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From the 11/19/2021 release of VAERS data:

Found 894,019 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 446 out of 8,941

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VAERS ID: 1807733 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4509 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hemiparesis, Vaccination site hypoaesthesia
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: ATPFIZER INC202101345848

Write-up: Numbness weakness in the affected extremity (the same as vaccination site); Numbness weakness in the affected extremity (the same as vaccination site); This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-049534. A 21-years-old male patient received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: FG4509), via intramuscular route on 28Sep2021 as dose 1, single (age at vaccination 21 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Sep2021 the patient experienced unilateral weakness of limbs, application site numbness. The outcome of the events was unknown. Reporter Comment : Treatment of side effect 1: symptomatic - expectative No follow-up attempts possible. No further information expected.


VAERS ID: 1807735 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Application site pain, Arthralgia, Facial paralysis, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: Headache; Application site pain; Arthralgia; Pyrexia; Left half of face numb; This case was received (Reference number: AT-BASGAGES-2021-049586) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Left half of face numb) in a 39-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced FACIAL PARALYSIS (Left half of face numb) (seriousness criterion medically significant) and PYREXIA (Pyrexia). On 29-Sep-2021, the patient experienced APPLICATION SITE PAIN (Application site pain). 29-Sep-2021, the patient experienced ARTHRALGIA (Arthralgia). On 30-Sep-2021, the patient experienced HEADACHE (Headache). At the time of the report, FACIAL PARALYSIS (Left half of face numb) outcome was unknown and APPLICATION SITE PAIN (Application site pain), ARTHRALGIA (Arthralgia), HEADACHE (Headache) and PYREXIA (Pyrexia) had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. company comment:This case concerns a 39-year-old, female patient with no relevant medical history, who experienced the serious expected event of Facial paralysis. The events occurred on the same day after the administration of the first dose mRNA-1273. The rechallenge was unknown as there is no information provided about the second dose. The benefit-risk relationship of mRNA-1273is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Translation document received on 18-Oct-2021 and dosage text updated.; Sender''s Comments: This case concerns a 39-year-old, female patient with no relevant medical history, who experienced the serious expected event of Facial paralysis. The events occurred on the same day after the administration of the first dose mRNA-1273. The rechallenge was unknown as there is no information provided about the second dose. The benefit-risk relationship of mRNA-1273is not affected by this report.


VAERS ID: 1808924 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-09-28
   Days after vaccination:96
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300 2913 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: COVID-19; Vaccination failure; This case was received via Regulatory Agency (Reference number: DE-PEI-202100203284) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure) in a 55-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 300 4731 and 300 2913) for COVID-19 vaccination. No Medical History information was reported. On 24-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion medically significant) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant). At the time of the report, COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure) outcome was unknown. No concomitant medication was reported. Patient reported that he experienced Fever, headache and limb pain. Patient done with PCR test on 28-Sep-2021 with result positive and CT done with results 30/31. Treatment medication was not provided by the reporter. The case was assessed as serious as per Regulatory Authority?s report. This case concerns a 55-year-old male with no reported medical history, who experienced the unexpected serious AESI event of COVID-19. Vaccination failure was considered as an additional event by the reporter, although the window between the two doses of vaccine was 42 days. These events occurred 1 month and 24 days after vaccination with the second dose of mRNA-1273 (Spikevax ) . The re -challenge for this case is not applicable. The benefit-risk relationship of mRNA-(Spiekvax) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Translation document received on 18-Oct-2021 include translated sender''s comment.; Sender''s Comments: This case concerns a 55-year-old male with no reported medical history, who experienced the unexpected serious AESI event of COVID-19. Vaccination failure was considered as an additional event by the reporter, although the window between the two doses of vaccine was 42 days. These events occurred 1 month and 24 days after vaccination with the second dose of mRNA-1273 (Spikevax ) . The re -challenge for this case is not applicable. The benefit-risk relationship of mRNA-(Spiekvax) is not affected by this report.


VAERS ID: 1809690 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-09-28
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210923; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: in Hong Kong; Test Date: 20210928; Test Name: COVID-19 virus test; Test Result: Positive ; Comments:
CDC Split Type: HKPFIZER INC202101398888

Write-up: overseas case of covid-19; overseas case of covid-19; This is a spontaneous report from a non-contactable healthcare professional via a Regulatory Authority (Regulatory authority report number: not provided), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003788), license party for bnt162b2 (COMIRNATY). As of 0:00 am, 08-Oct-2021, DH announced that one additional confirmed case of COVID-19 after Comirnaty vaccination and one overseas case of COVID-19 after Comirnaty vaccination. This case was created for one overseas case of COVID-19 after Comirnaty vaccination. A 20-year-old male patient received first dose of BNT162B2 (COMIRNATY/ Tozinameran, solution for injection, Batch/Lot number was not reported), via unspecified route of administration on 23Jul2021 as dose 1, single, and received second dose via unspecified route of administration on 16Aug2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history, concomitant medication and past product were not reported. On 28Sep2021, the patient experienced vaccination failure of Covid-19. It was reported that on 23Sep2021, the patient tested negative before traveling on 25Sep2021 by flight. The patient''s specimen collected 28Sep2021 tested positive, and he was asymptomatic and confirmed as COVID-19. The adverse event of COVID-19 was considered as Important Medical Event. The outcome of the event was unknown. The causality assessment for suspect BNT162B2 and events vaccination failure, and asymptomatic COVID-19 was reported as possible as per both reporter and company (BioNTech SE). Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. This is one of two reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS003787 (master case) and 2021FOS003788. Follow-up closed. No further information is possible.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101398890 same reporter/drug, different patient


VAERS ID: 1809698 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AERIUS [DESLORATADINE]; EUTHYROX
Current Illness: Birch pollen allergy (Allergic to birch); Ragweed allergy (Allergic to ambrosia)
Preexisting Conditions: Comments: Allergic to birch and ambrosia. I use Euthyrox and Aerius.
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: Body temperature; Result Unstructured Data: 39.6 C
CDC Split Type: HRJNJFOC20211039389

Write-up: MYALGIA; RIGORS; HIGH TEMPERATURE; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, HR-HALMED-300051131) on 20-OCT-2021 and concerned a 52 year old female. The patient''s weight was 54 kilograms, and height was not reported. The patient''s concurrent conditions included: birch pollen allergy, and ragweed allergy, and other pre-existing medical conditions included: Allergic to birch and ambrosia. I use Euthyrox and Aerius. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry date was not reported) 0.5 ml, 1 total, administered on SEP-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included desloratadine for drug used for unknown indication, and levothyroxine sodium for drug used for unknown indication. On 28-SEP-2021, the patient experienced myalgia (Muscle pain), rigors, headache and laboratory data included body temperature (NR: 36 - 37) was 39.6 C which indicates high temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myalgia, rigors, high temperature, and headache. This report was serious (Other Medically Important Condition).


VAERS ID: 1809700 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Headache, Lymphadenopathy, Musculoskeletal stiffness, Nausea, Pyrexia, Vaccination site erythema, Vaccination site oedema, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic rhinitis (allergic rhinitis); Vasomotor rhinitis (vasomotor rhinitis)
Preexisting Conditions: Comments: Vasomotor and Allergic rhinitis
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: Body temperature; Result Unstructured Data: 38.5 C; Test Date: 202109; Test Name: Body temperature; Result Unstructured Data: 37.4 C; Test Date: 20210928; Test Name: Body temperature; Result Unstructured Data: 39.8 C
CDC Split Type: HRJNJFOC20211037668

Write-up: AXILLARY LYMPH NODES ENLARGED; PYREXIA; NAUSEA; FRONTAL HEADACHE; MUSCLE STIFFNESS; VACCINATION SITE PAIN; VACCINATION SITE EDEMA; VACCINATION SITE ERYTHEMA; This spontaneous report received from a consumer via Regulatory Authority (EVHUMAN Vaccines, HR-HALMED-300051222) was received on 20-OCT-2021 and concerned a 28 year old female. The patient''s weight was 103 kilograms, and height was not reported. The patient''s concurrent conditions included: allergic rhinitis, and vasomotor rhinitis, and other pre-existing medical conditions included: Vasomotor and Allergic rhinitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: ABZ5320 expiry: UNKNOWN) .5 ml, 1 total, administered on 28-SEP-2021 for covid-19 vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced vaccination site pain, vaccination site edema and vaccination site erythema. Laboratory data included: Body temperature 39.8 C. On 29-SEP-2021, the patient experienced pyrexia, nausea, frontal headache and muscle stiffness. On 30-SEP-2021, the patient experienced axillary lymph nodes enlarged. On unspecified date SEP-2021, Laboratory data included: Body temperature 38.5 C, 37.4 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and frontal headache on 30-SEP-2021, was recovering from vaccination site pain, pyrexia, axillary lymph nodes enlarged, vaccination site edema, and vaccination site erythema, and had not recovered from muscle stiffness. This report was serious (Other Medically Important Condition).


VAERS ID: 1809760 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chest pain, Dyspnoea exertional, Headache, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.; Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.; Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.; Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.; Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.; Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.; This case was received via Agency (Reference number: IT-MINISAL02-795551) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of ABDOMINAL PAIN (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.), CHEST PAIN (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.), DYSPNOEA EXERTIONAL (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.), HEADACHE (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.), PYREXIA (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.) and VOMITING (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 vaccination. No Medical History information was reported. On 28-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 28-Sep-2021, the patient experienced ABDOMINAL PAIN (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.) (seriousness criterion hospitalization), CHEST PAIN (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.) (seriousness criterion hospitalization), DYSPNOEA EXERTIONAL (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.) (seriousness criterion hospitalization), HEADACHE (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.) (seriousness criterion hospitalization), PYREXIA (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.) (seriousness criterion hospitalization) and VOMITING (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.) (seriousness criterion hospitalization). At the time of the report, ABDOMINAL PAIN (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.), CHEST PAIN (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.), DYSPNOEA EXERTIONAL (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.), HEADACHE (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.), PYREXIA (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.) and VOMITING (Yesterday, after the 2nd dose of Moderna vaccine, the patient presented with fever up to 39?C, vomiting, abdominal and chest pain, and headache. Exertional dypsnea.) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were reported. Patient received 2nd dose of the vaccine and experienced fever with a temperature of 39 degree Celsius. Patient went to ER on 29-Sep -2021. Patient was not allergic to drugs and/or substances. Patient had rosy skin, well perfused and no sweaty. Cardiopulmonary objectivity was within normal limits.Patient had flat abdomen and was painful on deep palpation over the entire area. There were no signs of peritoneal defense and no palpable masses in abdomen. On an unknown date, patient underwent Echo pocus abdomen:Abdominal aorta within normal limits for caliber and pathway in observable tracts. No marks. Company Comment: This case concerns a 42-year-old female patient with no reported relevant medical history, who experienced the unexpected serious events of Abdominal pain, Chest pain, Dyspnoea exertional, Headache, Pyrexia, Vomiting. The events occurred on the same day with the unspecified dose of Spikevax. The rechallenge was unknown since the events outcomes were unknown at the time of report and no information available on the second dose. The benefit-risk relationship of the product is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Translation document received on 15-Oct-2021 contains updated event verbatim and reporter''s comments.; Sender''s Comments: This case concerns a 42-year-old female patient with no reported relevant medical history, who experienced the unexpected serious events of Abdominal pain, Chest pain, Dyspnoea exertional, Headache, Pyrexia, Vomiting. The events occurred on the same day with the unspecified dose of Spikevax. The rechallenge was unknown since the events outcomes were unknown at the time of report and no information available on the second dose. The benefit-risk relationship of the product is not affected by this report.


VAERS ID: 1809769 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006321 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: I woke up on Tuesday morning with feeling of chest tightness, difficulty breathing, retrosternal pain and pain in the left part of the temple.; I woke up on Tuesday morning with feeling of chest tightness, difficulty breathing, retrosternal pain and pain in the left part of the temple.; I woke up on Tuesday morning with feeling of chest tightness, difficulty breathing, retrosternal pain and pain in the left part of the temple.; This case was received via the Regulatory Authority (Reference number: IT-MINISAL02-795902) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (I woke up on Tuesday morning with feeling of chest tightness, difficulty breathing, retrosternal pain and pain in the left part of the temple.), DYSPNOEA (I woke up on Tuesday morning with feeling of chest tightness, difficulty breathing, retrosternal pain and pain in the left part of the temple.) and CHEST PAIN (I woke up on Tuesday morning with feeling of chest tightness, difficulty breathing, retrosternal pain and pain in the left part of the temple.) in a 43-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3006321) for COVID-19 vaccination. No Medical History information was reported. On 26-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 28-Sep-2021, the patient experienced CHEST DISCOMFORT (I woke up on Tuesday morning with feeling of chest tightness, difficulty breathing, retrosternal pain and pain in the left part of the temple.) (seriousness criterion hospitalization), DYSPNOEA (I woke up on Tuesday morning with feeling of chest tightness, difficulty breathing, retrosternal pain and pain in the left part of the temple.) (seriousness criterion hospitalization) and CHEST PAIN (I woke up on Tuesday morning with feeling of chest tightness, difficulty breathing, retrosternal pain and pain in the left part of the temple.) (seriousness criterion hospitalization). At the time of the report, CHEST DISCOMFORT (I woke up on Tuesday morning with feeling of chest tightness, difficulty breathing, retrosternal pain and pain in the left part of the temple.), DYSPNOEA (I woke up on Tuesday morning with feeling of chest tightness, difficulty breathing, retrosternal pain and pain in the left part of the temple.) and CHEST PAIN (I woke up on Tuesday morning with feeling of chest tightness, difficulty breathing, retrosternal pain and pain in the left part of the temple.) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment information was unknown. Patient had herpetic encephalitis was in a comatose state for one week, which resulted in renal tubular necrosis and acute pancreatitis last year. Company Comment: This case concerns a 43 year old male patient with no relevant medical history, who experienced the unexpected events of chest discomfort, dyspnoea, chest pain. The events occurred approximately 2 days after the first dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Received on 15-Oct-21. Reaction/event as reported by primary source is updated. Reporter''s comments is updated.; Sender''s Comments: This case concerns a 43 year old male patient with no relevant medical history, who experienced the unexpected events of chest discomfort, dyspnoea, chest pain. The events occurred approximately 2 days after the first dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1809783 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214013 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arthritis rheumatoid; Hashimoto''s thyroiditis; Mitral insufficiency; Vasculitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: fever 40?, generalized pruritus, especially on the nipples, fatigue, increased weakness; fever 40?, generalized pruritus, especially on the nipples, fatigue, increased weakness; fever 40?, generalized pruritus, especially on the nipples, fatigue, increased weakness; This case was received via Agency (Reference number: IT-MINISAL02-796251) on 15-Oct-2021 and was forwarded to Moderna on 15-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (fever 40?, generalized pruritus, especially on the nipples, fatigue, increased weakness), FATIGUE (fever 40?, generalized pruritus, especially on the nipples, fatigue, increased weakness) and PRURITUS (fever 40?, generalized pruritus, especially on the nipples, fatigue, increased weakness) in a 60-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214013) for SARS-CoV-2 vaccination. Concurrent medical conditions included Mitral insufficiency, Hashimoto''s thyroiditis, Arthritis rheumatoid and Vasculitis. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 28-Sep-2021, the patient experienced PYREXIA (fever 40?, generalized pruritus, especially on the nipples, fatigue, increased weakness) (seriousness criterion life threatening), FATIGUE (fever 40?, generalized pruritus, especially on the nipples, fatigue, increased weakness) (seriousness criterion life threatening) and PRURITUS (fever 40?, generalized pruritus, especially on the nipples, fatigue, increased weakness) (seriousness criteria medically significant and life threatening). At the time of the report, PYREXIA (fever 40?, generalized pruritus, especially on the nipples, fatigue, increased weakness), FATIGUE (fever 40?, generalized pruritus, especially on the nipples, fatigue, increased weakness) and PRURITUS (fever 40?, generalized pruritus, especially on the nipples, fatigue, increased weakness) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant medication was not provided Treatment medication was not provided Company Comment: This case concerns a 60-year-old, female patient with no relevant medical history, who experienced the unexpected events of pyrexia, fatigue and pruritus. The occurrence of the events pyrexia, fatigue and pruritus were unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since the occurrence of the events with respect to the mRNA-1273 vaccine administration were unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The records does not contain the onset date for the events and the date of mRNA-1273 vaccine administration as well as the dose number were also unknown. The seriousness criteria of life-threatening for the events were captured in the records and so it was captured and maintained. Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Translation received on 18 Oct 2021,with translated event reported by primary source and sender''s comments; Sender''s Comments: This case concerns a 60-year-old, female patient with no relevant medical history, who experienced the unexpected events of pyrexia, fatigue and pruritus. The occurrence of the events pyrexia, fatigue and pruritus were unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since the occurrence of the events with respect to the mRNA-1273 vaccine administration were unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The RA SD does not contain the onset date for the events and the date of mRNA-1273 vaccine administration as well as the dose number were also unknown. The seriousness criteria of life-threatening for the events were captured in the RA SD and so it was captured and maintained.


VAERS ID: 1809940 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Myalgia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20211038227

Write-up: SYNCOPE; MYALGIA; CHILLS; This spontaneous report received from a consumer via Regulatory Authority (EVHUMAN Vaccines, NL-LRB-00690866) on 20-OCT-2021 concerned a 19 year old female of an unspecified race and ethnic origin. The patient''s weight was 63 kilograms, and height was 169 centimeters. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE395 expiry: unknown) 1 dosage forms,(total dose:0.5ml) with frequency time 1 total, administered on 28-SEP-2021 for covid-19 immunisation. No concomitant medications were reported. On 28-SEP-2021, the patient experienced syncope, myalgia and chills. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 30-SEP-2021, and was recovering from syncope, and myalgia. This report was serious (Other Medically Important Condition).


VAERS ID: 1810055 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: positive Iu international unit(s)
CDC Split Type: PTJNJFOC20211041267

Write-up: DRUG INEFFECTIVE; This spontaneous report received from a other health professional via a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202110-42) on 21-OCT-2021 concerned a 42 year old male. The patient''s height, and weight were not reported. No past medical history and concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C18-05 and expiry: unknown) 0.5 ml, 1 total administered on 15-JUL-2021 for covid-19 immunisation. The drug start period was 2 months. No concomitant medications were reported. On 28-SEP-2021, the patient''s SARS-CoV (severe acute respiratory syndrome coronavirus)-2 PCR (polymerase chain reaction) test resulted positive Iu international unit (s) and experienced drug ineffective The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug ineffective was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1815705 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-09-28
   Days after vaccination:166
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Dyspnoea, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Rituximab
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Waldenstorm''s macroglobulinemia.
Allergies:
Diagnostic Lab Data: Test Date: 09/28/2021; Test Name: Pyrexia; Result Unstructured Data: Test Result: Pyrexia; Test Date: 09/29/2021; Test Name: Test PCR; Test Result: Positive.
CDC Split Type: BEPFIZER INC202101350263

Write-up: This is a spontaneous report from a contactable physician (patient), downloaded via the regulatory authority (BE-FAMHP-DHH-N2021-107401). A 75-year-old male patient received the 2nd dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Apr 15, 2021; and received the 1st dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Mar 25, 2021; both single dose, for COVID-19 immunisation. Medical history included Waldenstorm''s macroglobulinemia. Concomitant medication included rituximab (injection) taken for Waldenstorm''s macroglobulinemia, start and stop date not reported. The patient experienced COVID-19 (hospitalization, medically significant), pyrexia (hospitalization), and dyspnea (hospitalization); all on Sep 28, 2021. The clinical course reported as follows: Had two doses of Pfizer on Mar 25, 2021 and Apr 15, 2021. Elapsed time period of 5 months: Alteration of overall health with pyrexia and dyspnea. Polymerase chain reaction positive Sep 29, 2021. Evolution of the ADR: Ongoing improvement. Physician office visit for events. The patient underwent lab tests and procedures, which included SARS-CoV-2 test: positive on Sep 29, 2021; and body temperature: pyrexia on Sep 28, 2021. Therapeutic measures were taken as a result of events. The outcome of events: recovering. Reporter''s comments: Treatment: Yes (not specified). Evolution of the ADR: Ongoing improvement. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.


VAERS ID: 1816124 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0161 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acoustic stimulation tests, Hypoacusis
SMQs:, Hearing impairment (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: Atopic
Allergies:
Diagnostic Lab Data: Test Name: hearing test; Result Unstructured Data: Test Result:50; Comments: db
CDC Split Type: FIPFIZER INC202101370173

Write-up: Hypoacusis unilateral; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FI-FIMEA-20215340. A 48-year-old female patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration on 24Sep2021 (Batch/Lot Number: FH0161) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included Atopic tendencies. The patient''s concomitant medications were not reported. The patient experienced hypoacusis unilateral (hearing loss in the right ear at the bass head ad 50 dB) (medically significant) on 28Sep2021 with outcome of not recovered. A year earlier hearing normal. No follow-up attempts possible. No further information expected.


