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From the 9/10/2021 release of VAERS data:

Found 686,636 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 338 out of 6,867

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VAERS ID: 1499782 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Headache, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: AMITRIPTYLINE
Current Illness: Migraine
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: Nausea; Headache; Fever chills; Stomach ache; This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever chills) in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Migraine. Concomitant products included AMITRIPTYLINE from 05-Jun-2019 to an unknown date for Migraine. On 18-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On 19-Jul-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 19-Jul-2021, ABDOMINAL PAIN UPPER (Stomach ache), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever chills) 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) (Intramuscular) was unknown. Treatment medication for these events were not reported by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. 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. No further information is expected at this time.


VAERS ID: 1499803 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test
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), 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: MINTEC; OMEPRAZOL
Current Illness:
Preexisting Conditions: Comments: The patient''s medical history was not reported.
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Diarrhea; Aching joints; Nausea; Fever chills; Headache; chills; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), DIARRHOEA (Diarrhea), ARTHRALGIA (Aching joints), NAUSEA (Nausea), PYREXIA (Fever chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s medical history was not reported. Concomitant products included OMEPRAZOL for Hernia hiatal, MENTHA X PIPERITA OIL (MINTEC) for Irritable bowel. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). 18-Jul-2021, the patient experienced CHILLS (chills). On 20-Jul-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On 18-Jul-2021, NAUSEA (Nausea), PYREXIA (Fever chills) and HEADACHE (Headache) had resolved. On 19-Jul-2021, ARTHRALGIA (Aching joints) had resolved. On 20-Jul-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, PAIN IN EXTREMITY (Painful arm) was resolving and CHILLS (chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative covid-19 test (Negative) Negative COVID-19 test. No treatment medication was reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1499807 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Nausea; Fever; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) in a 37-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 18-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 19-Jul-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 20-Jul-2021, PYREXIA (Fever) and NAUSEA (Nausea) had resolved. At the time of the report, HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided. Treatment medication was not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.`; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.`


VAERS ID: 1499834 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Myalgia, Pyrexia, Tonsillitis
SMQs:, Rhabdomyolysis/myopathy (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: flu like symptoms; Tonsillitis; Muscle ache; Joint ache; Fever; Headache; Tiredness; This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), TONSILLITIS (Tonsillitis), MYALGIA (Muscle ache), ARTHRALGIA (Joint ache), FATIGUE (Tiredness), PYREXIA (Fever) and HEADACHE (Headache) in a 33-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. Concurrent medical conditions included Tonsillitis. On 18-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion disability). 18-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion disability). On 19-Jul-2021, the patient experienced TONSILLITIS (Tonsillitis) (seriousness criterion disability), MYALGIA (Muscle ache) (seriousness criterion disability), ARTHRALGIA (Joint ache) (seriousness criterion disability) and PYREXIA (Fever) (seriousness criterion disability). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion disability). On 20-Jul-2021, MYALGIA (Muscle ache), ARTHRALGIA (Joint ache), FATIGUE (Tiredness), PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown and TONSILLITIS (Tonsillitis) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Events were classified as serious by regulatory authority (seriousness criteria: Disability). However, as per medical criteria none of the events was serious (not RA listed and resolved).; Sender''s Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Events were classified as serious by regulatory authority (seriousness criteria: Disability). However, as per medical criteria none of the events was serious (not RA listed and resolved).


VAERS ID: 1501742 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: COJNJFOC20210746643

Write-up: SEIZURE; FAINTING; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity unspecified. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, one total, administered on 17-JUL-2021 at around 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-JUL-2021 at 07:00 the patient had seizure and fainting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure and fainting was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210746643-Covid-19 vaccine ad26.cov2.S-Seizure, Fainting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1504189 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNK / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Nausea, Pruritus, Pyrexia, Rash, SARS-CoV-2 test, Swelling face, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 test Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Muscle ache; Feverish; Headache; Fatigue; Nausea; Dizziness; Facial swelling; Itching; Rash; Vomiting; This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), SWELLING FACE (Facial swelling), PRURITUS (Itching), RASH (Rash), VOMITING (Vomiting), MYALGIA (Muscle ache), PYREXIA (Feverish), HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 21-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), SWELLING FACE (Facial swelling) (seriousness criterion medically significant), PRURITUS (Itching) (seriousness criterion medically significant), RASH (Rash) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 19-Jul-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizziness), VOMITING (Vomiting), PYREXIA (Feverish), HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved, SWELLING FACE (Facial swelling), RASH (Rash) and MYALGIA (Muscle ache) was resolving and PRURITUS (Itching) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) COVID-19 test Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were given by the reporter. No Treatment information were 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. However events for this case are tagged as serious based on the Regulatory Report given, as per medical judgement the events for this case are non serious. 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. However events for this case are tagged as serious based on the Regulatory Report given, as per medical judgement the events for this case are non serious. No further information is expected at this time.


VAERS ID: 1504654 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-18
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache, Hyperpyrexia, Inappropriate schedule of product administration, Injection site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), 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:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: Body temperature; Result Unstructured Data.
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Inappropriate schedule of product administration; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jul-2021 and was forwarded to Moderna on 23-Jul-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA in a 40-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). On 19-Jul-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant), HEADACHE, CHILLS, INJECTION SITE PAIN, ARTHRALGIA and FATIGUE. On 18-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) had resolved. At the time of the report, HYPERPYREXIA, CHILLS, INJECTION SITE PAIN and ARTHRALGIA was resolving and HEADACHE and FATIGUE had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jul-2021, Body temperature: high (High). No concomitant medications were reported. No treatment details were reported. This case concerns a 40-year-old male with a serious unexpected event of hyperpyrexia, and non-serious chills, injection site pain, arthralgia, headache, fatigue, and inappropriate schedule of product administration. Event onset within 24 hours after second dose mRNA-1273. 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 40-year-old male with a serious unexpected event of hyperpyrexia, and nonserious chills, injection site pain, arthralgia, headache, fatigue, and inappropriate schedule of product administration. Event onset within 24 hours after second dose mRNA-1273. 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: 1504747 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Bradycardia, Headache, Hypotension, Muscle spasms, Oxygen saturation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient family history included allergies (father), laxative abuse syndrome (LAS) his grandmother.
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: Oximetry; Result Unstructured Data: normal; Comments: was ok; Test Date: 20210718; Test Name: Blood glucose; Result Unstructured Data: 100 mg/dL
CDC Split Type: PTJNJFOC20210739695

Write-up: FAINT/NAUSEA/BLURRED VISION/FELT GENERALLY UNWELL; BRADYCARDIA; HYPOTENSION; MUSCLE SPASMS; HEADACHE; This spontaneous report received from a parent concerned a 27 year old male. The patient''s height, and weight were not reported. The patient''s family history included allergies (father) and his grandmother had laxative abuse syndrome (LAS). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE393, expiry: UNKNOWN) dose was not reported, 1 total, administered on 18-JUL-2021 12:20 on left arm for prophylactic vaccination. No concomitant medications were reported. On 18-JUL-2021, the patient fainted twice in vaccination centre. On the same day, after vaccination the patient had muscle spasms. The patient felt generally unwell and fainted. It was reported that, when the patient was on stretcher he experienced headache. The physician mentioned hypotension and bradycardia but the patient did not know the values, the patient drank water and had a blurred vision and fainted again and later the patient regained consciousness. It was reported that, the patient was under observation for 2 hours at vaccination centre. The patient also experienced nausea. When the patient arrived at home he ate and drank and remained lying down with legs elevated. The patient''s laboratory data included blood glucose (NR: not provided) 100 mg/dL, and oximetry (NR: not provided) was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from faint/nausea/blurred vision/felt generally unwell, and muscle spasms on 18-JUL-2021, was recovering from headache, and the outcome of hypotension and bradycardia was not reported. This report was associated with product quality complaint: 90000186365. The suspected product quality complaint has been confirmed to be voided (does not meet PQC criteria) based on the PQC evaluation/investigation performed. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210739695-covid-19 vaccine ad26.cov2.s-faint/nausea/blurred vision/felt generally unwell and bradycardia. 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: 1507219 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-18
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
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: Non-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202100925577

Write-up: Deep vein thrombosis; This is a spontaneous report from a contactable physician via a sales representative. A 33-year-old female patient received second dose of bnt162b2 (COMIRNATY; Solution for injection; Batch/Lot number: not reported) via intramuscular route, administered in deltoid Left on 25Jun2021 as dose 2, single for covid-19 immunisation. Relevant Medical history included non-tobacco user from an unknown date and non-obese. The patient''s concomitant medications were not reported. Patient previously received first dose of bnt162b2 (COMIRNATY; Solution for injection; Batch/Lot number: not reported) intramuscular route on 04Jun2021 as dose 1, single for COVID-19 immunisation. On 18Jul2021, the patient experienced deep vein thrombosis. Reporter considered event as non-serious. Therapeutic interventions included treatment with anticoagulants (still taking them). The outcome of the event was recovering. Information on the lot/batch number has been requested.; Sender''s Comments: Based on temporal association and profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event reported cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1507490 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004226 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP062828

Write-up: Anaphylactic shock (cough, pharynx itchy sensation); This regulatory authority case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock (cough, pharynx itchy sensation)) in a 49-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004226) for COVID-19 vaccination. No Medical History information was reported. On 18-Jul-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock (cough, pharynx itchy sensation)) (seriousness criterion medically significant). On 18-Jul-2021, ANAPHYLACTIC SHOCK (Anaphylactic shock (cough, pharynx itchy sensation)) had resolved. No concomitant medication 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 event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1507492 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004226 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: JPTAKEDA2021TJP062870

Write-up: Anaphylaxis (cough, tingling sensation in the throat); This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis (cough, tingling sensation in the throat)) in a 49-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004226) for COVID-19 vaccination. No Medical History information was reported. On 18-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis (cough, tingling sensation in the throat)) (seriousness criterion medically significant). On 18-Jul-2021, ANAPHYLACTIC REACTION (Anaphylaxis (cough, tingling sensation in the throat)) had resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis (cough, tingling sensation in the throat)) to be possibly related. No concomitant medication information was provided by the reporter. On an unknown date, the body temperature of the patient before the first dose of this vaccine was 36.5 degrees Celsius. On 18-Jul-2021, at 10:25, the patient received the first dose of this vaccine. At 10:30, cough developed, and the patient complained of tingling sensation in the throat. No treatment information was provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1509129 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD985 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHJNJFOC20210747990

Write-up: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a female of unspecified age. Initial information was processed along with the additional information received on 23-JUL-2021. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD985, expiry: UNKNOWN) dose was not reported, 1 total administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUL-2021, the patient was diagnosed with COVID-19 infection with all typical symptoms (suspected clinical vaccination failure) and on 22-JUL-2021, the patient lost her sense of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The case is associated with Product Quality Complaint number # 90000186883. This case, from the same reporter is linked to 20210753692.; Sender''s Comments: V0: 20210747990-covid-19 vaccine ad26.cov2.s -Suspected Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1509161 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: PTJNJFOC20210752640

Write-up: SYNCOPE; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-B202107-3732] concerned a 25 year old male, unspecified race and ethnicity. The patient''s weight was 80 kilograms, and height was 186 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: XE393 expiry: Unknown) 0.5 ml, 1 total administered on 17-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 18-JUL-2021, the patient experienced syncope. The action taken with covid-19 vaccine was not applicable. The patient recovered with sequelae from syncope on 18-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Concomitant Medication: N/A; Medication Error occurred: N/A; Other Information: N/A; Sender''s Comments: V0:20210752640- covid-19 vaccine ad26.cov2.s-SYNCOPE. 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: 1510819 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916732

Write-up: COVID-19; This is a spontaneous report from a contactable consumer or other non healthcare professional received from the Regulatory Agency (RA). The regulatory authority report number is GB-RA-WEBCOVID-202107180919307990-LOKAR. Safety report unique identifier GB-RA-ADR 25669581. A 36-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration on 17Jul2021, as single dose for COVID-19 immunisation. The patient medical history included suppressed lactation from an unknown date and unknown if ongoing 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. Patient has not had symptoms associated with COVID-19, and not had a COVID-19 test. Patient was not currently breastfeeding. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration on 19May2021, as single dose for COVID-19 immunisation. On 18Jul2021, the patient experienced COVID-19. The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 1511231 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003658 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP063585

