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From the 1/14/2022 release of VAERS data:

Found 1,031,637 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

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VAERS ID: 1969123 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCUE1 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body mass index, Pain in extremity, Venous thrombosis limb
SMQs:, Embolic and thrombotic events, venous (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma; Calcaneal spur; Chondropathy (iliotibial band syndrome); Chronic pain; Edema legs; Essential hypertension (without indication of hypertensive crisis); Fatty liver (fatty degeneration, not elsewhere classified); Hypercholesterolemia; Lymphedema (stage II); Meniscal degeneration (Posterior horn of the medial meniscus); Mixed hyperlipidaemia; Obesity; Osteoarthritis; Prolapse; Stenosis (connective tissue or intervertebral discs: cervical region [cervicothoracic]); Varicose veins of lower extremities without mention of ulcer or inflammation
Allergies:
Diagnostic Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:35-40
CDC Split Type: DEPFIZER INC202101742833

Write-up: Left calf pain; Leg venous thrombosis; This is a spontaneous report received from a non-contactable reporter (Physician) from the regulatory authority -WEB. Regulatory number: DE-PEI-CADR2021205814. Other Case identifier(s): DE-CADRPEI-2021205814 (Webportal), DE-PEI-202100231522. A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Lot number: SCUE1) as dose number unknown,0.3 ml single for covid-19 immunisation. Relevant medical history included: "Prolapse of the nucleus pulposus" (unspecified if ongoing); "Stenosis of the intervertebral foramina" (unspecified if ongoing), notes: connective tissue or intervertebral discs: cervical region [cervicothoracic]; "Bronchial asthma" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Fatty liver" (unspecified if ongoing), notes: fatty degeneration, not elsewhere classified; "hypercholesterolemia" (unspecified if ongoing); "Varicosities of the lower extremities without ulceration or inflammation" (unspecified if ongoing); "Edema of the legs" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Chronic unmanageable pain" (unspecified if ongoing); "Calcaneus spur" (unspecified if ongoing); "meniscal damage" (unspecified if ongoing), notes: Posterior horn of the medial meniscus; "Chondropathy" (unspecified if ongoing), notes: iliotibial band syndrome; "Lymphedema of the lower extremities" (unspecified if ongoing), notes: stage II; "Mixed hyperlipidaemia" (unspecified if ongoing); "Essential hypertension" (unspecified if ongoing), notes: without indication of hypertensive crisis. The patient''s concomitant medications were not reported. The following information was reported: VENOUS THROMBOSIS LIMB (medically significant) with onset 22Nov2021, outcome "unknown", described as "Leg venous thrombosis"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Left calf pain". The patient underwent the following laboratory tests and procedures: body mass index: 35-40. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1969253 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG9428 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Hyperhidrosis, Myalgia, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101734286

Write-up: Tachycardia; Sweating increased; Tiredness; Headache; Myalgia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: ES-AEMPS-1059419 (AEMPS). A 45 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 (Lot number: FG9428) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Tiredness"; HEADACHE (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Headache"; MYALGIA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Myalgia"; TACHYCARDIA (medically significant) with onset 27Nov2021, outcome "unknown", described as "Tachycardia"; HYPERHIDROSIS (medically significant) with onset 27Nov2021, outcome "unknown", described as "Sweating increased". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969476 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling abnormal, Immunisation, Malaise, SARS-CoV-2 test, Vertigo, Visual field defect
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Optic nerve disorders (broad), Retinal disorders (broad), Vestibular disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101751757

Write-up: Vertigo; Patient received booster (third) dose; spaced out; unwell.; I felt like i was seeing things move in my peripheral vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112071741554560-35PMX. Other Case identifier(s): GB-MHRA-ADR 26299625. A 50 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Lot number: FH4751, Expiration Date: Feb2022) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLELot number: UNKNOWN Route of administration: Unspecified), administration date: 13May2021, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered"; Bnt162b2 (DOSE 1, SINGLELot number: UNKNOWN Route of administration: Unspecified), administration date: 26Feb2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "Patient received booster (third) dose"; FEELING ABNORMAL (medically significant) with onset 2021, outcome "not recovered", described as "spaced out"; VERTIGO (medically significant) with onset 23Nov2021, outcome "recovered" (24Nov2021), described as "Vertigo"; MALAISE (medically significant) with onset 2021, outcome "unknown", described as "unwell."; VISUAL FIELD DEFECT (medically significant) with onset 2021, outcome "unknown", described as "I felt like i was seeing things move in my peripheral vision". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test.The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101802138 same patient / different dose


VAERS ID: 1969813 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Migraine, Myalgia, Nausea, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Asthma; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: headache; Fatigue; Migraine headache; Fever chills; Nausea; Muscle ache; Painful arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26325087) on 13-Dec-2021 and was forwarded to Moderna on 13-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (Fatigue), PAIN IN EXTREMITY (Painful arm), MIGRAINE (Migraine headache), PYREXIA (Fever chills), NAUSEA (Nausea) and MYALGIA (Muscle ache) in a 46-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)) since an unknown date. Previously administered products included for Asthma: CLENIL MODULITE (Clenil Modulite inhaler - 50 micrograms and 2 puffs taken twice a day) in October 2021. Past adverse reactions to the above products included No adverse reaction with CLENIL MODULITE. Concurrent medical conditions included Asthma. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criteria disability and medically significant). On 23-Nov-2021, the patient experienced FATIGUE (Fatigue) (seriousness criteria disability and medically significant), MIGRAINE (Migraine headache) (seriousness criteria disability and medically significant), PYREXIA (Fever chills) (seriousness criteria disability and medically significant), NAUSEA (Nausea) (seriousness criteria disability and medically significant) and MYALGIA (Muscle ache) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criteria disability and medically significant). On 23-Nov-2021, NAUSEA (Nausea) had resolved. On 24-Nov-2021, MYALGIA (Muscle ache) had resolved. On 25-Nov-2021, FATIGUE (Fatigue) and PYREXIA (Fever chills) had resolved. On 28-Nov-2021, PAIN IN EXTREMITY (Painful arm) had resolved. On 05-Dec-2021, MIGRAINE (Migraine headache) had resolved. At the time of the report, HEADACHE (headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment details were not provided. 1st and 2nd COVID vaccinations were Astra Zeneca (end of Feb & mid May) and side effects after the first were moderate (fatigue, headache, sore arm) and less so after the second. Flu jab in mid Nov was fine, bit of a sore arm for 2-3 days. Side effects after the Moderna Booster were much, much worse and the migraine like headache on the left side of her head was so worrying that she was about to contact GP / 111, but ironically felt too unwell to do so. The worst was over after 7 days, but to a lesser extend headaches came and went for a second week. Unable to work for 5 out of the first 7 days post jab. Company comment: This is a regulatory case concerning a 46 year-old, female patient with a history of Asthma, concomitant Steroid therapy (beclometasone dipropionate), administration of influenza vaccine in mid november and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine AstraZeneca approximately 6 months prior), who experienced the serious (due to medically important condition and disability) unexpected, according data set, events of headache, fatigue, pain in extremity, migraine, pyrexia, nausea and myalgia. Events were assessed as serious by the Regulatory Authority. The events fatigue, migraine, pyrexia, nausea and myalgia occurred approximately 1 day after the booster dose of mRNA-1273 vaccine; the event pain in extremity the same day and the event headache on an unknown date. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The medical history, of Asthma, concomitant Steroid therapy (beclometasone dipropionate), administration of influenza vaccine in mid november and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine AstraZeneca approximately 6 months prior) remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 46 year-old, female patient with a history of Asthma, concomitant Steroid therapy (beclometasone dipropionate), administration of influenza vaccine in mid november and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine AstraZeneca approximately 6 months prior), who experienced the serious (due to medically important condition and disability) unexpected, according to data set, events of headache, fatigue, pain in extremity, migraine, pyrexia, nausea and myalgia. Events were assessed as serious by the Regulatory Authority. The events fatigue, migraine, pyrexia, nausea and myalgia occurred approximately 1 day after the booster dose of mRNA-1273 vaccine; the event pain in extremity the same day and the event headache on an unknown date. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The medical history, of Asthma, concomitant Steroid therapy (beclometasone dipropionate), administration of influenza vaccine in mid november and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine AstraZeneca approximately 6 months prior) remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1969885 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 4004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Stomach pain; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26324914) on 13-Dec-2021 and was forwarded to Moderna on 13-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and ABDOMINAL PAIN UPPER (Stomach pain) in a 60-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 4004732) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 22-Dec-2019 to 14-Jan-2020. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 23-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant). On 24-Nov-2021, PYREXIA (Fever) had resolved. On 28-Nov-2021, ABDOMINAL PAIN UPPER (Stomach pain) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by reporter No treatment medications provided by the reporter. Company Comment - This regulatory authority case concerns a 60-year-old male patient with no details on relevant medical history, who experienced the unexpected serious (medically significant) events of abdominal pain upper and pyrexia after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule. The event pyrexia occurred on the same day after the third dose of mRNA- 1273 vaccine and abdominal pain upper occurred approximately 1 day after the vaccination. The rechallenge was not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 60-year-old male patient with no details on relevant medical history, who experienced the unexpected serious (medically significant) events of abdominal pain upper and pyrexia after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule. The event pyrexia occurred on the same day after the third dose of mRNA- 1273 vaccine and abdominal pain upper occurred approximately 1 day after the vaccination. The rechallenge was not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 1969911 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Immunisation, Influenza, 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: 20211129; Test Name: PCR test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101757990