VAERS ID: 1816676 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 FF8288 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Depressed level of consciousness, Disturbance in attention, Headache, Interchange of vaccine products, Malaise, Off label use, Pain in extremity
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Dienogest
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Latex allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101347213

Write-up: Obnubilation; pain in legs; malaise; headache; lack of concentration; back pain; patient received first dose as the Moderna vaccine and second dose as BNT162B2; patient received first dose as the Moderna vaccine and second dose as BNT162B2; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority (IT-MINISAL02-795295). A 52-year-old female patient received the second dose of BNT162B2 (Lot Number: FF8288), via an unspecified route of administration in the left arm (reported as: left shoulder), on 28Sep2021 as a single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included dienogest, estradiol valerate. The patient received the first dose of MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273); Lot number: 214014) on 31Aug2021 for COVID-19 immunisation. The patient experienced obnubilation, pain in legs, malaise, headache, lack of concentration, and back pain on 29Sep2021. The patient received first dose as the Moderna vaccine and second dose as BNT162B2 on 28Sep2021. Therapeutic measures were taken as a result of obnubilation, pain in legs, malaise, headache, lack of concentration, and back pain, which included unspecified treatment. The clinical outcome of obnubilation, pain in legs, malaise, headache, lack of concentration, and back pain was recovering and of patient received first dose as the Moderna vaccine and second dose as BNT162B2 was unknown. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: The superficial way in which the incident was handled after the administration error was unacceptable. I think it would be useful to monitor patients with different doses of vaccine, since there is still no literature on the subject. - Heterologous vaccination with Moderna as first dose - Concomitant conditions: None - Allergies: Latex - Sent by Covid19-sheet Concomitant therapy: dienogest: estroprogestinic First vaccine dose: Moderna Lot 214014 administrated 31Aug2021


VAERS ID: 1816693 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-28
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Fatigue, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101350392

Write-up: Muscular pain; Exacerbation of asthma in a patient who has been asymptomatic for years; Exhaustion; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-795611. A 48-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 23Sep2021 09:53 (Batch/Lot Number: FG3739) as DOSE 1, 0.3 ml, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced muscular pain, exacerbation of asthma in a patient who has been asymptomatic for years , exhaustion on 28Sep2021 with outcome of not recovered. Treatment with Ventolin. Waiting for specialist visit. Seriousness criteria reported as medical significant.


VAERS ID: 1816779 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214013 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Fatigue, Headache, Hyperpyrexia, Hypertension, Oral herpes, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Hypertension (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hashimoto''s disease; Mitral insufficiency (MITRAL INSUFF); Polymyalgia; Rheumatoid arthritis; Vasculitis (ANCA-ASSOCIATED VASCULITIS)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples; Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples; Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples; Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples; Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples; Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples; Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples; Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples; This case was initially received via regulatory authority(Reference number: IT-MINISAL02-796955) on 15-Oct-2021. The most recent information was received 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 ASTHENIA (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples), PYREXIA (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples), ORAL HERPES (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples), HEADACHE (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples), FATIGUE (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples), PRURITUS (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples), HYPERTENSION (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples) and HYPERPYREXIA (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples) in a 60-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214013) for COVID-19 immunisation. Concurrent medical conditions included Rheumatoid arthritis, Vasculitis (ANCA-ASSOCIATED VASCULITIS), Mitral insufficiency (MITRAL INSUFF), Hashimoto''s disease and Polymyalgia. On 27-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced ASTHENIA (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples) (seriousness criterion life threatening), PYREXIA (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples) (seriousness criterion life threatening), ORAL HERPES (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples) (seriousness criterion life threatening), HEADACHE (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples) (seriousness criterion life threatening), FATIGUE (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples) (seriousness criterion life threatening), PRURITUS (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples) (seriousness criterion life threatening), HYPERTENSION (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples) (seriousness criterion life threatening) and HYPERPYREXIA (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples) (seriousness criterion life threatening). At the time of the report, ASTHENIA (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples), PYREXIA (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples), ORAL HERPES (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples), HEADACHE (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples), FATIGUE (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples), PRURITUS (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples), HYPERTENSION (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples) and HYPERPYREXIA (Fever of 40 for three days, hypertension, breathlessness, exhaustion, headache, increased weakness, cold sores, diffuse pruritus especially nipples) had resolved with sequelae. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication reported. No treatment medication reported. Concurrent conditions time of reaction was 11:00 a.m. Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Follow-up received contains added event and medical history On 19-Oct-2021: Translation received on 20-OCT-2021 included : event verbatim and updated narrative.; Sender''s Comments: This case concerns a 60-year old female patient, with medical history of Rheumatoid arthritis, Vasculitis, Hashimoto''s disease and Polymyalgia who experience serious (life threating) unexpected events of hypertension, headache, asthenia, pyrexia, oral herpes, fatigue and pruritus and serious adverse event of special interest of hyperpyrexia. The events occurred 1 day after most recent dose of Spikevax (mRNA-1273 ? Moderna COVID-19 vaccine). The re-challenge is not applicable as there is no available information regarding dose number. The history of reumathoid arthritis, Hashimoto''s disease and polymyalgia could be confounders to the events of asthenia and fatigue. The benefit-risk relationship of Spikevax (mRNA-1273 ? Moderna COVID-19 vaccine) is not affected by this report. Events seriousness captured as per Regulatory Authority assessment in the Source Document.


VAERS ID: 1816899 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 FH8021 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Muscular weakness, Respiratory distress, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC202101360183

Write-up: Respiratory distress; Dyspnea; Asthenia; Fatigue; Dizziness; Tachycardia; Lower limb weakness; This is a Spontaneous report from a non-contactable other health professional. This is a report received from regulatory authority via email. Regulatory authority report number is 17873-10. A 19-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: FH8021 and Expiration Date: 01Jan2022), via intramuscular, administered in Arm Left on 28Sep2021 (at the age of 19-year-old), as dose 1, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no infectious disease in the last 15 days prior to vaccination and was healthy before vaccination. Patient had no allergies. On 28Sep2021, 5 min after vaccination, the patient experienced asthenia, fatigue, dizziness, tachycardia, dyspnea, respiratory distress, and lower limb weakness. The patient was kept under observation and the events of asthenia, fatigue, dizziness, tachycardia, sensation of shortness of breath were remit spontaneously. Patient received no treatment for the events. The outcome of the events respiratory distress and lower limb weakness was unknown while for other events was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1816901 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30150BA / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: body temperature; Result Unstructured Data: Test Result:greater than or equal to 38 Centigrade
CDC Split Type: MXPFIZER INC202101360206

Write-up: Fever greater than or equal to 38 Celsius degrees; Headache; Nausea; Abscess; This is a spontaneous report from a non-contactable other health professional. This is a report received from Health Authority (RA) via email. Regulatory authority report number is 17896-10. A 26-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm on 27Sep2021 (Lot Number: 30150BA; Expiration Date: 01Nov2021) (at the age of 26-years-old) as dose 1, single for covid-19 immunisation. Medical history included allergies. The patient''s concomitant medications were not reported. Patient had no infectious disease in the last 15 days prior to vaccination and patient was healthy before vaccination. The patient experienced fever greater than or equal to 38 Celsius degrees, headache, abscess and nausea on 28Sep2021. The timeframe between vaccination and starting of symptoms was 3 hours (as reported). It was unknown if the patient received treatment for the event. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1816951 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diverticulitis
SMQs:, Gastrointestinal nonspecific inflammation (broad)

Life Threatening? No
Birth Defect? No
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: NLJNJFOC20211042183

Write-up: DIVERTICULITIS; This spontaneous report received from a consumer Via a Regulatory authority (regulatory authority, NL-LRB-00693507) on 21-OCT-2021 concerned a 30 year old male. The patient''s weight was 130 kilograms and height was 197 centimeters. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 21C16-03, expiry: unknown) 1 dosage forms, frequency time 1 total, 0.5 ml administered on 16-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 28-SEP-2021, the patient experienced diverticulitis. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diverticulitis. This report was serious (Other Medically Important Condition).


VAERS ID: 1816976 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Blood pressure measurement, Chest discomfort, Chest pain, Cold sweat, Discomfort, Dyspnoea, Electrocardiogram, Feeling hot, Heart rate, Heart rate increased, Hyperventilation, Malaise, Pain, Palpitations, Respiratory rate, SARS-CoV-2 test, Tachycardia, Tremor
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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), Eosinophilic pneumonia (broad), Hypoglycaemia (broad), Dehydration (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MOLLER''S CARDIO
Current Illness: Tobacco user (The patient uses snuff daily.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: Blood pressure; Result Unstructured Data: Blood pressure of 160/90 and 156/108 was measured.; Test Date: 20210928; Test Name: ECG; Result Unstructured Data: Small complexes with regular frequency. Initially hard to determine whether it was sinus tachycardia or atrioventricular nodal reentrant tachycardia, and Lewis lead did not give more exact information. ECG was later interpreted as sinus tachycardia, but it was commented that it is unusual with frequency up to 200.; Test Date: 20210928; Test Name: Pulse rate; Result Unstructured Data: Pulse rates of 170 and 174, and up to 200 was measured.; Test Date: 20210928; Test Name: Respiratory rate; Result Unstructured Data: Respiratory rate of 26 was measured.; Test Date: 202109; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative.
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: Tachycardia; Palpitations; Clammy; severe felling unwell; Cold sweat; Feeling anxious; Chest pain; Dyspnea; Hyperventilation; Shaking; Feeling of warmth; Chest pressure; severe Discomfort; Pain; extremely High pulse rate; This case was received via regulatory authority (Reference number: NO-NOMAADVRE-E2B_00054226) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) and PALPITATIONS (Palpitations) in a 27-year-old male patient who received mRNA-1273 (Spikevax) for Vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Tobacco user (The patient uses snuff daily.). Concomitant products included CYANOCOBALAMIN, FISH OIL, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, TOCOPHERYL ACETATE (MOLLER''S CARDIO) for an unknown indication. On 28-Sep-2021 at 8:48 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced TACHYCARDIA (Tachycardia) (seriousness criterion hospitalization) and PALPITATIONS (Palpitations) (seriousness criterion hospitalization). On an unknown date, the patient experienced COLD SWEAT (Clammy), MALAISE (severe felling unwell), COLD SWEAT (Cold sweat), ANXIETY (Feeling anxious), CHEST PAIN (Chest pain), DYSPNOEA (Dyspnea), HYPERVENTILATION (Hyperventilation), TREMOR (Shaking), FEELING HOT (Feeling of warmth), CHEST DISCOMFORT (Chest pressure), DISCOMFORT (severe Discomfort), PAIN (Pain) and HEART RATE INCREASED (extremely High pulse rate). On 29-Sep-2021, TACHYCARDIA (Tachycardia) and PALPITATIONS (Palpitations) had resolved. At the time of the report, COLD SWEAT (Clammy), MALAISE (severe felling unwell), COLD SWEAT (Cold sweat), ANXIETY (Feeling anxious), CHEST PAIN (Chest pain), DYSPNOEA (Dyspnea), HYPERVENTILATION (Hyperventilation), TREMOR (Shaking), FEELING HOT (Feeling of warmth), CHEST DISCOMFORT (Chest pressure), DISCOMFORT (severe Discomfort), PAIN (Pain) and HEART RATE INCREASED (extremely High pulse rate) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: negative. (Negative) Negative.. On 28-Sep-2021, Blood pressure measurement: abnormal (abnormal) Blood pressure of 160/90 and 156/108 was measured.. On 28-Sep-2021, Electrocardiogram: abnormal (abnormal) Small complexes with regular frequency. Initially hard to determine whether it was sinus tachycardia or atrioventricular nodal reentrant tachycardia, and Lewis lead did not give more exact information. ECG was later interpreted as sinus tachycardia, but it was commented that it is unusual with frequency up to 200.. On 28-Sep-2021, Heart rate: abnormal (abnormal) Pulse rates of 170 and 174, and up to 200 was measured.. On 28-Sep-2021, Respiratory rate: 26 (abnormal) Respiratory rate of 26 was measured.. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No treatment information provided. Reporter comment included The patient reported contact with another healthcare professional and physician. The patient reports acute onset of PALPITATION, with pulse rate of 170 to 200 about nine hours after VACCINATION. The patient developed EXTREMELY HIGH HEART RATE, CHEST PAIN, DYSPNEA and COLD SWEATS. The patient contacted emergency care and was brought to the HOSPITAL. Carotid sinus massage and Valsalva maneuver was performed without effect on the HIGH HEART RATE. The patient then got adenosine; 5 mg, 10 mg and finally 15 mg. 15 mg resulted in a short break on the ECG, but it did not terminate the TACHYCARDIA. The patient got SEVERE DISCOMFORT, seemed in PAIN and was ANXIOUS, with rates up to 200. The patient then received 5 mg Seloken with some effect, and rate decreased to 130. The patient received additional 5 mg zeloken [sic: Seloken] with good effect, and frequency decreased to 100-110. As soon as the situation calmed down, the patient felt fine and in good condition. The patient was HOSPITALIZED for one night. The patient had several investigations with ECG, blood tests and echocardiography, and constant observation of the heart with telemetry. The patient reports never having experienced anything like this before, and that there is no family history of a cardiac disorder. The patient uses snuff and coffee daily, and alcohol now and then. The patient had felt tired the last week and had taken a COVID-19 virus test that was negative. Company Comment: This case concerns a 27-year-old male patient with a history of tobacco use, who experienced the serious unexpected events of Tachycardia and Palpitations. The events occurred on the same day after the first dose of COVID-19 Vaccine Moderna (mRNA-1273). The rechallenge was not applicable, as the events happened after the first dose of the vaccine. The medical history of tobacco use could remain a confounder. The benefit-risk -continued in company comment. Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Translated document received on 20-OCT-2021 contained concomitant medicines and dosage text was updated and reporter comment was added.; Sender''s Comments: This case concerns a 27-year-old male patient with a history of tobacco use, who experienced the serious unexpected events of Tachycardia and Palpitations. The events occurred on the same day after the first dose of COVID-19 Vaccine Moderna (mRNA-1273). The rechallenge was not applicable, as the events happened after the first dose of the vaccine. The medical history of tobacco use could remain a confounder. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 1818945 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-09-28
   Days after vaccination:139
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX 8680 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Headache, Pain in extremity, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Tendinopathies and ligament disorders (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: 20210928; Test Name: SARS-CoV-2 test; Test Result: Positive; Comments: CT values 22.6 / 23.1 (ROCHE cobas.)
CDC Split Type: DEPFIZER INC202101350310

Write-up: pain in limb; cough; headache; Vaccination failure; COVID-19; This is a spontaneous report from a non-contactable consumer, downloaded from the Regulatory Authority authority number: 202100204068. An 85-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 12May2021 (Batch/Lot Number: EX 8680) as dose 2, single, and dose 1 via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: EW 8904) as dose 1, single for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure, with Covid-19 on 28Sep2021. The patient also had pain in limb, cough, and headache on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 28Sep2021 CT values 22.6 / 23.1 (ROCHE cobas). The events vaccination failure and COVID-19 had not resolved while the outcome of the rest of the events was unknown. The assessment of all the events with the suspect product Comirnaty was reported as: B. Indeterminate. No follow-up attempts are possible. No further information is expected. Sender''s comment: Initials: PRIVACY. PCR proof from 28Sep2021 positive, CT values 22.6 / 23.1 (ROCHE cobas) Symptoms: body aches, cough, headache.


VAERS ID: 1818977 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Hypoaesthesia, Magnetic resonance imaging heart, Thalamic infarction
SMQs:, Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: cMRI; Result Unstructured Data: Test Result:confirmation of diagnosis of thalamic infarction; Comments: cMRI confirmation of diagnosis of thalamic infarction left medial, new left ventricular hypertrophy in known type. Hypertension, no atrial fibrillation, no stenosis of the internal carotid artery, no intracardiac thrombi
CDC Split Type: DEPFIZER INC202101350096

Write-up: Numbness and reduced strength on the right brachiocephalic; Numbness and reduced strength on the right brachiocephalic; confirmed thalamic infarction on the left medial; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB with regulatory authority number DE-PEI-CADR2021188267. A 51-year-old male patient received bnt162b2 (COMIRNATY; reported strength: 0.3 mL; reported as Comirnaty (mRNA TOZINAMERAN)), via an unspecified route of administration on 24Sep2021 (Batch/Lot Number: Unknown) as dose number unknown, single for covid-19 immunisation. Medical history included ongoing arterial hypertension. The patient received the first dose of bnt162b2 (COMIRNATY; reported strength: 0.3 mL) on an unspecified date for covid-19 immunisation. There were no concomitant medications. On 28Sep2021, the patient experienced numbness and reduced strength on the right brachiocephalic and confirmed thalamic infarction on the left medial which resulted in hospitalization. The patient underwent lab tests and procedures on an unspecified date which included magnetic resonance imaging heart (cMRI) showed confirmation of diagnosis of thalamic infarction left medial, new left ventricular hypertrophy in known type. Hypertension, no atrial fibrillation, no stenosis of the internal carotid artery, no intracardiac thrombi. The outcome of the events was not recovered. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? no Information on risk factors or previous illnesses arterial hypertension / inpatient admission, cMRI confirmation of diagnosis of thalamic infarction left medial, new left ventricular hypertrophy in known type. Hypertension, no atrial fibrillation, no stenosis of the internal carotid artery, no intracardiac thrombi The RA assessment for all the events with the suspect product Comirnaty is D. Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1819604 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-28
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Aortic thrombosis, Carotid artery thrombosis, Cerebrovascular accident, Computerised tomogram abdomen, Thrombosis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210929; Test Name: Angiography TSA CT; Result Unstructured Data: Test Result:unknown results; Test Date: 20211001; Test Name: abdomen CT; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101364989

Write-up: Multiple District Thrombosis; floating thrombus in the abdominal aorta; floating thrombus in left Carotid artery; stroke; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Agency-WEB. The regulatory authority report number is IT-MINISAL02-796902. A 74-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: FF2834), via intramuscular route of administration on 01Sep2021, as Dose 1, Single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 28Sep2021, the patient experienced floating thrombus in the abdominal aorta, floating thrombus in left carotid artery, stroke. On 29Sep2021, the patient underwent lab tests and procedures which included Angiography TSA CT: unknown results, on 01Oct2021 Abdomen CT Angiography: unknown results. The clinical outcome of events was not recovered. Reporter''s comment: Multiple District Thrombosis (Left Common Carotid and Abdominal Aorta). No follow-up attempts possible. No further information expected.


VAERS ID: 1819958 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-21
Onset:2021-09-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214025 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Deep vein thrombosis, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: 20210830; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Thrombosis venous deep; This case was received via the Agency (Reference number: FR-AFSSAPS-LY202111879) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEEP VEIN THROMBOSIS (Thrombosis venous deep) in a 52-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214025) for COVID-19 vaccination. No Medical History information was reported. On 21-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced DEEP VEIN THROMBOSIS (Thrombosis venous deep) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Thrombosis venous deep) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not provided Treatment information was not provided Company comment: This case concerns a 52-year-old female patient with no relevant medical history, who experienced serious unexpected event of Deep vein thrombosis. The event occurred seven days following the administration of an unknown dose of Spikevax. The outcome of the event was unknown at the time of this report and no further details regarding the clinical course of the event was reported. The action taken with the suspect product and rechallenge results were retained as per RA source document (as not applicable and unknown, respectively). The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 52-year-old female patient with no relevant medical history, who experienced serious unexpected event of Deep vein thrombosis. The event occurred seven days following the administration of an unknown dose of Spikevax. The outcome of the event was unknown at the time of this report and no further details regarding the clinical course of the event was reported. The action taken with the suspect product and rechallenge results were retained as per RA source document (as not applicable and unknown, respectively). The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1819978 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005292 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Dysphonia, Lacrimation increased, Malaise, Rhinorrhoea, Swelling of eyelid
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Lacrimal disorders (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210929; Test Name: Blood pressure; Result Unstructured Data: 118/72 mmHg
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Swelling of eyelid; Phonation difficulty; Nasal discharge; Lacrimation; Suspected anaphylaxis; Malaise; This case was received via the RA (Reference number: 2021TJP109683) on 19-Oct-2021 and was forwarded to Moderna on 21-Oct-2021. This case, initially reported to the RA by a physician, was received via the RA (Ref, v21129586). On an unknown date, the patient received the 1st dose of this vaccine. On 28-Sep-2021, at 14:30, the patient received the 2nd dose of this vaccine. Malaise developed. On 29-Sep-2021, around 07:00, aspirin was taken for headache prevention. Around 08:30, the patient visited a hospital for marked swelling of eyelid, phonation difficulty, nasal discharge, and lacrimation. Blood pressure was maintained at 118/72, but respiratory symptoms were observed. Adrenaline was injected intramuscularly for suspected anaphylaxis. Antihistamines and steroids were administered, and the symptoms were resolving. The outcome of malaise, swelling of eyelid, phonation difficulty, nasal discharge, lacrimation, and suspected anaphylaxis 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: About 18 hours had passed since the vaccination with this vaccine, which is slow for immediate-type allergy. The possibility of allergic symptoms by aspirin cannot be denied The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship; Sender''s Comments: This case concerns a 33-year-old female patient with no previous relevant medical history, who experienced the expected serious event of Anaphylactic reaction and the unexpected serious events of Malaise, Sweeling of eyelid, Dysphonia, Rhinorrhoea, Lacrimation increased after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event Malaise occurred on the day after the second dose of Spikevax and onset of the rest of the events occurred 1 day after the second dose. Anaphylaxis was suspected and treatment with injected adrenaline, antihistamines and steroids were given. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of Spikevax vaccine is not affected by this report


VAERS ID: 1820137 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Lethargy, Pain, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101363045

