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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 289 out of 7,116

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VAERS ID: 1576352 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Cold sweat, Decreased appetite, Eye pruritus, Influenza like illness, Myalgia, Pyrexia, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: flu like symptoms; cold sweats; runny eyes; Fever; Itchy eyes; Muscle pain; Stomach ache; Appetite lost; This case was received via a regulatory authority (Reference number: ADR 25762197) 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 INFLUENZA LIKE ILLNESS (flu like symptoms), COLD SWEAT (cold sweats), RHINORRHOEA (runny eyes), PYREXIA (Fever), EYE PRURITUS (Itchy eyes), MYALGIA (Muscle pain), ABDOMINAL PAIN UPPER (Stomach ache) and DECREASED APPETITE (Appetite lost) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), EYE PRURITUS (Itchy eyes) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach ache) (seriousness criterion medically significant) and DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion medically significant), COLD SWEAT (cold sweats) (seriousness criterion medically significant) and RHINORRHOEA (runny eyes) (seriousness criterion medically significant). On 03-Aug-2021, EYE PRURITUS (Itchy eyes) had resolved. On 04-Aug-2021, PYREXIA (Fever), ABDOMINAL PAIN UPPER (Stomach ache) and DECREASED APPETITE (Appetite lost) had resolved. On 05-Aug-2021, MYALGIA (Muscle pain) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), COLD SWEAT (cold sweats) and RHINORRHOEA (runny eyes) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. No concomitant medications were provided. Treatment medications was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company comment: Very limited information regarding this events has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information is not expected.


VAERS ID: 1576362 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Diplopia, Dizziness, Muscular weakness, Periorbital swelling, Pyrexia, SARS-CoV-2 test, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant (Been on AstraZeneca intranasal trial.); Surgery
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Normal (no cause found); Test Name: CT scan; Result Unstructured Data: Normal (no cause found); Test Date: 20210805; 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: Light headedness; Muscle weakness; Puffy eyes; Blurred vision; Double vision; Fever; This case was received via Regulatory Authority (Reference number: ADR 25763271) on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision), PYREXIA (Fever), DIZZINESS (Light headedness), VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Muscle weakness) and PERIORBITAL SWELLING (Puffy eyes) in a 33-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Clinical trial participant (Been on AstraZeneca intranasal trial.) and Surgery in 2014. Previously administered products included for an unreported indication: FLUENZ TETRA. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced DIPLOPIA (Double vision) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), VISION BLURRED (Blurred vision) (seriousness criterion medically significant) and PERIORBITAL SWELLING (Puffy eyes) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced DIZZINESS (Light headedness) (seriousness criterion medically significant) and MUSCULAR WEAKNESS (Muscle weakness) (seriousness criterion medically significant). On 05-Aug-2021, PYREXIA (Fever), VISION BLURRED (Blurred vision) and MUSCULAR WEAKNESS (Muscle weakness) had resolved. At the time of the report, DIPLOPIA (Double vision) had not resolved and DIZZINESS (Light headedness) and PERIORBITAL SWELLING (Puffy eyes) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Aug-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. On an unknown date, Blood test: normal (normal) Normal (no cause found). On an unknown date, Computerised tomogram: normal (normal) Normal (no cause found). The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product information was not provided by reporter. No treatment information was provided. The patient also had Orthoptic and ophthalmology consult which did show any cause. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time. Of note, the patient''s medical history of Diplopia is a confounding factor that may play a possible contributory role.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time. Of note, the patient''s medical history of Diplopia is a confounding factor that may play a possible contributory role.


VAERS ID: 1576364 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Oropharyngeal pain, Pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)

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

Write-up: Sore throat; Headache; Chills; Fatigue extreme; Ache; This case was received via a regulatory authority (Reference number: 25763281) on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache), FATIGUE (Fatigue extreme), HEADACHE (Headache), CHILLS (Chills) and OROPHARYNGEAL PAIN (Sore throat) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced FATIGUE (Fatigue extreme) (seriousness criterion medically significant). On 05-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 06-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant). At the time of the report, PAIN (Ache), FATIGUE (Fatigue extreme) and HEADACHE (Headache) had not resolved, CHILLS (Chills) was resolving and OROPHARYNGEAL PAIN (Sore throat) had resolved with sequelae. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant and treatment information provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 38-year-old male with serious unexpected events of pain, fatigue, headache, chills, and oropharyngeal pain. Event latency 3 days after second dose mRNA-1273. Events resolved with sequelae. Based on 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: This case concerns a 38-year-old male with serious unexpected events of pain, fatigue, headache, chills, and oropharyngeal pain. Event latency 3 days after second dose mRNA-1273. Events resolved with sequelae. Based on 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: 1576369 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-08-03
   Days after vaccination:60
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: Back pain, Ear pain, Eye pain, Fatigue, Headache, Inappropriate schedule of product administration, Injection site pain, Injection site urticaria, Nausea, Neck pain, Pain, Pruritus, Tension headache, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Hypersensitivity (narrow), Arthritis (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? 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 virus test (Positive); Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: pain; hives; itching; headache; Injection site hives; Tiredness; Pain back; Pain neck; Pain in eyes; Earache; Pain injection site; Tension headaches; Nausea; Inappropiate schedule vaccine administered; This case was received via Regulatory Authority (Reference number: ADR 25763954) on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (pain), URTICARIA (hives), PRURITUS (itching), TENSION HEADACHE (Tension headaches), EYE PAIN (Pain in eyes), EAR PAIN (Earache), INJECTION SITE PAIN (Pain injection site), BACK PAIN (Pain back), HEADACHE (headache), NECK PAIN (Pain neck), INJECTION SITE URTICARIA (Injection site hives), FATIGUE (Tiredness) and NAUSEA (Nausea) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased and COVID-19 virus test (Positive) on 03-Jan-2021. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced TENSION HEADACHE (Tension headaches) (seriousness criterion medically significant), INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). 03-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropiate schedule vaccine administered). On 04-Aug-2021, the patient experienced EYE PAIN (Pain in eyes) (seriousness criterion medically significant), EAR PAIN (Earache) (seriousness criterion medically significant), BACK PAIN (Pain back) (seriousness criterion medically significant), NECK PAIN (Pain neck) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 05-Aug-2021, the patient experienced INJECTION SITE URTICARIA (Injection site hives) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant), URTICARIA (hives) (seriousness criterion medically significant), PRURITUS (itching) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). The patient was treated with PARACETAMOL ongoing since an unknown date for Pain, at an unspecified dose and frequency. On 03-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropiate schedule vaccine administered) had resolved. On 05-Aug-2021, TENSION HEADACHE (Tension headaches) and EYE PAIN (Pain in eyes) had resolved, INJECTION SITE PAIN (Pain injection site) was resolving. On 06-Aug-2021, EAR PAIN (Earache), BACK PAIN (Pain back) and NAUSEA (Nausea) had resolved, NECK PAIN (Pain neck) was resolving. At the time of the report, PAIN (pain), URTICARIA (hives), PRURITUS (itching), HEADACHE (headache), INJECTION SITE URTICARIA (Injection site hives) and FATIGUE (Tiredness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment included antihistamine pill. Concomitant product was not provided. During this experience she had on her period. 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. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.


VAERS ID: 1576403 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Amenorrhoea, Menstrual disorder, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), 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: PARACETAMOL
Current Illness:
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: Palpitations; Menstruation; Menstrual flow altered; This case was received via regulatory authority; (Reference number: ADR 25766988) on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), AMENORRHOEA (Menstruation) and MENSTRUAL DISORDER (Menstrual flow altered) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included PARACETAMOL for Pain menstrual. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced MENSTRUAL DISORDER (Menstrual flow altered) (seriousness criterion medically significant). On an unknown date, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant) and AMENORRHOEA (Menstruation) (seriousness criterion medically significant). At the time of the report, PALPITATIONS (Palpitations), AMENORRHOEA (Menstruation) and MENSTRUAL DISORDER (Menstrual flow altered) outcome was unknown. 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 Route) was unknown. Treatment information was not provided by the reporter. Patient had unusual low menstrual bleeding after each dose, but regular and even less after the second dose (when menstruation was also closer to the vaccine day), together with known sore arm/temperature/occasional palpitations. Period was regular as usual in between the two doses. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. 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: 1576405 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA LOT 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Diverticulitis, Feeling abnormal, Hyperhidrosis, Pyrexia, Rheumatoid arthritis, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific inflammation (broad), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

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

Write-up: individual digits; set; joint pain; administration; sweating; hours; chills; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (individual digits) and DIVERTICULITIS (set) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. LOT 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased and Scoliosis. On an unknown date, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (individual digits) (seriousness criterion medically significant), DIVERTICULITIS (set) (seriousness criterion medically significant), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (administration), HYPERHIDROSIS (sweating), CHILLS (chills) and FEELING ABNORMAL (hours). At the time of the report, RHEUMATOID ARTHRITIS (individual digits), DIVERTICULITIS (set), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (administration), HYPERHIDROSIS (sweating), CHILLS (chills) and FEELING ABNORMAL (hours) had not resolved and PYREXIA (Fever) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient''s medical history included joint hypermobility syndrome. It was stated that fever set in approximately 6 hours after vaccine administration; peaked approximately 18 hours after vaccine administration at approx 39.5 degrees Celsius. Intense sweating and chills. Still above normal 3 days later but slowly coming down. Joint pain commenced approx 3 hours after vaccine administration; peaked approx 30 hours after administration. Affected all joints but particularly bad in knees, spine and individual digits. Did not feels like normal muscular joint point but more like someone was trying to force all joints apart. No concomitant medication reported. No Treatment medication reported. Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The company believes that only the events of Rheumatoid arthritis and Diverticulitis are IME''s and potentially serious and the rest of the events are non-serious.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The company believes that only the events of Rheumatoid arthritis and Diverticulitis are IME''s and potentially serious and the rest of the events are non-serious.


VAERS ID: 1576417 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Rash pruritic, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Migraine
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Itching; Swollen arm; Itchy rash; High temperature; This case was received via RA (Reference number: 25768905) on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (Itching), PERIPHERAL SWELLING (Swollen arm), RASH PRURITIC (Itchy rash) and PYREXIA (High temperature) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Migraine. Previously administered products included for Migraine: NUROFEN (weekly on irregular basis during July) in July 2021 and Ibuprofen. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and RASH PRURITIC (Itchy rash) (seriousness criterion medically significant). On an unknown date, the patient experienced PRURITUS (Itching) (seriousness criterion medically significant). On 05-Aug-2021, PYREXIA (High temperature) had resolved. At the time of the report, PRURITUS (Itching) and RASH PRURITIC (Itchy rash) had not resolved and PERIPHERAL SWELLING (Swollen arm) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. Treatment medication was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness criteria for the events was captured by regulatory authority, however based on medical judgement the case is non serious. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness criteria for the events was captured by regulatory authority, however based on medical judgement the case is non serious. No further information is expected.


VAERS ID: 1576433 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Sweating; Shivering; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), CHILLS (Shivering) and PYREXIA (Fever) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On 04-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, HYPERHIDROSIS (Sweating) and CHILLS (Shivering) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; 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: 1576464 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   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: Chills, Headache, Peripheral swelling, Pruritus, Pyrexia, Rash, SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20200804; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Itching; Lying in bed through all day and night until the morning of 4th Aug; Chills; pain at injection site; swelling at injection site; RASH; Swelling arm; Fever chills; This case was received via regulatory authority on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), PRURITUS (Itching), HEADACHE (Lying in bed through all day and night until the morning of 4th Aug), CHILLS (Chills) and PYREXIA (Fever chills) in a 51-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 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant). On 05-Aug-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant). On an unknown date, the patient experienced PRURITUS (Itching) (seriousness criterion medically significant), HEADACHE (Lying in bed through all day and night until the morning of 4th Aug) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE SWELLING (swelling at injection site) and RASH (RASH). On 05-Aug-2021, PYREXIA (Fever chills) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling arm), PRURITUS (Itching), HEADACHE (Lying in bed through all day and night until the morning of 4th Aug) and CHILLS (Chills) was resolving and VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE SWELLING (swelling at injection site) and RASH (RASH) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2020, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. 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: 1576487 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Pain in arm; Headache; Nausea; This case was received via regulatory agency (Reference number: ADR 25751982) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), HEADACHE (Headache) and NAUSEA (Nausea) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included No adverse event. Concomitant products included LEVONORGESTREL (MIRENA) for Contraception. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 04-Aug-2021, NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication not provided Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness criteria for the events was captured by regulatory authority, however based on medical judgement the case is non serious. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness criteria for the events was captured by regulatory authority, however based on medical judgement the case is non serious. No further information is expected.


