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From the 11/12/2021 release of VAERS data:

Found 875,292 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 170 out of 8,753

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VAERS ID: 1861622 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: New York  
Vaccinated:2021-09-30
Onset:2021-10-15
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Amnesia, Aphasia, Disorientation, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Wellbutrin, Junel, probiotic, Omega 3 oils, clonazepam
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Disorientation, memory loss, word retrieval difficulties, tremor in left hand


VAERS ID: 1863420 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Delaware  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 076C21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered, Product temperature excursion issue
SMQs:, Medication errors (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: USMODERNATX, INC.MOD20213

Write-up: 2 second doses administered after exposure to room temperature greater than 24 hours; 2 second doses administered after exposure to room temperature greater than 24 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 second doses administered after exposure to room temperature greater than 24 hours) and PRODUCT TEMPERATURE EXCURSION ISSUE (2 second doses administered after exposure to room temperature greater than 24 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-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 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 second doses administered after exposure to room temperature greater than 24 hours) and PRODUCT TEMPERATURE EXCURSION ISSUE (2 second doses administered after exposure to room temperature greater than 24 hours). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2 second doses administered after exposure to room temperature greater than 24 hours) and PRODUCT TEMPERATURE EXCURSION ISSUE (2 second doses administered after exposure to room temperature greater than 24 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were mentioned. No treatment details were reported. Storage condition at the time of the excursion: refrigerated storage. Maximum temperature reached: 10 degrees Celsius. Excursion duration: 1 hour 20 minutes. Date vial(s) moved from freezer to refrigerator: 01-Oct-2021. This case was linked to MOD-2021-374033, MOD-2021-373996, MOD-2021-374534, MOD-2021-373961, MOD-2021-374033 (Patient Link).


VAERS ID: 1863850 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (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: USMODERNATX, INC.MOD20213

Write-up: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021 at 8:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 15-Oct-2021 at 8:00 AM, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. no concomitant drugs were reported. no treatment drugs were reported.


VAERS ID: 1863851 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (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: USMODERNATX, INC.MOD20213

Write-up: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.


VAERS ID: 1863852 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (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: USMODERNATX, INC.MOD20213

Write-up: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details was provided. No treatment medication details was provided. REMOVED FROM FREEZER 8 AM, 10/15/21


VAERS ID: 1863853 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (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: USMODERNATX, INC.MOD20213

Write-up: Dose administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-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 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the published expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the published expiry date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by reporter. No treatment medication was reported by reporter. Vial was removed from refrigerator on 15-Oct-2021, 08:00.


VAERS ID: 1864000 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Georgia  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal pain upper, Asthenia, Balance disorder, Chills, Dizziness, Drug ineffective, Dyspnoea, Fatigue, Feeling abnormal, Feeling cold, Irritable bowel syndrome, Mobility decreased, Muscular weakness, Pain in extremity, Pyrexia, Suspected COVID-19, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: USPFIZER INC202101509832

Write-up: had every one of the typical Covid symptoms; had every one of the typical Covid symptoms; extreme fatigue/ fatigue and weakness; Muscle weakness/ leg weakness; sort of dizziness that made her feel off balance; sort of dizziness that made her feel off balance; Stomach ache; Chills; can''t lift like she did before this; lost 3 pounds through this; Upset stomach; was miserable for almost 3 weeks; it triggered IBS symptoms as well; freezing; felt like she had a fever but she didn''t have a thermometer to check her temperature; weakness/ still feeling weak; sore arm; Shortness of breath; This is a spontaneous report from a contactable consumer (patient''s friend). This consumer reported similar events for himself and another patient. This report is 2nd of 2 reports. A patient of an unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that she had a friend that had typical covid symptoms which she also had, and these symptoms only lasted at most 3 or 4 days. Typical covid symptoms experienced are extreme fatigue/ fatigue and weakness, muscle weakness/ leg weakness, sort of dizziness that made patient felt off balance, stomach ache, chills, shortness of breath, can''t lift like the patient did before this, lost 3 pounds through this, upset stomach, was miserable for almost 3 weeks, it triggered IBS (irritable bowel syndrome) symptoms as well, freezing, felt like had a fever but didn''t have a thermometer to check temperature, weakness/ still feeling weak, sore arm. Event typical covid symptoms was medically significant. The outcome of the events were recovered on an unknown date. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101507250 Same reporter/vaccine/event, different patients


VAERS ID: 1864244 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (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: USMODERNATX, INC.MOD20213

Write-up: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Product removed from freezer 8 AM,15-OCT-2021 No Treatment information was provided. No concomitant medication was provided


VAERS ID: 1793880 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Condition aggravated, Furuncle, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: asthma / hypothyroidism
Allergies: seasonal/cats/dogs
Diagnostic Lab Data:
CDC Split Type:

Write-up: a rash / boil that I had every summer as a kid, and have not had since, has now reared its ugly head again back. Its been approx 20 years since I have had to deal with this.


VAERS ID: 1804079 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Chest pain, Cough, Dyspnoea, Food intolerance, Gastric disorder, Headache
SMQs:, Anaphylactic reaction (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Na
CDC Split Type:

Write-up: Gastro, severe chest pain, severe joint pain, shortness of breath, sensitive stomach, lack of intolerance to food, headache, cough, weakness


VAERS ID: 1809429 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNK / 3 - / SYR
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / 3 - / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Gastrointestinal disorder, Influenza, Pain, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB202121

Write-up: Severe gastrointestinal symptoms. Pain, vomiting diarrhoea. The flu symptoms were predicted but stomach issues have been significant; Severe gastrointestinal symptoms. Pain, vomiting diarrhoea. The flu symptoms were predicted but stomach issues have been significant; Severe gastrointestinal symptoms. Pain, vomiting diarrhoea. The flu symptoms were predicted but stomach issues have been significant; Severe gastrointestinal symptoms. Pain, vomiting diarrhoea. The flu symptoms were predicted but stomach issues have been significant; Severe gastrointestinal symptoms. Pain, vomiting diarrhoea. The flu symptoms were predicted but stomach issues have been significant; This case received by GSK via regulatory authority on 21st-October-2021 This case was reported by a consumer via regulatory authority and described the occurrence of gastrointestinal disorder in a 62-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis. Co-suspect products included TOZINAMERAN (BIONTECH COMIRNATY COVID-19 MRNA VACCINE) for prophylaxis. On 15th October 2021, the patient received the 3rd dose of Influenza vaccine Quadrivalent 2021-2022 season (parenteral) and the 3rd dose of BIONTECH COMIRNATY COVID-19 MRNA VACCINE (parenteral). On 15th October 2021, less than a day after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced gastrointestinal disorder (serious criteria disability), pain (serious criteria disability), vomiting (serious criteria disability), diarrhoea (serious criteria disability) and flu symptoms (serious criteria disability). On an unknown date, the outcome of the gastrointestinal disorder, pain, vomiting, diarrhoea and flu symptoms were not recovered/not resolved. It was unknown if the reporter considered the gastrointestinal disorder, pain, vomiting, diarrhoea and flu symptoms to be related to Influenza vaccine Quadrivalent 2021-2022 season. Additional details were reported as follows: The time to onset for the events gastrointestinal disorder, pain, vomiting, diarrhoea and flu symptoms was reported as 1 day, however it was captured as less than a day as per vaccination date and event onset date. The time to onset for the events gastrointestinal disorder, pain, vomiting, diarrhoea and flu symptoms was 1 day with BIONTECH COMIRNATY COVID-19 MRNA VACCINE. It was unknown if the reporter considered the gastrointestinal disorder, pain, vomiting, diarrhoea and flu symptoms to be related to BIONTECH COMIRNATY COVID-19 MRNA VACCINE. Initial information received from consumer via regulatory authority on 21st October 2021: gastrointestinal disorder, pain, vomiting, diarrhoea and flu symptoms Case narrative : Severe gastrointestinal symptoms. Pain, vomiting and diarrhoea. The flu symptoms were predicted but stomach issues have been significant. The patient was taking Covid Booster Pfizer and Flu combined for: Covid Booster Flu.


VAERS ID: 1813951 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Injection site pain, Loss of personal independence in daily activities
SMQs:, Dementia (broad), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin 1000 mg, Bendroflumethiazide 2.5 mg, Metoprolol 100 mg, Glipizide 5 mg, Rivaroxaban 20 mg, Atorvastatin 10 mg, Losartan 50 mg, Amlodipine 10 mg, Fish Oil 1000 mg, B-12, multivitamin, Calcium 1000 mg, Folic Acid, Naproxin Sodium 2
Current Illness: None
Preexisting Conditions: Hypertension, Type 2 Diabetes
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Intense, persistent pain at the injection site lasting more than ten days. Normal doses of acetaminophen and naproxen sodium provide no relief. Pain is enough to inhibit normal daily activities.


VAERS ID: 1819439 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Immunisation, Lymphadenopathy, Myalgia, Off label use
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101400471

Write-up: Lymphadenopathy; Muscle ache; Chills; Booster; Booster; This is a spontaneous report from a contactable consumer received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110161746178140-KBCKW, Safety Report Unique Identifier GB-MHRA-ADR 26085054. A 34-year-old female patient received third, booster dose of BNT162B2 (COMIRNATY, solution for injection), via unspecified route of administration, on 15Oct2021 (at the vaccination age of 34-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not symptoms associated with COVID-19 and did not have a COVID-19 test. Patient was not pregnant at the time of report. Patient was not currently breastfeeding. The patient experienced lymphadenopathy, muscle ache and chills; all on 15Oct2021 and all with seriousness of important medically significant, and experienced booster dose on 15Oct2021. As reported, patient is not enrolled in clinical trial. The outcome of the event lymphadenopathy, muscle ache, Chills was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1819440 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Immunisation, Off label use, Product administered to patient of inappropriate age, SARS-CoV-2 test, Vaccination site swelling
SMQs:, Arthritis (broad), Medication errors (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: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211008; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101401022

Write-up: vaccination site swelling day after booster vaccine; Joint pain; Off label use; Booster; Patient was 5-month-old; This is a spontaneous report from a contactable consumer received from the Regulatory Authority; report number is GB-MHRA-WEBCOVID-202110161911597510-ORNJN. Safety Report Unique Identifier is GB-MHRA-ADR 26085108. A 5-month-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 15Oct2021 (Lot number and expiry date not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included suspected COVID-19 from 04Oct2020 to 14Oct2021. Concomitant medications were not reported. Historical vaccine included first and second doses of BNT162B2 on unspecified dates as dose 1, single and dose 2, single for COVID-19 immunization. The patient experienced vaccination site swelling day after booster vaccine on 16Oct2021 with outcome of unknown, and joint pain on 16Oct2021 with outcome of recovering; off label use and booster on 15Oct2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Oct2021 No - Negative COVID-19 test. The events vaccination site swelling and joint pain were reported as serious, medically significant while the other events were non-serious. Case narrative: Vaccination site swelling day after booster vaccine, joint pain across whole body particularly fingers. No S/Es such as this with dose 1 or dose 2. 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. No further information is expected.


VAERS ID: 1822689 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-10-15
   Days after vaccination:77
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Lymphadenopathy, Muscle fatigue, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Swelling; Muscle fatigue; Muscle soreness; Chills; Headache; Nausea; Fever; Lymphadenopathy; This case was received via the RA (Reference number: GB-MHRA-ADR 26085543) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymphadenopathy), SWELLING (Swelling), MUSCLE FATIGUE (Muscle fatigue), MYALGIA (Muscle soreness), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004674) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced LYMPHADENOPATHY (Lymphadenopathy) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant), MUSCLE FATIGUE (Muscle fatigue) (seriousness criterion medically significant), MYALGIA (Muscle soreness) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Lymphadenopathy) had not resolved and SWELLING (Swelling), MUSCLE FATIGUE (Muscle fatigue), MYALGIA (Muscle soreness), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter.Treatment product was not provided by the reporter. Patient had axillary lymphadenopathy of the left side (the same arm where Covid vaccine was given.) Because of the muscle fatigue and pain at the injection site, it hurts to raise arm. That, alongside the swelling in armpit, the patient was unable to hold a position where arm isn''t in chronic pain. Patient also had fatigue, muscle soreness all over, fever, headache, constant nausea, loss of appetite and chills. Patient was not able to be at work at the moment because of these symptoms. Injection sight soreness and much milder lymph node swelling were only symptoms after the first dose and the swelling resolved after a couple of weeks. Company Comment This case concerns a 28-year-old, female patient with no relevant medical history, who experienced the unexpected events of Lymphadenopathy, Swelling, Muscle fatigue, Myalgia, Chills, Headache, Nausea and Pyrexia . The events of Myalgia, Chills, Headache, Nausea and Pyrexia are unexpected as they are retained as serious per the RA source document. The event Lymphadenopathy occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine, while the other events occurred on an unknown date. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 28-year-old, female patient with no relevant medical history, who experienced the unexpected events of Lymphadenopathy, Swelling, Muscle fatigue, Myalgia, Chills, Headache, Nausea and Pyrexia . The events of Myalgia, Chills, Headache, Nausea and Pyrexia are unexpected as they are retained as serious per the RA source document. The event Lymphadenopathy occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine, while the other events occurred on an unknown date. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1823916 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-10-15
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN C9CRELHYPXLX / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Contusion
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: Exsira Epitec Alzam Trazedone Ativan
Current Illness: Laryngitis
Preexisting Conditions: Depression and anxiety
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Severe bruising on legs one week after injection and are getting worse


VAERS ID: 1824810 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVJNJFOC20211054567

Write-up: ANAPHYLACTIC REACTION; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, LV-SAM-2021106768) on 27-OCT-2021 concerned a 40 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: ACA5775 expiry: UNKNOWN) .5 ml, 1 total administered on 15-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-OCT-2021 14:40, the patient experienced anaphylactic reaction. The patient was hospitalized (date and duration unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction on 16-OCT-2021. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1826551 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Endometriosis, 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: Endometriosis; Suspected COVID-19 (Unsure when symptoms started and stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101380635

Write-up: Endometriosis; Bleeding menstrual heavy; This is a spontaneous report from a contactable consumer (patient). This report is received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110150749451220-PMGCX, Safety Report Unique Identifier GB-MHRA-ADR 26080867. A 32-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: fj5782), via an unspecified route of administration on 12Oct2021 (at the age of 32-years-old) (off label use) as dose 3 (booster), single for covid-19 immunisation. Medical history included endometriosis and suspected covid-19 (unsure when symptoms started and stopped) from an unknown date and unknown if ongoing. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial.The patient''s concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was unknown), via an unspecified route of administration on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. On 15Oct2021, the patient experienced bleeding menstrual heavy and on an unspecified date had endometriosis. The reporter considered the events as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The outcome of event bleeding menstrual heavy was not resolved and other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1826566 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Concussion, Dizziness, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Head injury
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101400388

Write-up: Nausea; Dizziness; Headache/hit on the head became sore; symptoms of concussion started to exhibit themselves; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202110172321280820-PE7WW with Safety Report Unique Identifier of GB-MHRA-ADR 26085780. A 27-year-old male patient received second dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via unspecified route of administration on 15Oct2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history reported as on 09Oct2021, following a rugby game the patient received a knock on the head and failed a Head Injury Assessment (HIA). The patient felt fine the following days and continued with day-to-day life as normal. The patient did not have symptoms associated with COVID-19 and was not enrolled in the clinical trial. Concomitant medications were not reported. Following the vaccination, on 15Oct2021, the area where the patient was hit on the head became sore and symptoms of concussion started to exhibit themselves such as a headache, dizziness and light nausea. This lasted for 1 to 1 and a half days. The events headache, dizziness and nausea were reported as serious for being medically significant. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events nausea and dizziness was resolved on unknown date in Oct2021; while that of the event headache was resolved on 16Oct2021, after the duration of 1 day. The clinical outcome of the events symptoms of concussion started to exhibit themselves was unknown. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1826844 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2018 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Electroencephalogram, Loss of consciousness, Nausea, Seizure, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: Loss of consciousness (In the early Aug2021); Tremulousness (In the early Aug2021)
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 202108; Test Name: EEG; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: JPPFIZER INC202101382582

