneous urticaria (since birth)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202100998803

Write-up: This is a spontaneous report from a contactable consumer (patient) via Regulatory Authority. A 29-year-old female patient received first dose of bnt162b2 (COMIRNATY; Lot Number: FD7221), via an unspecified route of administration, administered in left arm on 02Aug2021 at 10:15 (at the age of 29-years-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Medical history included chronic spontaneous urticaria (difficult to control grade) since birth. The patient was not allergic to any medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine and bilastine, both taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced chronic spontaneous urticaria crisis on 02Aug2021 at 10:15 (as reported). It was reported that patient already had a history of chronic spontaneous urticaria since birth. After 30 min, a crisis of it started. As it is classified as difficult to control, patient used 3 tablets of bilastine 20mg and 1.5 tablet of prednisone 25mg. The same happened in the next 24 hours and also in the 48 hours. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was recovering.


VAERS ID: 1584856 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Ejection fraction, Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101032154

Write-up: Myopericarditis; LVEF preserved; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) downloaded from the Medicines Agency (MA) WEB (ES-AEMPS-969886). A 29-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF2752), dose 2 intramuscular, administered in arm left on 30Jul2021 as single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY, Lot Number: FC1435), dose 1 intramuscular, administered in arm left on 09Jul2021 as single for COVID-19 immunisation. The patient has not passed COVID-19. On 02Aug2021, the patient experienced myopericarditis. The patient was hospitalized. The patient had diagnosis of post-vaccination myopericarditis, left ventricular ejection fraction (LVEF) preserved, trivial implementation (IM) and pericardial effusion exclusion. The patient received the treatment of Ibuprofen for the events. The outcome of the event myopericarditis was resolved on 06Aug2021 and LVEF was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1585216 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214007 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysgeusia, Erythema, Facial paralysis, Nausea, Oedema, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Taste and smell disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hearing impairment (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: ; Erythema; Dysgeusia; Oedema; Nausea; This case was received via regulatory authority (Reference number: FR-AFSSAPS-TS20213341) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of FACIAL PARALYSIS in a 59-year-old female patient who received mRNA-1273 (batch no. 214007) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Aug-2021, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced FACIAL PARALYSIS (seriousness criterion medically significant), ERYTHEMA (Erythema), DYSGEUSIA (Dysgeusia), OEDEMA (Oedema) and NAUSEA (Nausea). On 02-Aug-2021, FACIAL PARALYSIS, ERYTHEMA (Erythema), DYSGEUSIA (Dysgeusia), OEDEMA (Oedema) and NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment medication was not provided. patient''s relevant history included RAS. The action taken with mRNA-1273 in response to the event was not applicable. 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: 1585297 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100991999

Write-up: Cystitis; This is a spontaneous report from a contactable consumer received from the Regulatory Authority and Healthcare products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108020853048310-TGZCL, Safety Report Unique Identifier is GB-MHRA-ADR 25739298. A 33-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (lot number and expiry date were unknown) as single dose 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 at the time of the vaccination. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date (lot number and expiry date were unknown) for COVID-19 immunisation. The patient experienced cystitis on 02Aug2021 which was described as waking up first thing with pain when she passed urine and the unbearable urge to go when she could not. The patient had negative COVID-19 virus test on unspecified date. The outcome of the event was not recovered. The event was considered serious, medically significant. No follow-up attempts are possible; information about lot number cannot be requested. No further information is expected.


VAERS ID: 1585319 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Influenza, Lymph node pain, Lymphadenopathy, Myalgia, Nausea, Pain in extremity, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), 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: EVRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100991996

Write-up: swelling; Lymph node tenderness; pain in arm; BNT162B2: first dose on 05Jun2021 and second dose on 02Aug2021; Swollen lymph nodes/lymph nodes due to swelling; Flu; Headache; Muscle ache; Nausea; Fatigue; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108021119462360-PU5LF, Safety Report Unique Identifier: GB-MHRA-ADR 25740256. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Aug2021 (Lot Number: FE3380) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased and contraception. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication included EVRA taken for contraception from 2019. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05Jun2021 (Lot Number: EW3143) as dose 1, single for COVID-19 immunisation. The patient experienced swelling and lymph node tenderness on an unspecified date; and swollen lymph nodes, flu, headache, muscle ache, nausea, and fatigue on 02Aug2021. Clinical course reported no symptoms directly after vaccine. However, sleepless night caused by pain in arm and lymph nodes due to swelling. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the events swollen lymph nodes, flu, headache, muscle ache, nausea, and fatigue was not recovered, and for swelling, lymph node tenderness, and pain in arm was unknown. Regulatory authority assessed the events as serious, medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585330 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Lower respiratory tract infection, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992400

Write-up: chest infection; chest tightness feeling; Chest pain; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021203164230-U3FBN. Safety Report Unique Identifier is GB-MHRA-ADR 25740395. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31Jul2021 as single dose for covid-19 immunisation. Medical history included lactation decreased. 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 previously received the first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient experienced chest infection on an unspecified date, chest pain on 02Aug2021 and chest tightness feeling on an unspecified date. Clinical course was as below: It felt like a chest infection when I breathe it is painful and sometimes can feel sharp stabbing pain but always a tightness feeling. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 02Aug2021, No - Negative COVID-19 test. The outcome of the events not recovered. Serious criteria for the case was reported as medical significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585336 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 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 INC202100992112

Write-up: Armpit pain; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021243497790-XFH32. Safety Report Unique Identifier GB-MHRA-ADR 25740806. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (Batch/Lot Number: FF3319) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, was not currently breastfeeding and was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced armpit pain on 02Aug2021. The event was reported as serious (Other medically important condition). 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 armpit pain was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585337 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Oxygen saturation, Petechiae, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (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: Anaphylaxis (anaphylaxis to clindamycin); Flu; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Blood pressure 90/120; Test Name: Pulse rate; Result Unstructured Data: Pulse rate 74; Test Name: Oxygen saturation; Result Unstructured Data: Oxygen saturation 98%
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Petechial rash; Rash urticarial; This regulatory authority case was reported by a physician and describes the occurrence of PETECHIAE (Petechial rash) and URTICARIA (Rash urticarial) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased, Anaphylaxis (anaphylaxis to clindamycin) and Flu. Previously administered products included for an unreported indication: CLINDAMYCIN. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced URTICARIA (Rash urticarial) (seriousness criterion medically significant). On an unknown date, the patient experienced PETECHIAE (Petechial rash) (seriousness criterion medically significant). The patient was treated with CETIRIZINE for Adverse event, at an unspecified dose and frequency. At the time of the report, PETECHIAE (Petechial rash) and URTICARIA (Rash urticarial) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 90/120 (normal) Blood pressure 90/120. On an unknown date, Heart rate: 74 (normal) Pulse rate 74. On an unknown date, Oxygen saturation: 98 (normal) Oxygen saturation 98%. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Patient reported that she experienced itchy arm moved to back legs, after 30 minutes of receiving 2nd dose. Patient is used antihistamines for 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. Very limited information regarding these events 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 events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time


VAERS ID: 1585351 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FP8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Fall, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), 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: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Thyroiditis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Inconclusive; Comments: Inconclusive test
CDC Split Type: GBPFIZER INC202100992121

Write-up: Loss of balance; Falling over; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202108021354041890-0WCWH, and Safety Report Unique Identifier is GB-MHRA-ADR 25741214. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FP8813, Expiry date not reported), via an unspecified route of administration on 29Jul2021 as DOSE 2 for COVID-19 immunisation. Medical history included thyroiditis and immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response). Concomitant medications were not reported. Historical vaccine included BNT162B2 (lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced loss of balance on 02Aug2021 with outcome of not recovered, and falling over on 02Aug2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: inconclusive on an unspecified date, Inconclusive test. The events were reported as serious, medically significant by the health authority. Case narrative: Balance problem/falling over. Having to hold onto furniture or walls when upright. Fine lying or sitting down. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585357 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Heart rate, Loss of consciousness, Muscle rigidity, Oxygen saturation, Respiratory rate, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Test Date: 20210802; Test Name: Blood glucose level; Test Result: 5.3 mmol; Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Test Result:118/70 mmHg; Comments: 1213; Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Test Result:113/68 mmHg; Comments: 1215; Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Test Result:117/74 mmHg; Comments: 1230; Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Test Result:116/73 mmHg; Comments: 1235; Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Test Result:113/66 mmHg; Comments: 1240; Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Test Result:114/72 mmHg; Comments: 1245; Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Test Result:112/67 mmHg; Comments: 1250; Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Test Result:122/70 mmHg; Comments: 1257; Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Test Result:114/73 mmHg; Comments: 1305; Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Test Result:105/58 mmHg; Comments: 1335; Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Test Result:112/47 mmHg; Comments: 1347; Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Test Result:125/82 mmHg; Comments: 1410; Test Date: 20210802; Test Name: Pulse rate/P; Result Unstructured Data: Test Result:74; Comments: 1213; Test Date: 20210802; Test Name: Pulse rate/P; Result Unstructured Data: Test Result:73; Comments: 1215; Test Date: 20210802; Test Name: Pulse rate/P; Result Unstructured Data: Test Result:69; Comments: 1230; Test Date: 20210802; Test Name: Pulse rate/P; Result Unstructured Data: Test Result:72; Comments: 1235; Test Date: 20210802; Test Name: Pulse rate/P; Result Unstructured Data: Test Result:73; Comments: 1240; Test Date: 20210802; Test Name: Pulse rate/P; Result Unstructured Data: Test Result:66; Comments: 1245; Test Date: 20210802; Test Name: Pulse rate/P; Result Unstructured Data: Test Result:68; Comments: 1250; Test Date: 20210802; Test Name: Pulse rate/P; Result Unstructured Data: Test Result:71; Comments: 1257; Test Date: 20210802; Test Name: Pulse rate/P; Result Unstructured Data: Test Result:79; Comments: 1305; Test Date: 20210802; Test Name: Pulse rate/P; Result Unstructured Data: Test Result:62; Comments: 1335; Test Date: 20210802; Test Name: Pulse rate/P; Result Unstructured Data: Test Result:70; Comments: 1347; Test Date: 20210802; Test Name: Pulse rate/P; Result Unstructured Data: Test Result:83; Comments: 1410; Test Date: 20210802; Test Name: Oxygen saturation/O2 sats; Test Result: 95 %; Comments: 1213; Test Date: 20210802; Test Name: Oxygen saturation/O2 sats; Test Result: 96 %; Comments: 1215; Test Date: 20210802; Test Name: Oxygen saturation/O2 sats; Test Result: 95 %; Comments: 1230; Test Date: 20210802; Test Name: Oxygen saturation/O2 sats; Test Result: 96 %; Comments: 1235; Test Date: 20210802; Test Name: Oxygen saturation/O2 sats; Test Result: 96 %; Comments: 1240; Test Date: 20210802; Test Name: Oxygen saturation/O2 sats; Test Result: 97 %; Comments: 1245; Test Date: 20210802; Test Name: Oxygen saturation/O2 sats; Test Result: 97 %; Comments: 1250; Test Date: 20210802; Test Name: Oxygen saturation/O2 sats; Test Result: 97 %; Comments: 1257; Test Date: 20210802; Test Name: Oxygen saturation/O2 sats; Test Result: 98 %; Comments: 1305; Test Date: 20210802; Test Name: Oxygen saturation/O2 sats; Test Result: 100 %; Comments: 1335; Test Date: 20210802; Test Name: Oxygen saturation/O2 sats; Test Result: 100 %; Comments: 1347; Test Date: 20210802; Test Name: Oxygen saturation/O2 sats; Test Result: 98 %; Comments: 1410; Test Date: 20210802; Test Name: Respiratory rate/resps; Result Unstructured Data: Test Result:20; Comments: 1235; Test Date: 20210802; Test Name: Respiratory rate/resps; Result Unstructured Data: Test Result:11; Comments: 1250
CDC Split Type: GBPFIZER INC202100992277