VAERS ID: 1576637 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-08-03
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), 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: 20210803; Test Name: antigen test; Test Result: Positive ; Comments: Nasal Swab; Test Date: 20210804; Test Name: COVID-19 PCR Test; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: IEPFIZER INC202101011892

Write-up: tested positive for COVID-19; tested positive for COVID-19/had no symptoms; This is a spontaneous report from a contactable consumer. Safety Report Unique Identifier IE-COVAES-2251c38c-3759-4f8b-af61-11e31775e28a. A 20-years-old male patient received an unknown dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 08Jun2021 at 08:00 am (age at vaccination was 19 years) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 03Aug2021, patient tested positive for COVID-19 (drug ineffective). The patient had tested positive for COVID 19 in Ireland on the 04Aug2021 after having returned from a trip to Spain. There have been no symptoms showing. He was well but two antigen and one PCR test have shown positive results. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab test which included antigen test (nasal swab): positive on 03Aug2021 and COVID-19 PCR test (nasal swab): positive on 04Aug2021. No treatment was received for the adverse event. The outcome of the event was unknown. Information about lot/batch no requested.


VAERS ID: 1576823 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   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 EY0573 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy heart, Body temperature, Cardiac failure, Computerised tomogram, Echocardiogram, Haemodynamic instability, Hepatic failure, Myocarditis, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (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 Date: 20210804; Test Name: myocardial biopsy; Result Unstructured Data: Test Result:myocarditis; Test Date: 20210802; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210804; Test Name: contrast-enhanced CT; Result Unstructured Data: Test Result:the cause was not identified; Test Date: 20210804; Test Name: Echocardiography; Result Unstructured Data: Test Result:Right ventricular overload
CDC Split Type: JPPFIZER INC202101023328

Write-up: hepatic heart failure; hepatic heart failure; Renal failure; Hemodynamic breakdown; Myocarditis; This is a spontaneous report from a contactable Other Health Professional received from the Agency Regulatory Authority. Regulatory authority report number is v21122654. The patient was a 61-year and 6-month-old female. Body temperature before vaccination was 36.8 degrees Centigrade. The patient had no family history. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included 12Jul2021 first dose vaccination. On 12Jul2021, the patient previously received the first dose of BNT162B2 (COMIRNATY, Lot number FC5947, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 02Aug2021 at 17:20 (the day of vaccination), the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) via an unspecified route of administration, at the age of 61-year-old as a single dose for COVID-19 immunization. On 03Aug2021 at 13:00 (19 hours 40 minutes after the vaccination), the patient experienced myocarditis. On 03Aug2021 (next day after the vaccination), the patient was admitted to the hospital. The outcome of the event was unknown. The course of the event was as follows: On 02Aug2021, the patient received the second dose of BNT162B2. In the afternoon of 03Aug2021, the patient experienced dyspnoea. In the morning of 04Aug2021, the patient was conveyed in emergency. Poor oxygenation. Echocardiography showed Right ventricular overload, but the cause was not identified by contrast-enhanced CT. Because hepatic heart failure and Renal failure were concurrent occured, Hemodynamic breakdown. Then the patient received Cardio Pulmonary Resuscitation intubation and Extracorporeal Membrane Oxygenation. After that, the patient was transferred from this hospital to another hospital. The patient received myocardiac biopsy and the patient was diagnosed myocarditis. The reporting Other Health Professional classified the event as serious (hospitalization and life-threatening) and assessed that the event was related to BNT162B2. Other possible cause of the event such as any other diseases was not reported. The reporting Other Health Professional commented as follows: The reporter suspected that myocarditis was caused by vaccination.


VAERS ID: 1577023 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: 200/100 mmHg
CDC Split Type: PHJNJFOC20210823510

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096419] concerned a 63 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021 10:32, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 200/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0;20210823510-covid-19 vaccine ad26.cov2.s -Elevated BP. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event


VAERS ID: 1577024 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: 200/90 mmHg, Elevated
CDC Split Type: PHJNJFOC20210823623

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA,PH-PHFDA-300096415] concerned a 68 year old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A expiry: UNKNOWN) dose was not reported, 1 total administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021 at 10:46, the patient experienced elevated bp (Blood Pressure). Laboratory data included: Blood pressure (NR: not provided) 200/90 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated bp. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210823623- covid-19 vaccine ad26.cov2.s-Elevated BP. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577025 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: 170/110 mmHg, ELEVATED
CDC Split Type: PHJNJFOC20210823636

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a other health care professional via a Regulatory Authority [PHIFDA PH-PHFDA-300096458] concerned a 56 year old female with unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A and expiry: unknown) dose was not reported, 1 total administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, at 16:00 the patient experienced elevated blood pressure. Laboratory data included: blood pressure (NR: not provided) 170/110 mmHg (Elevated). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210823636-COVID-19 VACCINE aD26.COV2.S- Elevated Blood Pressure-This event is considered un-assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1577046 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: 190/100 mmHg
CDC Split Type: PHJNJFOC20210824198

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096477] concerned a 59 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021 10:20, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 190/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210824198-Covid-19 vaccine ad26.cov2.s-Elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577050 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: 220/80 mmHg, ELEVATED
CDC Split Type: PHJNJFOC20210824253

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096399] concerned a 49 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021 10:25 hours, the patient''s laboratory data included blood pressure was (NR: not provided) 220/80 mmHg, which showed elevated blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated Blood Pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210824253-covid-19 vaccine ad26.cov2.s-elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577051 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: 250/120 mmHg, Elevated
CDC Split Type: PHJNJFOC20210824303

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096550] concerned a 44 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021 18:28, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 250/120 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210824303 -Covid-19 vaccine ad26.cov2.s -Elevated Blood Pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577056 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: 200/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210824354

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096405] concerned a 73 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A) dose was not reported,1 total administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021 at 10:32, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 200/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210824354 -COVID-19 VACCINE AD26.COV2.S-Elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)


VAERS ID: 1577060 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: 190/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210824392

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096553] concerned a 57 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 213C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, at 20:00, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 190/110 mmHg (elevated). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210824392-Covid-19 vaccine ad26.cov2.s-Elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577064 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: PHJNJFOC20210824439

Write-up: LOSS OF CONSCIOUSNESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096856] concerned a 36 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 212C21A expiry: UNKNOWN) dose was not reported, 1 Total administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021 at 13: 53, the patient experienced loss of consciousness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210824439-covid-19 vaccine ad26.cov2.s- loss of consciousness.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: 1577073 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: 180/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210824533

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096540] concerned a 42 year old female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 213C21A, expiry: unknown) dose was not reported, frequency time 1 total administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, at 08:20 the patient experienced elevated blood pressure (BP). Laboratory data included: Blood pressure (NR: not provided) 180/110 mmHg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure (BP). This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210824533-Covid-19 vaccine ad26.cov2.s -Elevated BP. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577078 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, Elevated
CDC Split Type: PHJNJFOC20210824579

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096543] concerned a 37 year old male patient of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, at 18:02, the patient experienced elevated blood pressure(BP). Laboratory data included: Blood pressure (NR: not provided) Elevated 180/100mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0. 20210824579-covid-19 vaccine ad26.cov2.s -elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)..


VAERS ID: 1577111 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, Elevated
CDC Split Type: PHJNJFOC20210825039

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300096445] concerned a 67 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, at 13:35, the patients laboratory data included blood pressure was (NR: not provided) 180/100 mmHg which showed elevated blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP (blood pressure). This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210825039-covid-19 vaccine ad26.cov2.s -Elevated Blood Pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577116 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108031531; Test Name: Blood pressure; Result Unstructured Data: 220/130 mmHg, Elevated
CDC Split Type: PHJNJFOC20210825169

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority (PHIFDA, PH-PHFDA-300096482) concerned a 63 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2. s (suspension for injection, intramuscular, batch number: 213C21A and expiry: unknown) dose was not reported, 1 total administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021 at 15:31, the patient experienced elevated BP (Blood pressure) which was found to be 220/130 mmHg was reported. The action taken with Covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from elevated bp. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210825169-COVID-19 VACCINE AD26.COV2.S-Elevated BP. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577141 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C2IA / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Haematemesis, Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210825998

Write-up: HEMATEMESIS; VOMITING; HEADACHE; NAUSEA; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300097449] concerned a 66 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C2IA, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 01-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, at 12:00, the patient experienced hematemesis, vomiting, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hematemesis, vomiting, headache, and nausea. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210825998-Covid-19 vaccine ad26.cov2.S- Hematemesis. 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: 1577328 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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 FE6208 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Fall, Fatigue, Gait inability, Headache, Insomnia, Nausea, Nervousness, Sedation, Vaccination site pain, Vertigo
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NIFEREX [IRON POLYSACCHARIDE COMPLEX]
Current Illness: Sinusitis
Preexisting Conditions: Medical History/Concurrent Conditions: Breathing difficult (in the spring of 2021)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101016250

Write-up: feels scared; nausea; severe dizziness; fatigue; headache; feeling completely drugged; can not stand or walk; falls inside the bathroom; not slept much; spins enormously in front of eyes and head; chills; pain at the vaccination site; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB SE-MPA-2021-070010, Case identifiers SE-VISMA-1628096414387. A 30-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration at the age of 30-year-old on 03Aug2021 17:20 (Lot Number: FE6208) as single dose for COVID-19 immunisation. Medical history included Breathing difficult from 2021 (in the spring of 2021) and not onging, ongoing sinusitis. Concomitant medication included iron polysaccharide complex (NIFEREX) taken for an unspecified indication from 01May2021 to an unspecified stop date. The patient experienced pain at the vaccination site on 03Aug2021, chills on 04Aug2021, nausea on 04Aug2021 05:20, severe dizziness on 04Aug2021, fatigue on 04Aug2021, headache on 04Aug2021, feeling completely drugged on 04Aug2021, can not stand or walk on 04Aug2021, falls inside the bathroom on 04Aug2021, feels scared on 04Aug2021 17:20, not slept much on 04Aug2021, spins enormously in front of eyes and head on 04Aug2021. The clinical course was reported as follows: Reported suspected side effects were pain at the vaccination site 03Aug2021 and nausea, chills, headache, severe dizziness and fatigue 04Aug2021. The woman woke up at 05:20 (12 hours after dose 2) of nausea. Chills became more and more apparent. The woman tried to fall asleep again, but wanted to try getting up and getting out of bed a bit and feeling completely drugged. The woman gets a powerful headache, wants to vomit - but does not. The woman experiences severe dizziness and lost control over herself, it spins enormously in front of eyes and head. The woman can not stand or walk by herself and falls inside the bathroom, but manages to hold on to the edge of the bathtub - this goes well. After 24 hours, the woman feels scared, but has more control over herself. She is nauseous and tired (but has not slept much either). The case was judged to be serious, life-threatening. The outcome of events severe dizziness, fatigue, headache and chills was recovering. The outcome of other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1579293 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chills, Diarrhoea, Extrasystoles, Headache, Hypertension, Hypoaesthesia, Myalgia, Nausea, SARS-CoV-2 test, Seasonal allergy, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Eosinophilic pneumonia (broad), Tachyarrhythmia terms, nonspecific (narrow), Conjunctival disorders (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Hypokalaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Numbness facial; Pain muscle; Tummy ache; Headache; Nausea; Hay fever; Shivering; Heartbeats skipped; Blood pressure high; Shaking; Diarrhea; This case was received via regulatory authority(Reference number: ADR 25765814) on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EXTRASYSTOLES (Heartbeats skipped), HYPERTENSION (Blood pressure high), TREMOR (Shaking), DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Tummy ache), SEASONAL ALLERGY (Hay fever), CHILLS (Shivering), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Pain muscle) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced EXTRASYSTOLES (Heartbeats skipped) (seriousness criterion medically significant), HYPERTENSION (Blood pressure high) (seriousness criterion medically significant), TREMOR (Shaking) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant), SEASONAL ALLERGY (Hay fever) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced ABDOMINAL PAIN (Tummy ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and MYALGIA (Pain muscle) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness facial). On 04-Aug-2021, TREMOR (Shaking) had resolved. On 05-Aug-2021, CHILLS (Shivering) had resolved. On 06-Aug-2021, EXTRASYSTOLES (Heartbeats skipped) and HYPERTENSION (Blood pressure high) had resolved, DIARRHOEA (Diarrhea) and SEASONAL ALLERGY (Hay fever) was resolving. At the time of the report, ABDOMINAL PAIN (Tummy ache), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Pain muscle) had not resolved and HYPOAESTHESIA (Numbness facial) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. 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: 1579344 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

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

Write-up: This case was received and was forwarded to Moderna on 04-Aug-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 33-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 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 04-Aug-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant). On 03-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 04-Aug-2021, CHILLS (Chills) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.Concomitant product use was not provided by the reporter.Treatment information was not provided.Patient had not experienced fever and not elevated by paracetamol. Patient has not tested positive for COVID-19 since having the vaccine. She was not enrolled in clinical trial and adverse reaction did not occur as a result of an exposure during pregnancy.Company Comment : This is a case of product exposure during pregnancy with associated chills for this 33-year-old female. No further contact is expected.; Sender''s Comments: This is a case of product exposure during pregnancy with associated chills for this 33-year-old female. No further contact is expected.