Write-up: convulsion; loss of consciousness; nausea; tremulousness of hands; This is a spontaneous report from a physician received from the Regulatory Agency (RA). Regulatory authority report number is v21129454. The patient was a 15-year-old male (age at 1st vaccination). Body temperature before vaccination was 36.3 degrees Centigrade. The patient had no family history. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included: In the early Aug2021, the patient presented with loss of consciousness and tremulousness of hands. The patient underwent EEG in a local general hospital and no abnormalities showed. On 14Oct2021 at 17:33 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF2018, Expiration date 31Dec2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 15Oct2021 at about 07:00 (1 day after the vaccination), the patient experienced convulsion. On 15Oct2021 (1 day after the vaccination), the outcome of the event was recovered. The course of the event was as follows: After getting up, the patient complied of nausea and presented with loss of consciousness and began to have tremulousness of hands. The symptoms subsided subsequently, and the patient regained his consciousness. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The relationship between the medical history in Aug2021 and the vaccination this time is unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1826854 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1763 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Physical deconditioning, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101382986

Write-up: Convulsion/Generalised convulsion; physical deconditioning; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21129483. A 28-year-old (reported as 28-year and 10-month-old) male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 15Oct2021 at 14:30 (Batch/Lot Number: FJ1763; Expiration Date: 31Jan2022) (at the age of 28 years old (reported as 28-year and 10-month-old)) as dose 1, single for COVID-19 immunisation. The patient had no medical and family history. The patient had no concomitant medications. There were no points provided on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status, etc.). The patient experienced convulsion/generalised convulsion and physical deconditioning on 15Oct2021 at 14:35. The course of the event was as follows: At 14:30 of 15Oct2021, the patient received the vaccination. When the patient sat at a waiting room, he noticed physical deconditioning. Immediately after that, generalised convulsion appeared for several seconds, but the patient quickly recovered. The event convulsion/generalised convulsion was reported as serious (medically significant). The patient was introduced to a Hospital, and he visited the Hospital (as reported). The patient underwent laboratory tests and procedures which included body temperature: 36.8 centigrade on 15Oct2021 before vaccination. The outcome of event was unknown. The reporter assessed the causality between the event and the vaccines as related. The reporter commented as follows: Assessment based on intracranial CT, MRI, etc. is necessary, but a possibility of the influence of the vaccination cannot be denied. No follow up attempts are possible. No further information is expected.


VAERS ID: 1826855 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1763 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest pain, Dizziness, Nausea, Palpitations, Panic attack
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Panic attack (The patient has been visiting clinic for panic attack and sleeplessness.); Sleeplessness (The patient has been visiting clinic for panic attack and sleeplessness.)
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101383022

Write-up: Panic attack; chest pain; palpitations; giddiness; queasy; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21129486. A 27-year and 7-month-old female patient received first dose of bnt162b2 (COMIRNATY; Lot Number: FJ1763; Expiration Date: 31Jan2022) via an unspecified route of administration on 15Oct2021 at 14:15 (at 27-year and 7-month-old) as single dose for covid-19 immunisation. Relevant med history was reported as follows: the patient had been visiting clinic for panic attack and sleeplessness. The patient''s concomitant medications were not reported. Body temperature before the vaccination on 15Oct2021 was 36.0 Centigrade. On 15Oct2021 at 14:15 (the day of the vaccination), the patient received the first dose of bnt162b2. On 15Oct2021 at 14:30 (15 minutes after the vaccination) chest pain, palpitations, giddiness and queasy appeared. The patient was in a recumbent position on a bed, but the symptoms did not improve.Events required Physician Office Visit. The patient was referred to Hospital and was transferred to the another hospital by ambulance in Oct2021. The reporter classified the event as non-serious and assessed the causality between the event and the vaccines as unassessable. Other possible cause of the event such as any other diseases was: Panic attack. The reporter commented as follows:Panic attack with needle insertion was primarily considered. The outcome of the events was reported as unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1826859 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ7489 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Cold sweat, Feeling abnormal, Pulse absent
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Hypersensitivity (narrow), 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: blood pressure; Result Unstructured Data: Test Result:72 per minutes; Comments: at 10:45; Test Date: 20211015; Test Name: blood pressure; Result Unstructured Data: Test Result:90/40; Comments: at 10:50; Test Date: 20211015; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202101383322

Write-up: Anaphylaxis; feels poorly; cold sweat; Pulse absent; blood pressure 72 per minute; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21129499. A 49-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on 15Oct2021 10:30 (Lot Number: FJ7489; Expiration Date: 31Jan2022) (at the age of 49-year-old) as dose 2, single for COVID-19 immunisation. There was no medical history. The patient''s concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire. Patient''s Body temperature before vaccination was 36.0 degrees Centigrade on 15Oct2021. On 15Oct2021 at 10:30 (the day of vaccination), the patient received the second dose of BNT162B2. Event onset date was reported as 15Oct2021 at 10:45 (15 minutes after the vaccination). The event course was reported as follows: There were feels poorly and cold sweat, Pulse absent. Blood pressure 72 per minute, Heart beat was able to listen. The patient received Bosmin at right thigh via dose of 0.3cc intramuscular of administration. IV of Saline 250cc was ensured. At 10:50 (20 minutes after the vaccination) blood pressure was recovered to 90/40. The patient was feeling normal until the end of IV treatment. Then the patient went home (1 hour later). The reporter classified the event as serious (medically significant) and the causality between the event and BN162B2 as related. There was no other possible cause of the event such as any other diseases. The reporter commented that it was considered as Anaphylaxis. The third dose (illegible characters). Events outcome was recovered on 15Oct2021. Follow up attempts are completed, no further information is expected.


VAERS ID: 1826868 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK8562 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Anaphylactic shock, Blood pressure decreased, Blood pressure measurement, Body temperature, Cold sweat, Dizziness, Heart rate, Heart rate decreased, Hypoaesthesia, Nausea, Oxygen saturation, Pallor
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:88/54 mmHg; Test Date: 20211015; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:84/58 mmHg; Test Date: 20211015; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:129/50 mmHg; Test Date: 20211015; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before the vaccination; Test Date: 20211015; Test Name: HR; Result Unstructured Data: Test Result:53; Comments: bpm; Test Date: 20211015; Test Name: HR; Result Unstructured Data: Test Result:64; Comments: bpm; Test Date: 20211015; Test Name: HR; Result Unstructured Data: Test Result:73; Comments: bpm; Test Date: 20211015; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:99; Test Date: 20211015; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:99
CDC Split Type: JPPFIZER INC202101383799

Write-up: Anaphylactic shock; HR was 53 bpm; anaphylaxis; queasy; pallor facial / complexion ill; cold sweat; numbness in hand; giddiness; Blood pressure 88/54 mmHg / 84/58 mmHg / blood pressure was 129/50/Blood pressure decreased; This is a spontaneous report from a contactable physician received from the. Regulatory authority report number is v21130021. The patient was a 22-year and 9-month-old male. Body temperature before vaccination was 36.3 degrees Centigrade. The patient had no family history.There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 15Oct2021 at 10:48 (the day of the vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FK8562, Expiration date 31Jan2022) via an unspecified route of administration as a single dose for COVID-19 immunization. On 15Oct2021 at 10:53 (same day of the vaccination), the patient experienced anaphylaxis, queasy, pallor facial, cold sweat, numbness in hand, giddiness. On 15Oct2021 (same day of the vaccination), the outcome of the event was recovered. The course of the event was as follows: around 5 minutes after the patient received the COMIRNATY, the patient complaint felt queasy and giddiness. The patient had symptoms of pallor facial and cold sweat, the patient did not measure blood pressure and oxygen saturation test (as reported). The blood pressure was 88/54 mmHg, HR was 53 bpm, oxygen saturation was 99%. The patient took rest on bed in lower limbs up position. Measurement of the blood pressure again, it was 84/54 mmHg, HR was 64 bpm, therefore at 10:58 via intramuscular injection EPIPEN 0.3mg in the right thigh. Around 15 minutes after the patient received the EPIPEN, the blood pressure was 129/50, HR was 73 bpm, oxygen saturation was 99%, the symptoms were recovered. Actually, after that the patient still had symptom of the queasy, complexion ill, numbness in hand and persisted. the patient was transported to the PRIVACY hospital by ambulance. The reporting physician classified the event as serious (medically significant). The reporter assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: after the patient received the COMIRNATY, around 5 minutes blood pressure decreased with anaphylactic shock was be admitted, because of there was no other possible cause of the events, considered it was related to COMIRNATY vaccine. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1827016 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20211054792

Write-up: VACCINATION FAILURE; COVID-19;This spontaneous report received from a physician via a Regulatory authority (regulatory authority, PT-INFARMED-B202110-1215) on 27-OCT-2021 and concerned a 49 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: unknown) .5 ml, 1 total administered on 21-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 15-OCT-2021, the patient experienced vaccination failure and covid-19. Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) Positive Iu international unit (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and covid-19 was not reported. This report was serious (Other Medically Important Condition). This case was associated with product complaint.; Reporter''s Comments: Other information-Single dose: Janssen, 06-21-2021, Lot XD974. Symptom onset on 10-13-2021: fever and myalgia. PCR test positive at 10-15-2021


VAERS ID: 1828148 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 20220124)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Maternal exposure during pregnancy; Armpit pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26103110) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Armpit pain) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Pregnancy (Estimated due date: 20220124). Concomitant products included FOLIC ACID for Folic acid supplementation, ASPIRIN [ACETYLSALICYLIC ACID] for Normal pregnancy. On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. The patient''s last menstrual period was on an unknown date and the estimated date of delivery was 24-Jan-2022. On 15-Oct-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). At the time of the report, AXILLARY PAIN (Armpit pain) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Since the patient received the second dose of the vaccine the patient experienced: - pain on the arm where the injection was made; lasted 1 day; resolved. - pain and swollen lymph nodes in armpit where (same arm the injection was made); slightly less painful however still swollen; not resolved. - muscular pain thought the body, overnight during the first night; resolved. Patient was exposed to the medicine first-trimester (1-12 weeks). COMPANY COMMENT: This case of Maternal exposure during pregnancy concerns a 40-year-old, female patient with no relevant medical history, who experienced the unexpected event of Axillary pain. The patient received the second dose of vaccine in the 1st trimester of gestation. The event occurred on the day of the second dose of Moderna CoviD-19 Vaccine with an unknown outcome. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.; Sender''s Comments: This case of Maternal exposure during pregnancy concerns a 40-year-old, female patient with no relevant medical history, who experienced the unexpected event of Axillary pain. The patient received the second dose of vaccine in the 1st trimester of gestation. The event occurred on the day of the second dose of Moderna CoviD-19 Vaccine with an unknown outcome. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.


VAERS ID: 1830063 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJS782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Malaise, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101392991

Write-up: Faint; Dizziness; Ill feeling; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110150914415660-PSINP, Safety Report Unique Identifier GB-MHRA-ADR 26081208. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FJS782) via an unspecified route of administration on 14Oct2021 as dose 3 (Booster) single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Unsure if patient was enrolled in clinical trial. On 15Oct2021, the patient experienced faint (medically significant), dizziness and ill feeling. The patient underwent lab tests and procedures which included SARS-COV-2 test: no - negative COVID-19 test on an unspecified date. The outcome of the events faint, dizziness and ill feeling was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830074 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products, SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; AMLODIPINE; ASPIRIN (E.C.); ATORVASTATIN; AZATHIOPRINE; FOLIC ACID; INSULIN LISPRO; LISINOPRIL; MORPHINE; PARACETAMOL; PREDNISOLONE; VITAMIN B COMPOUND STRONG
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Cholesterol; Diabetes; Pain relief; Prevention; Renal transplant; Transplant (Recently had a bone marrow transplant or taking medicines following a transplant (e.g. kidney, l...); Vitamin B1 deficiency
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101393094

Write-up: Shaking; Interchange of vaccine products; This is a spontaneous report from a contactable consumer or other non-health care professional received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110151029399660-MZ0PV. Safety Report Unique Identifier is GB-MHRA-ADR 26081530. A 73-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FF8288, Expiry date was not reported), via an unspecified route of administration on 14Oct2021 (at the age of 73-year-old) as Dose 3 (Booster), Single for COVID-19 immunization. Medical history included transplant (Recently had a bone marrow transplant or taking medicines following a transplant (e.g. kidney, l), from an unknown date and unknown if ongoing, Blood pressure high from an unknown date and unknown if ongoing, Prevention from an unknown date and unknown if ongoing, Cholesterol from an unknown date and unknown if ongoing, Renal transplant from an unknown date and unknown if ongoing, Diabetes from an unknown date and unknown if ongoing, Pain relief (Analgesic therapy) from an unknown date and unknown if ongoing, Vitamin B1 deficiency from an unknown date and unknown if ongoing. Concomitant medication(s) included Amitriptyline was taken for an unspecified indication, start and stop date were not reported; Amlodipine was taken for Blood pressure high, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) was taken for Prevention, start and stop date were not reported; Atorvastatin was taken for Cholesterol, start and stop date were not reported; Azathioprine was taken for renal transplant, start and stop date were not reported; folic acid was taken for an unspecified indication, start and stop date were not reported; Insulin lispro was taken for diabetes, start and stop date were not reported; influenza vaccine (INFLUENZA VIRUS) was taken for an unspecified indication from 13Oct2021 to 13Oct2021; Lisinopril was taken for Blood pressure high, start and stop date were not reported; Morphine was taken for an unspecified indication, start and stop date were not reported; Paracetamol was taken for Pain relief, start and stop date were not reported; Prednisolone was taken for renal transplant, start and stop date were not reported; nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (VITAMIN B COMPOUND STRONG) was taken for vitamin b1 deficiency, start and stop date were not reported. The patient did not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Historical vaccine includes of COVID-19 VACCINE ASTRAZENECA, Solution for injection, Lot Number: A86004, Expiry date was not reported), via an unspecified route of administration on 04Feb2021 as Dose 1, Single for COVID-19 immunization. On 15Oct2021, patient experienced shaking, in 2021 the patient had Interchange of vaccine products. The patient underwent lab tests and procedures which included COVID-19 virus test was Negative (No - Negative COVID-19 test) on an unspecified date. The outcome of the event was not recovered. No follow-up attempts were needed. No further information was expected.