Write-up: Flu; Lack of Effect; COVID-19; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 (Lot number: FK9413, Expiration Date: 28Feb2022) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturers unknown, Dose 1), for COVID-19 Immunisation; Covid-19 vaccine (Manufacturers unknown, Dose 2), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 29Nov2021, outcome "unknown", described as "Lack of Effect"; COVID-19 (medically significant) with onset 29Nov2021, outcome "unknown", described as "COVID-19"; IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "Booster"; INFLUENZA (non-serious), outcome "unknown", described as "Flu". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) positive. It was reported that the patient was given the Pfizer booster on 22Nov (so my third dose) and caught covid 7 days later, confirmed via PCR test this morning. Currently feeling like having the flu. Summary of Investigation: The Regulatory Authority investigation could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. All reviewed records for the involved batch indicated that the batch met the established requirements at time of release. No impact assessment is required according to SOP-67372 v9.0. No corrective or preventive actions were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release. Conclusion: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The 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 determined to be the associated lot(s) of the reported lot FK9413. 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. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The Regulatory Authority determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969969 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN ACA5778 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Fatigue, Headache, Pyrexia, Vaccination site pain, Vaccination site warmth
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypothyreosis (Hypothyroidism)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRJNJFOC20211238578

Write-up: Burning sensation; Headache; Fatigue; Fever; Vaccination site burning; Vaccination site warmth; This spontaneous report received from a consumer by a Regulatory Authority (regulatory authority, HR-HALMED-300052752) concerned a 38 year old female. The patient''s weight was 65 kilograms, and height was not reported. The patient''s concurrent conditions included: hypothyreosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: ACA5778 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 22-NOV-2021 for covid-19 immunisation (Dose number in series 1). No concomitant medications were reported. On 22-NOV-2021, the patient experienced vaccination site burning, vaccination site warmth, fatigue, and fever. On 23-NOV-2021, the patient experienced burning sensation, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from fever on 24-NOV-2021, and was recovering from burning sensation, vaccination site burning, vaccination site warmth, headache, and fatigue. This report was serious (Other Medically Important Condition).


VAERS ID: 1969987 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Diarrhoea, Fatigue, Headache, Heart rate, Insomnia, Muscular weakness, Myalgia, Peripheral swelling, Tachycardia, Tinnitus
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cervical radiculopathy; Hypothyroidism; Psoriasis; Psoriatic arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: Heart rate; Result Unstructured Data: Test Result:120 BPM (tachycardia)
CDC Split Type: IEPFIZER INC202101762101

Write-up: Swelling in the arm; Sleeplessness; Legs weakness; Chest pain; Muscle pain; Diarrhoea; Headache; Tachycardia 120 BPM; Joint pain; Tinnitus of both ears; Feeling tired; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority-WEB. Regulatory number: IE-HPRA-2021-087209 (RA). Other Case identifier: IE-HPRA-CVARR2021112322819 (RA). A 43 year-old male patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Lot number: FH8469) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Cervical radiculopathy" (unspecified if ongoing); "Psoriatic arthritis" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (medically significant) with onset 22Nov2021 20:00, outcome "not recovered", described as "Swelling in the arm"; INSOMNIA (medically significant) with onset 22Nov2021 20:00, outcome "not recovered", described as "Sleeplessness"; MUSCULAR WEAKNESS (medically significant) with onset 22Nov2021 20:00, outcome "not recovered", described as "Legs weakness"; CHEST PAIN (medically significant) with onset 22Nov2021 20:00, outcome "not recovered", described as "Chest pain"; MYALGIA (medically significant) with onset 22Nov2021 20:00, outcome "not recovered", described as "Muscle pain"; DIARRHOEA (medically significant) with onset 22Nov2021 20:00, outcome "not recovered", described as "Diarrhoea"; HEADACHE (medically significant) with onset 22Nov2021 20:00, outcome "not recovered", described as "Headache"; TACHYCARDIA (medically significant) with onset 22Nov2021 20:00, outcome "not recovered", described as "Tachycardia 120 BPM"; ARTHRALGIA (medically significant) with onset 22Nov2021 20:00, outcome "not recovered", described as "Joint pain"; TINNITUS (medically significant) with onset 22Nov2021 20:00, outcome "not recovered", described as "Tinnitus of both ears"; FATIGUE (medically significant) with onset 22Nov2021 20:00, outcome "not recovered", described as "Feeling tired". The patient underwent the following laboratory tests and procedures: heart rate: (22Nov2021) 120 bpm (tachycardia). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969992 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Gingival swelling, Immunisation, Interchange of vaccine products, Lip swelling, Off label use, Pain of skin, Rash, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101762044

