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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 313 out of 7,116

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VAERS ID: 1579313 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, SARS-CoV-2 test, Uterine haemorrhage, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (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: CODEINE; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Early miscarriage; Lactation decreased; Miscarriage
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: HCG level blood tests; Result Unstructured Data: Test Result:Miscarriage; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984753

Write-up: miscarriage; brown spotting/Red blood and brown blood (with some small clots) continued over the day; Uterine bleeding; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011911048630-LHSJG. Safety Report Unique Identifier GB-MHRA-ADR 25738317 . A 34-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 21Jul2021 (Batch/Lot Number: FC9001) as dose 1 ,single for Covid-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient had an early miscarriage in May2021; this did not complete (confirmed by weekly HCG level blood tests) until 9th July 2021. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications included codeine and paracetamol taken for miscarriage from 05Jun2021 to 07Jun2021. The patient experienced miscarriage on an unspecified date with outcome of unknown, uterine bleeding on 01Aug2021 with outcome of not recovered, and brown spotting/red blood and brown blood (with some small clots) continued over the day on an unspecified date with outcome of unknown. The patient underwent lab tests which included human chorionic gonadotropin: miscarriage on 09Jul2021 and Covid-19 virus test: No - Negative COVID-19 test, on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The events were assessed as non-serious by regulatory authority. The clinical course was reported as follows: Noticed this morning that there was brown spotting in panty-liner - upon wiping, there was red blood. Red blood and brown blood (with some small clots) continued over the day. Not yet finished. The only other thing relevant here is that I recently had a miscarriage (May-July 2021) and this had completed early July. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1579315 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic fatigue syndrome; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100984744

Write-up: Bad nausea; bad headaches; tiredness; Vomiting; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108011949319940-UUZBH, Safety Report Unique Identifier GB-MHRA-ADR 25738344. A 27-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 30Jul2021 (Lot number and expiry date were not reported) as single dose for COVID-19 immunisation. Medical history included going through diagnosis for chronic fatigue syndrome and immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef)). Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced bad nausea, bad headaches, and tiredness; all on unspecified date. The patient also experienced vomiting on 01Aug2021. The patient had negative COVID-19 virus test on unspecified date. The outcome of the events was unknown. The events were considered serious, medically significant. No follow-up attempts are possible; information about lot number cannot be obtained.


VAERS ID: 1579364 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
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: Bronchitis, 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 Date: 20210804; 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: Bronchitis; This case was received via MHRA (Reference number: ADR 25758295) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of BRONCHITIS (Bronchitis) in a 53-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced BRONCHITIS (Bronchitis) (seriousness criterion medically significant). At the time of the report, BRONCHITIS (Bronchitis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information not provided. Concomitant medications were not provided. Company comment:Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1579368 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
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: Concussion, Malaise, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Fainted; Concussion; Unwell; Feverish; Faint; This case was received via Regulatory Authority (Reference number) 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 SYNCOPE (Fainted), SYNCOPE (Faint), CONCUSSION (Concussion), MALAISE (Unwell) and PYREXIA (Feverish) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 31-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant). On an unknown date, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), CONCUSSION (Concussion) (seriousness criterion medically significant), MALAISE (Unwell) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). On 01-Aug-2021, SYNCOPE (Faint) had resolved with sequelae. At the time of the report, SYNCOPE (Fainted), CONCUSSION (Concussion), MALAISE (Unwell) and PYREXIA (Feverish) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. Events included aches and pains.Post vaccination patient not tested positive for COVID-19 and was not enrolled in any clinical trials. Patient was not pregnant and was not breastfeeding at the time of reporting. It was reported that patient had no symptoms associated with COVID-19 Lab data included ECG, blood tests, blood pressure and all were confirmed fine. 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: 1579369 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
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: Feeling abnormal, Headache, Pain, SARS-CoV-2 test
SMQs:, Dementia (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: NASONEX
Current Illness: Rhinitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Foggy feeling in head; Throbbing pain; Headache dull; This case was received via United Kingdom MHRA (Reference number: ADR 25758211) 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 FEELING ABNORMAL (Foggy feeling in head), PAIN (Throbbing pain) and HEADACHE (Headache dull) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Rhinitis. Concomitant products included MOMETASONE FUROATE (NASONEX) for Rhinitis. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced FEELING ABNORMAL (Foggy feeling in head) (seriousness criterion medically significant), PAIN (Throbbing pain) (seriousness criterion medically significant) and HEADACHE (Headache dull) (seriousness criterion medically significant). At the time of the report, FEELING ABNORMAL (Foggy feeling in head), PAIN (Throbbing pain) and HEADACHE (Headache dull) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the 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: 1579537 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea, Dysmenorrhoea, Hypomenorrhoea, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100991878

Write-up: intense short periods; intense short periods; Pain menstrual; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-RA-WEBCOVID-202108021100393320-DHRWE, Safety Report Unique Identifier GB-RA-ADR 25740092. A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on unspecified date (Lot number: FF3319) as second dose, single for COVID-19 immunization. Medical history included lactation decreased. The patient''s concomitant medications were not reported. The patient previously took bnt162b2 on unspecified date (Lot number: not reported) as first dose, single for COVID-19 immunization and experienced period was late. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and not currently breastfeeding. The patient experienced intense short periods (absence of menstruation) on an unspecified date with outcome of unknown. The patient experienced pain menstrual on 01Aug2021 with outcome of not recovered. The patient further reported intense short periods, usually 5 days long now only 2. The patient underwent lab tests and procedures which included covid-19 virus test: No - Negative COVID-19 test on 31Jul2021. 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: 1579538 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dyspnoea, Fatigue, Headache, Nausea, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100991894

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202108021102184850-N2Z2R; safety report unique identifier: GB-MHRA-ADR 25740100). A 33-year-old patient, of an unspecified gender, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# FE3380), at the age of 33, via an unspecified route of administration, on Aug 1, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test, and has not tested positive for COVID-19 since the vaccination. Patient not enrolled in a clinical trial. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# and expiry date unknown), on unspecified date, for COVID-19 immunisation. The patient experienced nausea on Aug 1, 2021. The patient also experienced painful arm, tiredness, headache, pain in ankle and shortness of breath; all on Aug 2, 2021. The outcome of the serious events (medically significant): not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1579547 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bone pain, Bone swelling, Limb discomfort, Lymph node pain, Lymphadenopathy, Myalgia, Pain in extremity, Presyncope, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Muscle pain
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100991902

Write-up: muscle pain; heavy arm; Near fainting; pain near collarbone; pain near collarbone and it started swelling; left arm ache; she can feel a walnut sized swollen gland on the left side of her neck which is extremely painful to touch; she can feel a walnut sized swollen gland on the left side of her neck which is extremely painful to touch; Swollen glands; 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-202108022123129010-VJ8EC, Safety Report Unique Identifier is GB-MHRA-ADR 25743821. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 (Lot/batch number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included muscle pain from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced muscle pain, heavy arm, near fainting, pain near collarbone, pain near collarbone and it started swelling, left arm ache and she can feel a walnut sized swollen gland on the left side of her neck which was extremely painful to touch on an unspecified date; swollen glands on 01Aug2021. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on unspecified date. The outcome of the event ''swollen glands'' was not recovered; events ''muscle pain'', ''heavy arm'' and ''near fainting'' was recovering; outcome of the other events was unknown. The clinical course was reported as follows: It started with a heavy arm and muscle pain near where the vaccine was administered to. Then pain near collarbone and it started swelling to the point where she can feel a walnut sized swollen gland on the left side of her neck which was extremely painful to touch. As well as swollen glands near her armpit which is makes her whole left arm ache. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional information: Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1579558 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Intermenstrual bleeding, Ovulation delayed, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 and Patient is not currently breastfeeding.
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: Ovulation is also delayed; Spotting between menses; This case was received via Agency Regulatory Authority (Reference number: ADR 25760313) 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 INTERMENSTRUAL BLEEDING (Spotting between menses) and OVULATION DELAYED (Ovulation is also delayed) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002621) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19 and Patient is not currently breastfeeding. The patient''s past medical history included Lactation decreased. On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced INTERMENSTRUAL BLEEDING (Spotting between menses) (seriousness criterion medically significant). On an unknown date, the patient experienced OVULATION DELAYED (Ovulation is also delayed) (seriousness criterion medically significant). At the time of the report, INTERMENSTRUAL BLEEDING (Spotting between menses) had not resolved and OVULATION DELAYED (Ovulation is also delayed) 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. Concomitant product use was not provided by the reporter. It was reported that following the vaccine patient period was 3 days late. It lasted 5 days as usual but it started brown spotting started 4 days after her period stopped. On Day 5 and there is no sign of it stopping. Patient ovulation is also delayed. Patient has not tested positive for COVID-19 since having the vaccine No treatment information was provided. Patient relevant investigations or tests were reported as None. Very limited information regarding this event/s has been provided at this time. No further information is expected; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. No further information is expected


VAERS ID: 1579650 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100991885

Write-up: Dizziness/Dizzy; 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-202108021028307450-2S4CM, Safety Report Unique Identifier: GB-MHRA-ADR 25739972. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 01Aug2021 (Lot number was not known) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced dizziness/dizzy on 01Aug2021. Clinical course reported: started being dizzy a few hours after the vaccine, on and off. Woke up the second day, still feeling really dizzy. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event was not recovered. Regulatory authority assessed the event as serious: medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1579674 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-08-01
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: SARS-CoV-2 test, Seizure, Tonic convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SILDENAFIL [SILDENAFIL CITRATE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210808; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101021454

Write-up: Tonic seizures; seizures; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108091346230570-P2TN5, Safety Report Unique Identifier GB-MHRA-ADR 25772172. A 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Aug2021 (Lot number was not reported) as single dose for COVID-19 immunization. Medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. No history of seizures. Concomitant medication included sildenafil citrate (SILDENAFIL) taken for vaccination from 08Aug2021. The patient experienced 3 seizures (2 before ambulance, 1 with ambulance crew) in Aug2021 (18hrs after vaccine). The patient also had tonic seizures on 09Aug2021. The events were considered serious (caused/prolonged hospitalization, life threatening). The COVID-19 virus test on 08Aug2021 was No - Negative COVID-19 test. Hospital still running tests. The outcome of seizures was not recovered, of tonic seizures was unknown. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1579790 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100997988

Write-up: abdominal pain, of high intensity; multiple episodes of vomiting; This is a spontaneous report from a non-contactable consumer. A 31-year-old female patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 02Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. In Aug2021, the patient experienced abdominal pain, of high intensity, and multiple episodes of vomiting; the patient was hospitalized for observation on an unspecified date in Aug2021 as a result of the events. The attending physician confirmed the clinical picture was a consequence of the vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about Batch/Lot number cannot be obtained. No further information is expected.


VAERS ID: 1579803 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FD0348 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Coma scale, Depressed level of consciousness, Heart rate, Nausea, Oxygen saturation, Respiratory rate increased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), 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: 20210801; Test Name: BP; Result Unstructured Data: Test Result:150/110; Test Date: 20210801; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210801; Test Name: consciousness Result Unstructured Data: Test Result:200; Test Date: 20210801; Test Name: HR; Result Unstructured Data: Test Result:50; Comments: per minute; Test Date: 20210801; Test Name: spo2; Test Result: 100 %
CDC Split Type: JPPFIZER INC202100986995

Write-up: Consciousness decreased; queasy; Respiratory rate increased; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21122073. A 64-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number: FD0348, Expiration date: 31Oct2021), via an unspecified route of administration on 01Aug2021 at 15:23 (the day of vaccination), at the age of 64 years old as dose 1, single for COVID-19 immunization. The patient had no family history. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status): History of loss of consciousness after influenza vaccination. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.3 degrees centigrade on 01Aug2021. The event onset date was reported as on 01Aug2021 at 16:05 (42 minutes after vaccination). The course of the event was as follows: During follow-up after vaccination, 23 minutes later after the vaccination, the events queasy and respiratory rate increased appeared. Consciousness decreased also appeared and the physician was called. On 01Aug2021, the patient''s blood pressure (BP) was 150/110, heart rate (HR) 50/min, oxygen saturation (SpO2) 100% and consciousness was 200. A route was secured with normal saline and symptom disappeared 5 minutes after starting steroids. On 01Aug2021 (the day of vaccination), the outcome of the event was recovered. The reporting physician classified the events as non-serious and assessed the causality between the event and BNT162B2 as unassessable. Other possible causes of the event such as any other diseases was that symptoms might be probably due to injection procedure (not component). No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: It may be a reaction of injection, not a component of the vaccine.


VAERS ID: 1579807 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 EY0573 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Fall, Loss of consciousness, Oxygen saturation, Pallor, Physical examination, Presyncope, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vagal reaction (at the time of blood collection several years before)
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: blood pressure; Result Unstructured Data: Test Result:156; Test Date: 20210801; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Date: 20210801; Test Name: SpO2; Test Result: 99 %; Test Date: 20210801; Test Name: examination of the patient; Result Unstructured Data: Test Result:face and body skin were nearly pallor; Comments: The face and body skin were nearly pallor.Last about 10 seconds
CDC Split Type: JPPFIZER INC202100987352

Write-up: Loss of consciousness; Convulsion; fall; blood pressure 156; vagal reflexes; face and body skin were nearly pallor; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122083. A 20-year-old male patient received BNT162B2 (COMIRNATY; Solution for injection, Lot number EY0573, Expiration date 30Sep2021), via an unspecified route of administration on 01Aug2021 at 13:39 (at the age of 20-year-old) (the day of vaccination), as dose 1, single for COVID-19 immunization. Medical history included vagal reflexes at the time of blood collection several years before. The patient''s concomitant medications were not reported. On 01Aug2021, body temperature before vaccination was 36.2 degrees Centigrade. The patient had no family history. On 01Aug2021 at 13:44 (5 minutes after the vaccination), the patient experienced Loss of consciousness, convulsion and had fall. On 01Aug2021, the patient experienced vagal reflexes, face and body skin were nearly pallor, blood pressure of 156. The course of the event was as follows: approximately five minutes after the vaccination, loss of consciousness occurred while the patient sitting in the waiting room, resulting in a fall on 01Aug2021 at 13:44. An examination of the patient was immediately started. The face and body skin were nearly pallor which lasted about 10 seconds. The patient had mild Convulsion of the hands and feet. However, verbal stimuli were continued and the patient regained consciousness. The convulsion recovered. When emergency rescue team arrived, the patient was able to have a conversation. The SpO2 99% and blood pressure 156 on 01Aug021. The patient was able to walk by being supported, and he was transported to hospital. On 01Aug2021 (the day of vaccination), the outcome of the Loss of consciousness and face and body skin were nearly pallor was recovered and for rest of the events the outcome was unknown. The reporting physician classified the event (Loss of consciousness, convulsion) as serious (Medically significant) and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Reviewing the course, it was difficult to consider that the patient had anaphylactic shock and the symptoms were considered as vagal reflexes. The patient experienced the same symptom at the time of blood collection several years before, therefore it was considered necessary to take measures at the time of the next vaccination


VAERS ID: 1579811 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100987603

Write-up: Neurally mediated syncope/syncope; dizziness; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122101. The patient was a 48-year and 0-month-old male. Body temperature before vaccination was unknown. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On an unknown date, the patient previously received the first dose of COVID-19 vaccine (Manufacturer unknown). On an unknown date, the patient received the second dose of COVID-19 vaccine (Manufacturer unknown). On 01Aug2021 at 03:00, the patient experienced neurally mediated syncope. On 01Aug2021, the outcome of the event was recovered. The course of the event was as follows: The patient slept and got up, when went to the restroom, he experienced dizziness and syncope. The reporting physician classified the event as non-serious and the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was physical deconditioning. Pfizer is a marketing authorization holder of COVID-19 vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Information on the lot/batch number has been requested.