VAERS ID: 1830093 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Muscle twitching, SARS-CoV-2 test, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ovarian tumour benign
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101392883

Write-up: Shaking/mouth shaking; Difficulty breathing; Chest pain; Muscle twitching; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). This report is received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110151237238390-95W4D, Safety Report Unique Identifier GB-MHRA-ADR 26082169. A 25-years-old non-pregnant female patient received third dose of BNT162B2 (COMIRNATY Covid-19 vaccine, Formulation, Lot number was not known), via an unspecified route of administration on 15Oct2021 10:45 (at the age of 25-years-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included ovarian tumour from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. On 15Oct2021, the patient experienced shaking/mouth shaking, difficulty breathing, chest pain, muscle twitching, shortness of breath. She was okay after the first 15 minutes she got the jab, when she got up to leave, she had shortness of breath/difficulty breathing, chest pain and her lower jaw/bottom lip would not stop shaking but she was not cold. She ate, but much did not subside, she stayed behind and was supervised. Most of the issues eased, however the chest pain comes and goes, and the mouth shaking was still there. She got her jab at 10:45am and now it was 12:45pm. The patient underwent lab tests and procedures which included Covid-19 virus test: negative (No - Negative COVID-19 test) on 15Oct2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of event shaking, difficulty breathing was not recovered, chest pain, muscle twitching was resolving, and shortness of breath was resolved on 15Oct2021. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1830095 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOSTER NEXTHALER
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma (for which Forster Nexthaler 100/6 is taken, twice a day); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101392830

Write-up: about 6-7 hours after receiving vaccine; Chills; Fever; Headache; same reaction was had with first dose of pfizer vaccine; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110151249014340-1JZFF, Safety Report Unique Identifier GB-MHRA-ADR 26081904. A 28-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not reported) via an unspecified route of administration on 15Oct2021 (at the age of 28-years-old) as dose 2, single for COVID-19 immunisation. The historical vaccine included first dose of bnt162b2 for COVID-19 immunisation. Medical history included steroid therapy, Allergic asthma for which Forster Nexthaler 100/6 is taken, twice a day. Taking regular steroid treatment (e.g. orally or rectally). Concomitant medications included Forster Nexthaler 100/6, twice a day for allergic asthma. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. On an unspecified date in 2021, the patient experienced same reaction was had with first dose of Pfizer vaccine. On 15Oct2021, the patient experienced about 6-7 hours after receiving vaccine, chills, fever and headache. The events were assessed as medically significant. About 6-7 hours after receiving vaccine, excruciating headache, high fever and chills throughout the night. Extreme episode lasted until 10:00 following morning, from 10:00 onwards same symptoms (but slightly milder) persisted. Same reaction was had with first dose of Pfizer vaccine, 4 weeks ago. 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 sars-cov-2 test: negative (No- Negative COVID-19 test) on 14Oct2021. The outcome of the events was resolved for 6-7 hours after receiving vaccine and same reaction was had with first dose of Pfizer vaccine on an unspecified date in 2021 while for the other events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1830102 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-11
Onset:2021-10-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6451 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Dizziness postural, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: temperature; Result Unstructured Data: Test Result:slight; Test Date: 20211015; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101393180

Write-up: Shaking; Dizzy on standing; Slight temperature; Aching joints; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110151335088030-GN8BP, Safety Report Unique Identifier number is (GB-MHRA-ADR 26082448). An 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Oct2021 (batch/lot Number: FG6451) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced shaking, dizzy on standing, slight temperature and aching joints on 15Oct2021. The events were reported as serious (medically significant). The clinical course was reported as follows: today 15Oct2021 a.m. he has had shaking, slightly raised temperature and aching in his joints. Today 15Oct2021 pm still not well (as reported). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 15Oct2021. The outcome of shaking was not recovered however stop date of this event was also reported as "15Oct2021". The outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830106 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0112 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101393154

Write-up: Faint; This is a spontaneous report from a contactable Other-HCP received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110151403572570-WDPEJ Safety Report Unique Identifier GB-MHRA-ADR 26082476. A 15-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: fk0112) via an unspecified route of administration, on 15Oct2021 (at the age of 15-year-old), as DOSE 1, SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. 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 was not enrolled in clinical trial. Patients report did not relate to possible blood clots or low platelet counts. The patient experienced faint on 15Oct2021. The seriousness criteria of the event were reported as medically significant. Outcome of the event was recovered on an unspecified date in Oct2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1830109 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Dyskinesia, Headache, Nausea, SARS-CoV-2 test, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (narrow), Dyskinesia (narrow), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: quite hot; Result Unstructured Data: Test Result:increased; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101393237

Write-up: shaking; had goosebumps like she was cold but she was quite hot; Abnormal involuntary movements; Headache; Nauseous; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110151435359410-JOBEJ, Safety Report Unique Identifier GB-MHRA-ADR 26082625. The 14-year-old female patient received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Lot number was not reported) via an unspecified route of administration on 14Oct2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not have symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test negative and body temperature increased on an unspecified date. On 15Oct2021 the patient experienced abnormal involuntary movements, headache, and nauseous, on an unspecified date patient had goosebumps like she was cold but she was quite hot and shaking. It was reported that the involuntary shaking happened at 01:40 hours and patient woke up shaking and she could not stop. She felt nauseous and had goosebumps like she was cold, but she was quite hot. She was very distressed about it. Patient relative calmed patient with 7/11 breathing and this helped the shakes subside some, but she continued shaking the rest of the night every few minutes. Patient shakes subsided when she got up in the morning, but the headache persists. She did not go to school today. The event seriousness was reported as medically significant. Patient was not tested positive for COVID-19 since having the vaccine. The outcome of the event shaking was resolved on an unknown date in 2021, abnormal involuntary movements, nauseous was resolved on 15Oct2021, headache was not resolved, had goosebumps like she was cold but she was quite hot was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1830124 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Heart failure; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Kidney failure; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201227; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101393024

Write-up: Nausea; Headache; Cold sweat; Chronic fatigue; This is a spontaneous report from a contactable consumer or other non-healthcare professional received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110151634588210-YQJMD, Safety Report Unique Identifier GB-MHRA-ADR 26082839. An 83-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FJ5782), via an unspecified route of administration on 14Oct2021 as dose 3 (booster), single for COVID-19 immunisation. The patient medical history included renal failure from an unknown date and unknown if ongoing, cardiac failure from an unknown date and unknown if ongoing, suspected covid-19 from 27Dec2020 to 06Jan2021, immunodeficiency from an unknown date and unknown if ongoing. Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodeficiency), diabetes mellitus from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 15Oct2021, the patient experienced nausea, headache, cold sweat, chronic fatigue. The events were reported as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 27Dec2020, Yes - Positive COVID-19 test. The outcome of all events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830129 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Pain in extremity
SMQs:, 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: MONTELUKAST; NAPROXENE [NAPROXEN]; SEREFLO; SPIRIVA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101393150

Write-up: Pain in arm; Joint pain; Tiredness; Painful joints; This is a spontaneous report from a contactable consumer and received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110151653577170-QQYAK, Safety Report Unique Identifier GB-MHRA-ADR 26082886. A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: Unknown), via an unspecified route of administration on 14Oct2021 as Dose 3 (Booster), Single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) on 27Sep2021, montelukast taken for asthma from 01Jan2016, naproxen (NAPROXENE) taken for arthritis from 01Sep2021, fluticasone propionate, salmeterol xinafoate (SEREFLO) taken for asthma from 01Jan2019, and tiotropium bromide monohydrate (SPIRIVA) taken for asthma from 01Jan2019. 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 was not enrolled in clinical trial. On an unspecified date in 2021, the patient experienced painful joints. On 15Oct2021 she had pain in arm, joint pain, and tiredness. It was reported that patient had vaccine around 3pm. That night slept from 7pm until 6:30 following morning. Woke up with sore arm and as the day progressed developed painful joints. The events assessed as serious (medically significant). The outcome of the event arthralgia was reported as unknown and while for all other events was not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1830137 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0112 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dysgeusia, Oropharyngeal discomfort, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEXOFENADINE; XOLAIR
Current Illness: Chronic urticaria; Urticaria
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis (Anaphylaxis to nuts)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101392960

Write-up: Hives; Taste peculiar; Throat discomfort; Dizzy; This is a spontaneous report from a contactable consumer (the patient) received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110151852560230-PXT31. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 26083230. A 45-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Fk0112, Expiration date: Not reported), via an unspecified route of administration on 15Oct2021 (at the age of 45-year-old) as single dose for COVID-19 immunization. The patient''s medical history included urticaria chronic, urticaria: both were ongoing and anaphylaxis to nuts from an unknown date and unknown if ongoing. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant and not currently breastfeeding at the time of vaccination. The patient''s concomitant medications included fexofenadine taken for urticaria from 01May2020 to an unspecified stop date and omalizumab (XOLAIR, solution for injection) taken for urticaria chronic from 01May2020 to an unspecified stop date. The patient experienced hives, taste peculiar, throat discomfort and dizzy on 15Oct2021 (same day when vaccine was administered). The case was assessed as serious- Other medically important condition. Patient stated, she was anaphylactic to nuts she did not need adrenaline, she took two fexofenadine 180 mgs and it settled. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Therapeutic measures taken as a result of hives with two fexofenadine 180 mgs. The outcome of all the events was resolved on 15Oct2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830148 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Comments: ~~~
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101393057

Write-up: Body ache; Tiredness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110152047426510-QXBJW and Safety Report Unique Identifier GB-MHRA-ADR 26083753. A 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: FG3712), via an unspecified route of administration on 14Oct2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history included cardiac failure and immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and immunodeficiency). The patient''s concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown) dose 1, via an unspecified route of administration on an unknown date as dose 1, single and dose 2 via an unspecified route of administration on an unknown date as dose 2, single for covid-19 immunisation. Patient has not had symptoms associated with covid-19, not had a covid-19 test. Patient was not enrolled in clinical trial. It was reported that on an unspecified date, the patient experienced body ache and tiredness on 15Oct2021. The case was assessed as serious (medically significant) by the health authority. The outcome of event body ache was unknown and not recovered for event tiredness. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1830153 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101393136

Write-up: Faint; This is a spontaneous report from a contactable other health care professional received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110152226083930-9QQIO. Safety Report Unique Identifier GB-MHRA-ADR 26084169. A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 15Oct2021 (at the age of 12-years-old) as dose 1, single for COVID-19 immunization. The patient history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Unsure if patient is enrolled in clinical trial. On 15Oct2021, the patient experienced pupil fainted striaght after vacination observed. The outcome of the event was resolved on an unspecified date in 2021. Reaction: Does your report relate to possible blood clots or low platelet counts. If yes, we will ask you additional questions at the end of this report: No. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1830156 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Malaise, Pain in extremity, SARS-CoV-2 test, Seizure, Somnolence
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211012; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101392897

Write-up: seizure attack/ Asthmatic attack; sleepy; Sore arms; General malaise; Seizure; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110152312172580-VZXKO, Safety Report Unique Identifier GB-MHRA-ADR 26084333. A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF8288) via unspecified route of administration on 13Oct2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. On 15Oct2021 patient experienced seizure and on unspecified date seizure attack/ asthmatic attack, sleepy, sore arms, general malaise. Case Narrative: My daughter has been seizure free for last 5 years out of which last one year without medication. She has been absolutely fine throughout and only had three seizure episodes earlier since her diagnosis. She had well controlled medication regime and two years back she started weaning out and for last one year she did not have any medication. On 13th Oct she was administered the Pfizer COVID 19 vaccine at school. She complained about sore arms and general malaise. Today (15th Oct), two days after her vaccine, she came back from school and suddenly had a seizure attack which lasted for 2 - 3 minutes. She was administered Buccolam and she recovered. 999 call was made and paramedics came and examined her. Her vital signs were all normal and she regained consciousness but remained very sleepy. Therapeutic measures were taken as a result of seizure, seizure attack/ asthmatic attack. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 12Oct2021, No - Negative COVID-19 test. Any relevant investigations or tests conducted: Under observation at home now. The clinical outcome of the event seizure recovered on 15Oct2021, seizure attack, sleepy was not recovered while sore arms and general malaise unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830170 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Laboratory test, Myalgia, Thyroid function test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Breathlessness; Hypothyroidism (Hypothyroidism for 9 months in 2017-2018); Migraine; Thyroid disorder; TSH
Allergies:
Diagnostic Lab Data: Test Name: Thyroid Antibodies; Result Unstructured Data: Test Result:abnormally high Thyroid Antibodies; Comments: abnormally high Thyroid Antibodies; Test Name: thyroid function test; Result Unstructured Data: Test Result:TSH, T4 and T3 levels appear normal; Comments: TSH, T4 and T3 levels appear normal
CDC Split Type: GBPFIZER INC202101392911

Write-up: 1st noticed where the injection was given is aching This has intensified over night lifting it the pain intensifies; Numbness in hand/ noticed numbness in right hand this has have increased over night; Muscle ache; This is a spontaneous report from a contactable consumer (Patient) downloaded from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110160826471120-XGWPH, Safety Report Unique Identifier GB-MHRA-ADR 26084603. A 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FJ5782), via an unspecified route of administration, administered in right arm on 15Oct2021 at 18:58 (at the age of 37-years-old) as dose 1, single for COVID-19 immunization. Medical history included hypothyroidism from 2017 to 2017 (Hypothyroidism for 9 months in 2017-2018), breathlessness, TSH, high thyroid antibodies, sensitive to dust, perfumes smoke fumes and strong oders and migraine. Concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant, not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 15Oct2021, the patient experienced muscle ache, and same day at 19:30, patient experienced numbness in hand/ noticed numbness in right hand this has have increased over night, and at 21:30, patient first noticed where the injection was given is aching this has intensified overnight lifting it the pain intensifies. The patient stated that she don''t take medications, had a history of previously having Hypothyroidism for 9 months in 2017-2018 of which she discontinued medication and changed my diet to whole food plant based. Her TSH, T4 and T3 levels appear normal now on regular checkups but she had abnormally high Thyroid Antibodies which her GP says that it just means overtime she will develop hypothyroidism, Hashimotos or Graves disease. She stated she was sensitive to dust, perfumes smoke fumes and strong oders that trigger migraines and breathlessness. Her throat chronically needs to be cleared and was evident when eating and after eating and more intense when having gluten products. The patient underwent lab tests and procedures which included Thyroid Antibodies: abnormally high thyroid antibodies, thyroid function test: TSH, T4 and T3 levels appear normal, both on an unspecified date. The outcome of event first noticed where the injection was given is aching this has intensified overnight lifting it the pain intensifies was unknown while other events were not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830174 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101393186

Write-up: Restless legs; This is a spontaneous report from a contactable consumer. This is a report received from a Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110161042163260-KBBK6, safety report unique identifier is GB-MHRA-ADR 26084703. The 41-year-old (non-pregnant) female patient received dose 3 of bnt162b2 (COMIRNATY, solution for injection) (Batch/Lot number: Unknown) via an unspecified route of administration on 14Oct2021 as dose 3 (Booster), Single for COVID-19 immunization. The medical history included steroid therapy taking regular steroid treatment (e.g., orally, or rectally). The patient concomitant medications were not reported. Patient did not have symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. On 15Oct2021 the patient experienced restless legs. The event seriousness for restless legs was reported as medically significant. The patient underwent lab tests and procedures which included SARS-CoV-2 test negative on No - Negative COVID-19 test. Patient was not tested positive for COVID-19 since having the vaccine. The outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1830176 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0112 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Negative
CDC Split Type: GBPFIZER INC202101392931

Write-up: Armpit pain; Enlargement of lymph nodes; This is a spontaneous report from a contactable consumer or other non hcp received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110161108073100-LGE9R. Safety Report Unique Identifier is GB-MHRA-ADR 26084735. A 43-year-old female patient received BNT162B2 (COMIRNATY, Solution for Injection), dose 3 via an unspecified route of administration on 14Oct2021 (Lot Number: Fk0112) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 15Oct2021, the patient experienced armpit pain and enlargement of lymph nodes. Both the events were considered as medically significant. The patient underwent sars-cov-2 test resulted in negative on 15Oct2021. The outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830191 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Headache, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: L-THYROXINE [LEVOTHYROXINE]; SERTRALINE; ZOPICLONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101392939