Write-up: Sore, itchy hives over her trunk, back and arms; Sore, itchy hives over her trunk, back and arms; Broad itchy rash / rash appered in 5 to 10 mins; Off label use; Interchange of vaccine products; Booster; Swollen lips and gums; Broad itchy rash / rash appered in 5 to 10 mins; Swollen lips and gums; This is a spontaneous report received from a contactable reporter (Pharmacist) from the Regulatory Authority-WEB. Regulatory number: IE-HPRA-2021-087264 (HPRA). Other Case identifier: IE-HPRA-CVARR2021112422837 (HPRA). A 56-year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Lot number: FH8469) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER: Unknown, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Vaxzevria (DOSE NUMBER: Unknown, batch number: unknown, rash post vaccination with Vaxzevria, which required hospitalization, Start Date of Reaction: 2021), for COVID-19 immunization, reaction(s): "Rash"; Vaxzevria (DOSE NUMBER: Unknown, batch number: unknown, had a worse reaction to Vaxzevria), for COVID-19 immunization, reaction(s): "worse reaction". The following information was reported: OFF LABEL USE (medically significant) with onset 22Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "Booster"; GINGIVAL SWELLING (medically significant), LIP SWELLING (medically significant) all with onset 22Nov2021, outcome "recovered" and all described as "Swollen lips and gums"; RASH (medically significant), RASH PRURITIC (medically significant) all with onset 22Nov2021, outcome "recovered" and all described as "Broad itchy rash / rash appered in 5 to 10 mins"; PAIN OF SKIN (medically significant), URTICARIA (medically significant) all with onset 24Nov2021, outcome "not recovered" and all described as "Sore, itchy hives over her trunk, back and arms". Therapeutic measures were taken as a result of gingival swelling, rash, lip swelling, pain of skin, urticaria, rash pruritic. The patient was treated with cetirizine (brand unknown) and Telfast (fexofenadine). Clinical course: the reporter stated that on 22Nov2021 after vaccination (5 minutes later) the patient developed a broad itchy rash. It progressed to swollen lips and gums. After taking cetirizine (brand unspecified), it reduced completely. Two days later, on 24Nov2021, the patient came back with sore, itchy hives over her trunk, back and arms. It had not reduced with cetirizine (brand unspecified). The out-of-hours doctor recommended Telfast, but there was no change after taking it. The General Practitioner was contacted for steroids, to prevent a hospital admission and the patient was waiting for a prescription, at the time of reporting. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1970022 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006322 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Chest pain, Haematemesis, Pyrexia
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: This case was received via Agency (Reference number: IT-MINISAL02-816257) on 13-Dec-2021 and was forwarded to Moderna on 13-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of HAEMATEMESIS in a 26-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3006322) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Nov-2021, the patient experienced HAEMATEMESIS (seriousness criterion medically significant), CHEST PAIN, ABDOMINAL PAIN UPPER and PYREXIA. At the time of the report, HAEMATEMESIS, CHEST PAIN, ABDOMINAL PAIN UPPER and PYREXIA 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 case concerns a 26 year-old male patient with no reported medical history who experienced the unexpected serious event of hematemesis. The event occurred approximately 2 days after vaccination with mRNA-1273 vaccine, the dose sequence number was not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. The report comes from the Regulatory Authority study. All the data in our possession has already been entered.; Sender''s Comments: This case concerns a 26 year-old male patient with no reported medical history who experienced the unexpected serious event of hematemesis. The event occurred approximately 2 days after vaccination with mRNA-1273 vaccine, the dose sequence number was not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1970056 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Laryngeal oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: GLOTTIS EDEMA; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-817095) on 14-Dec-2021 and was forwarded to Moderna on 14-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LARYNGEAL OEDEMA (GLOTTIS EDEMA) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Hypertension. On 22-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced LARYNGEAL OEDEMA (GLOTTIS EDEMA) (seriousness criterion life threatening). At the time of the report, LARYNGEAL OEDEMA (GLOTTIS EDEMA) was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not provided. Company comment: This is a regulatory case concerns a 48-year-old patient of unknown gender, with no relevant medical history, who experienced the unexpected, serious (life threatening) event of Laryngeal oedema. The event occurred on the same day after receiving an unknown dose number of mRNA-1273 vaccine. By the time of the report, the patient was still recovering. The rechallenge was not applicable, as dose number is unknown. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.; Reporter''s Comments: 02/12/2021 Pharmacovigilance asked if available minutes PS. Pending; Sender''s Comments: This is a regulatory case concerns a 48-year-old patient of unknown gender, with no relevant medical history, who experienced the unexpected, serious (life threatening) event of Laryngeal oedema. The event occurred on the same day after receiving an unknown dose number of mRNA-1273 vaccine. By the time of the report, the patient was still recovering. The rechallenge was not applicable, as dose number is unknown. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.


VAERS ID: 1970106 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-22
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Venous thrombosis limb
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101742956

Write-up: booster; Left common femoral vein thrombosis extended to saphenous vein, superficial femoral vein and popliteal vein; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: IT-MINISAL02-817687 (MINISAL02). A 92 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left (Lot number: FG3739, Expiration Date: 29Nov2021) as dose 3 (booster),single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (2nd dose Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization), outcome "unknown", described as "booster"; VENOUS THROMBOSIS LIMB (hospitalization) with onset 22Nov2021, outcome "recovering", described as "Left common femoral vein thrombosis extended to saphenous vein, superficial femoral vein and popliteal vein". Therapeutic measures were taken as a result of venous thrombosis limb included anticoagulant therapy. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1970154 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-06
Onset:2021-11-22
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, CSF cell count, CSF glucose, CSF protein, CSF protein abnormal, CSF white blood cell count, Epstein-Barr virus antibody, Facial paralysis, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Taste disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Taste and smell disorders (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Hearing impairment (broad), Immune-mediated/autoimmune disorders (narrow), 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, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211203; Test Name: Anti-GM1 antibody test; Result Unstructured Data: Test Result:Negative; Test Date: 20211203; Test Name: Anti-GQ1b antibody test; Result Unstructured Data: Test Result:Negative; Test Date: 20211203; Test Name: Cerebrospinal fluid test; Test Result: 2 uL; Test Date: 20211203; Test Name: Cerebrospinal fluid test; Test Result: 76 mg/dl; Test Date: 20211203; Test Name: Cerebrospinal fluid test; Test Result: 76 mg/dl; Test Date: 20211203; Test Name: Cerebrospinal fluid test; Result Unstructured Data: Test Result:Protein-cytological dissociation present; Test Date: 20211203; Test Name: total cerebrospinal fluid white blood cell count; Result Unstructured Data: Test Result:50 cells/mcL; Test Date: 20211203; Test Name: EB virus IgM; Result Unstructured Data: Test Result:positive
CDC Split Type: JPPFIZER INC202101792078