Write-up: Anaphylaxis; This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 20-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003658) for COVID-19 vaccination. No Medical History information was reported. On 18-Jul-2021 at 4:10 PM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). The patient was treated with DEXCHLORPHENIRAMINE MALEATE (intravenous) on 18-Jul-2021 for Anaphylaxis, at an unspecified dose and frequency and SALINE [SODIUM CHLORIDE] on 18-Jul-2021 for Anaphylaxis, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) was resolving. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be possibly related. On an unknown date, body temperature before the vaccination: 36.6 degrees Celsius. No concomitant products were reported. The patient experienced rose-pink rash with itching in the left ear auricle and right forearm. The symptoms suggested anaphylaxis, vital signs were stable with dyspnea. The route was secured for drip infusion of saline, and an intravenous infusion of d-chlorpheniramine maleate was administered. Subsequently, itching disappeared, and rash was also alleviated. The reporter stated that the patient was considered to experience allergic symptoms which did not cause a shock symptom. The patient was advised not to receive the second vaccination at a large scale vaccination site. Other contributing factors included atopic dermatitis. It was reported that a follow-up investigation would be made. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1512131 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003654 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Loss of consciousness, Presyncope
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? 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:
CDC Split Type: JPTAKEDA2021TJP062956

Write-up: Loss of consciousness; Vasovagal reflex (feels poorly); This case was received via Regulatory Authority (Reference number: 2021TJP062956) on 20-Jul-2021 and was forwarded to Moderna on 28-Jul-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) and PRESYNCOPE (Vasovagal reflex (feels poorly)) in a 19-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003654) for COVID-19 vaccination. No Medical History information was reported. On 18-Jul-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criteria hospitalization and medically significant) and PRESYNCOPE (Vasovagal reflex (feels poorly)) (seriousness criterion hospitalization). The patient was hospitalized on 18-Jul-2021 due to LOSS OF CONSCIOUSNESS and PRESYNCOPE. At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness) and PRESYNCOPE (Vasovagal reflex (feels poorly)) was resolving. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered LOSS OF CONSCIOUSNESS (Loss of consciousness) and PRESYNCOPE (Vasovagal reflex (feels poorly)) to be possibly related. Concomitant product use was not provided by the reporter. No treatment information was provided. On 18-Jul-2021, at 10:05, feels poorly developed, and the patient subsequently lost consciousness. Symptoms of vasovagal reflex were noted. The patient was transported to an emergency outpatient department. The patient improved after the transport. There were no symptoms of queasy, vomiting, or respiratory discomfort. After 10 minutes of follow-up, symptoms improved, and the patient returned home. This case, initially reported to the Regulatory Authority by a pharmacist, was received via PMDA (Ref. v21120384). 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.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded


VAERS ID: 1513799 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT REPORTED / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Palpitations, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (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: CITALOPRAM; IBUPROFEN; PARACETAMOL; PARAMOL [DIHYDROCODEINE BITARTRATE;PARACETAMOL]; PIRITON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Backache; Hay fever; Head pain; Lactation decreased; Migraine; Stress
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916801

Write-up: Palpitations; Heart racing; Felt faint; Tingling feet/hands; 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-202107182313568660-HUM3N, Safety Report Unique Identifier GB-MHRA-ADR 25670177. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not reported), via an unspecified route of administration on 16Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history included lactation decreased, stress, backache, headache, migraine, and hay fever. The patient had not had symptoms associated with COVID-19, was not pregnant, was not enrolled in clinical trial and was not currently breastfeeding. The patient received historical vaccine, which included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Concomitant medications included citalopram taken for stress, ibuprofen taken for back pain, paracetamol taken for head pain and dihydrocodeine bitartrate, paracetamol (PARAMOL [DIHYDROCODEINE BITARTRATE, PARACETAMOL]) taken for migraine, chlorphenamine maleate (PIRITON) taken for hay fever. On 18Jul2021, the patient experienced palpitations, heart racing, felt faint and tingling feet/hands. The patient underwent lab tests and procedures which included Covid-19 virus test: negative on an unspecified date: No - Negative COVID-19 test. The patient had not tested positive for COVID-19 since having the vaccine. The outcome of the events was recovered on 18Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1513811 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Paraesthesia, Pyrexia, SARS-CoV-2 test, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (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 Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 virus test was reported as negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Vertigo; Diarrhea; Vomiting; Chills; Fever; Pins and needles; This regulatory authority case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), PARAESTHESIA (Pins and needles), DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills) and PYREXIA (Fever) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced PARAESTHESIA (Pins and needles) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 19-Jul-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On 21-Jul-2021, the patient experienced VERTIGO (Vertigo) (seriousness criterion medically significant). On 19-Jul-2021, CHILLS (Chills) had resolved. On 20-Jul-2021, VOMITING (Vomiting) and PYREXIA (Fever) had resolved. On 21-Jul-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, VERTIGO (Vertigo) and PARAESTHESIA (Pins and needles) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, SARS-CoV-2 test: negative (Negative) COVID-19 virus test was reported as negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment information was not provided. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1513814 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-07-18
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhage, Menstrual disorder, Muscle spasms, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (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; MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]; MODAFINIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201215; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: bleeding; cramps; Menstruation abnormal; This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased and Suspected COVID-19 (Unsure when symptoms stopped) on 14-Dec-2020. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]) for Heavy periods, MODAFINIL for Hypersomnia, LEVOTHYROXINE for Hypothyroidism. On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced MENSTRUAL DISORDER (Menstruation abnormal). On an unknown date, the patient experienced HAEMORRHAGE (bleeding) (seriousness criterion medically significant) and MUSCLE SPASMS (cramps). At the time of the report, HAEMORRHAGE (bleeding) and MUSCLE SPASMS (cramps) outcome was unknown and MENSTRUAL DISORDER (Menstruation abnormal) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. There was no treatment medication reported. For many years the patient have been taking Microgynom continuously to control her periods and very rarely have any spotting at all. If she do it was very light and usually as a result of a delayed or missed pill. On this occasion though she experienced close to a full period without any disruption in her pill taking. Patient has not tested positive for COVID-19 since having the vaccine. Patient is 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. Very limited information has been provided at this time. 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. Very limited information has been provided at this time. No further information is expected


VAERS ID: 1514110 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-07-18
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Oculomucocutaneous syndrome, Rash
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to vaccine (Influenza vaccine.); Drug allergy (Ibuprofen); Drug allergy (Cefcapene pivoxil hydrochloride hydrate); Drug allergy (Benzoyl peroxide.); Fruit allergy (Pineapple); Fruit allergy (Melon.); Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: body temperature before vaccination-36.4 degrees Celsius.
CDC Split Type: JPTAKEDA2021TJP063586

Write-up: Oculomucocutaneous syndrome; Rash; This case was received via Regulatory Authority(Reference number: 2021TJP063586) on 20-Jul-2021 and was forwarded to Moderna on 28-Jul-2021. This regulatory authority case was reported by a nurse and describes the occurrence of OCULOMUCOCUTANEOUS SYNDROME (Oculomucocutaneous syndrome) in a 27-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Cefcapene pivoxil hydrochloride hydrate), Penicillin allergy, Drug allergy (Benzoyl peroxide.), Drug allergy (Ibuprofen), Fruit allergy (Melon.), Fruit allergy (Pineapple) and Allergy to vaccine (Influenza vaccine.). On 20-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced OCULOMUCOCUTANEOUS SYNDROME (Oculomucocutaneous syndrome) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced RASH (Rash). The patient was treated with BETAMETHASONE at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE DK) at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, OCULOMUCOCUTANEOUS SYNDROME (Oculomucocutaneous syndrome) was resolving and RASH (Rash) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 36.4 (normal) body temperature before vaccination-36.4 degrees Celsius.. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. After second dose on 18 Jul 2021 at 15:15, the patient developed a rash of approximately 5cm by 15 cm slightly medial to the vaccination site and intense itching. Concomitant medications were not reported. The reporter did not provide causal relationship between mRNA-1273 (COVID 19 Vaccine Moderna) and the events. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.However patient has known history of multiple Allergies including allergy to Influenza vaccine.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.However patient has known history of multiple Allergies including allergy to Influenza vaccine.


VAERS ID: 1514112 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neuropathy peripheral, Paraesthesia, Vasculitis
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Vasculitis (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP064280

Write-up: Peripheral nerve disorder (numbness of both lower extremities); Paraesthesia; Vasculitis; This regulatory authority case was reported by a physician and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral nerve disorder (numbness of both lower extremities)) in a 26-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced NEUROPATHY PERIPHERAL (Peripheral nerve disorder (numbness of both lower extremities)) (seriousness criterion medically significant), PARAESTHESIA (Paraesthesia) and VASCULITIS (Vasculitis). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral nerve disorder (numbness of both lower extremities)), PARAESTHESIA (Paraesthesia) and VASCULITIS (Vasculitis) had not resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. It was reported that immediately after the patient received the vaccination, experienced numbness, which was gradually aggravated from the left shoulder to both lower extremities. The patient visited a dermatologist two hours after the vaccination. Vital signs were normal. The numbness was noted in the whole area distal to both knees, and it was especially severe in the whole dorsum of foot. The symptoms of peripheral nerve disorder, paresthesia, and vasculitis were noted. These symptoms were aggravated in a sitting position, and the possibility of orthopedic disease was also considered. Sensory and movement disorders or clear muscle weakness were not noted, and peripheral neuro disorder was most suspected based on non-segmental paresthesia. The examination was not possible at the current hospital, and the patient was thus referred to a nearby neurology hospital. Follow-up investigation will be made. No treatment information was provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1514129 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: MXPFIZER INC202100922275

Write-up: yesterday I had a nosebleed and expelled a small clot; yesterday I had a nosebleed and expelled a small clot; This is a spontaneous report from a non-contactable consumer (patient), received from Marketing Program NCSP 002496. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), dose 2 via an unspecified route of administration on 17Jul2021 as SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that, yesterday I had a nosebleed and expelled a small clot on 18Jul2021, the bleeding had stopped but I do not know if this reaction is normal. The patient experienced yesterday i had a nosebleed and expelled a small clot on 18Jul2021. The outcome of the events was recovered on an unspecified date. No FU attempts are needed. No further information expected. Information about batch number cannot be obtained.


VAERS ID: 1514944 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 210A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral thrombosis, Computerised tomogram, Headache, Ischaemic stroke, Magnetic resonance imaging
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
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: The patient did not had any preexisting pathology and did not use any continuous medication, says that he was an athlete and had a very healthy life.
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: Magnetic resonance imaging; Result Unstructured Data: appeared ischemical vascular accident (isc), it was found with a micro; Test Date: 20210718; Test Name: Computerized tomography; Result Unstructured Data: Did not present any change
CDC Split Type: BRJNJFOC20210749887

Write-up: INTENSE HEADACHE; ISCHEMICAL VASCULAR ACCIDENT; MICROCLOTS IN THE THALAMUS REGION; This spontaneous report received from a consumer concerned a 42 year old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient did not have pre-existing pathology and did not used any continuous medication. It was reported that he was an athlete and had a very healthy life at the time of vaccination. The patient received Covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: 210A21A, expiry: unknown) dose was not reported with frequency1 total administered on 30-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUL-2021, the patient experienced ischemical vascular accident (ISC) in the thalamus region and then he took glucose immediately and waked up, but he was still disoriented, spoke disconnected words and mental confusion, also taken to the hospital. Laboratory tests of the patient included the first computerized tomography (CT) reported as not presented any change, but in the magnetic resonance examination (MRI) reported as ischemical vascular accident (ISC) found with a microclots in the thalamus region. The other lab exams were normal. In addition to the hospital doctors team, the patient had a particular neurologist doctor who was also following the case. On 22-JUL-2021, the patient experienced or began with intense headache. Treatment medication included tramadol used for headache. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ischemical vascular accident, intense headache and microclots in the thalamus region was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0- 20210749887-Covid-19 vaccine ad26.cov2.S- Ischemical Vascular Accident, Microclots in the thalamus region. 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: 1515840 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202100917437

Write-up: I took the Pfizer vaccine and I''m breastfeeding; I took the Pfizer vaccine and I''m breastfeeding; mastitis; This is a spontaneous report from a non-contactable consumer (patient) from Customer Service. This consumer reported information for both mother and child. This is the mother report. A female patient of unspecified age received BNT162B2 (COMIRNATY, Solution for injection, Batch Number/Lot Number were not reported) via unspecified route on an unspecified date as single dose for COVID-19 Immunization. Medical history and concomitant medications was not reported. On an unspecified date Friday patient took the Pfizer vaccine and she was breastfeeding. Yesterday (On 18-Jul-2021) a mastitis started, and the physician prescribed cefalexin. The patient would like to know if she can use the drug or if it will interfere with her immunization. The patient also reported, that if there is a recommendation on how many days after using the vaccine, she should start using the medication and also she can take ibuprofen. The clinical outcome of the event mastitis 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) : BR-PFIZER INC-202100929545 child case


VAERS ID: 1516926 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202100916819