Write-up: vomited; loss of consciousness; Syncope; extensor rigidity; This is a spontaneous report from a contactable healthcare professional received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021421178430-HWYWP, Safety Report Unique Identifier is GB-MHRA-ADR 25741405. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FF3319), via an unspecified route of administration on 02Aug2021 (at the age of 18 years old) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. On 02Aug2021, the patient experienced loss of consciousness, syncope, extensor rigidity, and vomited at 1347. The events were reported as non-serious. The patient underwent lab tests and procedures, all on 02Aug2021, which included blood glucose level: 5.3 mmol; blood pressure: 118/70 mmhg, 113/68 mmhg, 117/74, 116/73 mmhg, 113/66 mmhg, 114/72 mmhg, 112/67 mmhg, 122/70 mmhg, 114/73 mmhg, 105/58 mmhg, 112/47 mmhg, 125/82 mmhg; pulse rate: 74, 73, 69, 72, 73, 66, 68, 71, 79, 62, 70, 83; oxygen saturation: 95%, 96%, 95%, 96%, 96%, 97%, 97%, 98%, 100%, 100%, 98%, respiratory rate: 20 and 11. The clinical course was reported as follows: Fainted 10 minutes after vaccination, a flicker of extensor rigidity in the chair but did not fall. Patient came round whilst still in the chair and felt better immediately. Taken to the floor in the recovery position. Took two hours to fully recover but no further loss of consciousness. Observations were normal throughout: 1213 - 118/70 P 74 O2 sats 95%; 1215 - 113/68 P 73 O2 sats 96%; 1230 - 117/74 P 69 O2 sats 95%; 1235 - 116/73 P 72 resps 20 Sats 96%; 1240 - 113/66 P 73 O2 96%; 1245 - 114/72 P 66 O2 97%; 1250 - 112/67 P 68 O2 97% Resps 11; 1257 - 122/70 P 71 O2 97%; 1305 - 114/73 P 79 O2 98%; Glucose 5.3 mmol; 1335 - 105/58 P 62 Sats 100%; 1347 - vomited: 112/47 P 70 sats 100%; 1355 - sat up; 1405 - was eating; 1410 - sat on chair 125/82 P 83 O2 98% - felt much better. Patient was left in the care of his mother. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report did not relate to possible blood clots or low platelet counts. The outcome of the events was recovered on 02Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585358 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: platelet counts; Result Unstructured Data: Test Result:low
CDC Split Type: GBPFIZER INC202100992386

Write-up: Syncope; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021430080610-GUNI4. Safety Report Unique Identifier: GB-MHRA-ADR 25741458 A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 02Aug2021 (Lot Number: FF3319, At age of 28 Year old) as DOSE 1, single for COVID-19 immunization. The patient medical history and the concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced syncope on 02Aug2021 with outcome of recovered. The event was assessed non-serious. The lab tests included platelet counts low. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1585378 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Lethargy, Lymphadenopathy, Pain in extremity
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992385

Write-up: pain in arm; Lethargic; Chills; Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108021550099570-MIBGG, Safety Report Unique Identifier GB-MHRA-ADR 25741843. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 31Jul2021 (Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. Historical vaccine was taken for first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date (Lot Number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced Pain in arm, Lethargic Chills Swollen armpit on side of vaccination site. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced pain in arm on an unspecified date with outcome of unknown, swollen lymph nodes on 02Aug2021 with outcome of not recovered, lethargic on an unspecified date with outcome of unknown, chills on an unspecified date with outcome of unknown. All the events were assessed serious as medically significant. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1585412 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319-L795 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Hyperhidrosis, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992088

Write-up: Armpit pain; sweating/Sweating increased armpits; Swelling; This is a spontaneous report from a contactable consumer (patient). This is a report received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108021930235610-AOKQQ. Safety Report Unique Identifier is GB-MHRA-ADR 25743209. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF3319-L795), via an unspecified route of administration on 01Aug2021 as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test, was not pregnant, and was not currently breastfeeding. The patient''s concomitant medications were not reported. On 02Aug2021, the patient experienced armpit pain, sweating/sweating increased armpits, and swelling. The events were reported as serious per other medically important condition. The clinical course was reported as follows: Extremely painful in the armpit, more so when doing any form of exercise, was not able to participate in the class or run as she normally would hence why she would say the effect was bad enough to affect everyday activities. The swelling was noticeable to the eye not just to touch. Also noticed that the armpit that was affected was sweating much more than the armpit on the side that didn''t receive the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585424 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant, Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992125

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-202108022102047020-CK37Y. Safety Report Unique Identifier GB-MHRA-ADR 25743665. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number not known; expiration date not provided), via an unspecified route of administration on 02Aug2021 (at the age of 39-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient''s medical history included lactation decreased from an unknown date and unknown if ongoing. The patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not pregnant and is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced leg pain on 02Aug2021. The event was assessed as serious (medically significant). The patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585425 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Myalgia, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ANADIN PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: TMJ syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992150

Write-up: Sore throat; Shivering; Generalised muscle aches; This is a spontaneous report from a contactable consumer received from the regulatory authority report number GB-MHRA-WEBCOVID-202108022107225300-JIMXS, Safety Report Unique Identifier is GB-MHRA-ADR 25743682. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD8813), via an unspecified route of administration on 31Jul2021 at dose 1, single for COVID-19 immunisation. Medical history included temporomandibular joint (TMJ) syndrome. Patient has not had symptoms associated with COVID-19. Concomitant medication included paracetamol (ANADIN PARACETAMOL) taken for TMJ syndrome. On 02Aug2021, the patient experienced sore throat, shivering, and generalised muscle aches. The events were medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was no - negative COVID-19 test on 02Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585449 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992092

Write-up: Lymph node pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA).The regulatory authority report number is GB-MHRA-WEBCOVID-202108030327228130-D3PFM. Safety Report Unique Identifier is GB-MHRA-ADR 25744157. A 39-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (lot number: Ff3319) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. He has not had symptoms associated with COVID-19 and not enrolled in clinical trial. The patient experienced lymph node pain on 02Aug2021 with outcome of not recovered. Event was reported as medically significant by health authority. He has not tested positive for COVID-19 since having the vaccine. He underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 02Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585450 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Nasal dryness, Pain
SMQs:, 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
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992095

Write-up: Shivers; Headache; Dry nose; Ache; This is a spontaneous report from a contactable consumer. This report is received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108030339056680-MSMHZ and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25744156. A 35-year old female patient (not pregnant, not currently breastfeeding; age at vaccination: 35-year old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown), via an unspecified route of administration on 02Aug2021 as dose 2, single for COVID-19 immunisation. Medical history included decreased lactation. The patient''s concomitant medications were not reported. The patient experienced shivers, headache, dry nose and ache (all medically significant) on 02Aug2021 with outcome of not recovered. No follow-up attempts are possible; information about lot number cannot be obtained.


VAERS ID: 1585452 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal dreams, Chills, Headache, Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992383

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202108030543320790-TZQRA; safety report unique identifier: GB-MHRA-ADR 25744512). A 36-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Aug 1, 2021, single dose, for COVID-19 immunisation. Medical history included pregnancy. Patient has not had symptoms associated with COVID-19, nor had a COVID-19 test. Patient is not enrolled in a clinical trial. Historical vaccine included BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), on unspecified date, for COVID-19 immunisation. The patient''s concomitant medications not reported. On Aug 2, 2021, patient experienced lucid dreams, ache, headache and shivers. The outcome of lucid dreams, ache: unknown; headache: recovering; and shivers recovered. Patient has not tested positive for COVID-19 since the vaccination. Serious case (other medically important condition). No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1585458 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100991993

Write-up: This is a spontaneous report from a contactable consumer received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108030642598120-Q7BT3,Safety Report Unique Identifier GB-MHRA-ADR 25744724. A 29-year-old male patient (age at vaccination: 29-year-old) received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot FE3380) via unspecified route of administration on 02Aug2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced insomnia (medically significant) on 02Aug2021 with outcome of not recovered. The patient underwent laboratory test which included Sars-cov-2 test: negative on unknown date. No follow up attempts are possible. No further information is expected.


VAERS ID: 1585467 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Diarrhoea, Fatigue, Pain in extremity
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: GBPFIZER INC202100998592

Write-up: Diarrhoea; Fatigue; Chills; Painful arm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202108031553488480-XJDYL, Safety Report Unique Identifier GB-MHRA-ADR 25747899. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Aug2021 (at the age of 30 years old) (Batch/Lot Number: FE3380) as dose 2, single for COVID-19 immunization. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant at time of vaccination. The patient''s concomitant medications were not reported. The patient experienced diarrhoea on 03Aug2021, painful arm on 02Aug2021, fatigue and chills on 03Aug2021. The events were reported as medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585474 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disorientation, Dizziness, Dizziness postural
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998660

Write-up: disorientated; Light-headed; Dizzy on standing; This is a spontaneous report from a contactable consumer (patient) received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108031954138550-3HJPI. Safety Report Unique Identifier [GB-MHRA-ADR 25749733]. A 39-year-old female patient (age at vaccination: 39-year-old) received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, lot FD8813), via an unspecified route of administration on 02Aug2021 as dose 2, single for Covid-19 immunization. Medical history included, decreased lactation. The patient''s concomitant medications were not reported. The patient experienced disorientated (room was spinning when lying down) on an unspecified date. On 02Aug2021, felt light-headed had to lie down, and also experienced dizzy on standing. Events were reported as serious medically significant. The outcome of disorientation was recovering; for other events was recovered on 03Aug2021. No follow-up attempts are possible; no further information is expected.