Write-up: Generalised muscle aches; Nausea; Fever; Headache; Gastrointestinal upset; This is a spontaneous report from a contactable consumer. This is the first of two reports. The first report is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110161424588800-XOQBJ, Safety Report Unique Identifier GB-MHRA-ADR 26084901. A 38-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 3 via an unspecified route of administration on 15Oct2021, at the age of 38 years, (Batch/Lot number: Unknown) as dose 3(booster), single for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant; patient is not currently breastfeeding. Concomitant medications included l-thyroxine [levothyroxine]; sertraline; zopiclone. Historical vaccine included 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) on 07Jan2021 for COVID-19 immunization. On 25Mar2021, at the age of 38 years, she received 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) for COVID-19 immunization which was considered as inappropriate schedule of vaccine administered. On 15Oct2021, the patient experienced headache and gastrointestinal upset. On 16Oct2021, the patient experienced generalized muscle aches, nausea and fever. The events are serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome for the events headache, generalized muscle aches, gastrointestinal upset and nausea was not recovered; outcome for fever was recovering. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1830197 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF828 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy (Peanut and sesame allergy)
Allergies:
Diagnostic Lab Data: Test Name: ecg; Result Unstructured Data: Test Result:unknown results; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101401072

Write-up: feeling faint; breathless; Palpitations; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202110170825392900-KQSJO, Safety Report Unique Identifier GB-MHRA-ADR 26085258. A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FF828), via an unspecified route of administration on 15Oct2021 (at the age of 14 years old) as dose 1, single for COVID-19 immunisation. The patient''s medical history included peanut and sesame allergy. Patient has not had symptoms associated with COVID-19. Concomitant medications were not reported. The patient previously took epinephrine (EPIPEN). The patient experienced feeling faint and breathless on an unspecified date. He had 4 occurrences and one so severe for which he visited ER for electrocardiogram (ECG) trace. The patient experienced palpitations on 15Oct2021. The events were medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the palpitations was not recovered while of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830413 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5790 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Dizziness, Feeling abnormal, Heart rate, Heart rate decreased, Oxygen saturation, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Vestibular disorders (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: Iodine allergy
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: BP; Result Unstructured Data: Test Result:102/55 mmHg; Comments: At 15:08; Test Date: 20211015; Test Name: BP; Result Unstructured Data: Test Result:134/101 mmHg; Comments: At 15:20; Test Date: 20211015; Test Name: BP; Result Unstructured Data: Test Result:130/92 mmHg; Comments: At 15:45; Test Date: 20211015; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20211015; Test Name: HR; Result Unstructured Data: Test Result:45; Comments: At 15:08; Test Date: 20211015; Test Name: HR; Result Unstructured Data: Test Result:60; Comments: At 15:20; Test Date: 20211015; Test Name: HR; Result Unstructured Data: Test Result:61; Comments: At 15:45; Test Date: 20211015; Test Name: SpO2; Test Result: 97 %; Comments: At 15:08
CDC Split Type: JPPFIZER INC202101393448

Write-up: HR 45; Vasovagal reaction/Vasovagal reflex; The patient suddenly felt poorly; plunged into darkness/The patient still had a slightly strange feeling in the head; BP: 102/55 (normally, about 120/80)/ mildly decreased blood pressure; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21129503. The patient was a 42-year-old male (age at first vaccination). Body temperature before vaccination was 36.7 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 allergies: Iodine allergy. On 15Oct2021 at 15:04 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FJ5790, Expiration date 31Dec2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 15Oct2021 at about 15:08 (about 2 hours after the vaccination), the patient experienced Feels poorly, being plunged into darkness, mildly decreased blood pressure, Vasovagal reflex. On 15Oct2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: At 15:04, the patient received the vaccination. At 15:08, the patient walked to the waiting room and sat in a chair. The patient suddenly felt poorly and was plunged into darkness. The patient became unable to stand up and fell down. No LOC, no Chest symptom, no Dermatological symptom. BP: 102/55 (normally, about 120/80) HR: 45 SpO2: 97%. The patient was placed in a lying position on a bed, and his legs were lifted. After a while, symptoms became stable. At 15:20, BP: 134/101; HR: 60. At 15:45, BP: 130/92; HR: 61. The patient still had a slightly strange feeling in the head but could walk alone, so went home. The reporter did not provide seriousness assessment. The reporting physician commented as follows: The causality between the product and the event was unknown. However, it was thought to be so called ''vasovagal reaction'' to the needle sting.


VAERS ID: 1830539 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROJNJFOC20211057579

Write-up: Fever; This spontaneous report received from a consumer via a Regulatory Authority (RO-NMA-2021-SPCOV13478) on 28-OCT-2021 and concerned a 26 year old female. The patient''s weight was 52 kilograms, and height was 161 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: ACA4541 expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 15-OCT-2021 for product use for unknown indication. No concomitant medications were reported. On 15-OCT-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from fever on 16-OCT-2021. This report was serious (Life Threatening).


VAERS ID: 1834630 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fall, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101393125

Write-up: LOC; Breathlessness; Collapse; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is GB-MHRA-TPP21264958C61880YC1634289727814, safety report unique identifier is GB-MHRA-ADR 26082617. A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 15Oct2021(age at the time of vaccination was 21-year-old) as dose number unknown, 0.3 ml single for COVID-19 immunization. The patient''s medical history included ill-defined disorder from an unknown date and unknown if ongoing. The patient''s concomitant medications included sertraline taken for ill-defined disorder from 14Jul2021 to 14Jul2021. On 15Oct2021, the patient experienced breathlessness, LOC and collapse, LOC and collapse occurred within 24 hours and then again at 3 days collapse and LOC abd breathlessness He was admitted to hospital for 4 days on an unspecified date due to all events. No other cause found. The outcome of breathlessness and LOC was recovered on an unspecified date, while outcome of another event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1834660 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Myalgia, Off label use, Product use issue, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211016; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400538

Write-up: Fever; Generalized muscle aches; Rigors; Maternal exposure during breast feeding; Off label use; This is a spontaneous report from a contactable consumer received from a Regulatory Authority. This is the first of 2 reports. This is for mother case. The regulatory authority report number is GB-MHRA-WEBCOVID-202110161828190110-ZFU7N, Safety Report Unique Identifier GB-MHRA-ADR 26085094. A 34-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 15Oct2021 (at the age of 34-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included ongoing breast feeding. 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. Patient previously received historical vaccine which included dose 1 of BNT162b2 (on 16Jan2021) and dose 2 (on 25Mar2021) for covid-19 immunization. On 15Oct2021, the patient experienced fever, generalized muscle aches and rigors. Events fever, generalized muscle aches and chills were considered serious (medically significant). It was reported that on 15Oct2021, the patient had suspected covid-19 but sars-cov-2 test result was negative. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Oct2021 No - Negative COVID-19 test. Outcome of the events fever and generalized muscle aches was not recovered. Outcome of event chills was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101417285 For baby


VAERS ID: 1834662 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Headache, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101400599

Write-up: high temperature; headache; SARS-CoV-2 infection; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110161950333740-KNA2Q, Safety Report Unique Identifier GB-MHRA-ADR 26085123. A 14-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration on 12Oct2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced high temperature on an unspecified date, headache on an unspecified date, sars-cov-2 infection on 15Oct2021. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 15Oct2021 (Yes - Positive COVID-19 test). Headache then high temperature. The patient was not enrolled in clinical trial. The events were reported as eventually medically significant. The outcome of the was not recovered for SARS-CoV-2 infection, unknown for headache, high temperature. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1834664 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling hot, Malaise, Miliaria, 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), 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: Diabetic; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400602

Write-up: feeling unwell; very hot; increasingly swelling arm; Heat rash; 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-202110162018476800-NUBUP, Safety Report Unique Identifier GB-MHRA-ADR 26085127. A 19-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration on 14Oct2021 as dose 3 (booster), single for COVID-19 immunisation. Medical history included type one diabetic, immunodeficiency. Has an illness or condition, not listed above, which reduces the immune response (e.g., immunodeficiency). Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. On an unspecified date, feeling unwell, very hot, increasingly swelling arm. On 15Oct2021, heat rash. Patient has 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 an unspecified date (No - Negative COVID-19 test). Outcome of event was feeling unwell, very hot, swelling arm unknown, heat rash not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1834665 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest discomfort, Heart rate, Oxygen saturation, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (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: Anemia; Epilepsy; Hashimoto''s disease
Allergies:
Diagnostic Lab Data: Test Name: blood pressure checkked; Result Unstructured Data: Test Result:Result : High; Comments: blood pressure checked (too high).; Test Name: heart rate monitor; Result Unstructured Data: Test Result:Result : Normal; Comments: heart rate monitor (normal); Test Name: O2 monitor; Result Unstructured Data: Test Result:Result : Normal; Comments: O2 monitor (normal); Test Date: 20210930; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400814

Write-up: Chest pressure; This is a spontaneous report from a contactable consumer or other non-health care professional received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110162110040530-RCHPO. Safety Report Unique Identifier GB-MHRA-ADR 26085146. A 48-year-old non-pregnant female patient received third dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: Ff8222, Expiry date was not reported), via an unspecified route of administration on 15Oct2021 as Dose 3 (Booster), Single (at the age of 48-year-old) for COVID-19 immunization. Medical history included epilepsy, anaemia, Hashimoto''s from an unknown date and unknown if ongoing. Concomitant medication(s) included influenza vaccine (INFLUENZA VIRUS) was taken for an unspecified indication from 01Oct2021 to an unspecified stop date. The patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Unsure if patient has had symptoms associated with COVID-19. Patient was not currently breastfeeding. On 15Oct2021, patient experienced chest pressure. The event caused medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was negative (No - Negative COVID-19 test) on 30Sep2021, O2 monitor result normal (O2 monitor (normal), heart rate monitor was result normal (heart rate monitor (normal), blood pressure checked was result high (blood pressure checked (too high) on an unspecified date. The outcome of the event was recovering. No follow-up attempts were needed. No further information was expected.


VAERS ID: 1834667 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Tinnitus
SMQs:, Hearing impairment (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 INC202101400810

Write-up: Tinnitus; Ringing in ear; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110162134458770-LHQ6R, Safety Report Unique Identifier GB-MHRA-ADR 26085152. A 12-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for Injection, Lot number was not reported), via an unspecified route of administration on 15Oct2021 (at the age of 12 years old), as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced tinnitus on 15Oct2021 and ringing in ear on an unspecified date in 2021. Events were medically significant. On an unspecified date, the patient underwent SARS-COV-2 test which resulted negative. Outcome was unknown for ringing in ear and event tinnitus was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1834671 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Flushing, Heart rate, Hypersensitivity, Oropharyngeal pain, Rash, SARS-CoV-2 test, Syncope, Tachycardia, Urticaria
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Eczema; Food allergy
Allergies:
Diagnostic Lab Data: Test Name: Pulse; Result Unstructured Data: Test Result:140; Comments: Tachycardia pulse of 140 at highest; Test Date: 20211015; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400751

Write-up: Sore / scratchy throat; Feeling faint; Flushing; Shivering; Tachycardia; Hives; Acute allergic reaction; Rash; This is a spontaneous report from a contactable consumer (patient). This report is received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110162209476320-QMKR1, Safety Report Unique Identifier GB-MHRA-ADR 26085167. A 36-years-old non-pregnant female patient received third dose of BNT162B2 (COMIRNATY Covid-19 vaccine, Formulation: Solution for injection, Lot Number: FF8288), via an unspecified route of administration on 15Oct2021 (at the age of 36-years-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included allergy, eczema, allergy to mushrooms from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took penicilline and experienced allergy to penicillin. On 15Oct2021, the patient experienced sore / scratchy throat, feeling faint, flushing, shivering, tachycardia, hives. On an unspecified date in 2021 had acute allergic reaction and rash. 15-20 minutes after vaccine was given severe hives spreading across the entire body and face and growing until individual hives met and joined. Tachycardia pulse of 140 at highest. Sore/scratchy throat. Flushing and hives hot to touch. Feeling faint. Shivering. The reporter considered the events as serious (medically significant). The patient underwent lab tests and procedures which included pulse: 140 (Tachycardia pulse of 140 at highest) on an unspecified date, Covid-19 virus test: negative (No - Negative COVID-19 test) on 15Oct2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Treatment oral antihistamine cetirizine 10mg and chlorpenamine 12 mg in split doses given. Tachycardia improved after cetirizine and first dose of chlorpromazine. Rash improved after 12mg of chlorpromazine about 6 hours after it began but came back, 3 hours after last dose milder. The outcome of events sore / scratchy throat, feeling faint, flushing, shivering, tachycardia, hives, acute allergic reaction was resolved on an unspecified date in 2021 and rash was resolving. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1834675 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Musculoskeletal stiffness, Pain, Poor quality sleep, SARS-CoV-2 test, Torticollis
SMQs:, Dystonia (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (broad), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started and stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400782

Write-up: Stiff neck; Fatigue; Poor sleep; very painful; difficult to turn head; This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-WEBCOVID-202110162318178500-V2YSM, Safety Report Unique Identifier GB-MHRA-ADR 26085191. A 40-year-old male patient received (COMIRNATY, Solution for Injection, Batch/Lot number: Unknown), dose 3 via an unspecified route of administration on 15Oct2021 as (at the age of 40-year-old) dose 3 (BOOSTER), single for COVID-19 immunisation. Medical history included suspected COVID-19 (unsure when symptoms started and stopped). The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 15Oct2021, the patient experienced poor sleep. On 16Oct2021, he had stiff neck, and fatigue. On an unspecified date in 2021, he experienced very painful, and difficult to turn head. It was reported that his neck started to ache about 24 hours after jab. After 36 hours it has become very painful and difficult to turn head. On an unknown date, the patient underwent SARS-COV-2 test which resulted negative. Outcome was not resolved for stiff neck, and fatigue, was resolving for poor sleep and was unknown for rest of the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1834684 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Headache, Lymph node pain, Lymphadenopathy, Musculoskeletal chest pain, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendix disorder; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101401038

Write-up: Very swollen lymph nodes; painful lymph nodes; pain across check; Headache; Chest pain; Glands swollen; Pain in arm; Rib pain; This is a spontaneous report from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110170946498750-LRBIR, Safety Report Unique Identification Number:GB-MHRA-ADR 26085300. A contactable consumer reported a 13-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14Oct2021 as dose 1, single for COVID-19 immunization. Medical history included suspected covid-19 from 24Jul2021 to 31Jul2021 (He had COVID 65 days before and was very sick), appendix disorder from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. It was reported that the patient experienced headache, chest pain, glands swollen, pain in arm, rib pain, very swollen lymph nodes, painful lymph nodes, pain across check on 15Oct2021. It was reported that the adverse reaction did not occur as a result of an exposure during pregnancy. It was reported that the patient had been to doctor and was advised to take rest. The patient underwent lab tests and procedures which included sars-cov-2 test yes - positive covid-19 test on 26Jul2021. Outcome of the event headache was reported as recovered on 16Oct2021, chest pain recovered on 17Oct2021, pain in arm was reported as recovering, glands swollen, and rib pain was reported as not recovered and outcome of all the other events was reported as unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1834697 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Medication errors (narrow), 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? 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 INC202101400786

Write-up: Myocarditis; inappropriate schedule of vaccine administered; 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-202110171124372930-LQH6N. Safety Report Unique Identifier GB-MHRA-ADR 26085371. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on 15Oct2021 (at the age of 40-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Historical Vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on 26Jun2021 as dose 1, single for COVID-19 immunization and on 06Jul2021 experienced myocarditis and recovered on 22Jul2021. On 15Oct2021, patient experienced myocarditis, inappropriate schedule of vaccine administered. The event caused medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was negative (No - Negative COVID-19 test) on an unspecified date. The outcome of the events myocarditis was recovering. No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.