VAERS ID: 1579346 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hallucination, Myalgia, Nasopharyngitis, Nausea, Pain, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Hallucinations; Cold; Muscle aches; Nausea; Vomiting; Ache; This case was received via regulatory authority RA (Reference number: 25751521) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations), NASOPHARYNGITIS (Cold), PAIN (Ache), MYALGIA (Muscle aches), NAUSEA (Nausea) and VOMITING (Vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant). On an unknown date, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), NASOPHARYNGITIS (Cold) (seriousness criterion medically significant), MYALGIA (Muscle aches) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). At the time of the report, HALLUCINATION (Hallucinations), NASOPHARYNGITIS (Cold), MYALGIA (Muscle aches), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown and PAIN (Ache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided by the reporter. Treatment information was not reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the 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: 1579352 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test negative, Skin burning sensation, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19; Test Result: Negative ; Result Unstructured Data: Patient has not tested positive for COVID-19
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Skin burning sensation; Vomiting; This case was received via regulatory authority (Reference number: ADR 25752623) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Skin burning sensation) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced SKIN BURNING SENSATION (Skin burning sensation) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On 04-Aug-2021, VOMITING (Vomiting) had resolved. At the time of the report, SKIN BURNING SENSATION (Skin burning sensation) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: negative (Negative) Patient has not tested positive for COVID-19. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1579354 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 1 - / OT

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

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

Write-up: Fever; Muscle ache; Chills; Tiredness; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Muscle ache), CHILLS (Chills) and FATIGUE (Tiredness) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. Not known and UNKNOWN) for COVID-19 vaccination. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (RIGEVIDON) from 30-Sep-2011 to an unknown date for Contraception. In 2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever) was resolving, MYALGIA (Muscle ache) and FATIGUE (Tiredness) had not resolved and CHILLS (Chills) had resolved. No treatment medications were reported. Patient had experienced muscle ache after first vaccination. She had severe side effects after second dose. Patient did not test positive for COVID-19 after having the vaccine. Patient did not enroll in the clinical trail. Patient is not breast feeding currently. Company comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time


VAERS ID: 1579356 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Fever; Muscle pain; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and MYALGIA (Muscle pain) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever) was resolving and MYALGIA (Muscle pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) 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. The events doesn?t seem to be serious by medical judgement, but they were assessed as serious as per regulatory authority report.; 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. The events doesn?t seem to be serious by medical judgement, but they were assessed as serious as per regulatory authority report.


VAERS ID: 1579362 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Extrasystoles, Fatigue, Headache, Nausea, Pruritus, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tachyarrhythmia terms, nonspecific (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (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 Date: 20210124; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (itching), FATIGUE (Tiredness), DIARRHOEA (Diarrhea), HEADACHE (Headache), EXTRASYSTOLES (Heartbeats skipped), PYREXIA (Fever), CHILLS (Shivering), TREMOR (Shaking) and NAUSEA (Nausea) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased.On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion disability), DIARRHOEA (Diarrhea) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), EXTRASYSTOLES (Heartbeats skipped) (seriousness criterion disability), PYREXIA (Fever) (seriousness criterion disability), CHILLS (Shivering) (seriousness criterion disability), TREMOR (Shaking) (seriousness criterion disability) and NAUSEA (Nausea) (seriousness criterion disability). On an unknown date, the patient experienced PRURITUS (itching) (seriousness criterion disability). At the time of the report, PRURITUS (itching), FATIGUE (Tiredness), DIARRHOEA (Diarrhea), HEADACHE (Headache), EXTRASYSTOLES (Heartbeats skipped), PYREXIA (Fever) and NAUSEA (Nausea) had not resolved and CHILLS (Shivering) and TREMOR (Shaking) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.No concomitant medications were reported.No treatment information was provided.Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1579567 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Eye irritation, Fatigue, Headache, SARS-CoV-2 test
SMQs:, Corneal 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: Lactation decreased
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Headache; Burning eyes; Fatigue; This case was received via Regulatory Authority(Reference number: ADR 25761411) 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 HEADACHE (Headache), FATIGUE (Fatigue) and EYE IRRITATION (Burning eyes) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Lactation decreased. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and EYE IRRITATION (Burning eyes) (seriousness criterion medically significant). On 05-Aug-2021, EYE IRRITATION (Burning eyes) had resolved. At the time of the report, HEADACHE (Headache) and FATIGUE (Fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Patient has not had symptoms associated with COVID-19 and not currently breastfeeding. 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: 1579577 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Body temperature, Fatigue, Headache, Injection site pain, Pain in extremity, Pyrexia, Rash erythematous, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), 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: 20210803; 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: Painful arm; Red rash; Back pain; Body temperature; Injection site pain; Headache; Fever chills; Tired out; This case was received via Regulatory Authority (Reference number: ADR 25762744) 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 PAIN IN EXTREMITY (Painful arm), RASH ERYTHEMATOUS (Red rash), BACK PAIN (Back pain), BODY TEMPERATURE (Body temperature), INJECTION SITE PAIN (Injection site pain), HEADACHE (Headache), PYREXIA (Fever chills) and FATIGUE (Tired out) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant), BACK PAIN (Back pain) (seriousness criterion medically significant), BODY TEMPERATURE (Body temperature) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant) and FATIGUE (Tired out) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm), RASH ERYTHEMATOUS (Red rash) and FATIGUE (Tired out) was resolving, BACK PAIN (Back pain) had not resolved, BODY TEMPERATURE (Body temperature), HEADACHE (Headache) and PYREXIA (Fever chills) had resolved and INJECTION SITE PAIN (Injection site pain) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-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. No concomitant drugs were reported. No treatment information was 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: 1579663 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

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

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

Write-up: Fever; This case was received via Regulatory Authority (Reference number: ADR 25771712) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included CHLORPHENAMINE MALEATE (BOOTS ALLERGY RELIEF) from 01-May-2021 to an unknown date for an unknown indication. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 04-Aug-2021, PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment was reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time.


VAERS ID: 1579809 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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 UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Nausea
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100987374

Write-up: Intense Nausea; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 73-year-old female patient received BNT162B2 (COMIRNATY, Solution for Injection; lot number and expiration date: unknown), via intramuscular route on 03Aug2021 (the day of vaccination), at the age of 73 years old as dose 2, single for COVID-19 immunization. Medical history included arrhythmia. Concomitant medications included oral warfarin. Historical vaccine included BNT162B2 (COMIRNATY, Solution for Injection; lot number and expiration date: unknown), via intramuscular route on 13Jul2021 (the day of vaccination), as dose 1, single for COVID-19 immunization. The adverse events occurred after using the vaccine. On 03Aug2021 (after the vaccination), the patient experienced adverse event. The details of the clinical course as following: After observation in the hospital, the patient complained of intense nausea for about 15 minutes. No skin symptoms and there was no decrease in blood pressure. There were no other findings suggestive of anaphylaxis, but just in case, epinephrine (BOSMIN) was administered and ambulance was requested. Although there was a tendency for lightness during standby, ambulance transportation was carried out 45 minutes later. This event resulted in emergency room (ER) visit. The seriousness was not provided and the outcome of nausea was unknown at the time of report at the time of report. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.; Sender''s Comments: A possible contributory role of the suspect drug to the reported events " Intense Nausea" cannot be completely excluded based on temporal association. 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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1579875 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004229 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bradycardia, Presyncope
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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: JPTAKEDA2021TJP071908

Write-up: Bradycardia; Vasovagal reflex (sick feeling, decreased blood pressure); This case was received via regulatory authority (Reference number: 2021TJP071908) on 03-Aug-2021 and was forwarded to Moderna on 14-Aug-2021. This case was received via regulatory authority (Reference number: 2021TJP071908) on 03-Aug-2021 and was forwarded to Moderna on 14-Aug-2021. This case, reported by a physician, was received by regulatory authority Limited via Modernas adverse reaction reporting site (TASK0020696). Bradycardia was assessed as serious. On an unknown date, body temperature before the vaccination: 36.6 degrees Celsius. On 03-Aug-2021, at 17:35, the patient received the 1st dose of the vaccine. At 17:45, sick feeling, decreased blood pressure, and bradycardia developed. The patient was diagnosed with vasovagal reflex. The outcome of vasovagal reflex (sick feeling, decreased blood pressure) and bradycardia was reported as recovered. Follow-up investigation will be impossible. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; 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 start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1579896 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003656 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dermatitis atopic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP072271

Write-up: Anaphylactic reaction; This case was received via agency (Reference number: 2021TJP072271) on 04-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case, initially reported to the Agency by a supervisor, was received via the (Ref, v21122384). Anaphylaxis was assessed as serious by the . On, an unknown date, the patient received the 1st dose of the vaccine. On an unknown date, body temperature before the vaccination: 36.6 degrees Celsius. On 03-Aug-2021, at 11:00, the patient received the 2nd dose of the vaccine. At 11:10, the patient experienced nausea and feeling of dyspnea (blood pressure 118/74, PR 68, PaO2 98%). At 12:18, the patient experienced skin redness from the neck to the anterior chest and stenotic sound (+) during inspiration. The patient was diagnosed with anaphylaxis. The symptoms subsided with intramuscular injection of adrenaline. The outcome of anaphylaxis was reported as resolving. Follow-up investigation will be impossible. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1579976 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: 190/110 mmHg, elevated
CDC Split Type: PHJNJFOC20210824115

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300096507] concerned a 46 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021 16:02, the patient experienced elevated BP (blood pressure). Laboratory data included: Blood pressure (NR: not provided) 190/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210824115-covid-19 vaccine ad26.cov2.s -Elevated Blood Pressure. Follow-up received regarding Other Information: non serious to serious. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1579977 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: 200/120 mmHg, Elevated
CDC Split Type: PHJNJFOC20210824227

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300096555] concerned a 43 year old female of unspecified race and ethnic origin The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A expiry: UNKNOWN) dose was not reported, 1 Total administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021 at 18:26, the patient experienced elevated BP (Blood Pressure). Laboratory data included: Blood pressure (NR: not provided) 200/120 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210824227-Covid-19 vaccine ad26.cov2.s-Elevated BP. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1580051 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Erythema, Hypersensitivity
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESONIX [BUDESONIDE]; BUFOMIX; MONTELUKAST; DESLORATADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to animals; Asthma; Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202100993192

Write-up: Became red all over the body except for palm areas that were normal colored; Began to feel difficulty breathing; Feels like some kind of allergic reaction; This is a spontaneous report from a non-contactable consumer (patient). A 47-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch number was not reported/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. Medical history included asthma from an unknown date, Known Allergies: Pollen Allergy from an unknown date, Known Allergies: certain animals (cat, horse) from an unknown date. Concomitant medications included budesonide (DESONIX); budesonide, formoterol fumarate (BUFOMIX) ; montelukast; desloratadine. The patient experienced became red all over the body except for palm areas that were normal colored , began to feel difficulty breathing, feels like some kind of allergic reaction, all on 03Aug2021 13:00 with outcome of recovering. Therapeutic measures were taken for all events. Patient received cortisone and liquid antihistamine as treatment for the event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No follow-up attempts are possible; information about LOT/batch number cannot be obtained.