VAERS ID: 1579820 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 EW0207 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure decreased, Blood pressure measurement, Body temperature, Confusional state, Gastrointestinal disorder, Loss of consciousness, Oxygen saturation, Pallor, Peripheral circulatory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad)

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, 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: 20210801; Test Name: blood pressure; Result Unstructured Data: Test Result:below 80; Comments: about 15:35 Blood pressure decreased; Test Date: 20210801; Test Name: blood pressure; Result Unstructured Data: Test Result:no result; Comments: after received BOSMIN 0.3mg twice: Blood pressure decreased; Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210801; Test Name: spO2; Test Result: 92 %; Comments: about 15:35
CDC Split Type: JPPFIZER INC202100988831

Write-up: Anaphylactic shock; Sudden loss of consciousness; Blood pressure decreased below 80/Blood pressure decreased again; Mild digestive symptom; Pallor facial; Twilight state; Mild peripheral circulatory failure; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21122154. A 21-year-old male patient received bnt162b2 (COMIRNATY),via an unspecified route of administration on 01Aug2021 15:30 (Batch/Lot Number: EW0207; Expiration Date: 30Sep2021) (at age 21-years-old) as dose 1, single for covid-19 immunisation. There were no medical history. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.6 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 01Aug2021 at 15:30(the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY). On 01Aug2021 at 15:35(5 minutes after the vaccination), the patient experienced Anaphylactic shock, Sudden loss of consciousness, Blood pressure decreased below 80/Blood pressure decreased again, Mild digestive symptom, Pallor facial, Twilight state, Mild peripheral circulatory failure. On 01Aug2021 (the days of vaccination), the patient was admitted to the hospital. On 02Aug2021 (1 day after the vaccination), the patient discharged from hospital. On 02Aug2021 (1 day after the vaccination), the outcome of the event was recovered.The course of the event was as follows: Symptoms appeared 5-10 minutes after vaccination and Sudden loss of consciousness. The patient experienced Blood pressure decreased below 80. (the heart rate was weak and can not be measured), Sp02 was 92%. There were no skin symptoms, no respiratory symptoms,and the patient experienced Mild digestive symptom. The patient experienced Pallor facial, Twilight state, Mild peripheral circulatory failure. After received BOSMIN 0.3mg twice, the symptoms became recovering, and the blood pressure decreased again one hour later,the patient received BOSMIN 0.3mg again, request an ambulance. The reporting physician classified the events as serious(Life-threatening/hospitalized) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: This was Anaphylactic shock caused by the vaccination. The patient received BOSMIN 0.3mg*3, Oxygen inhalation, intravenous drip(Solu-Cortef 100mg). The symptoms became recovering for a while, but because the blood pressure decreased again, request an ambulance.


VAERS ID: 1579824 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FE8206 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Choking sensation, Dyspnoea, Oropharyngeal discomfort, Vital signs measurement
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: Anaphylactic reaction; Cardiac catheter ablation
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Many kinds of vital signs; Result Unstructured Data: Test Result:normal
CDC Split Type: JPPFIZER INC202100993502

Write-up: Anaphylactic shock; Pharynx strange sensation of; Choking sensation in pharynx; mild Dyspnoea; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21119576. The patient was a 30-year and 4-month-old (age at the first vaccination) male.The patient had no family history. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included Anaphylaxis of bee''s, the patient was in status post cardiac catheter ablation. On 01Aug2021 (the day of first vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FE8206, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Aug2021 14:45 (the same day of first vaccination), the patient experienced Anaphylactic shock. On 01Aug2021 (the same day of first vaccination), the outcome of the event was recovered. The course of the event was as follows: About 12 minutes after the vaccination, Pharynx strange sensation of appeared. Many kinds of vital signs were normal, Choking sensation in pharynx and mild Dyspnoea appeared, considered about the patient''s history, Epipen 1A intramuscularly injected. After the intramuscular injection, Symptoms disappeared quickly. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. The reporting physician commented as follows: The patient had history of Anaphylaxis, please be careful, Can be judged as Contraindications.


VAERS ID: 1579870 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002540 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Feeling abnormal, Hyperthyroidism, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyperthyroidism (narrow), Vestibular disorders (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP071896

Write-up: Thyroid hyperfunction disorders; Sick feeling; Floating sensation; Lightheaded feeling; Queasy; This case, initially reported to the Regulatory authority by a physician, was received via the RA (Ref, v21122134). Thyroid hyperfunction disorders was assessed as serious by the Agency. On an unknown date, the patient received the 1st dose of the vaccine. On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 01-Aug-2021, at 09:30, the patient received the 2nd dose of the vaccine. While waiting in a sitting position after the vaccination, the patient experienced floating sensation (+) and queasy (+). 37 degrees Celsius, 142/84, and 99%. The patient rested in a supine position. Lightheaded feeling developed. At 10:33, the patient returned home. Finally, 110/89 and 82/min. The patient was considered to experience thyroid hyperfunction disorders. The outcome of queasy, sick feeling, floating sensation, lightheaded feeling, and thyroid hyperfunction disorders was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per assessment by Authority; Reporter''s Comments: Not reported.; Sender''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per assessment by Authority


VAERS ID: 1581964 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9096 / 1 RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Type of test was swab test); Seafood allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202100986394

Write-up: I am with my face all red and swollen/ I have redness, swelling and itching on my whole face/ Yesterday my face was swollen and red/ the face continues swollen; face all red and swollen/ I have redness, swelling and itching on my whole face/ the day before yesterday I started to have redness on my face, which passed at night/my face was swollen and red; I am with my face all red and swollen/ I have redness, swelling and itching on my whole face/ I had itchy all over my body; the face continues swollen and with rash; headache; This is a spontaneous report received via COVAES from a contactable Other HCP (patient). A 33-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration, administered in Arm Right on 30Jul2021 10:45 (at the age of 33 years old) (Batch/Lot number: FA9096) as dose 1, single for covid-19 immunisation. Medical history included Shrimp allergy, covid-19 (type of test was swab test). Patient didn''t receive any other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Patient didn''t receive any other medications/products within 2 weeks of vaccination (include prescribed medicines, store bought medicines, dietary supplements and herbal remedies). The patient''s concomitant medications were not reported. Adverse event information: Patient stated that "I received the Pfizer vaccine on the day 29Jul2021 and since Sunday I have been having reaction, I have redness, swelling and itching on my whole face and I would like to know what I should do". Adverse events start date was on 01Aug2021 at 09:00 PM. The adverse events didn''t result in any of the following (Doctor or other healthcare professional office/clinic visit / Emergency room/department or urgent care / Hospitalization / Prolongation of existing hospitalization (vaccine received during existing hospitalization) / Life threatening illness (immediate risk of death from the event) / Disability or permanent damage / Patient died / Congenital anomaly or birth defect). Upon follow-up on 03Aug2021, the patient stated that he was vaccinated on Friday and the day before yesterday he started to have redness on my face, which passed at night. Yesterday his face was swollen and red. The patient had itchy all over my body. He went to the hospital where it was applied corticoid (promethazine and hydrocortisone). The redness and the pruritus passed, but the face continues swollen and with rash. The physicians said that it could be reactions to the vaccine, but the expected that he had was only the headache. They never heard about in the other reactions. They passed him medications to use at home. The patient recovered from the event redness facial and pruritus generalized on an unspecified date. The outcome of the event headache was unknown while the outcome of other events was not recovered. Follow-up (03Aug2021): New information reported from a contactable Other HCP (patient) includes: reaction data (added events rash and headache), vaccine lot number and treatment information.


VAERS ID: 1582292 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: COVID-19 virus test; Result Unstructured Data: Positive
CDC Split Type: CHJNJFOC20210831389

Write-up: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION (1DAY OF FEVER, SMALL COLD, EXHAUSTION); This spontaneous report received from a patient via a company representative concerned a 3 decade old male of 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, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient was vaccinated on JUN-2021 but on AUG-2021, patient tested positive for covid-19 after travelling and experienced suspected clinical vaccination failure. The patient had a mild case of COVID-19 infection with 1 day of fever, small cold, exhaustion. Laboratory data included COVID-19 virus test the result was positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210831389- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure- This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. V0:20210831389 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- covid-19 infection -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: 1583206 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101007514

Write-up: Syncope; Abdominal pain; Nausea; This is a spontaneous report from a contactable other health professional via the regulatory authority. The Regulatory Authority number is 595841. A 19-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced syncope (medically significant) on 01Aug2021 with outcome of not recovered, abdominal pain (non-serious) on 01Aug2021 with outcome of not recovered, nausea (non-serious) on 01Aug2021 with outcome of not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1583487 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101036930

Write-up: This is a spontaneous report from a contactable other healthcare professional, via the regulatory authority (report number: 599432). A 52-year-old patient, of an unspecified gender, received BNT162B2 (Comirnaty, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. The patient experienced Bell''s palsy (Aug 1, 2021); with outcome of not recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1584609 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-01
   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 1F030A / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Diarrhoea, Fatigue, Nausea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: COVID-19 nasal swab test; Test Result: Negative
CDC Split Type: DEPFIZER INC202100991270

Write-up: circulatory fall; Fatigue; nausea; diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old non-pregnant female patient received the second dose of BNT162B2 (COMIRNATY solution for injection; lot number: 1F030A), via an unspecified route of administration on 29Jul2021 13:15 (at the age of 34-years-old) at dose 2, single in the right arm for COVID-19 immunisation. The patient''s medical history and concomitant medications were reported as none. The patient has no past drug reactions. Historical vaccine included the first dose of BNT162B2 (COMIRNATY; lot number: FD9234) received on 17Jun2021 11:15 (at the age of 34-years-old) in the left arm for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. On 01Aug2021 09:00, the patient experienced circulatory fall, fatigue, nausea, and diarrhea. No treatment was received for the events. The patient underwent COVID-19 nasal swab test on 31Jul2021 with negative result. Outcome of all the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1584842 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-08-01
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7959 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COSLAN [MEFENAMIC ACID]; PARACETAMOL ABAMED; EBASTEL FORTE FLAS; METAMIZOL ALTER; IBUPROFENO ALTER; BUSCAPINA; ALMAX FORTE; IBEROGAST
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101016285

Write-up: This is a spontaneous report received from a contactable consumer or other non-health care professional downloaded from the Regulatory Authority, regulatory authority number ES-AEMPS-964969. A 27-years-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FD7959), via an intramuscular route of administration, administered in Arm Left on 10Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included mefenamic acid (COSLAN [MEFENAMIC ACID]), paracetamol (PARACETAMOL ABAMED), ebastine (EBASTEL FORTE FLAS), metamizole magnesium (METAMIZOL ALTER), ibuprofen (IBUPROFENO ALTER), hyoscine butylbromide (BUSCAPINA), almagate (ALMAX FORTE), angelica archangelica root, carum carvi fruit, chelidonium majus herb, glycyrrhiza glabra root, iberis amara, matricaria recutita flower, melissa officinalis leaf, mentha x piperita leaf, silybum marianum fruit (IBEROGAST) taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant during the administration of the vaccine. She not passed Covid-19. The patient experienced menstrual hemorrhagia on 01Aug2021. The outcome of the event was reported as recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1584851 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   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 FC1435 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Echocardiogram, Electrocardiogram, Haemoglobin, Investigation, Myocarditis, N-terminal prohormone brain natriuretic peptide, Troponin C, Troponin T
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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVOCABASTINE; HYDROCHLOROTHIAZIDE; FUROSEMIDE; AMLODIPINE; LORATADINE; ALOPURINOL; MONTELUKAST; OLMESARTAN; SALBUTAMOL; RELVAR; FLUTICASONE FUROATE; DOXAZOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Essential hypertension; Hyperuricaemia; Seasonal asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:VI not dilated. without alterations of segmental; Comments: contractility, and FEVO visually estimated of 50%. Non-dilated RV with normal function. Transmitral pattern of impaired relaxation, mitral valve without evidence of regurgitation, no stenosis. Aortic valve without alterations. wave in mitral annulus by ITD 9 cm / s. ITV TSVI 15 cm. Absence of pericardial or pleural effusion; Test Date: 20210803; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:SR at 94 bpm, T peaked in V2, without other repola; Comments: SR at 94 bpm, T peaked in V2, without other repolarization alterations.; Test Date: 20210803; Test Name: Haemoglobin; Result Unstructured Data: Test Result:16.7 g/dl; Test Name: Killip IICP scan; Result Unstructured Data: Test Result:Coronary arteries without significant injuries; Test Name: proBNP; Result Unstructured Data: Test Result:normal; Test Date: 20210803; Test Name: Cardiac troponin C; Result Unstructured Data: Test Result:339 ng/L; Test Name: troponin T; Result Unstructured Data: Test Result:246 ng/L; Test Name: troponin T; Result Unstructured Data: Test Result:268 ng/L; Test Name: troponin T; Result Unstructured Data: Test Result:339 ng/L; Test Name: troponin T; Result Unstructured Data: Test Result:266 ng/L; Test Name: troponin T; Result Unstructured Data: Test Result:376 ng/L
CDC Split Type: ESPFIZER INC202101032017

Write-up: Acute myocarditis; This is a spontaneous report from a contactable physician downloaded from the RA [ES-AEMPS-967530]. A 34-year-old male patient received 2nd dose of BNT162b2 (COMIRNATY, lot FC1435) single dose on 30Jul2021 at left arm for COVID-19 immunisation. Medical history included Dyslipidaemia, Seasonal asthma, Essential hypertension in Cardiology follow-up, Hyperuricaemia. Concomitant drugs included levocabastine, hydrochlorothiazide, furosemide, Amlodipine, Loratadine, Allopurinol, Montelukast, Olmesartan, Salbutamol, fluticasone furoate, vilanterol trifenatate (RELVAR), Fluticasone Furoate, Doxazosin. Historical vaccine included 1st dose of BNT162b2 (COMIRNATY) on 09Jul2021 for COVID-19 immunisation. The patient experienced acute myocarditis on 01Aug2021. Seriousness criterion was hospitalization and life threatening. Clinical course: The patient with referred PAD who began on 01Aug2021 with intermittent, puncture-type chest pain, with sweating and general malaise, which worsened with ambulation and deep inspiration. ECG shows peaked T in V2 without other repolarization alterations. Serialization of myocardial damage enzymes was performed, observing progressive rise of them. Troponin T (high sensitivity) TnT 246 - 268 - 339.0 ng / L (vn 0.0 - 14.0). Electrocardiogram on 03Aug2021: SR at 94 bpm, T peaked in V2, without other repolarization alterations. Analytical Emergencies: Hb 16.7 g / dl, Cardiac troponin C: 339ng/L. TTE on 04Aug2021: LV not dilated. no alterations in segmental contractility, and a visually estimated FEVO of 50%. Non-dilated RV with normal function. Transmitral pattern of impaired relaxation, mitral valve without evidence of regurgitation, no stenosis. Aortic valve without alterations. wave in mitral annulus by ITD 9 cm / s. ITV TSVI 15 cm. Absence of pericardial or pleural effusion. Troponin T 266, yesterday 376, normal proBNP. To the Killip IICP scan that morning. Coronary arteries without significant injuries. The outcome of the event was resolving. No follow-up attempts possible. No further information expected.