VAERS ID: 1834709 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6431 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Decreased appetite, Feeling abnormal, Feeling cold, Feeling hot, Illness, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; RAMIPRIL; SIMVASTATIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101400700

Write-up: Immediately hot; Chills; Shaking; Sickness; Cold; Felt odd; not eating; Off label use; Interchange of vaccine products; This is a spontaneous report from a contactable consumer (patient). This report is received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110171230138430-3IHMT, Safety Report Unique Identifier GB-MHRA-ADR 26085412. A 66-year-old female patient received third dose of BNT162B2 (COMIRNATY Covid-19 vaccine, Formulation: Solution for injection, Lot Number: FG6431), via an unspecified route of administration on 15Oct2021 (at the age of 66-year-old) (off label use) (interchange of vaccine products) as dose 3 (booster), single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included AMLODIPINE, RAMIPRIL taken for an unspecified indication, start and stop dates were not reported, influenza vaccine (INFLUENZA VIRUS) taken for immunisation from 08Oct2021 to an unspecified stop date, SIMVASTATIN taken for an unspecified indication from Sep2021 to an unspecified stop date. Patient has not had symptoms associated with COVID-19. Historical vaccine included that patient received first and second dose of COVID-19 VACCINE ASTRAZENECA (Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and dose 2, single for covid-19 immunisation. On 16Oct2021, the patient experienced immediately hot, chills, shaking, sickness, and cold. Patient was vaccinated on Friday 15th and fine during the evening. OK Saturday morning (16th). Ate 6 nuts at 3pm. Immediately hot, felt odd, and started to shake uncontrollably. Husband helped her to bed. Started being sick at 4pm, still shaking, cold, and unable to hold anything due to the violent shakes. Violently sick for an hour. Shaking stopped at 6pm, slept until Sunday (17th) morning. Delicate today, drinking but not eating. Still cold. She had Astra Zenica for the first two vaccines. The reporter considered the events as serious (medically significant). The patient underwent lab tests and procedures which included Covid-19 virus test negative (COVID-19 test) on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event chills was recovering, immediately hot was recovered on an unspecified date in 2021, while outcome of events shaking and sickness was recovered on 16Oct2021, and outcome of event cold was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1834718 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101400971

Write-up: Enlarged lymph nodes (excl infective); Armpit pain; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110171534321780-IJ1GM, Safety Report Unique Identifier GB-MHRA-ADR 26085507. A 47-years-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection) via an unspecified route of administration on 15Oct2021 (at the age of 47-years-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included suspected COVID-19 from 25Aug2021 and ongoing. The patient''s concomitant medications was not reported. 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 15Oct2021, the patient experienced enlarged lymph nodes (infective), armpit pain. The patient underwent lab tests and procedures which included on 26Aug2021 COVID-19 virus test with positive COVID-19. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1834719 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400764

Write-up: Fatigue; Ache; Injection site pain; This is a spontaneous report from a contactable consumer or other non-HCP received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110171546383880-1CPCJ. Safety Report Unique Identifier is GB-MHRA-ADR 26085513. A 37-year-old female patient received third dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 15Oct2021 (at the age of 37-years-old) as dose 3 (booster), single for COVID-19 immunization. Patient was not pregnant at the time of vaccination and was not currently breastfeeding. Medical history included clinical trial participant. The concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19, since having the vaccine. The patient experienced injection site pain on 15Oct2021, fatigue and ache on 16Oct2021 (1 day after the third dose). The seriousness criteria of the events were reported as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test with result as negative (No - Negative COVID-19 test) on an unspecified date. The outcome of the events was recovering. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1834728 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0112 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Feeling hot, Headache, Inappropriate schedule of product administration, Nasopharyngitis, Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101401029

Write-up: Shivers; Headache; Cold like symptoms; Itchy; Red rash; It is red, itchy and hot but not raised; Inappropriate schedule of vaccine administered; 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-202110171952306780-2OMOJ, safety report unique identifier is GB-MHRA-ADR 26085661. This is the first of 2 reports. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: FK0112), via an unspecified route of administration on 15Oct2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She was a non-smoker and non-drinker and exercise regularly. Past drug included Antihistamine. The patient previously received 1st dose of BNT162B2 (lot number: unknown) on 24Jul2021 for COVID-19 immunization and experienced rash erythematous, antihistamines. Prior to COVID and she was fit and healthy with no medical conditions. Patient did not have symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. she had inappropriate schedule of vaccine administered on 15Oct2021. Also, the patient experienced shivers, headache, cold like symptoms, itchy, and It was hot but, not raised on an unspecified date and red rash (all over my body i.e. legs, arms, torso, lower back and feet) on 17Oct2021. All these events were reported as medically significant. The outcome of red rash was not recovered, while outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101408239 Same patient/vaccine different dose/event


VAERS ID: 1834731 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-10
Onset:2021-10-15
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Discomfort, Fatigue, Feeling hot, Pain, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400992

Write-up: discomfort; swollen arm; felt hot; Exhaustion; Fever; Generalized aching; Fever chills; Stomach upset; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110172033476360-HG1JA, Safety Report Unique Identifier GB-MHRA-ADR 26085685. A 42-year-old male patient received third/booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Fj5782) via an unspecified route of administration on 10Oct2021(at the age of 42-year-old), as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The Patient was not had symptoms associated with COVID-19. The Patient was not enrolled in clinical trial. On 15Oct2021, the patient experienced Stomach upset, on 16Oct2021 the patient experienced fever, generalized aching, fever chills and exhaustion. On unspecified date, the patient had discomfort, swollen arm and felt hot. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. It was reported that patient woke up next day with fever, chill and severe aching all over. Slept almost 24 hours on and off in extreme discomfort especially from aching. The outcome of the events Exhaustion, Stomach upset, Fever chills, generalized aching, Fever, discomfort was recovering and felt hot, swollen arm was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1834746 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, Pain, 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 INC202101401001

Write-up: Swollen arm; Lymph node pain; Ache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110180242206680-W6VDX, Safety Report Unique Identifier GB-MHRA-ADR 26085834. A 37-year-old female patient received third dose of BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 15Oct2021 (Batch/Lot number was not known, age at the time of vaccination: 37-year-old) as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. The patient experienced swollen arm, lymph node pain, ache on 15Oct2021. The events were considered as serious medically significant. The clinical outcome of the event swollen arm was recovered with sequelae on an unknown date, lymph node pain was not recovered, ache was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1834747 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal dreams, Insomnia, Pyrexia, Restless legs syndrome, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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 INC202101400580

Write-up: Insomnia; Vaginal bleeding; Vivid dreams; Fever; Restless legs; 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-202110180251191030-3XYFY. Safety Report Unique Identifier GB-MHRA-ADR 26085836. A 18-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Oct2021 (at the age of 18-year-old ) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced insomnia on 16Oct2021, vaginal bleeding on 15Oct2021, vivid dreams on 15Oct2021, fever on 15Oct2021, restless legs on 15Oct2021. The patient not had symptoms associated with COVID-19. The patient did not have a COVID-19 test. The patient was not pregnant. The patient was not currently breastfeeding. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The events were reported as eventually medically significant. The outcome of the events was recovering for Fever, not recovered for Restless legs, Vivid dreams, Vaginal bleeding, Insomnia. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1834770 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Fatigue, Lethargy, Malaise, Nausea, Paraesthesia, Type III immune complex mediated reaction
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101400637

Write-up: nausea; fatigue; lethargy; felt unwell; red area approx 4cm x 4.5cm; very hot to touch; Arthus reaction; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202110181020299190-BY8BU, Safety Report Unique Identifier GB-MHRA-ADR 26086061. A 53-year-old female patient received third dose of BNT162B2 (COMIRNATY, Solution for Injection, Batch/Lot Number: FG3712), via an unspecified route of administration on 15Oct2021 (at the age of 53-year-old) 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 and not had a COVID-19 test. Patient was not pregnant and not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unknown date, the patient experienced nausea, fatigue, lethargy, felt unwell, red area approximately 4cm x 4.5cm, very hot to touch. On 15Oct2021, the patient experienced arthus reaction. All the events were considered as medically significant. The clinical case narrative included: very hot to touch, red area approximately 4cm x 4.5cm also felt unwell for the first 24 hours after administration, nausea, lethargy and fatigue. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). The outcome of the events felt unwell, red area approximately 4cm x 4.5cm, very hot to touch were unknown and for rest of the events it was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1834782 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Interchange of vaccine products, Nausea, Off label use, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BOOTS PARACETAMOL; PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101400473

Write-up: Painful arm; Headache dull; Nausea; Fever; Infusion associated shivering; Diarrhoea; Tiredness; Off-label use; Interchange of vaccine products; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110181207081620-0LLJX, Safety Report Unique Identifier GB-MHRA-ADR 26086357. A 75-year-old female patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration on 15Oct2021 (Lot number was not reported) as dose 3 (booster), single (at the age of 75-years-old) for COVID-19 immunization. Historical vaccine included first dose of AstraZeneca via an unspecified route of administration received on 29Jan2021 and second dose on 09Apr2021 for COVID-19 immunisation. The patient had off-label use (interchange of vaccine products). The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medication included paracetamol (BOOTS PARACETAMOL) taken for an unspecified indication from 15Oct2021 to an unspecified stop date; paracetamol taken for an unspecified indication from 13Oct2021 to an unspecified stop date and Influenza virus on 13Oct2021 for immunization. On 15Oct2021, the patient experienced painful arm, headache dull, nausea, fever, infusion associated shivering, diarrhoea and tiredness. The outcome of the event painful arm was recovering. The event of headache recovered on 17Oct2021, the events nausea, infusion associated shivering, diarrhea, tiredness and fever recovered on 18Oct2021. The events were assessed as medically significant. No treatment was received for the events. 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: 1834800 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood glucose increased, Body temperature, Chest pain, Chills, Cluster headache, Dyspnoea, Interchange of vaccine products, Malaise, Neuralgia, Night sweats, Off label use, Pollakiuria, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Medication errors (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: GLICLAZIDE; METFORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; COVID-19; Diabetic (taking statins medications)
Allergies:
Diagnostic Lab Data: Test Name: High temperature; Result Unstructured Data: Test Result:High; Test Name: after the first covid jab; Result Unstructured Data: Test Result:Unknown Results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400670

Write-up: Chest pain; Short of breath; Nerve pain; Cluster headache; Shivering; Low back pain; Upper back pain; raised my Blood Sugars; feel rough; frequent urination; Back ache; back ache; Night sweats; High temperature; Interchange of vaccine products; Off label use; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional received from the Regulatory authority report number GB-MHRA-WEBCOVID-202110181355055090-VTLFM, Safety Report Unique Identifier GB-MHRA-ADR 26086506. A 45-year-old male patient received third dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on 15Oct2021 (at the age of 45-years-old) as Dose 3 (Booster), Single for COVID-19 immunization. Medical history included Diabetic (Diabetic and taking statins medications, I was diagnosed as diabetic during this admission) on an unknown date, Clinical trial (two weeks on a clinical trial with Steroids, antibiotics and Remdesivir 200mg Medications before plus) on an unknown date, Covid-19 (I was hospitalised with Covid 10 last December till 2nd January 2021) from Dec2020 to 02Jan2021. Concomitant medication(s) included gliclazide (GLICLAZIDE) was taken for diabetes mellitus, start and stop date were not reported; metformin (METFORMIN) was taken for diabetes mellitus, start and stop date were not reported. The patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Historical vaccine included first dose of (COVID-19 VACCINE ASTRAZENECA, Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on 25Jan2021 as Dose 1, Single for COVID-19 immunization and experienced (ill on unknown date) and second dose of (COVID-19 VACCINE ASTRAZENECA, Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on 09Apr2021 as Dose 2, Single for COVID-19 immunization. On an unspecified date, patient experienced back ache, after the first covid jab, chest pain, short of breath, nerve pain, cluster headache, shivering, low back pain, upper back pain, raised my blood sugars, feel rough, frequent urination, back ache. On 15Oct2021, patient experienced off label use, interchange of vaccine products. On 16Oct2021, patient experienced night sweats, high temperature. The events caused medically significant. The patient underwent lab tests and procedures which included High temperature was high on unspecified date, after the first covid jab was unknown results on unspecified date, COVID-19 virus test was Negative (No - Negative COVID-19 test) on unspecified date. It was reported that he was diagnosed as diabetic during this admission. After the First Covid Jab, he was ill for 24 hours. After the Second Jab, he had no side effects at all. After the Pfizer Booster jab, he spent 24 hours in bed with high temperature, night sweats and as stated side effects. Currently, its day three, and he still feel rough, with Back ache and frequent urination as Covid booster raised my Blood Sugars. Does your report relate to possible inflammation of the heart (myocarditis or pericarditis) was reported as no. The outcome of the events back ache, after the first covid jab, nerve pain, high temperature, cluster headache was recovering; night sweats, chest pain, short of breath, shivering, low back pain, upper back pain was not recovered; the other events are unknown. No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.