VAERS ID: 1585475 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998703

Write-up: Supraclavicular lymph nodes enlarged; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108032012233760-TFRG9, Safety Report Unique Identifier is GB-MHRA-ADR 25749762. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (lot number: FE3380) as single dose for COVID-19 immunisation. Medical history included pain. She has not had symptoms associated with COVID-19, not had a COVID-19 test, and not enrolled in clinical trial. Concomitant medication included paracetamol taken for pain from 01Aug2021. The patient experienced supraclavicular lymph nodes enlarged on 02Aug2021 with outcome of not recovered. Event was reported as medically significant by health authority. She has not tested positive for COVID-19 since having the vaccine No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585481 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Cold sweat, Dyspepsia, Ear pain, Headache, Nausea, Neuralgia, Pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Neuralgia; Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20201014; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negetive; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101006118

Write-up: Earache; Indigestion; Neuralgia; Nausea; Stomachache; Headache; Chills; Cold sweat; Ache; This is a spontaneous report from a contactable consumer or other non healthcare professional received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108040919519960-QMAGT. A 40-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: FD8813) via an unknown route of administration (at the age of 40-year-old) on 02Aug2021 as dose 2, single for covid-19 immunisation. Medical history included pregnancy, neuralgia. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 02Aug2021, the patient experienced ache, headache, cold sweat, nausea and stomachache. On 03Aug2021, the patient had earache, indigestion and neuralgia. It was reported that the symptoms developed 2 hours after vaccination and starting with nausea. All over body aching started within 3 hours followed by chills and cold sweats. Nausea went away overnight but started the day with a severe headache. The patient had intense ingestion started around midday on day 2 accompanied by earache and neuralgia. The chills and aches returned at the end of day 2 and into day 3. The patient had headache and indigestion/earache and neuralgia gone at the start of day 3. Adverse reaction did not occur as a result of an exposure during pregnancy. The patient received paracetamol for aches and Gaviscon for indigestion. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 14Oct2020. The outcome of the events ache, cold sweat and indigestion was recovering. The patient had recovered from the event nausea on 02Aug2021. The events headache, chills, neuralgia and stomachache were reported as resolved on 03Aug2021 while the event earache was resolved on 04Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585483 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Vaccination site pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005807

Write-up: Armpit pain; Injection site pain; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108040943140400-7FUKS. Safety Report Unique Identifier GB-MHRA-ADR 25751965. A 31-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE3380), dose 2 via an unspecified route of administration on 02Aug2021, (at the age of 31 years) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, and not had a COVID-19 test. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was unknown), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 02Aug2021, the patient experienced injection site pain and armpit pain on 04Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event armpit pain was not resolved, and the event injection site pain was resolving. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585485 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Cough, Diarrhoea, Neck pain, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; BENDROFLUAZIDE; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Lactation decreased; Water retention
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005838

Write-up: Coughing; Chest pain; Neck pain; Fever; Diarrhea; This is a spontaneous report from a contactable consumer or other non HCP received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202108041003114010-MQTNW Safety Report Unique Identifier GB-MHRA-ADR 25752117. A 32-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration on 01Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history included Lactation decreased, Blood pressure high, Water retention. The patient concomitant medications included amlodipine (AMLODIPINE) taken for hypertension from 30Jun2018, bendroflumethiazide (BENDROFLUAZIDE) taken for fluid retention from 30Dec2018, ramipril taken for hypertension from 25May2021. The patient not had symptoms associated with COVID-19. The patient was not pregnant. The patient was not currently breastfeeding. On 02Aug2021, 1 day after first dose patient experienced fever, diarrhea. on 03Aug2021, 2 days after first dose patient experienced coughing, chest pain, neck pain. The patient underwent lab tests and procedures which included sars-cov-2 test was Negative COVID-19 test on an unspecified date. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The events were serious and eventually medically significant. The outcome of the events diarrhea was recovered on 04Aug2021, while outcome of event coughing, chest pain, neck pain, fever was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585486 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Discomfort, Disturbance in attention, Fatigue, Headache, Hyperhidrosis, Inappropriate schedule of product administration, Influenza like illness, Lymphadenopathy, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: LORATADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005815

Write-up: discomfort; Unable to focus; Armpit pain; Swollen lymph nodes; Dose 1/31May2021 dose 2/02Aug2021; Fever; Generalised muscle aches; Sweating; Headache; Flu like symptoms; Exhaustion; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number is GB-MHRA-WEBCOVID-202108041107431620-XFCBY. Safety Report Unique Identifier GB-MHRA-ADR 25752546. A 23-year-old male patient received BNT162B2 (BNT162B2, Solution for injection, Lot Number: FE3380, expiry date: not reported) dose 2 via an unspecified route of administration on 02Aug2021 as single dose for COVID-19 immunisation. Medical history included allergic rhinitis. Patient has not had symptoms associated with COVID-19. The patient previously received BNT162B2 (BNT162B2, Solution for injection, Lot Number: EW3143, expiry date: not reported) dose 1 via an unspecified route of administration on 31May2021 as single dose for COVID-19 immunisation. Concomitant medication included loratadine taken for allergic rhinitis. On an unspecified date, the patient experienced discomfort and was unable to focus. On 02Aug2021, the patient experienced fever, generalised muscle aches, sweating, headache, flu like symptoms, exhaustion and inappropriate schedule of vaccine administered. On 03Aug2021, the patient experienced armpit pain, swollen lymph nodes. Additional information as reported: Intense symptoms (1-6) almost immediately after vaccination in the morning. Unable to focus enough to work from home. Evening day after vaccination, armpit pain and swollen lymph nodes in armpit began, causing significant discomfort. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Seriousness criteria was reported as disability. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome of discomfort reported as recovered. The outcome of sweating was reported as recovered on 03Aug2021. The outcome of fever, headache, flu like symptoms, exhaustion, reported as recovering. The outcome of generalised muscle aches, armpit pain, swollen lymph nodes reported as not recovered. The outcome of unable to focus was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585499 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Heart rate, Lymphadenopathy, Myalgia, Palpitations, Pyrexia, SARS-CoV-2 test, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; GEDAREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heavy periods (Proprietary medicinal product name: GEDAREL Date of start of drug: 20Jan2021); Lactation decreased; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped); Temporomandibular joint disorder (Active Drug substance names: AMITRIPTYLINE Date of start of drug: 10Dec2020)
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: fever; Result Unstructured Data: Test Result:Low grade fever; Test Name: heart rate; Result Unstructured Data: Test Result:125/min; Comments: with a resting heart rate of around 125/min, but up to 140/min (normally 60-70) that felt like it was almost painfully pounding; Test Name: heart rate; Result Unstructured Data: Test Result:140/min; Comments: with a resting heart rate of around 125/min, but up to 140/min (normally 60-70) that felt like it was almost painfully pounding; Test Name: heart rate; Result Unstructured Data: Test Result:normally 60-70; Comments: with a resting heart rate of around 125/min, but up to 140/min (normally 60-70) that felt like it was almost painfully pounding; Test Name: heart rate; Result Unstructured Data: Test Result:normal; Comments: RHR has now returned to an almost normal level; Test Date: 20201016; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005845

Write-up: Blurred vision; Heart racing; Swollen lymph nodes; Low grade fever; Fatigue; Generalised muscle aches; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041712041200-1DN0G, Safety Report Unique Identifier: GB-MHRA-ADR 25755422. A 35-year-old non-pregnant and not currently breastfeeding female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number unknown), via an unspecified route of administration on 02Aug2021 (at the age of: 35-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient''s medical history included suppressed lactation, suspected COVID-19, (Unsure when symptoms started, Unsure when symptoms stopped), temporomandibular joint syndrome (Active Drug substance names: AMITRIPTYLINE, Date of start of drug: 10Dec2020), heavy menstrual bleeding (Proprietary medicinal product name: GEDAREL, Date of start of drug: 20Jan2021). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medications included amitriptyline (AMITRIPTYLINE) taken for temporomandibular joint syndrome (from 10Dec2020 to an unspecified stop date); desogestrel, ethinylestradiol (GEDAREL) taken for heavy menstrual bleeding (from 20Jan2021 to an unspecified stop date). On 02Aug2021, the patient experienced fatigue. On 04Aug2021, the patient experienced blurred vision, heart racing, generalized muscle aches, low grade fever and swollen lymph nodes. The patient stated that she woke up on Day 2 post-vaccination and was unable to read computer screen for 3 hours, with a resting heart rate of around 125/min, but up to 140/min (normally 60-70) that felt like it was almost painfully pounding. RHR has now returned to an almost normal level, and vision issue resolved, but it was concerning. The patient underwent lab tests and procedures which included body temperature: low grade fever on 03Aug2021, heart rate: 125/min, with a resting heart rate of around 125/min, but up to 140/min (normally 60-70) that felt like it was almost painfully pounding, heart rate: 140/min, with a resting heart rate of around 125/min, but up to 140/min (normally 60-70) that felt like it was almost painfully pounding, heart rate: normally 60-70, with a resting heart rate of around 125/min, but up to 140/min (normally 60-70) that felt like it was almost painfully pounding, heart rate: normal, RHR has now returned to an almost normal level, COVID-19 test: Negative on 16Oct2020. All the events were serious (medically significant). The outcome of the event swollen lymph nodes was not recovered, and fatigue was recovering. The outcome of the events blurred vision, heart racing, generalized muscle aches and low-grade fever was recovered on 04Aug2021. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1585503 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Rhinorrhoea
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005841

Write-up: Fatigue; Weakness; tiredness; runny nose; This is a spontaneous report from a contactable consumer received. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041810406260-SKVX6, Safety Report Unique Identifier GB-MHRA-ADR 25755699. A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF3319) via an unspecified route of administration on 31Jul2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. On 02Aug2021, the patient experienced fatigue. On an unspecified date in 2021, the patient experienced tiredness, runny nose and weakness. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event fatigue was not recovered. The outcome of the events tiredness, runny nose and weakness were unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585614 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Arthralgia, Blood pressure measurement, Emotional disorder, Fatigue, Headache, Heart rate, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Oropharyngeal pain, Palpitations, SARS-CoV-2 test, Scan
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Arthritis (broad), Medication errors (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PERTUSSIS VACCINE; FOLIC ACID; PREGNACARE ORIGINAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER;CY; SODIUM CROMOGLICATE; MOMETASONE FUROATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Hepatitis C (through treatment previously and the virus was cleared in 2014)
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:seems fine; Comments: seems fine; Test Name: heart rate; Result Unstructured Data: Test Result:130; Comments: my heart rate goes up to 130.; Test Date: 20210202; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: scans; Result Unstructured Data: Test Result:normal; Comments: All scans to date have been normal
CDC Split Type: GBPFIZER INC202100998611