VAERS ID: 1584853 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-08-01
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Aspartate aminotransferase, Blood chloride, Blood chromium, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood glucose, Blood lactate dehydrogenase, Blood sodium, Blood urea, Echocardiogram, Electrocardiogram, Haemoglobin, International normalised ratio, Magnetic resonance imaging heart, Myocardial necrosis marker, Myocarditis, N-terminal prohormone brain natriuretic peptide, Physical examination, Platelet count, Prothrombin level, Troponin T, White blood cell count
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? 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 Name: tpta; Result Unstructured Data: Test Result:29.2; Test Name: aspartate amino; Result Unstructured Data: Test Result:23.6; Test Name: cl; Result Unstructured Data: Test Result:103; Test Name: chromium; Result Unstructured Data: Test Result:0.92; Test Name: ck; Result Unstructured Data: Test Result:204; Test Name: ck-mb; Result Unstructured Data: Test Result:9.6; Test Name: glucose; Result Unstructured Data: Test Result:104; Test Name: ldh; Result Unstructured Data: Test Result:183; Test Name: na; Result Unstructured Data: Test Result:136; Test Name: urea; Result Unstructured Data: Test Result:30; Test Name: echocardiogram; Result Unstructured Data: Test Result:without relevant findings in cardiac MRI; Comments: edema and late enhancement in the lower middle, inferolateral and anterolateral segments compatible with acute myocarditis with normal biventricular systolic function.; Test Name: electrocard; Result Unstructured Data: Test Result:minimum changes in repolarization; Comments: minimum changes in repolarization on the lower face.; Test Name: electrocard; Result Unstructured Data: Test Result:rs 55 bpm, rr ''pattern with inverted t in v1. rest; Comments: rs 55 bpm, rr ''pattern with inverted t in v1. rest of axes and intervals within normality parameters.; Test Name: hb; Result Unstructured Data: Test Result:14.5; Test Name: inr; Result Unstructured Data: Test Result:7.06; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:non-dilated or hypertrophic left ventricle. light; Comments: non-dilated or hypertrophic left ventricle. light hypokinesia of the middle and apical segments of the lower, inferolateral and anterolateral faces. lvef 60%. right ventricle not dilated or hypertrophic. segmentary contractility and normal systolic function. normofunctioning valves. pericardium of normal characteristics. t2 stir: suggested transmural hyperintense area of edema in the lower, inferolateral and anterolateral middle segment that extends to the subepicardium of the basal anterolateral segment late enhancement: sub picardial uptake affecting approximately 50% of the myocardial thickness in the middle lower and inferolateral segment and that extends affecting 75% of the myocardial thickness of the middle anterolateral segment.; Test Name: myocardial damage enzymes; Result Unstructured Data: Test Result:increase in enzymes of myocardial damage; Test Name: myocardial damage enzymes; Result Unstructured Data: Test Result:show a decrease since admission; Comments: show a decrease since admission without signs or symptoms of heart failure; Test Name: probnp; Result Unstructured Data: Test Result:89; Comments: at entry 270, 12.1. 286 and 64.9 respectively; Test Name: physical examination; Result Unstructured Data: Test Result:beg, conscious and oriented in the three spheres.; Comments: beg, conscious and oriented in the three spheres. normohydrated, normocolored and well perfused. eupneic and february. symmetrical chest, without skin injuries. no signs of dysnea, no shooting. no cyanosis. palpation pain in the 3rd rib region. ac: regular rhythm. no ap: mvc blows or extratons hear without added noises.; Test Name: platelets; Result Unstructured Data: Test Result:204,000; Test Name: ap; Result Unstructured Data: Test Result:91; Comments: %; Test Name: cardiac troponin; Result Unstructured Data: Test Result:230; Test Name: leuc; Result Unstructured Data: Test Result:6700; Comments: pmn 54%
CDC Split Type: ESPFIZER INC202101032714

Write-up: Myopericarditis/ acute myocarditis; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Agency-WEB, regulatory authority number ES-AEMPS-968487. A 34-year-old male patient received the first dose of bnt162b2 (COMIRNATY) via intramuscular on 16Jul2021 (Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history was not reported. No interest or no allergies. Concomitant medications were not reported. The patient experienced myopericarditis (event reported as serious as hospitalization and life threatening) on 01Aug2021. It was reported that the patient went to the ER because yesterday he presented pressure in the chest with number of the left arm up to the elbow, accompanied by difficulty swallowing and neck pain that submitted spontaneously in about 1h and a fourth, not associated with effort. Today, about 10pm, it had presented a new, more intense episode which it had formed slightly but it continued with annoyance. it was not modified by movements. Referred slight respiratory difficulty with speaking fatigue. 1st dose of COVID COMIRNATY vaccine on 16Jul2021. On arrival at the emergency, electrocardiogram was performed with minimum changes in repolarization on the lower face. It was decided to admit the intensive care unit due to increase in enzymes of myocardial damage on arrival. Good evolution during stay in the unit, controlling the pain with conventional analgesia. The myocardial damage enzymes showed a decrease since admission without signs or symptoms of heart failure. Ecocadiogram was performed without relevant findings in cardiac MRI. Edema and late enhancement in the lower middle, inferolateral and anterolateral segments compatible with acute myocarditis with normal biventricular systolic function. Given the clinical stability, he was transferred to the conventional hospitalization floor. Physical examination: beg, conscious and oriented in the three spheres. normohydrated, normocolored and well perfused. eupneic and february. symmetrical chest, without skin injuries. no signs of dysnea, no shooting. no cyanosis. palpation pain in the 3rd rib region. ac: regular rhythm. no ap: mvc blows or extratons hear without added noises. to high normal scanning. Ecg: rs 55 bpm, rr ''pattern with inverted t in v1. rest of axes and intervals within normality parameters. Analytical: glucose 104, urea 30, cr 0.92, got (aspartate amino) 23.6, ldh 183, na 136, cl 103, ck 204, ck-mb 9.6, ctnt 230, probnp 89 (at entry 270, 12.1. 286 and 64.9 respectively), hb 14.5, leuc 6700 (pmn 54%), 204,000 platelets, ap 91%, inr 7.06, tpta 29.2. Cardiac MRI: non-dilated or hypertrophic left ventricle. light hypokinesia of the middle and apical segments of the lower, inferolateral and anterolateral faces. lvef 60%. right ventricle not dilated or hypertrophic, segmentary contractility and normal systolic function. normofunctioning valves. pericardium of normal characteristics. T2 stir: suggested transmural hyperintense area of edema in the lower, inferolateral and anterolateral middle segment that extends to the subepicardium of the basal anterolateral segment late enhancement: subepicardial uptake affecting approximately 50% of the myocardial thickness in the middle lower and inferolateral segment and that extends affecting 75% of the myocardial thickness of the middle anterolateral segment. Conclusion: study compatible with acute myocarditis. Normal biventricular function principal diagnosis: acute myopericarditis course: hemodynamically stable, the hospital was decided. Recommendations and treatment alta: - ibuprofen 600 mg every 8h 10 days if pain / - colchicine. 5 mg every 12 hours 3 months omeprazole 20 mg night while treating with ibuprofen. Review with ecocardiogram and control analytics in 1 month: - echocardiogram 01Sep2021 - review in the cardiology office of the team of dr. PRIVACY on 08Sep2021 at 1:15 pm. after an episode of myocarditis / myocadiocarditis was contraindicated to exercise for 6 months. Therapeutic measures were taken. Event outcome was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585228 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100991881

Write-up: Upper abdominal pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-APPCOVID-20210802181043, Safety Report Unique Identifier is GB-MHRA-ADR 25742710. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 (Lot number was not reported) as dose number unknown, single 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 upper abdominal pain on 01Aug2021. It was reported that patient had severe upper abdominal pain. The event was reported as serious (medically significant). Patient is not enrolled in clinical trial. The patient had 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: 1585230 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Pain in extremity, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210725; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101006083

Write-up: Tingling feet/hands; Fatigue; Pain in arm; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-APPCOVID-20210804080403, Safety Report Unique Identifier GB-MHRA-ADR 25751283. A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Fe3380), via an unspecified route of administration on 01Aug2021 (at the age of 31-year-old), as dose number unknown, single for COVID-19 immunization. The patient''s medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient was not pregnant at the time of vaccination. Patient was not currently breastfeeding and was not enrolled in clinical trial. Concomitant medications were not reported. On 01Aug2021, after vaccination, the patient experienced pain in arm. On 02Aug2021, 1 day after vaccination, the patient experienced fatigue. On 03Aug2021, 2 days after vaccination, the patient experienced tingling feet/hands. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative, on 25Jul2021. The clinical outcome of event tingling feet/hands was reported as not resolved. The clinical outcome of all other events was reported as resolving. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585245 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Monoplegia, Vaccination site rash, Vaccination site swelling
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Vaccination site rash; Vaccination site swelling; Paralysis arm; This case was received via RA (Reference number: 25740361) 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 MONOPLEGIA (Paralysis arm) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Aug-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced MONOPLEGIA (Paralysis arm) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, MONOPLEGIA (Paralysis arm), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown. Concomitant products were not provided. Treatment medication were 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 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: 1585291 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   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: Axillary pain, Lymphadenopathy, Pain, Tenderness
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 INC202100992425

Write-up: pain; Swollen lymph nodes/ one or two small lumps around my collarbone/neck area; Left armpit pain/ sore to touch; tenderness around the left side of my collarbone/ sore to touch; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). Regulatory authority report number [GB-MHRA-WEBCOVID-202108020755582340-OF7H8], Safety Report Unique Identifier [GB-MHRA-ADR 25739256]. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 30Jul2021 (Lot Number: FF3319) as single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient had not symptoms associated with COVID-19 or had not a COVID-19 test. Patient was not pregnant or was not currently breastfeeding. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for COVID-19 immunization. Concomitant medications were not reported. The patient experienced pain on an unspecified date, swollen lymph nodes on 01Aug2021, left armpit pain on 01Aug2021, tenderness on 01Aug2021. Events reported as serious as medically significant. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of event pain was recovering, of event swollen lymph nodes was not recovered, remains events was unknown. The clinical course was reported as follows: I woke up on 01Aug2021 and noticed I had pain in my left armpit and tenderness around the left side of my collarbone, which is the side I had my vaccine. Later on that evening, around 9pm, I felt one or two small lumps around my collarbone/neck area. They are still there now (8am, 02Aug2021) and are sore to touch. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585292 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-01
   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 FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Fatigue, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992000

Write-up: Fever chills; Abdominal pain; Nauseous; Tired out; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108020803436900-RKTAX. Safety Report Unique Identifier GB-MHRA-ADR 25739297. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jul2021 (Batch/Lot Number: FF3319) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for Covid-19 immunisation. The patient experienced fever chills, abdominal pain, nauseous and tired out on 01Aug2021. The events were reported as serious (other medically important condition). The clinical course was reported as follows: came on quite suddenly 55 hours after vaccination. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of abdominal pain and nauseous was not recovered while the outcome of fever chills and tired out was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585298 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 PE3380 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Flatulence, Inappropriate schedule of product administration, Insomnia, Irritable bowel syndrome, Lymph node pain, Lymphadenopathy, Musculoskeletal chest pain, Renal pain, SARS-CoV-2 test
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLEXANE; ESTRADOT; METFORMIN; PROGESTERONE; SERETIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic; In vitro fertilization; Lactation decreased; Comments: ~~~
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992314

Write-up: gastrointestinal discomfort; feeling of tenderness around kidneys & thoracic region; feeling of tenderness around kidneys & thoracic region; unusual amount of gas; Swollen glands; Very painful lymph glands; Gastrointestinal upset; Insomnia; exacerbated IBS symptoms; Patient received dose 1 of BNT162B2 on 25May2021 and dose 2 on 01Aug2021; This is a spontaneous report from a contactable consumer. This is a report received from The regulatory authority report number is GB-MHRA-WEBCOVID-202108020909559420-S5ODR, safety report unique identifier is GB-MHRA-ADR 25739570. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 01Aug2021, at the age of 43 years old, (Lot Number: PE3380) as dose 2, single COVID-19 immunisation. Medical history included lactation decreased, in vitro fertilisation from an unknown date and unknown if ongoing. Asthmatic (since childhood), use Seretide and Ventolin IVF treatments over the last 7 years. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medications included enoxaparin sodium (CLEXANE) taken for in vitro fertilisation from 01Jun2021 to 22Jul2021; estradiol (ESTRADOT) taken for in vitro fertilisation from 21Jun2021 to 22Jul2021; metformin taken for in vitro fertilisation from 29May2021 to 22Jul2021; progesterone taken for in vitro fertilisation from 08Jul2021 to 22Jul2021; fluticasone propionate, salmeterol xinafoate (SERETIDE) taken for asthma from 01Jan2013 to an unspecified stop date. The patient previously took dose 1 of bnt162b2 on 25May2021 (lot number EW3143) for Covid-19 immunisation. On 01Aug2021, the patient experienced gastrointestinal discomfort, feeling of severe tenderness around kidneys & thoracic region, unusual amount of gas, swollen glands, gastrointestinal upset, insomnia, very painful lymph glands. The outcome of the events swollen glands, very painful lymph glands, gastrointestinal upset, insomnia was not recovered while other events was unknown. The patient underwent lab tests and procedures which included Covid-19 virus test: No - Negative COVID-19 test, on 30Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. The events were assessed as serious and medically significant by regulatory authority. The clinical course was reported as follows: Very painful and visibly swollen lymph glands under left arm (vaccine given in left arm). Gastrointestinal discomfort and exacerbated IBS symptoms - feeling of severe tenderness around kidneys & thoracic region as well as unusual amount of gas. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585305 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Confusional state, Dental paraesthesia, Eye movement disorder, Face injury, Feeling abnormal, Hypoaesthesia, Hypopnoea, Musculoskeletal stiffness, Pain, Paraesthesia, Paraesthesia oral, Vaccination site movement impairment
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Ocular motility disorders (narrow), Arthritis (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992117

Write-up: Left side of mouth and teeth and cheek feel numb; Cant lift my left arm; pain in left arm pit; Eyes cant catch up with my movements; tingly/Tingling lips; Teeth tingly; Pins and needles; Face injury; Shallow breathing; Spaced out; Confused; Pain; Stiffness; This is a spontaneous report from a contactable consumer received from a regulatory authority. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 31Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased 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 and not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient received dose 1 of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced left side of mouth and teeth and cheek feel numb on an unspecified date with outcome of unknown, cant lift my left arm on an unspecified date with outcome of unknown, pain in left arm pit on an unspecified date with outcome of unknown and eyes cant catch up with my movements an unspecified date with outcome of unknown, tingly/tingling lips, on an unspecified date with outcome of recovering, teeth tingly on an unspecified date with outcome of recovering, shallow breathing on 01Aug2021 with outcome of not recovered, spaced out on 01Aug2021 with outcome of not recovered, confused on 01Aug2021 with outcome of not recovered, pain on 01Aug2021 with outcome of not recovered, stiffness on 01Aug2021 with outcome of not recovered, pins and needles on 02Aug2021 with outcome of not recovered, face injury 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. Additional Information: Pins and needles and face tingling all in the left side. My jab was in left arm. Left side of mouth and teeth and cheek feel numb and tingly. Cant lift my left arm. A lot of pain in left arm pit. Feel spcaed out like walking on air. Eyes cant catch up with my movements. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1585310 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Abdominal pain, Arthralgia, Fatigue, Headache, Inappropriate schedule of product administration, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL; PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Lactation decreased; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992009

Write-up: Aching joints; Tiredness; Nausea; Belly ache; Headache; Patient received dose 1 of BNT162B2 on 18Jun2021 and dose 2 on 01Aug2021; Pain in arm; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021028132300-SRGIU. A 20-years-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, via an unspecified route of administration on 01Aug2021 (lot number: not known), at the age of 20-years-old, as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased, pain and anxiety from an unknown date and unknown if ongoing. Patient is not enrolled in clinical trial. Concomitant medication included paracetamol taken for pain from 02Aug2021 to an unspecified stop date; propranolol taken for anxiety from 09Mar2017 to an unspecified stop date. The patient received the dose 1 of BNT162B2 (lot number: not known), via an unspecified route of administration on 18Jun2021 for COVID-19 immunisation. On 01Aug2021, the patient experienced pain in arm. On 02Aug2021, the patient also experienced aching joints, tiredness, nausea, belly ache and headache. Outcome of the events was 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. No further information is expected.