Write-up: chest discomfort/chest felt tight; Dyspnoea/short of breath; lethargy; Throat tightness; throbbing pain on the left side under her breast; This is a spontaneous report from a contactable consumer(patient). Regulatory authority report number is AEFI-A-036101. A 31-year-old female patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 28Sep2021 at age of 31-year-old at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 28Sep2021 18:30, the patient experienced chest discomfort/chest felt tight, dyspnoea/short of breath, lethargy, throat tightness and throbbing pain on the left side under her breast. The events information was detailed as follows: since she have had shortness of breath, she was a fit person who did F45 workouts 5-6days per week. She had walked 300m to the end of road and short of breath, she had put washing on the clothes horse and get out of breath. She felt like she couldn''t fill her lungs with air, even when trying to make a deep breath across her chest felt tight and a throbbing pain on the left side under her breast. The outcome of the event was not recovered yet. The report was serious with seriousness criteria of medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820153 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-09-28
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cauda equina syndrome, Musculoskeletal pain, Neuralgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101363062

Write-up: Musculoskeletal pain; Neuralgia; Cauda equina syndrome; This is a spontaneous report from a contactable physician from the Regulatory authority report number is AEFI-A-035934. A 72-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 24Aug2021 (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 musculoskeletal pain (hospitalization) on 28Sep2021 09:00, neuralgia (hospitalization) on 28Sep2021 09:00, Cauda equina syndrome (hospitalization) on 28Sep2021 09:00. Reporters description of AEFI: Cauda equina syndrome. The outcome of the events musculoskeletal pain and neuralgia was recovered on an unspecified date, of Cauda equina syndrome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820161 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fibromyalgia, Neuralgia
SMQs:, Peripheral neuropathy (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: NZPFIZER INC202101363070

Write-up: Fibromyalgia; Neuralgia; This is a spontaneous report from a contactable consumer (patient) from the Regulatory authority report number is AEFI-A-036083. A 34-year-old female patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 28Sep2021 (at the age of 34 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fibromyalgia (medically significant) on 28Sep2021 15:33, neuralgia (medically significant) on 28Sep2021 15:33. Clinical course: Flare up of fibromyalgia - 10/10, whole body nerve pain, what felt like brain zaps. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820234 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006273 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Cough, Haemorrhage in pregnancy, Malaise, Maternal exposure during pregnancy
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: MATERNAL EXPOSURE DURING PREGNANCY; PAIN IN THE CHEST; COUGH; VAGINAL BLEEDING EARLY PREGNANCY; GENERAL FEELING OF NOT BEING WELL; This case was received (Reference number: SE-MPA-2021-087926) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of HAEMORRHAGE IN PREGNANCY (VAGINAL BLEEDING EARLY PREGNANCY), MALAISE (GENERAL FEELING OF NOT BEING WELL), CHEST PAIN (PAIN IN THE CHEST), COUGH (COUGH) and MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3006273) for COVID-19 vaccination. No Medical History information was reported. On 27-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Sep-2021, the patient experienced MALAISE (GENERAL FEELING OF NOT BEING WELL) (seriousness criterion medically significant). On 29-Sep-2021, the patient experienced HAEMORRHAGE IN PREGNANCY (VAGINAL BLEEDING EARLY PREGNANCY) (seriousness criterion medically significant). On 02-Oct-2021, the patient experienced CHEST PAIN (PAIN IN THE CHEST) (seriousness criterion medically significant) and COUGH (COUGH) (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, HAEMORRHAGE IN PREGNANCY (VAGINAL BLEEDING EARLY PREGNANCY), MALAISE (GENERAL FEELING OF NOT BEING WELL), CHEST PAIN (PAIN IN THE CHEST), COUGH (COUGH) and MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY) had not resolved. No concomitant and treatment medication were provided. The events were reported to occur at 7 week gestation period. Company Comment: This case concerns Maternal exposure during pregnancy in a 30 year-old female patient with no reported medical history, who experienced the unexpected serious events of Vaginal bleeding in early pregnancy, Malaise, Chest pain, and Cough. The event s occurred within 6 days of the second dose of mRNA-1273 vaccine. The patient received the second dose of Spikevax at 7 week gestation period. The seriousness criteria of Medically significant is maintained for all events for consistency with the RA report, however the source document does not including information supporting this seriousness criteria for all events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Translation document received on 21-Oct-2021 where dose text, reaction/event reported by primary source was updated according to translated document.; Sender''s Comments: This case concerns Maternal exposure during pregnancy in a 30 year-old female patient with no reported medical history, who experienced the unexpected serious events of Vaginal bleeding in early pregnancy, Malaise, Chest pain, and Cough. The event s occurred within 6 days of the second dose of mRNA-1273 vaccine. The patient received the second dose of Spikevax at 7 week gestation period. The seriousness criteria of Medically significant is maintained for all events for consistency with the RA report, however the source document does not including information supporting this seriousness criteria for all events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1820247 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Dizziness, Rash
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210929; Test Name: blood test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: TWPFIZER INC202101424669

Write-up: SKIN RASH (NON-INJECTION SITE); DIZZINESS; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority(regulatory authority number: TW-TFDA-TVS-1100008458), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003864), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100008458. A 48-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: unknown) on 27-Sep-2021 via intramuscular at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. The patient experienced skin rash (non-injection site) and dizziness on 28-Sep-2021. On 27-Sep-2021, the patient received 1st dose of vaccination. On 28-Sep-2021, the patient developed dizziness and rash on his head and neck, then the patient went to the nearby clinics. On 29-Sep-2021, the skin rash improved, and the patient went to an emergency department and underwent blood test. The rash appeared on his neck, hand band back, which is similar to urticaria. It was reported that "the next time it is expected to check the rheumatoid immunoceal, and VICP Application method, you can understand". Skin rash (non-injection site) and dizziness met the seriousness criterion of hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: The reporter and company (BioNTech SE) assessed the events ''Skin rash'' and ''Dizziness'' as possible with Comirnaty.


VAERS ID: 1820264 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G043A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101424700

Write-up: CONVULSIONS (SEIZURE / CONVULSION); FEELING ABNORMAL (TACTILE, PAIN, COLD, HOT FEELING ABNORMAL); immortal pain; This is a spontaneous report from a non-contactable healthcare professional via Taiwan Center for Disease Control (regulatory authority number: TW-TFDA-TVS-1100008356) based on information received by Pfizer from BioNtech SE (manufacturer control number: TW-Fosun-2021FOS003918), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Taiwan Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008356. A 52-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1G043A, expiration date: 22-Oct-2021) on 28-Sep-2021 via intramuscular at unspecified dosing frequency for COVID-19 immunization. No medical history was reported. Concomitant medication(s) and past product were not reported. The patient experienced convulsions (seizure/convulsion) and feeling abnormal (tactile, pain, cold, hot feeling abnormal) on 28-Sep-2021. On 28-Sep-2021, it was reported that the patient had "an immortal pain and a spascular condition after about 5 minutes of vaccine". The patient requested the emergency department and was given anti-epileptic and septic treatment drugs and then hospitalized. Convulsions (seizure/convulsion) and feeling abnormal (tactile, pain, cold, hot feeling abnormal) met the seriousness criterion of Hospitalization. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: The reporter and company (BioNTech SE) assessed the events ''feeling abnormal'' and ''convulsions'' as possible with Comirnaty. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1820266 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Dyspnoea, Headache, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101424702

Write-up: HEADACHE; MUSCLE ACHE; NAUSEA; DIZZINESS; DYSPNEA; WEAKNESS; This is a spontaneous report from a non-contactable healthcare professional via regulatory agency (regulatory authority number: TW-TFDA-TVS-1100008362) based on information received by Pfizer from BioNtech SE (manufacturer control number: TW-Fosun-2021FOS003920), license party for bnt162b2 (COMIRNATY). A 16-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via unknown route of administration on 24Sep2021 as dose 1, single for COVID-19 immunisation. No medical history was reported. Concomitant medication(s) and past product were not reported. The patient experienced headache, muscle ache, nausea, dizziness, dyspnea and weakness on 28Sep2021. Headache, muscle ache, nausea, dizziness, dyspnea and weakness met the seriousness criterion of Caused/Prolonged Hospitalisation. At the time of the report, the outcomes of the events were unknown. The primary reporter causality assessment for the between COMIRNATY and all events was possible whereas, per company (BioNTech SE), it was possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820275 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Coma scale, Computerised tomogram, Dysphagia, Haemorrhage intracranial, Hemiparesis, Investigation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), 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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Infarction; Intravascular hemolysis; Urothelial carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: Blood pressure; Result Unstructured Data: Test Result:229/105 mmHg; Test Date: 20210928; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:E4M6VA; Test Date: 20210928; Test Name: CT scan; Result Unstructured Data: Test Result:ICH at right parietal lobe and right cerebellum; Comments: with IVH; Test Date: 20210928; Test Name: Investigation; Result Unstructured Data: Test Result:RUE/LUE/RLE/LLE 4/1/4/2
CDC Split Type: TWPFIZER INC202101424501

Write-up: DYSPHAGIA; LEFT WEAKNESS; INTRACRANIAL HEMORRHAGE; This is a spontaneous report from a non-contactable healthcare professional via regulatory authority (Regulatory authority report number: TW-TFDA-TVS-1100008484), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003937), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008484. A 70-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 28-Sep-2021 via unknown route at unspecified dose/unspecified dosing frequency for COVID-19 immunization. Medical history included old infarction, intravascular hemolysis (IVH), urothelial carcinoma and hypertension without medications. Concomitant medication(s) and past product were not reported. The patient experienced dysphagia, left weakness and intracranial hemorrhage on 28-Sep-2021. On the afternoon of 28-Sep-2021, the patient was given the first dose of vaccine. On the same day, he became dysphagia and left weakness from 18:00. He could not speak any words at 23:00. Then, he was sent to emergency room. Initial glasgow coma scale (GCS) was E4M6VA with muscle power RUE/LUE/RLE/LLE 4/1/4/2. And high blood pressure was 229/105 mmHg. His family denied fever, upper respiratory infection (URI) symptoms, Travel history-Occupation-Contact history-Cluster (TOCC) related to COVID-19. CT was arranged, which showed intracerebral hemorrhage (ICH) at right parietal lobe and right cerebellum with IVH. After consulting neurosurgeon, surgery was indicated. The patient underwent extraventricular drainage insertion and hemotoma removal. Then, he was transferred to neurosurgical intensive care unit (NSICU) for futher treatment. On 30-Sep-2021, no one answered the follow-up care call. Dysphagia, left weakness and intracranial hemorrhage met the seriousness criterion of Life Threatening. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: Drug: COMIRNATY Event: Muscle weakness left-sided, Dysphagia, Intracranial hemorrhage Per Reporter = Possible Per Company = Possible


VAERS ID: 1820280 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Electrocardiogram, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: blood test; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: EKG; Result Unstructured Data: Test Result:normal
CDC Split Type: TWPFIZER INC202101424558

Write-up: FEVER; CHEST PAIN; This is a spontaneous report from a non-contactable healthcare professional via regulatory authority (Regulatory authority report number: TW-TFDA-TVS-1100008544), based on information received by Pfizer from BioNTech (manufacturer control number: TW-Fosun-2021FOS003957), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008544. A 12-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 24Sep2021 via intramuscular at unspecified dosage regimen for COVID-19 immunisation. Medical history, concomitant medication(s) and past product were not reported. The patient experienced fever and chest pain on 28Sep2021. On 24Sep2021, the patient received a dose of vaccination. On 28Sep2021, the patient developed fever and chest pain (about 1 time per day). It was reported that "9/27 symptoms continue", The patient went to hospital emergency, and the result of EKG and blood test were normal. On 30Sep2021, the patient''s mother indicates that the patient had no chest pain, no fever, appetite (unspecificed), and had gone to the school. It was reported that " the case, the case is concerned, if there is a need to contact the health office". Fever and chest pain met the seriousness criterion of hospitalization. At the time of the report, the outcome of the events was recovered. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: Drug: COMIRNATY; Chest pain, fever- Per reporter: Possible, Per Company (BioNTech): Possible No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1820282 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Discomfort, Dizziness, Feeling of body temperature change, Headache, Myalgia, Nausea, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101424584

Write-up: HEADACHE; MUSCLE ACHE; NAUSEA; VOMIT; DIZZINESS; GASTROINTESTINAL DISCOMFORT; BODY APPEARS UNCOMFORTABLE (HOT & COLD); body appears uncomfortable/disgusting; This is a spontaneous report from a non-contactable healthcare professional via Center for Disease Control (regulatory authority number: TW-TFDA-TVS-1100008582), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003968), license party for bnt162b2(COMIRNATY). An 18-year-old female patient started to receive first dose of BNT162B2 (COMIRNATY, solution for injection, batch number was unknown), via an intramuscular route of administration on 28Sep2021 (at the age of 18-year-old), as DOSE 1, SINGLE for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. The patient experienced body appears uncomfortable (Hot and Cold) on 28Sep2021 at 20:00 and headache, muscle ache, nausea, vomit, dizziness and gastrointestinal discomfort on 29Sep2021. On 28Sep2021, the patient was given first dose of vaccination at the hospital. At around 8 o''clock in the evening, the patient had a body appears uncomfortable (Hot and Cold). On 29Sep2021, the patient developed dizziness, disgusting and gastrointestinal discomfort, so the patient was given medical treatment in the hospital. The patient was given acetaminophen 500 mg via oral three times a day. The physician reminded the patient if the situation was exacerbated, it was recommended to return again. It was reported that "It also notbs" the drug adverse reactions that are suspected of Tozinameran (COMIRNATY). Events headache, muscle ache, nausea and vomit, body appears uncomfortable (Hot and Cold), dizziness and gastrointestinal discomfort met the seriousness criterion of hospitalization. The outcome of the events was unknown at the time of this report. Initial report was received on 13Oct2021. Follow-up closed; no further information is possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Drug: Comirnaty, Causality Assessments as per reporter: Headache, Muscle ache, Nausea, Vomiting, feeling hot and cold, Dizziness, Gastrointestinal discomfort was Possible, Per Company (BioNTech SE) = Possible.


VAERS ID: 1820298 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Cold sweat, Electrocardiogram, Fatigue, Feeling hot, Pyrexia, Somnolence
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown results; Test Name: electrocardiogram; Result Unstructured Data: Test Result:unknown results
CDC Split Type: TWPFIZER INC202101419208

Write-up: TIRED; SLEEPINESS; COLD SWEATING; CHEST TIGHTNESS; fever; exhausted; body slightly hot; This is a spontaneous report from a non-contactable healthcare professional via the Center for Disease Control- (regulatory authority number: TW-TFDA-TVS-1100008622), based on information received by Pfizer from BioNtech SE (manufacturer control number TW-Fosun-2021FOS004048), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008622. A 17-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1G042A-CDC) on 28-Sep-2021 via Intramuscular at 0.3 ml and unknown frequency for COVID-19 immunization in (address redacted). Medical history, concomitant medication and past product were not reported. The patient experienced tired, sleepiness, cold sweating, chest tightness on 30-Sep-2021. The patient was exhausted and the body was slightly hot on 28-Sep-2021. The next day, the patient was at home not arrived in the hospital because of teaching. The patient still feel that the body was fever. It was reported that "it was impossible, chest tightness, but in the afternoon, it is better to go home". When patient went to sleep, symptoms would be aggravated. The patient went to the three joint hospitals and traced the electrocardiogram and blood. The patient was given a muscle relaxant. After 2 hours, the symptoms had improved, but occasionally, there was a case of distressed. It was reported that "unable to join us today". On 30-Sep-2021, (address redacted)adversity reported, assisted the online notification and called the telephone number. There was not answer. Then, the guard provided another mobile phone. It would answer the current physical condition. The patient indicated that there was no situation and the situation of night sweats. It was reported that "It means that tomorrow will go to the school to ask the parents. The case will express 8 points to get 8 o''clock". The visitors had been prepared for the case of the patient and the case was understood. On 30-Sep-2021, because of the case in the (address redacted), it meant that it was 5 o''clock in the evening. Therefore, at 22:00 on 30-Sep-2021, connected to the mobile phone again. The answer and the post must pay attention to the post. It was reported that "Matters, the card is known, and thank you for concern and continue to reciprust". Tired, sleepiness, cold sweating and chest tightness met the seriousness criterion of other medically important condition. The actions taken for Tozinameran (COMIRNATY) regarding the tired, sleepiness, cold sweating and chest tightness were not applicable. At the time of the report, the outcomes of tired, sleepiness, cold sweating and chest tightness were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality assessment for COMIRNATY for events chest tightness, sweating, sleepiness, tiredness was possible both per Reporter and per Company (BioNtech SE). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1820300 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain
SMQs:, Anaphylactic reaction (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101406016

Write-up: CHEST PAIN; CHEST TIGHTNESS; This is a spontaneous report from a non-contactable healthcare professional via Regulatory authority report number: TW-TFDA-TVS-1100008623, based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004050), license party for bnt162b2 (COMIRNATY). A female patient of an unspecified age received unknown dose of bnt162b2 (COMIRNATY, Tozinameran, Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration on 27Sep2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On 28Sep2021, patient experienced chest pain and chest tightness. The patient had come to emergency for medical treatment due to chest pain and chest tightness on 28Sep2021. The patient was given intravenous drip, blood and oral drugs. Chest pain and chest tightness met the seriousness criterion of other medically important condition. The outcome of the events was reported as unknown. Causality Assessment for COMIRNATY and Event chest pain, Chest tightness as Per Reporter as Possible and as Per Company (BioNTech) as Possible. Follow-up closed, no further information is possible.


VAERS ID: 1820301 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Chest pain, Fatigue, Headache, Hypotension, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Dehydration (broad), Hypokalaemia (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:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: blood pressure; Result Unstructured Data: Test Result:Low
CDC Split Type: TWPFIZER INC202101415272

Write-up: TIRED; HEADACHE; NAUSEA; CHEST PAIN; LOW BLOOD PRESSURE; WEAK; This is a spontaneous report from a non-contactable health care professional via Center for Disease Control (regulatory authority number: TW-TFDA-TVS-1100008800), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004053), license party for BNT162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008800. A 16-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1G042A-CDC) on 28-Sep-2021 via intramuscular at 0.3 ml dosing frequency for COVID-19 immunization. Concomitant medication(s) and past product were not reported. The patient experienced tired, headache, nausea, chest pain, low blood pressure and weak on 28-Sep-2021. The patient was 16 years old, high school campus BNT concentrated inoculation (hospital entered the school).On 28-Sep-2021 the patient had a headache, nausea, chest pain, weak, low blood pressure The parent were brought the patient back, and after returning home, the patient would be hospitalized to hospital. The physician arranged hospitalization. The case was currently in hospital, and the visitors were also in the case. It was improved, still unsuitable, visitors to pay attention to and prevail to informed the vaccine. The following was to track care .This notification of vaccine adverse reactions. 01-Oct-2021 with a case call, the case was said to be improved, still discomfort, visitors to care and prevail to inform the vaccine adverse reactions. Tired, headache, nausea, chest pain, low blood pressure and weak met the seriousness criterion of caused hospitalisation. The actions taken for Tozinameran (COMIRNATY) regarding the tired, headache, nausea, chest pain, low blood pressure and weak were not applicable. At the time of the report, the outcomes of tired, headache, nausea, chest pain, low blood pressure and weak was unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: Events of ''tiredness; Headache; Nausea; chest pain; Low blood pressure; Weakness'' was possibly related to COMIRNATY as per reporter and Company (BioNTech SE). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1820302 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (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: TWPFIZER INC202101415173

Write-up: TIRED; FEVER; DIZZINESS; ARM PAIN; This is a spontaneous report from a non-contactable healthcare professional via Center for Disease Control (Regulatory authority report number: TW-TFDA-TVS-1100008801), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004057), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008801. A 15-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1G042A-CDC) on 28-Sep-2021 via Intramuscular at 0.3 ml and unknown frequency for COVID-19 immunization. Medical history, concomitant medication and past product were not reported. The patient experienced tired, fever, dizziness and arm pain on 28-Sep-2021 and ate antipyretics. At night, patient went to doctor and was informed that the normal reaction after vaccination. It had been improved after rest at home. Tired, fever, vaccination, dizziness and arm pain met the seriousness criterion of other medically important condition. The actions taken for Tozinameran (COMIRNATY) regarding tired,fever,vaccination,dizziness and arm pain were not applicable. At the time of the report, the outcomes of tired, fever, vaccination, dizziness and arm pain were recovering. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment for the events tiredness, fever, vaccination, dizziness, and pain in arm was possible per reporter and per Company (BioNTech SE). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1820303 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101424452

Write-up: CHEST TIGHTNESS; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (Regulatory authority report number: TW-TFDA-TVS-1100008628), based on information received by Pfizer (manufacturer control number: TW-Fosun-2021FOS004058), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100008628.An unknown age female patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: Unknown) on 28-Sep-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication and past product were not reported. The patient experienced chest tightness after vaccination on 28-Sep-2021. It was reported that "breathing". Chest tightness met the seriousness criterion of caused hospitalization. The action taken for Tozinameran (COMIRNATY) regarding chest tightness was not applicable. At the time of the report, the outcome of chest tightness was unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: Event of Chest tightness was possibly related to COMIRNATY as per reporter and Company (Regulatory Authority). No follow-up attempts are possible; information on the batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1820306 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Fatigue, Pain in extremity
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101415218

Write-up: DIARRHEA; DIZZINESS; ABDOMINAL PAIN; ARM PAIN; TIRED; This is a spontaneous report from a non-contactable health care professional via Center for Disease Control (regulatory authority number: TW-TFDA-TVS-1100008805), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004062), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008805. A 16-year-old male patient started to receive 1 dose of Tozinameran (COMIRNATY) (batch number: 1G042A-CDC) on 28-Sep-2021 via Intramuscular at 0.3 ml and unknown frequency for COVID-19 immunization. Medical history, concomitant medication and past product were not reported. Patient was tired and experienced the upper arm pain, slight dizziness, abdominal pain and diarrhea after vaccination on 28-Sep-2021. Patient indicated that the patient often had diarrhea, but the frequency of diarrhea increased after vaccination, and appetite seemed to be relatively poor. On 01-Oct-2021, the symptoms were also gradually improved. Tired diarrhea, vaccination, dizziness, abdominal pain, arm pain met the seriousness criterion of other medically important condition. The actions taken for Tozinameran (COMIRNATY) regarding tiredness, diarrhea, vaccination, dizziness, abdominal pain and arm pain were not applicable. At the time of the report, the outcomes of tiredness diarrhea, vaccination, dizziness, abdominal pain, arm pain were recovering. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment for the events Tiredness, Pain in arm, Abdominal pain, Dizziness, Vaccination, and Diarrhea was possible as per reporter and per company (BioNTech SE).