Write-up: left facial palsy / right facial palsy; numbness of the left leg/ numbness of the limbs; Bilateral and flaccid muscular weakness in the upper or lower limbs; Taste disorder; Guillain-barre syndrome; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: v21132161. A 19-year and 7-month-old male patient received bnt162b2 (COMIRNATY, Solution for injection), administration date 06Nov2021 (the day of vaccination) (Batch/Lot number: unknown) via an unspecified route of administration as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient had no family history. Vaccination history included: Bnt162b2 (The 1st dose, MANUFACTURER UNKNOWN), administration date: 16Oct2021 (the day of vaccination), for COVID-19 immunisation. Body temperature before vaccination was unknown. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, disability, medically significant) with onset 22Nov2021 (16 days after vaccination), outcome "not recovered", described as "Guillain-barre syndrome"; FACIAL PARALYSIS (hospitalization, disability, medically significant) with onset 29Nov2021, outcome "not recovered", described as "left facial palsy / right facial palsy"; TASTE DISORDER (hospitalization, disability) with onset 22Nov2021, outcome "not recovered", described as "Taste disorder"; HYPOAESTHESIA (hospitalization, disability) with onset 24Nov2021, outcome "not recovered", described as "numbness of the left leg/ numbness of the limbs"; MUSCULAR WEAKNESS (hospitalization, disability) with onset 22Nov2021, outcome "not recovered", described as "Bilateral and flaccid muscular weakness in the upper or lower limbs". The patient was hospitalized for guillain-barre syndrome, facial paralysis, taste disorder, hypoaesthesia, muscular weakness (start date: 03Dec2021, discharge date: 11Dec2021, hospitalization duration: 8 day(s)). The patient underwent the following laboratory tests and procedures: antibody test: (03Dec2021) negative; (03Dec2021) negative; csf cell count: (03Dec2021) 2 uL; csf glucose: (03Dec2021) 76 mg/dl; csf protein: (03Dec2021) 76 mg/dl; csf protein abnormal: (03Dec2021) protein-cytological dissociation present; csf white blood cell count: (03Dec2021) 50 cells/mcl; epstein-barr virus antibody: (03Dec2021) positive. Therapeutic measures were taken as a result of guillain-barre syndrome, facial paralysis, taste disorder, hypoaesthesia, muscular weakness. The course of the event was as follows: On 22Nov2021, Taste disorder appeared. On 24Nov2021, numbness of the left leg appeared. On 26Nov2021 numbness of the limbs appeared. On 29Nov2021, left facial Nerve paralysis appeared. On 02Dec2021, right facial Nerve paralysis appeared. The patient was admitted to this hospital from 03Dec2021 to 11Dec2021 with a diagnosis of Guillain-Barre syndrome. intravenous immunoglobulin; IVIg was administered, and the symptom showed a tendency of recovery. The reporting physician classified the event as serious (Disability, hospitalized from 03Dec2021 to 11Dec2021) and the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was unknown. The reporting physician commented as follows: As EB virus IgM positive was observed, the cause may be both preceding infection with EB virus and COVID-19 vaccine. There is a considerable possibility of the vaccine. GBS Investigation Form information as follows: Clinical symptoms: On 22Nov2021, Bilateral and flaccid muscular weakness in the upper or lower limbs appeared. Other symptoms was reported as facial diplegia with paresthesia(A subtype of Guillain Barre. A subtype of Guillain Barre due to COVID-19 vaccination reported in many overseas cases). The Hughes Functional Grading Scale scores in the worst phase of disease until this report was reported as Minor symptoms or signs of neuropathy. Course of disease: Disease showing a monophasic pathological pattern with the interval of 12 hours to 28 days between the onset of muscular weakness and the nadir, followed by clinically stable phase (This option should be selected based on the course until this report). Electrophysiological study was performed on 03Dec2021. Consistent with GBS: Decreased M wave amplitude and Other findings consistent with GBS. Cerebrospinal fluid test was performed on 03Dec2021. Cell count 2/uL, Glucose 76mg/dL, Protein76 mg/dL. Protein-cytological dissociation present(Increased cerebrospinal fluid protein level above the laboratory reference range and total cerebrospinal fluid white blood cell count below 50 cells/mcL). Differential diagnosis was performed. Imaging examination (Magnetic resonance imaging (MRI)) was not performed. Autoantibody test was performed on 03Dec2021. Anti-GM1 antibody test and Anti-GQ1b antibody test showed Negative. There was no Preceding infection. On 03Dec2021 (27 days after the vaccination), the patient was admitted to the hospital(discharged on 11Dec2021). On 11Dec2021 (35 days after the vaccination), the outcome of the event was not recovered. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1970172 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-22
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0115 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Eye haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retinal 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: LVPFIZER INC202101763569

Write-up: Eye haemorrhage; This is a spontaneous report received from a contactable reporter (Consumer) from the Agency WEB. Regulatory number: LV-SAM-2021117171 (RA). A 50 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 12Nov2021 (Lot number: FK0115) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: EYE HAEMORRHAGE (medically significant) with onset 22Nov2021 16:00, outcome "recovering", described as "Eye haemorrhage". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1970177 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Erythema multiforme, Skin reaction
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MTPFIZER INC202101698266

Write-up: severe skin reaction; angio-neurotic oedema; A generalized erythema multiforme; This is a spontaneous report received from contactable reporter(s) (Physician) from License Party. A 28 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (First Dose, Batch/lot not available), administration date: 29Oct2021, for Covid-19 immunization. The following information was reported: SKIN REACTION (hospitalization) with onset 22Nov2021, outcome "recovered" (30Nov2021), described as "severe skin reaction"; ANGIOEDEMA (medically significant) with onset 22Nov2021, outcome "unknown", described as "angio-neurotic oedema"; ERYTHEMA MULTIFORME (medically significant) with onset 22Nov2021, outcome "unknown", described as "A generalized erythema multiforme". The patient was hospitalized for skin reaction (start date: 23Nov2021, discharge date: 27Nov2021, hospitalization duration: 4 day(s)). The event "severe skin reaction" was evaluated at the physician office visit. Therapeutic measures were taken as a result of skin reaction. Clinical Course: Severe skin reaction which required 4 days of hospitalization, consultant to get all her medical follow-up. A generalized erythema multiforme and angio-neurotic oedema just 3 days after the 2nd dose. She needed hospital admission for IV steroids and antihistamines, on the 30th November her symptoms had fully settled and was on a tapering steroid dose. Now the Physician wants to know if there are some tests to check if there are tests recommended by Pfizer to check allergies for excipients in Comirnaty, because she''s anxious to take the booster and the physician has written an exemption but he''s worried that it won''t be recognized abroad. The lot number for bnt162b2 was not provided and will be requested during follow up. Follow-up (16Dec2021): This is a spontaneous follow-up report received from contactable reporter (Physician) from License Party. Updated information includes: Patient Initials, Historical vaccine, Vaccine administration date, Physician office visit, Treatment received, Event. Follow-up attempts completed, information about batch number cannot be obtained.; Sender''s Comments: Based on the available information in the case, the causal association between the events skin reaction, angioedema, erythema multiforme and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1972183 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101753837

Write-up: Painful mass in the left axillary region; Off-label use; 2x Spikevax, 1x Comirnaty; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: BE-FAMHP-DHH-N2021-109833 (Regulatory Authority). Spontaneous COVID-19 report received by the authorities on 24Nov2021. A 42 year-old male patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Lot number: FH8469) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Spikevax (dose 2), administration date: 10Mar2021, for COVID-19 immunisation; Spikevax (dose 1), administration date: 10Feb2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (disability) with onset 22Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 22Nov2021, outcome "unknown", described as "2x Spikevax, 1x Comirnaty"; IMMUNISATION (disability) with onset 22Nov2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (disability) with onset 23Nov2021, outcome "not recovered", described as "Painful mass in the left axillary region". Therapeutic measures were taken as a result of axillary pain included Paracetamol 2x/day. Reporter''s comments: Treatment - Yes Paracetamol 2x/day Evolution of the ADR - No improvement ADR description - Painful mass in the left axillary region Comirnaty - Pfizer/BioNTech [22Nov2021](3)(FH8469) COVID-19 VACCINE MODERNA [10Mar2021](2)(300042722) COVID-19 VACCINE MODERNA [10Feb2021](1)(300042722) No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - Yes Paracetamol 2x/day Evolution of the ADR - No improvement ADR description - Painful mass in the left axillary region Comirnaty - Pfizer/BioNTech [22/11/2021](3)(FH8469) COVID-19 VACCINE MODERNA [10/03/2021](2)(300042722) COVID-19 VACCINE MODERNA [10/02/2021](1)(300042722)


VAERS ID: 1972515 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Confusional state, General physical health deterioration, Immunisation, Malaise, Mobility decreased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm (Some years ago); Heart disease, unspecified (Some years ago); Heart failure; Stent placement
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101803992