VAERS ID: 1583233 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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: Blood glucose decreased, Blood pressure decreased, Maternal exposure during pregnancy, Syncope, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CRPFIZER INC202101005416

Write-up: 25 weeks pregnant; I was about to faint; drop in blood pressure or sugar; drop in blood pressure or sugar; pain at the vaccination site, in my left arm; This is a spontaneous report from a contactable pharmacist (patient). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Aug2021 at 11:30 in left arm (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation at the age of 33-year-old. The medical history and concomitant medications were not reported. The patient was 25 weeks pregnant. The patient received second dose of vaccine on 03Aug2021 at 11:30, during the day she did not feel anything but at night she felt pain at the vaccination site, in her left arm. On 04Aug2021, after exercising and having breakfast, the patient had a drop in blood pressure or sugar and she was about to faint, however her husband arrived on time, gave her honey and she recovered. At the time of report, the patient was recovered and the pain in her arm was only a little milder than the day before, it was improving. The mother was 25 Weeks pregnant at the onset of the event. Therapeutic measures were taken as a result of the patient was about to faint, drop in blood pressure or sugar. The outcome for vaccination site pain was recovering and the patient recovered from other events. Information on the lot/batch number has been requested.; Sender''s Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. 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,Linked Report(s) : CR-PFIZER INC-202100975687 same patient/ reporter/ drug different events (1st dose)


VAERS ID: 1585457 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   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: Chills, Nausea
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992158

Write-up: Chills; Nausea; This is a spontaneous report from a contactable consumer received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108030626308210-MNCID, Safety Report Unique Identifier is GB-MHRA-ADR 25744658. A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FD8813), via an unspecified route of administration on 02Aug2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient experienced chills and nausea on 03Aug2021. The events were reported as serious per other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event chills was recovering, outcome of the event nausea was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585465 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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: Nausea, Pallor, Seizure
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101020812

Write-up: nauseated; pale; Seizure; This is a spontaneous report from a two contactable other hcp downloaded from the Agency WEB, regulatory authority number GB-MHRA-WEBCOVID 202108031105211060-YF67Y, Safety Report Unique Identifier GB-MHRA-ADR 25746002. A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FE3380), via an unspecified route of administration on 03Aug2021 (at the age of 22 years old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On 03Aug2021, the patient experienced seizure, nauseated, pale (pallor). The patient not had symptoms associated with COVID-19. The patient not had a COVID-19 test. The events were reported as eventually medically significant and non-serious. The outcome of the events was recovered for seizure on 03Aug2021, unknown for nauseated and pale. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585471 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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: Headache, Malaise, Pyrexia, SARS-CoV-2 test, Tonsillar erythema
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998704

Write-up: Headache; Fever chills; Red tonsils; Sickness; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108031756597470-BRXEJ, Safety Report Unique Identifier is GB-MHRA-ADR 25748778. A 20-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Aug2021 (lot number: FE3380 NBG) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. He has not had symptoms associated with COVID-19 and not enrolled in clinical trial. The patient experienced headache, fever chills, red tonsils, and sickness, all on 03Aug2021 with outcome of not recovered. He has not tested positive for COVID-19 since having the vaccine. He underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 01Aug2021. Case reported as medically significant by health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585477 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Lymphadenopathy, 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: Clinical trial participant; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101005846

Write-up: Pain in whole arm and fingers; Pain in whole arm and fingers; Pain in armpit swollen lymph nodes in armpit; Pain in armpit; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108040845328260-ZHYGJ, Safety Report Unique Identifier GB-MHRA-ADR 25751507. A 32-year-old female (non-pregnant and not currently breastfeeding) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection, Lot Number: FE3380; Batch no/Expiry date: not reported) via an unspecified route of administration on 02Aug2021 as dose 1, single for COVID-19 immunization. Medical history included suppressed lactation and clinical trial participant. 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 and patient was clinical trial participant Study details was Office for national statistics. On 03Aug2021, the patient experienced Pain in armpit, swollen lymph nodes in armpit all on side of vaccine and on an unspecified date, patient experienced with pain in whole arm and fingers. Events considered as Medically significant. On 05Jan2021, the patient underwent lab tests and procedures which included Sars-cov-2 test results positive for COVID-19 test. Outcome of the event pain in whole arm and fingers was unknown and outcome of pain in armpit, swollen lymph nodes in armpit was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585488 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN LYSINE; PARACETAMOL
Current Illness: Cluster headaches; Cramps
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped); Comments: Patient is not pregnant,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: Fever; Chills; Diarrhea; Felt faint; Nausea; Fever chills; Vomiting; Headache; Diarrhoea; This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (Felt faint), DIARRHOEA (Diarrhoea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever chills), VOMITING (Vomiting) and HEADACHE (Headache) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Lactation decreased and Suspected COVID-19 (Unsure when symptoms stopped) on 06-Mar-2020. Concurrent medical conditions included Cramps and Cluster headaches. Concomitant products included PARACETAMOL for Cluster headaches, IBUPROFEN LYSINATE (IBUPROFEN LYSINE) for Cramps. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced DIARRHOEA (Diarrhoea) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced DIZZINESS (Felt faint) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (Felt faint), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting) was resolving and DIARRHOEA (Diarrhoea), NAUSEA (Nausea), PYREXIA (Fever chills) and HEADACHE (Headache) had not resolved. 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. Patients was a clinical trial participant Study details: Imperial college and ipsos mori study 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: 1585491 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   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: Headache, Lymphadenopathy, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101006099

Write-up: Swollen lymph nodes; Fever chills; Headache; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority; report number is GB-MHRA-WEBCOVID-202108041235249690-4APKD, Safety Report Unique Identifier: GB-MHRA-ADR 25753092. A 40-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 02Aug2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unknown date for covid-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 03Aug2021 the patient experienced swollen lymph nodes, fever chills and headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. The events were reported as serious (medically significant). The outcome of the event swollen lymph nodes was not resolved for rest of the events the outcome was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585496 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-03
   Days after vaccination:5
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: Axillary pain, Blood test, Chest X-ray, Discomfort, Fatigue, Malaise, Pain, SARS-CoV-2 test, Sleep disorder, Swelling, Tremor
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:Unknown results; Test Name: chest xray; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101006172

Write-up: shaking; discomfort; tiredness; Severe shooting pains from armpit to chest/bad pain; no sleep; swallen armpit; Armpit pain; Feeling unwell; This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-WEBCOVID-202108041620123070-7OPBI, Safety Report Unique Identifier is GB-MHRA-ADR 25754862. A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Fe1510) via an unspecified route of administration into the arm on 29Jul2021 as dose2, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as dose1, single for Covid-19 immunisation. Patient has not had symptoms associated with Covid-19. On an unspecified date, the patient experienced shaking, discomfort, tiredness, severe shooting pains from armpit to chest/bad pain, no sleep and swollen armpit. On 03Aug2021, he experienced armpit pain and feeling unwell. Additional information included severe arm shoulder pain morning after injection, afternoon shaking in hands lasted for 2 hours afternoon severe shooting pains from armpit to chest, no sleep at night because of the pain, following morning swollen armpit in injection arm with bad pain and discomfort, feeling unwell and tiredness, 6 days in and armpit was still badly swollen and feeling unwell. Patient has not tested positive for Covid-19 since having the vaccine. Patient was not enrolled in clinical trial. Suspect reactions included to please provide details of any relevant investigations or tests conducted: Doctors are carrying out blood tests and also chest x-ray. The patient underwent lab tests which showed blood test, chest x-ray as unknown results on an unspecified date and Covid-19 virus test as negative on an unspecified date, negative Covid-19 test. Outcome was resolved for events shaking, discomfort, tiredness and not resolved for events armpit pain, feeling unwell and unknown for rest of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585523 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014684

Write-up: facial droop; Palsy Bells; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061252144300-YSXGE. Safety Report Unique Identifier GB-MHRA-ADR 25765479. A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: FE3380), dose 2 via an unspecified route of administration on 02Aug2021 as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient was not enrolled in clinical trial. The patient experienced facial droop on an unspecified date, palsy bells on 03Aug2021. Less than 36hr following the second dose of the vaccine, the patient developed a left Bell''s Palsy. The facial droop progressed in severity over the next 72hr. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event facial droop was reported as recovering and for palsy bells was not recovered. Additional information: Less than 36hr following the second dose of the vaccine, the patient developed a left Bell''s Palsy. The facial droop progressed in severity over the next 72hr. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585528 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Monoparesis, Nausea, Night sweats, Photophobia, Pyrexia, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular 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: LOPERAMIDE
Current Illness:
Preexisting Conditions: Comments: The medical history was not provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: feeling fevered; nauseous; unable to raise; Nausea; Fatigue; Night sweats; Fever; Left arm paresis; Light sensitivity to eye; This case was received via Regulatory Authority (Reference number: 25768853) on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MONOPARESIS (Left arm paresis), PHOTOPHOBIA (Light sensitivity to eye), DIZZINESS (feeling fevered), NIGHT SWEATS (Night sweats), PYREXIA (Fever), NAUSEA (nauseous), NAUSEA (Nausea), FATIGUE (Fatigue) and VACCINATION SITE PAIN (unable to raise) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The medical history was not provided by the reporter. Concomitant products included LOPERAMIDE for Irritable bowel. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced MONOPARESIS (Left arm paresis) (seriousness criterion medically significant), PHOTOPHOBIA (Light sensitivity to eye) (seriousness criterion medically significant), NIGHT SWEATS (Night sweats) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (feeling fevered) (seriousness criterion medically significant), NAUSEA (nauseous) (seriousness criterion medically significant) and VACCINATION SITE PAIN (unable to raise) (seriousness criterion medically significant). On 04-Aug-2021, PHOTOPHOBIA (Light sensitivity to eye) and NAUSEA (Nausea) had resolved. On 05-Aug-2021, FATIGUE (Fatigue) had resolved. At the time of the report, MONOPARESIS (Left arm paresis), NIGHT SWEATS (Night sweats) and PYREXIA (Fever) was resolving and DIZZINESS (feeling fevered), NAUSEA (nauseous) and VACCINATION SITE PAIN (unable to raise) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was reported. The evening of vaccine (6-7hrs after), patient felt nauseous & sweat, had generally fatigues. Next day arm was very sore, unable to raise at all and later the next day started feeling fevered again. 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: 1585532 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-08-03
   Days after vaccination:34
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: Acoustic stimulation tests, Bell's palsy, Computerised tomogram, Facial paralysis, Investigation, Nerve injury, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hearing impairment (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: CARBIMAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperthyroidism; Lactation decreased; Nerve damage
Allergies:
Diagnostic Lab Data: Test Name: hearing tests; Result Unstructured Data: Test Result:Unknown; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown; Test Name: ear examinations; Result Unstructured Data: Test Result:Unknown; Test Name: vision examinations; Result Unstructured Data: Test Result:Unknown; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014541