VAERS ID: 1834812 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Diarrhoea, Influenza, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101401018

Write-up: Flu; Diarrhea; Tight chest; Off label use; Interchange of vaccine products; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202110181622319780-E5KBP, Safety Report Unique Identifier GB-MHRA-ADR 26086739. A 63-year-old female patient received BNT162B2 (formulation: solution: for injection, Batch/Lot Number: FF8288), via an unspecified route of administration on 15Oct2021 (at the age of 63-year-old) as a dose 3 (BOOSTER), single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Historical vaccine included that the patient received COVID-19 VACCINE on an unspecified date for covid-19 immunization. Patient was not enrolled in clinical trial. Unsure if the patient had had symptoms associated with COVID-19. On 15Oct2021, the patient experienced flu, diarrhea, tight chest, off label use and interchange of vaccine products. All the events were serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 test: negative on an unspecified date (No - Negative COVID-19 test). The outcome of the events was recovering for the events flu, diarrhea and tight chest. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1834839 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Accident cerebrovascular (CVA (2 years ago)); Atrial fibrillation (AF); Dyspepsia; Hypercholesteraemia; Osteoarthritis; Polymyalgia rheumatica; Urine incontinence
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101426272

Write-up: COVID-19/ SARS-CoV-2 infection; COVID-19/ SARS-CoV-2 infection; Off label use; Booster dose; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202110211151304640-RIFOL, Safety Report Unique Identifier GB-MHRA-ADR 26103636. An 80-year-old male patient received BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) first dose on 20Dec2020, and the second dose on 10Jan2021, and third (booster) dose on an unknown date in 2021, all via an unspecified route of administration as a single dose for COVID-19 immunisation. Medical history included polymyalgia rheumatica, urine incontinence, osteoarthritis, dyspepsia, accident cerebrovascular (2 years ago), atrial fibrillation and hypercholesteraemia. It was unsure if patient had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. Concomitant medications were not reported. On 15Oct2021, the patient experienced COVID-19 and SARS-CoV-2 infection (also reported on 19Oct2021); reported as serious for causing hospitalization. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The report was not related to possible blood clots or low platelet counts. The report was not related to possible myocarditis or pericarditis. The clinical outcome of the event COVID-19/SARS-CoV-2 infection was resolving at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1834861 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6431 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products, Muscular weakness, Off label use
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), 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: BISOPROLOL; METFORMIN; SITAGLIPTIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Blood sugar increased; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101400452

Write-up: muscle weakness; off label use; Interchange of vaccine products; This is a solicited report from the UK-MHRA Yellow Card Vaccine Monitor program from a contactable consumer. This is a report received from the Regulatory authority report number GB-MHRA-YCVM-202110181536069510-ACVQZ, Safety Report Unique Identifier GB-MHRA-ADR 26086680. A 68-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Oct2021 (Lot Number: FG6431) as dose 3 (booster), single for COVID-19 immunization. Medical history included immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef), Blood pressure high, blood glucose increased, and type 2 diabetes mellitus. Patient has not had symptoms associated with COVID-19; Not had a COVID-19 test. Historical vaccine included dose 1 of COVID-19 VACCINE ASTRAZENECA, via an unspecified route of administration on 04Feb2021 (Lot number was not reported) as dose 1, single for COVID-19 immunization and dose 2 of COVID-19 VACCINE ASTRAZENECA, via an unspecified route of administration on 13Apr2021 (Lot number: PW40009) as dose 2, single for COVID-19 immunization. Concomitant medications included bisoprolol taken for Blood pressure high from 01Jan2008 to an unspecified stop date; metformin taken for blood glucose increased from 01Jan2006 to an unspecified stop date; sitagliptin taken for blood glucose increased from 01Jan2012 to an unspecified stop date. The patient experienced off label use (interchange of vaccine products). The patient had muscle weakness (assessed as medically significant) on an unknown date. The outcome of muscle weakness was recovered on an unknown date. Patient is not enrolled in clinical trial. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the available information, a possible contributory role of vaccination with BNT162B2 to the reported event muscle weakness 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: 1834877 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Limb discomfort, Multiple sclerosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain disorder NOS; Cholesterol (under treatment); Hypertension (under treatment); Parkinson''s disease (her mother); Thyroid disorder NOS (since she was 24-years-old)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202101393315

Write-up: confusion in her mind; heavy legs; whether there was a possibility that the vaccination had ''woken up the multiple sclerosis''; This is a spontaneous report from a contactable consumer via the medical information team. A 55-years-old female patient received first dose of bnt162b2 (COMIRNATY) intramuscular on 15Oct2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Relevant medical history included thyroid removal when she was 24-years-old, hypertension under treatment, cholesterol under treatment. In 2004 she experienced very sudden headache for 15 days. She underwent a MRI that showed ''a white substance in her brain''. In order to investigate the possibility the patient to have multiple sclerosis, fluid was taken from the spine and an examination was performed. However, the patient has never taken the results. Since then (in 2004) the patient was fine. Family history included mother had Parkinson''s disease.The patient''s concomitant medications were not reported. On 15Oct2021 a few minutes after vaccination the patient experienced heavy legs. The adverse event comes and go. Then the patient moved her legs normally. On 17Oct2021 in the evening she experienced confusion in her mind (no dizziness, she could not explain it). The outcome was unknown. The patient asked whether there was a possibility that the vaccination had ''woken up the multiple sclerosis''. No further information expected. Information about the batch number cannot be obtained.


VAERS ID: 1835005 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ7489 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Dizziness, Feeling abnormal, Heart rate, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: blood pressure; Result Unstructured Data: Test Result:98/41 mmHg; Comments: 11:30; Test Date: 20211015; Test Name: blood pressure; Result Unstructured Data: Test Result:119 mmHg; Test Date: 20211015; Test Name: blood pressure; Result Unstructured Data: Test Result:114/61 mmHg; Comments: 12:10; Test Date: 20211015; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20211015; Test Name: pulse rate; Result Unstructured Data: Test Result:62/min
CDC Split Type: JPPFIZER INC202101385079

Write-up: light-headed feeling; blood pressure was 98/41; queasy; feels poorly; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). Regulatory authority report number is v21129500. A 17-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Oct2021 11:20 (Lot Number: FJ7489; Expiration Date: 31Jan2022) at the age of 17 years old, as first dose, single for covid-19 immunisation. Medical history was reported as none. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. On 15Oct2021, the patient experienced feels poorly. On 15Oct2021 11:30, the patient experienced light-headed feeling, blood pressure was 98/41 mmHg, queasy. It was reported that 10 minutes after vaccination (at 11:30), the patient experienced light-headed feeling. The patient also felt queasy so she turned to consultation. The patient''s blood pressure was 98/41. The patient was administrated with Saline drip 500ml, observation was conducted. When 250ml was administrated, the patient''s blood pressure was 119 mmHg. Pulse rate 62/min. Same symptoms continued, treatment ended with 500ml. At 12:10, the patient''s blood pressure was 114/61 and showed recovering. The patient went home then. Body temperature before vaccination was 36.4 degrees Centigrade on 15Oct2021. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. All the events required physician office visit. Therapeutic measures were taken as a result of all the events. Outcome of all the events was recovering. The reporting physician commented as follows: The patient did not want to receive second dose of vaccine in reporter''s clinic. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1835020 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-15
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Chest pain, Dyspnoea, Haemorrhage subcutaneous, Mammogram
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atopy
Allergies:
Diagnostic Lab Data: Test Date: 20211018; Test Name: Blood test; Result Unstructured Data: Normal; Test Date: 20211018; Test Name: Mammography; Result Unstructured Data: Normal
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Bruise like subcutaneous haemorrhage; Chest pain; Shortness of breath; This case was received via Agency Regulatory Authority (Reference number: 2021TJP110883) on 21-Oct-2021 and was forwarded to Moderna on 29-Oct-2021. This case was reported by a physician via the company''s medical representative. Subcutaneous haemorrhage-like bruising was reported as a serious by the RA. The patient had atopic constitution and had taken betamethasone only in Jul-2021 and in Aug-2021. On 05-Oct-2021, the patient received the 1st dose of this vaccine. On 15-Oct-2021, subcutaneous haemorrhage-like bruising developed just below the vaccination site in the upper arm and in the breast on the side of the vaccination. The patient also had chest pain and shortness of breath. On 18-Oct-2021, the patient visited a hospital. Chest pain and shortness of breath disappeared. The color of bruise was light, and it was about a 10-coin in size. Blood test and mammography showed no abnormalities. The symptoms were resolving. The outcome of subcutaneous haemorrhage-like bruising just below the vaccination site in the upper arm and in the breast on the side of the vaccination, chest pain, and shortness of breath was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This is a spontaneous case concerning a 31-year-old, female patient with no relevant history, who experienced the unexpected serious event of Haemorrhage subcutaneous. The event occurred approximately 11 days after the 1st dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable (information about 2nd dose was not provided). The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1835030 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005702 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure decreased, Blood pressure measurement, Chest X-ray, Cyanosis, Echocardiogram, Oxygen saturation, Seizure
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: Blood pressure; Result Unstructured Data: Test Result:75/45 mm[Hg]; Test Date: 20211015; Test Name: Chest X-ray; Result Unstructured Data: No pulmonary edema.; Test Date: 20211015; Test Name: Cardiac ultrasonography; Result Unstructured Data: No abnormality in myocardial wall motion.; Test Date: 20211015; Test Name: SpO2; Result Unstructured Data: Decreased.
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Disturbed consciousness; Generalized convulsion; Decreased blood pressure; Cyanosis; Oxygen saturation; This case was received via Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP112036) on 21-Oct-2021 and was forwarded to Moderna on 29-Oct-2021. This case, initially reported to the regulatory authority by a physician, was received via the A (Ref, v21129695). On an unknown date, the patient received the 1st dose of this vaccine. On 15-Oct-2021, the patient received the 2nd dose of this vaccine. Around 17:40, the patient lost consciousness with generalized convulsion and was raced to and admitted to a hospital. Convulsion seizure developed only once, but decreased consciousness and blood pressure persisted, and blood pressure decreased to 75/45 mmHg. Disturbed consciousness, cyanosis, and decreased SpO2 were observed. Rapid fluid replacement and oxygen administration were performed, and no abnormality in myocardial wall motion was confirmed by cardiac ultrasonography. No pulmonary edema was confirmed by chest X-ray. There was no bradycardia, tachycardia, skin symptom, or respiratory symptom other than cyanosis. On 20-Oct-2021, the symptoms were resolving, and the patient was discharged from the hospital. The outcome of disturbed consciousness, generalized convulsion, decreased blood pressure, cyanosis, and decreased SpO2 was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Abnormal decreased blood pressure that caused transient loss of consciousness and generalized convulsion seizure was considered to be related to this vaccination.; Sender''s Comments: This case concerns a 43-year-old, male patient with no relevant medical history, who experienced the unexpected and serious events of altered state of consciousness, seizure, blood pressure decreased, cyanosis and oxygen saturation (decreased). The events occurred the same day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) was administered. The rechallenge was not applicable since events happened after the second dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1835127 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG 9428 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure fluctuation, Dizziness, Palpitations, Panic reaction
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202101397637

Write-up: pressure fluctuations; panic feeling; palpitations; dizziness; This is a spontaneous report from a contactable consumer. A 29-year-old male patient received bnt162b2 (COMIRNATY; Lot Number: FG9428 and expiration date was not reported), via an unspecified route of administration on 15Oct2021 at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On the same day of vaccination, the patient experienced palpitations and slight dizziness. These symptoms lasted for about 10-15 minutes and subsided. Then on Sunday, 17Oct2021 at 4:00 pm these symptoms reappeared (palpitations, dizziness), which lasted about an hour. He further reported that he felt like he was panicking, he had a pressure fluctuation. The reporter asked whether he should do any tests before the second dose due to the adverse reactions he had experienced. The employee recommended contacting a doctor. The reporter is 29 years old. He agrees to be contacted. The outcome of the events was recovered.


VAERS ID: 1836031 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-10-15
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004494 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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: CHMODERNATX, INC.MOD20213

Write-up: Due to Covid vaccination massive reduction of platelets from 119 to 86, Measurements of platelets: Jul 15, 2021: 119 / Sep 17, 2021: 113 / Oct 15, 2021: 86; This regulatory authority case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (Due to Covid vaccination massive reduction of platelets from 119 to 86, Measurements of platelets: Jul 15, 2021: 119 / Sep 17, 2021: 113 / Oct 15, 2021: 86) in a 50-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3004494) for COVID-19 vaccination. No Medical History information was reported. On 15-Sep-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 15-Oct-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced THROMBOCYTOPENIA (Due to Covid vaccination massive reduction of platelets from 119 to 86, Measurements of platelets: Jul 15, 2021: 119 / Sep 17, 2021: 113 / Oct 15, 2021: 86) (seriousness criterion medically significant). At the time of the report, THROMBOCYTOPENIA (Due to Covid vaccination massive reduction of platelets from 119 to 86, Measurements of platelets: Jul 15, 2021: 119 / Sep 17, 2021: 113 / Oct 15, 2021: 86) had not resolved. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. No concomitant product was provided. No treatment information was provided. Company Comment: This case concerns a 50 year old female with no reported history who experienced the serious, unlisted AESI of Thrombocytopenia one month after an unknown dose of mRNA-1273. Re-challenge is unknown as no information on dose number or other dose is reported. Benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Received on 26-Oct-2021-event verbatim updated.; Sender''s Comments: This case concerns a 50 year old female with no reported history who experienced the serious, unlisted AESI of Thrombocytopenia one month after an unknown dose of mRNA-1273. Re-challenge is unknown as no information on dose number or other dose is reported. Benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1836263 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-10-15
   Days after vaccination:99
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE628 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Carcinoembryonic antigen, Computerised tomogram thorax, Neurone-specific enolase, Tumour marker increased, Tumour marker test
SMQs:, Tumour markers (narrow)

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: PANTOLOC; XYZALL; SERETIDE; OLEOVIT D3; SULTANOL
Current Illness: Angina pectoris (complaints of angina pectoris); Bronchial asthma (Asthma bronchiale); House dust mite allergy; Vitamin D deficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of lung (Status post adenocarcinoma of left upper lobe); COVID-19 (Status post Covid infection); Lung upper lobectomy (Status post thoracotomy and lobectomy - left upper lobe); Thoracotomy (Status post thoracotomy and lobectomy - left upper lobe)
Allergies:
Diagnostic Lab Data: Test Date: 20151008; Test Name: CEA; Result Unstructured Data: Test Result:0.4 ng/ml; Test Date: 20160606; Test Name: CEA; Result Unstructured Data: Test Result:0 ng/ml; Test Date: 20160915; Test Name: CEA; Result Unstructured Data: Test Result:0.4 ng/ml; Test Date: 20170116; Test Name: CEA; Result Unstructured Data: Test Result:0 ng/ml; Test Date: 20170504; Test Name: CEA; Result Unstructured Data: Test Result:0 ng/ml; Test Date: 20171109; Test Name: CEA; Result Unstructured Data: Test Result:0 ng/ml; Test Date: 20180417; Test Name: CEA; Result Unstructured Data: Test Result:0.4 ng/ml; Test Date: 20181025; Test Name: CEA; Result Unstructured Data: Test Result:0 ng/ml; Test Date: 20211015; Test Name: CEA; Result Unstructured Data: Test Result:19 ng/ml; Test Date: 20150317; Test Name: CEA; Result Unstructured Data: Test Result:1 ug/L; Test Date: 201911; Test Name: CT-Thorax; Result Unstructured Data: Test Result:stable CT chest findings (no relapse); Test Date: 20160915; Test Name: NSE; Result Unstructured Data: Test Result:16.2 ug/L; Test Date: 20170116; Test Name: NSE; Result Unstructured Data: Test Result:16.3 ug/L; Test Date: 20170504; Test Name: NSE; Result Unstructured Data: Test Result:18.7 ug/L; Test Date: 20171109; Test Name: NSE; Result Unstructured Data: Test Result:15 ug/L; Test Date: 20180417; Test Name: NSE; Result Unstructured Data: Test Result:16.2 ug/L; Test Date: 20181025; Test Name: NSE; Result Unstructured Data: Test Result:15.3 ug/L; Test Date: 20211015; Test Name: NSE; Result Unstructured Data: Test Result:19.3 ug/L; Test Date: 20160915; Test Name: CYFRA; Result Unstructured Data: Test Result:0.6 ng/ml; Test Date: 20170116; Test Name: CYFRA; Result Unstructured Data: Test Result:1.6 ng/ml; Test Date: 20170504; Test Name: CYFRA; Result Unstructured Data: Test Result:1.2 ng/ml; Test Date: 20171109; Test Name: CYFRA; Result Unstructured Data: Test Result:0.9 ng/ml; Test Date: 20180417; Test Name: CYFRA; Result Unstructured Data: Test Result:0.7 ng/ml; Test Date: 20181025; Test Name: CYFRA; Result Unstructured Data: Test Result:0.7 ng/ml; Test Date: 20211015; Test Name: CYFRA; Result Unstructured Data: Test Result:3.6 ng/ml
CDC Split Type: ATPFIZER INC202101454837