VAERS ID: 1585312 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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, Headache, Myalgia, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LUCETTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992061

Write-up: Chills; Fever; Headache; Muscle ache; Painful arm; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021031187940-LTCBB, Safety Report Unique Identifier: GB-MHRA-ADR 25740008. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 01Aug2021 (Lot Number: FE3380) as dose 2, single for COVID-19 immunisation. Medical history included contraception. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Concomitant medication included drospirenone, ethinylestradiol (LUCETTE) taken for contraception. The patient experienced chills, fever, headache, muscle ache, and painful arm on 01Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of all events was not recovered. Regulatory authority assessed the events as serious: medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585314 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 FD8813 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 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 INC202100992485

Write-up: Enlarged lymph nodes (excl infective); 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-202108021041266660-G2NTC, Safety Report Unique Identifier GB-MHRA-ADR 25740053. A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31Jul2021 (Batch/Lot Number: Fd8813) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included lactation decreased from an unknown date. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced enlarged lymph nodes (excl infective) on 01Aug2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient was waiting for doctor. The patient underwent lab tests and procedures which included sars-cov-2 test: negative, No - Negative COVID-19 test on an unspecified date. The outcome of the event was not resolved. The event was reported as serious due to medially significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585334 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   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 NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Body temperature, Body temperature increased, Dizziness, Dyspepsia, Lymphadenopathy, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:high temp at 39.4; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992329

Write-up: dizziness; swollen glands/swollen glands in neck; stomach pain; swelling under armpit; burning stomach pain; Body temperature increased/high temp at 39.4; This is a spontaneous report from a contactable consumer. This is a report received from the Medicines Healthcare Products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202108021222207940-XS9UO, Safety Report Unique Identifier GB-MHRA-ADR 25740654. A 30-year-old female patient second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number not known; expiration date not provided), via an unspecified route of administration on 30Jul2021 as DOSE 2, SINGLE for COVID-19 immunisation. Patient''s medical history included lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced ''dizziness'', ''swollen glands/swollen glands in neck'', ''stomach pain'', ''swelling under armpit'', and ''burning stomach pain'' on unspecified dates; ''body temperature increased/high temp of 39.4'' on 01Aug2021. Patient''s clinical course is as follows: It was reported that the patient had high temp of 39.4, swelling under armpit, swollen glands in neck, burning stomach pain, and had inability to do day to day tasks. The events were assessed as serious (medically significant). The 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 with result of ''negative; No- Negative COVID-19 test'' and temperature with result of ''high temp at 39.4'' on unspecified dates. Outcome of the event ''body temperature increased/high temp of 39.4'' was not recovered; outcome of the remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1585349 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-08-01
   Days after vaccination:30
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: Menstrual disorder, 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: Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992361

Write-up: Disorder menstrual; pain; This is a spontaneous report from a contactable consumer received from the The regulatory authority report number is GB-MHRA-WEBCOVID-202108021341267780-XMSKD and Safety Report Unique Identifier is GB-MHRA-ADR 25741156. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Jul2021 (batch/lot number was not reported) as single dose for covid-19 immunisation. Medical history included hypothyroid. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced pain in 2021 with outcome of unknown, disorder menstrual on 01Aug2021 with outcome of not recovered. First period after vaccine late, patient had incredibly heavy and with severe pain. The case was reported as serious (medically significant). Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585365 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-01
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, Fatigue, Feeling abnormal, Headache
SMQs:, Dementia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992368

Write-up: Fatigue; Chills; hour/spaced out; approx/headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108021501089220-7ASAE, Safety Report Unique Identifier GB-MHRA-ADR 25741623. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Aug2021 (at the age of 32-year-old) as single dose for COVID-19 immunisation. Medical history included suspected COVID-19 from 19Mar2020 to 26Mar2020. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date for COVID-19 immunisation. The patient experienced hour/spaced out and approx/headache on an unspecified date in Aug2021 with outcome of recovering, fatigue and chills on 02Aug2021 with outcome of recovering, all reported as medically significant. Clinical course reported as follow: Started to get fatigue and chills approx 1 hour after injection. seems a bit quick. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585372 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Fatigue, Headache, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100991888

Write-up: Head pain; Tiredness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108021519496540-6Q2OV, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25741762. A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (at the age of 37 year old) (Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased and depression. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication included escitalopram taken for depression from 13Sep2014 to an unspecified stop date. The patient experienced tiredness on 01Aug2021 and head pain on 02Aug2021. The outcome of the events was not recovered. The events were medically significant. The patient underwent lab tests and procedures which included Negative COVID-19 test on an unspecified date. 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: 1585373 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of personal independence in daily activities, Lymph node pain, Lymphadenopathy
SMQs:, Dementia (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 INC202100991998

Write-up: Enlarged and extremely painful lymphnodes on the neck and armpit; Limiting ability to perform every day tasks; Enlarged lymph nodes (excl infective); This is a spontaneous report from a contactable consumer received from the United Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108021520192230-4L8LB, Safety Report Unique Identifier GB-MHRA-ADR 25741749. A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 31Jul2021 (Lot Number: FD8813) as second dose, single for COVID-19 immunisation. Medical history included lactation decreased. The patient''s concomitant medications were reported as none; not taking any medication. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not pregnant and not currently breastfeeding. On 01Aug2021, the patient experienced enlarged lymph nodes (excel infective). The patient further reported enlarged and extremely painful lymph nodes on the neck and armpit, same side as the injection side, limiting ability to perform everyday tasks (unspecified date). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the event enlarged lymph nodes (excl infective) was not recovered, however end date of 01Aug2021 was reported. Outcome of all the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585376 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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: Illness, Myalgia, Nausea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992175

Write-up: nauseous; Aching muscles; Sickness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021530210280-UUDQZ, Safety Report Unique Identifier: GB-MHRA-ADR 25741790. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31Jul2021 (Lot number was not known) as dose 2, single for COVID-19 immunisation. Medical history included depression. Patient has not had symptoms associated with COVID-19. Concomitant medication included citalopram taken for depression. The patient experienced nauseous and aching muscles on an unspecified date; and sickness on 01Aug2021. 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: no - negative COVID-19 test on an unspecified date. The outcome of the event sickness was not recovered; and for other events was unknown. Regulatory authority assessed the events as serious: medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1585377 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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: Lymph node pain, Lymphadenopathy, Pain
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 INC202100992266

Write-up: pain; Swollen lymph nodes/swollen under the armpit-very sore to touch and causing pain; Swollen lymph nodes/swollen under the armpit; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202108021543117560-W9EOL], Safety Report Unique Identifier [GB-MHRA-ADR 25741817]. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, in arm on 31Jul2021 (Lot number: not reported) as second dose, single for COVID-19 immunisation. Medical history included lactation decreased. The patient has not had symptoms associated with COVID-19 and not had a covid-19 test. Patient is not pregnant and not currently breastfeeding. The patient''s concomitant medications were not reported. On unspecified date, the patient experienced pain . On 01Aug2021, the patient experienced swollen lymph nodes/swollen under the armpit. The patient further reported swollen under the armpit - very sore to touch and causing pain. Same arm as the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the event swollen lymph nodes was not recovered. Outcome of all the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585399 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Maternal exposure during pregnancy, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100992446

Write-up: Stomach cramps; Nausea; Diarrhea; Maternal exposure during pregnancy/Patient was exposed to the medicine Third-trimester (29-40 weeks); This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108021705322830-WXCKQ, Safety Report Unique Identifier GB-MHRA-ADR 25742338. A 21-year-old female patient received First dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 at 21-year-old (Lot Number: FE3380) as dose 1, single for COVID immunization. Medical history included Lactation decreased, ongoing pregnancy, Folic acid supplementation. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for Folic acid supplementation. The patient experienced maternal exposure during pregnancy/patient was exposed to the medicine third-trimester (29-40 weeks) on 01Aug2021, stomach cramps on 02Aug2021, nausea on 02Aug2021, diarrhea on 02Aug2021. The events were medical significant. The mother reported she was pregnant while taking bnt162b2. The patient underwent lab tests and procedures which included negative COVID-19 virus test on 02Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient was exposed to the medicine Third trimester (29-40 weeks). Outcome of events stomach cramps, nausea and diarrhea were not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585405 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenopia, Headache, Pain in extremity, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Corneal disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992267

Write-up: Drowsiness; Headache; Eye strain; Pain in arm; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108021739087500-GVOMK, safety report unique identifier is GB-MHRA-ADR 25742513. A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date were not reported), via an unspecified route of administration on 01Aug2021 (at the age of 27-years) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Thus, 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 01Aug2021 with outcome of recovering. The patient also experienced drowsiness, headache, and eye strain, all on 02Aug2021 with outcome of not recovered. The events were considered serious, medically significant. No follow-up attempts are possible, information about lot number cannot be obtained.


VAERS ID: 1585409 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Lymph node pain, Lymphadenopathy, SARS-CoV-2 test, Sleep disorder
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: IBUPROFEN
Current Illness: Swollen lymph nodes
Preexisting Conditions: Comments: I have taken ibuprofen for the swollen lymph nodes I have referred to in the adverse effects after having the vaccine. Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992250

Write-up: Painful enough to disturb sleep; Chills; The lymph node under the arm pit closest to where the vaccine was administered is swollen and painful.; swollen lymph nodes/the lymph node under the arm pit closest to where the vaccine was administered is swollen and painful; This is a spontaneous report from a contactable consumer. This is a report received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA).Regulatory authority report number is GB-MHRA-WEBCOVID-202108021844141790-VJFP4. Safety Report Unique Identifier: GB-MHRA-ADR 25742915. A 32-year-old male patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Batch/Lot Number: FE1510; expiration date not provided), via an unspecified route of administration on 31Jul2021 as DOSE 2, SINGLE for COVID-19 immunization. Patient''s medical history included swollen lymph nodes from 01Aug2021 and ongoing. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included ibuprofen from 01Aug2021 and unknown if ongoing for swollen lymph nodes. The patient experienced ''swollen lymph nodes/the lymph node under the arm pit closest to where the vaccine was administered is swollen and painful'' and ''the lymph node under the arm pit closest to where the vaccine was administered is swollen and painful'' on 01Aug2021; chills on 02Aug2021; ''painful enough to disturb sleep on an unspecified date. Patient''s clinical course is as follows: The lymph node under the arm pit closest to where the vaccine was administered is swollen and painful. Painful enough to disturb sleep. It is ongoing as it stands currently (02Aug2021 at 18:45). Chills were in the early hours of the 2nd august and lasted approximately 3 hours. It was reported that the patient took ibuprofen for the swollen lymph nodes he has referred to in the adverse effects after having the vaccine. The events were assessed as serious (medically significant). The 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 with result of ''negative; No - Negative COVID-19 test'' on an unspecified date. Outcome of the event chills was recovered on 02Aug2021; outcome of the remaining events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585417 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Hot flush, Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Nausea, Peripheral swelling, SARS-CoV-2 test
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 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 INC202100992370

Write-up: hot flushes; redness around injection site; Swelling and redness around injection site; injection site nausea; Swollen arm; Muscle pain; Headache; Hot flush; Muscle ache; Nausea; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021954293130-JG0DT, Safety Report Unique Identifier GB-MHRA-ADR 25743284. A 21-year-old female patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 01Aug2021 (Lot number was not reported) (at the age of 21 year old) as Dose 1, single 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 experienced hot flushes on an unspecified date with outcome of not recovered, injection site nausea on an unspecified date with outcome of not recovered, redness around injection site on an unspecified date with outcome of not recovered, swollen arm on 01Aug2021 with outcome of not recovered, muscle pain on 01Aug2021 with outcome of not recovered, headache on 01Aug2021 with outcome of not recovered, hot flush on 01Aug2021 with outcome of unknown, muscle ache on 01Aug2021 with outcome of not recovered, nausea on 01Aug2021 with outcome of recovered , swelling and redness around injection site on an unspecified date with outcome of unknown. Muscle pain and ache received treatment. The events were serious due to medically significant and disabling. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test). Detail information was reported as: Muscle pain and ache is severe, cant lift, stretch, use or lay on arm which vaccine was injected into. Even Paracetamol doesn''t ease pain. Hot flushes come sporadically, Headache randomly within day, Swelling and redness around injection site. Nausea about an hour after vaccine received. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. No follow-up attempts are needed, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1585423 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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, Lymphadenopathy, Mass, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992319

Write-up: Swollen lymph nodes; Pain in arm; Tender lump formed above collarbone; Pain runs from armpit to collarbone area; Pain runs from armpit to collarbone area; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108022046041430-NPL3S, Safety Report Unique Identifier GB-MHRA-ADR 25743548. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 (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 is not pregnant and is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced swollen lymph nodes on 02Aug2021, pain in arm on 01Aug2021, tender lump formed above collarbone and pain runs from armpit to collarbone area on 2021. 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 an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the swollen lymph nodes and pain in arm was not recovered while of the remaining events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585430 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FB8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Nasopharyngitis, 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: AMOXICILLIN; LORATADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Toothache
Allergies:
Diagnostic Lab Data: Test Date: 20210725; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992310

Write-up: Cold; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108022125352690-2JHUS. Safety Report Unique Identifier (GB-MHRA-ADR 25743812). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (Batch/Lot Number: FB8813) (at the age of 30-years-old) as dose 2, single for COVID-19 immunisation. Medical history included toothache from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medications included amoxicillin taken for toothache from Jul2021 to Jul2021. loratadine taken for an unspecified indication, start and stop date were not reported. The patient experienced cold on 01Aug2021. The events were 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 25Jul2021. The outcome of cold was recovering however it was also reported that the stop date of this event was on "02Aug2021". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585433 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Arthralgia, Fatigue, Limb discomfort, Musculoskeletal stiffness, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100992440

Write-up: Nausea; Joint ache; Tiredness; Neck stiff; Arm discomfort; This is a spontaneous report from a contactable consumer received from the regulatory authority, report number is GB-MHRA-WEBCOVID-202108022202406470-TUIHM, Safety Report Unique Identifier GB-MHRA-ADR 25744006. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) on 01Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, Patient is not enrolled in clinical trial. The patient experienced nausea, joint ache, tiredness, neck stiff on 02Aug2021 with outcome of not recovered, arm discomfort on 01Aug2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1585437 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 PE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Dizziness, Headache, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (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: FEXOFENADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100991974

Write-up: Dizziness; Diarrhea; Fever; Nausea; Headache; Muscle ache; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108022246095110-NVQPJ, Safety Report Unique Identifier GB-MHRA-ADR 25744084. A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: PE3380; expiration date not provided), via an unspecified route of administration on 01Aug2021 (at the age of 22-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included lactation decreased and allergy both from unspecified dates and unknown if ongoing. 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. Concomitant medication included fexofenadine from an unspecified date and unknown if ongoing for allergy. The patient experienced nausea and headache on 01Aug2021; dizziness, diarrhea, and fever on 02Aug2021; muscle ache on an unspecified date in Aug2021. The events were assessed as serious (medically significant). The patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event fever was recovering; outcome of the remaining events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585442 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Asthenia, Dizziness, Fatigue, Headache, Migraine, Pain in extremity, SARS-CoV-2 test, Somnolence, Speech disorder
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Migraine
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100991937

Write-up: Drowsiness; Migraine/getting worse constantly; Dizziness; inability to speak due to lack of energy; inability to speak due to lack of energy; headache; tiredness; achy arm; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108022332372880-GNPK6, Safety Report Unique Identifier GB-MHRA-ADR 25744106. A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Aug2021 (Lot number was not reported) as second dose, single for COVID-19 immunisation. Medical history included migraine, lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and not currently breastfeeding. The patient''s concomitant medications were not reported. On 02Aug2021, the patient experienced drowsiness, migraine and dizziness. On unspecified date in Aug2021, the patient experienced headache, tiredness, achy arm, and inability to speak due to lack of energy. The patient further described started out as a headache, achy arm and tiredness. Evolved to a migraine which is getting worse constantly and to dizzy spells, drowsiness and inability to speak due to lack of energy. 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: No-negative COVID-19 test on unspecified date. Outcome of the events headache, tiredness, achy arm was recovering. Outcome of the events drowsiness, migraine and dizziness was not recovered. Outcome of all the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585443 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-08-01
   Days after vaccination:71
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Dysmenorrhoea, Feeding disorder, Feeling of body temperature change, Gait inability, Influenza, Menstruation delayed, Menstruation irregular, Nasopharyngitis, Pain, Paraesthesia oral, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100991935

Write-up: flu; tingly; cold; pain; unable to eat; Late period; Period pains; my abdomen has been solid and bloated; unable to walk; throwing up; felt hot and cold; My next period did not come until beginning of August; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory authority report number [GB-MHRA-WEBCOVID-202108022333149180-AARSO], Safety Report Unique Identifier [GB-MHRA-ADR 25744107]. A female patient of unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 22May2021 (Lot/batch number was not known) as dose number unknown, single for COVID-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. On an unspecified date, the patient experienced flu, tingly, cold, pain, unable to eat, late period, period pains, abdomen has been solid and bloated, unable to walk, throwing up and felt hot and cold. Her next period did not come until beginning of Aug2021. The events were assessed as serious (medically significant). Therapeutic measures were taken as a result of period pains. The outcome of the event ''late period'' was recovering; events ''her next period did not come until beginning of august'', ''abdomen has been solid and bloated'', ''unable to walk'', ''throwing up'' and ''felt hot and cold'' as unknown; and outcome of the other events was not recovered. The clinical course was reported as follows: Patient had one period the first week of June after her vaccine which was a lot more painful than it had ever been but was mostly manageable with pain killers. Her next period did not come until beginning of August, it had her rolling around on the floor in pain, throwing up, unable to walk, abdomen has been solid and bloated, has been unable to eat, get comfortable, have felt hot and cold, skin and bones have felt like they do when you have the flu (achey and tingly). Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional information: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1585476 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, SARS-CoV-2 test, Vaccination site swelling
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (Fostair Inhaler two puffs twice a day); Lactation decreased; Steroid therapy (Taking regular steroid treatment (orally or rectally))
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998635

Write-up: swollen armpit gland; Swollen vaccine site; This is a spontaneous report from a contactable consumer received from the Regulatory Authority; report number is GB-MHRA-WEBCOVID-202108032159486040-AYUUG, Safety Report Unique Identifier is GB-MHRA-ADR 25750347. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 (Lot Number: FD8813, Expiry date not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included suppressed lactation, asthma (Fostair Inhaler two puffs twice a day), and steroid therapy (taking regular steroid treatment (orally or rectally)). Concomitant medications were not reported. The patient previously took beclometasone dipropionate, formoterol fumarate (FOSTAIR). bnt162b2 for covid-19 immunisation. 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 swollen armpit gland on an unspecified date with outcome of unknown, and swollen vaccine site on 01Aug2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Aug2021 No - Negative COVID-19 test. The events were reported as serious, medically significant by the health authority. Narrative case summary and further information: Swollen armpit gland - same arm vaccine was given. Swollen vaccine site also. 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: 1585615 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Dizziness, Headache, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Nausea, Pain, 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), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CYCLIZINE; FOLIC ACID; CITALOPRAM HYDROBROMIDE
Current Illness: Pregnancy (Estimated due date: 20220113)
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Hyperemesis
Allergies:
Diagnostic Lab Data: Test Date: 20201219; 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 INC202100992039