Write-up: nerve damage; Drooping of right side of face; Palsy Bells/Bell''s palsy in right side of face; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108071600470980-OWPFL. Safety Report Unique Identifier is GB-MHRA-ADR 25770625. A 29-year-old non-pregnant female patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection) via an unspecified route of administration on 30Jun2021 for COVIID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included Nerve damage, Lactation decreased and Hyperthyroidism. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Concomitant medication included carbimazole (CARBIMAZOL) taken for hyperthyroidism from 10May2020 to an unspecified stop date. On 03Aug2021, the patient experienced palsy bells/ Bell''s palsy in right side of face; on an unspecified date, nerve damage and drooping of right side of face. The patient underwent lab tests and procedures which included COVID-19 virus test: negative, No - Negative COVID-19 test, CT scan: unknown, hearing tests: unknown, ear examinations: unknown, vision examinations: unknown on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event Palsy Bells/Bell''s palsy in right side of face was not recovered and other event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1585572 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Depressed mood, Diarrhoea, Epistaxis, Headache, Insomnia, Muscle spasms, Nausea, Pyrexia, SARS-CoV-2 test, Vaccination site anaesthesia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Dead leg for almost a week where the injection was done.; Depressed mood; Bleeding nose; Vomiting; Diarrhea; Headache dull; Nausea; Spasm muscle; Fever; Insomnia; This case was received via RA (Reference number: 25773867) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Depressed mood), PYREXIA (Fever), EPISTAXIS (Bleeding nose), INSOMNIA (Insomnia), NAUSEA (Nausea), VOMITING (Vomiting), DIARRHOEA (Diarrhea), MUSCLE SPASMS (Spasm muscle), HEADACHE (Headache dull) and VACCINATION SITE ANAESTHESIA (Dead leg for almost a week where the injection was done.) in a 45-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced INSOMNIA (Insomnia) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and MUSCLE SPASMS (Spasm muscle) (seriousness criterion medically significant). On 05-Aug-2021, the patient experienced DEPRESSED MOOD (Depressed mood) (seriousness criterion medically significant), EPISTAXIS (Bleeding nose) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant) and HEADACHE (Headache dull) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE ANAESTHESIA (Dead leg for almost a week where the injection was done.) (seriousness criterion medically significant). On 05-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, DEPRESSED MOOD (Depressed mood), EPISTAXIS (Bleeding nose), INSOMNIA (Insomnia) and NAUSEA (Nausea) had not resolved, VOMITING (Vomiting), DIARRHOEA (Diarrhea), MUSCLE SPASMS (Spasm muscle) and HEADACHE (Headache dull) was resolving and VACCINATION SITE ANAESTHESIA (Dead leg for almost a week where the injection was done.) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was 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: 1585574 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-08-03
   Days after vaccination:56
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: Bell's palsy, Drooling, Ear pain, Eye disorder, Feeling abnormal, SARS-CoV-2 test
SMQs:, Dementia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (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 INC202101028841

Write-up: Palsy Bells/my right side of the face wasn''t working; Feeling weird; she was dribbling; I had pain behind my ear; eye felt a little funny; This is a spontaneous study report from a contactable consumer or other non-healthcare professional. This is a report received from the Regulatory Authority Medicines Healthcare Products Regulatory Agency (MHRA). Regulatory authority report number (GB-MHRA-WEBCOVID-202108091116069050-SUXHX). Safety Report Unique Identifier (GB-MHRA-ADR 25773882). A 29-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was unknown), via an unspecified route of administration on 08Jun2021, as dose 1, single for COVID-19 immunization. Medical history included lactation decreased. Concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On the night of Tuesday 03Aug2021, her eye felt a little funny and she had pain behind her ear. On Wednesday 04Aug2021, she woke up feeling fine but when drinking some tea felt she was dribbling. Her eye started feeling weird again around 1pm (04Aug2021) and she checked and found her right side of the face was not working/Palsy Bells (04Aug2021). Immediately she phoned the GP and was seen within 30 minutes. The patient underwent lab tests and procedures which included Covid-19 virus test and the result was negative. The outcome of the event feeling weird was recovered on an unspecified date in Aug2021, the event palsy bells/ my right side of the face was not working was not recovered, and the other events was unknown. No follow up attempts are possible; Information about lot/batch number cannot be obtained.


VAERS ID: 1585600 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-08-03
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Epilepsy, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AERIUS [DESLORATADINE]
Current Illness:
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: Epileptic seizure; This case was received via Regulatory Authority (Reference number: ADR 25777160) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EPILEPSY (Epileptic seizure) in a 46-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included DESLORATADINE (AERIUS [DESLORATADINE]) from 03-May-2012 to an unknown date for Grass allergy. On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021 at 10:15 AM, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021 at 4:00 PM, the patient experienced EPILEPSY (Epileptic seizure) (seriousness criteria hospitalization, disability, medically significant and life threatening). The patient was hospitalized for 4 days due to EPILEPSY. At the time of the report, EPILEPSY (Epileptic seizure) 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. It was reported that the patient did not have symptoms associated with COVID-19. It was reported that after getting vaccinated, the patient was busy all day and had slept little. He never had any problems with little sleep. He had a sudden totally unexpected epileptic seizure around 16.00 and a car crash which was not fatal. He mentioned that it was too much of a coincidence getting this just hours after the vaccine. He was a well trained healthy patient otherwise. He stayed four days in hospital. He underwent computed tomography (CT), magnetic resonance imaging (MR), electroencephalography (EEG), blood test and got his blood pressure checked, results or findings were not reported for any of the tests. On an unknown date, he got COVID-19 virus test done, which was negative. He did not test positive for COVID-19 since having the vaccine. He was not enrolled in clinical trial. No treatment information provided. Company''s 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: 1585620 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: Body temperature; Result Unstructured Data: Test Result:abnormal
CDC Split Type: GBPFIZER INC202100998271

Write-up: Body temperature abnormal; Pain in arm; This is a solicited report from the RA Yellow Card Vaccine Monitor program from a contactable consumer. This is a report received from the Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-YCVM-202108031249149680-VRZSQ. Safety Report Unique Identifier GB-MHRA-ADR 25750452. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Aug2021 (Batch/Lot number was not reported), at the age of 18-year-old, as single dose for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The patient medical history and concomitant medications were not reported. The patient experienced pain in arm on 03Aug2021 with outcome of recovered on 03Aug2021 and body temperature abnormal on 05Aug2021 with outcome of recovered on 06Aug2021. The events were reported as serious (medically significant). The patient underwent lab tests and procedures which included body temperature: abnormal on 05Aug2021. Patient is not enrolled in clinical trial. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events pain in extremity and body temperature abnormal and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1585639 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-08-03
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: lateral flow tests; Test Result: Positive; Comments: Have tested positive with two lateral flow tests.
CDC Split Type: GBPFIZER INC202101012046

Write-up: Have tested positive with two lateral flow tests; Have tested positive with two lateral flow tests; This is a spontaneous report from a contactable consumer. A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER7812), intramuscular in the arm left on 28May2021 16:00 as dose 1, single (at the age of 41-years-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID prior to vaccination. Since the vaccination, the patient tested for COVID-19. On 03Aug2021 18:00, the patient had tested positive with two lateral flow tests. No treatment was received. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 03Aug2021 Have tested positive with two lateral flow tests. The outcome of the events was unknown.


VAERS ID: 1586167 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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 FE8206 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Hypoaesthesia, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INSULIN INJECTION
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy; Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100993570

Write-up: Numbness of limbs; TRUNK REDNESS; Itching; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution . A non-pregnant 47-year-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 03Aug2021 14:45 (Lot Number: FE8206; Expiration Date: 31Oct2021) as single dose (at the age of 47) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Medical history included eggp lant allergy from an unknown date and unknown if ongoing, type1 diabetes mellitus from an unknown date and unknown if ongoing. Patient received Flu vaccination for influenza immunization developing allergy (with symptoms of Itchy skin and numb limbs due to influenza vaccination). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included insulin injection taken for an unspecified indication, start and stop date were not reported. On 03Aug2021 15:00 (15 minutes after the vaccination), the patient experienced numbness of limbs, trunk redness and itching. The outcome of the events was recovered with treatment including Atarax-P drip infusion The reporter stated the event result in doctor or other healthcare professional office/clinic visit. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Hypoaesthesia and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1586234 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004731 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspepsia, Vaccination complication
SMQs:, Gastrointestinal nonspecific dysfunction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrodesis; Depression; Helicobacter pylori infection; Hemiparesis; Hemiplegia; Hiatus hernia; Neuropathic pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Epigastric burning; Vaccination related malaise; This case was received via Agency Regulatory Authority (Reference number: LM20212098) on 11-Aug-2021 and was forwarded to Moderna on 11-Aug-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of DYSPEPSIA (Epigastric burning) and VACCINATION COMPLICATION (Vaccination related malaise) in a 42-year-old female patient who received mRNA-1273 (COVID19 Moderna) (batch no. 3004731) for COVID-19 vaccination. The patient''s past medical history included Helicobacter pylori infection, Neuropathic pain, Depression, Arthrodesis, Hemiparesis, Hiatus hernia and Hemiplegia. On 03-Aug-2021, the patient received first dose of mRNA-1273 (COVID19 Moderna) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced DYSPEPSIA (Epigastric burning) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (Vaccination related malaise) (seriousness criterion hospitalization). On 03-Aug-2021, VACCINATION COMPLICATION (Vaccination related malaise) had resolved. At the time of the report, DYSPEPSIA (Epigastric burning) was resolving. For mRNA-1273 (COVID19 Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No Treatment medication reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Patient?s medical history of Helicobacter infection, hiatus hernia, hemiplegia, hemiparesis, neuralgia, depression, arthrodesis, could be potentially confounders for the events.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Patient?s medical history of Helicobacter infection, hiatus hernia, hemiplegia, hemiparesis, neuralgia, depression, arthrodesis, could be potentially confounders for the events.


VAERS ID: 1586286 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-03
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myasthenia gravis crisis
SMQs:, Immune-mediated/autoimmune 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myasthenia gravis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100995839

Write-up: Myasthenia gravis crisis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123124. A 47-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FD0889; Expiration Date: 30Sep2021), via an unspecified route of administration on 30Jul2021 (at unknown age) as single dose for COVID-19 immunisation. Medical history included Myasthenia gravis as an underlying disease. The patient''s concomitant medications were not reported. The patient was a 47-year old male. Body temperature before vaccination was not provided. There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status, etc) which included Myasthenia gravis as an underlying disease. On 30Jul2021 (The date of the vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot# FD0889, Expiration date 31Sep2021), via an unspecified route of administration as single dose for COVID-19 immunization. On 03Aug2021 at 9:00AM (4 days after the vaccination), the patient experienced Myasthenia gravis crisis. The course of the event was as follows: Before admission, the patient had independent ADL. On 30Jul2021, the patient received the second COVID-19 vaccination. After receiving vaccination, the patient felt malaise with no pyrexia. In the morning on 03Aug2021, the patient experienced dyspnoea, dysphagia, and neck muscle weakness. On the same day, the patient visited the reporter''s hospital as an outpatient. The patient was diagnosed as having a state of myasthenia gravis crisis and admitted to the hospital.The reporter classified the events as serious (Hospitalized from 03Aug 2021) and assessed that the event was the causality between the event and bnt162b2 as related. There was no other possible cause of the event such as any other diseases. On 03Aug2021 (4 days after the vaccination), the outcome of events was not recovered. Reporter''s comment: The patient was considered to have aggravated myasthenia gravis related to the vaccine and admitted to the hospital. The patient would be treated with high-dose intravenous immunoglobulin therapy. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: The patient was considered to have aggravated myasthenia gravis related to the vaccine and admitted to the hospital. The patient would be treated with high-dose intravenous immunoglobulin therapy.


VAERS ID: 1586287 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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 FE8206 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Choking sensation, Heart rate, Oropharyngeal discomfort, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypertension (narrow), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MONTELUKAST; RELVAR ELLIPTA [FLUTICASONE FUROATE;VILANTEROL TRIFENATATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to food (peach, peanuts, beans, corn and eggs); Asthma bronchial; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: BP; Result Unstructured Data: Test Result:203/116; Test Date: 20210803; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination; Test Date: 20210803; Test Name: HR; Result Unstructured Data: Test Result:98; Test Date: 20210803; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202100995921

Write-up: BP 203/116; pharynx strange sensation of; pharynx strangled sensation of; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21122272. The patient was a 53-year and 11-month-old female. Body temperature before vaccination was 36.1 degrees Centigrade. The patient had a medical history of asthma bronchial, allergic reaction to food (peach, peanuts, beans, corn and eggs) and hypertension. The patient took montelukast and fluticasone furoate/ vilanterol trifenatate (RELVAR ELLIPTA) as concomitant drugs. On 03Aug2021 at 13:05 (the day of vaccination, at age of 53-year-old), 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 03Aug2021 at 13:30 (the days of the vaccination), 25 minutes after vaccination, the patient experienced pharynx strange sensation of and pharynx strangled sensation of. BP 203/116, HR 98 SpO2 98%. Fexofenadine OD (60) 1T oral was administered for events. Vital measuring was recovering afterwards. Blood pressure was recovering. As of 03Aug2021 (the days of the vaccination), 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. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Non-serious.; Reporter''s Comments: Non-serious.