Write-up: Fainting; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107180840404440-IMLW3. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 25669544 A 32-years-old female patient received bnt162b2 (BNT162B2)(PFIZER-BIONTECH COVID-19 VACCINE) , dose 2 via an unspecified route of administration on 17Jul2021 (Batch/Lot Number: ff3319) as DOSE 2, SINGLE for covid-19 immunization. The patient also received dose 1 of bnt162b2 on unknown date. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient medical history and concomitant medications were not reported. The patient experienced fainting (medically significant) on 18Jul2021 with outcome of recovering and dizziness (medically significant) on 18Jul2021 with outcome of not recovery. Patient is not enrolled in clinical trial No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516936 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-18
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210716; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916625

Write-up: Vomiting; Diarrhea; Bowel incontinence; Hot flush; This is a spontaneous report from a contactable consumer. This report is received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107181226458880-QDYWO. Safety Report Unique Identifier is GB-MHRA-ADR 25669696. A patient of unspecified age and gender received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), (Lot number was not reported), via an unspecified route of administration at single dose on Jul2021 for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced vomiting on 18Jul2021 with outcome of unknown, diarrhea on 18Jul2021 with outcome of unknown, bowel incontinence on 18Jul2021 with outcome of unknown, hot flush on 18Jul2021 with outcome of unknown.Seriousness criteria:medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Jul2021 No - Negative COVID-19 test. Additional information: Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516939 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Seizures (being investigated but not known epileptic)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916741

Write-up: Seizure; Seizure; This is a spontaneous report from a contactable other healthcare professional received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107181422192070-LS2EE, Safety Report Unique Identifier GB-MHRA-ADR 25669764. A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FC9001) on 18Jul2021 as dose 2, single for COVID-19 immunization, at the age of 22-years-old. The patient medical history included previously suffering seizures and was being investigated but not known epileptic; she was also a very anxious patient. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced seizure on 18Jul2021. The event was reported as serious as important medical event. The report did not relate to possible blood clots or low platelet counts. Patient was seen by medics and under review. Patient had not tested positive for COVID-19 since having the vaccine. The patient had recovered from the event on 18Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516948 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Cardiac flutter, Chest pain, Dizziness, Electrocardiogram, Heart rate increased, Hypertension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:180; Comments: sudden 180 bpm heart rate without any exercise. after couple of hours heart rate went down to 120 with dull left chest pain.; Test Name: blood test; Result Unstructured Data: Test Result:Unknown; Test Name: ECG; Result Unstructured Data: Test Result:Unknown; Test Name: Very high blood pressure; Result Unstructured Data: Test Result:Very high blood pressure
CDC Split Type: GBPFIZER INC202100916739

Write-up: lightheaded; dizziness; chest pain; fainting; Very high blood pressure; fluttering heart beat; Heart rate high; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107181918537920-PWKSN. Safety Report Unique Identifier GB-MHRA-ADR 25669930. A 33-year-old patient of an unspecified gender received BNT162B2 (at the age of 33-year-old) (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Jul2021 (Lot Number: FA1027) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient had not a COVID-19 test. The patient experienced lightheaded (medically significant, life threatening) on an unspecified date with outcome of unknown, dizziness (medically significant, life threatening) on an unspecified date with outcome of unknown, chest pain (medically significant, life threatening) on an unspecified date with outcome of unknown, fainting (life threatening) on an unspecified date with outcome of unknown, heart rate high (medically significant, life threatening) on 18Jul2021 with outcome of recovering, very high blood pressure (medically significant, life threatening) on an unspecified date with outcome of unknown, fluttering heart beat (medically significant, life threatening) on an unspecified date with outcome of unknow. The patient underwent lab tests and procedures which included blood pressure measurement: 180 on an unspecified date sudden 180 bpm heart rate without any exercise. After couple of hours heart rate went down to 120 with dull left chest pain, blood test: unknown on an unspecified date, electrocardiogram: unknown on an unspecified date. The course of events was as follows: Sudden 180 bpm heart rate without any exercise. fluttering heart beat, dizziness lightheaded, fainting feeling. After couple of hours heart rate went down to 120 with dull left chest pain. Very high blood pressure. 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: 1516949 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916736

Write-up: Leg pain; This is a spontaneous report from a contactable consumer received from the / Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107181924152660-ALMX9, Safety Report Unique Identifier GB-MHRA-ADR 25669934. A 35-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FF3319), via an unspecified route of administration on 18Jul2021 (at 35 years) as single dose for covid-19 immunisation. Medical history included pregnancy. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine.Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. On 18Jul2021 the patient experienced leg pain serious as medically significant and described as follows: shooting pains down left leg (same side as vaccine) started approx 6 hours after vaccine. Adverse reaction did not occur as a result of an exposure during pregnancy. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516951 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Dehydration, Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular, Muscle spasms, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Fertility disorders (broad), Hypoglycaemia (broad), Dehydration (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: Dehydration
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916375

Write-up: cold sweats; pain; cramping; dehydration; period arrived earlier than expected; period heavy and lasted longer than usual; pins and needles all over her body; Period pains; 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-202107182155069660-RTJIG, Safety Report Unique Identifier is GB-MHRA-ADR 25670076 A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date and dose 2 on 17Jul2021, via an unspecified route of administration as single dose for COVID-19 immunisation. Medical history included dehydration. She has not had symptoms associated with COVID-19, not had a COVID-19 test, and not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced cold sweats, pain, cramping, and dehydration on an unspecified date; period pains on 18Jul2021. Case narrative: After both her first and second jabs, her period arrived earlier than expected. After the first jab, it was heavy and lasted longer than usual. This time, the pain has been incredibly strong. She has been experiencing cold sweats, pins and needles all over her body, severe cramping, and dehydration. She has not tested positive for COVID-19 since having the vaccine. The patient recovered from period pains on 18Jul2021, and from all other events on an unspecified date. Case was reported as medically significant by health authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516968 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Headache, Hyperhidrosis, Myalgia, Nausea, Pain in extremity, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916717

Write-up: loss of appetite; Pain at the site of injection; Pain all down the left side (side of injection) was sore to touch; Headache; Muscle pain; Nauseous; Sweating; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107190704071000-F1KNH. Safety Report Unique Identifier: GB-MHRA-ADR 25670697. A 38-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FC9001), via an unspecified route of administration on 17Jul2021 at single dose for COVID-19 immunization. Relevant medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medications were not reported. The patient experienced headache on 18Jul2021, muscle pain on 18Jul2021, nauseous on 18Jul2021, sweating on 18Jul2021, loss of appetite on an unspecified date, pain at the site of injection on an unspecified date and pain all down the left side (side of injection) was sore to touch on an unspecified date. The events were serious as medically significant. Clinical course was provided as follows. As well as the above the patient also felt a loss of appetite, even when not feeling nauseous. Pain at the site of injection and all down the left side (side of injection) was sore to touch, as if had been constantly punched. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome for loss of appetite on an unspecified date, pain at the site of injection on an unspecified date and pain all down the left side (side of injection) was sore to touch was unknown, other events were not resolved. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1516991 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Electrocardiogram, Inflammatory marker test, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune 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: Medical History/Concurrent Conditions: Pericarditis
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown; Test Name: ECG; Result Unstructured Data: Test Result:ECG was ok; Test Name: Inflammation marker in blood; Result Unstructured Data: Test Result:Unknown
CDC Split Type: GBPFIZER INC202100928868

Write-up: Pericarditis; Blood test; Chest pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number -MHRA-WEBCOVID-202107200842377740-SAEKI, Safety Report Unique Identifier -MHRA-ADR 25678851. A 31-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot Number: FD8813), via an unspecified route of administration on 16Jul2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included pericarditis. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test.The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced pericarditis, blood test, On 18Jul2021, chest pain.The patient underwent lab tests and procedures which included blood test: unknown on, electrocardiogram: ecg was ok on, inflammatory marker test: unknown on. When to hospital. Had ECG trace and blood test. Had inflammation marker in blood. ECG was ok. Diagnosed with pericarditis and told to take ibuprofen. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event chest pain was recovered and other events were unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1517048 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation
SMQs:, Supraventricular tachyarrhythmias (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 INC202100911813

Write-up: I have never been diagnosed with heart aFib.Yesterday night following my vaccine, my ScanWatch alerted me to say that it detected signs of afib.; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 18Jul2021 (Lot Number: FD8813) as single dose (at age of 31-years-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. On 18Jul2021 patient experienced atrial fibrillation. Patient stated that he had never been diagnosed with heart atrial fibrillation (afib). The night before the report, on 18Jul2021, (reported as yesterday night) following his vaccine, his scanwatch alerted he to say that it detected signs of afib. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received. Outcome of the event was unknown.


VAERS ID: 1517234 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Dyspnoea, Hypertensive crisis, Malaise, Normocytic anaemia, Thrombocytopenia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210760337

Write-up: MALAISE WITH DYSPNEA AT NIGHT ACUTE RENAL FAILURE, THROMBOCYTOPENIA, NORMOCYTIC ANAEMIA HYPERTENSIVE CRISIS POORLY RESPONSIVE TO ANTIHYPERTENSIVE THERAPY; MALAISE WITH DYSPNEA AT NIGHT ACUTE RENAL FAILURE, THROMBOCYTOPENIA, NORMOCYTIC ANAEMIA HYPERTENSIVE CRISIS POORLY RESPONSIVE TO ANTIHYPERTENSIVE THERAPY; MALAISE WITH DYSPNEA AT NIGHT ACUTE RENAL FAILURE, THROMBOCYTOPENIA, NORMOCYTIC ANAEMIA HYPERTENSIVE CRISIS POORLY RESPONSIVE TO ANTIHYPERTENSIVE THERAPY; MALAISE WITH DYSPNEA AT NIGHT ACUTE RENAL FAILURE, THROMBOCYTOPENIA, NORMOCYTIC ANAEMIA HYPERTENSIVE CRISIS POORLY RESPONSIVE TO ANTIHYPERTENSIVE THERAPY; MALAISE WITH DYSPNEA AT NIGHT ACUTE RENAL FAILURE, THROMBOCYTOPENIA, NORMOCYTIC ANAEMIA HYPERTENSIVE CRISIS POORLY RESPONSIVE TO ANTIHYPERTENSIVE THERAPY; MALAISE WITH DYSPNEA AT NIGHT ACUTE RENAL FAILURE, THROMBOCYTOPENIA, NORMOCYTIC ANAEMIA HYPERTENSIVE CRISIS POORLY RESPONSIVE TO ANTIHYPERTENSIVE THERAPY; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, IT-MINISAL02-760347] concerned a 55 year old of unspecified sex. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C16-03) 0.5 ml, 1 total administered on 04-JUL-2021 for sars-cov-2 vaccination. No concomitant medications were reported. On 18-JUL-2021, the patient experienced malaise with dyspnea at night acute renal failure, thrombocytopenia, normocytic anaemia, hypertensive crisis poorly responsive to antihypertensive therapy, and was hospitalized (date unspecified). Number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from malaise with dyspnea at night acute renal failure, thrombocytopenia, normocytic anaemia hypertensive crisis poorly responsive to antihypertensive therapy. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0;20210760337-COVID-19 VACCINE AD26.COV2.S- dyspnea at night, acute renal failure, thrombocytopenia, normocytic anaemia, hypertensive crisis . 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). 20210760337-COVID-19 VACCINE AD26.COV2.S-malaise. This event(s) is labeled and is therefore considered potentially related.


VAERS ID: 1517489 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003658 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Collagen disorder; Primary biliary cholangitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP062961

Write-up: Anaphylaxis; This case was received via Regulatory Authority (Reference number: 2021TJP062961) on 20-Jul-2021 and was forwarded to Moderna on 28-Jul-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 53-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003658) for COVID-19 vaccination. Concurrent medical conditions included Primary biliary cholangitis and Collagen disorder. On 18-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Jul-2021 at 10:30 AM, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). On 18-Jul-2021, ANAPHYLACTIC REACTION (Anaphylaxis) had resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be possibly related. Concomitant medication use information was not provided by reporter. It was reported that on unknown date before vaccination patient had body temperature of 36.5 degree celcius It was reported that On 18-Jul-2021, at 10:04, the patient received the 1st dose of this vaccine. That day at 10:30, the patient developed flushing and mild pruritus from the face to the neck. There was no respiratory symptom.. There was no other symptom. Treatment medication use information was not provided by reporter. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1517518 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Arrhythmia, Investigation, Iron deficiency, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Investigation; Result Unstructured Data: Test Result:Anemia and arrhythmia
CDC Split Type: MXPFIZER INC202100917363

Write-up: arrhythmia; low in iron; agitated; tremor; This is a spontaneous report received from a contactable consumer or other non hcp (parent) via email. A female (pregnant: unknown) patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 10Jul2021 09:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient previously took first dose of BNT162B2 on 09Jul2021 for covid-19 immunisation and experienced blurry vision (Recovered), Headache (Recovered), and tremor. The patient experienced arrhythmia, low in iron on an unspecified date, agitated and tremor on 18Jul2021. The second dose was vaccinated on 10Jul2021 at 9:00 am. During the flight she felt better, she did several studies and all were favourable, she was only detected arrhythmias and low in iron. She was checked by the neurologist, cardiologist, ophthalmologist and pediatrician. Today 18Jul2021, she felt shaken and trembling again. The patient underwent lab tests and procedures which included investigation: anemia and arrhythmia on an unspecified date. Outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-202100917351 Events for 1st dose, experienced.