Write-up: Headache; Ache; Fever; Dizzy spells; Nauseous; Maternal exposure during pregnancy; first dose on 06Jun2021, second dose on 01Aug2021; This is a solicited report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-YCVM-202106061353267670-AQU6X. Safety Report Unique Identifier GB-MHRA-ADR 25742703. This is a maternal report. A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation at age of 31 years old. Medical history included ongoing pregnancy, estimated due date: 13Jan2022, hyperemesis from 12May2021, and folic acid supplementation. Patient last menstrual period date was 08Apr2021. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medications included cyclizine taken for hyperemesis from 12May2021 to an unspecified stop date; folic acid taken for folic acid supplementation, start and stop date were not reported; citalopram hydrobromide taken for an unspecified indication from 05Jun2020 to an unspecified stop date. Historical vaccine included the first dose of BNT162B2 via an unspecified route of administration on 06Jun2021 (Batch/Lot Number: EW3143) for COVID-19 immunisation. The patient experienced maternal exposure during pregnancy on 01Aug2021 with outcome of unknown, fever on 01Aug2021 with outcome of resolved on 02Aug2021, ache on 02Aug2021 with outcome of not recovered, headache on 02Aug2021 with outcome of not recovered, nauseous on 01Aug2021 with outcome of recovering, dizzy spells on 01Aug2021 with outcome of not recovered. The case was serious per medically significant. The mother reported she became pregnant while taking PFIZER-BIONTECH COVID-19 VACCINE. The mother was 16 Weeks pregnant at the onset of the event. Patient was exposed to the vaccine Second-trimester (13-28 weeks). The mother was due to deliver on 13Jan2022. Patient did not think vaccination had an adverse effect on any aspect of the pregnancy. Details of scans or investigations: All fine. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 19Dec2020. Patient has not tested positive for COVID-19 since having the vaccine. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible, information about 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 Maternal exposure during pregnancy, Pyrexia, Pain, Headache, Nausea, and Dizziness and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1585616 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 20Feb2022)
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100984679

Write-up: Tiredness; Maternal exposure during pregnancy; This is a solicited report from the RA from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202108020639168420-KBATD, Safety Report Unique Identifier is GB-MHRA-ADR 25739019. A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (Lot number was not reported) (at the age of 31-year-old) as single dose for COVID-19 vaccination. Medical history included ongoing pregnancy and estimated due date reported as 20Feb2022, suspected covid-19 from 29Mar2020 (no information whether ongoing) and unsure when symptoms stopped. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient last menstrual period date on 11May2021. The patient experienced maternal exposure during pregnancy on 01Aug2021, tiredness on 01Aug2021. The mother reported she became pregnant while taking BNT162B2. The mother was 11 Weeks pregnant at the onset of the event. The mother was due to deliver reported as on 20Feb2022. The case was reported as serious due to other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test Negative COVID-19 test on 20Jul2021. Patient is not enrolled in clinical trial. The outcome of the event tiredness was recovered on 01Aug2021. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Sender''s Comments: Based on the close temporal association there is possibility of causal association between the event fatigue and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, as appropriate.


VAERS ID: 1585617 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Maternal exposure during pregnancy, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy (Estimated due date: 26Jan2022); Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992508

Write-up: Maternal exposure during pregnancy; Nausea; This is a solilcited case from the RA from a contactable contactable physician. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202108021108523410-VJD4O, Safety Report Unique Identifier GB-MHRA-ADR 25740173. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 at age of 30 years old (Lot number was not reported) as dose 2, single for COVID-19 vaccination. Medical history included ongoing pregnancy (Estimated due date: 26Jan2022), suspected COVID-19 from 01Aug2021 and ongoing. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced maternal exposure during pregnancy on an unspecified date with outcome of unknown, nausea (medically significant) on 01Aug2021 with outcome of not recovered. The patient underwent lab tests and procedures which included no - negative covid-19 test on an unknown date. 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 the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event nausea and the suspect drug BNT162B2.


VAERS ID: 1585631 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Inappropriate schedule of product administration, Lymphadenopathy, Neck pain, Pain in extremity, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101006268

Write-up: neck on the left side (same side as injection site) has swollen up and was tender to touch and move; neck on the left side (same side as injection site) has swollen up and was tender to touch and move; Arm was also still sore from injection site up to lymph nodes on neck; Swollen lymph nodes; first dose on 02Jun2021, second dose on 01Aug2021; ThThis is a spontaneous report from a contactable consumer (patient). This is the second of two reports. The first report is a report received from The regulatory authority report number is GB-MHRA-WEBCOVID-202108022248008040-UHZRN. Safety Report Unique Identifier is GB-MHRA-ADR 25744088 . A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (Lot number was not reported) as dose 2, single 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. Historical vaccine included first dose of BNT162B2 on 02Jun2021 for COVID-19 immunisation and patient had shivers, irritable and irritable bowel. The patient''s concomitant medications were not reported. The patient experienced swollen lymph nodes on 02Aug2021. The event seriousness criteria was medically significant. The patient reported swollen lymph nodes suddenly came on one day after receiving second vaccine. Her neck on the left side (same side as injection site) has swollen up and was tender to touch and move. Arm was also still sore from injection site up to lymph nodes on neck. 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 04Jul2021. Patient is not enrolled in clinical trial. The outcome of event swollen lymph nodes was not recovered; of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100991964 Same patient/drug, different dose/event


VAERS ID: 1585635 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 FE338U / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Inappropriate schedule of product administration, Lymphadenopathy, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101006904

Write-up: Painful when bringing arm close to the body; Dose 2 on 31Jul2021 outside the range of 19-42 days; Swollen lymph nodes; breathlessness; Tight chest; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202108032151310140-39GA4, Safety Report Unique Identifier GB-MHRA-ADR 25750337. A 27-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FE338U), dose 2 via an unspecified route of administration on 31Jul2021 as DOSE 2, SINGLE for covid-19 immunization. Patient was not pregnant at time of vaccination. Patient was not currently breastfeeding. Medical history included suppressed lactation. Concomitant medications were not reported. Patient has not had symptoms associated with covid-19. Not had a covid-19 test. Patient was not enrolled in clinical trial. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number-FA5843) on 29May2021 for covid-19 immunization and experienced adverse events (heavy periods, fatigue, pain). On 01Aug2021, the patient experienced breathlessness and tight chest. On 02Aug2021, the patient experienced swollen lymph nodes. On unspecified date, the patient experienced painful when bringing arm close to the body. It was stated that tight chest day after vaccine dose 2, normal daily activities caused breathlessness, eased up when resting. Mostly uncomfortable. Swollen lymph node in underarm where jab given. Painful when bringing arm close to the body. Patient has not tested positive for covid-19 since having the vaccine. The events were serious (medically significant). Treatment was received for event swollen lymph nodes. Outcome of the event tight chest was recovered on 02Aug2021. Outcome of the event swollen lymph nodes was recovered on 03Aug2021. Outcome of the event breathlessness was recovered on unspecified date in 2021. Outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100998582 Same reporter/patient/drug and different dose/event


VAERS ID: 1586007 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-01
   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 UNKNOWN / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Electric shock sensation, Fatigue, Feeling abnormal, Head discomfort, Headache, Hypersomnia, Malaise, Mental impairment, Vertigo
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Telfast
Current Illness: Environmental allergies, sneezing
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None. GP recommended paracetamol/ibuprofen.
CDC Split Type:

Write-up: Brain fog, dizziness/vertigo, full feeling in head, buzzing sensation in head, headaches (generally mild). Feel concussed, unable to think or function and generally unwell. Feel constantly tired and need to lie down/sleep.


VAERS ID: 1586141 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FF3622 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Heart rate, Loss of consciousness, Oxygen saturation, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

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: Diabetes mellitus (sometimes take Insulin orally for Diabetes mellitus)
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: blood pressure; Result Unstructured Data: Test Result:68/39 mmHg; Test Date: 20210801; Test Name: blood pressure; Result Unstructured Data: Test Result:94/72 mmHg; Test Date: 20210801; Test Name: blood pressure; Result Unstructured Data: Test Result:117/58 mmHg; Comments: at 12:15; Test Date: 20210801; Test Name: pulse rate; Result Unstructured Data: Test Result:74; Test Date: 20210801; Test Name: pulse rate; Result Unstructured Data: Test Result:81; Test Date: 20210801; Test Name: pulse rate; Result Unstructured Data: Test Result:80; Comments: at 12:15; Test Date: 20210801; Test Name: SpO2; Test Result: 99 %; Comments: at 12:15
CDC Split Type: JPPFIZER INC202100986831

Write-up: Temporary loss of consciousness/stand but didn''t move with eyes open and no reaction to people; blood pressure decreased/blood pressure was 68/39 mmHg; Vasovagal reflex; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21119584. The patient was a 69-year and 10-month-old female. 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) sometimes take Insulin orally for Diabetes mellitus. The patient received BNT162B2 (COMIRNATY; Lot Number: FF3622; Expiration Date: 30Nov2021), via an unspecified route of administration on 01Aug2021 11:20 (at the age of 69-years-old) as dose 2, single for COVID-19 immunization. The patient''s concomitant medications were not reported. On 01Aug2021 at about 11:20 (the day of the vaccination), the patient experienced Vasovagal reflex. The course of the event was as follows: During the interview, the patient could understand and answer the questions and didn''t complaint about physical condition. Soon after the vaccination, the patient stands but didn''t move with eyes open and no reaction to people. Letting the patient sit down, the patient''s blood pressure was 68/39 mmHg and pulse rate was 74 times/minute. About 2 minutes later, the patient could react to people and said the patient''s own name, admitting consciousness level was recovering. It was considered as Temporary loss of consciousness and Vasovagal reflex caused by decreased blood pressure. In the First Aid Room, the patient was made to drink water and observed about 30 minutes later, blood pressure was 94/72 mmHg and pulse rate was 81 times/minute, considering blood pressure was recovering. Since then, symptoms were not aggravated, didn''t complaint about physical condition, could communicate very well, so it was possible to go home. 1 hours later after vaccination, the patient went home with family. At 12:15 VS (Vital Signs) were B.P 117/58 mmHg, HR 80, SpO2 99%, communication OK, going home after the physician''s confirmation. On 01Aug2021 (the day of the vaccination), the outcome of the events was recovered. The reporting physician classified the event as non-serious and the causality between the event and BNT162B2 as unassessable. Other possible cause(s) of the event such as any other diseases was none/unknown (as reported).


VAERS ID: 1586153 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 EY0573 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Dysphoria, Heart rate, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Depression (excl suicide and self injury) (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contrast media allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: BP; Result Unstructured Data: Test Result: 77/52 mmHg; Comments: 9:00; Test Date: 20210801; Test Name: BP; Result Unstructured Data: Test Result: 94/67 mmHg; Comments: 9:15; Test Date: 20210801; Test Name: BP; Result Unstructured Data: Test Result: 119/86 mmHg; Comments: 9:57; Test Date: 20210801; Test Name: body temperature; Result Unstructured Data: Test Result: 36.4 Centigrade; Comments: before vaccination; Test Date: 20210801; Test Name: P; Result Unstructured Data: Test Result: 63; Comments: 9:00; Test Date: 20210801; Test Name: P; Result Unstructured Data: Test Result: 58; Comments: 9:15; Test Date: 20210801; Test Name: P; Result Unstructured Data: Test Result: 56; Comments: 9:57; Test Date: 20210801; Test Name: SpO2; Test Result: 95%; Comments: 9:00; Test Date: 20210801; Test Name: SpO2; Test Result: 99%; Comments: 9:15; Test Date: 20210801; Test Name: SpO2; Test Result: 98%; Comments: 9:57.
CDC Split Type: JPPFIZER INC202100987892

Write-up: Anaphylaxis; Dysphoria; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21122152. A 62-year and 6-month-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Aug2021 08:50 (Batch/Lot Number: EY0573; Expiration Date: 30Sep2021) (at the age of 62-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Body temperature before vaccination was 36.4 degrees centigrade. Medical history included contrast media allergy. The patient''s concomitant medications were not reported. On 01Aug2021 at 09:00, the patient experienced anaphylaxis. The course of the event was as follows On 01Aug2021 at 08:50 (the day of vaccination), the patient received first dose of Pfizer vaccine. After that dysphoria appeared. On 01Aug2021 at 09:00 (10 minutes after the vaccination), BP77/52, SpO2 95, P63, gave O2 2L/min. On 01Aug2021 at 09:15 (25 minutes after the vaccination), BP 94/67, SpO2 99, P58. On 01Aug2021 at 09:57 (1 hour and 7 minutes after the vaccination), BP 119/86, SpO2 98 (RA), P56. After that the patient walked home. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Anaphylaxis recovering quickly. On 01Aug2021, the patient recovered from the events.


VAERS ID: 1586166 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: 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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100993489

Write-up: difficulty breathing; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A 28-year-old patient of an unspecified gender received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on 01Aug2021 (Batch/lot number unknown), at age 28 years old, as dose 1, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient previously took oseltamivir phosphate (TAMIFLU) and experienced drug eruption. Historical vaccine included influenza vaccine received on an unspecified date for immunization and the patient had adverse reactions. The patient had experience of adverse reactions to influenza vaccine and TAMIFLU with drug eruption. On 01Aug2021, about 17:00 (after the vaccination), the patient complained of difficulty breathing during observation after vaccination. At about 18:30, SOLU-MEDROL was administered, and the patient was admitted to the hospital on 01Aug2021. The patient was discharged from hospital the next day on 02Aug2021. The outcome of event was unknown. The seriousness was not provided. The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1586191 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure decreased, Blood pressure measurement, Body temperature, Coma scale, Depressed level of consciousness, Dysphoria, Gaze palsy, Musculoskeletal stiffness, Seizure
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vasovagal reaction
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Blood pressure; Result Unstructured Data: Test Result:70s; Test Date: 20210801; Test Name: Blood pressure; Result Unstructured Data: Test Result:98; Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination.; Test Date: 20210801; Test Name: JCS; Result Unstructured Data: Test Result:1
CDC Split Type: JPPFIZER INC202100994613

Write-up: Seizure; Mild consciousness clouding; Consciousness disturbed; Eyeballs rolling upward; Blood pressure decreased; Dysphoria; Left hand stiffness; This is a spontaneous report from a contactable physician received from the The patient was a 39-year and 10-month-old male. Body temperature before vaccination was 36.9 degrees Centigrade. Information on the patient''s family history was unknown. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 01Aug2021 at 15:23 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) at the age of 39-year-old via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Aug2021 at 15:38 (the day of vaccination), the patient experienced blood pressure decreased, seizure. On 01Aug2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was as follows: 15 minutes after the first dose of vaccination, the patient complained of dysphoria, moved to a wheelchair and was found to have eyeballs rolling upward, left hand stiffness, and mild consciousness clouding. (A few seconds) first vital signs measurement showed a blood pressure of 70s and fluid replacement started with peripheral route secured. Consciousness disturbed (JCS 1 approximately), dysphoria. Sent to the hospital for emergency treatment after the blood pressure recovered to 98. There was no rash nor SpO2 decreased. The reporting physician classified the event as serious (likely lead to disability) and assessed that the event was related to bnt162b2. About other possible causes of the event such as any other diseases the reporter reported that although there is also a possibility of vasovagal reflex, it was anyway a symptom caused by vaccination. The reporting physician commented as follows: It is a symptom shortly after vaccination, the relation with vaccination cannot be denied.