VAERS ID: 1586304 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-08-03
   Days after vaccination:31
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: Acute myocardial infarction, Chest pain, Electrocardiogram
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:I II aVL''s ST increased; Comments: I II aVL''s ST increased
CDC Split Type: JPPFIZER INC202100996859

Write-up: STEMI; Chest pain; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21122307. The patient was a 78-year-old female. Body temperature before vaccination was unknwon. The point to be considered on the vaccine screening questionnaire was unknown. Concomitant medications were not reported. On 25May2021, the patient received the first dose of COVID-19 Vaccine - Manufacturer Unknown (lot number unknown) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 03Jul2021 (the day of vaccination), the patient received the second dose of COVID-19 Vaccine - Manufacturer Unknown (lot number unknown) via an unspecified route of administration as a single dose at the age of 78-year-old for COVID-19 immunisation. On 03Aug2021 at 08:40 (1 month after vaccination), the patient experienced chest pain. On 03Aug2021 (1 month after vaccination), the patient was admitted to the hospital. The course of the event was as follows: At 8: 40, chest pain occurred, and the patient applied for first aid, confirmed I II aVL''s ST increased after ECG, diagnosed as STEMI , and performed CAG and PCT. The reporting physician classified the event as serious (hospitalization from 03Aug2021) and assessed that the causality between the event and COVID-19 Vaccine - Manufacturer Unknown as unassessable. Therapeutic measures were taken as a result of events. The outcome of events was unknown. The lot number for bnt162b2, was not provided and will be requested during follow up.


VAERS ID: 1587519 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-03
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Polymerase chain reaction
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: 20210803; Test Name: PCR; Test Result: Positive
CDC Split Type: CRPFIZER INC202101022098

Write-up: Positive for SARS COV2; Positive for SARS COV2; This is a spontaneous report from a non-contactable consumer by a Pfizer colleague through COVAES. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on Jun2021 (Batch/Lot Number: Unknown, Not available/provided to reporter at the time of report completion) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. After vaccination in Jun2021 with the first dose of Pfizer vaccine against COVID-19, presented fatigue, flu symptoms, has no sense of smell or taste. On Tuesday 03Aug2021, a PCR test (swabbing) was performed, the test result, delivered on 05Aug2021, was positive for SARS COV 2. The patient continues with symptoms. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included polymerase chain reaction (PCR): positive on 03Aug2021. The outcome was not recovered. No follow-up attempts are possible, information on the lot/batch number cannot be request. No further information is expected.


VAERS ID: 1588864 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Cough, Drug ineffective, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Histamine intolerance; Multiple allergies
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: fever; Result Unstructured Data: Test Result:until 38 Centigrade; Test Date: 20210803; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: DEPFIZER INC202101017960

Write-up: cough; fever until 38 degree; pain in upper body; tested positive after two vaccinations; tested positive after two vaccinations; This is a spontaneous report from a contactable consumer (patient). This is a report based on information received by Pfizer from LLP-BioNtech SE, license party for Comirnaty. A 34-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: unknown) and the second dose of BNT162B2 (lot number: unknown), both on an unspecified date at single dose for COVID-19 immunisation. Medical history included allergies and histamine intolerance. The patient''s concomitant medications were not reported. The patient was tested positive on COVID-19 (PCR test) on 03Aug2021. Until today (05Aug2021) no symptoms. The patient experienced symptoms since the evening (05Aug2021): cough, fever until 38 degree, pain in upper body. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 03Aug2021, fever: until 38 centigrade on 05Aug2021. The outcome of events was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1589133 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998516

Write-up: Chest pain; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority. Regulatory authority report number: GB-MHRA-APPCOVID-20210803203856, Safety Report Unique Identifier: GB-MHRA-ADR 25749979. A 21-year-old male patient received unknown dose number of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 02Aug2021 17:00 as single dose for COVID-19 immunisation. No relevant medical history. He has not had symptoms associated with COVID-19 and not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced chest pain on 03Aug2021 07:00. Event was reported as serious by health authority (disability). Case narrative: He had his vaccine around 17:00 on the 02/08/2021. Today at 07:00 03/08/2021, he started having excruciating pain in his chest (right side) and the pain still hasn''t gone at the time of writing this (20:46). Feeling area of chest and it''s painful. Moving around also hurt. He underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 02Aug2021. The outcome of chest pain was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589209 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   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: Investigation, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: lateral flow test; Test Result: Negative ; Test Date: 20210801; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998353

Write-up: Ache; Fever; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202108031245011300-ELBG5. Safety Report Unique Identifier is GB-MHRA-ADR 25746546. A 31-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FD8813), via an unspecified route of administration on 02Aug2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. The patient experienced ache and fever on 03Aug2021. The events were reported as serious per other medically important condition. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Any relevant investigations or tests conducted included negative lateral flow test on Aug2021. The patient underwent a COVID-19 virus test on 01Aug2021: No - Negative COVID-19 test. The patient had not recovered from the reported events. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1589210 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fainting; fear of needles.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998321

Write-up: This is a spontaneous report from a contactable pharmacist, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202108031257269350-LUCHJ; safety report unique identifier: GB-MHRA-ADR 25746572). A 32-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# FD8813; expiration date: not provided), at the age of 32, via an unspecified route of administration, on Aug 3, 2021, single dose, for COVID-19 immunisation. Patient''s medical history included fear of needles and ''fainted before'' from unknown dates and unknown if ongoing. Patient has not had symptoms associated with COVID-19, nor had a COVID-19 test. Patient not enrolled in a clinical trial. The patient''s concomitant medications not reported. The patient fainted on Aug 3, 2021 and had a small abrasion on the skin on his head. Patient''s clinical course as follows: Reportedly, patient was put in recovery position, and had a small abrasion on the skin on his head. The events assessed serious (medically significant). Patient has not tested positive for COVID-19 since the vaccination. The report does not relate to possible blood clots or low platelet counts. Outcome of fainting recovered on Aug 3, 2021; outcome of small abrasion on the skin on his head: unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1589240 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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: Typical aura without headache
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998650

Write-up: Acephalalgic migraine; 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-202108031703588950-CTISL, Safety Report Unique Identifier GB-MHRA-ADR 25748346. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number not known; expiration date not provided), via an unspecified route of administration on 03Aug2021 as DOSE 2, SINGLE for COVID-19 immunisation. 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. Patient is not enrolled in clinical trial. The patient experienced acephalalgic migraine on 03Aug2021. The event was assessed as serious (medically significant). The patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1589247 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   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: Arthralgia, Headache, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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 INC202100998205

Write-up: Vomiting; Nausea; Joint ache; Headache; /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-202108031803526830-84ENU. Safety Report Unique Identifier is GB-MHRA-ADR 25748918. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; Lot Number: FE3380; batch no/Expiry date: not reported) via an unspecified route of administration on 02Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 03Aug2021, the patient experienced vomiting and nausea, joint ache, headache. The patient underwent lab tests and procedures which included sars-cov-2 test results negative for COVID-19 test on 03Aug2021. Outcome of the events joint ache and headache not recovered and outcome of the events vomiting, and nausea was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589254 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   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, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998568

Write-up: Vomiting; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108031849035830-BIM1T, Safety Report Unique Identifier: GB-MHRA-ADR 25749202. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Aug2021 (Lot number 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 vomiting and headache on 03Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of both events was recovered on 03Aug2021. 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: 1589266 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   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: Dyspnoea, Heart rate, Heart rate increased, Muscular weakness, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased.
Allergies:
Diagnostic Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:fluttering; Test Name: very different to anxious heart rate; Result Unstructured Data: Test Result:Increased
CDC Split Type: GBPFIZER INC202100998253

Write-up: very different to anxious heart rate; nauseous; short of breath; weak arms and legs; Heart rate; Shortness of breath; 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-202108031949191470-HHDMT, Safety Report Unique Identifier GB-MHRA-ADR 25749611. A 30-year-old female patient had received BNT162B2 second dose of (PFIZER-BIONTECH COVID-19 VACCINE solution for injection),(Lot number was not reported) via an unspecified route of administration on 02Aug2021 as dose 2, single for COVID-19 immunisation.Dose 1, single for COVID-19 immunization was taken Historical Vaccine. The patient medical history included suppressed lactation from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient had no symptoms associ-ated with COVID-19 and did not do a COVID-19 test. Patient was not pregnant and was not currently breastfeeding. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date,the patient had experienced very different to anxious heart rate (heart rate increased),nauseous (nausea),short of breath (dyspnoea) and muscle weakness.On 03Aug2021, the patient had experienced heart rate and shortness of breath (dyspnoea).This events were considered as medically significant. The patient underwent lab tests and procedures which included heart rate: fluttering on an unspecified date, heart rate: increased on an unspecified date. The clinical outcome of the events was unknown for heart rate increased , nausea ,dyspnea and muscular weakness and for the event heart rate was resolving dyspnea was resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589272 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-03
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Mood swings, SARS-CoV-2 test
SMQs:, Dementia (broad), Depression (excl suicide and self injury) (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: CLONAZEPAM; HYDROXYCHLOROQUINE; LAMOTRIGINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Inflammatory arthritis; Juvenile myoclonic epilepsy; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998206

Write-up: I feel aggressive Tearful Anxious; Mood swings; This is a spontaneous report from a contactable consumer(Patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108032027094180-OUASV. Safety Report Unique Identifier GB-MHRA-ADR 25749896. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 01Aug2021 as dose 1, single for COVID-19 immunisation. Medical history included rheumatoid arthritis: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr, epilepsy, Inflammatory arthritis and Juvenile myochlonic epilepsy. Concomitant medication(s) included clonazepam (CLONAZEPAM) taken for epilepsy from 01Mar2011 to an unspecified stop date; hydroxychloroquine (HYDROXYCHLOROQUINE) taken for arthritis from 01Jul2021 to an unspecified stop date; lamotrigine (LAMOTRIGINE) taken for epilepsy from 2007 to an unspecified stop date. Patient has not had symptoms associated with COVID-19. Reporter stated that, she was not due on her period she feels aggressive Tearful Anxious. On 03Aug2021, the patient experienced mood swings and on an unspecified date, i feel aggressive tearful anxious. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date, No-Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event mood swings was not recovered and I feel aggressive Tearful Anxious was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589310 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   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 FE338AE / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Pain, Pain in extremity, Peripheral swelling, Swelling, Vaccination site pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998435

Write-up: Normal pain from the injection spot; extreme pain underarm; hurts to raise arm, feels swollen and painful; hurts to raise arm, feels swollen and painful; pain; Swelling; This is a spontaneous report from a contactable consumer received from the The regulatory authority report number is GB-MHRA-WEBCOVID-202108040514026360-GFMSF, Safety Report Unique Identifier: GB-MHRA-ADR 25750731. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Aug2021 (Lot Number: FE338AE) as dose 2, single for COVID-19 immunisation. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced pain on an unspecified date and swelling on 03Aug2021. Clinical course reported: normal pain from the injection spot, but extreme pain underarm, hurts to raise arm, feels swollen and painful. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event pain was recovered on an unspecified date; swelling was not recovered; and for other events was unknown. Regulatory authority assessed the events as serious: medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589312 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Clinical trial participant
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 INC202100998196

Write-up: Rash; This is a spontaneous report from a contactable consumer or other non HCP received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108040611101390-SLDIL, Safety Report Unique Identifier GB-MHRA-ADR 25750906. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number Not known and Expiration date was not reported), dose 2 via an unspecified route of administration on 01Aug2021 as DOSE 2, SINGLE for covid-19 immunization. Medical history included clinical trial participant from an unknown date and unknown if ongoing. Concomitant medications were not reported. patient has not had symptoms associated with covid-19. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported) on unspecified date as dose 1 single for covid-19 immunization. On 03Aug2021, 2 days after second dose the patient experienced rash. Patient has not tested positive for covid-19 since having the vaccine. The event was reported as serious (disability). The patient underwent lab tests and procedures which included covid-19 virus test negative on 03Aug2021. Outcome of the event was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1589313 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-03
   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 FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: 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: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998274

Write-up: Pain in leg; Tingling feet/hands; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108040637563060-Z54KU, Safety Report Unique Identifier is GB-MHRA-ADR 25750982. A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (Lot Number: FE3380) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pain in leg and tingling feet/hands on 03Aug2021. It was reported that there was pain in one part of leg. Localised to top of vein below his knee, causing foot to tingle. The events were reported as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included SARS-COV-2 test with No - Negative COVID-19 test result on an unspecified date. The patient has not recovered from pain in leg and tingling feet/hands. No follow up attempts are possible. No further information is expected.