VAERS ID: 1517687 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6029 / 2 RA / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gilbert''s syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202100940120

Write-up: Acute myocarditis; This is a spontaneous report from a contactable consumer (patient) received via a regulatory authority. A 18-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration, administered in Arm Right on 15Jul2021 01:00 PM (Lot Number: FE6029) as DOSE 2, SINGLE for covid-19 immunisation in Hospital. Medical history included gilbert''s syndrome. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient previously received the first single dose of bnt162b2 (COMIRNATY) on 10Jun2021 01:00 PM administered in Arm Right (Lot Number: FD4342) for covid-19 immunisation. The patient experienced acute myocarditis (hospitalization, disability, life threatening) on 18Jul2021 09:00 with outcome of recovering. The patient was hospitalized for acute myocarditis for 5 days. The event Acute myocarditis resulted in Emergency room/department or urgent care and Diagnostics and treatment in a cardiology clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.


VAERS ID: 1519219 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1820095 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
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: KRJNJFOC20210763669

Write-up: ACUTE PARALYSIS; OTHER EVENTS; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 4 decade 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: 1820095, expiry: 04-JUL-2021) dose was not reported, 1 total, administered on 12-JUN-2021 at deltoid for prophylactic vaccination. No concomitant medications were reported. On 18-JUL-2021, the patient experienced acute paralysis and other events. The patient received outpatient treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the other events and acute paralysis was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210763669-Covid-19 vaccine ad26.cov2.s-Acute paralysis. 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: 1520845 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613, EN1749 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Migraine, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache (headache associated with 2 black dots and floaters in vision 2 days after first vaccine); Lactation decreased; Visual disturbances (headache associated with 2 black dots and floaters in vision 2 days after first vaccine)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916327

Write-up: This is a spontaneous report from a contactable physician received from the The regulatory authority report number is GB-MHRA-WEBCOVID-202107181420322820-JHO1T. A 41-years-old not pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, batch/lot number: EN1749 it looks like an N and FD5613) via an unspecified route of administration on 18Jul2021 (at the age of 41-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included suppressed lactation, headache associated with 2 black dots and floaters in vision 2 days after first vaccine (unspecified details) and general physician (GP) advised seeing optician but she did not have time and it eventually settled after 2 weeks. The patient''s concomitant medications were not reported. The patient experienced hazy vision on 18Jul2021. It was reported that around an hour after vaccine given the patient noticed disturbance of vision - blurring- in right side of visual field, right eye especially but thought it was in both eyes. It was reported that there was no headache. On examination it was reported that patient had reduced vision right visual field and unable to count fingers out of field of vision. PEARL Eye movements was normal and no redness of eyes. It was reported that could be possible migraine without the headache but advised to attend accident and emergency and needing computerized tomography (CT) head.. It was also stated that the report does not relate to possible blood clots or low platelet. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. All the events were reported as medically significant by the reporter. The outcome of the event hay vision was not resolved while outcome of other event was unknown. No follow-up attempts are possible. No further information was expected.


VAERS ID: 1520851 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fall, Gastric disorder, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916465

Write-up: seizure/twitch/jerk (seizure?); fell; light headed; felt funny in his stomach; Syncope vasovagal/fainted; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107181614479040-K2NBT, Safety Report Unique Identifier: GB-MHRA-ADR 25669814. A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Jul2021 (Lot Number: ff3319) as dose 1, single for COVID-19 immunisation. The patient''s medical history was not reported. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced seizure on an unspecified date and syncope vasovagal on 18Jul2021. Clinical course reported: patient fainted and fell from the chair. Someone caught him before he fell to the ground so there were no injuries. Patient fainted with his eyes open and had a twitch/jerk (seizure?) which lasted for 2-3 seconds. He woke up right after the seizure. Patient mentioned that before he felt light headed and he felt funny in his stomach first. Patient is not enrolled in clinical trial. The outcome of the events seizure was recovered on an unspecified date and syncope vasovagal was recovered on 18Jul2021; and for the rest of events was unknown. Regulatory authority assessed the events as non-serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520853 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination site rash
SMQs:, 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: PARACETAMOL; SYMBICORT TURBOHALER
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Headache; Lactation decreased; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916525

Write-up: Rash/ white rash on the arm that she got the vaccine in; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107181640047130-8ZBUK. Safety Report Unique Identifier: GB-MHRA-ADR 25669826. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Jul2021 (Lot Number: fc9001) as dose 2, single for COVID-19 immunization. Medical history included suppressed lactation, asthma, steroid therapy (taking regular steroid treatment), and headache. Patient is not pregnant nor currently nor breastfeeding. Concomitant medications included paracetamol taken for headache and budesonide, formoterol fumarate (SYMBICORT TURBOHALER), daily taken for mild asthma. The patient previously took salbutamol sulfate (SALAMOL) taken occasionally as required (rarely). The patient experienced white rash on the arm that she got the vaccine in, medically significant on 18Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. The patient has not recovered from the event. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520867 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Muscle twitching, Nausea, Off label use, Product use issue, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: QUETIAPINE; VENLAFAXINE
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Derealisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916345

Write-up: Maternal exposure during breast feeding; Maternal exposure during breast feeding; Fever; Twitching; Nausea; This is a spontaneous report from a contactable consumer, received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202107181848376970-Z8SSU, Safety Report Unique Identifier GB-MHRA-ADR 25669909. A 32-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FC9001), via an intramuscular route of administration on 15Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history included ongoing breast feeding, derealization and depression-all from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant at the time of vaccination. Patient was not enrolled in clinical trial. Concomitant medications included quetiapine (QUETIAPINE) taken for derealization from 01Sep2016; venlafaxine taken for depression from 01Apr2021. It was reported that the patient received BNT162B2, vaccination while she was breasting feeding (Off label use, Drug use in unapproved population). On 18Jul2021, patient experienced fever, twitching and nausea. The event fever, twitching and nausea were considered as medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of events fever, twitching and nausea was not recovered, while for other event outcome was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100929597 Child case


VAERS ID: 1520886 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-18
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916517

Write-up: Vaginal bleeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107182104088480-GYBQ2, Safety Report Unique Identifier GB-MHRA-ADR 25670012. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number not known; expiration date not provided), via an unspecified route of administration on 07Jul2021 as DOSE 1, SINGLE for COVID-19 immunisation. Patient''s medical history and concomitant medications were not reported. It was unsure if patient has had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced vaginal bleeding on 18Jul2021. The event was assessed as serious (medically significant). 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. No further information is expected.


VAERS ID: 1520914 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstrual disorder, Menstruation irregular, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 07/15/2021; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100923033

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202107190817056030-RQINE; safety report unique identifier: GB-MHRA-ADR 25670992). A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# not reported), via an unspecified route of administration, on Jul 17, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient experienced altered menstrual flow (medically significant) on Jul 18, 2021; and period came a week early (medically significant) on an unspecified date. Clinical course: Period came a week early. She normally has a period every 28-30 days. Patient has not tested positive for COVID-19 since the vaccination. Patient is not enrolled in a clinical trial. The patient underwent lab tests and procedures, which included COVID-19 virus test: No - Negative COVID-19 test on Jul 15, 2021. The outcome of the altered menstrual flow: not recovered; of the other event unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1520919 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Feeling cold, Syncope, Tinnitus
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923172

Write-up: Body started to become cold; stomach was really upset nearly to throw up; noise came into her ears; Fainting; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107190828297360-MDF7S and Safety Report Unique Identifier GB-MHRA-ADR 25671036. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD8813) dose 2 via an unspecified route of administration on 17Jul2021 as single dose for COVID-19 immunisation. 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 fainting on 18Jul2021, body started to become cold on an unspecified date. Her body started to become cold instantly after 12 hours from the vaccine and in the same time her stomach was really upset nearly to throw up then a noise came into her ears, she started to see black and she was nearly fainting. Patient managed to come into the living room and sit on the sofa, she never fainted in her life before or felt like that. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Outcome of event fainting was recovered on 18Jul2021 and the other events were unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520920 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923209

Write-up: Headache; Fatigue; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107190829242180-TC4VX, Safety Report Unique Identifier GB-MHRA-ADR 25671031. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 at single dose for COVID-19 immunisation. Medical history included clinical trial participant. 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 headache on 18Jul2021, fatigue on 18Jul2021. Case was reported as medically significant condition. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1520924 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923094

Write-up: Heavier period than usual; Menstrual cramp; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number, Safety Report Unique Identifier. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (Lot Number: FC9001) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient did not have a COVID-19 test. Patient is not currently breastfeeding. The patient experienced medical significant menstrual cramp on 18Jul2021. Additional information included: The patient had menstrual changes. It was heavier period than usual and more painful. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of menstrual cramp was not recovered, of other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520929 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100922996

Write-up: Heavy periods/lasting for longer than usual; Painful periods; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107190910279430-K5RJN, Safety Report Unique Identifier is GB-MHRA-ADR 25671351. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration on 18Jul2021 (at the age of 32 years old) at single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced heavy periods (medically significant) on 18Jul2021, painful periods (medically significant) on 18Jul2021. Clinical course: Period heavier than normal and period pain more intense (also lasting for longer than usual). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1520935 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Insomnia, Lymphadenopathy, Pain, Pain in extremity
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100922890

Write-up: pain; Have had little sleep; Pain is shooting into my peck and down my arm; Pain is shooting into my peck and down my arm; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. Regulatory authority report number, Safety Report Unique Identifier. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FE1510, Expiry date not reported), via an unspecified route of administration on 17Jul2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Patient had not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Historical vaccine included bnt162b2, on an unspecified date dose 1 single for COVID-19 immunisation. Concomitant medications were not reported. The patient experienced pain on an unspecified date with outcome of unknown, swollen lymph nodes on 18Jul2021 with outcome of recovering, have had little sleep on an unspecified date with outcome of unknown, and pain is shooting into my peck and down my arm on an unspecified date with outcome of unknown. The events were reported as serious, medically significant. Narrative case summary and further information: Painful and swollen lymph nodes in left armpit post vaccine. Pain is shooting into my peck and down my arm. Have had little sleep. Patient had not tested positive for COVID-19 since having the vaccine No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520953 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Inappropriate schedule of product administration, Injected limb mobility decreased, Lymph node pain, Mass, Off label use, Pain
SMQs:, 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: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923022

Write-up: Noticeable lump; unable to lift arm above shoulder height without pain; Dosage text: Dose 1, Date of start of drug: 19May2021; Dosage text: Dose 2, Date of start of drug: 17Jul2021; off label use; pain; Pain in lymph node in armpit on left arm; Lymph node pain; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202107191100221720-CPHPP, Safety Report Unique Identifier GB-MHRA-ADR 25672047. A 29-year-old female patient received 2nd dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot Number: FE1510), via an unspecified route of administration at single dose on 17Jul2021 for COVID-19 immunization. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Patient received the first dose of BNT162B2 on 19May2021 (Batch/lot number : G8885). Concomitant medication included sertraline (Manufacturer unknown) taken for an unspecified indication. The patient experienced pain on unknown date, Pain in lymph node in armpit on left arm (same as arm where vaccine was injected) on 18Jul2021. Noticeable lump and unable to lift arm above shoulder height without pain on unknown date. Pain worse if area touched. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of events Pain in lymph node in armpit on left arm was not recovered, of others was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520954 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Lymphadenopathy
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100922978

Write-up: Swollen glands; Chest pain; This is a spontaneous report from a contactable consumer. This report is received from the Regulatory Authority. The regulatory authority report number. Safety Report Unique Identifier. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 17Jul2021 for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced swollen glands on 18Jul2021, chest pain on 18Jul2021. Case was reported as medically significant condition. 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; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1520984 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, SARS-CoV-2 test
SMQs:, Taste and smell disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923108

Write-up: Loss of taste; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107191144389210-DL553, Safety Report Unique Identifier GB-MHRA-ADR 25672164. A 34-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jul2021(vaccination at age of 34 years old) (Lot Number: FE1510) as Dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced loss of taste on 18Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. Clinical course as reported: 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: 1521002 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Pain, SARS-CoV-2 antibody test
SMQs:, Retroperitoneal fibrosis (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; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Test Result: Negative ; Comments: Patient has not tested positive for COVID-19 since having the vaccine
CDC Split Type: GBPFIZER INC202100923189