VAERS ID: 1586192 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 EW0201 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Headache, Heart rate, Nausea, Oxygen saturation, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Medical History/Concurrent Conditions: Migraine; Primary cerebellar degeneration
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: BP; Result Unstructured Data: Test Result:138/82 mmHg; Comments: at 13:13; Test Date: 20210801; Test Name: BP; Result Unstructured Data: Test Result:125/90 mmHg; Comments: at 13:32; Test Date: 20210801; Test Name: BP; Result Unstructured Data: Test Result:160/100 mmHg; Comments: at 13:37; Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210801; Test Name: P; Result Unstructured Data: Test Result:60; Comments: Times/min, at 13:13; Test Date: 20210801; Test Name: P; Result Unstructured Data: Test Result:62; Comments: Times/min, at 13:32; Test Date: 20210801; Test Name: SpO2; Test Result: 98 %; Comments: at 13:13; Test Date: 20210801; Test Name: SpO2; Test Result: 98 %; Comments: at 13:32
CDC Split Type: JPPFIZER INC202100994902

Write-up: blood pressure increased (BP: 160/100 mmHg); Headache; vomiting; queasy; This is a spontaneous report from a contactable physician received from the Regulatory Authority. A 52-year and 7-month-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Aug2021 12:38 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) at the same age, as dose 1, single for covid-19 immunisation. Body temperature before vaccination was 36.5 degrees Centigrade. The patient had underlying disease included spinocerebellar degeneration and migraine. On 01Aug2021 at around 13:00 (the day of vaccination), the patient experienced headache and vomiting. The course of the event was as follows: At around 13:00, the patient complained of headache and had bed rest. At about 13:13, BP 138/82 mmHg, P 60 times/min, SpO2 98%. At 13:15, the patient complained of queasy and vomiting later. Observation conducted. Around 13:32, BP 125/90 mmHg, P 62 times/min, SpO2 98%. Headache recovering. At about 13:37, the patient took a sitting position, BP: 160/100 mmHg, and was in a wheelchair, without complaint of symptoms. The outcome of the event was recovered on 01Aug2021. The reporting physician classified the event as non-serious and did not provide the causality assessment. The reporting physician commented as follows: The patient had underlying disease included migraine. Headache, blood pressure increased, and vomiting after vaccination. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: The patient had underlying disease included migraine. Headache, blood pressure increased, and vomiting after vaccination.


VAERS ID: 1586296 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Asthenia, Body temperature, Bronchospasm, Cough, Dizziness, Dyspnoea, Laryngeal discomfort, Nausea, Respiratory distress, Respiratory rate, Tachypnoea, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol allergy; Allergy to plants; Asthma; Depression; Diabetes mellitus; Dizziness; Drug allergy; Spinal stenosis
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: body temperature; Result Unstructured Data: Test Result:36 Centigrade; Comments: before vaccination; Test Date: 20210801; Test Name: Respiratory rate; Result Unstructured Data: Test Result:30; Comments: times/min
CDC Split Type: JPPFIZER INC202100996229

Write-up: queasy; dizziness aggravated; Anaphylaxis; weakness; dyspnoea; wheezing/bilateral wheezing(Bronchospasm); cough; Respiratory distress; Tachypnoea 30 times/ minute; Pharyngolaryngeal/oral strange sensation; bronchial spasm; This is a spontaneous report from a contactable other healthcare professional received from a Regulatory Authority. Regulatory authority report number is v21122324. A 54-year-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date unknown), via an unspecified route of administration, on 01Aug2021 16:20 (the day of vaccination, at the age of 54 years), as Dose 1 single, for COVID-19 immunisation. Body temperature before vaccination was 36 degrees Centigrade, on 01Aug2021. Medical history include asthma, diabetes mellitus, depression, spinal stenosis, and dizziness from an unknown date and unknown if ongoing. Patient had Allergy history with alcohol, tetracyclic antidepressants, and plants. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient has no disease that was in treatment when received vaccination. The patient has no symptoms before vaccination. The patient''s concomitant medications were not reported. On 01Aug2021 (the day of vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 01Aug2021 at about 16:20, the patient received the vaccine. At 16:30, patient had weakness, dyspnoea, and wheezing/ Bilateral wheezing (Bronchial spasm), cough, respiratory distress, Tachypnoea 30 times/ minute, Pharyngolaryngeal/oral strange sensation and bronchial spasm appeared. At 16:50 (30 minutes after the vaccination), the patient diagnosed with anaphylaxis and treated with EPIPEN, Solu-Medrol 40mg, POLARAMINE 1A, and required for emergency. At 16:55, queasy and dizziness aggravated. When emergency arrive, the respiratory symptoms tended to recover, but the patient was admitted to the hospital for process observing purpose. After that, no aggravation. Table for anaphylaxis: Diagnosis: anaphylaxis: Symptoms (5 minutes after vaccination): Bilateral wheezing (Bronchial spasm); Respiratory distress (Tachypnoea 30 times/ minute, increased use of auxiliary respiratory muscles); Dyspnoea without wheezing or stridor; Pharyngolaryngeal/oral strange sensation/itching; Cough; Weakness. Therapeutic measures taken with Adrenaline, Antihistamine, Steroid, oxygen, and Spiriva Inhalation for the reported events. On 03Aug2021 (2 days after the vaccination), the outcome of the events was recovered, and the patient was discharged. The reporting other HCP classified the event as serious (Hospitalized from 01Aug2021 to 03Aug2021) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. Comment: POLARAMINE 1A and Solu-Medrol 40mg IV. EPIPEN 0.3mg. Respiratory symptoms recovering due to IM. As cough was continuing, the patient was admitted to the hospital for process observing purpose from 01Aug2021 to 03Aug2021. No follow-up attempts are possible, information about batch number cannot be obtained.


VAERS ID: 1586297 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 EW0201 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Allergy to vaccine, Auscultation, Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation, Pruritus
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contrast media allergy; Diabetes mellitus; Hypertension; Sarcoidosis
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Chest auscultation; Result Unstructured Data: Test Result:no abnormal; Test Date: 20210801; Test Name: BP; Result Unstructured Data: Test Result:160/98; Test Date: 20210801; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination; Test Date: 20210801; Test Name: HR; Result Unstructured Data: Test Result:78; Test Date: 20210801; Test Name: SpO2; Test Result: 96 %; Comments: RA
CDC Split Type: JPPFIZER INC202100996298

Write-up: Allergy to vaccine; BP 160/98; Itching in the precordium and back; This is a spontaneous report from a contactable physician received from the Regulatory Authority. A 50-year and 9-month-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EW0201; Expiration Date: 30Sep2021), via an unspecified route of administration on 01Aug2021 14:52 (at the age of 50-year and 9-month-old) at single dose, for covid-19 immunisation. Medical history included diabetes mellitus, hypertension, sarcoidosis, allergic to iodine contrast media and gadolinium contrast media. The patient had no special family history. The patient''s concomitant medications were not reported. The patient experienced BP (blood pressure) 160/98 on 01Aug2021 15:00, itching in the precordium and back on 01Aug2021 15:00, and allergy to vaccine on an unspecified date. Event onset date was 01Aug2021 at 15:00 (8 minutes after the vaccination). The course of the event was as follows: Around 10 minutes after the vaccination, the patient experienced itching in the precordium and back. BP was 160/98, HR (heart rate) was 78, SpO2 (Oxygen saturation) was 96% (RA), no abnormal by chest auscultation, no skin eruption. After a total of 30 minutes of observation, condition of the patient had not deteriorated, so the patient returned home. The patient brought fexofenadine hydrochloride (ALLEGRA) 60mg back. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was unable to conclude that was an allergy to vaccine, considered it was possible. Other lab tests and procedures which included body temperature before vaccination was 36.0 degrees Centigrade. On 01Aug2021 (the day of vaccination), the outcome of the event was recovering.


VAERS ID: 1586300 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FF4204 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Cold sweat, Dizziness, Dysphoria, Dysstasia, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Interstitial pneumonia; Large intestine carcinoma (treated with anti-cancer drug)
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: blood pressure; Result Unstructured Data: Test Result:88/; Test Date: 20210801; Test Name: blood pressure; Result Unstructured Data: Test Result:130/; Test Date: 20210801; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100996519

Write-up: Dysphoria; Giddiness; could not stand up; vasovagal reflex?; significant cold sweat on face; blood pressure 88/; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21122334. A 81-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 01Aug2021 11:07 (Lot Number: FF4204; Expiration Date: 31Oct2021) (at age 81-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Body temperature before vaccination was 36.4 degrees Centigrade. Medical history included interstitial pneumonia, large intestine carcinoma treated with anti-cancer drug. The concomitant medication included anti-cancer drug. On 01Aug2021 at 11:07, the patient experienced vasovagal reflex (as reported) with outcome of recovering. 15 minutes after the second dose (there was no problem when first dose) at 01Aug2021 11:22, the patient was going to stood up to toilet, dysphoria and giddiness appeared and could not stand up. Then the patient was moved to Emergency room by a wheelchair. By the physician, there was significant cold sweat on face, blood pressure 88/. Consciousness was normal and able to respond. IV treatment of 500ml was given. During the elevation of the lower extremities, 15 minutes, cold sweat improved, blood pressure also improved by 130/. Since had underlying disease, the patient was transported by ambulance, under observation. On 01Aug2021, the outcome of the events was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was the patient was treated with anti-cancer drug for large intestine carcinoma.


VAERS ID: 1586314 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FF4204 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Amaurosis fugax, Arthralgia, Body temperature, Cold sweat, Constipation, Fall, Hypoaesthesia, Joint swelling, Myofascial pain syndrome, Product administered at inappropriate site, Pyrexia, Somnolence, Suicide threat, Vision blurred
SMQs:, Peripheral neuropathy (broad), Suicide/self-injury (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Calculus urinary (Hospitalization for 1 day to crush the stones)
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:40 Centigrade; Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:39.2 Centigrade; Test Date: 202108; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: JPPFIZER INC202100997856

Write-up: Left a suicide note on his cell phone; Pyrexia of about 40 degrees centigrade/39.2 C; Numbness middle finger, little finger, and index finger/Both hands were numb/Numbness below both knees, under calves, ankles and near toes; Was about to fall/fall; Cold sweat; Seemed like vision was blurred; Fell asleep; All the joints were swollen and painful; All the joints were swollen and painful; It was pitch black; Vaccine administered at inappropriate site; Pain around the medulla oblongata; Not being able to go to the bathroom; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male received BNT162b2 (COMIRNATY, Solution for injection, Lot number FF4204, Expiration date 31Oct2021), via an unspecified route of administration, injection in the left shoulder, on 01Aug2021 at 15:28 (also reported as 15:58), at the age of 56 years old, as 2nd single dose, for COVID-19 immunization. Historical vaccine included the 1st single dose of BNT162b2 on 11Jul2021 (Lot number FA5765, Expiration date 30Sep2021). Medical history included calculus ureteric requiring hospitalization for 1 day to crush the stones and treatment with unspecified IV drip, drinking water and kabu (the patient slept until the crushed stones came out and felt like going to the bathroom many times). Other than that, the patient had never had a major illness. The patient had been a healthy child since he was little. Never missed school due to illness. The patient had never been seriously injured. The patient concomitant drugs were not provided. On 01Aug2021, when the patient received the BNT162b2 injection in the left shoulder, at that moment numbness appeared on the middle finger, little finger, and index finger. When pressing it, the entire left hand was numb. He added that after pulling out the needle, he was about to fall, so he ''put power on his lower abdomen'' (as reported) and walked to stay in place and went to the waiting area with a cool face as like nothing had happened. He was having a lot of cold sweat while waiting for 15 minutes in the waiting area. It seemed like vision was blurred, he closed his eyes and when he re-opened his eyes, it was pitch black despite the room being bright. The patient went to the bathroom and was in agony alone. The patient did not want to be seen by anyone while in pain. The patient didn''t want to fall down and show weaknesses in public, so he went home as if nothing had happened. When the patient got home, he fell asleep. From midnight to dawn, the patient had a pyrexia of about 40 degrees centigrade. The whole body was already in trouble. All the joints were swollen and painful, and the left and right hands were numb and unable to move. Both hands were numb. There was numbness below both knees, under calves, ankles and near toes. There was pain no matter where the patient moved the joint, the patient was helpless. The patient thought there was nothing he could do. Despite the numb hands, the patient was able to call an ambulance while making mistaken calls several times. Before calling the ambulance, the patient''s body temperature was around 40 degrees centigrade and when the patient measured his body temperature in the ambulance, it was 39.2 degrees centigrade (uncertain). His normal temperature was about 36 degrees centigrade. The patient never had such a high pyrexia. The patient had never had a major illness. On 02Aug2021, the following day, at about 11:00, the patient called an ambulance. Actually, the hospital started at 9am, and the patient wanted to go to the nearest family doctor and see a doctor. The patient was not in a state that he could not stand up. Afterwards he left a suicide note on his cell phone, and the patient had an ambulance crew putting him in an ambulance. There was a hospital in that area that had a well-known doctor, so the patient thought it would have been nice if they could take him to one of those hospitals. The patient was lucky to be transported to his first-choice hospital. There, the patient was told that he could not be hospitalized and he was prescribed with acetaminophen (CALONAL 200) 15 times, and the patient took all the prescribed Calonal in hopes. The patient did not want to show weaknesses in public and returned home on his own. The patient opened the front door, but could not enter the room and had a fall. The patient felt like going to die from heat stroke, he felt like crawling forward. The patient managed to enter the room and turn on the air conditioner with the remote control. The patient thought he was about to die. The patient added that there was no pain and itching when he received the first dose, nothing had happened, and he thought that was because the injection had been administered in what he thought being the correct position. While the second shot was received in the shoulder and during the injection the patient felt uncomfortable as previously described. He added that according to him there was a young nurse in her twenties who injected the vaccine casually at inappropriate site when the doctor was not looking. At the time of the reporting, pyrexia had gone down, but it was still around 38 degrees centigrade. The patient drank a lot of water, sports drinks, barley tea, etc. The patient continued to have pain around the medulla oblongata, about the neck and base of head. The patient continued to have the air conditioner with the room temperature at about 25 degrees centigrade, and at that temperature he was not sweating anymore. The hardest thing was not being able to go to the bathroom. The patient drank a lot of water. The patient was recovering from pyrexia, had not recovered from pain around the medulla oblongata and constipation, and had recovered from sweating and pitch black vision. The outcome of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1586315 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 EW0203 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Dysphonia, Nausea, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic shock (After ate shrimp, allergic shock occurred. Steroid and antiallergic drug were injected.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100999548

Write-up: Anaphylaxis; Nausea; itchy sensation in the throat; Phonation difficulty; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122395. A 43-year and 3-month-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection), via intramuscular route on 01Aug2021 09:50 (at the age of 43 years old) (the day of vaccination) (Batch/Lot Number: EW0203; Expiration Date: 30Sep2021) as dose 1, single for COVID-19 immunization. There were points to be considered on the vaccine screening questionnaire: medical history included after ate shrimp, allergic shock occurred. Steroid and antiallergic drug were injected. The patient concomitant medications were not reported. On 01Aug2021 at 09:55 (5 minutes after the vaccination), the patient experienced Anaphylaxis. The course of the event was as follows: at 09:50, the patient received the vaccination. At 09:55 nausea, phonation difficulty and itchy sensation in the throat occurred. POLARAMINE 1 tablet and BETASELEMIN 1 tablet for these symptoms. At 10:12, the patient received 200 ml SOLDEM and 200 mg Solu-Cortef injection. The itchy sensation in the throat was improved. At 12:15, after iv drip, the symptoms improved. The skin symptoms, circulation symptoms and digestive organ symptoms was not appeared. Therapeutic measures were taken as a result of events. The reporting physician classified the events as non-serious and assessed that the events was related to bnt162b2. There was no possible cause of the events such as any other diseases. The outcome of the events was resolved on 01Aug2021. The reporter commented as follows: Mild allergic symptoms appeared and improved after steroid injection. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1586318 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Altered state of consciousness, Blood pressure decreased, Body temperature, Heart rate decreased, Presyncope, Seizure
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202100999562

Write-up: convulsion; Consciousness disturbed; Pulse rate decreased; Blood pressure decreased; Vasovagal reflex; This is a spontaneous report from a contactable other HCP received from the Regulatory authority. Regulatory authority report number is v21123132. A 32-year and 6-month-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Aug2021 11:40 (Lot Number: EY0583; Expiration Date: 31Oct2021) as single dose (at the age of 32-year and 6-month-old) for covid-19 immunisation. Body temperature before vaccination was 36.6 degrees Centigrade. Medical history was none. The patient''s concomitant medications were not reported. The patient underwent lab tests and procedures which included body temperature: 36.6 centigrade on 01Aug2021 before the vaccination. On 01Aug2021 at 11:40 (the same time of vaccination) (as reported), the patient experienced vasovagal reflex. 10 minutes after the vaccination (as reported), pulse rate decreased, blood pressure decreased, consciousness disturbed, and convulsion appeared. The patient was placed under observation with a drip infusion (of normal saline 500 mL) for 30 minutes, but the symptoms did not improve. The patient was emergently transferred to hospital. On 01Aug2021 (the day of the vaccination), the outcome of the event was recovering. The reporting other HCP classified the event as serious (Medically significant) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1588706 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
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: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210832459