VAERS ID: 1589322 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   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 FF 3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Body temperature, Contusion, Fatigue, Headache, Laboratory test, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased.
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210802; Test Name: lat flow test; Test Result: Negative ; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101005765

Write-up: bruised arm; armpit; headache; fatigue; Bruising; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108040828379750-TQQY2. Safety Report Unique Identifier GB-MHRA-ADR 25751466. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Aug2021 (Lot Number: FF 3319) as dose 2,single for COVID-19 immunisation. Medical history included Lactation decreased. Patient was not pregnant. Patient was not currently breastfeeding. Patient has not had symptoms associated with COVID-19. Concomitant medication included paracetamol. Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunisation. The patient experienced bruised arm, armpit, headache, fatigue on unknown date, bruising on 03Aug2021. The patient had bruised arm, but also armpit, down side of breast, unable to lift arm, very uncomfortable and sore (Also fatigue, bit of a headache). The patient also took temperature the last few mornings and did a lat flow test with a negative result on day of vaccine. The patient had negative COVID-19 test. Outcome of bruising was not resolved. Outcome of other events was unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589327 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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, Myalgia, Organic erectile dysfunction, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005706

Write-up: vomiting; morning; Muscle soreness; Headache; 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-202108040913026950-3Z8BM. Safety Report Unique Identifier GB-MHRA-ADR 25751856. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via an unspecified route of administration on 03Aug2021 (Batch/Lot Number: FD8813) as single dose for COVID-19 immunization. The patient medical history was not reported. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced vomiting on an unspecified date, morning on an unspecified date, muscle soreness on 03Aug2021, headache on 03Aug2021. Fine at first followed by muscle soreness the, Headache, Vomiting in morning. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The events were reported as serious due to medically significant. The outcome of the events muscle soreness and headache was not recovered, while the other events were unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589335 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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, Diarrhoea, Headache, Influenza like illness, Malaise, Nausea, Pyrexia, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction; Asthma (had childhood asthma as well); Food allergy (Severe allergic reaction (epi pen carrier) to all nuts, sesame, pink peppercorns and some seeds.); Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Lactation decreased; Rectal bleeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005988

Write-up: flu like symptoms; generally unwell; shivering; sore arm at injection site; Nausea; Feverish; Diarrhea; Generalized joint pain; 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-202108041000525450-DXOJC Safety Report Unique Identifier GB-MHRA-ADR 25752072. A 28-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration on 03Aug2021 (at the age of 28 years) as second dose, single for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included allergic reaction, rectal bleeding, lactation decreased, asthma, immunodeficiency. Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef), food allergy, severe allergic reaction (epi pen carrier) to all nuts, sesame, pink peppercorns and some seeds, as well as childhood asthma. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced flu like symptoms, generally unwell, shivering, sore arm at injection site. On 03Aug2021, the patient experienced headache. On 04Aug2021, the patient experienced feverish, diarrhea, generalized joint pain, nausea. It was reported that headache and sore arm at injection site started a few hours after 2nd dose Pfizer vaccine. Woke up the next day shivering, unable to get warm but running a temperature and feeling generally unwell with flu like symptoms. After a few hours of this, patient also developed nausea and diarrhea. The outcome of flu like symptoms, generally unwell, shivering was reported as recovering. The outcome of sore arm at injection site was unknown. The outcome of other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589336 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Illness, Nausea, Pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; PARACETAMOL; VOLTRAL [DICLOFENAC SODIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Shoulder injury; Shoulder pain; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005906

Write-up: dizzy; headache; very sick; Dizziness; Tiredness; Ache; Nausea; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108041001040560-USH1N, Safety Report Unique Identifier GB-MHRA-ADR 25752084. A 35-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE3380), via an unspecified route of administration on 03Aug2021 (at the age of 35 year old) as dose 2, single for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date. Medical history included lactation decreased from an unknown date and unknown if ongoing , suspected covid-19 from an unknown date and unknown if ongoing. Unsure when symptoms started. Unsure when symptoms stopped , limb injury from an unknown date and unknown if ongoing , arthralgia from an unknown date and unknown if ongoing. Patient is not currently breastfeeding.Concomitant medication(s) included ibuprofen taken for limb injury, start and stop date were not reported; paracetamol taken for limb injury, start and stop date were not reported; diclofenac sodium (taken for arthralgia, start and stop date were not reported. The patient experienced dizzy on an unspecified date, headache on an unspecified date, dizziness on 03Aug2021, tiredness on 03Aug2021, ache on 03Aug2021, nausea on 03Aug2021, very sick on an unspecified date.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. Additional information: Felt fine after vaccine until 7hrs later, felt incredibly tired, bad headache and dizzy. Went to bed, drank lots of water. Did not sleep well, woke up feeling very sick and aching all over. Awoke in morning still aching and a bit dizzy but not as bad. Patient has not tested positive for COVID-19 since having the vaccine.Patient is not enrolled in clinical trial. The outcome of tiredness was recovered on 04Aug2021, ache was not recovered, very sick was unknown. The outcome of other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589339 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 INC202101006022

Write-up: diarrhea; Abdominal pain; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority). The regulatory authority report number is . Safety Report Unique Identifier: . A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 02Aug2021 (Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced diarrhea (medically significant) on an unspecified date with outcome of unknown, severe abdominal pain (medically significant) on 03Aug2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: No - Negative COVID-19 test. Patient has not had symptoms associated with COVID-19. 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 lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589342 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Fatigue, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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 Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005957

Write-up: Fatigue; Backache; Fever; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108041023074120-DSLAV Safety Report Unique Identifier GB-MHRA-ADR 25752171. A 23-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 03Aug2021 as dose 1, single (at age of 23-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. On 03Aug2021, patient experienced fever, backache. On 04Aug2021, patient experienced fatigue. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The case classified as serious (medically significant). The outcome of the event backache was not recovered while outcome of the other events was recovering. No follow-up attempts are possible, Information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1589367 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   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: Arthralgia, Chills, Headache, Lethargy, Lymphadenopathy, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (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), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Chest infection (in last 10 years); Heart murmur (from birth); Lactation decreased; Lung pain
Allergies:
Diagnostic Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:Unknown Results; Test Date: 20210705; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101006029

Write-up: nausea; fever; lethargic; aching joints; Swollen lymph nodes; chills; Fever chills; Joint pain; Headache; Lethargy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The Regulatory authority report number is (GB-MHRA-WEBCOVID-202108041250131360-JCEXX) and the Safety Report Unique Identifier is (GB-MHRA-ADR 25753240). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Aug2021 09:00 (Batch/Lot number was not reported) as Dose 2, Single for COVID-19 immunization. Patient medical history included heart murmur from birth, chest infections in last 10 years, lactation decreased, suspected COVID-19 from 05Jul2021 and ongoing, lung pain. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication(s) included paracetamol (PARACETAMOL) taken for Lung pain. The patient experienced chills on 03Aug2021 02:30, then nausea and fever, lethargic and aching joints on an unspecified date, swollen lymph nodes on 03Aug2021 19:00, fever chills, joint pain, headache, lethargy on 03Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: Positive on 05Jul2021. Clinical course was reported as follow: Previously tested positive for Covid 05Jul, still suffering from post covid symptoms. 2nd Vaccine given 9am 02Aug, chills started 2.30am 03Aug. Then nausea, headache with severe joint pain and very lethargic. Around 7pm on 3rd August noticed swollen lymph nodes in neck, under arm and groin area. Fever still present 04Aug along with swelling of lymph nodes and aching joints. The outcome of Swollen lymph nodes, Lethargy on 03Aug2021 was not recovered, other events outcome was recovering. Patient has not tested positive for COVID-19 since having the vaccine. Case was reported as serious due to Other medically important condition. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589374 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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: Hallucination, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101006097

Write-up: Hallucination; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041402453440-LF3ZE, Safety Report Unique Identifier GB-MHRA-ADR 25753846. A 19-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration on 03Aug2021 (at the age of 19-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On 03Aug2021, the patient experienced hallucination. The event was medically significant. The patient underwent lab tests which showed sars-cov-2 test as no, negative covid-19 test. Outcome of the event was resolved on 04Aug2021. Narrative case summary and further information included case narrative: Hallucination lasted 2 hours. 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: 1589381 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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 FB8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chest discomfort, Fatigue, Inappropriate schedule of product administration, Palpitations, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), 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: Suppressed lactation
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005629

Write-up: chest tightness; Vaccinated arm very heavy and tender; Armpit pain/Next morning armpit sore at rest.; 1st vaccination date: 10Jun2021 2nd vaccination date: 03Aug2021; Palpitations; Tight chest; Fatigue; This is a spontaneous report from a contactable consumer received from the Regulatory Authroity. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041503155040-5YLDH, Safety Report Unique Identifier GB-MHRA-ADR 25754249. A 29-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Lot Number: FB8813), dose 2 via an unspecified route of administration in arm on 03Aug2021 (at the age of 29 years) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased. No previous heart issues. 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. Historical vaccine included first dose of BNT162B2 on 10Jun2021 (lot: CW3143) for COVID-19 immunisation. The patient received 1st vaccination date: 10Jun2021 2nd vaccination date: 03Aug2021, and experienced chest tightness on an unspecified date with outcome of recovering , palpitations, tight chest and fatigue all on 03Aug2021 with outcome of not recovered , armpit pain/next morning armpit sore at rest on 04Aug2021 with outcome of not recovered , vaccinated arm very heavy and tender on an unspecified date with outcome of unknown. All events were assessed as serious with medically significant. The clinical course was reported as follows: Felt tired a couple of hours after the vaccine. By 12 hours later was experiencing frightening palpitations and chest tightness. clinical returned called by 10pm and advised to try to relax and go to A&E if a wave lasts more than 15 mins. This has been ongoing but never reaching 15 minutes of fluttering. Vaccinated arm very heavy and tender. Next morning armpit sore at rest. 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: 1589392 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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: Axillary pain, Cold sweat, Myalgia, Pain in extremity, Pyrexia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative
CDC Split Type: GBPFIZER INC202101005774

Write-up: feel faint; Muscle ache; Feverish; Fever chills; Cold sweat; sore arm; sore arm; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041554228060-CNJQQ. Safety Report Unique Identifier is GB-MHRA-ADR 25754584. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose on 03Aug2021 at the age of 32-year-old for COVID-19 immunization. Medical history included lactation decreased. Concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not pregnant, was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient felt faint on an unspecified date with outcome of recovering, muscle ache on 04Aug2021 with outcome of recovered on 04Aug2021, feverish on 04Aug2021 with outcome of recovering, fever chills on 04Aug2021 with outcome of recovered on 04Aug2021, cold sweat on 04Aug2021 with outcome of recovered on 04Aug2021, sore arm on 03Aug2021 with outcome of recovering. Patient had a sore arm 1-2 hours after injection, then 19 hours after she felt feverish and had sore muscles and ached all over, then she started to feel faint. COVID-19 virus test on 03Jun2021 was no - negative. The events was considered serious as other medically important condition. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589402 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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: Vertigo
SMQs:, Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005746

Write-up: Vertigo; This is a spontaneous report from a contactable consumer, received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108041717067880-56K0A, Safety Report Unique Identifier GB-MHRA-ADR 25755293. A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Aug2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation at age of 31 years old. Medical history included Lactation decreased. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunisation. The patient experienced vertigo (medically significant) on 03Aug2021. Vertigo experienced 3 Hours, 5 hours and 32hours after vaccine. Event outcome was not recovered. 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. No further information is expected.


VAERS ID: 1589404 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Disease recurrence, Fatigue, Migraine, Myalgia, Nasopharyngitis, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (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: PROPRANOLOL; SERTRALIN [SERTRALINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Lactation decreased; Migraine
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negetive; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005713

Write-up: Vomiting; Migraine; Migraine; Muscle ache; Cough; Cold; Tiredness; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041728034630-JKIBC, Safety Report Unique Identifier GB-MHRA-ADR 25755335. A 32-years-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot Number: FE3380), the second dose via an unspecified route of administration on 03Aug2021 as single dose for COVID-19 immunisation. Medical history included lactation decreased from an unknown date, migraine from an unknown date, depression from an unknown date. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medication included propranolol taken for migraine from 01Feb2017 to an unspecified stop date; sertraline (SERTRALIN) taken for depression from 01Feb2017 to an unspecified stop date. The patient experienced vomiting on 04Aug2021, migraine on 04Aug2021, muscle ache on 04Aug2021, cough on 04Aug2021, cold on 03Aug2021, tiredness on 03Aug2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The events were reported as serious due to medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 03Aug2021 (No - Negative COVID-19 test). The outcome of the event vomiting and muscle ache was recovering, while the other events were not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589410 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-03
   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 - / 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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101006170

Write-up: Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041804523220-N7TPQ, Safety Report Unique Identifier GB-MHRA-ADR 25755514. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 01Aug2021 as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19. The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. On 03Aug2021, the patient experienced diarrhea. The reporter considered the event as serious (other medically important condition). 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 resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589415 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-03
   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: 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: SYMBICORT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005966

Write-up: persistent headache; Headache; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041831527560-EV3FQ. A 35-years-old female patient received second dose of bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on 01Aug2021 as DOSE 2, SINGLE for covid-19 immunization. Medical history included pregnancy and asthma. Concomitant medications included budesonide and formoterol fumarate taken for asthma. The patient experienced persistent headache on an unspecified date and headache on 03Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. Therapeutic measures were taken as a result of persistent headache and headache. Persistent headache, worsened on day 2 than day 1, regular paracetamol was not helping. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The events were assessed as serious. The outcome of event for persistent headache was unknown while of Headache was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.