Write-up: maternal exposure during pregnancy / patient was exposed to the vaccine Third-trimester (29-40 weeks); Tiredness; Palpitations; Reaction emotional; Joint ache; Sore throat; Agitation; Headache; first dose of BNT162B2 on 05Jun2021, dose 2 on 02Aug2021; This is a solicited report from a contactable consumer (patient). This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-YCVM-202106051806125340-XTGS6, Safety Report Unique Identifier GB-MHRA-ADR 25747811. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Aug2021 (Lot Number: FE3380) as single dose for COVID-19 vaccination. Medical history included asthma and Hepatitis C, went through treatment previously and the virus was cleared in 2014. Viral load was retested this year and remains 0. Concomitant medications included pertussis vaccine (reported as whooping cough vaccine) 2 weeks before 04Aug2021 for immunization at patient''s GP surgery recommended during pregnancy, folic acid taken for folic acid supplementation; ascorbic acid, betacarotene, biotin, calcium pantothenate, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, magnesium, nicotinamide, phytomenadione, pyridoxine hydrochloride, riboflavin, selenium, thiamine mononitrate, tocopheryl acid succinate, zinc (PREGNACARE ORIGINAL) taken for pregnancy vitamins from 22Jan2021 to an unspecified stop date, eye drops (Sodium Cromoglicate) and nose spray (Mometasone Furoate) on a relatively ad hoc basis. The patient previously received first dose of BNT162B2 (lot number Ew3143) on 05Jun2021 for COVID-19 vaccination and experienced maternal exposure during pregnancy. The patient experienced maternal exposure during pregnancy on an unspecified date, patient was exposed to the vaccine Third-trimester (29-40 weeks), tiredness, palpitations, reaction emotional, joint ache, sore throat, agitation, headache on 03Aug2021. Events were reported as medical significant. It was also reported that post week 31 started having occasional heart palpitations where patient''s heart rate went up to 130 or so for about 20 minutes and the patient had to lie down. The patient''s blood pressure seems fine. Waiting for blood tests. Estimated due date: 21Sep2021. Unsure if patient has had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was unsure if vaccination had an adverse effect on any aspect of the pregnancy. All scans to date had been normal. The patient was pregnant while taking BNT162B2. The patient was 32 Weeks pregnant at the onset of the event. The patient was due to deliver on 21Sep2021. The patient also underwent lab tests and procedures which included COVID-19 virus test: negative on 02Feb2021. The outcome of event tiredness was recovering, the outcome of events palpitations, reaction emotional, joint ache, sore throat, agitation, headache was not recovered. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: There is reasonable possibility of causal association between the event tiredness, palpitations, joint ache, sore throat, headache, , inappropriate schedule of vaccination and the suspect drug BNT162B2. The events agitation, reaction emotional is more likely an intercurrent condition of pregnancy unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate


VAERS ID: 1586095 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypersensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101008775

Write-up: initial anaphylactic reaction with laryngospasm; initial anaphylactic reaction with laryngospasm; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority. WEB, regulatory authority number IT-MINISAL02-765647. A female patient of an unspecified age received first dose of BNT162B2 (COMIRANTY; Solution for injection, Batch/Lot Number: FF3318; Expiration Date: Oct2021) via intramuscular route of administration, administered in left arm on 02Aug2021 at 10:12 as Dose 1, 0.3 ug Single for COVID-19 immunization. The patient''s medical history included multifactorial allergic crisis. The patient''s concomitant medications were not reported. On 02Aug2021, the patient presented an initial anaphylactic reaction with laryngospasm. Venous catheterization was placed. Administration of trimeton and venous infusion of cortisone was given as a treatment. On 02Aug2021, the outcome of the events was resolved. No follow up attempts are possible. No further information is expected.


VAERS ID: 1586132 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003605 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphangitis, Vaccination complication
SMQs:

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

Write-up: She feels a pulse under the armpit; Swollen axillary lymph nodes (in the arm where the vaccine was administered), Sore at axillary lymph nodes, Even more swollen axillary lymph nodes despite; This case was received via regulatory authority (Reference number: 00295) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHANGITIS (Swollen axillary lymph nodes (in the arm where the vaccine was administered), Sore at axillary lymph nodes, Even more swollen axillary lymph nodes despite) in a 34-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003605) for an unknown indication. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced LYMPHANGITIS (Swollen axillary lymph nodes (in the arm where the vaccine was administered), Sore at axillary lymph nodes, Even more swollen axillary lymph nodes despite) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION COMPLICATION (She feels a pulse under the armpit). The patient was treated with PARACETAMOL (TACHIPIRINA) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (She feels a pulse under the armpit) and LYMPHANGITIS (Swollen axillary lymph nodes (in the arm where the vaccine was administered), Sore at axillary lymph nodes, Even more swollen axillary lymph nodes despite) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported. second dose of patient was scheduled on 9-Aug-2021.; 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: 1586146 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9880 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Decreased appetite, Feeling abnormal, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100987398

Write-up: feeling queasy; vomiting; Feels poorly; inappetence; This is a spontaneous report from other health professional received from the Agency. Regulatory authority report number is v21122118. A 64-year and 11-month-old female (also reported as age at vaccination) patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 31Jul2021 12:30 (the day of vaccination) (Batch/Lot Number: FC9880; Expiration Date: 30Sep2021) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history reported as none: There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Body temperature before vaccination was 36.2 degrees Centigrade. It was unknown if the patient had family history. The patient''s concomitant medications were not reported. On 02Aug2021 08:00 (2 days after the vaccination), the patient experienced feeling queasy, vomiting, feels poorly, and inappetence. The course of the event was as follows: After the first vaccination, the patient experienced Feels poorly, inappetence. On 02Aug2021, in the morning, experienced queasy, outpatient visit to this hospital. Primperan was used. Fluid replacement with external solution was performed. The reporting other health professional 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. The reporting other health professional commented as follows: none. The patient underwent lab tests and procedures which included body temperature: 36.2 centigrade on 31Jul2021 before vaccination. On 02Aug2021 (2 days after the vaccination), the outcome of the events was recovering.


VAERS ID: 1586148 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure fluctuation, Blood pressure measurement, Body temperature, Radial pulse abnormal, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aichmophobia
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: blood pressure; Result Unstructured Data: Test Result:transiently increased; Test Date: 20210802; Test Name: blood pressure; Result Unstructured Data: Test Result:72 mmHg; Comments: systolic blood pressure; Test Date: 20210802; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100987450

Write-up: allergy (anaphylaxis); the radial pulse became poorly palpable; vomiting; blood pressure transiently increased/ systolic blood pressure decreased to 72 mmHg again; This is a spontaneous report from a contactable physician received from the Devices Agency (DA). The regulatory authority report number is v21122179. A 13-year-old (reported as 13-year and 5-month-old) female patient received bnt162b2 (COMIRNATY; Batch/Lot Number: EY0583; Expiration Date: 31Oct2021), via an unspecified route of administration, on 02Aug2021 at 09:40 (at the age of 13 years old) as dose 1, single for COVID-19 immunisation. Medical history included aichmophobia. Body temperature before vaccination was 36.7 degrees Centigrade. Event onset day reported 02Aug2021 at 10:02 (22 minutes after the vaccination). On 02Aug2021 (the same day of the vaccination), the outcome of the event was recovering. The course of the event was as follows: At 09:40 AM, the patient received the vaccination. The patient had vomiting during monitoring. At 10:02 AM, the radial pulse became poorly palpable. After normal saline 1000 mL was intravenously administered by drip infusion, blood pressure transiently increased, but systolic blood pressure decreased to 72 mmHg again. After EPIPEN was Intramuscular injection, the symptom rapidly improved. The reporting physician classified the event as serious (medically significant) and assessed that the event was related to bnt162b2. The outcome of the events was recovering. Reporter''s comment: There seemed to be causative factors such that the patient did exercise before the vaccination and that the patient had aichmophobia. However, according to the reaction to EPIPEN, it was judged that the patient might have had allergy (anaphylaxis).; Reporter''s Comments: There seemed to be causative factors such that the patient did exercise before the vaccination and that the patient had aichmophobia. However, according to the reaction to EPIPEN, it was judged that the patient might have had allergy (anaphylaxis).


VAERS ID: 1586156 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Fall, Nausea, Pallor
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ventricular extrasystoles
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100988125

Write-up: A possibility of anaphylaxis could not be ruled out; queasy; Complexion ill; fell down; This is a spontaneous report from a contactable physician received from the Medical Devices Agency (MDA) (Regulatory Authority report number: v21102155). The patient was a 14-year and 8-mouth-old male. Body temperature before vaccination was 36.7 degrees Centigrade. There were points to be considered on the vaccine screening questionnaire: ventricular extrasystoles. On 02Aug2021 at 14:50 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EY5423, Expiration date: 31Aug2021) as dose 1, single, with route of administration unspecified, for COVID-19 immunization. The event onset time was reported as on 02Aug2021 at 14:57 (7 minutes after the vaccination). The course of the event was as follows: On 02Aug201, at 14:50, the patient received the vaccination. At 14:57 (also reported as 14:59), the patient sat in observation, he was complexion ill and queasy. The patient fell down and had a rest as soon as possible. A possibility of anaphylaxis could not be ruled out. At 15:00 BOSMIN 0.5 mg was injected intramuscular, and the symptoms improved after that. Considering the possibility of deterioration in the future, the patient was introduced to other hospitals. 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. Follow-up attempts have been completed. No further information is expected.