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): 108729 (Biontech). A 93 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 93 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "slight heart failure" (unspecified if ongoing); "aneurysm" (unspecified if ongoing), notes: Some years ago; "treated in the heart" (unspecified if ongoing), notes: Some years ago; "stent placement" (unspecified if ongoing). The patient took concomitant medications (many medications such as blood thinners). Vaccination history included: Comirnaty (1st dose), administration date: 13Apr2021, when the patient was 92 years old, for Covid-19 immunisation; Comirnaty (2nd dose), administration date: 05May2021, when the patient was 92 years old, for Covid-19 immunization, reaction(s): "general condition worsened", "restricted mobility in the hands", "confusion", "malaise", "weakness". The following information was reported: IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "Booster"; MOBILITY DECREASED (medically significant) with onset Dec2021, outcome "not recovered", described as "restricted mobility in the hands"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) with onset Dec2021, outcome "not recovered", described as "general condition worsened"; CONFUSIONAL STATE (non-serious) with onset Dec2021, outcome "not recovered", described as "confusion"; MALAISE (non-serious) with onset Dec2021, outcome "not recovered", described as "malaise"; ASTHENIA (non-serious) with onset Dec2021, outcome "not recovered", described as "weakness". Clinical course included 2 weeks after booster vaccination, patient had the same symptoms that occurred after the second vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101782600 Same patient/event/product, different dose


VAERS ID: 1973120 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure abnormal, Blood pressure measurement, Immunisation, Influenza like illness, Interchange of vaccine products, Myalgia, Off label use, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Hypertension (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Allergies:
Diagnostic Lab Data: Test Name: Blood Pressure; Result Unstructured Data: Test Result:206/110 mmHg; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101768462

Write-up: aching muscles; Aching joints; Abnormal blood pressure readings; Flu like symptoms; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112091842037370-ERX2L (RA). Other Case identifier(s): GB-MHRA-ADR 26314002 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr... The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1: MANUFACTUERER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (Dose 2: MANUFACTUERER UNKNOWN), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 22Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "Booster"; INFLUENZA LIKE ILLNESS (medically significant) with onset 23Nov2021, outcome "recovered" (29Nov2021), described as "Flu like symptoms"; MYALGIA (non-serious), outcome "unknown", described as "aching muscles"; ARTHRALGIA (non-serious), outcome "unknown", described as "Aching joints"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "Abnormal blood pressure readings". The event "abnormal blood pressure readings" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: 206/110 mmHg; sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient reported aching muscle and joints. Abnormal blood pressure readings for two days around 3 days after the booster readings of 206/110 which caused me to seek medical help from an out of hours surgery. 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. This case did not relate to possible inflammation of the heart (myocarditis or pericarditis). Onset latency for Flu like symptoms was 01 day. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1973130 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Immunisation, Interchange of vaccine products, Nasal discomfort, Nasopharyngitis, Off label use, Oropharyngeal pain
SMQs:, Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101768492

Write-up: sore throat; Cold; Blocked nose since having it and still not better currently; Stomach cramps; off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112091904507690-JJVFZ (RA). Other Case identifier(s): GB-MHRA-ADR 26314025 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 22Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "Booster"; OROPHARYNGEAL PAIN (medically significant), outcome "not recovered", described as "sore throat"; ABDOMINAL PAIN UPPER (medically significant) with onset 22Nov2021, outcome "recovering", described as "Stomach cramps"; NASOPHARYNGITIS (medically significant), outcome "unknown", described as "Cold"; NASAL DISCOMFORT (medically significant), outcome "unknown", described as "Blocked nose since having it and still not better currently". Clinical course: it was reported that patient had Stomach craps, cold, blocked nose since having it and still not better currently and sore throat. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1973426 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6270 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Hepatitis B, Hepatitis B DNA assay, Hepatitis B antigen, Hepatosplenomegaly, Incorrect route of product administration, Magnetic resonance imaging, Mononucleosis heterophile test, Myocarditis, Ultrasound abdomen
SMQs:, Liver related investigations, signs and symptoms (narrow), Liver infections (narrow), Drug abuse and dependence (broad), Cardiomyopathy (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatitis B; Mononucleosis
Allergies:
Diagnostic Lab Data: Test Date: 20211129; Test Name: Monotest and IgG; Result Unstructured Data: Test Result:positive antibodies for elevated HBV PCR; Test Date: 20211129; Test Name: HBV PCR; Result Unstructured Data: Test Result:elevated; Test Date: 20211129; Test Name: MRI; Result Unstructured Data: Test Result:picture compatible with myocarditis; Comments: Positive cardiac MRI for picture compatible with myocarditis; Test Date: 20211129; Test Name: Monotest; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211129; Test Name: Echo abdomen; Result Unstructured Data: Test Result:Mild hepatosplenomegaly
CDC Split Type: ITPFIZER INC202101763580

Write-up: Associated with HBV infection with mild hepatosolenomegaly; Associated with HBV infection with mild hepatosolenomegaly; Acute perimyocarditis 24 hours after the second dose of Pfizer COVID-19 vaccine; Inappropriate route of vaccination; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB. Regulatory number: IT-MINISAL02-818266 (MINISAL02). A 20 year-old male patient received bnt162b2 (COMIRNATY), intradermal, administered in arm left, administration date 22Nov2021 (Lot number: FG6270, Expiration Date: 31Dec2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mononucleosis" (unknown if ongoing); "Hepatitis B" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, single, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (hospitalization, medically significant) with onset 22Nov2021, outcome "unknown", described as "Inappropriate route of vaccination"; MYOCARDITIS (hospitalization, medically significant) with onset 28Nov2021, outcome "recovering", described as "Acute perimyocarditis 24 hours after the second dose of Pfizer COVID-19 vaccine"; HEPATITIS B (hospitalization, medically significant), HEPATOSPLENOMEGALY (hospitalization), outcome "unknown" and all described as "Associated with HBV infection with mild hepatosolenomegaly". The event "acute perimyocarditis 24 hours after the second dose of pfizer covid-19 vaccine" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: hepatitis b antigen: (29Nov2021) positive antibodies for elevated hbv pcr; hepatitis b dna assay: (29Nov2021) elevated; magnetic resonance imaging: (29Nov2021) picture compatible with myocarditis, notes: Positive cardiac MRI for picture compatible with myocarditis; mononucleosis heterophile test: (29Nov2021) unknown results; ultrasound abdomen: (29Nov2021) mild hepatosplenomegaly. Therapeutic measures were taken as a result of myocarditis. Reporter Comment: Immediately after second dose vaccine COVID-19 Pfizer access in ER for chest pain. Admission to cardiology with final diagnosis of perimyocarditis. Associated with HBV infection with mild hepatosplenomegaly. Sender comment: 06Dec2021 Local Center of Pharmacovigilance requested control of ADR onset date, sending medical reports. Pending 09Dec2021 Regional Center of Pharmacovigilance: this reporting form is updated from NON SERIOUS to SERIOUS as the suspected adverse reaction described represents a clinically relevant event predicted from the IME list. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Immediately after second dose vaccine COVID-19 Pfizer access in ER for chest pain. Admission to cardiology with final diagnosis of perimyocarditis. Associated with HBV infection with mild hepatosolenomegaly


VAERS ID: 1973815 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-22
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: 20211122; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202101775567