VAERS ID: 1589417 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Muscular weakness, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
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 INC202101005655

Write-up: Headache fullness; Muscle weakness; Painful arm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108041855301610-EDN7B. Safety Report Unique Identifier is GB-MHRA-ADR 25755961. A 36-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), (Lot Number: FE3380), via an unspecified route of administration on 03Aug2021 at age of 36-year-old as single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication included sertraline. The patient experienced painful arm and muscle weakness on 03Aug2021, headache fullness on 04Aug2021. COVID-19 virus test on 03Aug2021 was No-Negative COVID-19 test. The event was considered as serious per disability. The outcome of the events was not recovered. 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: 1589418 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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, Back pain, Chills, Eye pain, Headache, Malaise, Off label use, Pain, Product use issue, Pyrexia, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Glaucoma (broad), Hypersensitivity (broad), Arthritis (broad), Medication errors (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: PROPRANOLOL
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005782

Write-up: i feel really ill; my body hurts all over; Off label use; Drug use in unapproved population; Back pain; Eye pain; Headache; Skin peeling; Joint pain; Chills; Feverish; This is a spontaneous report from a contactable consumer (patient). This consumer reported for the information of both mother and baby case. This is a maternal case report. The maternal report is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108041912598380-ZN4DV, Safety Report Unique Identifier GB-MHRA-ADR 25756133. A 29-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine) via an unspecified route of administration (at the age of 29-year-old) on 03Aug2021 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing breast feeding; anxiety. Patient had not symptoms associated with COVID-19 or had not a COVID-19 test Patient was not pregnant. Historical vaccine included the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine) on unspecified date for COVID-19 Immunisation. Concomitant medication included propranolol taken for anxiety from 31Jan2021. The patient experienced "I feel really ill and my body hurts all over" on an unspecified date, feverish on 03Aug2021, headache on 04Aug2021, skin peeling on 04Aug2021, joint pain on 03Aug2021, chills on 03Aug2021, back pain on 04Aug2021, eye pain on 04Aug2021. Above events reported as serious as medically significant. And the patient experienced off label use and drug use in unapproved population on an unspecified date. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of event I feel really ill was recovering, of event feverish, headache, skin peeling, joint pain, chills, back pain and eye pain was not recovered, of remain event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101013464 Baby case


VAERS ID: 1589421 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   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 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Feeling abnormal, SARS-CoV-2 test, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101005643

Write-up: feeling giddy and weird; tired; feeling giddy and weird; Blurry vision; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041927422420-EUU1H. Safety Report Unique Identifier GB-MHRA-ADR 25756186. A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Aug2021 (Lot Number: Fe3380) as single dose for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The concomitant medications were not reported. The patient experienced blurry vision on 03Aug2021. The events were considered as serious medically significant. Patient keep feeling giddy and weird and tired on an unspecified date. The COVID-19 virus test was No - Negative COVID-19 test on an unspecified date. The outcome of the event blurry vision was not recovered, of other events was unknwon. Patient has not tested positive for COVID-19 since having the vaccine No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589424 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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: Abdominal pain upper, Chills, Fatigue, Feeling hot, Headache, Joint stiffness, Malaise, Musculoskeletal stiffness, Pain, SARS-CoV-2 test, Vaccination site pain
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), 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; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Inconclusive test
CDC Split Type: GBPFIZER INC202101006054

Write-up: Headache; Shooting pain; Stomach pain; Chills; Feeling hot; Feeling sick; Stiff neck; Stiff knees; Fatigue; Pain injection site; 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-202108042015005580-BMZYE. Safety Report Unique Identifier GB-MHRA-ADR 25756498. A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Aug2021 (Batch/Lot number was not known) (at the age of 34 year old) as single dose for COVID-19 immunisation. Medical history included Lactation decreased, suspected covid-19 from 01Oct2020 to 17Oct2020. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced headache on 04Aug2021, shooting pain on 04Aug2021, stomach pain on 04Aug2021, chills on 04Aug2021, feeling hot on 04Aug2021, feeling sick on 04Aug2021, stiff neck on 04Aug2021, stiff knees on 04Aug2021, fatigue on 04Aug2021, pain injection site on 03Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: Inconclusive test on an unspecified date. This report was serious (medically significant). Patient was not enrolled in clinical trial. The outcome of the events Pain injection site, headache, shooting pain, feeling hot, stiff neck and fatigue was not recovered; of events stomach pain, chills, feeling sick and stiff knees was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589425 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Menstruation delayed, Nausea, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility disorders (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Lateral flow test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101012598

Write-up: Shooting pain; Nausea; Tiredness; Delayed period; Headache; This is a spontaneous report from a contactable consumer (Patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108042026132070-VS0JH. Safety Report Unique Identifier GB-MHRA-ADR 25756537. A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number FE3380) via an unspecified route of administration on 03Aug2021 (at the age of 22 years) as single dose for COVID-19 immunization. Medical history included headache. Unsure if patient had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Concomitant medication included paracetamol (PARACETAMOL) taken for headache from 03Aug2021 to an unspecified stop date. The patient previously took dianette. She was on dianette for a few years but came off it around November 2020 due to having a health problem with her legs. Reason for health problem was still unknown, but GP seemed confident it was not a blood clot. On 03Aug2021, the patient experienced headache, tiredness, delayed period. On 04Aug2021, the patient experienced shooting pain, nausea. It was reported that ongoing headache, tired and nauseous. Sharp shooting pain around the inside of arm (arm of injection). When the pain occured, it lasted for a few seconds, and tended to appear in 10-15-minute intervals. Throughout the day it was mainly been 25-minute intervals, but from 5:30pm today (at the time of reporting) they had been more frequent. Patient was also concerned that she has not had a period since her first vaccination in May. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Aug2021 and Lateral flow test- negative on an unspecified date. The outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589436 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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: Back pain, Fatigue, Headache, Hypoaesthesia, Musculoskeletal stiffness, Paraesthesia, SARS-CoV-2 test, Sensory disturbance, Vaccination site pain, Vaccination site warmth
SMQs:, Peripheral neuropathy (narrow), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESTRADIOL; IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hormone replacement therapy; Lactation decreased; Migraine; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005871

Write-up: the sensation; numbness; The injection site is hot; Fatigue; Stiff neck; Localised numbness; Pins and needles; Pain back; Injection site pain; Headache; 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-202108042222499860-P5UXG, Safety Report Unique Identifier GB-MHRA-ADR 25756900. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 47-years-old, dose 2 via an unspecified route of administration on 03Aug2021 (Lot Number: FD8813) as SINGLE for covid-19 immunisation. Medical history included Lactation decreased, suspected covid-19 from 07Mar2020 to an unknown date, Unsure when symptoms stopped, hormone replacement therapy, migraine. Concomitant medications included estradiol taken for hormone replacement therapy from 2020 to an unspecified stop date; ibuprofen taken for migraine, start and stop date were not reported. No known illnesses. Patient is not pregnant. Patient is not currently breastfeeding. The patient experienced the sensation on an unspecified date with outcome of recovering, numbness on an unspecified date with outcome of recovering , localised numbness on 04Aug2021 with outcome of not recovered, pins and needles on 04Aug2021 with outcome of not recovered , pain back on 04Aug2021 with outcome of not recovered , injection site pain on 03Aug2021 with outcome of not recovered , headache on 03Aug2021 with outcome of not recovered, fatigue on 04Aug2021 with outcome of not recovered, stiff neck on 04Aug2021 with outcome of not recovered, the injection site is hot on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test. Clinical course as follows: The injection site is tender and hot. It has been since the vaccination. I developed a headache approximately three hours later. Approximately 26 hours later, I was standing up, ironing clothing, when I felt suddenly fatigued and felt a strange sensation - parenthesis? - in the left side of my back, around the kidney. This sensation spread across the middle of my back, then moved lower on the left side. I had to stop ironing and seek advice. The pins and needles is surrounded by numbness (I''m still experiencing this) and the sensation is also in my arms and hands (the left side is more affected). My neck is also stiff. Awaiting advice. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. HA seriousness assessment: Other medically important condition. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589454 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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 FY8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Nausea, Neck pain, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEXOFENADINE; MEDIKINET XL; METHENAMINE HIPPURATE; MIRTAZAPINE; SERTRALINE; VITAMIN D [COLECALCIFEROL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005978

Write-up: Vomiting; Neck pain; Nausea; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108050132500820-RN3PC, Safety Report Unique Identifier GB-MHRA-ADR 25756970. A 35-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, (Lot Number: FY8813), via an unspecified route of administration on 03Aug2021 (at 35-years age) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. Patient had 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. Not had a COVID-19 test. Patient was not on breastfeeding. Concomitant medication(s) included fexofenadine (FEXOFENADINE) taken for an unspecified indication; methylphenidate hydrochloride (MEDIKINET XL) taken for an unspecified indication; methenamine hippurate (METHENAMINE HIPPURATE) taken for an unspecified indication; mirtazapine (MIRTAZAPINE) taken for an unspecified indication; sertraline (SERTRALINE) taken for an unspecified indication; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication. The patient was previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/Lot Number: unknown), via unspecified route on an unspecified date as dose 1, single for COVID-19 immunization. The patient had experienced nausea on 03Aug2021, vomiting and neck pain on 04Aug2021. 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 is expected.


VAERS ID: 1589455 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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: Chest discomfort, Chest pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE SODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005985

Write-up: tightness of chest; Pain chest; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108050147295650-ZWCDA. Safety Report Unique Identifier GB-MHRA-ADR 25756974. A 27-year-old (non-pregnant) female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 03Aug2021 as dose 2, single for COVID-19 immunization. The medical history included hypothyroidism. The concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for hypothyroidism from 01Oct2017. The historical vaccine included dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number was not reported) via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunization. Patient did not have symptoms associated with COVID-19. On an unspecified date the patient experienced tightness of chest and on 03Aug2021 pain chest. Patient further reported tightness of chest Struggling to breathe chest pains. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. Events considered as medically significant as per reporter. The outcome of the event tightness of chest was unknown, pain chest was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589481 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   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: Anxiety, Fatigue, Migraine, Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLENIL MODULITE
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; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012833

Write-up: Migraine; Tiredness; Painful arm; Anxiety; This is a spontaneous report from a contactable consumer. This report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108051053040130-YGIEA. Safety Report Unique Identifier GB-MHRA-ADR 25758659. A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number FD8813), dose 2 via an unspecified route of administration on 03Aug2021 (at the age of 31 years) as DOSE 2, SINGLE for covid-19 immunization. Patient was not pregnant at time of vaccination. Patient was not currently breastfeeding. Medical history included lactation decreased. Concomitant medications included beclometasone dipropionate (CLENIL MODULITE) taken for asthma, start and stop date were not reported. Unsure if patient has had symptoms associated with covid-19. Patient was not enrolled in clinical trial. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on unspecified date for covid-19 immunization. The patient underwent lab tests and procedures which included covid-19 virus test no -negative covid-19 test on unspecified date. On 03Aug2021, the patient experienced anxiety. On 04Aug2021, the patient experienced migraine, tiredness and painful arm. Patient has not tested positive for covid-19 since having the vaccine. The events were serious (medically significant). Outcome of the event tiredness was resolved on unspecified date in 2021. Outcome of the other events was resolving. No follow-up attempts are possible. No further information is expected


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