VAERS ID: 1586195 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Dyspnoea, Heart rate, Nausea, Oropharyngeal discomfort, Oxygen saturation, Pallor, Palpitations, Pyrexia, Tachycardia, Tremor
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: BP; Result Unstructured Data: Test Result:109/75; Comments: at 20:30; Test Date: 20210802; Test Name: body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: at 20:30; Test Date: 20210802; Test Name: body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: at 18:30; Test Date: 20210802; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: Before vaccination; Test Date: 20210802; Test Name: HR; Result Unstructured Data: Test Result:115; Comments: at 20:30; Test Date: 20210802; Test Name: SPO2; Test Result: 98 %; Comments: at 20:30
CDC Split Type: JPPFIZER INC202100995615

Write-up: Queasy; Pallor facial; Dyspnoea; body temperature of the patient was 37.7 centigrade; Anaphylaxis; Tachycardia; Pharynx strange sensation of; Palpitations; Tremulousness; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21122317. A 35-year and 10-month-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FD1945, Expiration date 31Oct2021), via an unspecified route of administration on 02Aug2021 at 14:30 (the day of vaccination) (at the age of 35-year and 10-month-old), as dose 1, single for COVID-19 immunization. Body temperature before vaccination was 37.0 degrees Centigrade on 02Aug2021. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. On 02Aug2021 at 14:40 (10 minutes after the vaccination), the patient experienced Anaphylaxis. On 02Aug2021 (the same day of the vaccination), the patient was admitted to the hospital. On 03Aug2021 (1 day after the vaccination), the patient was discharged. The course of the event was as follows: At 14:30, the patient received vaccination. At 14:40, the patient experienced Pharynx strange sensation of, Palpitations, Tremulousness, Tachycardia. The patient received IV drip on bed rest under monitoring. At 18:30, the body temperature of the patient was 37.7 centigrade and CALONAL 500mg was administrated orally. At 19:00, the patient experienced Queasy, Pallor facial, Tachycardia and Dyspnoea increased, Adrenaline 0.3mg Intramuscular injection was performed. At 20:30, the patient was sent to hospital to receive treatment. Latest vital signs were BP 109/75, HR 115, SPO2 98%, BT 37.7 centigrade. The reporting physician classified the event as serious (hospitalization) and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The outcome of the events was recovered on 03Aug2021 (1 day after the vaccination). The reporting physician commented as follows: The patient was suspected to have Anaphylaxis. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1586199 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Body temperature, Cough, Dysphonia, Dysphoria, Dyspnoea, Erythema, Heart rate, Oxygen saturation, Sensation of foreign body
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), Hypertension (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: BP; Result Unstructured Data: Test Result:168/122; Comments: at 10:52; Test Date: 20210802; Test Name: BP; Result Unstructured Data: Test Result:162/114; Comments: at 10:58; Test Date: 20210802; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8; Comments: at 10:52; Test Date: 20210802; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9; Comments: Before vaccination.; Test Date: 20210802; Test Name: pulse; Result Unstructured Data: Test Result:81; Comments: at 10:52; Test Date: 20210802; Test Name: pulse; Result Unstructured Data: Test Result:77; Comments: at 10:58; Test Date: 20210802; Test Name: SPO2; Test Result: 98 %; Comments: at 10:52; Test Date: 20210802; Test Name: SPO2; Test Result: 99 %; Comments: at 10:58
CDC Split Type: JPPFIZER INC202100995679

Write-up: Hoarseness; Redness of precordial and forearm; BP was168/122; Anaphylaxis; Dyspnoea; Lump feeling of Pharynx; Dysphoria; Cough; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122305. A 36-year and 11-month-old male patient received the first dose of bnt162b2 (Solution for injection, Lot number FC5947, Expiration date 30Sep2021) via an intramuscular route of administration on 02Aug2021 at 10:45 (the day of vaccination) (age at first vaccination: 36-year and 11-month-old) as a dose 1, single for COVID-19 immunization. The patient had Anaphylaxis to Rosaceae plants and fruits such as apple and peach (dates unspecified). Body temperature before vaccination was 36.9 degrees Centigrade on 02Aug2021. Concomitant medications were not reported. On 02Aug2021 at 10:50 (5 minutes after the vaccination), the patient experienced Anaphylaxis, dyspnoea, lump feeling of Pharynx, dysphoria and cough. At 10:52, BP was 168/122 and experienced hoarseness and redness of precordial and forearm.. On 02Aug2021 (the same day of the vaccination), the patient was admitted to the hospital. On 03Aug2021(1 day after the vaccination), the patient was discharged. On 03Aug2021 (1 day after the vaccination), the outcome of the event was recovered. The course of the event was as follows: At 10:45, the patient received Covid-19 vaccine (pfizer). At 10:50, the patient experienced dyspnoea, lump feeling of Pharynx, dysphoria and cough. At 10:52, BP was 168/122, KT 36.8, P 81, SPO2 98 percent, the patient experienced hoarseness and redness of precordial and forearm. At 10:54, 0.3mg was intramuscularly injected. At 10:58, BP (blood pressure) 162/114, P (pulse rate) 77, SPO2 (oxygen saturation) 99 percent, symptoms improved and the patient was hospitalized. The reporting physician classified the event as serious (hospitalization) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The outcome of events was recovered on 03Aug2021. The reporting physician commented as follows: Anaphylaxis appeared within 5 minutes after vaccination, the patient was recovering for Regulatory Authority. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1586208 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure decreased, Chills, Dysmenorrhoea, Fatigue, Headache, Hyperhidrosis, Malaise, Mood swings, Myalgia, Nausea, Pyrexia, Respiratory failure, Vertigo, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (narrow), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: DAFALGAN
Current Illness:
Preexisting Conditions: Comments: The patient had no allergy, no alcohol or drug use, no specific illnesses, general good health.
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210832089

Write-up: DROPS IN BLOOD PRESSURE; MOOD SWINGS; RESPIRATORY INSUFFICIENCIES; PERIOD-LIKE PAINS (WITHOUT BEING IN PERIOD OF MENSTRUATION); I AM SWEATING ALMOST ALL THE TIME I SWIM IN MY SWEAT ALL DAY (ALTHOUGH I''M NOT PARTICULARLY HOT); DIZZINESS; CHILLS; JOINT PAIN; VOMITING; MALAISE; HEADACHE; FEVER; MUSCLE PAIN; NAUSEA; FATIGUE; This spontaneous report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines, BE-FAMHP-DHH-N2021-104104] concerned a 22 year old female of unspecified race and ethnic origin. The patient''s weight was 65 kilograms, and height was 170 centimeters. The patient''s pre-existing medical conditions included: The patient had no allergy, no alcohol or drug use, no specific illnesses, general good health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 02-AUG-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included Dafalgan 1 gram (paracetamol) for unknown indication. On 02-AUG-2021, the patient experienced drops in blood pressure, mood swings, respiratory insufficiencies, period-like pains (without being in period of menstruation), she was sweating almost all the time she swim in her sweat all day (although she was not particularly hot), dizziness, chills, joint pain, vomiting, malaise, headache, fever (she had a big flu the first two days), muscle pain, nausea and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from drops in blood pressure, chills, headache, fever (she had a big flu the first two days), muscle pain, joint pain, vomiting, nausea, mood swings, dizziness, respiratory insufficiencies, malaise, fatigue, period-like pains (without being in period of menstruation), and she was sweating almost all the time she swim in her sweat all day (although she was not particularly hot). This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Treatment - No Evolution of the ADR - No improvement ADR description - Mood swings, period-like pains (without being in period of menstruation), dizziness, drops in blood pressure, respiratory insufficiencies, vomiting, I''m sweating almost all the time I swim in my sweat all day (even though I''m am not particularly hot) Information on the time link (ADR) I had a big flu the first two days and didn''t worry anymore, but even today when I no longer have a fever and my body aches are gone I continue to have symptoms that worry me and which no longer correspond to a "sick" state that accompanies them (that is to say that I am not tired but I do have phases of 1-2h occasionally throughout the day; Sender''s Comments: V0:20210832089-covid-19 vaccine ad26.cov2.s- drops in blood pressure,mood swings,respiratory insufficiencies,period-like pains (without being in period of menstruation), I am was sweating almost all the time she swim in her sweat all day (although I am not particularly hot),dizziness. 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). 20210832089-covid-19 vaccine ad26.cov2.s-chills, headache, fever, muscle pain, joint pain, vomiting, nausea, malaise, fatigue.This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1586278 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100995734

Write-up: had Acute leukaemia; urticaria suddenly appeared on the feet; This is a spontaneous report from a contactable pharmacist received via Medical Information Team. An 87-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection) on 02Aug2021 at the age of 87-year-old via an unspecified route of administration as a single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. Clinical course details: Received a call from a patient who was vaccinated the Pfizer corona vaccine on 02Aug2021 (the day of vaccination). The patient had acute leukaemia, should be under treatment. On 02Aug2021 (the day of vaccination), the patient received vaccination, then hospitalization for 1 day (from 02Aug2021 to 03Aug2021). Returned home since nothing appeared. It seemed that urticaria suddenly appeared on the feet at night of 03Aug2021 (one day after vaccination). The patient said that he had taken betamethasone;dexchlorpheniramine maleate (CELESTAMINE) orally at home. The reporting pharmacist asked if it was possible to take steroids for urticaria after vaccination. Outcome of the events was unknown. This report assessed as serious, hospitalization. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event Acute leukaemia and the suspect drug 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: 1586295 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-08-02
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Feeling abnormal, Sinus bradycardia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Disorders of sinus node function (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:unknown Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100996195

Write-up: Consciousness disturbed; Feels poorly; Sinus bradycardia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122306. The patient was an 80-year and 9-month-old female (age at first vaccination). Body temperature before vaccination was unknown. The patient''s family history was unknown. The 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) was unknown. On 30Jun2021, the patient received the first dose of COVID-19 Vaccine - Manufacturer Unknown (Lot number: unknown), via an unspecified route of administration as a single dose for COVID-19 immunization. The adverse event onset date was reported as on 02Aug2021 at 11:00 (33 days after the vaccination). On 02Aug2021 (33 days after the vaccination), the patient was admitted to the hospital. The outcome of the event was not provided. The course of the event was as follows: On 02Aug2021 at 11:00, the patient complained of feeling poorly and was sent to the hospital due to disturbed consciousness. The patient''s level of consciousness improved upon arrival but remained hospitalized for Sinus bradycardia and detailed investigations. The reporter classified the event as serious (Hospitalized since 02Aug2021) and assessed that the causality between the event and bnt162b2 as unassessable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 1586506 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Headache, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210832490

Write-up: MAINLY IN THE UPPER BACK (NECK/SHOULDERS); JOINT PAIN; FEVER; HEADACHE; MUSCLE PAIN; NAUSEA; This spontaneous report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines, BE-FAMHP-DHH-N2021-104079] concerned a 58 year old female of unspecified race and ethnicity. The patient''s weight was 78 kilograms and height was 172 centimeters. The patient''s pre-existing medical conditions included: hypothyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C16-05, expiry: unknown) dose was not reported, 1 total administered on 02-AUG-2021 for covid-19 immunization. No concomitant medications were reported. On 02-AUG-2021, the patient experienced Fever (37.8) upon waking up, headache, joint pain and muscle pain mainly in the upper back (neck/shoulders), slight nausea in the afternoon. The effects began on 02-AUG-2021 in the evening with great fatigue, they were intense on the day of 03-AUG-2021 and disappeared on 04-AUG-2021 in the morning after the last intake of paracetamol apart from a slight headache persisting since then. Evolution of the adverse drug reaction was healed and disappeared in 36 hours on 04-AUG-2021, after taking 4 doses paracetamol (Afebril). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mainly in the upper back (neck/shoulders) (Back pain with radiation), joint pain, fever, headache, muscle pain, and nausea on 04-AUG-2021. This report was serious (Disability Or Permanent Damage); Reporter''s Comments: Treatment - Yes With 4 doses of paracetamol (Afebril), the symptoms disappeared in 36 hours Evolution of the ADR - Healing: 36 hours ADR description - Fever (37.8) upon waking up, headache, joint pain and muscle pain mainly in the upper back (neck/shoulders), slight nausea in the afternoon Information on the temporal link (ADR) - The effects began on 2/8 in the evening with great fatigue, they were intense on the day of 3/8 and disappeared on 4/8 in he morning after the last intake of paracetamol apart from a slight headache persisting since then.; Sender''s Comments: V0:20210832490-COVID-19 VACCINE AD26.COV2.S-Mainly in the upper back ( neck/ shoulder) back pain with radiation . 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). 20210832490-COVID-19 VACCINE AD26.COV2.S-Joint pain ,Fever, Headache, Muscle pain ,Nausea . This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1588959 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004672 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Circumoral swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)