Write-up: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory number: PT-INFARMED-T202111-1945 (INFARMED). A 73 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 20Jun2021 (Lot number: FC5435) as dose 2, 0.3 ml single and (Batch/Lot number: unknown) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 22Nov2021, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 22Nov2021, outcome "unknown", described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) positive, notes: positive Iu international unit(s). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1973830 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Headache, Lymphadenopathy, Malaise, Myalgia, Nasal congestion, Oropharyngeal pain, Rhinorrhoea, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PULMICORT FLEXHALER; SEROQUEL SR; RIVOTRIL; BRINTELLIX; LOVENOX [LEVOFLOXACIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atheromatosis; Bronchiectasis; Emphysema pulmonary; Hernia; Hypocoagulable state (With Lovenox 40); Sinusitis; Thrombophilia (Due to proteins deficiency); Varicose vein
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101753836

Write-up: Headache; LOW BACK GIVEN WITH RADIATION TO THE BUTTOCKS AND LEG; APPEARANCE OF GANGLIO IN THE ARMPIT OF THE ARM WHERE THE VACCINE WAS ADMINISTERED WITH RADIATION TO THE BREAST; Pain throat; Asthenia; Arthralgia; Chills; Myalgia; Vaccination site pain; Nasal discharge; Congestion nasal; Malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. The reporter is the patient. Regulatory number: PT-INFARMED-V202112-450 (INFARMED). A 46 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 (Lot number: FF2382) as dose number unknown, 0.3ml single for covid-19 immunisation. Relevant medical history included: "Pulmonary Emphysema" (unspecified if ongoing); "Bronchiectasis" (unspecified if ongoing); "Thrombophilia" (unspecified if ongoing), notes: Due to proteins deficiency; "HYPOCOAGULATED" (unspecified if ongoing), notes: With Lovenox 40; "Atheromatosis of the iliaca" (unspecified if ongoing); "Hernia Discal L4, L5 S1" (unspecified if ongoing); "Varices" (unspecified if ongoing); "Sinusitis" (unspecified if ongoing). Concomitant medication(s) included: PULMICORT FLEXHALER; SEROQUEL SR; RIVOTRIL; BRINTELLIX; LOVENOX [LEVOFLOXACIN]. The following information was reported: VACCINATION SITE PAIN (medically significant) with onset 22Nov2021, outcome "recovered" (30Nov2021), described as "Vaccination site pain"; BACK PAIN (medically significant) with onset 26Nov2021, outcome "not recovered", described as "LOW BACK GIVEN WITH RADIATION TO THE BUTTOCKS AND LEG"; CHILLS (medically significant) with onset 23Nov2021, outcome "recovered" (30Nov2021), described as "Chills"; ASTHENIA (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Asthenia"; ARTHRALGIA (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Arthralgia"; HEADACHE (medically significant) with onset 01Dec2021, outcome "recovered" (01Dec2021), described as "Headache"; RHINORRHOEA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Nasal discharge"; NASAL CONGESTION (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Congestion nasal"; MALAISE (medically significant) with onset 22Nov2021, outcome "recovered", described as "Malaise"; LYMPHADENOPATHY (medically significant) with onset 25Nov2021, outcome "recovered" (30Nov2021), described as "APPEARANCE OF GANGLIO IN THE ARMPIT OF THE ARM WHERE THE VACCINE WAS ADMINISTERED WITH RADIATION TO THE BREAST"; OROPHARYNGEAL PAIN (medically significant) with onset 25Nov2021, outcome "recovering", described as "Pain throat"; MYALGIA (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Myalgia". Therapeutic measures were taken as a result of vaccination site pain, back pain, chills, asthenia, arthralgia, headache, rhinorrhoea, nasal congestion, malaise, lymphadenopathy, oropharyngeal pain, myalgia. The events appeared after administration of the suspected drug lasting 7 days for chills, 8 days for vaccination site pain, 5 days for adenopathy, 1 day for headache, the remaining reactions persist . Specific treatment of reactions with paracetamol 1000, local ice, gargles with green Tantun, Brufen 400, Nasomet nasal spray and sea water. The patient improved with the treatment. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1973870 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Chest pain, Chills, Dizziness, Dyspnoea, Fatigue, Headache, Immunisation, Lymphadenopathy, Pyrexia, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (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: SEPFIZER INC202101763379

Write-up: Swollen lymph nodes; Headache; Difficulty breathing; Fatigue; Chills; Pain in the chest; Dizziness; Fever; Arrhythmia; Booster; Pain at the vaccination site; This is a spontaneous report received from a contactable reporter (Consumer) Regulatory number: SE-MPA-2021-095627. Other Case identifier(s): SE-VISMA-1638396126966. A 47 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Lot number: 31134TB) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose, lot number: EL0725), administration date: 03Feb2021, for COVID-19 immunisation; Comirnaty (2nd dose, lot number: EP2166), administration date: 02Mar2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "Booster"; ARRHYTHMIA (medically significant) with onset 23Nov2021, outcome "unknown", described as "Arrhythmia"; LYMPHADENOPATHY (non-serious) with onset 24Nov2021, outcome "recovered" (28Nov2021), described as "Swollen lymph nodes"; HEADACHE (non-serious) with onset 23Nov2021, outcome "unknown", described as "Headache"; DYSPNOEA (non-serious) with onset 23Nov2021, outcome "recovered" (28Nov2021), described as "Difficulty breathing"; VACCINATION SITE PAIN (non-serious) with onset 22Nov2021, outcome "recovered" (27Nov2021), described as "Pain at the vaccination site"; FATIGUE (non-serious) with onset 23Nov2021, outcome "recovered" (28Nov2021), described as "Fatigue"; CHILLS (non-serious) with onset 23Nov2021, outcome "recovered" (28Nov2021), described as "Chills"; CHEST PAIN (non-serious) with onset 23Nov2021, outcome "unknown", described as "Pain in the chest"; DIZZINESS (non-serious) with onset 23Nov2021, outcome "recovered" (28Nov2021), described as "Dizziness"; PYREXIA (non-serious) with onset 23Nov2021, outcome "recovered" (27Nov2021), described as "Fever". Clinical course: headache, chest pain and arrhythmia. Recovered without damage to fever, swollen lymph nodes, fatigue, dizziness, pain at the vaccination site, chills and difficulty breathing. The case was judged not to be serious (as reported).No follow-up attempts are possible. No further information is expected.


VAERS ID: 1976930 (history)  
Form: Version 2.0  
Age: 3.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7898 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Off label use, Product use issue, Vaccination site inflammation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: ESPFIZER INC202101839779

Write-up: Angioedema; Vaccination site inflammation; Age at Time of Onset of Reaction: 45 months; Age at Time of Onset of Reaction: 45 months; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority-WEB. Regulatory number: ES-AEMPS-1071810. A 45 month-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 (Lot number: FG7898) at the age of 45 months as dose 2, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: ANGIOEDEMA (medically significant) with onset 22Nov2021, outcome "recovered" (23Nov2021), described as "Angioedema"; VACCINATION SITE INFLAMMATION (non-serious) with onset 22Nov2021, outcome "recovered" (23Nov2021), described as "Vaccination site inflammation"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 22Nov2021, outcome "unknown" and all described as "Age at Time of Onset of Reaction: 45 months". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1977102 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-24
Onset:2021-11-22
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram thorax, Dyspnoea, Fibrin D dimer, Fibrin D dimer increased, Hyponatraemia, Oxygen saturation, Oxygen saturation decreased, Pulmonary embolism, Respiration abnormal, Tachycardia
SMQs:, Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BISOPROLOL; COLECALCIFEROL; SERTRALINE
Current Illness: Anxiety; Knee osteoarthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Dizziness; Short-term memory loss
Allergies:
Diagnostic Lab Data: Test Date: 20211202; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:confirmed pulmonary embolism; Test Date: 2021; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:2.49; Test Date: 2021; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: GBPFIZER INC202101770391