Write-up: Tumour marker increased; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number AT-BASGAGES-2021-059742. A 63-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 08Jul2021 (Batch/Lot Number: FE628) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing Bronchial asthma, ongoing angina pectoris (complaints of angina pectoris), Lung upper lobectomy from 14Aug2015 to an unknown date (Status post thoracotomy and lobectomy - left upper lobe), Adenocarcinoma of lung from an unknown date not ongoing (Status post adenocarcinoma of left upper lobe), ongoing massive vitamin D deficiency, ongoing House dust mite allergy, thoracotomy from 14Aug2015 to an unknown date (Status post thoracotomy and lobectomy - left upper lobe), covid-19 from an unknown date and not ongoing (Status post Covid infection). Historical vaccine included the patient received first dose of Comirnaty on 17Jun2021 for COVID-19 immunisation. Concomitant medications included pantoprazole sodium sesquihydrate (PANTOLOC) Film-coated tablet; levocetirizine dihydrochloride (XYZALL) Film-coated tablet; fluticasone propionate, salmeterol xinafoate (SERETIDE); colecalciferol (OLEOVIT D3); salbutamol sulfate (SULTANOL) all taken for an unspecified indication, start and stop date were not reported. About 3 months after the second vaccination the patient experienced tumour marker increased on 15Oct2021. The event was reported as serious due to life threatening. Stable CT (Computerised tomogram) chest findings (no relapse) in Nov2019. CEA (Carcinoembryonic antigen), NSE (Neurone-specific enolase), CYFRA values enclosed since 17Mar2015. On 17Mar2015: CEA 1.00 ?g/l (0-5); on 08Oct2015: CEA 0.4 ng/ml (to 4.00); on 06Jun2016: CEA 0.0 ng/ml (to 4.00); on 15Sep2016: CEA 0.4 ng/ml (to 4.00); NSE 16.2 ?g/l (to 16.3); CYFRA 0.6 ng/ml (to 3.3); On 16Jan2017: CEA 0.0 ng/ml (to 4.00); NSE 16.3 ?g/l (to 16.3); CYFRA 1.6 ng/ml (to 3.3); On 04May2017: CEA 0.0 ng/ml (to 4.00); NSE 18.7 ?g/l (to 16.3); CYFRA 1.2 ng/ml (to 3.3); On 09Nov2017: CEA 0.0 ng/ml (to 4.00); NSE 15.0 ?g/l (to 16.3); CYFRA 0.9 ng/ml (to 3.3); On 17Apr2018: CEA 0.4 ng/ml (to 4.00); NSE 16.2 ?g/l (to 16.3); CYFRA 0.7 ng/ml (to 3.3); On 25Oct2018: CEA 0.0 ng/ml (to 4.00); NSE 15.3 ?g/l (to 16.3); CYFRA 0.7 ng/ml (to 3.3); On 15Oct2021: currently CEA 19 ng/ml (bis 4.00); NSE 19.3 ?g/l (bis 16.3); CYFRA 3.6 ng/ml (bis 3.3). The outcome of the event was unknown. Sender Comment: BASGAGES-comment: Follow-up information has been requested. No follow-up attempts possible. No further information expected.


VAERS ID: 1837271 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101403316

Write-up: Bell''s palsy; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 644905. A 45-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On 15Oct2021, the patient experienced bell''s palsy. The 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: 1837274 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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: AUPFIZER INC202101403382

Write-up: Loss of consciousness; Seizure; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 645229. A 15-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (dose number unknown) for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 15Oct2021, the patient experienced loss of consciousness and seizure; both the events were considered serious as medically significant. The patient recovered from the events on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1838110 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-01
Onset:2021-10-15
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Depersonalisation/derealisation disorder, Dissociation, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210903; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101400907

Write-up: Dissociation; Depersonalisation; This is a spontaneous report from a contactable consumer. This is report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110161716532080-RZ99F, Safety Report Unique Identifier number is GB-MHRA-ADR 26085636. A 12-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on Oct2021 (Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history included patient testing Yes - Positive COVID-19 test from 03Sep2021 to an unspecified date. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced dissociation and depersonalisation on 15Oct2021. The events were reported as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test : Yes - Positive COVID-19 test on 03Sep2021. 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: 1838117 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE; CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 virus test positive; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101400888

Write-up: Arthralgia/Severe joint pain in shoulders wrists and hips; 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-202110170008063200-FKJEL. Safety Report Unique Identifier GB-MHRA-ADR 26085201. A 51-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Oct2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included suspected COVID-19 on 15Dec2020 (Unsure when symptoms stopped) and COVID-19 virus test positive on 16Dec2020. Patient is not pregnant, Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medications included cetirizine and citalopram. The patient experienced severe joint pain in shoulders wrists and hips (arthralgia) (medically significant) on 15Oct2021 with outcome of recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1838131 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Off label use, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fever; Headache; Malaise; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210930; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400864

Write-up: Tiredness; Patient received COMIRNATY as third dose; Patient received COMIRNATY as third dose; This is a spontaneous report from a contactable consumer. This is a report received from a Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110170948470870-FMGJK Safety Report Unique Identifier GB-MHRA-ADR 26085315. A 71-year-old female patient received the third dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 15Oct2021 (at age of 71-year-old) (Batch/Lot Number: FF8288) as dose 3 (booster), single for COVID-19 immunization. Medical history included suspected covid-19 unsure when symptoms started and unsure when symptoms stopped, extreme headache, fever, sickness generally unwell. Phoned 111 at 3am 25Sep2021, no action taken by 111, went to (name redacted) A&E Sunday 26Sep2021 and was given intravenous paracetamol and high dose aspirin. Patient was not enrolled in clinical trial. Concomitant medications included influenza vaccine (INFLUENZA VIRUS) taken for immunization on 18Sep2021 and pneumococcal vaccine polysacch 23v (PNEUMOVAX 23) for immunization on 18Sep2021. The patient previously received BNT162B2 as dose 1 and dose 2 on an unspecified date for Covid-19 immunisation. Patient received COMIRNATY as third dose on 15Oct2021.The patient experienced tiredness on 16Oct2021. The event was reported as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent COVID-19 virus test on 30Sep2021 with No - Negative COVID-19 test result. The outcome of tiredness was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1838136 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature increased, Disorientation, Eye pain, Feeling hot, Headache, Heart rate, Hypoaesthesia, Hypoaesthesia oral, Lip swelling, Oxygen saturation, Paraesthesia, Paraesthesia oral, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to wasp sting
Allergies:
Diagnostic Lab Data: Test Name: Blood Pressure; Result Unstructured Data: Test Result:All ok; Test Name: Feeling hot; Result Unstructured Data: Test Result:Unknown results; Test Name: Heart rate; Result Unstructured Data: Test Result:All ok; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:All ok; Test Date: 20211008; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400502

Write-up: disorientated; Tingling lips; Tingling tongue; Tingling feet/hands; Feeling hot; Numb lips; Swollen lips; Numbness facial; Sore eyes; Headache; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110171042555770-ICFMY, Safety Report Unique Identifier GB-MHRA-ADR 26085379. The 44-year-old (non-pregnant) female patient received dose 3a of bnt162b2 (COMIRNATY, solution for injection, Lot Number: FJ5782) via an unspecified route of administration on 15Oct2021 (at the age of 44-year-old) as dose 3a (booster), single for COVID-19 immunisation. The medical history included past drug event fexofenadine for allergy to arthropod sting from 06Sep2021 to 10Sep2021, flucloxacillin for allergy to arthropod sting from 06Sep2021 to 10Sep2021, prednisolone for allergy to arthropod sting from 06Sep2021 to 10Sep2021, CHLORPHENAMINE MALEATE for allergy to arthropod sting from 04Sep2021 to 06Sep2021. The patient concomitant medications were not reported. The patient previously received dose 1 of bnt162b2 (COMIRNATY, solution for injection) (Lot Number: Unknown) via an unspecified route of administration on 22Jan2021 as dose 1, single for COVID-19 immunisation and dose 2 of bnt162b2 (COMIRNATY, solution for injection) (Lot Number: Unknown) via an unspecified route of administration on 11Mar2021 as dose 2, single for COVID-19 immunisation. The Patient did not have symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 15Oct2021 5min after booster jab at 18:20, the patient experienced tingling lips, tingling tongue, tingling feet/hands, feeling hot, numb lips, swollen lips, numbness facial, and on an unspecified time sore eyes and headache, on an unspecified date disorientated. It was reported that 5min after booster jab at 18:20 patient experienced tingling lips, tongue, fingers, numb face, swelling/red face & lips, sore/puffy eyes, very hot, slightly disorientated. Piriton administered at clinic. Ok after approx. 1 hour. @22:00 tingling lips & some numbness in face returned. Took Fexofenadine 120g. Following day at approx. midday, tingling lips returned: patient took 20mg prednisolone. Continuing to take fexofenadine 120mg and prednisolone 20g for 3 days. The event seriousness was reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: all ok on an unspecified date, heart rate: all ok on an unspecified date, oxygen saturation: all ok on an unspecified date, sars-cov-2 test negative on 08Oct2021, No - Negative COVID-19 test and feeling hot unknown results on an unspecified date. Therapeutic measures were taken as a result of disorientated, tingling lips, tingling tongue, tingling feet/hands, numb lips, swollen lips, numbness facial, sore eyes, headache. The outcome of the event disorientated, tingling lips was recovering and events tingling tongue, tingling feet/hands, feeling hot, numb lips, swollen lips, numbness facial, sore eyes, headache was recovered on 15Oct2021. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101437617 Same patient, differet dose/event


VAERS ID: 1838151 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Balance disorder, Lethargy, Nausea, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (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), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Flu prevention
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101401011

Write-up: Loss of balance; Nausea; Lethargy; Aching joints; Aching in limb; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110171930149620-HNSBW, Safety Report Unique Identifier GB-MHRA-ADR 26085668. A 74-years-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE8087, expiry date: not reported), on 15Oct2021 via an unspecified route of administration (at the age of 74-year-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included flu prevention. Patient has not had symptoms associated with COVID-19. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) taken for flu prevention from 2021 to an unspecified stop date. On 15Oct2021, the patient experienced aching joints, aching in limb, lethargy. On 16Oct2021, the patient experienced loss of balance and nausea. The patient spent 36 hours resting while the symptoms subsided. This was helped by taking paracetamol. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test: negative. Therapeutic measures were taken as a result of the events. The outcome of the events was recovered on 17Oct2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1838167 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6431 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Influenza, Interchange of vaccine products, Off label use, Onychoclasis, Oropharyngeal pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped); Comments: Erythromycin taking these for about 30yrs for spleen
Allergies:
Diagnostic Lab Data: Test Date: 20211004; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101401004

Write-up: Stroke; Off label use; Interchange of vaccine products; Sore throat; Flu; Brittle nails; Painful arm; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110181022426350-NJM3Y, Safety Report Unique Identifier GB-MHRA-ADR 26086044. A 70-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/LOT number: FG6431), via an unspecified route of administration on 15Oct2021 (at the age of 70-year-old) as dose 3 (booster) single for COVID-19 immunisation. Medical history included suspected COVID-19 from an unknown date and unknown if ongoing unsure when symptoms started, unsure when symptoms stopped. The patient concomitant medications were not reported. The patient previously took erythromycin and experienced spleen disorder, COVID-19 vaccine AstraZeneca for COVID-19 immunisation. Patient has not tested positive for COVID-19 since having the vaccine. Unsure if patient was enrolled in clinical trial. Few yrs ago had bloods taken from centre of life. On an unspecified date, patient experienced stroke, off label use, interchange of vaccine products, on 15Oct2021, sore throat, flu, brittle nails, painful arm. Lab tests included SARS-COV-2 test: positive on 04Oct2021. The outcome of stroke, off label use, interchange of vaccine products was unknown and for sore throat, flu, brittle nails, painful arm was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1838175 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Body temperature abnormal, Dyspnoea, Muscular weakness, Off label use, Product use issue
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Arthritis (broad), 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: BISOPROLOL; RAMIPRIL; RIVAROXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myeloproliferative neoplasm; Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: Body temperature; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: GBPFIZER INC202101401146

Write-up: Shortness of breath; Joint pain; Muscle weakness; Body temperature; Product use for unapproved combination; Off-label use; 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-202110181637430320-QIJBE, Safety Report Unique Identifier GB-MHRA-ADR 26086760. An 80-year-old female patient received third dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FF8222), via an unspecified route of administration on 15Oct2021 (at the age of 80-year-old) at dose 3 (booster), single for COVID-19 immunisation. Medical history included suspected COVID-19 from 04Apr2020 to an unknown date (Unsure when symptoms stopped), neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)), MPN (myeloproliferative neoplasm). Not had a COVID-19 test. Concomitant medications included bisoprolol taken for an unspecified indication, start and stop date were not reported; influenza vaccine (INFLUENZA VIRUS) taken for immunisation from 15Oct2021 to 15Oct2021; ramipril taken for an unspecified indication, start and stop date were not reported; rivaroxaban taken for an unspecified indication, start and stop date were not reported. On 15Oct2021 the patient received third dose of bnt162b2 (product use for unapproved combination and off-label use), and experienced shortness of breath, joint pain, muscle weakness, body temperature. The patient underwent lab tests and procedures which included body temperature: unknown result on 15Oct2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Report not related to possible inflammation of the heart (myocarditis or pericarditis). Outcome of event shortness of breath was recovering, joint pain was recovered on an unspecified date in Oct2021, muscle weakness, body temperature was recovered in 17Oct2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1838195 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101417642

Write-up: Fatigue; Vaccination site pain; Nausea; Dizziness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110191008373620-ZZSFY, Safety Report Unique Identifier GB-MHRA-ADR 26091111. A 66-years-old female patient received third dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: FF8222), via an unspecified route of administration on 14Oct2021 as dose 3(booster), single for covid-19 immunisation. The patient medical history, concomitant medications were not reported. The patient previously received thyroxine and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unknown date as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via unknown route of administration on an unknown date as dose 2, single for COVID-19 immunisation. Unsure if patient has had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced fatigue, vaccination site pain, nausea on an unspecified date. Dizziness on 15Oct2021. The events assessed as serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Sep2021. The outcome of dizziness was resolved on 18Oct2021 and while all other events was not recovered on an unspecified date. No follow up attempts are needed. No further information is expected.