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

Write-up: This case was received via Regulatory Authority (Reference number: 966143) on 11-Aug-2021 and was forwarded to Moderna on 11-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CIRCUMORAL SWELLING in a 34-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 3004672) for COVID-19 vaccination. No Medical History information was reported. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced CIRCUMORAL SWELLING (seriousness criterion disability). At the time of the report, CIRCUMORAL SWELLING was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No relevant concomitant medication information provided. No relevant treatment medication information provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1589112 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214007 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthmatic crisis
SMQs:, Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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: Allergic rhinitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Asthmatic crisis; This case was received via Regulatory Agency (Reference number: TO20216290) on 11-Aug-2021 and was forwarded to Moderna on 11-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of ASTHMATIC CRISIS (Asthmatic crisis) in a 30-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214007) for COVID-19 vaccination. Concurrent medical conditions included Allergic rhinitis. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced ASTHMATIC CRISIS (Asthmatic crisis) (seriousness criterion medically significant). At the time of the report, ASTHMATIC CRISIS (Asthmatic crisis) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product was not provided. Treatment medication was not reported. 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: 1589154 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NORGESTON; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Ill-defined disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012757

Write-up: hives; itch; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Authority.The regulatory authority report number is GB-MHRA-TPP45589506C3251139YC1627890631997.Safety Report Unique Identifier GB-MHRA-ADR 25757784. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: not reported), via an unspecified route of administration on 02Aug2021 (Age at vaccination 30-year-olg) as dose 2, single for COVID-19 immunisation. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunisation. Medical history included contraception and ill-defined disorder. Concomitant medications included levonorgestrel (NORGESTON) from 21Jul2021 to an unspecified stop date and omeprazole (OMEPRAZOLE) from 20May2021 to 19Jun2021 for ill-defined disorder. On 02Aug2021 (2 hours after 2nd dose), the patient experienced hives and itch. The case classified as serious (medically significant). The outcome of the event hives was resolving, and event itch was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: hives and itch 2 hours after 2nd dose.


VAERS ID: 1589172 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s disease; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100998374

Write-up: swelling of the area between the armpit and breast/painful to touch and without touching/at rest; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202108030912209890-UOMIK, Safety Report Unique Identifier GB-MHRA-ADR 25745289. A 34-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD8813), via an unspecified route of administration on 01Aug2021 as single dose for COVID-19 immunisation. Medical history included lactation decreased and Hashimoto''s disease. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant at the time of the vaccination. Patient is not currently breastfeeding. Concomitant medication included levothyroxine taken for Hashimoto''s disease from 01Jun2017. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), on unspecified date for COVID-19 immunisation. On 02Aug2021, the patient experienced moderate and visibly noticeable swelling of the area between the armpit and breast (same side of the body where the vaccine was injected). It was painful to touch and without touching/at rest. The patient had negative COVID-19 virus test on 28Jul2021. The outcome of the event was not recovered. The event was considered serious, medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589174 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998464

Write-up: Subclavicular lymphadenopathy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202108030916335800-ACK7F, Safety Report Unique Identifier is GB-MHRA-ADR 25745263. A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: FF3319) via an unspecified route of administration on 01Aug2021 as single dose for COVID-19 immunisation. Medical history included lactation decreased from an unknown date. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced subclavicular lymphadenopathy on 02Aug2021. The event was reported as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient has not recovered from the event. No follow-up attempts are possible. Information about Lot/ Batch number cannot be obtained. No further information is expected.


VAERS ID: 1589175 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disorientation, Dizziness, Nausea, Neck pain, SARS-CoV-2 test, Vision blurred
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Arthritis (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Labyrinthine disorder
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998259

Write-up: lightheaded; dizzy; disorientated; nauseous; Dizziness; Neck pain; Blurry vision; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108030922048890-4RJDD. A 38-years-old male patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: FE3380), via an unspecified route of administration on 01Aug2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included inner ear disorder from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as DOSE 1,SINGLE for covid-19 immunisation. The patient experienced lightheaded, dizzy, disorientated, nauseous on an unspecified date. The patient experienced dizziness, neck pain, blurry vision on 02Aug2021. The clinical information was reported as follows, it was reported that have suffered with labyrinthine a few times before which the symptoms are very similar to. Patient has not had symptoms associated with COVID-19. Whilst driving day after 2nd dose my vision became severely impaired and I became very nauseous and very dizzy/lightheaded. Had to stop car and get wife to drive. Still feel very disorientated and lightheaded. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The events were assessed as serious. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No Negative COVID-19 test. The outcome of event for dizziness and neck pain was not recovered, outcome of event for blurry vision was recovered on an unknown date. And outcome of other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589188 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Dizziness, Gait disturbance, SARS-CoV-2 test, Vertigo
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Vestibular disorders (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998679

Write-up: walking; dizziness/Dizziness when walking; head spinning when lying down; Head and legs feel ''very heavy'' when walking or sitting; Dizzy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108031045129390-DOJSN, Safety Report Unique Identifier GB-MHRA-ADR 25745827. A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: FE1510) via an unspecified route of administration at single dose on 02Aug2021 for COVID-19 immunization. Medical history included lactation decreased. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced walking, dizziness/dizziness when walking on an unspecified date, dizzy on 02Aug2021, head spinning when lying down, head and legs feel ''very heavy'' when walking or sitting on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 test: negative on 31Jul2021. The outcome of events walking, dizziness/dizziness when walking was recovering, outcome of dizzy was not recovered, outcome of events was unknown. Case was serious as medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589189 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Inappropriate schedule of product administration, Menstruation irregular, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No other medication being taken Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998403

Write-up: vaginal bleeding/woke up to vaginal bleeding with very heavy cramping 7 days before period was due/cramping much worse than usual, blood dark and clot like; vaginal bleeding/woke up to vaginal bleeding with very heavy cramping 7 days before period was due/cramping much worse than usual, blood dark and clot like; vaginal bleeding/woke up to vaginal bleeding with very heavy cramping 7 days before period was due/cramping much worse than usual, blood dark and clot like; received first dose on 28May2021/received second dose on 02Aug2021; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108031052277180-WRU9H; Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25745991. A 33-year-old female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Batch/Lot Number: FD8813; expiration date not provided) via an unspecified route of administration on 02Aug2021 (at the age of 33-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. It was reported that patient has no other medication being taken. Patient has not 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 previously took first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Batch/Lot Number: ET8885; expiration date not provided) via an unspecified route of administration on 28May2021 as DOSE 1, SINGLE for COVID-19 immunisation with no reactions. The patient experienced ''vaginal bleeding/woke up to vaginal bleeding with very heavy cramping 7 days before period was due/cramping much worse than usual, blood dark and clot like'' on 03Aug2021; ''received first dose on 28May2021/received second dose on 02Aug2021''. Patient''s clinical course is as follows: It was reported that morning after the second jab, patient woke up to vaginal bleeding with very heavy cramping 7 days before period was due. Cramping much worse than usual, blood dark and clot like. The event ''woke up to vaginal bleeding with very heavy cramping 7 days before period was due/cramping much worse than usual, blood dark and clot like'' was assessed as serious (medically significant); the event ''received first dose on 28May2021/received second dose on 02Aug2021'' was assessed as non-serious. The patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event ''vaginal bleeding/woke up to vaginal bleeding with very heavy cramping 7 days before period was due/cramping much worse than usual, blood dark and clot like'' was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589196 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Headache, Renal pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decreased lactation.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative.
CDC Split Type: GBPFIZER INC202100998262

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number is GB-MHRA-WEBCOVID-202108031131474800-POWA5; safety report unique identifier: GB-MHRA-ADR 25747106). A 19-year-old (non-pregnant) female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), at the vaccination age of 19, via an unspecified route of administration, on Aug 2, 2021, single dose, for COVID-19 immunization. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection), for COVID-19 immunization. Medical history included suppressed lactation. The patient''s concomitant medications not reported. Unsure if patient had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since the vaccination. Patient not enrolled in a clinical trial. On an unspecified date, patient experienced kidney pain. On Aug 2, 2021, patient experienced fatigue and stomach pain. On Aug 3, 2021, patient experienced pain kidney, pain joint and headache. Reportedly, moderate kidney pain started about 15 hours after the vaccine. It got worse throughout the day. The patient underwent lab tests and procedures, which included SARS-CoV-2 test: negative on an unspecified date. Patient has not tested positive for COVID-19 since the vaccination. The outcome kidney pain recovered; while for the other events: not recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1589197 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, 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: LISINOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210505; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998652

Write-up: Dizziness; Nausea; Headache; Tiredness; Day/Fever; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108031133084600-GVDQU. Safety Report Unique Identifier GB-MHRA-ADR 25746098. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Concomitant medication included lisinopril taken for hypertension. The patient experienced headache, tiredness and fever a day after the second vaccine (02Aug2021). Resolved by sleeping and taking paracetamol, felt better in the afternoon. Mid-morning following day (03Aug2021) experienced sudden dizziness and nausea, currently still resting with same symptoms. The events were assessed as serious (medically significant). Lab data includes COVID-19 virus test: No - Negative COVID-19 test on 05May2021. The outcome of the events fever and nausea was recovering; event tiredness was recovered on an unspecified date; event headache was recovered on 02Aug2021; event dizziness was not recovered. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1589211 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUSCOPAN; DULOXETINE; OMEPRAZOLE; PARACETAMOL; SOLIFENACIN; TRAMADOL.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder pain; Bladder pain syndrome; Chronic fatigue; Endometriosis; Esophageal acid reflux; Fever chills; Fibromyalgia; Irritable bowel syndrome; Lactation decreased; Pain.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998503