Write-up: acute pain; Acute back pain/burning feeling in lower back; This is a spontaneous report from a contactable consumer (patient). This report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107191314535360-XDKTN. Safety Report Unique Identifier GB-MHRA-ADR 25673003. A 30-year-old female patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number: FD8813), dose 1 via an unspecified route of administration on 18Jul2021 (at the age of 30-year-old) as dose 1, single for covid-19 immunisation. Medical history included hypothyroidism and lactation decreased. Concomitant medication included levothyroxine sodium taken for hypothyroidism from 01Nov2016. The patient received her vaccination in the morning of the 18Jul2021. Around one to two hours after receiving the vaccination she started to experience pain in her lower back. Over the course of around an hour the pain increased and became acutely painful. Around 8/10 on pain scale. The pain radiated from her lumber spine into the top of both her legs. It felt like the nerves in her lower back were almost burning and it was extremely painful to walk. She took paracetamol that did not even touch the pain and she could not move off of the sofa the rest of the day or move without being in considerable pain. Before she had the vaccination she was not experiencing any back pain and she also has not injured her back previous to the day of vaccination. Today is the 19Jul2021. The acute pain has now gone but she was left with an uncomfortable burning feeling in her lower back. 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 antibody test was negative, Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event acute pain was not resolved, the outcome of the other event was resolving. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521006 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Cough, Fatigue, Headache, Pain in extremity, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), 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
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923392

Write-up: Headache; Cough; Chills; Pain in arm; Joint pain; Fatigue; 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-202107191327510290-NFYNR, Safety Report Unique Identifier GB-MHRA-ADR 25673019. A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jul2021 (Lot Number: FF3319) as single dose (at age of 35-years-old) for COVID-19 immunisation. Medical history included lactation decreased. Concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 18Jul2021 patient experienced pain in arm, joint pain, fatigue, on 19Jul2021 she experienced headache, cough and chills. Events considered serious as medically significant. The patient underwent laboratory tests and procedures which included SARS-COV-2 test: negative on 08Jul2021 No - Negative COVID-19 test. Patient had not recovered from the events, at the time of the report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521007 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923308

Write-up: Stomachache; General body pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107191334438060-VJHRQ, Safety Report Unique Identifier is GB-MHRA-ADR 25673024. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. Patient had not 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''s concomitant medications were not reported. The patient experienced stomachache on 19Jul2021 with outcome of not recovered, general body pain on 18Jul2021 with outcome of recovering. The case was serious as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 12Jul2021. No follow-up attempts are possible. information about lot/batch number cannot be obtained.


VAERS ID: 1521010 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923315

Write-up: Stomach pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107191338439030-PM5WL, Safety Report Unique Identifier is GB-MHRA-ADR 25673031. A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 17Jul2021 at dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced stomach pain (hospitalization and medically significant) on 18Jul2021 with outcome of not recovered. The clinical course included severe stomach pain down right side (dose of Pfizer was in left arm). Ambulance called for pain. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1521036 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923156

Write-up: Light periods; Light period bleeds; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority. Regulatory authority report number. Safety Report Unique Identifier. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF3319) via an unspecified route of administration on 18Jul2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced light periods on 18Jul2021. It was reported that: Light period bleeds shortly after vaccine had been administered within 30min (18Jul2021). Still light bleeds on day two even though she was in the middle of her cycle. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of Light periods was recovering, of Light period bleeds was not recovered, of the other event was unknown No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521040 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Lymph node pain, Lymphadenopathy, Pyrexia, Swelling, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholesterol high
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923176

Write-up: swelling; sore lymph node; the site of the injection was a little sore; Swollen lymph nodes; Fever; Tiredness; Chills; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202107191645593160-QS1ID, Safety Report Unique Identifier GB-MHRA-ADR 25674329. A 33-year-old male patient received 2nd dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot Number: FD8813), via an unspecified route of administration at single dose on 17Jul2021 for COVID-19 immunization. Medical history included blood cholesterol increased. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medication(s) included atorvastatin (Manufacturer unknown) taken for blood cholesterol increased from 03Mar2021. The patient experienced swelling on an unspecified date, swollen lymph nodes on 18Jul2021, fever on 18Jul2021, tiredness on 18Jul2021, chills on 18Jul2021. The day after the vaccine the site of the injection was a little sore, but the main noticeable thing was the swelling under his armpit that was very tender. The evening on that day the fever and chills developed and carried on until the morning - stopped him from sleeping. Still got a temperature, sore lymph node and feeling very tired. Patient had had to take the day off work. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Case was reported as serious, other medically important condition. Outcome of swelling was recovered on unspecified date, chills was recovered on 19Jul2021, fever was recovering, site of the injection was a little sore was unknown and the other events were not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521043 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dizziness, Dysstasia, Heart rate, Heart rate increased, Inappropriate schedule of product administration, Influenza, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Swallowing disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: Body temperature; Result Unstructured Data: Test Result:High; Test Name: Heart rate; Result Unstructured Data: Test Result:normal average is around 60-62; Test Date: 20210719; Test Name: Heart rate; Result Unstructured Data: Test Result:hit as high as the 160s; Comments: 80s on average; Test Date: 20200901; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100922982

Write-up: Dizziness; heart rate has also been exceptionally high all day; High temperature; Flu syndrome; throw up; nauseous; struggled to stay on his feet/unable to stay on his feet too long; first dose on 16May2021/second dose on 18Jul2021; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107191655024520-DE9VV, Safety Report GB-MHRA-ADR 25674303. A 27-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 27-year-old) on 18Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Swallowing disorder. Concomitant medication included lansoprazole taken for Swallowing disorder. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16May2021 for covid-19 immunisation. The patient experienced dizziness, heart rate has also been exceptionally high all day, high temperature, flu syndrome, throw up, nauseous, struggled to stay on his feet/unable to stay on his feet too long (all medically significant) on 19Jul2021. The patient experienced first dose on 16May2021/second dose on 18Jul2021 on 18Jul2021. The clinical course was reported as follows: he felt fine after the vaccine but the next morning woke up and had to call in sick to work. He felt as if he would throw up and struggled to stay on his feet. He no longer feel nauseous but am unable to stay on his feet too long. His heart rate has also been exceptionally high all day. His normal average is around 60-62, today has been up in the 80s on average and hit as high as the 160s when he has been in bed all day. 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: On 19Jul2021, Body temperature: high; Heart rate: hit as high as the 160s (80s on average). On unspecified date, Heart rate: normal average is around 60-62. On 01Sep2020, COVID-19 virus test: No - Negative COVID-19 test. The outcome of the events Dizziness, Heart rate high, High temperature, Flu syndrome was recovering, Nauseous was recovered on 19Jul2021, others was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1521059 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Menstruation irregular, Pain
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923345

Write-up: pain; Period began 2 days early; Painful periods; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number, Sender''s (Case) Safety Report Unique Identifier. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 16Jul2021 as single dose for covid-19 immunisation. Patient did not have symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Medical history included lactation decreased. Concomitant medications (as reported) included ibuprofen from 18Jul2021 to an unspecified stop date; paracetamol on 18Jul2021; both for painful periods. The patient experienced pain on an unspecified date, painful periods on 18Jul2021. Period began 2 days early. Periods were very rarely early. Periods also are very painful. Paracetamol had no effect and ibuprofen only keeps pain at bay for approximately 3 hours before pain resumes. It was painful enough that she was unable to sleep. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This case was reported as serious due to medical significant. The outcome of event pain and period began 2 days early was unknown, painful periods was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1521064 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Gait inability, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FAMOTIDINE; FEXOFENADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Ehlers-Danlos syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100922942

Write-up: hips/knee; Unable to walk; Muscle pain; Joint pain; 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-202107191838300300-TQDJL. Safety Report Unique Identifier GB-MHRA-ADR 25675122. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number unknown), dose 2 via an unspecified route of administration on 17Jul2021 as single dose for COVID-19 immunisation. Medical history included allergy, hypermobile Ehlers Danlos. Patient did not have symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medications included famotidine and fexofenadine taken for allergy. The patient experienced hips (pain) and knee (pain) on an unspecified date, muscle pain, joint pain and fever on 18Jul2021. Additional information: Severe muscle and joint pain in hips. Unable to walk. Joint pain in knee. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This case was reported as serious due to medical significant. The outcome of events hips (pain)/knee (pain), and unable to walk was unknown, the rest of events outcome was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1521067 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Defaecation urgency, Fatigue, Illness, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201125; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100923057

Write-up: felt like I was going to be sick; need the toilet but nothing happened; Stomach pain; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp received from The regulatory authority report number is GB-MHRA-WEBCOVID-202107191845535450-JFRHI. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Jul2021 (Lot Number: FL9001) as SINGLE for covid-19 immunisation. Medical history included Suppressed lactation, suspected covid-19 from 25Nov2020 to 29Nov2020. The patient''s concomitant medications were not reported. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient experienced stomach pain on 18Jul2021 with outcome of not recovered , fatigue on 18Jul2021 with outcome of recovering , felt like i was going to be sick on an unspecified date with outcome of recovering , need the toilet but nothing happened on an unspecified date with outcome of unknown. Bad stomach pain, felt like I was going to be sick/ need the toilet but nothing happened. Stomach pain continuing but feel less sick. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 25Nov2020. Yes - Positive COVID-19 test.seriousness assessment: Other medically important condition. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521075 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202100923286

Write-up: Swelling arm; Pain in arm; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107191902226070-DAUOG, Safety Report Unique Identifier GB-MHRA-ADR 25675429. A 23-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 18Jul2021 (Batch/Lot Number: FD5613), as single dose, for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing, COVID-19 from 22Jun2021 to 03Jul2021. Patient was not pregnant and was not pregnant at time of vaccination, was not currently breastfeeding, was not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced swelling arm (medically significant) on 19Jul2021 with outcome of not recovered, pain in arm (medically significant) on 18Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 22Jun2021. 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: 1521077 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Lymphadenopathy, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923099

Write-up: swollen glands; armpit; Swollen arm; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA).Regulatory authority report number is GB-RA-WEBCOVID-202107191915158160-AEDXX.Safety Report Unique Identifier : GB-RA-ADR 25675463. A 29-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH),dose 2 via an unspecified route of administration on 17Jul2021 (Lot number was not reported) as dose 2,single for COVID-19 immunization . Medical history included pregnancy. The patient previously received the first dose of BNT162B2 for COVID-19 immunisation on unknown date. The patient''s concomitant medications were not reported. The patient experienced swollen glands, armpit on an unspecified date with outcome of recovering, swollen arm on 18Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unknown date. (No - Negative COVID-19 test). Clinical course as reported: Patient has not had symptoms associated with COVID-19. Red swollen lump on injection site still growing in size. Swollen glands on same side in armpit and neck. 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1521086 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100922946

Write-up: Glands swollen/Lymph nodes swelled on neck same side as jab; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107192004568420-S2J3F, Safety Report GB-MHRA-ADR 25675752. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 (Lot Number: FD5613) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. The patient experienced glands swollen (medically significant) on 18Jul2021 with outcome of not recovered. Lymph nodes swelled on neck same side as jab as with the first dose, but reaction was instant not delayed. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unspecified date (No - Negative COVID-19 test). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521090 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Electrocardiogram, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Name: Blood test; Result Unstructured Data: Test Result:normal heart enzymes, cholesterol; Test Name: EKG; Result Unstructured Data: Test Result:normal; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923317

Write-up: Pins and needles; Numb lips; Body numbness/numbness/ Numbness in hand/ numbness in lower chest, spread to face and hands; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number, Safety Report Unique Identifier. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Lot number was not reported) as Dose 2, single for COVID-19 immunisation. The patient medical history was not reported. No relevant details to add. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced pins and needles, numb lips, numbness/ body numbness/ numbness in hand/ numbness in lower chest, spread to face and hands on 18Jul2021 with outcome of recovered on 18Jul2021. The events were reported as serious (medically significant). The clinical course included started as numbness in lower chest, spread to face and hands. Lasted around 1.5 hours. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test. Other relevant investigations or tests conducted: Went to A and E, EKG normal, blood pressure normal. Blood test showed normal heart enzymes, cholesterol. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are needed, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1521122 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923023

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107192307181160-HVWVC. Safety Report Unique Identifier GB-MHRA-ADR 25677035. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 17Jul2021 (Lot Number: FD8813) as single dose for COVID-19 immunisation. Medical history included Lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously took first dose BNT162B2 for COVID-19 immunisation. The patient experienced swollen lymph nodes on 18Jul2021. 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: negative on an unspecified date (No - Negative COVID-19 test). The outcome of event was not recovered. No follow up attempts are possible. No further information is expected.