VAERS ID: 1838201 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101417468

Write-up: Pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The Regulatory authority report number GB-MHRA-WEBCOVID-202110191105170460-CCEU2. Safety Report Unique Identifier GB-MHRA-ADR 26091529. A male patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 15Oct2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with covid-19. Patient had not tested positive for covid-19 since having the vaccine. Patient was not enrolled in clinical trial. The report does not relate to possible inflammation of the heart, myocarditis or pericarditis. On 15Oct2021, the patient experienced pain. The case was assessed as serious (medically significant) by the health authority. The patient underwent lab tests and procedures which included COVID-19 virus test resulted as negative covid-19 test. The outcome of event was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1838209 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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? 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 INC202101417515

Write-up: Painful lymphadenopathy; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110191423037030-LFIOW. A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown), dose 3 via an unspecified route of administration on 14Oct2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. On 15Oct2021, the patient experienced lymphadenopathy. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report relate to possible inflammation of the heart (myocarditis or pericarditis) was reported as no. The outcome of event was resolved on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained


VAERS ID: 1838215 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Immunisation
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? 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 INC202101417489

Write-up: Angioedema; Booster; This is a spontaneous report from a contactable other hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110191652577870-GJFFX and Safety Report Unique Identifier GB-MHRA-ADR 26093358. An female patient of an unspecified age received bnt162b2 (COMIRNATY,Batch/Lot Number: FF8288),dose 3 via an unspecified route of administration on 15Oct2021 as Dose 3 (booster),single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient experienced angioedema and booster on 15Oct2021. Therapeutic measures were taken as a result of angioedema which included epipen and chlorphenamine. Patient was taken to ambulance by paramedics and observed for a period and discharged without hospital. The outcome of the events was recovered on 15 oct2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1838227 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Breast pain, Dizziness, Dyspnoea, Erythema, Headache, Illness, Interchange of vaccine products, Musculoskeletal chest pain, Off label use, Pain, Pain in extremity, Peripheral swelling, Photosensitivity reaction, Pneumonia, Pyrexia, SARS-CoV-2 test, Skin warm, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Lipodystrophy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS; LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Glandular fever; Hashimoto''s disease; Interstitial lung disease; Suspected COVID-19 (Unsure when symptoms stopped); Thyroid disorder; Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: FEVERE, Comment: at 20s had glandular fever for over a year.
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:39.8; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101417557

Write-up: dizzy; Vomiting; sick extremely; underfelt breast, all over; underfelt breast, all over; Sun sensitivity; Rib pain; Breathing difficult; Lung infection; Painful L arm; Swollen arm; Skin warm; Skin red; Off label use; Interchange of vaccine products; Dizziness; Headache; High temperature; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110200941333970-AUH7N, Safety Report Unique Identifier GB-MHRA-ADR 26097273. A 53-year-old non pregnant female patient (not pregnant at the time of vaccination) received bnt162b2 (COMIRNATY Solution for injection Lot Number: FF8288), via an unspecified route of administration on 15Oct2021 as (at the age of 53 years old) as dose 3 (booster), single for COVID-19 immunization. Medical history included suspected covid-19 from 04Apr2020 to an unknown date Unsure when symptoms stopped, interstitial lung disease, glandular fever, thyroid disorder, glandular fever at 20s had glandular fever for over a year, hishimotos disease all from an unknown date and unknown if ongoing. Concomitant medications included influenza vaccine (INFLUENZA VIRUS) taken for immunization from an unspecified start date to 12Oct2021; levothyroxine (LEVOTHYROXINE) taken for under active thyroid gland caused by hishimotos disease, start and stop date were not reported. Historical vaccines included COVID-19 VACCINE ASTRAZENECA via an unspecified route of administration on 21Jan2021 and 10Apr2021 as dose 1, single and dose 2, single for COVID-19 immunization. The patient had previously received levothyroxine. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). Patient was not pregnant. Patient was not currently breastfeeding. On an unspecified date, the patient had experienced dizzy. On 15Oct2021, had headache, high temperature, dizziness, rib pain, breathing difficult, lung infection, painful l arm, swollen arm, skin warm, skin red, had interchange of vaccine products and off label use. On 16Oct2021, had vomiting, sun sensitivity, sick extremely, underfelt breast, all over. Had vaccine Friday afternoon, by 10pm had above symptom, by Saturday afternoon struggle breathing, in lots of pain head, underfelt breast, all over, dizzy, being sick extremely painful arm very red and hot. dialed 999 as asthmatic temperature was 39.8, taken into A and E by ambulance kept in overnight. The events resulted in emergency room visit. The events seriousness was assessed as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: positive Yes - Positive COVID-19 test; Temperature: 39.8, both on an unspecified date. The outcome of events dizzy, dizziness was not recovered and sun sensitivity, rib pain, breathing difficult, lung infection, painful l arm, swollen arm, skin warm, skin red was recovering and sick extremely, underfelt breast, all over was unknown and headache recovered with sequelae and vomiting was recovered on 17Oct2021 and high temperature recovered on 19Oct2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1838255 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Disorientation, Feeling cold, Headache, Immunisation, Insomnia, Interchange of vaccine products, Malaise, Myocarditis, Off label use, Palpitations, Rhinorrhoea, SARS-CoV-2 test, Tinnitus
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hearing impairment (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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? 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 INC202101426402

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202110211213038930-OO61E; safety report unique identifier: GB-MHRA-ADR 26103694). The 82-year-old female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# FJ5782), at the age of 82, via an unspecified route of administration, on Oct 15, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. Patient did not have symptoms associated with COVID-19. Patient was not enrolled in a clinical trial. On Oct 16, 2021, patient felt cold, had insomnia, palpitations, felt unwell, headache, temporospatial disorientation, runny nose, GI upset, tinnitus; and on an unspecified date general malaise and myocarditis. Patient was given paracetamol for headache. Patient put on bedrest but was insomniac. First symptom headache (still happening). General malaise for entire period. General malaise, myocarditis, felt cold, insomnia, palpitations, felt unwell, headache, temporospatial disorientation, runny nose, GI upset and tinnitus reported medically significant. The patient underwent lab tests and procedures, which included SARS-CoV-2 test negative on No - Negative COVID-19 test. The outcome of general malaise, myocarditis: recovering; felt cold, insomnia, palpitations, felt unwell, temporospatial disorientation, GI upset recovered on Oct 20, 2021; headache: recovering as of Oct 20, 2021; runny nose: not recovered; tinnitus: recovered on Oct 18, 2021. No follow-up attempts needed. No further information expected.


VAERS ID: 1838469 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-11
Onset:2021-10-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Conduction disorder, Echocardiogram, Electrocardiogram, Electrocardiogram abnormal, Myocardial necrosis marker, Myocardial necrosis marker increased, Myocarditis, Systolic dysfunction
SMQs:, Cardiac failure (broad), Myocardial infarction (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), 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? Yes
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: 20211015; Test Name: echocardiography/ echocardiogram; Result Unstructured Data: Test Result:Cardiac contraction disorder and conduction disord; Comments: Cardiac contraction disorder and conduction disorder; Test Date: 20211015; Test Name: ECG; Result Unstructured Data: Test Result:mild ECG abnormalities; Test Date: 20211015; Test Name: Myocardial escape enzyme; Result Unstructured Data: Test Result:Significant elevated
CDC Split Type: JPPFIZER INC202101404764

Write-up: cardiac contraction disorder; conduction disorder; Acute myocarditis; Significant elevated myocardial escape enzyme; felt chest pain; mild ECG abnormalities; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21130147. A 15-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number was unknown, Expiration date was unknown) via an unspecified route of administration on 11Oct2021 at 01:00 (the day of the vaccination, as reported) (at the age of 15-year-old) as dose 2, single for COVID-19 immunization. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s medical history was reported as none. The patient''s concomitant medications were not reported. The patient previously received COVID-19 vaccine (manufacturer unknown) on unspecified date as dose 1, single for COVID-19 immunisation. On 15Oct2021 at 01:00 (also reported as 4 days after the vaccination), the patient experienced acute myocarditis. On 15Oct2021 (also reported as 4 days after the vaccination), the patient was admitted to the hospital. The course of the event was reported as follows: on 15Oct2021, the patient felt chest pain before dawn and the patient was transported by emergency. Elevated myocardial escape enzyme and mild ECG abnormalities were admitted (15Oct2021), the patient was diagnosed as acute myocarditis. On the same day, the patient was transported to other hospital, hospitalization for observation. Subjective symptoms were disappeared from the moment when the patient was transported by emergence, it did not get worse after that and passed. The symptom of elevated myocardial escape enzyme was recovering naturally lightened, through the investigation of echocardiogram and echocardiography cardiac contraction disorder and conduction disorder were admitted (15Oct2021). The reporting physician classified the event as serious (hospitalization from 15Oct2021 to 18Oct2021). The causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was spontaneous idiopathic myocarditis (Viral etc). On 18Oct2021 (7 days after the vaccination), the outcome of the events was resolved. The reporting physician commented as follows (reporter''s comment): The period after the mRNA vaccination was acute myocarditis prevalent time, prevalent age/gender, therefore causal relationship with the vaccine was presumed. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events be ruled out. 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: 1838725 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3023 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Feeling abnormal, 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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101394210

Write-up: The patient lost consciousness due to vasovagal reflex in a sitting position in a chair.; The patient lost consciousness due to vasovagal reflex in a sitting position in a chair.; feels poorly; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21129542. The patient was a 25-year and 11-month-old male (age at first vaccination). On 15Oct2021 at 14:15 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FH3023, Expiration date 31Dec2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.7 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 15Oct2021 at 14:20 (5 minutes after the vaccination), the patient experienced Vasovagal reflex. The course of the event was as follows: After vaccination, the patient experienced feels poorly. The patient lost consciousness due to vasovagal reflex in a sitting position in a chair. Subsequently, after being placed under observation on a stretcher, the symptoms resolved, and the patient went home. On 15Oct2021 (the day of vaccination), the outcome of the events was recovered. 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.; Sender''s Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on temporal relationship and since it is part of the product safety profile. 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: 1840866 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101403342

Write-up: Facial paralysis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. The regulatory authority report number is 644907. A 35-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient experienced facial paralysis on 15Oct2021. The 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: 1840874 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, Troponin, Troponin increased
SMQs:, Myocardial infarction (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: Troponin level; Result Unstructured Data: Test Result:increased
CDC Split Type: AUPFIZER INC202101403426

Write-up: Myocarditis; Troponin increased; This is a spontaneous report from a contactable other health professional. This is a report received from the Regulatory Authority. Regulatory authority report number 645189. A 19-years-old male patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced myocarditis and troponin increased on 15Oct2021. The patient was recovering from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1840897 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-15
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, SARS-CoV-2 test, Suspected 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had not asymptomatic covid-19 infection. The patient had no symptoms of headache and dyspnea (shortness of breath) last 8 days before reporting. The patient had no pre-existing diseases or conditions of Chronic decompensated respiratory disease, Chronic heart disease, Diabetes, Advanced stage chronic renal disease, Immunosuppression, High risk pregnant woman and carrier of chromosomal diseases or immune fragility status. The patient had not contacted with a confirmed or suspected Covid-19 patient.
Allergies:
Diagnostic Lab Data: Test Date: 20211017; Test Name: Body temperature; Result Unstructured Data: higher than 38 degree Celsius; Test Date: 20211017; Test Name: COVID-19 antigen test; Result Unstructured Data: Positive
CDC Split Type: BRJNJFOC20211032974

Write-up: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 38 year old male of unspecified race and ethic origin. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: The patient had not asymptomatic covid-19 infection. The patient had no symptoms of headache and dyspnea (shortness of breath) last 8 days before reporting. The patient had no pre-existing diseases or conditions of Chronic decompensated respiratory disease, Chronic heart disease, Diabetes, Advanced stage chronic renal disease, Immunosuppression, High risk pregnant woman and Carrier of chromosomal diseases or immune fragility status. The patient had not contacted with a confirmed or suspected Covid-19 patient. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 1821287 expiry: UNKNOWN) dose was not reported, 1 total administered on 17-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-OCT-2021, the patient experienced suspected covid-19 infection (suspected clinical vaccination failure). On 17-OCT-2021, the patient after the consultation with the pharmacy professional, had a fever higher than 38 degree Celsius. The patient reported and experienced other symptoms such as cough, body pain and throat inflammation. The symptoms remained strong for only one day, followed by a progressive decrease over the days. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. After with the positive result, patient went to physician for treatment but without further information or instructions because of the mild symptoms. The patient did not taken another test and was on isolation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000197909. This case, from the same reporter is linked to 20211100817. This case was reassessed as serious based on additional information received from patient on 01-NOV-2021 and central complaint vigilance department on 31-OCT-2021, the following information was updated and incorporated into case narrative: Event (Suspected Clinical Vaccination Failure was added and symptoms like fever, cough, body pain and throat inflammation was subsumed), patient''s demographic (date of birth, age at the time of event, age at the time of vaccination), patient''s negative medical history, product quality complaint number, additional reporter(contact), product lot number and physician office visit was added.; Sender''s Comments: V1: 20211032974-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: 1840902 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-10-15
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7204 / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Chorioretinopathy
SMQs:, Retinal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101407837

Write-up: I got Central Serous Chorioretinopathy; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in Arm Right on 16Sep2021 (Lot Number: FD7204) as single dose (at the age of 38-years-old) for COVID-19 immunization. The patient''s medical history was not reported. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. No other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. Historical vaccine was bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Right on 09Aug2021 (Lot Number: FD7206) as single dose for COVID-19 immunization. The patient reported, "I got central serous chorioretinopathy" on 15Oct2021. No treatment received for the event. The event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered. The event was serious (disability). Since the vaccination, the patient has not been tested for COVID-19.


VAERS ID: 1841487 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Dizziness, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MARVELON; METHOTREXATE
Current Illness: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control; Eczema
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:high; Comments: high temp
CDC Split Type: GBPFIZER INC202101417693

Write-up: chills; high temp; lightheadedness; fever; Rigors; Headache; This is a spontaneous report from a contactable consumer. This is the reports received from the United Kingdoms Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory authority report number is GB-MHRA-WEBCOVID-202110171007350250-IGNK3, Safety Report Unique Identifier GB-MHRA-ADR 26085308. A 27-year-old non-pregnant female patient received the third dose of BNT162B2 (COMIRNATY, solution for injection, lot number was not known), via an unspecified route of administration, on 14Oct2021, as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included ongoing immunodeficiency (taking other treatments or medicines, not listed above, known to lower the immune response and i), birth control and eczema. Concomitant medications included desogestrel, ethinylestradiol (MARVELON) taken for birth control from 01Jun2013 and methotrexate taken for eczema from 07Mar2020. Historical vaccine included the BNT162B2 (COMIRNATY, solution for injection, lot number was not reported) via an unspecified route of administration, on an unspecified date, as dose number unknown, single for COVID-19 immunization. Patient had 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 currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 15Oct2021 (1 day after the third dose), the patient experienced lightheadedness, fever, rigors, headache. On an unspecified date, had chills and high temp. Clinical information included started rigoring the morning after with chills, fever and a high temp. Also had lightheadedness and headaches. The seriousness criteria of the event were reported as medically significant. The patient underwent lab tests and procedures which included body temperature: high on an unspecified date high temp. Outcome of the event lightheadedness, fever, rigors was recovering and outcome of the event headache, chills, high temp was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1841499 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FP8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Vulval haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211018; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101443188

Write-up: Vulval bleeding; This is a spontaneous report from two contactable consumer or other non hcp downloaded from the regulatory authority number GB-MHRA-WEBCOVID-202110190124461160-VYCXY, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 26090357. A 52-year-old non pregnant female patient received third dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FP8222), via an unspecified route of administration on 15Oct2021 (at the age of 52-years-old) as dose 3 (booster), single for COVID-19 immunisation. Patient last menstrual period date 01Oct2021. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. The patient experienced vulval bleeding on 15Oct2021. The event was reported as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Oct2021 No - Negative COVID-19 test. Outcome of the event was recovered on 17Oct2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1841507 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Coordination abnormal, SARS-CoV-2 test
SMQs:, Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLIN; CODEIN; INFLUENZA VIRUS; IRBESARTAN; PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101417799

Write-up: Lack of coordination; food had no taste; This is a spontaneous report from a contactable other-healthcare professional received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110191110021070-ZOCEJ, Safety Report Unique Identifier GB-MHRA-ADR 26091509. A 63-year-old female patient received bnt162b2 (COMIRNATY, Solution for Injection, Lot number was not reported), via an unspecified route of administration on 14Oct2021, as dose 3, (booster), single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication''s included amitriptyline hydrochloride (AMITRIPTYLIN) taken for analgesic therapy; codeine phosphate (CODEIN) taken for analgesic therapy; influenza vaccine (INFLUENZA VIRUS); irbesartan; and paracetamol taken for analgesic therapy. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 15Oct2021, the patient experienced lack of coordination and food had no taste. It was reported that approximately 20 hrs after receiving her booster jab. On getting out of bed nearly fell forward, then found difficulty coordinating lower limbs, food had no taste. After returning to bed, 3 hrs later symptoms had passed. On an unspecified date, the patient underwent SARS-COV-2 test which resulted negative. Events were resolved on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.


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