Write-up: admitted with decreasing oxygen saturation (SATs) on exertion; Pulmonary embolism (PE) confirmed on computed tomography pulmonary angiogram (CTPA); Abnormal breathing; Hyponatremia; increasing shortness of breath (SOB) over 3-4 weeks; Tachycardia; found to have a riased D dimer of 2.49; This is a spontaneous report received from a contactable reporter (Physician) from the Regulatory Agency. Regulatory number: GB-MHRA-EMIS-2725-f991a7a4-4e5b-4aec-88c7-881288473522. Other Case identifier(s): GB-MHRA-ADR 26313732. A 85 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 24Oct2021 (Batch/Lot number: unknown) as dose number unknown, 30 ug single for covid-19 immunisation. Relevant medical history included: "Anxiety" (ongoing); "Short-term memory loss", start date: 12Aug2021, stop date: 15Sep2021; "Dizziness", start date: 02Jun2021, stop date: 01Jul2021; "Knee osteoarthritis", start date: 22Dec2020 (ongoing). Concomitant medication(s) included: BISOPROLOL, start date: 22Sep2021, stop date: 23Sep2021; COLECALCIFEROL taken for anxiety, start date: 02Nov2021; SERTRALINE taken for anxiety, start date: 02Nov2021; INFLUENZA VIRUS taken for influenza immunisation, administration date 16Nov2021. The following information was reported: PULMONARY EMBOLISM (life threatening) with onset 02Dec2021, outcome "not recovered", described as "Pulmonary embolism (PE) confirmed on computed tomography pulmonary angiogram (CTPA)"; DYSPNOEA (life threatening) with onset 2021, outcome "unknown", described as "increasing shortness of breath (SOB) over 3-4 weeks"; OXYGEN SATURATION DECREASED (hospitalization, life threatening) with onset 2021, outcome "unknown", described as "admitted with decreasing oxygen saturation (SATs) on exertion"; TACHYCARDIA (life threatening) with onset 2021, outcome "unknown", described as "Tachycardia"; FIBRIN D DIMER INCREASED (life threatening) with onset 2021, outcome "unknown", described as "found to have a riased D dimer of 2.49"; RESPIRATION ABNORMAL (life threatening) with onset 02Dec2021, outcome "not recovered", described as "Abnormal breathing"; HYPONATRAEMIA (life threatening) with onset 22Nov2021, outcome "not recovered", described as "Hyponatremia". The patient underwent the following laboratory tests and procedures: computerised tomogram thorax: (02Dec2021) confirmed pulmonary embolism; fibrin d dimer: (2021) 2.49; oxygen saturation: (2021) decreased. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1977122 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA LOT 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Postmenopausal haemorrhage, Uterine pain, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; EVOREL CONTI; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: uterine discomfort; stomach cramps; Vaginal bleeding; Vaccination site pain; Aching joints; Fatigue; This case was initially received via regulatory authority (Reference number: GB-MHRA-ADR 26262330) on 02-Dec-2021. The most recent information was received on 15-Dec-2021 and was forwarded to Moderna on 15-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Vaginal bleeding), UTERINE PAIN (uterine discomfort), ABDOMINAL PAIN UPPER (stomach cramps), VACCINATION SITE PAIN (Vaccination site pain), ARTHRALGIA (Aching joints) and FATIGUE (Fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. LOT 3004732) for COVID-19 immunisation. Previously administered products included for Product used for unknown indication: 003189.01.012 in 2014, 000635.01.014, COVID-19 MRNA VACCINE BNT162B2 and 000454.01.013; for HRT: EVOREL CONTI on 05-Apr-2019; for COVID-19 vaccination: COVID-19 MRNA VACCINE BIONTECH on 28-Feb-2021. Past adverse reactions to the above products included Break through bleeding with EVOREL CONTI; No adverse event with 000454.01.013, 000635.01.014 and 003189.01.012; and Vaccination site pain with COVID-19 MRNA VACCINE BIONTECH and COVID-19 MRNA VACCINE BNT162B2. Concomitant products included ESTRADIOL, NORETHISTERONE ACETATE (EVOREL CONTI) from 05-Apr-2019 to an unknown date for HRT, ASPIRIN [ACETYLSALICYLIC ACID] from 01-Jan-2016 to an unknown date for Prevention, INFLUENZA VACCINE (INFLUENZA VIRUS) from 07-Oct-2021 to 07-Oct-2021 for Vaccination. On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 25-Nov-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Vaginal bleeding) (seriousness criterion medically significant). On an unknown date, the patient experienced UTERINE PAIN (uterine discomfort) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (stomach cramps) (seriousness criterion medically significant). On 23-Nov-2021, VACCINATION SITE PAIN (Vaccination site pain), ARTHRALGIA (Aching joints) and FATIGUE (Fatigue) had resolved. At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Vaginal bleeding) had not resolved and UTERINE PAIN (uterine discomfort) and ABDOMINAL PAIN UPPER (stomach cramps) was resolving. After 2 years stability on HRT medication Evorel Conti patches, patient experienced unexpected light vaginal bleeding and other period symptoms including stomach cramps. Prior to bleeding had pre-menstrual symptoms (including uterine discomfort) as previously experienced prior to the menopause. She was on HRT medication since 2014 initially Mirena coil and oestrogen patches (5 years duration) with no breakthrough bleeding, after first few weeks of starting this HRT regimen. Then she switched to Evorel Conti patches in April 2019, initial intermittent breakthrough bleeding for 4/5 months but stabilized since September 2019 with no menstrual symptoms so current symptoms are unexpected. Company Comment - This regulatory case concerns a 61-year-old, female patient with medical history of Evorel Conti (estradiol) use, who experienced the unexpected, serious (medically significant) events of postmenopausal haemorrhage, uterine pain, abdominal pain upper, vaccination site pain, arthralgia and fatigue. All events except uterine pain and abdominal pain upper which occurred on an unknown date, occurred 1 day after administration of the third dose of the Moderna mRNA-1273 vaccine. The event postmenopausal haemorrhage occurred 4 days after administration of the third dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. The rechallenge was not applicable as there are no plans for future dosing. The history of Evorel Conti use remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 15-Dec-2021: Follow up received as seriousness updated, suspect product indication updated and narrative was updated accordingly.; Sender''s Comments: This regulatory case concerns a 61-year-old, female patient with medical history of Evorel Conti (estradiol) use, who experienced the unexpected, serious (medically significant) events of postmenopausal haemorrhage, uterine pain, abdominal pain upper, vaccination site pain, arthralgia and fatigue. All events except uterine pain and abdominal pain upper which occurred on an unknown date, occurred 1 day after administration of the third dose of the Moderna mRNA-1273 vaccine. The event postmenopausal haemorrhage occurred 4 days after administration of the third dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. The rechallenge was not applicable as there are no plans for future dosing. The history of Evorel Conti use remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1977282 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; SARS-COV-2 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Stomach cramps; Nerve pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26334207) on 15-Dec-2021 and was forwarded to Moderna on 15-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramps) and NEURALGIA (Nerve pain) in a 41-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) and SARS-COV-2 VACCINE from 17-May-2021 to an unknown date for an unknown indication. On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced NEURALGIA (Nerve pain) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramps) was resolving and NEURALGIA (Nerve pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No medication history information was provided. Patient reported severe nerve pain in the legs and Buttocks worsening over the first five days. Severe diarrhea for one week with stomach cramps and loss of weight. Symptoms after two weeks still appear, and she was prescribed nerve pain medication. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment This case concerns a 41-year-old female patient with no reported medical history, who experienced the serious unexpected events of Abdominal pain upper and Neuralgia. The event of Neuralgia occurred one day after the third dose of mRNA-1273 vaccine while the event of Abdominal pain upper occurred on an unspecified date after the third dose of mRNA-1273 vaccine. The benefit -risk relationship of mRNA -1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 41-year-old female patient with no reported medical history, who experienced the serious unexpected events of Abdominal pain upper and Neuralgia. The event of Neuralgia occurred one day after the third dose of mRNA-1273 vaccine while the event of Abdominal pain upper occurred on an unspecified date after the third dose of mRNA-1273 vaccine. The benefit -risk relationship of mRNA -1273 vaccine is not affected by this report.