VAERS ID: 1521124 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Cataract, Dysmenorrhoea, Dyspnoea, Hypomenorrhoea, Intermenstrual bleeding, Liver function test, Liver function test abnormal, Premenstrual syndrome
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (narrow), Fertility 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: MIRENA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: IUD embedded; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: liver function tests; Result Unstructured Data: Test Result:deranged
CDC Split Type: GBPFIZER INC202100922963

Write-up: Bilateral cataracts; Deranged liver function tests; Breathlessness; Cramps/ and bloating- all normal period signs; light period; Cramps/ and bloating- all normal period signs; PMS; Spotting menstrual; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number GB-MHRA-WEBCOVID-202107192313424270-PMLBX, Safety Report Unique Identifier GB-MHRA-ADR 25677046. A 22-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 2 via an unspecified route of administration on 18Jul2021 as dose 2, single for COVID-19 immunization. Medical history included suppressed lactation and IUD. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant, Patient is not currently breastfeeding, Concomitant medication included levonorgestrel (MIRENA). The patient was on the IUD (Mirena coil) and had not bled for 72 days. Got the vaccine and suddenly started spotting/ light period. PMS. Cramps/ and bloating- all normal period signs she used to get. The patient experienced bilateral cataracts, deranged liver function tests, breathlessness, spotting menstrual on 18Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of events bilateral cataracts, deranged liver function tests, breathlessness, bloating, light period, menstrual cramps was recovered, spotting menstrual was recovering and another event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1521127 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923388

Write-up: Pins and needles; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The Regulatory Authority report number GB-MHRA-WEBCOVID-202107192339055700-LMKFN, Safety Report Unique Identifier GB-MHRA-ADR 25677058. A 36-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 15Jul2021 (Batch/Lot Number: FC9001), as single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test, was not currently breastfeeding, was not enrolled in clinical trial. The patient experienced pins and needles (medically significant) on 18Jul2021 with outcome of recovering. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521131 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Monoplegia, Night sweats, Palpitations, Sleep apnoea syndrome
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923371

Write-up: heart attacks; Night sweat; Palpitation; Sleep apnea; Arm paralysis; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-RA-WEBCOVID-202107192359005460-GQ4JP. Safety Report Unique Identifier GB-RA-ADR 25677077. A 33-years-old female patient received BNT162B2 (COVID-19 MRNA VACCINE mRNA BIONTECH), dose 2 via an unspecified route of administration on 12Jul2021 with Batch/Lot Number: FD8813 as single dose for covid-19 immunisation. Medical history included suppressed lactation from an unknown date. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. After one week since the vaccine (18Jul2021) patient experienced sweating profusely at night coupled with a fuzzy feeling in my left hand and arm as if there is some kind of nerve issue since the jab (arm paralysis), palpitation, sleep apnea, on an unknown date, patient experienced heart attack (coded as anxiety). Outcome of event anxiety was unknown, of other events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521160 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100929148

Write-up: Swollen lymph nodes; 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-202107201348123480-RGOAN, Safety Report Unique Identifier GB-MHRA-ADR 25680540. A 32-year-old female patient (not pregnant, not currently breastfeeding) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FD8813), via an unspecified route of administration on 17Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. The doctor confirmed that the patient had swollen lymph nodes (medically significant) on 18Jul2021 with outcome of not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521440 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Coma scale, Dizziness, Gait disturbance, Heat illness, Oxygen saturation, Somnolence
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: BP; Result Unstructured Data: Test Result: 136/60; Test Date: 20210718; Test Name: BP; Result Unstructured Data: Test Result: 120/60; Test Date: 20210718; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210718; Test Name: Body temperature; Result Unstructured Data: Test Result: 37.1 Centigrade; Test Date: 20210718; Test Name: JCS; Result Unstructured Data: Test Result: 1; Test Date: 20210718; Test Name: SpO2; Test Result: 98%; Test Date: 20210718; Test Name: SpO2; Test Result: 96%.
CDC Split Type: JPPFIZER INC202100918250

Write-up: Suspicion of heat illness; Giddiness; difficulty in walking on her own; JCS-1 and slightly somnolence; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21120225. A 94-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FD1945, Expiration date 31Oct2021) on 18Jul2021 at 11:00 (at the age of 94-years-old) via an unspecified route of administration as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were reported as none. Body temperature before vaccination was 36.4 degrees Centigrade. On 18Jul2021 at 11:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration as a single dose for COVID-19 immunization. On 18Jul2021 at 11:30 (30 minutes after the vaccination), the patient experienced Suspicion of Heat illness. Patient experienced JCS-1 and slightly somnolence on 18Jul2021, Giddiness on 18Jul2021, difficulty in walking on her own on 18Jul2021. The course of the event was as follows: During the observation after vaccination, Giddiness appeared, the patient asked to lie down, and moved to bed in the observation room. On 18Jul2021, BP 120/60, SpO2 96%, BT 37.1 degree centigrade, able to take fluids orally. Slightly somnolence. No allergy symptoms. Tended to improve with follow-up observation, but the patient experienced difficulty in walking on her own (BP 136/60, SpO2 98%). There was a possibility of Heat illness, and she was transported to the emergency room. Patient received treatment for event Suspicion of heat illness. The reporting physician classified the event as non-serious and assessed, but the causality between the event and bnt162b2 did not provided. The outcome of the events was unknown. The reporting physician commented as follows: Suspicion of heat illness. No follow up attempts are possible. No further information is expected.


VAERS ID: 1521465 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation abnormal, Rash, Rash erythematous, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Acute central respiratory depression (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: blood pressure; Result Unstructured Data: Test Result:146/97 mmHg; Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:unknown Centigrade; Comments: before the vaccination; Test Date: 20210719; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 20210719; Test Name: BPM; Result Unstructured Data: Test Result:84; Comments: times/min; Test Date: 20210719; Test Name: spo2; Test Result: 97 %
CDC Split Type: JPPFIZER INC202100918813

Write-up: Urticaria; red rash generalised; skin eruption generalised; This is a spontaneous report from a contactable Pharmacist received from the Agency Regulatory Authority. Regulatory authority report number is v21120248. A 54-year-old female patient received bnt162b2 (COMIRNATY), the first dose via unspecified route of administration on 17Jul2021 (lot number: FD0889, expiration date: 30Sep2021) at single dose for COVID-19 immunisation. The relevant medical history was not reported. Concomitant medications were not reported. Body temperature before vaccination was unknown. The patient family history was unknown. On 18Jul2021 (1 day after the vaccination), the patient experienced red rash generalised. On 19Jul2021 (1 day after the vaccination), the outcome of the event was recovering. The course of the event was as follows: On 17Jul2021, the patient received COMIRNATY. From the noon of 18Jul2021, Urticaria appeared slowly. On 19Jul2021, expanded slowly, not recovering, so visited our hospital at 13:00 of the same day, that time, body temperature was 36.8 centigrade, spo2 was 97%, BPM was 84times/m, blood pressure was 146/97mmHg. KN3 500ml and normal 100ml bypath and POLARAMINE 5mg 1A and Solu-Cortef 100mg 1V were started. At 14:45, IV of POLARAMINE and Solu-Cortef finished, red rash generalised was recovering a little. At 15:00, went home. The reporting Pharmacist classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown. The reporting Pharmacist commented as follows: Physician of hospital thought that it was not definitely caused by the vaccination, from the time when rash was discovered, not accord with anaphylaxis , also not seemed to be toxicoderma, reactions was from the next day of vaccination, skin eruption generalised was over 30% of body area, requested for steroid, so reported. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1521467 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0348 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Blood pressure decreased, Blood pressure measurement, Body temperature, Hyperhidrosis, Presyncope, Tension
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asperger''s disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: blood pressure; Result Unstructured Data: Test Result:about 80; Comments: 16:15; Test Date: 20210718; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100918848

Write-up: Vasovagal reflex; sweaty; symptom of cerebral Anaemia; blood pressure was 80; overstressing; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21120257. The patient was a 35-year and 5-month-old male. Body temperature before vaccination was 37.0 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included Asperger. On 18Jul2021 at 16:00 (the day of vaccination), the patient received the 1st dose of bnt162b2 (COMIRNATY intramuscular injection, Lot number FD0348, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization at age of 35-year-old. On 18Jul2021 at 16:30 (30 minutes after the vaccination), the patient experienced Vasovagal reflex. The patient had overstressing on 18Jul2021. On 18Jul2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: After 15 minutes of vaccination, Sweaty, Blood pressure was about 80, symptom of head Anaemia appeared. Outcome of the events was recovered on 18Jul2021. The reporting physician classified the event as non-serious and assessed that the event was unrelated to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Due to overstressing, Considered that no special problem.; Sender''s Comments: Based on the limited information provided and plausible temporal association, the causality between the suspect drug and the events cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 1521504 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pharyngeal paraesthesia
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ELDECALCITOL; AMLODIN; HYDROCHLOROTHIAZIDE; PRANLUKAST
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Hypertension; Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100921191

Write-up: Breathing difficulty; Tingling sensation in the throat; This is a spontaneous report from a contactable physician received via Agency Regulatory Authority. A non-pregnant 79-year-old female patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FF0843, Expiration date 31Oct2021) on 18Jul2021 at 09:45 (the day of vaccination) at age of 79-year-old via intramuscular in the left arm for COVID-19 immunization. Other medical history included hypertension, osteoporosis and asthma. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received eldecalcitol capsules, amlodipine besilate (AMLODIN tablets), hydrochlorothiazide tablets and pranlukast tablets within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had allergies to loxoprofen sodium (LOXONIN) previously. On 27Jun2021 at 09:45, the patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown) via intramuscular in the left arm for COVID-19 immunization. On 18Jul2021 at 10:00 (15 minutes after the vaccination), the patient complained of tingling sensation in the throat and breathing difficulty. No skin symptoms developed. The patient was transferred to the emergency department because the symptoms persisted. The patient was treated with intravenous drip with maintenance infusion and symptoms improved as well. The patient returned home. The reporter stated the events result in emergency room/department or urgent care. The outcome of the events was resolved in Jul2021 with treatment including calcium chloride dihydrate;potassium chloride;sodium acetate trihydrate;sodium chloride (SOLACET F) via intravenous drip. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts possible. No further information expected.; Sender''s Comments: A possible contributory role of the suspect drug to the reported events "Breathing difficulty" and "Tingling sensation in the throat" 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: 1521521 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity, Peripheral arterial occlusive disease, Skin discolouration
SMQs:, Embolic and thrombotic events, arterial (narrow), Hypotonic-hyporesponsive episode (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Arteriosclerosis obliterans; Coronary stent placement; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100923755

Write-up: chronic arteriosclerosis obliterans acute aggravation; pain in lower limbs; Skin discolouration; This is a spontaneous report from a contactable pharmacist received from the Regulatory authority report number is v21120500. An 85-year and 2-month-old male patient received bnt162b2 (COMIRNATY, Lot# FC8736, Expiration date 30Sep2021) via an unspecified route of administration on 18Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension, diabetes mellitus, aortic stenosis, chronic arteriosclerosis obliterans in both legs and post coronary stent placement. The patient''s concomitant medications were not reported. On 18Jul2021 at 9:00 (the day of the vaccination), the patient experienced the chronic arteriosclerosis obliterans acute aggravation. On 18Jul2021 (the day of the vaccination), the patient was admitted to the hospital. On 19Jul2021 (1 day after the vaccination), the outcome of the event was not recovered. The course of the event was as follows: On 18Jul2021 form 9:00, the patient has pain in lower limbs, afterwards Skin discolouration occurred, on the same day at 18:00, the patient was emergency transported. The patient was admitted to the hospital for medical treatment because of the chronic arteriosclerosis obliterans acute aggravation. The reporting pharmacist classified the event as serious (hospitalization from 18Jul2021) and the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was reported as yes without any details. The reporting pharmacist commented as follows: The patient was during hospitalization, it was asked to report since a vascular event occurred immediately after the second administration of the Pfizer vaccine although the causal relationship was negative.