Write-up: Armpit pain; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108031257372400-IPDBS, Safety Report Unique Identifier is GB-MHRA-ADR 25746590. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 as DOSE 2, single for COVID-19 immunisation. Medical history included suppressed lactation (lactation decreased), pain, bladder pain, pyrexia (fever chills), gastrooesophageal reflux disease, fibromyalgia, irritable bowel syndrome, chronic fatigue, endometriosis, and interstitial cystitis. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Patient is not currently breastfeeding. Patient was not pregnant. Concomitant medications included hyoscine butylbromide (BUSCOPAN) taken for irritable bowel syndrome, start and stop date were not reported; duloxetine taken for fibromyalgia, start and stop date were not reported; omeprazole taken for gastrooesophageal reflux disease, start and stop date were not reported; paracetamol taken for pyrexia (fever chills), start and stop date were not reported; solifenacin taken for bladder pain, start and stop date were not reported; and tramadol taken for pain, start and stop date were not reported. Historical vaccine included BNT162B2 (lot number and expiry date not known), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced armpit pain on 02Aug2021 with outcome of not recovered. The event was reported as serious, medically significant by the health authority. Case Narrative: Pain in armpit under arm of site of injection. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1589212 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Increased appetite, Myalgia, Nausea, Pyrexia, Renal pain, Tearfulness
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (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? 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 INC202100998452

Write-up: Nausea; Kidney pain; Tearfulness; Increased appetite; Fever chills; Localised muscle pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202108031300344910-9ENJE, Safety Report Unique Identifier GB-MHRA-ADR 25746689. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced nausea, kidney pain, tearfulness, increased appetite, fever chills, and localised muscle pain on 02Aug2021. The events were reported as medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the events was recovered on 03Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1589214 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Adnexa uteri mass, 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: PARACETAMOL.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain; Pregnancy.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100998190

Write-up: Adnexal mass; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108031312353820-1DTPX, Safety Report Unique Identifier GB-MHRA-ADR 25746894. A 44-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FD8813) via an unspecified route of administration on 01Aug2021 (at the age of 44-year-old) as dose 2, single for COVID-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) included with COVID-19 immunization. Medical history included pregnancy from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Concomitant medication(s) included paracetamol taken for pain from 02Aug2021 to an unspecified stop date. On 02Aug2021, the patient experienced adnexal mass. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unspecified date. Additional information: Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589217 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998468

Write-up: Chills; Fever; Hives; This is a spontaneous report from a contactable consumer received from the Regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108031349506960-IKOLB, Safety Report Unique Identifier is GB-MHRA-ADR 25746973. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF3319, Expiry date not reported), via an unspecified route of administration as DOSE 2, SINGLE on 02Aug2021 (age at vaccination was 30 years) for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Historical vaccine included BNT162B2 (lot number and expiry date not known), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced chills on 02Aug2021 with outcome of recovering, fever on 02Aug2021 with outcome of recovered on an unspecified date, and hives on 02Aug2021 with outcome of recovered on an unspecified date. The events were reported as serious, medically significant. Narrative case summary and further information: Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589235 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood pressure measurement, Contrast media reaction, Dyspnoea, Heart rate, Oxygen saturation, Pallor, Speech disorder, Vital signs measurement, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alopecia; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef)).
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased.
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: BP; Result Unstructured Data: Test Result:normal; Test Date: 20210802; Test Name: pulse; Result Unstructured Data: Test Result:normal; Test Date: 20210802; Test Name: oxygen saturation; Test Result: 100 %; Test Date: 20210802; Test Name: vital signs; Result Unstructured Data: Test Result:good
CDC Split Type: GBPFIZER INC202100998329

Write-up: after 10 minutes; cramping in abdominal; Breathing difficult; difficulty talking; vomiting; pale; This is a spontaneous report from a contactable pharmacist. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108031552159500-NIILK, Safety Report Unique Identifier is GB-MHRA-ADR 25748028. A 36-year-old female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: FD8813), via an unspecified route of administration as single dose on 02Aug2021 for COVID-19 immunisation. Medical history included lactation decreased, ongoing immunodeficiency (has an illness or condition, not listed above, which reduces the immune response e.g. immunodef), and ongoing alopecia. She has not had symptoms associated with COVID-19, not had a COVID-19 test, not pregnant, and not currently breastfeeding. Unsure if she was enrolled in clinical trial. The patient''s concomitant medications were not reported. Historical vaccine included flu jab in 2020 for immunization and experienced breathing difficult. The patient experienced contrast media reaction (reported as after 10 minutes) on an unspecified date; breathing difficult, pale, cramping in abdominal, and vomiting on 02Aug2021. Case narrative: Patient had to use salbutamol inhaler immediately after vaccination, saying she couldn''t catch her breath. She said this had happened immediately following her first dose (discrepancy; as reported), but that it resolved in 10 minutes. She was pale and had difficulty talking, but fully conscious. After 10 minutes, the pharmacist suggested she sit outside in the fresh air and to sit back in a chair rather than sit bent forward. Her symptoms hadn''t resolved within 30 minutes and the pharmacist suggested there was no further use in using the inhaler. The pharmacist suggested calling for paramedic attendance as it was now some 30 minutes post-vaccination and called a local fast-response paramedic service. Within two minutes, a paramedic was in attendance. All the patient''s vital signs were good - oxygen saturation was 100%, BP and pulse were normal. Patient complained of cramping in abdominal region. Paramedics were in attendance for an hour, monitoring and suggesting breathing exercises. At first, the patient resisted hospitalisation, but after being given water and then vomiting this and her breakfast, she agreed to be taken to hospital. It transpired she had a similar reaction to a flu jab last year, but the effect was only short-lived. She also had ongoing issues - alopecia and immune system problems but did not want to see her GP. This report is not related to possible blood clots or low platelet counts. The patient recovered from pale, difficulty talking, and breathing difficult on 02Aug2021; from vomiting, contrast media reaction, and cramping in abdominal on an unspecified date. Case reported as medically significant by health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589241 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998341

Write-up: Glands swollen; Chills; Headache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108031708345440-V3S22, Safety Report Unique Identifier GB-MHRA-ADR 25748461. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Aug2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced glands swollen on 03Aug2021 with outcome of not recovered, chills on 02Aug2021 with outcome of not recovered, headache on 02Aug2021 with outcome of not recovered. Patient has not tested positive for COVID-19 since having the vaccine. The events were assessed as serious and medically significant by regulatory authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1589255 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Hemiplegia, Hemiplegic migraine, SARS-CoV-2 test
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: MIGRALEVE [BUCLIZINE HYDROCHLORIDE;CODEINE PHOSPHATE;PARACETAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100998573

Write-up: Migraine hemiplegic; left side paralysis; suspected stroke; This is a spontaneous report from a contactable consumer. This is a report received from the Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108031852428450-HXPC8, Safety Report Unique Identifier GB-MHRA-ADR 25749217. A 32-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 30Jul2021 (lot number and expiry date were unknown) as single dose for COVID-19 immunisation. Medical history included migraine. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant at the time of the vaccination. Concomitant medication included buclizine hydrochloride, codeine phosphate, paracetamol (MIGRALEVE) taken for migraine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on unspecified date (lot number and expiry date were unknown) for COVID-19 immunisation. On 02Aug2021, the patient was taken to a&e with suspected stroke with left side paralysis, identified to be hemiplegic migraine. The patient had negative COVID-19 virus test on 01Aug2021. The outcome of hemiplegic migraine was recovering, while for the other events was unknown. The case has been considered serious due to seriousness criterion of other medically important condition. No follow-up attempts are possible; information about lot number cannot be obtained.


VAERS ID: 1589267 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Cough, Headache, Oropharyngeal pain, Pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: DERMOVATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atopic eczema; Eczema; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201226; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100998191

Write-up: cough; Headache; Ache; Coughing; Chills; Sore throat; This is a spontaneous report from a contactable consumer (Patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108031950325920-HEULD. Safety Report Unique Identifier GB-MHRA-ADR 25749856. A 35-years-old male patient received bnt162b2 (BNT162B2, Batch/Lot Number: FF3319), via an unspecified route of administration on 01Aug2021 as DOSE 2, SINGLE for covid-19 immunization. Medical history included eczema from an unknown date and unknown if ongoing, suspected covid-19 from 24Dec2020 to an unknown date Unsure when symptoms stopped, immunodeficiency from an unknown date and unknown if ongoing Taking other treatments or medicines, not listed above, known to lower the immune response and dermatitis atopic from an unknown date and unknown if ongoing. Patient is not enrolled in clinical trial. Concomitant medications included clobetasol propionate (DERMOVATE) taken for dermatitis atopic from 14Jan2019 to an unspecified stop date. The patient experienced cough on an unspecified date. On 02Aug2021, patient experienced headache, ache, coughing, chills and sore throat. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Dec2020 Yes - Positive COVID-19 test. It was reported that the patient had an ache in arm from the moment of injection. The next morning, patient had flu-like symptoms, with a cough and sore throat, followed by a growing headache and aching all over followed by chills in the evening. Two days after the injection, the aches and headache had reduced, but still have a sore throat and a cough, though they are both improving. Patient received a treatment for eczema as Topical steroid cream. The outcome for the events cough, headache, coughing and sore throat was recovering. And outcome for other events included ache and chills was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589273 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disturbance in attention, Dizziness, Feeling drunk, Gait disturbance, Head banging, Headache, Malaise
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Vestibular 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: SOLPADOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Impacted wisdom tooth; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998268

Write-up: Head banging; felt ill; Can''t concentrate; head hurts so much; felt drunk; Dizziness; staggering off walls; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202108032032410220-XJHPY, Safety Report Unique Identifier GB-MHRA-ADR 25749925. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Aug2021 as dose 2, single for covid-19 immunisation. Medical history included lactation decreased and impacted wisdom tooth from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant a time of vaccination. Patient is not currently breastfeeding. Concomitant medication included codeine phosphate, paracetamol (SOLPADOL) taken for impacted wisdom tooth from 01Aug2021 to an unspecified stop date. The patient experienced felt drunk, staggering off walls with dizziness on 02Aug2021, felt ill, head banging, cannot concentrate and head hurts so much on 03Aug2021. A few hours after injection patient was staggering off walls with dizziness. She felt drunk but had no other medication and certainly not any alcohol. Next day she has felt ill. Cannot concentrate and head hurts so much. The events were reported as medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of feeling drunk was recovering, dizziness recovered on 03Aug2021, head banging was not recovered, while the rest of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1589293 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Cold sweat, Fatigue, SARS-CoV-2 test
SMQs:, Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Obsessive-compulsive disorder; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100998218