VAERS ID: 1820315 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Decreased appetite, Fatigue, Pyrexia, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung disorder; Premature baby
Allergies:
Diagnostic Lab Data: Test Date: 20210929; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade
CDC Split Type: TWPFIZER INC202101419161

Write-up: body temperature was 37.8 Centigrade; TIRED; SLEEPINESS; LOSS OF APPETITE; This is a spontaneous report from a non-contactable healthcare professional via the Center for Disease Control- (regulatory authority number: TW-TFDA-TVS-1100008811), based on information received by Pfizer from BioNtech SE (manufacturer control number TW-Fosun-2021FOS004074), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008811. A 15-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1G042A-CDC) on 28-Sep-2021 via Intramuscular at 0.3ml and unknown frequency for COVID-19 immunization in (hospital redacted). Medical history, concomitant medication and past product were not reported. The patient experienced tired, sleepiness and loss of appetite on 28-Sep-2021. The patient started to sleep after returning home, wake up by the family in the middle of the night with a poor appetite. At 8 o''clock in the morning, the patient went to the clinic. The body temperature was 37.8 Centigrade and doctor prescribed. The appetite was still not good after returning for 2 days. The patient said that he was premature infants, the lungs were incomplete. However, the physician said that it should not affect. On 1-Oct-2021, the patient was already more energetic and would continue to be observed. It was reported that "care and assist in the income reaction of the vaccine". Tired, sleepiness and loss of appetite met the seriousness criterion of other medically important condition. The actions taken for Tozinameran (COMIRNATY) regarding tired, sleepiness and loss of appetite were not applicable. At the time of the report, the outcomes of tired, sleepiness and loss of appetite were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality assessment for COMIRNATY Decreased appetite, Sleepiness, Tiredness Per Reporter=Possible Per Company (BioNtech SE) =Possible


VAERS ID: 1820317 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Electrocardiogram, Sinus arrhythmia
SMQs:, Anaphylactic reaction (broad), Disorders of sinus node function (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: EKG; Result Unstructured Data: Test Result:Normal Sinus rhythm; Test Date: 20211001; Test Name: EKG; Result Unstructured Data: Test Result:Normal Sinus Rhythm with Sinus Arrhythmia; Comments: Rightward Axis
CDC Split Type: TWPFIZER INC202101415230

Write-up: CHEST PAIN; CHEST TIGHTNESS; sinus arrhythmia; This is a spontaneous report from a non-contactable healthcare professional via the regulatory authority (Regulatory authority report number: TW-TFDA-TVS-1100008813), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004079), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via the regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008813. A 17-year-old female patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) at 13:30 on 27-Sep-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization in the country. Medical history, concomitant medication and past product were not reported.The patient experienced chest pain and tightness at 14:00 on 28-Sep-2021. On 28-Sep-2021, Ekg showed: normal sinus rhythm. On 01-Oct-2021, Ekg showed: normal sinus rhythm with sinus arrhythmia rightward axis. Chest pain and tightness met the seriousness criterion of other medically important condition. The actions taken for Tozinameran (COMIRNATY) regarding chest pain and chest tightness were not applicable. At the time of the report, the outcomes of chest pain and chest tightness were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: Drug: bnt162b2 Chest pain, Chest tightness Per Reporter = Possible Per Company (BioNTech SE)= Possible


VAERS ID: 1820325 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain upper, Chest X-ray, Chest pain, Electrocardiogram
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: Chest X-ray; Result Unstructured Data: Test Result:NORMAL; Test Date: 20210928; Test Name: EKG; Result Unstructured Data: Test Result:Normal Sinus rhythm
CDC Split Type: TWPFIZER INC202101419206

Write-up: CHEST PAIN; STOMACH PAIN; ABDOMINAL PAIN; This is a spontaneous report from a non-contactable healthcare professional via the Center for Disease Control- (regulatory authority number: TW-TFDA-TVS-1100008734), based on information received by Pfizer from BioNtech SE (manufacturer control number TW-Fosun-2021FOS004088), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008734. A 16-year-old female patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) at 08:30 on 28-Sep-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization. No past medical history and allergy history. Concomitant medication and past product were not reported. The patient experienced stomach pain at 9:30 and chest pain at 12:30 on 28-Sep-2021. At 12:30, electrocardiography (EKG) showed normal sinus rhythm and chest PA was normal. At 14:50, the patient experienced lightweight pain. Abdominal pain, chest pain and stomach pain met the seriousness criterion of other medically important condition. The actions taken for Tozinameran (COMIRNATY) regarding the abdominal pain, chest pain and stomach pain were not applicable. At the time of the report, the outcomes of abdominal pain, chest pain and stomach pain were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality assessment for COMIRNATY for the events Stomach pain, Chest pain, and Abdominal pain was possible as per reporter and per company (BioNtech SE).


VAERS ID: 1820326 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101409841

Write-up: CHEST PAIN; HEART IS NOT SUITABLE; This is a spontaneous report from a non-contactable health care professional via Agency Regulatory Authority (regulatory authority number: TW-TFDA-TVS-1100008827), based on information received by Pfizer from BioNTech (manufacturer control number: TW-Fosun-2021FOS004089), license party for BNT162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Agency Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100008827. A 19-year-old female patient started to receive a dose (COMIRNATY) (batch number:unknown ) on 25-Sep-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. The patient experienced chest pain and heart was not suitable on 28-Sep-2021. The patient experienced chest pain and "heart is not suitable" and the physician gave orally Depyretin 1 # qid,the patient was treated for 3 days. After the diagnosis and treatment, the situation is stable and resolved. Chest pain and heart is not suitable met the seriousness criterion of other medically important condition. The action taken for (COMIRNATY) regarding the chest pain and heart is not suitable were not applicable. At the time of the report, the outcomes of chest pain and "heart is not suitable" were recovered. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality assessment Chest pain;Cardiac discomfort Per Reporter=Possible Per Company=Possible


VAERS ID: 1820327 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-28
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Body temperature increased, Chest discomfort, Computerised tomogram thorax, Electrocardiogram
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre 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: Test Date: 20210928; Test Name: Body temperature; Result Unstructured Data: Test Result:Not over 38 degrees; Comments: elevated; Test Date: 20210929; Test Name: Chest CT; Result Unstructured Data: Test Result:No active pulmonary abnormality is noted; the hear; Comments: No active pulmonary abnormality is noted; the heart size is within normal limit; no prominent pleural effusion; intact bony thorax.; Test Date: 20210929; Test Name: EKG; Result Unstructured Data: Test Result:Sinus rhythm
CDC Split Type: TWPFIZER INC202101419207

Write-up: CHEST TIGHTNESS; WEAKNESS; ELEVATED BT; This is a spontaneous report from a non-contactable healthcare professional via the Regulatory Authority- (regulatory authority number: TW-TFDA-TVS-1100008737), based on information received by Pfizer from BioNtech (manufacturer control number TW-Fosun-2021FOS004090), license party for bnt162b2. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100008737. A 17-year-old male patient started to receive a dose of BNT162B2 (batch number: unknown) at 16:30 on 23-Sep-2021 via at unspecified dosing frequency for COVID-19 immunization. No past medical history. Smoking: unknown. Drink: unknown. Concomitant medication and past product were not reported. The patient experienced mild chest tightness, weakness and elevated body temperature (not over 38 degrees) at night (19:00 PM) on 28-Sep-2021. The patient had no cough, no rhinorrhea, no vomiting, no diarrhea, no headache, no skin rash, no wound, no joint swelling or tenderness, no chest pain, no dyspnea, no cold sweating. Family had no sick. The patient denied travelling history, foreign travel history, obvious contact history, cluster history, a history of exposure abroad, COVID-19 diagnosis and isolation or hunting contact history. The patient denied outside county traveling history, contact history, hotspot exposure history and denied received cell newsletter. On 29-Sep-2021, EKG showed sinus rhythm. Chest CT showed no active pulmonary abnormality is noted; the heart size is within normal limit; no prominent pleural effusion; intact bony thorax. Chest tightness, weakness and elevated body temperature met the seriousness criterion of other medically important condition. The actions taken for BNT162B2 regarding the chest tightness, weakness and elevated body temperature were not applicable. At the time of the report, the outcomes of chest tightness, weakness and elevated body temperature were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality assessment for BNT162B2 Body temperature increased, Weakness, Chest tightness Per Reporter=Possible Per Company (BioNtech) =Possible


VAERS ID: 1820328 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Chest discomfort, Chest pain, Heart rate, PO2, Respiratory rate
SMQs:, Anaphylactic reaction (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: BP; Result Unstructured Data: Test Result:91/56 mmHg; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:92; Comments: times/min; Test Date: 2021; Test Name: Partial pressure O2; Test Result: 95 %; Test Date: 2021; Test Name: Respiratory rate; Result Unstructured Data: Test Result:20; Comments: times/min
CDC Split Type: TWPFIZER INC202101415116

Write-up: CHEST PAIN; CHEST TIGHTNESS; This is a spontaneous report from a non-contactable healthcare professional via regulatory authority (Regulatory authority report number: TW-TFDA-TVS-1100008828), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004091), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008828. A 16-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 24-Sep-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication and past product were not reported. The patient experienced chest pain and chest tightness on 28-Sep-2021. It was reported that "patients diagnosed with chest tightness and breathing continued". The patient gone to the hospital emergency medical treatment. The patient received cataflam 1 # tid and strocain 1 # tid and the patient was treated for 3 days. Life signs: BP 91/56 mmHG, HR: 92 times/min, RR: 20 times/min, BT: 36.8 C, SPO2: 95%. After treatment, the symptoms were improved, the patient returned to home, the physician informed the COVID19 vaccine adverse reactions. Chest pain and chest tightness met the seriousness criterion of other medically important condition. The actions taken for Tozinameran (COMIRNATY) regarding the chest pain and chest tightness were not applicable. At the time of the report, the outcomes of chest pain and chest tightness were recovering. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: The reporter and company (BioNTech SE) assessed the events ''chest pain'', ''chest tightness'' as possible with Comirnaty. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820332 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
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: TWPFIZER INC202101407873

Write-up: chest and bleak; This is a spontaneous report from a non-contactable health care professional via regulatory agency (regulatory authority number: TW-TFDA-TVS-1100008743), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004095), license party for BNT162b2 (COMIRNATY). A male patient of an unspecified age received BNT162B2 (COMIRNATY/ Tozinameran, solution for injection, Batch/Lot number was not reported), via unspecified route of administration on 27Sep2021 as dose number unknown, single for COVID-19 immunization. The patient medical history, concomitant medication and past product were not reported. The patient experienced chest and bleak on 28Sep2021. It was reported that there was no improvement in the future. Chest and bleak met the seriousness criterion of other medically important condition. Therapeutic measures were taken as a result of chest and bleak included T blood and oral medication were given after passuring treatment. At the time of the report, the outcome of chest and bleak was unknown. The causality assessment for the suspect Comirnaty and event chest and bleak was reported as Possible both Per Reporter and Per Company. Follow-up closed. No further information is possible.


VAERS ID: 1820350 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Echocardiogram
SMQs:, 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: heart supersonic wave; Result Unstructured Data: Test Result: no abnormal was found
CDC Split Type: TWPFIZER INC202101424673

Write-up: CHEST PAIN; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (regulatory authority number: TW-TFDA-TVS-1100008414), based on information received by Pfizer from BioNTech (manufacturer control number: TW-Fosun-2021FOS004217), license party for bnt162b2. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100008414. A 16-year-old male patient started to receive a dose of BNT162B2 (batch number: unknown) on 27-Sep-2021 at unspecified dosage regimen for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. The patient experienced chest pain on 28-Sep-2021. At 1 o''clock in the morning of 28-Sep-2021, the patient was accompanied by his family to the emergency department. The patient was given oral painkiller for chest pain and was arranged a heart supersonic wave, no abnormal was found. It was reported that" about noon, returned to the hospital". The patient had no other discomfort, and it was reported that "the table does not have to pay for the following after discussion". Chest pain met the seriousness criterion of hospitalization. The action taken for Regulatory Authority regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 13-Oct-2021. Causality assessment for the event chest pain was possible as per reporter and per company (BioNTech). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1822070 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-21
Onset:2021-09-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101361188

Write-up: Syncope; Chest discomfort; chest pain; vomiting; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority. Regulatory authority report number is 638352. A 27-year-old male patient received a dose of BNT162B2 (COMIRNATY; lot number unknown) via an unspecified route of administration on 21Sep2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 28Sep2021, the patient experienced chest discomfort, chest pain, syncope, and vomiting. The clinical outcomes of the events were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1822094 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hallucination, visual, Lethargy
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101362168

Write-up: Hallucination, visual; Dizziness; Lethargy; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 640550. A 32-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''s medical history and concomitant medications were not reported. The patient experienced hallucination, visual; Dizziness; Lethargy, all on 28Sep2021, with outcome of not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1822299 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Echocardiogram, Ejection fraction, Electrocardiogram, Myocarditis, N-terminal prohormone brain natriuretic peptide, Troponin
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Creatine kinase; Result Unstructured Data: Test Result:max 644 U/L; Test Date: 2021; Test Name: creatinin[phospho]kinase muscle brain; Result Unstructured Data: Test Result:64.7 U/L; Test Date: 2021; Test Name: echocardiography; Result Unstructured Data: Test Result:Ejection fraction minimal 42%; Comments: Ejection fraction minimal 42%, Fractional shortening minimal 22%; Test Date: 2021; Test Name: Ejection fraction; Result Unstructured Data: Test Result:minimal 42 %; Test Date: 2021; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:ST elevations; Test Date: 2021; Test Name: N-terminales pro brain natriuretic peptide; Result Unstructured Data: Test Result:max 905 pg/mL; Test Date: 2021; Test Name: troponin; Result Unstructured Data: Test Result:2037 pg/mL
CDC Split Type: DEPFIZER INC202101370134

Write-up: Myocarditis; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number DE-PEI-202100206158. A 15-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Sep2021 (Lot Number: Unknown) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 28Sep2021, the patient experienced myocarditis. The patient underwent the following laboratory tests: electrocardiogram showed ST elevations, echocardiography showed Ejection fraction minimal 42%, Fractional shortening minimal 22%, troponin up to max 2037 pg/mL, N-terminales pro brain natriuretic peptide max 905 pg/mL, Creatine kinase max 644 U/L, creatinin[phospho]kinase muscle brain 64.7 U/L. There was no evidence of myocarditis of other genesis. The patient was hospitalized due to the event in 2021. The event recovered on 02Oct2021. Result of Assessment od Comirnaty with the event myocarditis (source: Agency) was indeterminate. Sender''s comments: Initials: privacy Electrocardiogram: ST elevations, echocardiography: Ejection fraction minimal 42%, Fractional shortening minimal 22%, troponin up to max 2037 pg/mL, N-terminales pro brain natriuretic peptide max 905 pg/mL, Creatine kinase max 644 U/L, creatinin[phospho]kinase muscle brain 64.7 U/L. No evidence of myocarditis of other genesis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1822312 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G040A / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101394972

Write-up: Myocarditis; This is a spontaneous report from a non-contactable consumer or other non health professional from other area downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number DE-PEI-202100208545. A 15-years-old male patient received bnt162b2 (COMIRNATY, solution for injection), via intramuscular on 25Sep2021 (at the age of 15-years-old) (Batch/Lot Number: 1G040A) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient''s weight and height were not reported. The patient experienced myocarditis on 28Sep2021. The event was assessed as serious (hospitalization) by the health authority. Outcome of event was unknown. Sender comment: Medical report from the PRIVACY still pending. Requested on 15Oct2021. Article in the magazine. No follow-up attempts are possible. No further information expected.


VAERS ID: 1822552 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7887 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood pressure measurement, Blood triglycerides, Blood triglycerides increased, Computerised tomogram, Computerised tomogram head, Electrocardiogram, Electrocardiogram ambulatory, Glomerular filtration rate, Glycosylated haemoglobin, Haemoglobin, Heart rate, High density lipoprotein, Hypertension, Ischaemic stroke, Low density lipoprotein, Magnetic resonance imaging head, NIH stroke scale, Oxygen saturation, Platelet count, SARS-CoV-2 test, Ultrasound Doppler, White blood cell count
SMQs:, Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Hypertension (narrow), Lipodystrophy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NOVOMIX; PERINDOPRIL/INDAPAMIDE; LASILIX [FUROSEMIDE]; ALDACTONE [SPIRONOLACTONE]; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Disease risk factor; Hypertension arterial; Hysterectomy; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: creatinine; Result Unstructured Data: Test Result:74 umol/l; Test Date: 20210928; Test Name: blood pressure; Result Unstructured Data: Test Result:169/59; Test Name: triglycerides; Result Unstructured Data: Test Result:2.44 g/l; Test Date: 20210928; Test Name: brain CT and supra aortic trunk; Result Unstructured Data: Test Result:No recent ischemic plaque; Comments: No recent ischemic plaque detected. Occlusion of a branch of right M2, of recent appearance.; Test Date: 20211004; Test Name: cerebral CT scan; Result Unstructured Data: Test Result:concluding on the appearance of ischemic lesions; Comments: concluding on the appearance of ischemic lesions consisting of the right sylvian territory, without hemorrhagic transformation; Test Date: 20210928; Test Name: ECG; Result Unstructured Data: Test Result:regular sinus rhythm; Comments: regular sinus rhythm without conduction disturbance or repolarization; Test Date: 20211006; Test Name: Holter ECG; Result Unstructured Data: Test Result:a priori unremarkable; Test Date: 20210928; Test Name: glomerulal filtration rate; Result Unstructured Data: Test Result:63; Comments: ml/min/1.73m^2; Test Name: HBA1C; Test Result: 6.5 %; Test Date: 20210928; Test Name: hemoglobin; Result Unstructured Data: Test Result:16.5 g/dl; Test Date: 20210928; Test Name: heart rate; Result Unstructured Data: Test Result:71 bpm; Test Name: HDL-cholesterol; Result Unstructured Data: Test Result:0.39 g/l; Test Name: LDL-cholesterol; Result Unstructured Data: Test Result:1.64 g/l; Test Date: 20211011; Test Name: brain MRI; Result Unstructured Data: Test Result:unknown results; Test Date: 20210928; Test Name: NIHSS; Result Unstructured Data: Test Result:2; Test Date: 20210928; Test Name: saturation; Test Result: 93 %; Test Date: 20210928; Test Name: platelets; Result Unstructured Data: Test Result:171 x10 9/l; Test Date: 20210928; Test Name: covid-19 test; Test Result: Negative ; Test Date: 20210928; Test Name: echo-doppler supra aortic trunk; Result Unstructured Data: Test Result:minimal ateromatous arteriopathy; Comments: minimal ateromatous arteriopathy and commonplace for the patient''s age in the cervical arteries; Willis polygon could not be studied due to the absence of a good quality temporal window; Test Date: 20210928; Test Name: white blood cells; Result Unstructured Data: Test Result:7.95 x10 9/l
CDC Split Type: FRPFIZER INC202101370528

Write-up: Ischemic stroke/right sylvic ischemic stroke; triglycerides at 2.44 g/l; blood pressure was at 169/59; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-SE20212593. An 87-year-old female patient received BNT162B2 (COMIRNATY Solution for injection), intramuscular, administered in the left arm, on 24Sep2021 (lot number: FG7887), as dose 3 (booster), single, for COVID-19 immunisation. Relevant medical history included cardiac failure, type 2 diabetes mellitus, hypertension arterial, hysterectomy and person at risk of developing a severe form of COVID-19. The patient has no known allergies and toxic habits. The patient has no history of COVID-19. Concomitant medications included insulin aspart, insulin aspart protamine (crystalline) (NOVOMIX); indapamide, perindopril erbumine (PERINDOPRIL/INDAPAMIDE 2.5 mg/10 mg); furosemide (LASILIX 40 mg); spironolactone (ALDACTONE 2.5 mg); and paracetamol, all taken for unknown indications, start and stop dates not reported. Historical vaccine included BNT162B2 (COMIRNATY Solution for injection) received on 01Feb2021 (batch/lot number: EK9788) as dose 1, single; and on 25Feb2021 (batch/lot number: EP9598), as dose 2, single, for COVID-19 immunisation. On 28Sep2021, 4 days after the third dose, the patient experienced ischemic stroke/right sylvic ischemic stroke which resulted to hospitalization. Date of occurrence and description of the effect: On 28Sep2021 (Day 4), the patient was referred to the emergency room in a context of cephalalgia occurring at 7:30 then left facial paralysis of central appearance associated with left hemiplegia occurring at 10:30. On arrival at the Emergency Department at 12:30, blood pressure was at 169/59, heart rate was at 71 bpm, 93% ambient air saturation, the patient was euglycemic, and NIHSS was 2 (2 on the facial paralysis). The patient had facial paralysis central left, no sensory-motor deficit of the 4 limbs, no aphasia or expression or understanding, good temporo-spatial orientation, no oculomotor disorder, no cardiovascular disorder, and no ataxia; ECG showed regular sinus rhythm without conduction disturbance or repolarization; input biological assessment included hemoglobin at 16.5 g/dl, white blood cells at 7.95 x10 9/l, platelets at 171 x10 9/l, creatinine at 74 umol/l, glomerular filtration rate at 63 ml/min/1.73m^2; Brain CT and supra-aortic trunks showed no recent ischemic plaque detected, occlusion of a branch of right M2, of recent appearance. After collegial discussion, decision not to operate any thrombectomy or thrombolysis in view of the patient''s age and the low deficit. Treatment with LOVENOX and ASPEGIC and hydration was initiated. Etiological assessment: echo-doppler supra aortic trunk on 28Sep2021 showed minimal ateromatous arteriopathy and commonplace for the patient''s age in the cervical arteries, Willis polygon could not be studied due to the absence of a good quality temporal window; Holter ECG on 06Oct2021 showed a priori unremarkable; lipid balance on an unspecified date showed dyslipidemia with triglycerides at 2.44 g/l; LDL-cholesterol at 1.64 g/l, HDL-cholesterol at 0.39 g/l; HbA1c (glycosylated hemoglobin) on an unspecified date was 6.5%; PCR Covid-19 on 28Sep2021 was negative. Evolution: On 01Oct2021 (Day7), geriatric care was continued. On 04Oct2021 (Day 10), cerebral CT scan concluded on the appearance of ischemic lesions consisting of the right sylvian territory, without hemorrhagic transformation. Programming of a brain MRI on 11Oct2021 was reported with unknown results. The outcome of the event ischemic stroke/right sylvic ischemic stroke was not resolved. The outcome of the remaining events was unknown. Note: Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. Therapy 1985; 40: 111-8. No follow-up attempts possible. No further information expected.