VAERS ID: 1521557 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Bradycardia, Feeling abnormal, Pallor, Presyncope
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: body temperature; Result Unstructured Data: Test Result: 36.2 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202100924393

Write-up: tendency of Bradycardia; Vagal reflex; Feels poorly; Pallor facial; This is a spontaneous report from a contactable other HCP received from the Regulatory Authority. Regulatory authority report number is v21120369. A 28-year-old female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration (at the age of 28-year-old) on 18Jul2021 17:02 (Lot Number: FC5947; Expiration Date: 30Sep2021) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Body temperature before vaccination was 36.2 degrees centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient experienced tendency of bradycardia, feels poorly, pallor facial on 18Jul2021; vagal reflex on 18Jul2021 17:26. The event onset date was reported as 18Jul2021 at 17:26 (same day at the vaccination), the patient experienced Vagal reflex. The course of the event was as follows: After the vaccination, during the 15 minutes waiting, the patient complained Feels poorly. Pallor facial, tendency of Bradycardia. Moved to bed by walking. Raised up lower limbs and rested. About 15 minutes after, symptoms eased, returned home. On 18Jul2021(same day at the vaccination), The outcome of the event was reported as recovered. The reporter classified the event as non-serious and assessed that the event was unrelated to bnt162b2. There was no other possible cause of the event such as any other diseases. The outcome of the events was recovered on 18Jul2021. No follow-up attempts are needed. No further information is expected. ; Sender''s Comments: Based on the information available and a possible contributory role of the suspect BNT162B2 to the reported events of brady cardia and other can be completely excluded/unrelated; The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1521560 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Movement disorder, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210718; Test Name: Body temperature; Result Unstructured Data: Test Result:40 Centigrade.
CDC Split Type: JPPFIZER INC202100924719

Write-up: Pyrexia at 38 and 40 Centigrade; Difficult to move body; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21120400. A 92-year and 9-month-old female patient received the second dose of BNT162B2 (COMIRNATY; Lot Number was not reported), via an unspecified route of administration, on 17Jul2021 (day of the vaccination) (at the age of 92 years), as single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Body temperature before vaccination was not provided. On 18Jul2021 at 09:00 (1 day after the vaccination), pyrexia at 38 Centigrade appeared from morning. Pyrexia at 40 Centigrade from evening of 18Jul2021. The patient was transferred by ambulance, the patient was hospitalized for difficult to move the body that started on 18Jul2021 (09:00 AM). On 18Jul2021 (1 day after the vaccination), the patient was admitted to the hospital due to the events. On 19Jul2021 (2 days after the vaccination), the patient recovered from the events. The reporting physician classified the events as non-serious and assessed that the events were related to BNT162B2. There was no other possible cause of the events such as any other diseases. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1521566 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Internal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100926735

Write-up: Internal haemorrhage; bruised her left elbow; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient is scheduled to receive a second vaccine on her left arm tomorrow but on 18Jul2021, the patient bruised her left elbow and had internal haemorrhage. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1521809 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-18
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TOPIRAMATE
Current Illness: Shellfish allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Glaucoma; Menopause
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202100927942

Write-up: After 3 years of absence due to menopause, the patient started having very intense menstruation; After 3 years of absence due to menopause, the patient started having very intense menstruation; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FE1573), first dose via intramuscular route of administration, administered in left arm on 11Jul2021 at 09:15 (at the age of 48-year-old) as a single for COVID-19 immunisation. Medical history included epilepsy from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing, ongoing food allergy (allergy to shellfish), menopause from an unknown date and unknown if ongoing. Concomitant medication included topiramate (TOPIRAMATE) taken for an unspecified indication, start and stop date 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-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 18Jul2021, after 3 years of absence due to menopause, the patient started having very intense menstruation. No treatment was received for the events. The patient was also receiving enoxaparin (LOVENOX) 40mg during 12 days after the vaccination for clot prevention. The outcome of the events was reported as resolving.


VAERS ID: 1523513 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9099 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Inappropriate schedule of product administration, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202100941047

Write-up: extreme itchiness; Severe skin rashes all over around my body (80%); burning sensation; dose 1 on 02May2021 10:00; dose 2 on 18Jul2021 09:00; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Jul2021 09:00 (Batch/Lot Number: FA9099) as dose 2, single for covid-19 immunisation. The patient''s medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 02May2021 10:00 (Batch/Lot Number: EY4825) for covid-19 immunisation. The patient experienced extreme itchiness, severe skin rashes all over around her body (80%) and burning sensation on 18Jul2021 21:00. The patient had several skin rashes in 80% of her body with extreme itchiness and burning sensation. The events resulted in emergency room/department or urgent care. She was treated with Benadryl, Reactine, prednisone and Epipen. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events extreme itchiness, "severe skin rashes all over around my body (80%)" and burning sensation was not recovered. No follow up attempts are possible. No further information is expected.


VAERS ID: 1523816 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE HYDROCHLORIDE; YASMIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100929031

Write-up: Nausea diarrhoea vomiting; diarrhoea; vomiting; This is a spontaneous report from a contactable consumer. received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-EYC 00256548. Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 25671122. A 38-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included SERTRALINE HYDROCHLORIDE, YASMIN. The patient experienced nausea diarrhoea vomiting (medically significant) on 18Jul2021 with outcome of recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1523848 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
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 INC202100916565

Write-up: nausea; head ache; joint pain; chills; 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-202107182020524100-CI1V5, Safety Report Unique Identifier is GB-MHRA-ADR 25669974. A 30-years-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 17Jul2021 (Batch/Lot Number: FD8813) as single dose for covid-19 immunization. Medical history included suppressed lactation from an unknown date. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced nausea, headache, joint pain, chills on an unspecified date and fever on 18Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The events were reported as serious (medically significant). The patient was recovering from fever while outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1523858 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspepsia, Musculoskeletal chest pain, Off label use, Product use issue
SMQs:, Gastrointestinal nonspecific dysfunction (narrow), Medication errors (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: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923429

Write-up: This is the 1st of 2 spontaneous reports from a contactable consumer, downloaded via the regulatory authority (report number is GB-MHRA-WEBCOVID-202107191457475380-YZAHO; safety report unique identifier: GB-MHRA-ADR 25673689). This consumer reported information for both mother and baby. This is the mother report. A 38-year-old female patient received the BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# not known), via an unspecified route of administration, on Jul 17, 2021, single dose, for COVID-19 immunisation. Medical history included pregnancy and ongoing breast feeding. Patient has not had symptoms associated with COVID-19, nor had a COVID-19 test. Patient is not pregnant. The patient''s concomitant medications were not reported. The patient experienced maternal exposure during breast feeding on an unspecified date; and indigestion on Jul 18, 2021. Clinical course reported: extreme indigestion, never suffered with before (apart during pregnancy). Severe stabbing pain in ribs that prevented sleep. Patient has not tested positive for COVID-19 since the vaccination. Patient is not enrolled in a clinical trial. The outcome of the indigestion recovered on Jul 19, 2021; and severe stabbing pain in ribs unknown. Serious events (medically significant). No follow-up attempts possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1523928 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast swelling, Neck pain, Pain in extremity, SARS-CoV-2 test, Swelling, Vaccination site swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (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: BOOTS NASAL; CLARITYN [LORATADINE]; VENTOLINE [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928664

Write-up: Stabbing pains in both of his forearms; Noticeable swelling underneath his armpit; swelling arm/where the injection was given has swollen; Breast swelling; Neck pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number [-MHRA-WEBCOVID-202107200813508810-LCZ0L], Safety Report Unique Identifier [MHRA-ADR 25678675]. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the arm, on 18Jul2021 (Batch/Lot Number: FD8813), at the age of 27-years-old, as dose 2, single for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medication included oxymetazoline hydrochloride (BOOTS NASAL) taken for an unspecified indication, start and stop date were not reported; loratadine (CLARITYN) taken for an unspecified indication, start and stop date were not reported; salbutamol sulfate (VENTOLINE) taken for an unspecified indication, start and stop date were not reported. The patient experienced swelling arm/where the injection was given has swollen on 19Jul2021; breast swelling and neck pain on 18Jul2021; ''stabbing pains in both of his forearms'' and ''Noticeable swelling underneath his armpit'' on an unspecified date. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 17Jul2021. The outcome of the events ''stabbing pains in both of his forearms'' and ''Noticeable swelling underneath his armpit'' was unknown and outcome of the other events was not recovered. The clinical course was reported as follows: Stabbing pains in both of his forearms. And where the injection was given has swollen considerably. Noticeable swelling underneath his armpit and left "peck", the side the jab was given. Neck pain again on the side given. Since having the jab, he has felt what he can only describe as blood continuely rushing in his arm (as if you''ve laid on it funny). Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional information: Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1523947 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100928743

Write-up: hives; itchy; Giant hives; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202107200943272750-IVBA1, Safety Report Unique Identifier GB-MHRA-ADR 25679008. A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 (Lot Number: FD8813) as dose 1, single for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not pregnant and is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced hives and itchy on an unspecified date then giant hives on 18Jul2021. The events caused hospitalization and were medically significant. Therapeutic measures were taken as result of the events and included treatment with antihistamines and other medications. Outcome of the giant hives was not recovered while of the remaining events was unknown. The clinical course was reported as follows: Minor hives at first, very itchy. Increasingly worse to severe level. Large amount of antihistamines and other medications required to manage. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Checked at hospital and confirmed hives. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1523969 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Pain, SARS-CoV-2 test, Suspected COVID-19, Tension headache
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100929195

Write-up: Fatigue; Tension headaches; Ache; Breathlessness; Suspected COVID-19; 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-202107201151492930-ADNUD, Safety Report Unique Identifier GB-MHRA-ADR 25679763. A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 as single dose for COVID-19 immunisation. Medical history included lactation decreased from an unknown date. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced fatigue on 18Jul2021, tension headaches on 18Jul2021, ache on 18Jul2021, breathlessness on 18Jul2021, suspected COVID-19 on 18Jul2021. 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: no - negative covid-19 test on 20Jul2021. The outcome of the event suspected COVID-19 was unknown, while the other events were not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1524038 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Bloody discharge, Cough, Fatigue, Hyperaesthesia, Increased viscosity of upper respiratory secretion, Joint swelling, Malaise, Oropharyngeal pain, Pain in extremity, Peripheral swelling, Sneezing, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CHLORPHENAMINE MALEATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Overweight; Seasonal allergy; Suppressed lactation; Comments: I am overweight but otherwise healthy Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100928921

Write-up: coughing; painful joints in hands; generally unwell; mucus; swelling; sneezing; Mildly sore arm; ankles have swollen; sensitive to touch; Sore throat; Thick nasal mucus; Calf swelling/leg swelling; Swelling of feet; Hand pain; Tired all the time; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory authority report number is GB-MHRA-WEBCOVID-202107201813538310-84BGL, Safety Report Unique Identifier is GB-MHRA-ADR 25682410. A 24-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 (Lot number and expiry date were not reported) as dose 1, single for COVID-19 immunisation. Medical history included suppressed lactation (lactation decreased), overweight and hay fever. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medications included chlorphenamine maleate taken for seasonal allergy (hay fever) from 07Jul2007 to an unspecified stop date. The patient experienced coughing on an unspecified date with outcome of recovering, painful joints in hands on an unspecified date with outcome of recovering, generally unwell on an unspecified date with outcome of recovering, mucus on an unspecified date with outcome of recovering, swelling on an unspecified date with outcome of recovering, sneezing on an unspecified date with outcome of recovering, calf swelling/leg swelling on 19Jul2021 with outcome of not recovered, swelling of feet on 18Jul2021 with outcome of not recovered, hand pain on 18Jul2021 with outcome of not recovered, sore throat on 20Jul2021 with outcome of not recovered, thick nasal mucus on 19Jul2021 with outcome of not recovered, tired all the time on 18Jul2021 with outcome of not recovered, mild sore arm on an unspecified date with outcome of unknown, ankles have swollen on an unspecified date with outcome of unknown and sensitive to touch on an unspecified date with outcome of unknown. The events were reported as serious, medically significant by the health authority. Case narrative: Mildly sore arm for first couple of days, pain has now shifted to lower arm on side of vaccine site, and painful joints in hands, then Started having a sore throat, then started coughing up and sneezing thick yellowish mucus, now my legs, feet and ankles have swollen and are sensitive to touch. Very tired and generally unwell. I find the swelling quite concerning. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1524039 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100928976

Write-up: Swollen arm; under arm very sore and swollen to lift up painful looked like the lymph glands were swollen; under arm very sore and swollen to lift up painful looked like the lymph glands were swollen; This is a spontaneous report from a contactable consumer received from the Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107201815254680-WDITU, Safety Report GB-MHRA-ADR 25682420. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Jul2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced swollen arm, under arm very sore and swollen to lift up painful looked like the lymph glands were swollen but this symptom was not described as a side effect of the vaccine. It started just after the 2nd dose on the same day on 18Jul2021. The outcome of events was not recovered. Events were serious as medically significant. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1524067 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling hot, Lymphadenopathy, Rash erythematous, Skin warm, Vaccination site reaction
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100929198

Write-up: red hot band rash around arm under injection site occurred; red hot band rash around arm under injection site occurred; red hot band rash around arm under injection site occurred; Skin warm; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202107202202439240-EJ0MB, Safety Report Unique Identifier GB-MHRA-ADR 25683641. A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration at single dose on 17Jul2021 for COVID-19 immunisation. Medical history included lactation decreased from unspecified date. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced swollen lymph nodes on 18Jul2021, skin warm on 20Jul2021. Case narrative: Next day after Pfizer injection lymph nodes in armpit really swollen then red hot band rash around arm under injection site occurred. 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 swollen lymph nodes and skin warm was not recovered, while the other events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1524088 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Nausea, Suspected COVID-19
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decreased lactation.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100928729

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202107210538063160-7FIND; safety report unique identifier: GB-MHRA-ADR 25684114). A 38-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# FD8813), via an unspecified route of administration, on Jul 15, 2021, single dose, for COVID-19 immunization. Medical history included decreased lactation. Patient has not had a COVID-19 test. Patient is not pregnant, nor currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced nausea and suspected COVID-19 on Jul 18, 2021. The patient experienced diarrhea on Jul 19, 2021. The outcome of the events: not recovered. The events considered medically significant. Patient has not tested positive for COVID-19 since the vaccination. Patient is not enrolled in a clinical trial. No follow-up attempts possible. No further information expected.