Write-up: OCCURRENCE OF A CENTRAL PULMONARY EMBOLISM WITH RIDING THROMBUS; This spontaneous report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines, DE-PEI-202100163967] concerned a 52 year old male of unspecified race and ethnicity. The patient''s weight was 96 kilograms, and height was 189 centimeters. Concomitant diseases included no relevant, nicotine abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported expiry: unknown) 1 dosage forms, frequency one total, administered on 16-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 01-AUG-2021, the patient experienced occurrence of a central pulmonary embolism with riding thrombus, and was hospitalized (date unspecified). The patient had treatment for pulmonary embolism that included implementation of local lysis therapy, and full anticoagulation. The duration of hospitalization was not reported. Laboratory data included diagnosis of PE on 01-AUG-2021 and increase D-dimers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from occurrence of a central pulmonary embolism with riding thrombus. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210832459-Covid-19 vaccine ad26.cov2.s-Occurrence of a central pulmonary embolism with riding thrombus.. 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: 1588957 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination site mass, Vaccination site reaction
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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: 964991) 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 VACCINATION SITE MASS and VACCINATION SITE REACTION in a 34-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced VACCINATION SITE MASS (seriousness criterion medically significant) and VACCINATION SITE REACTION (seriousness criterion medically significant). At the time of the report, VACCINATION SITE MASS and VACCINATION SITE REACTION had not resolved. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. 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: 1589130 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-08-01
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Decreased appetite, Eye disorder, Fatigue, Headache, Hyperhidrosis, Inappropriate schedule of product administration, Lacrimation increased, Ocular hyperaemia, Oral infection, Pain, Rash, Seborrhoea, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal infections (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Lacrimal disorders (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENTOLIN [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (human hair); Asthma (mild); COVID-19; Desensitisation injection (13 years old); House dust mite allergy; Menopause (9 years ago without ANY effects)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998700

Write-up: Sweating; Greasy hair; Chest pain; Ache; Rash; Oral infection; Headache; Eyes red; Watering eyes; Eye abnormality; Exhaustion; Vaccination site pain; Appetite lost; first dose on 06Jun2021/ second dose on 01Aug2021; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-ADR 25741653, Safety Report Unique Identifier GB-MHRA-ADR 25741653. A 60-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose of (lot number: EW3143), via an unspecified route of administration at single dose on 06Jun2021 and second dose of (lot number: fe3380), via an unspecified route of administration at single dose on 01Aug2021 (vaccination age was 60 years old), both for COVID-19 immunisation. Medical history included menopause (9 years ago without ANY effects), asthma (mild), Desensitisation injection (13 years old), House dust mite allergy and Allergy to human hair, all unknown if it was ongoing. Additional history included COVID-19 from 2020 to an Aug2020. Concomitant medication(s) included salbutamol sulfate (VENTOLIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced sweating, greasy hair, chest pain, ache, rash, oral infection, headache, exhaustion, appetite lost, with outcome of unknown. The patient experienced eyes red, watering eyes, eye abnormality with outcome of recovering. The patient experienced vaccination site pain with outcome of recovered. Seriousness criteria was provided as other medically important condition. Treatment received for vaccination site pain included deep ice gel. Information reported by patient: Nearly a couple of weeks after my Pfizer vaccination my head has sweated a lot. I know I went through the menopause 9 years ago without any effects. Never suffered with menstrual problems EVER. So highly unlikely connected to that, my normally dry blonde hair seems very greasy, even after a wash. Not sure if this jab effected me hormonal. Now 8 weeks later I have had my second Pfizer jab yesterday so will await to see how I am. Still suffering, head sweats, hair seems to feel very different and greasy not constant sweats but if I brush my hair the grease is constantly there. I suffer with no other illnesses, but believe I had Covid at the beginning of 2020, lasting through to mid Aug, Mostly my symptoms were moderate, no breathing problems. I have very mild asthma since a child, had desensitising injections when I was 13 years old, they were over a course of possibly 12 months. The desensitize injections seem to work well for me. I was allergic to house dust mite and very slightly human hair. I take Ventolin poss two times a day or some days none. Prior to my desensitize injections as a child my asthma was quite bad with constant chest congestion. I do not suffer that now. The Covid I suffered last year was really well before we knew in UK what it was. My symptoms for that pain in chest bone area, aches all over, rash on ankles and wrists, infection in back of my mouth area, pain in side of head turning into bad headache which affected my eyes. My eyes seemed to turn into jelly and the white of my eyes were very red and watery. I did go off my food but could still taste but not as things normally taste, I thought loss of taste meant totally no taste so never associated it with a Covid symptom. Total exhaustion, we became in lockdown and was not treated for anything. When doctor surgeries opened I phoned and they told me to go to pharmacy to get antibiotic but pharma lady said no because my symptoms sounded viral. My eyes are only just settling now at night time they weep clear liquid. But nowhere near as bad as last year. I''m just wondering and have been searching if anyone else who may have not been officially diagnosed with Covid and has had any problems after their first vaccine. I had my second vaccine yesterday. Little sore around jab area but feel fine so far today. I have put deep ice gel on area, drank water and had paracetamol the same as I did after first jab. I had no other side effects from first jab. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589136 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chills, Lymphadenopathy, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (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: LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998308

Write-up: Left armpit is now painful and swollen; Left armpit is now painful and swollen; Swollen lymph nodes; Chills/shivering; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-APPCOVID-202108032357512340-TI0EU. Safety Report Unique Identifier GB-MHRA-ADR 25750436. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 01Aug2021 (at the age of 32-year-old), as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing, hypothyroidism 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. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medications included levothyroxine taken for hypothyroidism from 04Aug2013 to an unspecified stop date. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced left armpit is now painful and swollen on an unspecified date with outcome of unknown, chill/shivering on 01Aug2021 with outcome of recovered on 02Aug2021, swollen lymph nodes on 02Aug2021 with outcome of not recovered. The events were assessed as serious and medically significant by regulatory authority. The clinical course was reported as follows: Received vaccine in left arm. Left armpit is now painful and swollen, and have visible swollen nodes around collarbone/neck. First noticed this the following morning. Experienced chills/shivering during the night following the vaccine but this had resolved by the next morning. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1589170 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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: Chills, Fatigue, Headache, Influenza like illness, Malaise, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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 ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998522

Write-up: Illness; aching muscles; chills; tiredness; headache; flu like symptoms; sickness; fever; nausea; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Medicines Healthcare products Regulatory Agency (MHRA). Regulatory authority report number {GB-MHRA-WEBCOVID- 202108030841226820-H3FOZ} Safety Report Unique Identifier {GB-MHRA-ADR 25745146}. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 31Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced chills, tiredness, headache, flu like symptoms, sickness, fever and nausea in 2021 and illness on 01Aug2021. The events were reported as serious (other medically important condition). The clinical course was reported as follows: Had flu like symptoms for 36 hours resulting in me be bed bound, consider myself a healthy young adult and have never felt this ill before. Symptoms have included fever and chills, sickness and nausea extreme headache aching muscles and tiredness. 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 02Aug2021. The outcome of illness was not recovered while recovered in 2021 for the other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589173 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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, Influenza like illness, Lymphadenopathy, Onychalgia, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998655

Write-up: flu like aches; chills; fever; even fingers and nails were aching; even fingers and nails were aching; Swollen glands, very swollen glands under armpits on both sides, left armpit (closest to injection site) is still painful and very swollen; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108030912297060-HXY0R, Safety Report Unique Identifier GB-MHRA-ADR 25745216. A 30-year-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 01Aug2021 as single dose for COVID-19 immunisation. Medical history included anxiety. She has not had symptoms associated with COVID-19, not had a COVID-19 test, and not enrolled in clinical trial. Concomitant medication included sertraline taken for anxiety. The patient experienced flu like aches, chills, and fever on an unspecified date; swollen glands on 01Aug2021. Case narrative: Felt fine until she got into bed and then had flu like aches, even fingers and nails were aching. Fever and chills and then very swollen glands under armpits on both sides. All other side effects were subsiding but left armpit (closest to injection site) was still painful and very swollen. She has not tested positive for COVID-19 since having the vaccine. The outcome of swollen glands was not recovered, while outcome of other events was recovering. Case reported as medically significant by health authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1589191 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 upper, Dizziness, Fatigue, Feeling hot, Headache, Malaise, Myalgia, Nasopharyngitis, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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: BUSCOPAN; IBUPROFEN LYSINE; MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998264

Write-up: feeling hot; nauseous; felt sick; cold; painful arm; Fainting; Fever; Nausea; Dizzy spells; Muscle ache; Stomach cramps; Headache; Fatigue; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108031108489050-OS3XV,Safety Report Unique Identifier GB-MHRA-ADR 25746032. A 31-year-old female (non-pregnant) patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: FD8813), via an unspecified route of administration on 01Aug2021 (at the age of 31-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included lactation decreased. The patient concomitant medication included hyoscine butylbromide (BUSCOPAN) taken for irritable bowel syndrome, ibuprofen lysinate (IBUPROFEN LYSINE) taken for headache, ethinylestradiol, levonorgestrel (MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]) taken for contraception, paracetamol (PARACETAMOL) taken for headache. The patient previously received first dose of BNT162B2 for COVID-19 immunization. The patient experienced feeling hot, nauseous, felt sick, cold, painful arm, fainting on 02Aug2021, fever on 02Aug2021, nausea on 02Aug2021, dizzy spells on 02Aug2021, headache on 01Aug2021, fatigue on 01Aug2021, muscle ache on 02Aug2021, stomach cramps on 02Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test was negative covid-19 test. Age at vaccination was captured. On the afternoon after having the vaccine on 01Aug2021, patient felt very tired and had a headache. Her arm was also very painful. On the morning/afternoon of the 02Aug2021, she had a painful arm, fatigue, muscle aches and a headache. Patient also had some dizzy spells. On the evening of 02Aug2021, patient suddenly started feeling hot, nauseous and very dizzy. she had to sit down, then ended up fainting (someone was with me throughout). After coming round, she felt very panicked, kept going hot and cold, felt sick and had painful pins and needles in her hands. she then ended up nearly fainting a second time. This was about 30-40 minutes after recovering from the first incident. Similar process - felt very hot, dizzy and pins and needles. Also got stomach cramping throughout. On the day of 03Aug2021, still feeling dizzy and exhausted, though the fever has settled. Still have a bit of a headache and muscle aches. Arm pain (injection site) is easing. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient was not pregnant. The events were eventually medically significant. The outcome of the events was recovered for stomach cramps on unspecified date in 2021 recovering for fever, Fainting, painful arm, cold, felt sick, nauseous, feeling hot, not recovered for muscle ache, fatigue, headache, dizzy spells, nausea. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589193 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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: Lymphadenopathy, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998453

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202108031122235840-53NII, Safety Report Unique Identifier GB-MHRA-ADR 25746021. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 (lot number: FD8813), at dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient received the dose 1 of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced swollen lymph nodes on 01Aug2021 with outcome of not recovered. The patient underwent lab test which included Covid-19 virus test: No - Negative COVID-19 test, on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The event was assessed as serious per disability. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589194 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   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 FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: 20210801; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998376

Write-up: Fever; Diarrhea; This is a spontaneous report from a contactable consumer. This is a report received from the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number is GB-MHRA-WEBCOVID-202108031122291170-LCZCI, Safety Report Unique Identifier GB-MHRA-ADR 25746016. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: FE1510) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced fever and diarrhea on 01Aug2021. The events were 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 01Aug2021. The outcome of fever was recovered on 03Aug2021 and for the diarrhea was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589218 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210620; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100998514

Write-up: Fever; Vomited; Nausea; Headache; Muscle ache; 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-202108031350418050-DCRNQ], Safety Report Unique Identifier [GB-MHRA-ADR 25746998]. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (Batch/Lot number was Not known) as dose 1, single for COVID-19 immunisation. Medical history included suspected COVID-19 from 20Jun2021 to 10Jul2021. The patient''s concomitant medications were not reported. On 02Aug2021, the patient experienced fever, vomited, nausea, headache and muscle ache. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: Yes - Positive COVID-19 test on 20Jun2021. The outcome of the event ''vomited'' was recovered on 02Aug2021 and outcome of the other events was not recovered. Additional Information: No illnesses or medication taken. Patient has 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: 1589223 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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: Lymph node pain, Lymph node ulcer, 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: AMITRIPTYLIN; FLUOXETIN.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Lactation decreased; Migraine; Suspected COVID-19 (Unsure when symptoms stopped.)
Allergies:
Diagnostic Lab Data: Test Date: 20210613; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100998473

Write-up: Lymph node pain; Lymph node ulcer; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108031434203910-LHSBJ. Safety Report Unique Identifier GB-MHRA-ADR 25747338. A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: FE3380; expiration date not provided), via an unspecified route of administration on 31Jul2021 as DOSE 2, SINGLE for COVID-19 immunisation. Patient''s medical history included lactation decreased, migraine, and depression from unspecified dates and unknown if ongoing; suspected COVID-19 from 12Jun2021 to an unspecified date (unknown when symptoms stopped). Patient is not pregnant and is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications included amitriptyline hydrochloride (AMITRIPTYLIN) from an unspecified date and unknown if ongoing for migraine and fluoxetine hydrochloride (FLUOXETIN) from 16Mar2021 and unknown if ongoing for depression. The patient experienced lymph node pain and lymph node ulcer on 01Aug2021. The events were assessed as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test with result of ''positive; Yes - Positive COVID-19 test'' on 13Jun2021. Outcome of the events was not recovered. No follow up attempts are possible. No further information is expected.


VAERS ID: 1589225 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Off label use, Product use issue, Suppressed lactation
SMQs:, Functional lactation disorders (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998349

Write-up: decreased in milk supply when breastfeeding; decreased in milk supply when breastfeeding; decreased in milk supply when breastfeeding; This is a spontaneous report from a contactable consumer. This is the first of two reports. This consumer reported information for both mother and baby. This case is the mother case.The first report is a report downloaded from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108031450353230-736TO. [Safety Report Unique Identifier: GB-MHRA-ADR 25747396] A 33-year-old female patient received 2nd dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, lot number was not reported) via an unspecified route of administration on 30Jul2021 as dose 2, single for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not enrolled in clinical trial. Medical history included ongoing breast feeding. The patient''s concomitant medications were not reported. The patient experienced decrease in milk supply when breastfeeding (assessed as medically significant) on 01Aug2021 with outcome of not recovered. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected. ; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101011836 Baby case


VAERS ID: 1589248 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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: Hypersensitivity, Lymphadenopathy
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEXOFENADINE HYDROCHLORIDE; ROZEX [METRONIDAZOLE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; C-section (Had two c sections.); Hay fever; Trapped nerve (Currently on physio for trapped nerve in left arm)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998535

Write-up: allergic reaction; Swollen lymph nodes; This is a spontaneous report from a contactable consumer, received from The Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108031812081080-2JS96, Safety Report Unique Identifier GB-MHRA-ADR 25748972. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 (Lot Number: FD8813) as dose 2, single for COVID-19 immunisation. Medical history included c sections (Had two c sections), appendix removed, currently on physio for trapped nerve in left arm, hay fever, from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications included fexofenadine hydrochloride taken for hay fever from 24Jul2021 to an unspecified stop date and metronidazole (ROZEX) taken for an unspecified indication from 2011 to an unspecified stop date. The patient previously received the dose 1 of BNT162B2 on an unspecified date for Covid-19 immunisation. The patient experienced allergic reaction on an unspecified date with outcome of unknown and swollen lymph nodes on 01Aug2021 with outcome of not recovered. Therapeutic measure was taken as a result of allergic reaction which included antihistamine. Patient has not tested positive for COVID-19 since having the vaccine. The events were assessed as serious and medically significant by regulatory authority. Additional Information: Visited doctor, advised it could be a possible allergic reaction. To take antihistamine and keep an eye on it. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589253 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Axillary pain, Blood pressure measurement, Blood test, Chest pain, Dyspnoea, Electrocardiogram, Fatigue, Headache, Heart rate, Hypertension, Inappropriate schedule of product administration, Nausea, Palpitations, Scan
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased.
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:high; Comments: (which I have not had before); Test Name: blood tests; Result Unstructured Data: Test Result:no clots or heart attack; Test Name: ecg; Result Unstructured Data: Test Result:normal; Test Name: heart rate; Result Unstructured Data: Test Result:rapid; Test Name: heart scan; Result Unstructured Data: Test Result:normal
CDC Split Type: GBPFIZER INC202100998211