VAERS ID: 1822649 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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:Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101373980

Write-up: itchy; feeling tired and sick; feeling tired and sick; Booster; off label use; rash; Skin rash; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110131046395390-FUOJC. Safety Report Unique Identifier GB-MHRA-ADR 26070699. A 91-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BioNTech,Formulation: Solution for injection, lot number: FF8222), via an unspecified route of administration on 26Sep2021 as Dose 3 (Booster), 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. The patient has not tested positive for COVID-19 since had the vaccine. The patient was not enrolled in the clinical trial.On an unspecified date, she had itchy, booster, off-label use, feeling tired and sick, On 28Sep2021, the patient experienced rash and skin rash. The clinical course was rash appeared 2 Days after the booster, from the above injection site to elbow, very itchy still itchy and crusty after two weeks along with still feeling tired and sick. The case was classified as serious (medically significant). On an unknown date, the patient underwent lab tests and procedures which included a SARS-COV-2 test: negative (no-negative covid-19 test). The outcome of the events rash was resolving and events skin rash was resolved with the sequel, while the outcome of the events events itchy, booster, off label use, and feeling tired and sick was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1823127 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-09-28
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), 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: PHPFIZER INC202101375270

Write-up: Asymptomatic COVID-19; Asymptomatic COVID-19; This is a spontaneous report from a contactable healthcare professional received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300110030. A 46-year-old (also the age at time of vaccination) female patient received bnt162b2 (COMIRNATY), intramuscular on 16Jul2021 (Batch/Lot Number: FD5996) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had asymptomatic COVID-19 confirmed on 28Sep2021 07:00 and recovered in 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1823134 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-19
Onset:2021-09-28
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cough, Decreased appetite, Insomnia
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101375301

Write-up: Weakness generalized; cough; Appetite lost; insomnia; This is a spontaneous report from a contactable other HCP. This is a report received from the Regulatory Authority. Regulatory Authority report number PH-PHFDA-300110268. An 85-year-old male patient received bnt162b2 (COMIRNATY) intramuscular on 19Sep2021 (at the age of 85-year-old) (Lot Number: FD5996) as single dose (dose number unknown) for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 28Sep2021, the patient experienced weakness generalized, cough, appetite lost and insomnia; all the events were serious as involving hospitalization. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1823210 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 FA4632 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Brain death, Cardio-respiratory arrest, Chest pain, Pyrexia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMIODARONA [AMIODARONE]; SPIRONOLACTONE; CARVEDILOL; PRESTARIUM [PERINDOPRIL]; FUROSEMID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiomyopathy (dilated cardiomyopathy with depreciated ejection fraction); Cardiopulmonary arrest (Ventricular tachycardia and cardiopulmonary arrest resuscitated in 2007); Heart failure NYHA class II (Heart failure NYHA class II/III); Left anterior hemiblock; Mitral valve insufficiency (grade II mitral valve insufficiency); Ventricular tachycardia (Ventricular tachycardia and cardiopulmonary arrest resuscitated in 2007)
Allergies:
Diagnostic Lab Data: Test Date: 20211001; Test Name: COVID-19; Test Result: Negative
CDC Split Type: ROPFIZER INC202101412355

Write-up: posterior chest pain; Acute pulmonary edema; Fever; cardiopulmonary arrest resuscitated and followed by intubation; Brain death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number RO-NMA-2021-SPCOV13042. A 47-year-old male patient received bnt162b2 (COMIRNATY), third dose via intramuscular on 28Sep2021 (Batch/Lot Number: FA4632) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation (age at vaccination: 47-year-old). Comirnaty first dose administrated on 18Jan2021 via intramuscular (batch/lot number: EL1491) for Covid-19 immunisation. Comirnaty second dose administrated on 08Feb2021 via intramuscular (batch/lot number: EK9788) for Covid-19 immunisation. Medical history included dilated cardiomyopathy with depreciated ejection fraction, grade II mitral valve insufficiency, Heart failure NYHA class II/III, Left anterior hemiblock, Ventricular tachycardia and cardiopulmonary arrest resuscitated in 2007. Concomitant medication(s) included amiodarona [amiodarone]; spironolactone; carvedilol; perindopril (PRESTARIUM [PERINDOPRIL]); furosemide (FUROSEMID). From 28Sep2021 the patient presented febrile syndrome, posterior chest pain, acute pulmonary edema, cardiorespiratory arrest, resuscitated and intubated. At the time of reporting the patient is in intensive care department of the hospital in brain death. Affirmative, state degradation generalized appeared after vaccination with the 3rd dose of COVID-19 Vaccine Comirnaty / Pfizer-BioNTech, in 28Sep2021. On 01Oct2021 the patient was taken to ER following a resuscitated cardiorespiratory arrest. The patient was subsequently intubated, hemodynamically and respiratory unstable and finally in brain death. The events were reported as life threatening. A COVID-19 test performed on 01-Oct-2021 was negative. Outcome for all adverse events was not recovered. The patient was not diagnosed with SARS-CoV-2 infection before or after vaccination. No other details available regarding this case.


VAERS ID: 1823231 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-28
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004670 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocarditis
Allergies:
Diagnostic Lab Data: Test Date: 20210930; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: Myocarditis; This case was received via Regulatory Agency (Reference number: SE-MPA-2021-088055) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) in a 17-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3005238 and 3004670) for COVID-19 vaccination. The patient''s past medical history included Myocarditis in 2019. On 06-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by reporter. No treatment medications provided by the reporter. Company Comment: This case concerns a 17 year-old male patient with a history of myocarditis who experienced the expected serious event of myocarditis, an AESI, and the non-serious event of inappropriate schedule of vaccine administered. The event occurred approximately 1 day after the second dose of mRNA-1273, which was administered 22 days after the first dose. The rechallenge was not applicable as no additional dosing will be administered. The medical history of myocarditis and of inappropriate schedule of vaccine administered remain confounders. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Translation document received on 20-Oct-2021 and event verbatim updated.; Sender''s Comments: This case concerns a 17 year-old male patient with a history of myocarditis who experienced the expected serious event of myocarditis, an AESI, and the non-serious event of inappropriate schedule of vaccine administered. The event occurred approximately 1 day after the second dose of mRNA-1273, which was administered 22 days after the first dose. The rechallenge was not applicable as no additional dosing will be administered. The medical history of myocarditis and of inappropriate schedule of vaccine administered remain confounders. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report.


VAERS ID: 1823276 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest pain, Heart rate, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: BP; Result Unstructured Data: Test Result:118/90; Test Date: 20210928; Test Name: Heart rate; Result Unstructured Data: Test Result:94
CDC Split Type: TWPFIZER INC202101424672

Write-up: CHEST PAIN; PALPITATIONS; This is a spontaneous report from a non-contactable healthcare professional via the regulatory authority (regulatory authority number: TW-TFDA-TVS-1100008398), based on information received by Pfizer from BioNTech (manufacturer control number: TW-TFDA-TVS-1100008398), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via the regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008398. A 21-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: unknown) on 27Sep2021 via intramuscular as DOSE 1, SINGLE for COVID-19 immunization. No medical history was reported. Concomitant medication(s) and past product were not reported. The patient experienced chest pain and palpitations on 28Sep2021. In the morning of 27Sep2021, the patient received BNT COVID-19 vaccine. In the afternoon of 28Sep2021, the patient felt chest pain and palpitations. The patient felt aggravated and went to a hospital for emergency treatment. BP: 118/90, HR: 94. After the doctor''s diagnosis and treatment, the patient took oral propranolol 10 mg St and Vena 50 mg St. The patient left the hospital with Propranolol 10 mg TID and Vistaril 25 mg TID. Chest pain and palpitations met the seriousness criterion of Other Medically Important Condition. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13Oct2021. Follow-up closed, no further information is possible. Causality Assessment: Events Chest pain, Palpitations were assessed as serious and possibly related to Comirnaty per reporter and per company (BioNTech).


VAERS ID: 1823279 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101424708

Write-up: SYNCOPE; This is a spontaneous report from a non-contactable healthcare professional via regulatory authority (regulatory authority number: TW-TFDA-TVS-1100008437) based on information received by Pfizer from BioNtech (manufacturer control number: TW-Fosun-2021FOS003930), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008437. A 13-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: unknown) on 28Sep2021 via Intramuscular as DOSE 1, SINGLE for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. The patient experienced syncope on 28Sep2021. At noon of 28Sep2021, the patient received 1st dose of vaccination in the class, half of the class, the patient was sent to a hospital emergency department by the ambulance. The patient still felt that the head fainted and was given the needle Vena 30mg via IV drip and Taita No.2 500ml via IV drip. At 14:59 of 29Sep2021, it was reported that "has once again confirmed the case to the hospital, and call multiple times". Syncope met the seriousness criterion of hospitalization and was considered as Important Medical Event. At the time of the report, the outcome of the event was unknown. Initial report was received on 13Oct2021. Follow-up closed, no further information is possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1823281 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Blood test, Body temperature, Chest discomfort, Dyspnoea, Electrocardiogram
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210927; Test Name: temperature; Result Unstructured Data: Test Result:37 degrees; Test Name: EKG; Result Unstructured Data: Test Result:indicated temporarily elimination of myocarditis
CDC Split Type: TWPFIZER INC202101424797

Write-up: CHEST TIGHTNESS; BREATHING WAS NOT SMOOTH; ASTHMA; This is a spontaneous report from a non-contactable healthcare professional via Center for Disease Control (regulatory authority number: TW-TFDA-TVS-1100008478) based on information received by Pfizer from BioNtech SE (manufacturer control number: TW-Fosun-2021FOS003936), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008478. A 16-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: 1G042A-CDC) on 24-Sep-2021 via intramuscular at 0.3 ml/unspecified dosing frequency for COVID-19 immunization. No Medical history was reported. Concomitant medication(s) and past product were not reported. The patient experienced chest tightness, breathing was not smooth and asthma on 28-Sep-2021. On 24-Sep-2021, the patient was given BNT vaccine. On 27-Sep-2021, the patient only has a small temperature (37 degrees). On 28-Sep-2021, the patient began to feel asthma, chest tightness and ventilation leading to clinics. F/U electrocardiogram (Ekg) indicated temporarily elimination of myocarditis. It was reported that "today''s blood test, tomorrow, to pre-", currently patient symptoms improved. On 29-Sep-2021, three-business centralized vaccination BNT vaccine. The following was to track care. It was reported that "Business school protective paper notice the vaccine adverse reactions, assist in the system, and working in the case, the case is answering, saying that there is another recruitment of the heavy clinic, and the case is also improved, and the martial arts will follow The matter of observation, the case is aware of, and continues to reciprust." Chest tightness, breathing was not smooth and asthma met the seriousness criterion of Other Medically Important Condition. At the time of the report, the outcomes of the events were recovering. Initial report was received on 13-Oct-2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1823283 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-28
   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 - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101424793

Write-up: CHEST PAIN; MILD DYSPNEA SENSATION; This is a spontaneous report from a non-contactable healthcare professional via the Taiwan Center for Disease Control- (regulatory authority number: TW-TFDA-TVS-1100008491), based on information received by Pfizer from BioNtech SE (manufacturer control number TW-Fosun-2021FOS003940), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Taiwan Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008491. A male patient started to received a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 25-Sep-2021 via unknown route at unspecified dose/unspecified dosing frequency for COVID-19 immunization. No medical history was reported. Concomitant medication(s) and past product were not reported. The patient experienced chest pain and mild dyspnea sensation on 28-Sep-2021. It was reported that "No Cold Sweating, BNT VACCITION 3 Days AG Diagnosis and treatment". The patient''s symptoms improved, the doctor prescribed medication and the patient went home. Chest pain and mild dyspnea sensation met the seriousness criterion of Other Medically Important Condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality assessment between Comirnaty and the events chest pain and dyspnea was possible per reporter and company (BioNtech SE). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1823284 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
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: TWPFIZER INC202101424640

Write-up: CHEST TIGHTNESS; This is a spontaneous report from a non-contactable healthcare professional via the regulatory authority (Regulatory authority report number: TW-TFDA-TVS-1100008493), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003941), license party for bnt162b2 (COMIRNATY). A female patient of an unspecified age received BNT162B2 (COMIRNATY), unknown route of administration on an unspecified date (Batch/Lot number was unknown) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced chest tightness on 28Sep2021. The patient was given emergency medical treatment. Patient''s symptoms improved after medical treatment, the doctor prescribed medication and the patient went home. Chest tightness met the seriousness criterion of other medically important condition. At the time of the report, the outcome of the event was unknown. Drugs: COMIRNATY. Causality Assessment: Chest tightness; Per Reporter: Possible; Per Company (BioNTech): Possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1823292 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Deafness
SMQs:, Hearing impairment (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 Name: CXR; Result Unstructured Data: Test Result: Unknown results.
CDC Split Type: TWPFIZER INC202101424799

Write-up: HEARING LOSS OF LEFT EAR; This is a spontaneous report from a non-contactable health care professional via the Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100008579. This report is based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004037), license party for bnt162b2 (COMIRNATY). A male patient with unknown age started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 27-Sep-2021 via unknown route at unspecified dose/unspecified dosing frequency for COVID-19 immunization. No medical history was reported. Concomitant medications and past product were not reported. The patient experienced hearing loss of left ear after vaccination on 28-Sep-2021. On 27-Sep-2021, the patient was given BNT vaccine at about 1-2 clock in the afternoon. On 28-Sep-2021, the patient developed hearing loss of left ear. On 29-Sep-2021, the patient went to the hospital at night. After medical treatment, the patient was diagnosed with the loss of left ear burst spontaneous hearing. It was reported that "L''T Issnhl S / P L''T Myring Injection ON". CXR and HBOT (High Pressure Oxygen Treatment) were performed. The following was to track care. Hearing loss of left ear met the seriousness criterion of Other Medically Important Condition. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible Causality Assessment: Event hearing loss was possibly related to COMIRNATY as per reporter and Company (BioNTech SE). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1823297 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 1G043A-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Diarrhoea, Dizziness, Nausea, Physical examination, White blood cell count
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: CPK; Result Unstructured Data: Test Result:622; Test Date: 202109; Test Name: CK-MB; Result Unstructured Data: Test Result:1.6; Test Date: 202109; Test Name: Physical examination; Result Unstructured Data: Test Result:abdomen soft, mild distended, BS: hyperactive, no; Comments: abdomen soft, mild distended, BS: hyperactive, no rebounding pain, no peritoneal signs, throat no injected and breathing sounds bilateral clear.; Test Date: 202109; Test Name: WBC; Result Unstructured Data: Test Result:2860
CDC Split Type: TWPFIZER INC202101424551

Write-up: NAUSEA; DIZZINESS; DIARRHEA; ABD PAIN; This is a spontaneous report from a non-contactable health care professional via Center for Disease Control (regulatory authority number: TW-TFDA-TVS-1100008627), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004056), license party for BNT162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008627. A 12-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1G043A-CDC) on 28-Sep-2021 via intramuscular at unspecified dosing frequency for COVID-19 immunization in school. The patient had no past history of major systemic disease. Medical history, concomitant medication and past product were not reported. The patient experienced nausea, dizziness, diarrhea and abdominal pain on 28-Sep-2021. Thus, the patient was brought to our ER and medication. Diarrhea 2-3 times/day and sometime abd pain persisted. Without fever. So he was brought to our OPD for help. At OPD, findings of physical examination showed abdomen soft, mild distended, BS: hyperactive, no rebounding pain, no peritoneal signs, throat no injected and breathing sounds bilateral clear. Lab data: WBC:2860, CPK:622, CK-MB:1.6. The impressions were GI upset after BNT injection And R/O post BNT vaccine adverse effect. The patient was admitted for further evaluation and management. Nausea, dizziness, diarrhea and abdominal pain met the seriousness criterion of hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding nausea, dizziness, diarrhea and abdominal pain were not applicable. At the time of the report, the outcomes of nausea, dizziness, diarrhea and abdominal pain were unknown. The primary reporter and BioNTech SE assessed the causal relationship between bnt162b2 and events as possible. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1823316 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Chest discomfort, Depressed mood, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Depression (excl suicide and self injury) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101424713

Write-up: NO GAS, ARRHYTHMIA; POOR SPIRIT; DIFFICULTY BREATHING; CHEST TIGHTNESS; CHEST DISCOMFORT; This is a spontaneous report from a non-contactable health care professional via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100008370. This report is based on information received by Pfizer from BioNtech SE (manufacturer control number: TW-Fosun-2021FOS004203), license party for bnt162b2 (COMIRNATY). A 12-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 24-Sep-2021 via intramuscular at unspecified dosing frequency for COVID-19 immunization. No medical history was reported. Concomitant medication(s) and past product were not reported. The patient experienced poor spirit, difficulty in breathing, chest tightness and chest discomfort, no gas, arrhythmia on 28-Sep-2021. On 28-Sep-2021, the patient had poor spirit, difficulty in breathing, no chest pain, chest tightness and chest discomfort. Just received the hospital notice, the doctor suggested the medical examination, but the patient came back. At the time of the report, the patient was being hospitalized by train. The patient was able to walk independently. It was reported that "tell the master if there is a need for Negative Works". The health center would continue to care. Poor spirit, difficulty in breathing, chest tightness and chest discomfort, no gas, arrhythmia met the seriousness criterion of Hospitalization. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: Events poor spirit, difficulty in breathing, chest tightness and chest discomfort, no gas, arrhythmia were possibly related to COMIRNATY as per reporter and Company (BioNTech SE). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1823317 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Cold sweat, Dizziness, Heart rate, Heart rate decreased, Oxygen saturation, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: Blood pressure; Result Unstructured Data: Test Result:125/85 mg/dl; Test Date: 20210928; Test Name: Blood pressure; Result Unstructured Data: Test Result:65/41 mg/dl; Test Date: 20210928; Test Name: Blood pressure; Result Unstructured Data: Test Result:110/72 mg/dl; Test Date: 20210928; Test Name: Blood pressure; Result Unstructured Data: Test Result:109/82 mg/dl; Test Date: 20210928; Test Name: Pulse rate; Result Unstructured Data: Test Result:67 times; Test Date: 20210928; Test Name: Pulse rate; Result Unstructured Data: Test Result:55 times; Test Date: 20210928; Test Name: Pulse rate; Result Unstructured Data: Test Result:65 times; Test Date: 20210928; Test Name: Pulse rate; Result Unstructured Data: Test Result:59 times; Test Date: 20210928; Test Name: O2 saturation; Test Result: 99 %
CDC Split Type: TWPFIZER INC202101424711