VAERS ID: 1524212 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-07-18
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhage, Heavy menstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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: bleeding; Prolonged periods; This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding) in a 38-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 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Prolonged periods). On an unknown date, the patient experienced HAEMORRHAGE (bleeding) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (bleeding) had resolved and HEAVY MENSTRUAL BLEEDING (Prolonged periods) 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 Route) was unknown. No concomitant medications were reported. On an unknown date, patient had a COVID-19 virus test with result negative. Patient had very early period for last cycle (18 days) and had bleeding for a week now. Patient has been tracking cycles for years with an app and have a very regular 3-4 day cycle for years. There were no other unusual stresses in life that may have an impact. No treatment information was reported. Company Comment: Very limited information regarding these events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information cannot be requested.; Sender''s Comments: Very limited information regarding these events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information cannot be requested.


VAERS ID: 1524223 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Injection site oedema, Muscle spasms, SARS-CoV-2 test, Vaccination site swelling
SMQs:, Dystonia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: SUMATRIPTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Seroma
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: COVID-19 virus test Negative.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Muscle spasms; Joint pain; Pain in hip; Vaccination site swelling; Injection site edema; This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle spasms), INJECTION SITE OEDEMA (Injection site edema), ARTHRALGIA (Joint pain) and ARTHRALGIA (Pain in hip) in a 30-year-old male 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 Seroma. Concomitant products included SUMATRIPTAN for Migraine. On 18-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced INJECTION SITE OEDEMA (Injection site edema) (seriousness criterion medically significant), ARTHRALGIA (Pain in hip) (seriousness criterion medically significant) and VACCINATION SITE SWELLING (Vaccination site swelling). On 19-Jul-2021, the patient experienced MUSCLE SPASMS (Muscle spasms) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). On 22-Jul-2021, INJECTION SITE OEDEMA (Injection site edema) had resolved. At the time of the report, MUSCLE SPASMS (Muscle spasms), ARTHRALGIA (Joint pain) and ARTHRALGIA (Pain in hip) had not resolved and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) COVID-19 virus test Negative. 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: 1524391 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003605 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Cardiac troponin; Result Unstructured Data: Cardiac troponin increased
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: Miopericardite acuta; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Miopericardite acuta) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3003605) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter in total. On 18-Jul-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Miopericardite acuta) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Miopericardite acuta) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: increased (High) Cardiac troponin increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product information was not provided by reporter. No treatment information was provided. On 19-JUL-2021 Echocardiogram was done for the patient and the report was not reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Non significant FU document received on 29-JUL-2021 and updated information of lab data such as Echocardiogram and cardiac troponin increased.; 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: 1524425 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9880 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Body temperature, Cyanosis, Dyspnoea, Feeling abnormal, Hyperhidrosis, Nausea, Pallor, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Giddiness
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100923923

Write-up: Anaphylactic shock; Cyanosis; Slight dyspnoea; Queasy; Drenching sweats; Feels poorly; Pallor facial; vomiting; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES) and from the Regulatory authority report number is v21120948. A 50-year-old (reported as 50-year and 7-month-old) female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FC9880, Expiration date 30Sep2021) at 50-year-old, via an unspecified route of administration in arm left on 18Jul2021 at 11:32 at single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Medical 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 depression, and giddiness (both undergoing treatment). Body temperature before vaccination was 36.2 degrees Centigrade. Family history of the patient was unknown. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Jul2021 at 11:37 (5 minutes after the vaccination), the patient experienced drenching sweats, vomiting, cyanosis, slight dyspnoea, and queasy. The course of the event was as follows: During the follow-up observation after the vaccination, the patient developed feels poorly, pallor facial, drenching sweats, after lying in bed quietly, the symptom gradually abated. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. Other possible cause of the event such as any other diseases was depression. The reporting physician commented as follows: There was a depression in the patient''s background, which seemed to have caused a panic from excessive tension at the mass vaccination site. There were low possibility of anaphylactic shock or immediate allergic reaction. Since the vaccination, whether the patient had been tested for COVID-19 or not was unknown. On 18Jul2021 (the same day of the vaccination), the outcome of the events was resolved without treatment.


VAERS ID: 1524555 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Dizziness, Hyperglycaemia, Hypertension, Hypoaesthesia, Malaise
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Vestibular disorders (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: Hyperglycaemia; Test Result: 297 mg/dl; Test Date: 20210718; Test Name: Hypertension; Result Unstructured Data: Test Result:202/125
CDC Split Type: JPPFIZER INC202100935422

Write-up: Hypertension; Hyperglycaemia; Light headedness; Numbness of limbs; malaise; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21120712. The patient was a 24-year and 8-month-old female (age at vaccination). The patient had underlying disease of Diabetes mellitus. On 27Jun2021, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# FC8736, Expiration date 30Sep2021). On 18Jul2021 at 10:46 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) via an unspecified route of administration as dose 2, single (at the age of 24 years old) for COVID-19 immunization. On 18Jul2021 at around 11:05 (19 minutes after the vaccination), the patient experienced hypertension, hyperglycaemia. On 18Jul2021 (the same day of the vaccination), the patient was admitted to the hospital. The course of the event was as follows: Light headedness, numbness of limbs, malaise. hypertension 202/125, hyperglycaemia 297mg/dl. The reporting physician classified the events as serious (caused hospitalization from 18Jul2021 to 18Jul2021) and assessed that the causality between the event and bnt162b2 as unassessable. The outcome of the events was unknown. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Need hospitalization.


VAERS ID: 1524715 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-18
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DYMISTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202100929613

Write-up: Intense myalgia (mainly in the legs); intense nausea; General malaise; This is a spontaneous report from a contactable consumer or other non hcp. A 32-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FF0680), dose 1 intramuscular, administered in the left arm on 08Jul2021 at 12:30 (age at the time of vaccination 32-year-old) as dose 1, single for covid-19 immunisation. The patient''s medical history included controlled respiratory allergy (mites, grasses, etc). Prior to vaccination, the patient had not been diagnosed with COVID-19. Concomitant medication included azelastine hydrochloride, fluticasone propionate (DYMISTA). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 18Jul2021 at 12:00, the patient experienced intense myalgia, intense nausea and general malaise. Since the vaccination, the patient had not been tested for COVID-19. At the time of the report, the outcome of the events was not resolved.


VAERS ID: 1525274 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003653 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fixed eruption, Oculomucocutaneous syndrome, Stevens-Johnson syndrome
SMQs:, Severe cutaneous adverse reactions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP068315

Write-up: Severe drug eruption (suspected fixed drug eruption, suspected Stevens-Johnson syndrome); Severe drug eruption (suspected fixed drug eruption, suspected Stevens-Johnson syndrome); Oculomucocutaneous syndrome (mucosal erosion of lips, erosion of tongue, genital erosion, blistering of the entire body, erythema); This case was received via Regulatory Authority (Reference number: 2021TJP068315) on 23-Jul-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of OCULOMUCOCUTANEOUS SYNDROME (Oculomucocutaneous syndrome (mucosal erosion of lips, erosion of tongue, genital erosion, blistering of the entire body, erythema)), STEVENS-JOHNSON SYNDROME (Severe drug eruption (suspected fixed drug eruption, suspected Stevens-Johnson syndrome)) and FIXED ERUPTION (Severe drug eruption (suspected fixed drug eruption, suspected Stevens-Johnson syndrome)) in a 46-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003653) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced OCULOMUCOCUTANEOUS SYNDROME (Oculomucocutaneous syndrome (mucosal erosion of lips, erosion of tongue, genital erosion, blistering of the entire body, erythema)) (seriousness criteria hospitalization and medically significant). On 20-Jul-2021, the patient experienced STEVENS-JOHNSON SYNDROME (Severe drug eruption (suspected fixed drug eruption, suspected Stevens-Johnson syndrome)) (seriousness criteria hospitalization and medically significant) and FIXED ERUPTION (Severe drug eruption (suspected fixed drug eruption, suspected Stevens-Johnson syndrome)) (seriousness criterion hospitalization). The patient was hospitalized on 20-Jul-2021 due to FIXED ERUPTION, OCULOMUCOCUTANEOUS SYNDROME and STEVENS-JOHNSON SYNDROME. At the time of the report, OCULOMUCOCUTANEOUS SYNDROME (Oculomucocutaneous syndrome (mucosal erosion of lips, erosion of tongue, genital erosion, blistering of the entire body, erythema)), STEVENS-JOHNSON SYNDROME (Severe drug eruption (suspected fixed drug eruption, suspected Stevens-Johnson syndrome)) and FIXED ERUPTION (Severe drug eruption (suspected fixed drug eruption, suspected Stevens-Johnson syndrome)) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered OCULOMUCOCUTANEOUS SYNDROME (Oculomucocutaneous syndrome (mucosal erosion of lips, erosion of tongue, genital erosion, blistering of the entire body, erythema)), STEVENS-JOHNSON SYNDROME (Severe drug eruption (suspected fixed drug eruption, suspected Stevens-Johnson syndrome)) and FIXED ERUPTION (Severe drug eruption (suspected fixed drug eruption, suspected Stevens-Johnson syndrome)) to be possibly related. No concomitant medication information was provided by the reporter. On an unknown date, at unknown time, body temperature before the vaccination was 36.5 degrees Celsius. On On 18-Jul-2021, the patient visited a nearby hospital because of severe swelling around the mouth. On 19-Jul-2021, patient developed roughening of skin. On 21-Jul-2021, at the time of the visit to the hospital, the symptoms included mucosal erosion of lips, erosion of tongue, genital erosion, blistering of the entire body, and erythema. The symptoms were considered as oculomucocutaneous syndrome. No treatment information was provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1525509 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune 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? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: COVID-19 PCR; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: CAPFIZER INC202100921858

Write-up: Myocarditis; This is a spontaneous report from a contactable physician. A 16-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), intramuscular, administered in the left arm on 17Jul2021 at 12:00 (Lot Number and Expiry date unknown) as dose number unknown, single for COVID-19 immunization. The patient did not have any medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 18Jul2021 at 15:00 the patient experienced myocarditis. The patient visited the emergency room/department or urgent care due to the event. The patient was hospitalized for 3 days due to the event. The patient received ibuprofen as treatment for the event. The patient underwent a COVID-19 PCR test nasal swab on 19Jul2021 and got a negative result. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of myocarditis 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: 1525510 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Hypotension, Lymphadenopathy, Pyrexia, Tonic convulsion
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KEPPRA [LEVETIRACETAM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control; Epilepsy (controlled with medication and haven''t had seizure in 2.5 years prior to this); Latex allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202100922405

Write-up: Fever and swollen lymph node under right armpit. Tonic Seizure lasting 45 seconds at 1:45 am the night following second dose administration. Taken to ER by EMS with low blood pressure; Fever and swollen lymph node under right armpit. Tonic Seizure lasting 45 seconds at 1:45 am the night following second dose administration. Taken to ER by EMS with low blood pressure; Fever and swollen lymph node under right armpit. Tonic Seizure lasting 45 seconds at 1:45 am the night following second dose administration. Taken to ER by EMS with low blood pressure; Fever and swollen lymph node under right armpit. Tonic Seizure lasting 45 seconds at 1:45 am the night following second dose administration. Taken to ER by EMS with low blood pressure; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 17Jul2021 09:00 (Batch/Lot Number: Unknown) (at the age of 22-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included epilepsy (controlled with medication and haven''t had seizure in 2.5 years prior to this),latex allergy, and contraception; from unknown dates and unknown if ongoing. Patient was not pregnant at time of vaccination. Concomitant medications included levetiracetam (KEPPRA [LEVETIRACETAM]) taken for an unspecified indication, and unspecified medication taken for birth control; start and stop dates were not reported. Historical vaccine included first dose of PFIZER-BIONTECH COVID-19 VACCINE via an unspecified route of administration, administered in arm right on 23Mar2021 (Batch/Lot Number: Unknown) (at the age of 22-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered in public health clinic/ veterans administration facility. 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 18Jul2021 01:45, the patient experienced fever and swollen lymph node under right armpit. Tonic seizure lasting 45 seconds at 1:45 am the night following second dose administration. Taken to ER by EMS with low blood pressure. The events required emergency room/department or urgent care and hospitalization on unspecified date in 2021 for 1 day. Therapeutic measures were taken as a result of the events which included intravenous (IV) of Saline. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


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