Write-up: Chills; Cold sweat; Tiredness; This is a spontaneous report from a contactable consumer or other non-healthcare professional received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108032255485620-6NMVW, Safety Report GB-MHRA-ADR 25750408. A 23-year-old female (not pregnant during vaccination) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FD8813), dose 2 via an unspecified route of administration on 02Aug2021 (at the age of 23-year-old) as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing, suspected COVID-19 from 14Jan2021 to 21Jan2021, obsessive-compulsive disorder from an unknown date and unknown if ongoing. Patient was not pregnant and was not currently breastfeeding. Concomitant medications included sertraline taken for obsessive-compulsive disorder, start and stop date were not reported. The patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) dose 1 administered on an unknown date as dose 1, single for COVID-19 Immunization. On 02Aug2021 the patient experienced chills, cold sweat and tiredness. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Jan2021 (Yes - Positive COVID-19 test). Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The events were reported as medically significant. The outcome of the event chills and cold sweat was reported as recovered on 03Aug2021 while outcome of event tiredness was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589302 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Diarrhoea, Fatigue, Liver function test, Myalgia, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: lft; Test Result: Negative ; Comments: Negative; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998356

Write-up: fatigue; rigors; muscle aches; diarrhea; blocked nose; Sore throat; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108040022485500-OPYYE. Safety Report Unique Identifier: GB-MHRA-ADR 25750456. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number not known; expiration date not provided), via an unspecified route of administration on 31Jul2021 as DOSE 1, single for COVID-19 immunization. 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 fatigue, rigors, muscle aches, ''diarrhea/diarrhoea'', and blocked nose on unspecified dates; sore throat on 02Aug2021. Patient''s clinical course is as follows: It was reported that patient had rigors since vaccine, muscle aches, diarrhoea, fatigue, blocked nose and now sore throat. It was further reported that patient had completed a LFT prior to vaccination which was negative. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included ''lft'' with result of ''negative; Negative'' and COVID-19 virus test with result of ''No - Negative COVID-19 test'' on an unspecified date. Outcome of the event ''blocked nose'' was unknown; outcome of 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: 1589321 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Headache, Influenza like illness, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Acute pancreatitis (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: Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101005636

Write-up: Swollen lymph nodes; Stomach ache; Flu-like aching; Headache; This is a spontaneous report from a contactable consumer received from the Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108040811534230-AMTHF, Safety Report Unique Identifier GB-MHRA-ADR 25751360. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Aug2021 at her 34-year-old (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included Lactation decreased), suspected covid-19 from 19Jan2021 which was unsure when symptoms stopped. Patient is not pregnant, Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced headache on 02Aug2021 with outcome of not recovered , stomach ache and flu-like aching both on 03Aug2021 with outcome of recovering , swollen lymph nodes on 04Aug2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 21Jan2021. All events were assessed as serious with medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589326 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Diarrhoea, Fatigue, Headache, Illness, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
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 INC202101005764

Write-up: Joint pain; Generalised muscle aches; Sickness; Diarrhea; Tiredness; Weakness; Headache; High temperature; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108040910297060-JBFCA. Safety Report Unique Identifier GB-MHRA-ADR 25751738. A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 31-year-old, via an unspecified route of administration on 02Aug2021 (Batch/Lot Number: FE3380) at single dose for COVID-19 immunization. Medical history included lactation decreased. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced high temperature on 02Aug2021, and headache, joint pain, generalised muscle aches, sickness, diarrhea, tiredness, and weakness; all on 03Aug2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Outcome of events high temperature, and sickness was resolved, and of other events was resolving. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589328 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: 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? 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: 20210726; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005702

Write-up: Fever; Fever chills; Nausea; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority; report number is GB-MHRA-WEBCOVID-202108040915077720-IQUCL. Safety Report Unique Identifier is GB-MHRA-ADR 25751850. A male patient of an unspecified age received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 2 via an unspecified route of administration on 02Aug2021 (Lot Number: FF3319) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Historical Vaccine included dose 1 BNT162B2 for COVID-19 immunisation. The patient experienced fever on 02Aug2021 with outcome of recovered on 03Aug2021, fever chills on 02Aug2021 with outcome of recovered on 03Aug2021, nausea on 02Aug2021 with outcome of recovered on 04Aug2021. The events were serious due to medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 26Jul2021 (No - Negative COVID-19 test). Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589330 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Myalgia, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101005984

Write-up: Muscle ache; Dizziness; Headache; Sore throat; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108040947190150-QWIJG, Safety Report Unique Identifier GB-MHRA-ADR 25752006. A 34-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot Number: FD8813), via an unspecified route of administration on 02Aug2021 (age at vaccination 34-year-old) as DOSE 2, SINGLE for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Lot Number: unknown) on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. On 02Aug2021, the patient experienced headache, sore throat, on 03Aug2021, muscle ache, dizziness. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Aug2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event dizziness was recovered on an unspecified date in 2021 and other events were recovering. No follow-up attempts are possible. No further information is expected..


VAERS ID: 1589340 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Headache, Hypomenorrhoea, Myalgia, Nausea, Palpitations, Photophobia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Fertility disorders (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? 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: 20210801; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101006058

Write-up: Stomach cramps; Photophobia; High temperature; Light periods; Muscle pain; Headache; Heart pounding; Nausea; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041016079670-G0SJA, Safety Report Unique Identifier GB-MHRA-ADR 25752205. A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 30-years-old, dose 2 via an unspecified route of administration on 02Aug2021 (Batch/Lot Number: FF3319) as SINGLE for covid-19 immunisation. Medical history included Lactation decreased. The patient''s concomitant medications were not reported. Not taking any medicines or have any medical history that is known to affect immune response. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient experienced stomach cramps on 03Aug2021 with outcome of recovered on 04Aug2021, photophobia on 03Aug2021 with outcome of recovered on 04Aug2021, heart pounding on 02Aug2021 with outcome of recovered on 04Aug2021, nausea on 02Aug2021 with outcome of recovered on 04Aug2021, high temperature on 03Aug2021 with outcome of recovered on 03Aug2021, muscle pain on 02Aug2021 with outcome of recovered on 04Aug2021, headache on 02Aug2021 with outcome of recovered on 03Aug2021, light periods on 03Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 01Aug2021 No - Negative COVID-19 test. Patient is not enrolled in clinical trial. HA seriousness assessment: Other medically important condition. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589344 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Lymphadenopathy, Menstrual disorder, Myalgia, Nausea, Pain, Peripheral swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Menstrual cramps
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005897

Write-up: arm swelling; Menstrual flow altered; Generalised muscle aches; Shooting pain; Nausea; Fatigue; Swollen arm; Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041027357210-5HBZP. Safety Report Unique Identifier GB-MHRA-ADR 25752536. A 32-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration on 01Aug2021 as dose 2, single for COVID-19 immunization. Medical history included suppressed lactation, dysmenorrhoea. The patient previously received first dose of BNT162B2 on an unspecified date as dose 1, single for COVID-19 Immunization. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medications included ibuprofen (IBUPROFEN) taken for dysmenorrhoea, start and stop date were not reported. On an unspecified date the patient experienced arm swelling, generalised muscle aches, shooting pain, nausea, fatigue, swollen lymph nodes and swollen arm on 02Aug2021, menstrual flow altered on 04Aug2021. All the events were assessed as medically significant. All symptoms presented approximately 12 hrs after the second dose of vaccine. Fatigue and mild aches were experienced after first dose but resolved within 24hrs. All symptoms except lymph nodes improved by the second day post vaccine and by 3 days post vaccine all except lymph nodes and arm swelling had recovered. Menstrual cycle disruption occurred in that it was almost 2 weeks early. Patient is not enrolled in clinical trial. The clinical outcome of arm swelling was recovered on an unspecified date, generalised muscle aches recovered on 04Aug2021, shooting pain on 03Aug2021, nausea recovered on 02Aug2021, fatigue recovered on 04Aug2021, swollen arm and menstrual flow altered were recovering, swollen lymph nodes was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101013492 Same Patient, Same product, different dose and different Event.


VAERS ID: 1589369 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005934

Write-up: Chest heaviness; Breathlessness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108041317461320-B044C. [Safety Report Unique Identifier: GB-MHRA-ADR 25753513] A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: FF3319), via an unspecified route of administration on 02Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. The patient had previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), via unspecified route on an unspecified date as dose 1, single for COVID-19 immunization. The patient had experienced chest heaviness, breathlessness on 02Aug2021. The events seriousness was reported as serious. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589373 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Breast pain, Breast swelling, Dysmenorrhoea, Headache, Heavy menstrual bleeding, Menstruation irregular
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Lipodystrophy (broad), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101006031

Write-up: abdominal cramps; sore large breasts; headache; heavy bleeding; Swollen and sore large breasts; Period pains; Painful periods; Irregular periods; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041349378210-VNE5Z, safety report unique identifier is GB-MHRA-ADR 25753818. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 01Aug2021 as DOSE 2, SINGLE for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Medical history included suppressed lactation, pain. Concomitant medication included paracetamol taken for pain from 02Aug2021 to 04Aug2021. The patient previously received BNT162B2 dose 1 on unknown date for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. The patient currently has an IUD contraceptive. Since the implant she has not had a period or symptoms of a period (for at least 4 years) until she had her second Covid vaccination. The symptoms have been intense, heavy and unexpected. Swollen and sore large breasts, intense abdominal cramps and pains, headaches and heavy bleeding. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced abdominal cramps on an unspecified date with outcome of recovering , period pains on 02Aug2021 with outcome of not recovered , painful periods on 02Aug2021 with outcome of not recovered , irregular periods on 02Aug2021 with outcome of not recovered , Swollen and sore large breasts on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , heavy bleeding on an unspecified date with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589375 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Heavy menstrual bleeding, Menstruation irregular, Muscle spasms
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005700

Write-up: bleeding; cramping; Menstrual irregularity; Menstrual flooding; This is a spontaneous report from a contactable consumer received from the Regulatory authority report number GB-MHRA-WEBCOVID-202108041414267650-GWJ16, Safety Report Unique Identifier GB-MHRA-ADR 25753901. A female patient of an unspecified age received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 2 via an unspecified route of administration on 26Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient''s concomitant medications were not reported. Historical Vaccine included 1st dose of BNT162B2 for COVID-19 immunisation on an unknown date. The patient experienced bleeding on an unspecified date with outcome of unknown, cramping on an unspecified date with outcome of unknown, menstrual irregularity on 02Aug2021 with outcome of recovering, menstrual flooding on 02Aug2021 with outcome of recovering. The events were serious due to medically significant. Detail information was provided as: On the pill and half way through a packet. Very suddenly and extremely heavily began bleeding which has never happened before. It was accompanied by very painful cramping. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


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