Write-up: Blood pressure high; breathless; chest was also hurting; Inappropriate schedule of vaccine administered; Fatigue; Nausea; Headache; Armpit pain; Heart pounding; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108031832140920-R0HNA. Safety Report Unique Identifier GB-MHRA-ADR 25749337. A 33-year-old (non-pregnant and not currently breastfeeding) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection, Lot Number: FE1510), via an unspecified route of administration on 01Aug2021 (at the age of 33-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient medical history included lactation decreased. Concomitant medications were not reported. The patient previously received first dose of COMIRNATY (Batch/lot number: EW3143) on 04Jun2021 for COVID-19 immunization and experienced palpitations (Date of start of reaction/event was 15Jun2021 with outcome of event was not recovered/not resolved). It was reported that on an unspecified date in 2021, the patient experienced fatigue, chest was also hurting, blood pressure high and breathless. On 01Aug2021, heart pounding. On 02Aug2021 the patient had nausea, headache, armpit pain. Patient heart started randomly thumping a few weeks after patient 1st injection. It only happened now and again but it was enough to make patient worry as I''d never had anything like that before its very intense like patient heart is trying to jump out of patient chest. It didn''t really happen again for a couple of weeks until the day patient had patient 2nd dose and later that evening it happened again. The next day after patient 2nd dose patient felt like patient was going to be sick all day and had a headache and by about 8.30pm patient started getting pain in patient left armpit which kept patient awake at night for a long time as patient chest was also hurting. The day after patient did not feel sick but still had a headache and pain in the armpit and was very breathless on the morning. On an unspecified date, the patient underwent lab tests and procedures which included blood test was no clots or heart attack, electrocardiogram was normal, scan was normal, heart rate was rapid, blood pressure was high (which I have not had before). The outcome of event for nausea was recovered on 03Aug2021. For fatigue, headache, armpit pain was not recovered. For heart pounding, chest was also hurting, blood pressure high and breathless was unknown. Suspect Reactions Please provide details of any relevant investigations or tests conducted: "I visited a gp today 3rd Aug due to the heart thumping, breathlessness and armpit pain. I was sent for blood tests, which came back to show no clots or heart attack. I had an ecg and heart scan which they said was normal but my heart rate was rapid along with high blood pressure (which I have not had before) so I need to have a follow up appointment with gp in a few weeks to check heart rate and blood pressure. " No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589263 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Arthralgia, Headache, Lymphadenopathy
SMQs:, Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998338

Write-up: Swollen lymph nodes; Joint pain; 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-202108031931313660-VQMZT, Safety Report Unique Identifier GB-MHRA-ADR 25749488. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Not known), via an unspecified route of administration at dose 2, single on 01Aug2021 (at the age of 35-years-old) for COVID-19 immunisation. Medical history included lactation decreased, suspected COVID-19 from 27Feb2020 and unsure when symptoms stopped. The patient has not had a COVID-19 test. 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 headache on 01Aug2021; swollen lymph nodes and joint pain on 02Aug2021. The events were reported as serious (Other medically important condition). Patient has not tested positive for COVID-19 since having the vaccine. The outcome of headache was recovered on 03Aug2021, for joint pain was recovering and for swollen lymph nodes was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589264 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Arthralgia, Chills, Neuralgia, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARITYN [LORATADINE]; CUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ehlers-Danlos syndrome type III; Lactation decreased; Multiple allergies; Neuralgia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998306

Write-up: chills; fever; Neuralgia; joint pain/Arthralgia; Pain at injection site; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108031934566440-IX1ZS, Safety Report Unique Identifier GB-MHRA-ADR 25749495. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (Batch/Lot number was not reported) (at the age of 34-years-old) as dose 2, single for COVID-19 immunisation. Medical history included neuralgia, lactation decreased, Ehlers-Danlos syndrome type III and multiple allergies. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, was not currently breastfeeding and was not enrolled in clinical trial. Concomitant medication included loratadine (CLARITYN [LORATADINE]) taken for multiple allergies, start and stop date were not reported; ibuprofen (CUPROFEN) taken for Ehlers-Danlos syndrome type III, start and stop date were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation and experienced pain at injection site. The patient experienced chills, fever and neuralgia, joint pain/arthralgia on 02Aug2021. The events were reported as serious (other medically important condition). The clinical course was reported as follows: pain at injection site same as 1st dose on day 1. Day 2, joint paint, neuralgia (anything brushing against skin caused intense pain), fever chills. Day 3, fever chills have disappeared but joint pain and neuralgia remain although less severe than day 2. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test. The outcome of fever and chills was recovered on 03Aug2021, for joint pain/arthralgia and neuralgia was recovering and unknown for pain at injection site. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589281 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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: Headache, Lymph node pain, Lymphadenopathy, Mobility decreased, Myalgia, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998646

Write-up: unable to move my left arm; Swollen lymph nodes; swollen lymph node on left side that was incredibly painful to touch; Muscle ache; Headache; Pins and needles; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202108032105234290-HVPBN, Safety Report Unique Identifier GB-MHRA-ADR 25750099. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31Jul2021 as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. On an unknown date, the patient was unable to move left arm. On 01Aug2021, the patient had terrible muscle aches, a headache and pins and needles constantly in left arm that don''t seem to go away. On 02Aug2021, the patient experienced swollen lymph node on left side that was incredibly painful to touch. The outcome of the events was not recovered. The events were serious (disability and 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.


VAERS ID: 1589294 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Headache, Paraesthesia, Pyrexia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998222

Write-up: Pins and needles; Abdominal pain; Headache; Fever chills; 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-202108032258400990-FTPQN. A 35-years-old female patient (not pregnant at the time of vaccination) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, (Batch/Lot Number: Not known), via an unspecified route of administration on 31Jul2021 as dose 2, single for covid-19 immunization. Medical history included pregnancy from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient had experienced pins and needles, abdominal pain, headache, fever chills on 01Aug2021. The events seriousness was assessed as medically significant. The outcome of the events was not recovered. No follow-up attempts are possible. No further information was expected.


VAERS ID: 1589308 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-01
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: Electric shock, Pain, SARS-CoV-2 test, Spinal pain
SMQs:, Accidents and injuries (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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998506

Write-up: Spinal pain/Lower back pain focused in the spine; Electric shock; pain; This is a spontaneous report from a contactable consumer. This is a report received from the Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202108040337334300-EZS8W, Safety Report Unique Identifier is GB-MHRA-ADR 25750521. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FE3380), via an unspecified route of administration at dose 2, single on 02Aug2021 for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient experienced pain on Aug2021, spinal pain on 04Aug2021, and electric shock on 03Aug2021. The event was reported as serious per other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The clinical course was reported as follows: Lower back pain focused in the spine, severe pain. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event pain was unknown, the outcome of the event spinal pain was not recovered, while outcome of the event electric shock was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589311 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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-L795 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lethargy, Muscle swelling, Myalgia, Pain in extremity, Vaccination site warmth
SMQs:, Rhabdomyolysis/myopathy (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998195

Write-up: arm very sore; Vaccination site warmth; Muscle swelling; Lethargic; Localised muscle 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-202108040606405130-XV5HM Safety Report Unique Identifier GB-MHRA-ADR 25750909. A 39-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FF3319-L795 and expiry date: un-known), via an unspecified route of administration on 31Jul2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history was not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had no symptoms associated with COVID-19. Patient did not have a COVID-19 test. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW3143) via unspecified route of administration, on 05Jun2021 as DOSE 1, SINGLE for COVID-19 immunization. Concomitant medication included IBUPROFEN taken for an unspecified indication, start and stop date were not reported. On 01Aug2021, the patient experienced localised muscle pain, muscle swelling, lethargic and on 02Aug2021, had vaccination site warmth. On an unspecified date, had very sore arm. Therapeutic measures were taken because of vaccination site warmth and sore arm. Further reported that Paracetamol and Ibuprofen taken from 02Aug21, worse at night, interfered with sleep as arm very sore. The events accessed as a medically significant. The outcome of localised muscle pain, muscle swelling, lethargic, vaccination site warmth is not recovered and for arm very sore is unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589318 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Fatigue, Headache, Pain in extremity, Sweating fever
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
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998569

Write-up: Sweating fever; Headache; Fatigue; Painful arm; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202108040740175270-9BKYK, Safety Report Unique Identifier GB-MHRA-ADR 25751127. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Aug2021 (Lot number: not reported) at the age of 30 years old, as second dose, single for covid-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not pregnant and not currently breastfeeding. The patient''s concomitant medications were not reported. On 01Aug2021, the patient experienced sweating fever, headache, fatigue, and painful arm. Outcome of the event sweating fever was recovered on 03Aug2021. Outcome of the events headache, fatigue and painful arm was recovering. 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: 1589331 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dysphagia, Headache, Lymphadenopathy, Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005931

Write-up: hard to swallow; coughing; Throat pain; Ache; Runny nose; Glands are swollen; Fever; headache; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108040950184000-9BXHS, Safety Report Unique Identifier GB-MHRA-ADR 25752028. A 22-year-old female patient received 1st dose of bnt162b2 (covid-19 mrna vaccine BioNTech, lot number: fd8813), via an unspecified route of administration at single dose on 28jul2021 for covid-19 immunization. Medical history included headache. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with covid-19. Patient has not tested positive for covid-19 since having the vaccine. Patient was not enrolled in clinical trial. On 04Aug2021 patient experienced coughing, throat is swollen hard to swallow, on 01Aug2021 headache, body ache, fever, runny nose, glands are swollen and on 02Aug2021 throat pain. The patient underwent lab tests and procedures which included covid-19 virus test: negative on 03aug2021. The outcome of ache, fever is recovering, that of runny nose, throat pain, glands are swollen, hard to swallow is not recovered, and of coughing, headache was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589338 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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: Blindness, Chills, Confusional state, Diarrhoea, Dizziness, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005968

Write-up: Loss of vision; Dizziness; Confusion; Frontal headache; Nausea; Diarrhea; Shivers; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202108041007079590-R7TBY, Safety Report Unique Identifier GB-MHRA-ADR 25752162. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 31Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Concomitant medications included paracetamol taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unknown date as dose 1, single for COVID-19 immunization. On 01Aug2021 the patient had shivers and on 02Aug2021 the patient experienced loss of vision, dizziness, confusion, frontal headache, nausea and diarrhea. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. All the events were reported as medically significant. The outcome of the event loss of vision was recovered on 02Aug2021 while outcome of events diarrhea and confusion was recovering, and outcome of other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1589355 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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: Anxiety, Cognitive disorder, Crying, Depression, Disturbance in attention, Dyspnoea, Fatigue, Feeling abnormal, Hot flush, Insomnia, Irritability, Major depression, Pain in extremity, Vision blurred
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Lactation decreased; Post-traumatic stress disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005681

Write-up: Crying; Major depression; Shortness of breath; Insomnia; Depression; Blurred vision; Irritability; Fatigue; anxiety; tiredness; brain fog; sore arm; hot and cold flushes; affecting cognitive function; struggling to concentrate; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202108041140448710-AIFFR, Safety Report Unique Identifier GB-MHRA-ADR 25752704. A 32-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included anxiety, lactation decreased and Post-traumatic stress disorder (PTSD) from an unknown date and unknown if ongoing. Patient was not enrolled in clinical trial. Patient was not pregnant. The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date for COVID-19 immunisation. The patient experienced anxiety, tiredness, brain fog, sore arm and hot and cold flushes on an unspecified date in 2021 with outcome of recovering, depression on 02Aug2021 with outcome of not recovered, blurred vision on 02Aug2021 with outcome of recovering, irritability on 01Aug2021 with outcome of not recovered, fatigue on 01Aug2021 with outcome of not recovered, crying on 03Aug2021 with outcome of recovering, major depression on 03Aug2021 with outcome of recovering, shortness of breath on 03Aug2021 with outcome of not recovered, insomnia on 02Aug2021 with outcome of not recovered, all reported as medically significant. Clinical course reported as follow: Started with heavy tiredness and sore arm, moved to extreme fatigue and hot and cold flushes. This was then followed by hyper-irritability and increasing tiredness along with on/off shortness of breath and insomnia, affecting cognitive function. Patient has been dropping things, struggling to concentrate, unable to read properly and my vision has been blurred. This culminated in a sudden plummet into extreme depression and anxiety, and an awful brain fog. She felt like she has burnt through a load of brain cells, everything feels foggy and difficult, both physically and mentally. She kept wanting to cry and feel completely deflated and depressed all of a sudden, with no reason to be. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1589372 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101006001

Write-up: Diarrhea; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041347076990-IL8C4, Safety Report Unique Identifier GB-MHRA-ADR 25753791. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Aug2021 (Batch/Lot Number: FF3319) as single dose for COVID-19 immunisation. Medical history included Lactation decreased. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. The patient experienced diarrhea (medically significant) on an unspecified date in Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of the event was not recovered. The clinical course was reported as follows: ''Diarrhoea started on day two and three I have had to put the year 2020 as it will not allow me to put 21''. 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: 1589380 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-25
Onset:2021-08-01
   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: Burning sensation, Muscle rupture, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Accidents and injuries (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: Medical History/Concurrent Conditions: Epilepsy; decreased lactation.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005869

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202108041455200480-LWSFY; safety report unique identifier is GB-MHRA-ADR 25754261). A 39-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), via an unspecified route of administration, on Jul 25, 2021, single dose, for COVID-19 immunisation. Medical history included suppressed lactation and epilepsy. Patient has not had symptoms associated with COVID-19, nor had a COVID-19 test. Patient was not pregnant, nor currently breastfeeding. Patient not enrolled in a clinical trial. The patient''s concomitant medications not reported. The patient previously took topiramate for epilepsy and ended medication this year (2021), before first vaccine. The patient experienced tearing muscles (Aug 2021) and painful arm (Aug 1, 2021). One week after the 2nd vaccine, patient''s arm became incredibly sore. It had a burning type of sensation, then almost a feeling of tearing muscles. It is better, but still hurts when patient sleeps or makes certain movements. The outcome of tearing muscles: recovering. The outcome of painful arm recovered on Aug 4, 2021. The outcome of burning type of sensation: unknown. Patient has not tested positive for COVID-19 since the vaccination. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1589382 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Headache, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005970

Write-up: Headache; Heart racing; This is a spontaneous report from a contactable consumer. This is the second of 2 reports. The first report is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108041505224490-ZQZQD and Safety Report Unique Identifier is GB-MHRA-ADR 25754287. A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FD8813 and expiry date were not reported), via an unspecified route of administration on 01Aug2021 (at the age of 42-year-old) as a dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. . Patient is not enrolled in clinical trial. On 01Aug2021 (same day of vaccination), the patient experienced headache, heart racing. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Aug2021 (Took a lateral flow test to ensure wasn''t Covid). The events accessed as a medically significant. The outcome of events was recovered on 03Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589396 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-01
   Days after vaccination:11
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: Discomfort, Dysmenorrhoea, Hypomenorrhoea, Menstrual discomfort, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? 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 INC202101005996

Write-up: menstrual cramps; discomfort; nausea; Menstrual discomfort; Short menstruation/ light period; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Agency Regulatory Authority. Regulatory authority report number {GB-MHRA-WEBCOVID- 202108041606285110-K3IDM} Safety Report Unique Identifier {GB-MHRA-ADR 25754750}. A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ff3319) via an unspecified route of administration on 21Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test Patient is not pregnant. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Patient received the first dose of BNT162B2 on unknown date. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced menstrual cramps, discomfort, menstrual discomfort on 01Aug2021, short menstruation on 01Aug2021, nausea on an unspecified date with outcome of unknown. Patient very intense menstrual cramps, which I have never experienced (I have a very normal period and do not suffer with cramping) causing nausea and discomfort combined a very light period, much lighter than I normally experience. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of event menstrual discomfort was not recovered, of Short menstruation/ light period was recovering, of Menstrual cramps and discomfort was recovered on unknown date, of other was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589405 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Lymphadenopathy, Pain, SARS-CoV-2 test
SMQs:, Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GEDAREL; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005679

Write-up: Headache; Swollen lymph nodes; Joint ache; achy and sore; 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-202108041733201390-QJXVE; Safety Report Unique Identifier: GB-MHRA-ADR 25755342. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 01Aug2021 (at the age of 24-year-old) (Batch/Lot Number: Not Known; Expiry date: Not reported) as single dose for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medications included desogestrel/ethinylestradiol (GEDAREL) taken for contraception; paracetamol taken for pain relief. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date for COVID-19 immunisation. The patient experienced swollen lymph nodes on 02Aug2021, headache on 03Aug2021, joint ache on 01Aug2021. Clinical course reported as follow: On first day started to feel achy and sore, second day developed a swollen supraclavicular lymph node that was painful and a headache too. The events were assessed as medically significant. Patient had 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 unknown date. Patient had not recovered from swollen lymph nodes, headache and joint ache was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


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