Write-up: FULL BODY WEAKNESS; COLD SWEAT; PALE FACE; BLOOD PRESSURE DECREASED; HEART RATE DECREASED; dizziness; SYNCOPE; This is a spontaneous report from a non-contactable healthcare professional via for regulatory authority (regulatory authority number: TW-TFDA-TVS-1100008412) based on information received by Pfizer from BioNtech SE (manufacturer control number: TW-Fosun-2021FOS004215), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008412. A 19-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 28-Sep-2021 via Intramuscular at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. The patient experienced syncope, full body weakness, cold sweat, pale face, blood pressure decreased and heart rate decreased on 28-Sep-2021. On 28-Sep-2021, the patient received a dose of vaccination. At 16:05, the patient developed dizziness, full body weakness, cold sweat and pale face, blood pressure was 65/41 mg/dl, pulse was 55 times. At 16:15, the assistance called 119. It was reported that "At 16: 17, Flat lay". At 16: 18, blood pressure was 110/72 mg/dl, pulse was 65 times. At 16:21, the patient was given oxygen. At 16:25, Blood pressure was 109/82 mg/dl, pulse was 59 times, the patient''s lips became more ruddy, and it was reported that "119 to a case refused to take ambulance". SPO2 was 99%, blood pressure was 125/85 mg/dl, pulse was 67 times. At 17:00, the patient accompanied by family. and the his gait was stable. It was reported that "the health office is stepped on". Syncope was considered as Important Medical Event. At the time of the report, the outcomes of syncope, blood pressure decreased, and heart rate decreased were recovered, the outcomes of full body weakness, cold sweat, pale face, and dizziness were unknown. Initial report was received on 13-Oct-2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1824102 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-28
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, COVID-19 pneumonia, Chest scan, Drug ineffective, Headache, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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: Myfortic; Ursofalk; Amlodipine; Azithromycin; Symbicort; Cholecalciferol; Aranesp; Baraclude; Nexium [Esomeprazole Magnesium]; Folinate De Calcium; NovoRapid; Lantus; Prevymis; Singulair; Nebilet; Mycostatin; Ospen [Phenoxymethylpenicillin
Current Illness: Graft versus host disease in lung; Graft versus host disease in skin.
Preexisting Conditions: Medical History/Concurrent Conditions: Acute leukaemia; Stem cell transplant.
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: Thorax scan; Result Unstructured Data: pulmonary embolism. [Panlobar] lung infiltrate [text cut off]; Test Date: 20210928; Test Name: C-reactive protein; Result Unstructured Data: 51 mg/L; Test Date: 20210928; Test Name: SARS-CoV-2 antibody test; Test Result: Positive; Result Unstructured Data: Positive; Test Date: 20210928; Test Name: SARS-CoV-2 antibody test; Test Result: Negative; Result Unstructured Data: Negative; Test Date: 20210928; Test Name: SARS-CoV-2 test; Test Result: Positive; Result Unstructured Data: Positive.
CDC Split Type: CHMODERNATX, INC.MOD20213

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (NPS (nasopharyngeal swab) is performed, and comes back positive for SARS-CoV-2 infection), DRUG INEFFECTIVE (received two injections of the Moderna vaccine NPS (nasopharyngeal swab) is performed, and comes back positive for SARS-CoV-2 infection), PYREXIA (FS (febrile state) at 38.8?C), HEADACHE (Headache) and COVID-19 PNEUMONIA (SARS-CoV2 pneumonia) in a 60-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 immunisation. The patient''s past medical history included Acute leukaemia and Stem cell transplant in 2014. Concurrent medical conditions included Graft versus host disease in lung since 2014 and Graft versus host disease in skin since 2014. Concomitant products included MYCOPHENOLATE SODIUM (MYFORTIC), URSODEOXYCHOLIC ACID (URSOFALK), AMLODIPINE, AZITHROMYCINE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), COLECALCIFEROL (CHOLECALCIFEROL), DARBEPOETIN ALFA (ARANESP), ENTECAVIR (BARACLUDE), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), CALCIUM FOLINATE (FOLINATE DE CALCIUM), INSULIN ASPART (NOVORAPID), INSULIN GLARGINE (LANTUS), LETERMOVIR (PREVYMIS), MONTELUKAST SODIUM (SINGULAIR), NEBIVOLOL HYDROCHLORIDE (NEBILET), NYSTATIN (MYCOSTATINE), PHENOXYMETHYLPENICILLIN POTASSIUM (OSPEN [PHENOXYMETHYLPENICILLIN POTASSIUM]), POSACONAZOLE (NOXAFIL), RUXOLITINIB PHOSPHATE (JAKAVI), SODIUM BICARBONATE (NEPHROTRANS), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), TACROLIMUS MONOHYDRATE (PROTOPIC) and VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication. On 15-Sep-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced SARS-COV-2 TEST POSITIVE (NPS (nasopharyngeal swab) is performed, and comes back positive for SARS-CoV-2 infection) (seriousness criteria hospitalization and medically significant), PYREXIA (FS (febrile state) at 38.8?C) (seriousness criteria hospitalization and medically significant), HEADACHE (Headache) (seriousness criteria hospitalization and medically significant) and COVID-19 PNEUMONIA (SARS-CoV2 pneumonia) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DRUG INEFFECTIVE (received two injections of the Moderna vaccine NPS (nasopharyngeal swab) is performed, and comes back positive for SARS-CoV-2 infection) (seriousness criteria hospitalization and medically significant). At the time of the report, SARS-COV-2 TEST POSITIVE (NPS (nasopharyngeal swab) is performed, and comes back positive for SARS-CoV-2 infection) and DRUG INEFFECTIVE (received two injections of the Moderna vaccine NPS (nasopharyngeal swab) is performed, and comes back positive for SARS-CoV-2 infection) had not resolved and PYREXIA (FS (febrile state) at 38.8?C), HEADACHE (Headache) and COVID-19 PNEUMONIA (SARS-CoV2 pneumonia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2021, C-reactive protein (0-10): 51 (High) 51 mg/L. On 28-Sep-2021, Chest scan: abnormal (abnormal) pulmonary embolism. [Panlobar] lung infiltrate [text cut off]. On 28-Sep-2021, SARS-CoV-2 antibody test: positive (Positive) Positive and negative (Negative) Negative. On 28-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered SARS-COV-2 TEST POSITIVE (NPS (nasopharyngeal swab) is performed, and comes back positive for SARS-CoV-2 infection), DRUG INEFFECTIVE (received two injections of the Moderna vaccine NPS (nasopharyngeal swab) is performed, and comes back positive for SARS-CoV-2 infection), PYREXIA (FS (febrile state) at 38.8?C), HEADACHE (Headache) and COVID-19 PNEUMONIA (SARS-CoV2 pneumonia) to be possibly related. After discussion with hematologists and infectious diseases specialists, Patient was put on treatment with Levofloxacin 250 mg Q12H starting on 29-Sep-2021 for 7 days, Remdesivir 200 mg on 29-Sep-2021 then 100 mg [for] 4 days, Prednisone 40 mg starting on 29-Sep-2021 for 10 days, Regeneron 4 g starting on 29-Sep-2021, Tocilizumab on 29-Sep and 30-Sep-2021, Enoxaparin 100 mg BID. Treatment-Prednisone 40 mg QD, Levofloxacin 250 mg Q12H. Patient was hospitalized from 04-Sep-2021 to 14-Sep-2021 in a context of acute hypoxemic, non-hypercapnic respiratory failure likely of infectious origin. He was then discharged home before being admitted for lung rehabilitation therapy on 27-Sep-2021 namely to put in place nocturnal equipment for his OSAS. After discussion with the hematologists in charge of the patient, he was transferred for hospitalization given the immunosuppression in the context of his GvHD (graft-versus-host). On 28-Sep-2021, the patient had a FS (febrile state) at 38.8?C and result was high. On unknown date, the patient had an additional test performed that included a chest X-ray, however, the result was abnormal provided. On unknown date, the patient had an additional test performed that included a Pan lobar lung test, however, the result was lung infiltrate [affecting] between 60 and 70% of the pulmonary parenchyma consistent with SARS-CoV2 pneumonia. provided. The event Drug ineffective is not valid as the events started only 14 days after dose 2. This RA case concerns a 60 year old male with a history of leukemia with stem cell transplant and graft versus host disease of the lung on immunosuppressive therapy who experienced the serious, unlisted events of COVID-19 pneumonia and Drug ineffective (per RA) 14 days after dose 2 of MRNA-1273. Re-challenge is not applicable for dose 2. The history of immunosuppressive therapy for graft versus host disease of the lung remains a confounder as this can be a cause of the events. Benefit-risk rela Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Translation received on 25-OCT-2021 in which lab data updated, Description as Reported for all events updated. Narrative updated.; Sender''s Comments: This RA case concerns a 60 year old male with a history of leukemia with stem cell transplant and graft versus host disease of the lung on immunosuppressive therapy who experienced the serious, unlisted events of COVID-19 pneumonia and Drug ineffective (per RA) 14 days after dose 2 of MRNA-1273. Re-challenge is not applicable for dose 2. The history of immunosuppressive therapy for graft versus host disease of the lung remains a confounder as this can be a cause of the events. Benefit-risk relationship of mRNA-1273 is not affected by this report. The event Drug ineffective is not valid as there was not greater than 14 days between dose 2 and the start of events.


VAERS ID: 1825910 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-09-17
Onset:2021-09-28
   Days after vaccination:6951
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0810 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (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: SYMBICORT; PROPRANOLOL; FAMOTIDINE; VIT B12; VIT C
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101401868

Write-up: tinnitus. extremely loud; This is a spontaneous report received from a contactable nurse (patient). A 44-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in left arm on 17Sep2021 17:00, at 44 years of age (Batch/Lot Number: FD0810) as single dose for COVID-19 immunization. Medical history included penicillin allergy from an unknown date and unknown if ongoing and COVID-19 from Mar2020 to an unknown date. The patient didn''t receive any other vaccine within 4 weeks prior to the COVID vaccine. Since the vaccination the patient has not been tested for COVID-19. Concomitant medications included budesonide/formoterol fumarate (SYMBICORT), propranolol, famotidine, cyanocobalamin (VIT B12) and ascorbic acid (VIT C), all taken for an unspecified indication, since an unknown date. On 28Sep2021 the patient experienced tinnitus, extremely loud and always present such that it was hard to hear and focus on anything else. The event resulted in Doctor or other healthcare professional office/clinic visit and was assessed as medically significant. At the time of the report the event outcome was unknown.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event Tinnitus and the suspect BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees, and investigators, as appropriate.


VAERS ID: 1826509 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Flat affect, Hyperphagia, Hypophagia, Immunisation, Loss of personal independence in daily activities, Off label use, SARS-CoV-2 test, Trigeminal neuralgia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Demyelination (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 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No- Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101380808

Write-up: Facial pain/ neuralgia pain in face; Affecting abilities to eat and drink, carry out daily activities and go to work; Drink; Eat; Affecting; Off label use; Booster; 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-202110141616451800-VPLLR. Safety Report Unique Identifier GB-MHRA-ADR- 26079407. A 29-year-old non-pregnant female patient received third dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection), via an unspecified route of administration on 28Sep2021 (Batch/Lot number was not reported, Expiration date was not reported) as DOSE 3 (BOOSTER), SINGLE (at the age of 29-year-old) for COVID-19 immunization. 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 was not pregnant and not currently breastfeeding at the time of vaccination. Historical vaccine included previously received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date in Jan2021 (Batch/Lot number was not reported, Expiration date was not reported) as DOSE 1, SINGLE and second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported, Expiration date was not reported) as DOSE 2, SINGLE for COVID-19 immunization. Booster and off label use happened on 28Sep2021. The patient experienced drink/ oral intake reduced, eat/ excessive eating, affecting/ affect lack and affecting abilities to eat and drink, carry out daily activities and go to work on an unspecified date in Oct2021 and facial pain/ neuralgia pain in face on 04Oct2021. The events drink/ oral intake reduced, eat/ excessive eating, affecting/ affect lack and affecting abilities to eat and drink, carry out daily activities and go to work were assessed as serious- Other medically important condition. Clinical course was reported as: Neuralgia pain in face - affecting abilities to eat and drink, carry out daily activities and go to work, had similar reaction in Jan2021 after 1st dose, but not reported via yellow card, reporting now due to reoccurrence after the booster. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab test and procedure which included: COVID-19 virus test: Negative (No- Negative COVID-19 test) on an unspecified date. The outcome of the event facial pain/ neuralgia pain in face was resolving, whereas outcome of events drink/ oral intake reduced, eat/ excessive eating, affecting/ affect lack and affecting abilities to eat and drink, carry out daily activities and go to work were not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1826726 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-28
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Postmenopausal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: ITPFIZER INC202101376722

Write-up: very severe abdominal cramps and subsequent menstruation/been in menopause for over a year and a half/postmenopausal spotting; very severe abdominal cramps; This is a spontaneous report from a contactable physician downloaded from the regulatory agency-WEB, regulatory authority number IT-MINISAL02-797608. A 57-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), intramuscularly on an unspecified date in Sep2021 as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced very severe abdominal cramps and subsequent menstruation/been in menopause for over a year and a half/postmenopausal spotting on 28Sep2021. It was reported that 10 days after the administration of the first Pfizer dose, the patient experienced very severe abdominal cramps and subsequent menstruation. However, the patient has been in menopause for over a year and a half. The outcome of the events was recovered on 01Oct2021.Therapeutic measures were taken as a result of very severe abdominal cramps. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1826795 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 FG0978 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Feeling abnormal, Hypoaesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Dehydration (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:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: BP; Result Unstructured Data: Test Result:93/56 mmHg; Comments: 25minutes after vaccination
CDC Split Type: JPPFIZER INC202101368661

Write-up: BP 93/56 mmHg; After vaccination, the patient had feeling of to go pale; Numbness of upper extremities; This is a spontaneous report from a non-contactable pharmacist received via regulatory authority. An adult male patient received dose 1 of BNT162B2 (COMIRNATY; Solution for injection, Lot number FG0978, Expiration date 30Nov2021) intramuscular on 28Sep2021 as a single dose for COVID-19 immunization. Medical history was not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the vaccines. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. On 28Sep2021 after vaccination the patient had feeling of to go pale. Twenty-five minutes after vaccination, the patient''s blood pressure (BP) was 93/56 mmHg. Numbness of upper extremities occurred. The events were reported as non-serious. The patient did not receive any treatment for the events. The outcome of feeling of to go pale was recovering. Thirty-five minutes after vaccination the patient was recovering and returned home. It was unknown if since the vaccination the patient had been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event blood pressure decreased cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1827068 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-09-28
   Days after vaccination:132
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anaesthesia oral, Ear pain, Facial paralysis, Feeling abnormal, Glossodynia, Hypoaesthesia, Lymphadenopathy, Malaise, Noninfective gingivitis, Oral pain, Oropharyngeal pain, Pyrexia, Specialist consultation, Tongue blistering
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Gingival disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: stroke unit; Result Unstructured Data: Test Result: not to be a stroke.
CDC Split Type: SEPFIZER INC202101379451

Write-up: Numbness facial; paralysis on one side of the face; blister/sore on the tip of his tongue; blister/sore on the tip of his tongue; sore throat; inflammation throughout the gums and in the mouth; open sore all over the mouth; complete loss of taste; swollen lymph nodes; fever; general malaise; pain in the ear; feel strange on the left side his face; anesthetic in the mouth; This is a spontaneous report from a contactable consumer from the Regulatory Authority. The Regulatory Authority number SE-MPA-2021-087659. A 53-year-old male patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 19May2021 (Batch/Lot Number: EX8680) as single dose for covid-19 immunisation. Medical history included ongoing hypertension. The patient''s concomitant medications were not reported. The patient experienced numbness facial and paralysis on one side of the face, both on 28Sep2021 with outcome of not recovered, blister/sore on the tip of his tongue, sore throat, inflammation throughout the gums and in the mouth, open sore all over the mouth, complete loss of taste, swollen lymph nodes, fever, general malaise, pain in the ear, feel strange on the left side his face and anesthetic in the mouth, all on an unspecified date with outcome of not recovered. Clinical course was reported as 4 months after vaccination, suspected side effect began with paralysis on one side of the face. It started with a blister/sore on the tip of his tongue, then sore throat, inflammation throughout the gums, and in the mouth it felt like an open sore all over the mouth, complete loss of taste on the left side of the tongue, and not much more taste on the rest of the tongue, swollen lymph nodes, fever one night, general malaise, later pain in the ear, and from time to time swollen lymph nodes on the left side which lasted circa 10 days before the man began to feel strange on the left side his face. It felt like a dental anesthetic in the mouth, could not touch the left side of the face at all. The man was admitted to the stroke unit for further investigation and was ruled not to be a stroke. Still not recovered. The case was assessed as serious, hospital care, permanent physical impairment. Follow-up attempt are not possible. No expected further information.


VAERS ID: 1827109 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-28
   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 - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest discomfort, Cough, Lymphadenopathy, Pharyngeal swelling, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: Body temperature; Result Unstructured Data: Test Result: 38 Centigrade.
CDC Split Type: TWPFIZER INC202101425230

Write-up: FEVER/ temperature was 38 degrees; CHEST TIGHTNESS; LEFT THROAT SWELLING; COUGH; LYMPHADENOPATHY CERVICAL; This is a spontaneous report from a non-contactable healthcare professional via the Regulatory Authority (Regulatory authority report number: TW-TFDA-TVS-1100008858), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004154), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via the Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100008858. A 12-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 24-Sep-2021 via intramuscular at unspecified dosing frequency for COVID-19 immunization. Concomitant medication and past product were not reported. The patient experienced chest tightness, left throat swelling, neck lymphadenopathy, cough on 28-Sep-2021, and experienced fever on 02-Oct-2021. On 28-Sep-2021, patient''s body temperature was 38 degrees, pediatric advised the patient to went to the emergency. Acetaminophen 500mg (tablet) and strocain tablet were given. It was reported that patients said that it is not suitable for improvement, patients and accompanying mother''s family refuses hospitalization, the outpatient tracking observation. Fever, chest tightness, left throat swelling, neck lymphadenopathy, and cough met the seriousness criterion of caused hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the fever chest tightness, left throat swelling, neck lymphadenopathy, and cough were not applicable. At the time of the report, the outcomes of fever, chest tightness, left throat swelling, neck lymphadenopathy, and cough were not recovered. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality assessment for the drug bnt162b2 with the events fever, chest tightness, throat swelling non-specific, cough, and lymphadenopathy cervical per reporter and per company (BioNTech SE) was possible. No follow-up attempts are possible, information on the batch/lot number could not be obtained.


VAERS ID: 1828337 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-28
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Conjunctivitis bacterial, Eczema infected
SMQs:, Ocular infections (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: Atopy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Eczema infected; Conjunctivitis bacterial; This case was received via the regulatory authority (Reference number: FR-AFSSAPS-AN20213963) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of ECZEMA INFECTED (Eczema infected) and CONJUNCTIVITIS BACTERIAL (Conjunctivitis bacterial) in a 29-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Atopy. On 23-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced ECZEMA INFECTED (Eczema infected) (seriousness criterion medically significant) and CONJUNCTIVITIS BACTERIAL (Conjunctivitis bacterial) (seriousness criterion medically significant). At the time of the report, ECZEMA INFECTED (Eczema infected) and CONJUNCTIVITIS BACTERIAL (Conjunctivitis bacterial) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication details were provided. No Treatment medication details were provided. Company Comment: This case concerns a 29-year-old, male with relevant medical history of Atopy (genetic disposition to develop an allergic reaction), who experienced the serious unexpected events of Eczema infected and Conjunctivitis bacterial. The events occurred approximately 6 days after the first dose of Spikevax administration. The rechallenge was unknown, since the events occurred after the first dose with not resolved outcome at the time of report and no information available on the second dose. The medical history of Atopy considered as a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender''s Comments: This case concerns a 29-year-old, male with relevant medical history of Atopy (genetic disposition to develop an allergic reaction), who experienced the serious unexpected events of Eczema infected and Conjunctivitis bacterial. The events occurred approximately 6 days after the first dose of Spikevax administration. The rechallenge was unknown, since the events occurred after the first dose with not resolved outcome at the time of report and no information available on the second dose. The medical history of Atopy considered as a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.


VAERS ID: 1828339 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Acute myocarditis; This case was received(Reference number: FR-AFSSAPS-BR20213704) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Acute myocarditis) in a 37-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 25-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Acute myocarditis) was resolving. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by reporter. No treatment medications provided by the reporter. Company comment: This case concerns a 37-year-old, male patient with no relevant medical history, who experienced the unexpected AESI event of Myocarditis. The event occurred approximately 3 days after the first dose of Spikevax which resulted in Hospitalization. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Translation document received on 23-Oct-2021 and contain no new information. On 25-Oct-2021: Follow up document received and contains no new information.; Sender''s Comments: This case concerns a 37-year-old, male patient with no relevant medical history, who experienced the unexpected AESI event of Myocarditis. The event occurred approximately 3 days after the first dose of Spikevax which resulted in Hospitalization. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1829929 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-09-28
   Days after vaccination:99
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3143 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bacterial infection, COVID-19, COVID-19 pneumonia, Computerised tomogram thorax, Lung disorder, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (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? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: VERAPAMIL BIOGARAN; ASPIRINE PROTECT; DISCOTRINE; LIPTRUZET; DESLORATADINE ALMUS; IVABRADINE; PERINDOPRIL ARROW; AXIAGO; NICORANDIL ALMUS; MOLSIDOMINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardio-respiratory arrest; Coronary occlusion; Disease coronary artery (Spastic coronary artery disease); Dyslipidemia; Tabaquism (Active smoking 70 packs a year)
Allergies:
Diagnostic Lab Data: Test Name: Chest CT; Result Unstructured Data: Test Result:typical SARS CoV-2 pneumonia; Comments: typical SARS CoV-2 pneumonia; Test Name: Saturation; Result Unstructured Data: Test Result:90-94 %; Comments: 90-94; Test Date: 20210928; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: variant L452R, CT gene S at 26, CT gene N at 26 and CT gene ORF1ab at 25
CDC Split Type: FRPFIZER INC202101437224

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; Covid pneumonia; mechanically ventilated pneumopathy/meti-sensitive Staphylococcus aureus/Enterobacter aerogenes; meti-sensitive Staphylococcus aureus/Enterobacter aerogenes; This is a spontaneous report from a contactable physician downloaded from the regulatory agency-WEB, regulatory authority number FR-AFSSAPS-DJ20214090. A 55-year-old male patient received bnt162b2 (COMIRNATY), on 11May2021 (Batch/Lot Number: FA5831) as dose 1, single, then on 21Jun2021 (Batch/Lot Number: FC3143) as dose 2, single, both intramuscular for COVID-19 immunisation. Medical history included dyslipidaemia, tabaquism (active smoking 70 packs a year) and disease coronary artery (spastic coronary artery disease) from an unknown date; cardio-respiratory arrest and posterior retro-ventricular occlusion from 2015 to an unknown date. Concomitant medications included verapamil hydrochloride (VERAPAMIL BIOGARAN); acetylsalicylic acid (ASPIRINE PROTECT); glyceryl trinitrate (DISCOTRINE); atorvastatin calcium, ezetimibe (LIPTRUZET); desloratadine (DESLORATADINE ALMUS); ivabradine; perindopril erbumine (PERINDOPRIL ARROW); esomeprazole magnesium (AXIAGO); nicorandil (NICORANDIL ALMUS) and molsidomine, all taken for an unspecified indication, start and stop dates were not reported. On 28Sep2021, there was an occurrence of vaccination failure. The patient was hospitalized for the events from 28Sep2021 to an unknown date. Clinical summary was as follows: The patient presented with rapidly increasing dyspnoea, for which he was admitted to the Emergency Department on 28Sep2021. A chest CT scan was performed and found typical SARS CoV-2 pneumonia; the PCR came back positive on 28Sep2021. He presented with acute respiratory distress under high concentration mask. In this context, he was transferred to the ICU for further management. He was treated with NORADRENALINE during the sedation phases, which was quickly weaned. In addition, he remained stable. On the respiratory level: He received high-flow nasal oxygen therapy on arrival and was finally intubated and put on mechanical ventilation on 28Sep2021. He received five sessions of prone positioning. Sedation could be stopped on 05Oct2021, and he self-extubated on 07Oct2021. He was subsequently treated with non-invasive ventilation which was weaned on 09Oct2021. Due to the smoking intoxication and the probable COPD, a saturation target of 90-94% was set. Infection: He presented an early mechanically ventilated pneumopathy with meti-sensitive Staphylococcus aureus treated with AUGMENTIN then a mechanically ventilated pneumopathy with Enterobacter aerogenes treated with CEFEPIME. Moreover, the aftermath was simple. Discharge to the medicine department on 11Oct2021. Discharge planned for 15Oct2021. Biology: PCR SARS CoV2 positive, variant L452R, CT gene S at 26, CT gene N at 26 and CT gene ORF1ab at 25. No SARS CoV2 serology performed. Therapeutic measures were taken as a result of both events. The outcome of the events was recovering. The events were assessed as serious, life-threatening by the regulatory authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1829947 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cannabis abuse, episodic use (None except occasional cannabis use)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Myocarditis; This case was received via Agency Regulatory Authority (Reference number: FR-AFSSAPS-NC20214758) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of MYOCARDITIS (Myocarditis) in a 24-year-old male patient who received mRNA-1273 (COVID19 MODERNA) for COVID-19 vaccination. Concurrent medical conditions included Cannabis abuse, episodic use (None except occasional cannabis use). On 24-Sep-2021, the patient received first dose of mRNA-1273 (COVID19 MODERNA) (Intramuscular) 1 dosage form. On 28-Sep-2021, after starting mRNA-1273 (COVID19 MODERNA), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) was resolving. For mRNA-1273 (COVID19 MODERNA) (Intramuscular), the reporter did not provide any causality assessments. The patient received 0.20mg/ml dosage. Concomitant product was not provided by the reporter Treatment product was not provided by the reporter Company''s comment: This case concerns a 24-year old, male subject with a medical history of cannabis use, who experienced the serious expected event of Myocarditis(AESI). The event, which resulted in hospitalization, occurred 4 days after the first dose of COVID19 MODERNA. The patient''s age, gender, and medical history of cannabis use, all of which increase the risk of myocarditis, remain as confounders. The benefit-risk relationship of COVID19 MODERNA is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Translation received on 23-Oct-2021 contains significant information. Added patient history.; Sender''s Comments: This case concerns a 24-year old, male subject with a medical history of cannabis use, who experienced the serious expected event of Myocarditis(AESI). The event, which resulted in hospitalization, occurred 4 days after the first dose of COVID19 MODERNA. The patient''s age, gender, and medical history of cannabis use, all of which increase the risk of myocarditis, remain as confounders. The benefit-risk relationship of COVID19 MODERNA is not affected by this report.


VAERS ID: 1830078 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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: Arthralgia, Asthenia, Immunisation, Muscular weakness, Off label use, Pain, Pain in extremity, Vaccination site discomfort, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101393033

Write-up: Patient felt like pressure being put on injection site and very sore; Patient felt like pressure being put on injection site and very sore; weakness; Pain; aches and weakness are wrist and forearm; aches and weakness are wrist and forearm; aches and weakness are wrist and forearm; off label use; Booster; This is a spontaneous report from a contactable consumer other non health care professional received from the Regulatory Authority (UK-MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202110151043199340-WUUTE, Safety Report Unique Identifier GB-MHRA-ADR 26081537. A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: Not known), dose 3 via an unspecified route of administration on 28Sep2021 (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. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not breastfeeding. On an unspecified date, the patient experienced weakness and felt like pressure being put on injection site and very sore. On 28Sep2021, patient experienced pain. On 28Sep2021, patient received third dose of BNT162b2 (booster and off label use). Clinical course: First 24-36hours, patient had a little movement in arm, could lift elbow away from body. Patient felt like pressure being put on injection site and very sore. Since then, this had passed but aches and weakness were wrist and forearm. Events weakness, felt like pressure being put on injection site and very sore and pain were considered serious (medically significant). Outcome of the event pain was recovering. Outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1830253 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Asthenia, Computerised tomogram, Flatulence, Ileus paralytic, Immunisation, Lymphocytosis, Myelitis transverse, Off label use, Paraplegia, Pulmonary function test decreased, SARS-CoV-2 test, Urinary retention
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal obstruction (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Basal cell carcinoma; Bladder retention; Complete heart block (Pacemaker CHB (Not MRI compatible) HTN); CVA; Emphysema; Follicular thyroid cancer (Follicular Ca (hemithyroidectomy)); Gout; Hemithyroidectomy; Hypertension (Pacemaker CHB (Not MRI compatible) HTN); Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Name: CT; Test Result: Negative ; Comments: CT is negative for malignancies; Test Name: lymphocytosis; Result Unstructured Data: Test Result:Unknown Results; Test Date: 20211010; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101449720

Write-up: loss of strength; bladder retention; hyperreflexive paraplegia; abdomen is distended and tympanic; abdomen is distended and tympanic; Respiratory function is preserved although it was impaired at the beginning; paralytic ileus; Myelitis transverse; Off-label use; Booster; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110251358005090-T3WBM. Safety Report Unique Identifier is GB-MHRA-ADR 26117692. A male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 28Sep2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included hypothyroidism, emphysema, asthma, Bladder retention, Pacemaker CHB (Not MRI compatible) HTN, CVA (cerebrovascular accident), gout, BCC (basal cell carcinoma), Follicular Ca (hemithyroidectomy) from an unknown date. Additional information: Pacemaker CHB (Not MRI compatible) HTN, CVA x2 Emphysema, Asthma Gout Hypothyroidism Past BCC, Follicular Ca (hemithyroidectomy). Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced paralytic ileus on an unspecified date with outcome of recovering, myelitis transverse on 07Oct2021 with outcome of not recovered, loss of strength, bladder retention, hyperreflexive paraplegia, abdomen is distended and tympanic, Respiratory function is preserved although it was impaired at the beginning all on an unspecified date with outcome of unknown. Narrative case summary and further information: Case narrative: 10 day history of progressive loss of strength, bowel and bladder retention 1 week post booster P. jab (no problems noted with the first 2). Currently he has hyper reflexive paraplegia with bilateral Babinski; preserved strength in upper limbs, with brisk reflexes bilaterally, no brisk jaw reflex or cranial nerve dysfunction. Respiratory function is preserved although it was impaired at the beginning. His abdomen is distended and tympanic, possibly due to paralytic ileus secondary to transverse myelitis and he requires a bladder catheter. He is not encephalopathic and is cognitively intact. No MRI has been done due to pacemaker but he is due to have myelogram today. CT is negative for malignancies. Diagnostic impression: high, multifocal transverse myelitis C4/C5 < T8/10 post booster jab (most likely cause, by exclusion). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Report not relate to possible blood clots or low platelet counts. Report not relate to possible myocarditis or pericarditis. Relevant investigations or tests conducted: LP - lymphocytosis. CT none of relevance, MRI not done due to pacemaker. The patient underwent lab tests and procedures which included CT (computerised tomogram): CT is negative for malignancies on unspecified date, lymphocytosis: unknown results on unspecified date, sars-cov-2 test: negative on 10Oct2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1830349 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: 40 minutes after the first dose of the Moderna vaccine, developed a syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to the ground; 40 minutes after the first dose of the Moderna vaccine, developed a syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to the ground; 40 minutes after the first dose of the Moderna vaccine, developed a syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to the ground; 40 minutes after the first dose of the Moderna vaccine, developed a syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to the ground; This case was received via Regulatory Agency (Reference number: IT-MINISAL02-798749) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (40 minutes after the first dose of the Moderna vaccine, developed a syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to the ground), ATONIC SEIZURES (40 minutes after the first dose of the Moderna vaccine, developed a syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to the ground), INCONTINENCE (40 minutes after the first dose of the Moderna vaccine, developed a syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to the ground) and PRESYNCOPE (40 minutes after the first dose of the Moderna vaccine, developed a syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to the ground) in a 36-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. No Medical History information was reported. On 28-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced SYNCOPE (40 minutes after the first dose of the Moderna vaccine, developed a syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to the ground) (seriousness criteria hospitalization and medically significant), ATONIC SEIZURES (40 minutes after the first dose of the Moderna vaccine, developed a syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to the ground) (seriousness criterion hospitalization), INCONTINENCE (40 minutes after the first dose of the Moderna vaccine, developed a syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to the ground) (seriousness criterion hospitalization) and PRESYNCOPE (40 minutes after the first dose of the Moderna vaccine, developed a syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to the ground) (seriousness criterion hospitalization). At the time of the report, SYNCOPE (40 minutes after the last dose of the Moderna vaccine, developed a syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to the ground), ATONIC SEIZURES (40 minutes after the last dose of the Moderna vaccine, developed a syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to the ground), INCONTINENCE (40 minutes after the last dose of the Moderna vaccine, developed a syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to the ground) and PRESYNCOPE (40 minutes after the last dose of the Moderna vaccine, developed a syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to the ground) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant medications was not reported. Treatment medications was not reported. Patient received first dose of Moderna vaccine and 40 minutes after developed syncopal episode with urinary incontinence and loss of consciousness for about 8 minutes and resulting fall to ground. company comment: This case concerns a 36-year-old male patient with no relevant medical history, who experienced the unexpected events of Syncope, Atonic Seizures, Incontinence, and Presyncope. The event occurred on the same day after receiving a dose of mRNA-1273 (Spikevax) with outcome of hospitalization. The rechallenge unknown since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Translated received on 23 Oct 2021 include events description as reported and i-narrative updated.; Sender''s Comments: This case concerns a 36-year-old male patient with no relevant medical history, who experienced the unexpected events of Syncope, Atonic Seizures, Incontinence, and Presyncope. The event occurred on the same day after receiving a dose of mRNA-1273 (Spikevax) with outcome of hospitalization. The rechallenge unknown since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report.


VAERS ID: 1830498 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-09-28
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Nasopharyngitis
SMQs:, Anaphylactic reaction (broad), 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? 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: PHPFIZER INC202101375103

Write-up: COVID-19; COVID-19; cold; cough; This is a spontaneous report from a contactable Other Health Care Professional. This is a report received from the regulatory authority report number RA-300109744. A 31-years-old male patient received bnt162b2 (COMIRNATY, solution for injection), intramuscular on 19Aug2021 (at the age of 31-years-old) (Lot Number: FD5996) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 28Sep2021 21:00, the patient experienced cold, cough and COVID-19 . Outcome of events were recovered on an unspecified date in 2021. Product investigation included: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot FD5996. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.


VAERS ID: 1834365 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-09-28
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210929; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101384640

Write-up: COVID-19; Vaccination failure; This is a spontaneous report from a contactable other Health Professional downloaded from the Regulatory Authority-WEB EE-SAM-52892109296 and from Product Quality Complaint Group. A 73-years-old male patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EW6126, Expiry date: 31Jul2021) via intramuscular route of administration on 06May2021 as dose 2, 0.3 ml single, and first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: ER9480, Expiry date: 31Jul2021) via intramuscular route of administration on 25Mar2021 as dose 1, 0.3 ml single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 28Sep2021, the patient experienced Vaccination failure, and on 29Sep2021 COVID-19. On 29Sep2021, the patient underwent and procedure which included SARS-CoV-2 PCR test: positive. Patient stated, they had developed COVID infection with symptoms of sore throat. The course of the disease was mild, treatment symptomatic at home. The outcome of events was not recovered. Sender Comment: Serious (medically significant) vaccine ineffectiveness report. The causal relationship is considered possible. Follow-up (18Oct2021): This is a follow-up report from Product Complaint Team. New information provided from division Regulatory Authority included conclusion of the investigation for Batch ER9480 and Batch EW6126. Upon Follow-up on 18Oct2021 it was reported that Investigational report conclusion for Batch: ER9480 batch expiry date: 31Jul2021 conclusion of the investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the re-ported lot and product type. The final scope was determined to be the associated lot(s) of the re-ported lot ER9480. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed and for Batch: EW6126, batch expiry date: 31Jul2021 conclusion of investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was deter-mined to be the associated lot(s) of the reported lot EW6126. A complaint sample was not re-turned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : EE-PFIZER INC-202101416455 LOE/2nd dose


VAERS ID: 1834479 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-09-28
   Days after vaccination:150
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bradypnoea, COVID-19, Cardiac failure, Computerised tomogram, Computerised tomogram thorax, Cough, Cyanosis, Drug ineffective, Haemodynamic test, Hyperthermia, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Pulmonary congestion, Respiratory distress, SARS-CoV-2 test, Tachypnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (narrow), Accidents and injuries (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (Atrial fibrillation anticoagulated); Cardiac insufficiency; Cognitive disorder; COVID-19; Deafness; Dyslipidaemia; Hypertension (High blood pressure); Pulmonary embolism; Renal stone
Allergies:
Diagnostic Lab Data: Test Name: computed tomography; Result Unstructured Data: Test Result:COVID infection with 10% involvement; Comments: Picture of respiratory decompensation of mixed origin: COVID infection with 10% involvement on computed tomography. Pulmonary infection with favourable outcome under antibiotic, proportion of cardiac decompensation; Test Name: Chest computed tomography; Result Unstructured Data: Test Result:Ground glass infiltration in the lingua with; Comments: minimal damage (10%).; Test Date: 20211007; Test Name: haemodynamics; Result Unstructured Data: Test Result:Stable; Test Date: 20210929; Test Name: Oxygen saturation; Test Result: 75 %; Test Date: 20211007; Test Name: Oxygen saturation; Test Result: 97 %; Test Date: 20210928; Test Name: Polymerase Chain Reaction; Test Result: Positive
CDC Split Type: FRPFIZER INC202101384513

Write-up: respiratory distress; hyperthermia; Upon arrival in the ward: 75% Oxygen saturation; cyanosis; Vaccination failure; congestion; bradypnoea; COVID infection; cardiac decompensation; Pulmonary infection; polypnoeic; Cough; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LL20216776. A 94-years-old male patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection), intramuscular on May2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included Cognitive problems, Deafness, Atrial fibrillation (Atrial fibrillation anticoagulated), Pulmonary embolism, Dyslipidaemia, Cardiac insufficiency, High blood pressure, COVID-19 and left renal lithiasis. The concomitant medications were not reported. The patient received first dose of Comirnaty on Mar2021 for covid-19 immunisation. On 28Sep2021 the patient experienced covid infection. On 29Sep2021 the patient experienced vaccination failure, congestion, bradypnoea, upon arrival in the ward: 75% oxygen saturation and cyanosis. On an unknown date the patient experienced respiratory distress, hyperthermia, cardiac decompensation, pulmonary infection and polypnoeic. On an unknown date in 2021 the patient experienced cough. Therapeutic measures were taken as a result of congestion, bradypnoea, cyanosis, pulmonary infection. The events vaccination failure, covid infection, congestion, bradypnoea, upon arrival in the ward: 75% oxygen saturation, cyanosis, respiratory distress, hyperthermia caused hospitalization. The events vaccination failure, covid infection, congestion, bradypnoea, upon arrival in the ward: 75% oxygen saturation, cyanosis, respiratory distress, hyperthermia, cardiac decompensation, pulmonary infection were captured as serious. It was reported that On 28Sep2021, Severe Acute Respiratory Syndrome-Coronavirus-2 Test was Positive. Declaration of vaccine failure concerning a male patient with Polymerase Chain Reaction positive from the city dated 28Sep2021. He received 2 doses of Pfizer vaccine in March and Apr2021 (exact dates unknown). Arrived through the emergency room for Polymerase Chain Reaction positive in the city. Symptoms included: Cough increased for about 8 days. In emergency room: hyperthermia, congestion, put under 2L of Oxygen. Hospitalisation in geriatrics on 29Sep. Upon arrival in the ward: 75% Oxygen saturation, bradypnoea, cyanosis. Put under high concentration mask 15l upon arrival in the ward then reduced to 8l. Life-threatening prognosis. Outcome in the ward: as of 01Oct was improvement of oxygen saturation (under oxygen), clinically less polypnoeic, no respiratory distress, nor cyanosis, presence of a loose cough. Chest computed tomography performed included Ground glass infiltration in the lingua with minimal damage (10%). Picture of respiratory decompensation of mixed origin included COVID infection with 10% involvement on computed tomography. Pulmonary infection with favourable outcome under antibiotic and proportion of cardiac decompensation. At 07Oct the patient had Stable haemodynamics, fluctuating oxygen saturation (97% today) still under 2L oxygen. No cough nor sputum. The patient underwent lab tests and procedures which included computerised tomogram: covid infection with 10% involvement on an unknown date Picture of respiratory decompensation of mixed origin: COVID infection with 10% involvement on computed tomography. Pulmonary infection with favourable outcome under antibiotic, proportion of cardiac decompensation, computerised tomogram thorax: ground glass infiltration in the lingua with on an unknown date minimal damage (10%), haemodynamic test: stable on 07Oct2021, oxygen saturation: 75 % on 29Sep2021, oxygen saturation: 97 % on 07Oct2021 and sars-cov-2 test: positive on 28Sep2021. The outcome of the events bradypnoea, congestion, hyperthermia, cardiac decompensation was unknown, for the event respiratory distress, cyanosis the outcome was resolved on 01Oct2021, for the event cough the outcome was resolved on 07Oct2021, for the events upon arrival in the ward: 75% oxygen saturation, pulmonary infection and polypnoeic the outcome was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1834511 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthritis reactive, Disease recurrence, Psoriasis
SMQs:, Conjunctival disorders (narrow), Ocular infections (broad), Arthritis (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Psoriasis (Psoriaris since the age of 22 no more corticosteroids for years, just skin hydration)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101384567

Write-up: Exacerbation of psoriasis/major flare-up with lesions on the scalp and body; Arthritis reactive/pain and swelling in the joints of both hands; Disease recurrence; This is a spontaneous report from a contactable physician downloaded from the RA, regulatory authority number FR-AFSSAPS-NC20214731. This is first of two reports, for 2nd dose. A 48-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FG7387, Expiry date not reported), intramuscularly, administered in left arm on 27Sep2021 as dose 2, single for COVID-19 immunization. Medical history included psoriasis from an unknown date, since the age of 22 no more corticosteroids for years, just skin hydration. Patient previously received first dose of bnt162b2 (Lot number: FF2834, Expiry date not reported) via unspecified route of administration in left arm on 01Sep2021 as dose1, single, for COVID-19 immunization, and experienced small flare-up of psoriasis without daily discomfort on 02Sep2021. Concomitant medications included levothyroxine sodium (LEVOTHYROX) taken for an unspecified indication from 2008 to an unspecified stop date. On 28Sep2021, the patient experienced exacerbation of psoriasis/major flare-up with lesions on the scalp and body, arthritis reactive/pain and swelling in the joints of both hands, and disease recurrence. Time interval between beginning of drug administration and start of reaction/event: 27 days and time interval between last dose of drug and start of reaction/event:1 day, for events exacerbation of psoriasis and arthritis reactive. Time interval between beginning of drug administration and start of reaction/event: 1 day for disease recurrence and psoriasis. For treatment patient had Consultation and Corticosteroid therapy. The outcome of all the events was recovering. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101415200 Same patient, different events after different vaccine doses.


VAERS ID: 1834944 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 FG7387 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Paraesthesia, Vertigo, Vision blurred
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hospitalization (neurology department)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101384845

Write-up: dizziness sensation (vertigo); blurred vision; paraesthesia in the upper limbs; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-798299. A 32-year-old female patient received bnt162b2 (COMIRNATY), intramuscular in left arm on 28Sep2021 at 10:15 (Lot Number: FG7387, unknown expiration) as dose 1, 0.3 ml single at the age of 32 years old for COVID-19 immunisation. Medical history included hospitalisation from 30Aug2021 to 07Sep2021 in a neurology department. The patient''s concomitant medications were not reported. On 28Sep2021 (10 minutes after the vaccination), the patient experienced dizziness sensation (vertigo), blurred vision, and paraesthesia in the upper limbs. The patient received therapy with folates and Neuraben. The patient is recovering from the events. The events were assessed as serious (hospitalization). Reporter''s comment: The patient was admitted to the neurology department from 30Aug2021 to 07Sep2021 for check-ups. Batch/lot number: FG7387. Reaction/event as reported: About 10 minutes after anti-covid vaccination, experienced paraesthesia in the upper limbs, dizziness and sometimes blurred vision. Information on the lot/batch number has been requested.


VAERS ID: 1834973 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-28
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE; DELTACORTENE; BISOPROLOL FUMARATE; ENVARSUS; OMNIC; BACTRIM; CALCITRIOL; ACETYLSALICYLIC ACID; MYCOPHENOLIC ACID; VALGANCICLOVIR; BINOCRIT; FUROSEMIDE; DIBASE; OMEGA 3 TEVA; FOLINA [FOLIC ACID]; ROCALTROL; RAMIPRIL; OLEVIA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Dialysis (He previously contracted Covid-19, during a dialysis at the PRIVACY hospital, in December 2020.); Kidney transplant; Polycystic kidney
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101384783

Write-up: severe pain in the lower back; loss of sensation in the feet; subsequently the symptom spread to both legs; tingling sensation in the hands; This is a spontaneous report from a contactable consumer or other non-healthcare professional downloaded from the IT-MINISAL02-798810. A 45-years-old male patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: FG6273; Expiration Date: 30Nov2021), via intramuscular route, administered in left arm (left shoulder) on 11Sep2021 at 14:40 as dose 1, single for COVID-19 immunisation. The patient''s medical history included polycystic kidney (patient with polycystic kidney (ADPKD) who underwent a kidney transplant on 30May2021), kidney transplant on 30May2021 {(new kidney in iliac fossa, old kidneys still in place) at the privacy}, COVID-19 in Dec2020 (the patient previously contracted COVID-19, during a dialysis at the privacy hospital, in December 2020), dialysis in Dec2020 (the patient previously contracted Covid-19, during a dialysis at the privacy hospital, in December 2020). Concomitant medication(s) included pantoprazole (PANTOPRAZOLE); prednisone (DELTACORTENE); bisoprolol fumarate (BISOPROLOL FUMARATE); tacrolimus monohydrate (ENVARSUS); tamsulosin hydrochloride (OMNIC); sulfamethoxazole, trimethoprim (BACTRIM); calcitriol (CALCITRIOL); acetylsalicylic acid (ACETYLSALICYLIC ACID); epoetin alfa (BINOCRIT); furosemide (FUROSEMIDE); colecalciferol (DIBASE); esters of unsaturated fatty acids (OMEGA 3 TEVA); folic acid [FOLINA (FOLIC ACID)}; calcitriol (ROCALTROL); ramipril (RAMIPRIL); omega-3 triglycerides (OLEVIA); all were taken for an unspecified indication, start and stop date were not reported and mycophenolic acid (MYCOPHENOLIC ACID) taken for transplant rejection; valganciclovir (VALGANCICLOVIR) taken as antiviral treatment; start and stop date were not reported. On 28Sep2021, the patient experienced severe pain in the lower back associated with loss of sensation in the feet; subsequently the symptom spread to both legs with further tingling sensation in the hands. He was hospitalized for the reported event from 01Oct2021 to unknown date. The outcome of all events was not recovered. Health authority comment: patient with polycystic kidney (ADPKD) who underwent a kidney transplant on 30May2021 (new kidney in iliac fossa, old kidneys still in place) at the PRIVACY. He previously contracted Covid-19, during a dialysis at the PRIVACY hospital, in December 2020. In post-transplant recovery, she followed the immunosuppressive drug treatment indicated in the therapeutic plan consisting of several and numerous drugs. Simultaneously with the drug treatment, she is st. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1835096 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal growth restriction, Maternal exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal 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: Test Name: Ultrasound scan; Result Unstructured Data: Test Result:unknown result; Comments: I get additional ultrasounds to monitor growth; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:the placenta looked ''messy'' and there were bloods; Comments: the placenta looked ''messy'' and there were bloodspots between the placenta and uterus. The baby was also a week behind in the growth curve. Went from the 90th to the 11th percentile.
CDC Split Type: NLPFIZER INC202101406879

Write-up: Maternal exposure during pregnancy; Fetal growth retardation; This is a spontaneous report from a contactable consumer (parent). This is second of two reports.The first is a spontaneous report from a contactable consumer report downloaded from the regulatory authority, regulatory authority number is NL-LRB-00696602. A fetus patient of an unspecified gender received BNT162B2 (COMIRNATY), via transplacental on 28Sep2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had maternal exposure during pregnancy. The patient experienced fetal growth retardation on 28Sep2021 with outcome of unknown. The patient''s ultrasound scan showed that the placenta looked messy and there were bloods on the placenta and there were bloodspots between the placenta and uterus. The baby was also a week behind in the growth curve (reported as went from the 90th to the 11th percentile). No follow-up attempts possible. No further information expected. Information about LOT/Batch number can not be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101384451 mother case


VAERS ID: 1835849 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-28
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20213

Write-up: Perimyocarditis; This case was received via regulatory authority (Reference number: FI-FIMEA-20215620) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Perimyocarditis) in a 17-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. In September 2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced MYOCARDITIS (Perimyocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Perimyocarditis) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter No treatment information was provided. Company comment: This is a regulatory case concerning a 17 year-old, male patient with NO clinical history who experienced the expected serious event of MYOCARDITIS (AESI) The event occurred on unknown day after the FIRST dose of Spikevax. The rechallenge is unknown as per no information is available at the time of the report. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 17 year-old, male patient with NO clinical history who experienced the expected serious event of MYOCARDITIS (AESI) The event occurred on unknown day after the FIRST dose of Spikevax. The rechallenge is unknown as per no information is available at the time of the report. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1837499 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
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: Asthenia, Chills, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (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: AUPFIZER INC202101402775

Write-up: Syncope; Asthenia; Chills; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 643102. A 24-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 28Sep2021, the patient experienced asthenia, chills and syncope. It was reported "COMIRNATY COVID-19 vaccine (BNT162b2 (mRNA)) -Suspect (1 days); COMIRNATY COVID-19 vaccine (BNT162b2 (mRNA)) - Suspect (22 days)". Outcome of the events were recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1837501 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
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: Contusion, Epistaxis, Heavy menstrual bleeding, Petechiae, Pruritus, Purpura, Thrombocytopenia
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Accidents and injuries (narrow), Hypersensitivity (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: AUPFIZER INC202101402896

Write-up: Thrombocytopenia; Epistaxis; Heavy menstrual bleeding; Petechiae; Contusion; Pruritus; Purpura; This is a spontaneous report from a contactable health professional via the , regulatory authority report number 643458. A 38-year-old female patient received BNT162B2 (COMIRNATY), dose number unknown, via an unspecified route of administration on an unspecified date (Batch/Lot number unknown) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 28Sep2021, the patient experienced contusion, epistaxis, heavy menstrual bleeding, petechiae, pruritus, purpura and thrombocytopenia. The outcome of events contusion, epistaxis, heavy menstrual bleeding, petechiae, pruritus, purpura and thrombocytopenia was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1837826 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PERINDOPRIL; ROSUVASTATIN; PANTOPRAZOLE; FUROSEMIDE; MEBEVERINE; AMLODIPINE; GLICLAZIDE
Current Illness: Diabetes mellitus; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101384628

Write-up: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (RA)WEB, regulatory authority number EE-SAM-531721100115. A 72-year-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: ER9480; Expiration Date: 31Jul2021) via intramuscular route of administration on 13May2021 as dose 2, 0.3 ml single and received first dose COMIRNATY, solution for injection, Lot Number: EW6126; Expiration Date: 31Jul2021); via intramuscular route of administration on an unspecified date as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included ongoing hypertension and ongoing diabetes mellitus. Concomitant medications included perindopril for unknown indication, start and stop date were not reported, rosuvastatin for unknown indication, start and stop date were not reported, pantoprazole for unknown indication, start and stop date were not reported, furosemide for unknown indication, start and stop date were not reported, mebeverine for unknown indication, start and stop date were not reported, amlodipine for unknown indication, start and stop date were not reported, gliclazide for unknown indication, start and stop date were not reported. On 28Sep2021, the patient developed COVID infection and drug ineffective. SARS-CoV-2 PCR test was positive on the same day. The course of the disease was mild, the patient was recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Sep2021.The outcome of the events was recovering. The following Conclusion report received from team: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lots ER9480; expiration date: 31Jul2021 and EW6126; expiration date:31Jul2021. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Health Authority Comment: Serious (medically significant) vaccine ineffectiveness report. The causal relationship is considered possible. No follow-up attempts possible. No further information expected.


VAERS ID: 1838009 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   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 FG3739 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Full blood count, Headache, Immunisation reaction, Liver function test, Vertigo
SMQs:, Vestibular disorders (narrow), Arthritis (broad)

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: Test Date: 20210928; Test Name: afebrile; Result Unstructured Data: Test Result:afebrile; Test Date: 20210928; Test Name: Complete blood count; Result Unstructured Data: Test Result:normal; Test Date: 20210928; Test Name: liver function findings; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC202101395047

Write-up: Reactogenicity event; arthralgia; vertigo; headache; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-RN20213086. A 36-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 27Sep2021 (Lot Number: FG3739) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced reactogenicity event (disability) on 28Sep2021 with outcome of recovering, arthralgia (non-serious) on 28Sep2021 with outcome of recovering, vertigo (non-serious) on 28Sep2021 with outcome of recovering, headache (non-serious) on 28Sep2021 with outcome of recovering. The day after vaccination on 28Sep2021, a reactogenicity event with onset of arthralgia, vertigo and headache. The female patient is afebrile. Complete blood count and liver function findings normal. Medical consultation and commencement of treatment with Tanganil for 10 days. Sick leave from 28Sep2021 to 11Oct2021. Event in the process of recovery on the date of reporting.


VAERS ID: 1838138 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-09-28
   Days after vaccination:6
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: Diarrhoea, Dysmenorrhoea, Pain, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101401170

Write-up: pain; vomiting; diarrhoea; Painful periods; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110171246028400-DAMCC, Safety Report Unique Identifier is GB-MHRA-ADR 26085421. A 18-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection) (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 22Sep2021 at dose 2, single for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (COMIRNATY), via unspecified route of administration on an unknown date (Lot number: Unknown) for COVID-19 immunization. The patient medical history was not reported not had symptoms associated with COVID-19. The patients concomitant medications were not reported. The patient experienced pain and vomiting, diarrhoea on an unspecified date and painful periods on 28Sep2021, It was the start of her period and the amount of pain was considerably worse than any other period came with vomiting from the pain and also diarrhoea. All events are medically significant. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unknown date No - Negative COVID-19 test. The outcome of the event painful periods was recovered on 29Sep2021, diarrhoea was unknown and recovering for other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1838221 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 FG3716 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Immunisation, Off label use, 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101417488

Write-up: severe skin reaction; rash; Skin rash; come back raging/rash getting worse and spreading; Off label use; Booster; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is -202110191926346260-GABDP. Safety Report Unique Identifier GB-MHRA-ADR 26094287. A 45-years-old non pregnant female patient received third dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: FG3716) via an unspecified route of administration on 28Sep2021 (at the age of 45-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included deep vein thrombosis from May2019 to an unknown date. Not taking any long term medication, no significant or long term health conditions. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. The patient concomitant medications were not reported. On an unspecified date, the patient experienced severe skin reaction, rash/skin rash, come back raging/rash getting worse and spreading. On 28Sep2021, the patient experienced off label use and booster. Therapeutic measures were taken because of severe skin reaction (rash), rash (rash), skin rash (rash), come back raging/rash getting worse and spreading (condition aggravated) with Severe skin reaction 2 calls to 111, 3 GP conversations and appointments. Tried Fexofenadine 120mg followed by 5 days of steroids. Rash subsided on steroids but has now come back raging. GP prescribed Chlorphenamine but rash getting worse and spreading. The outcome of the events severe skin reaction, rash, skin rash, come back raging/rash getting worse and spreading was not recovered. Reaction: Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "No". No follow-up attempts are needed. No further information is expected.


VAERS ID: 1838420 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 FF2782 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Dizziness, Electrocardiogram, Heart rate, Heart rate decreased, Oxygen saturation immeasurable, Visual impairment
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Respiratory failure (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atopy; Cosmetic allergy (patient had no allergies to products other than pharmaceuticals such as cosmetics.)
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:100/53; Comments: before vaccination; Test Name: BP; Result Unstructured Data: Test Result:98/50; Comments: after vaccination; Test Date: 20210928; Test Name: body temperature/BT; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210928; Test Name: ECG; Result Unstructured Data: Test Result:nothing particular; Test Name: HR; Result Unstructured Data: Test Result:66; Comments: before vaccination; Test Name: HR; Result Unstructured Data: Test Result:50; Comments: after vaccination; Test Name: SPO2; Test Result: 98 %; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101302611

Write-up: Aphose before eyes; Giddiness; blood pressure decreased; heart rate decreased; This is a spontaneous report from a contactable other Health Care Professional received from the regulatory Authority . Regulatory authority report number is v21128477 and from the same contactable other health professional response of follow up letter. A 21-year-old female patient received the second dose of BNT162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FF2782; Expiration Date: 30Nov2021), via intramuscular route of administration on 28Sep2021 at 15:53 (the day of vaccination) (at the age of 21-year-old), as dose 2, single in left arm for COVID-19 immunisation. Body temperature before vaccination was 36.8 degrees Centigrade on 28Sep2021. Medical history included atopy, allergies to cosmetics. The patient''s concomitant medications within 2 weeks were none. There was no vaccination within 4 weeks. The patient had no allergies to products other than pharmaceuticals such as cosmetics. There was no relevant test taken. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. On 28Sep2021 at 15:53 (the day of vaccination), the patient received second dose of BNT162b2 (COMIRNATY). The event onset date was reported as 28Sep2021 at 15:58 (5 minutes after the vaccination). The patient experienced anaphylaxis, aphose before eyes. The course of the event was as follows: 3 to 4 minutes (as reported) after the vaccination of second dose, giddiness appeared. (illegible character) existed according to monitor. After route secured, POLARAMINE intravenous drip administered. On 19Oct2021, it was reported that, on 28Sep2021 at 15:58 (5 minutes after the vaccination), the patient experienced Giddiness and required visit to Emergency room visit. The event did not require any initiation of new medication/other treatment procedure. The symptoms occurred in sudden. The patient was meeting category (5) level 5 which indicated Not anaphylaxis (confirmed not to meet prerequisites for diagnosis). The reporter described all the signs and symptoms (of anaphylaxis) as follows: Before vaccination, BT: 36.8 degrees Centigrade, HR 66, BP 100/53, SPO2 98%. After vaccination, HR 50, BP 98/50. The event required medical intervention included Antihistamine and IV fluids. Nothing particular on electrocardiogram (EKG). Symptoms eased after about 1 hour and the patient retuned home. On 28Sep2021 (same day at the vaccination), the outcome of the events (Aphose before eyes, Giddiness) was resolved; and outcome of all other events was unknown. The reporter classified the event as non-serious. The reporter did not assess the causality between the vaccine and the event. Follow-up (19Oct2021): New information received from the same contactable other health professional response of follow up letter included: updated information for event anaphylaxis, patient route of administration (intramuscular) and anatomical location (arm left) updated, onset time (15:58) for event giddiness updated, new events (blood pressure decreased, heart rate decreased) added and clinical information updated. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1838461 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-17
Onset:2021-09-28
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Basedow's disease, Hyperthyroidism, SARS-CoV-2 test, Thyrotoxic crisis
SMQs:, Optic nerve disorders (broad), Hyperthyroidism (narrow), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211013; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab
CDC Split Type: JPPFIZER INC202101402821

Write-up: Hyperthyroidism; Thyroid crisis; Basedow''s disease; This is a spontaneous report from a contactable pharmacist received via Regulatory Authority . A 36-year-old non-pregnant female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number: unable to locate or read the details), via intramuscular route of administration in left arm on 17Sep2021 at 15:00 (the day of vaccination) (at the age of 36-year-old, not pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number: unable to locate or read the details), via intramuscular route of administration in left arm on 27Aug2021 at 15:00 (at the age of 36-year-old) for COVID-19 immunization. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine or not. It was unknown prior to vaccination, whether the patient was diagnosed with COVID-19 or not. On 28Sep2021 (11 days after the vaccination), the patient experienced hyperthyroidism, thyroid crisis and Basedow''s disease. The patient underwent lab tests and procedures which included test of COVID-19 antigen test, test type was Nasal swab and the result was negative on 13Oct2021. The reporter stated the events result in hospitalized for 7 days. Therapeutic measures were taken as a result of hyperthyroidism, thyroid crisis, Basedow''s disease with drug administration. The outcome of the event was recovered with sequel with treatment including drug administration on an unspecified date in 2021. No follow up attempts are possible. No further information is expected. Sender''s Comments: Based on the information currently available,The casual association between the reported event "Hyperthyroidism ,Thyrotoxic crisis and Basedow''s disease"and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1838550 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-09-28
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 - / OT

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: 20210928; Test Name: COVID-19 virus RT-PCR test; Test Result: Positive ; Comments: International unit(s)
CDC Split Type: PTPFIZER INC202101433328

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable other healthcare professional downloaded from the regulatory authority-WEB, regulatory authority number PT-INFARMED-B202110-1092. A 40-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FF0688) via intramuscular route of administration, on 14Jul2021 as DOSE 2, 0.3 ML SINGLE for covid-19 immunization. The patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: FA4632) via intramuscular route of administration, on 16Jun2021 as DOSE 1, 0.3 ML SINGLE for covid-19 immunization. The patient''s medical history and concomitant medications was not reported. On 28Sep2021 the patient experienced covid-19, and vaccination failure. It was reported that, the patient manifested symptoms associated with COVID-19, namely ageusia. On 28Sep2021 the patient underwent lab tests and procedures which included COVID-19 virus RT-PCR test: positive result (Iu International unit(s). The outcome of the event COVID-19 was reported as unknown. Health authority comment: Other information- RT PCR test positive on 28Sep2021 Ageusia 1st vaccine dose on 16Jun2021, Lot FA4632 No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: RT PCR test positive on 28Sep2021 Ageusia 1st vaccine dose on 16Jun2021, Lot FA4632


VAERS ID: 1838560 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 FG6273 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Chest discomfort, Chest pain, Cold sweat, Dizziness, Erythema, Headache, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101398711

Write-up: Chest pressure; Pharynx itchy sensation; Asphyxia; Neck erythema; cold sweat; headache; dizziness; Chest pain; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. This is a report received regulatory authority report number PT-INFARMED-T202109-2990 with Safety Report Unique Identifier PT-INFARMED-T202109-2990. A 16-year-old female patient received the 1st dose of BNT162B2 (COMIRNATY, lot number: FG6273) via intramuscular on 28Sep2021 as 0.3 ml single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient presented with cold sweats, headache, dizziness, chest pain associated with the utilization of Comirnaty/mRNA vaccine against COVID-19 (with modified nucleoside), 30 mcg/0.3 ml. No information provided about past clinical history, nor previous infection with the SARS-CoV-2 virus. The adverse drug reactions (ADR) started on vaccination day for dose 1, lasting no more than 1 day. Unknown if the suspect medication was suspended or will be maintained, because of ADR. Drug interaction was not suspected. No history of previous ADR to other medication, nor known allergies. Specific treatment was required for ADR with adrenaline intramuscular (IM) and clemastine + hydrocortisone, 200mg. Additional data included events: Chest pressure, Pharynx itchy sensation of, Asphyxia, Localized erythema/ Neck erythema, all on 28Sep2021 with hospitalization. Outcome of the events was unknown. The reporter''s assessment of the causal relationship of the [Chest pressure, Pharynx itchy sensation of, Asphyxia, Localized erythema ] with the suspect product was: Source of assessment: Notifier, Method of assessment: Algorithm , Result of Assessment: definitive. No follow-up attempts are possible. No further information is expected.


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