VAERS ID: 1977556 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Diarrhoea, Fatigue, Illness, Immunisation, Interchange of vaccine products, Off label use, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201204; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101770137

Write-up: Dose 1 and Dose 2: non-Pfizer Covid vaccine and Dose 3: Comirnaty; Dose 1 and Dose 2: non-Pfizer Covid vaccine and Dose 3: Comirnaty; dose 3 (booster); Diarrhea; Fever; Chills; Vomiting; Sickness; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112111824402000-0VQHX (MHRA). Other Case identifier(s): GB-MHRA-ADR 26323931 (MHRA). A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19" (unknown if ongoing), notes: Unsure when symptoms started, Unsure when symptoms stopped. Patient is not enrolled in clinical trial. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 22Nov2021, outcome "unknown" and all described as "Dose 1 and Dose 2: non-Pfizer Covid vaccine and Dose 3: Comirnaty"; IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "dose 3 (booster)"; DIARRHOEA (medically significant) with onset 2021, outcome "recovered" (2021), described as "Diarrhea"; PYREXIA (medically significant) with onset 2021, outcome "recovered" (2021), described as "Fever"; CHILLS (medically significant) with onset 2021, outcome "recovered" (2021), described as "Chills"; VOMITING (medically significant) with onset 2021, outcome "recovered" (2021), described as "Vomiting"; ILLNESS (medically significant) with onset 2021, outcome "recovered" (2021), described as "Sickness"; FATIGUE (medically significant) with onset 2021, outcome "recovered" (2021), described as "Fatigue". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (04Dec2020) no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Adverse reaction did not occur as a result of an exposure during pregnancy. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1977644 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chapped lips, Epistaxis, Feeling cold, Haemorrhage, Immunisation, Interchange of vaccine products, Malaise, Nasal disorder, Off label use, SARS-CoV-2 test, Vision blurred
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Medication errors (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Immunodeficiency (Taking other treatments or medicines, known to lower the immune response and i..)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101780186

Write-up: Chapped lips; Dose 1 and Dose 2:Non Pfizer COVID vaccine and Dose 3: Pfizer COVID vaccine; Dose 1 and Dose 2:Non Pfizer COVID vaccine and Dose 3: Pfizer COVID vaccine; Patient received third dose (booster) of bnt162b2; bleed; Blurred vision; Unwell; Feelings of cold; Small sores inside nostrils; blowing nose caused the sores to rupture and bleed slightly; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112130605505320-P74OQ (MHRA). Other Case identifier(s): GB-MHRA-ADR 26325706 (MHRA). A 52 year-old male patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, known to lower the immune response and i.. Patient did not have symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Past drug history included: Doxazosin; Eprosartan; Lansoprazole. Vaccination history included: Covid-19 vaccine (DOSE 2, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, manufacturer unknown), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 22Nov2021, outcome "unknown" and all described as "Dose 1 and Dose 2:Non Pfizer COVID vaccine and Dose 3: Pfizer COVID vaccine"; IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "Patient received third dose (booster) of bnt162b2"; HAEMORRHAGE (medically significant) with onset 2021, outcome "recovering", described as "bleed"; VISION BLURRED (non-serious) with onset 2021, outcome "recovering", described as "Blurred vision"; MALAISE (non-serious) with onset 2021, outcome "recovering", described as "Unwell"; CHAPPED LIPS (non-serious) with onset 24Nov2021, outcome "recovered" (06Dec2021), described as "Chapped lips"; FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "Feelings of cold"; NASAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Small sores inside nostrils"; EPISTAXIS (non-serious) with onset 2021, outcome "unknown", described as "blowing nose caused the sores to rupture and bleed slightly". Chapped lips and small sores inside nostrils which when blowing nose caused the sores to rupture and bleed slightly. Patient had a feeling of a cold. But patient was not really unwell. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Patient did not test positive for COVID-19 since having the vaccine. Clinical course: The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1977821 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA ON NHS RECORD / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Lower respiratory tract infection, Nasopharyngitis, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (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: COVID-19 VACCINE ASTRAZENECA
Current Illness: Pre-diabetic (Was pre-diabetic with a high BMI but have consciously lost a lot of weight this year and now have normal blood sugar levels according to blood tests arranged privately.); Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Body mass index high; Weight
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: chest infection; Coughing; Cold symptoms; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26330499) on 15-Dec-2021 and was forwarded to Moderna on 15-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COUGH (Coughing), NASOPHARYNGITIS (Cold symptoms) and LOWER RESPIRATORY TRACT INFECTION (chest infection) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. On NHS record) for an unknown indication. The patient''s past medical history included Suspected COVID-19 since 22-Nov-2021, Body mass index high and Weight. Concurrent medical conditions included Pre-diabetic (Was pre-diabetic with a high BMI but have consciously lost a lot of weight this year and now have normal blood sugar levels according to blood tests arranged privately.). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced COUGH (Coughing) (seriousness criterion medically significant) and NASOPHARYNGITIS (Cold symptoms) (seriousness criterion medically significant). On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (chest infection) (seriousness criterion medically significant). At the time of the report, COUGH (Coughing) and NASOPHARYNGITIS (Cold symptoms) had not resolved and LOWER RESPIRATORY TRACT INFECTION (chest infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant drug was reported. No treatment medications were provided. Patient was not currently breastfeeding. Cold and flu symptoms and fatigue for 3 weeks with a dry tickly cough that was getting worse. Have taken frequent LFD tests and a couple of PCRs - all negative but affecting sleep and work and wondering if this was a side effect or indication of something more serious or a chest infection. Company Comment: This case concerns a 42-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Cough, Nasopharyngitis and Lower respiratory tract infection. The events occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). All the events could be in connection with each other. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender''s Comments: This case concerns a 42-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Cough, Nasopharyngitis and Lower respiratory tract infection. The events occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). All the events could be in connection with each other. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 1978248 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Angioedema, Chest discomfort, Periorbital oedema, Scan, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: scan; Result Unstructured Data: Test Result:Nil compromised respiratory
CDC Split Type: NZPFIZER INC202101760262

Write-up: Anaphylactic reaction; facial angioedema; Chest discomfort; Periorbital oedema; Throat tightness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: AEFI-A-050836 (RA). A 50 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 22Nov2021 10:06, outcome "recovering", described as "Anaphylactic reaction"; ANGIOEDEMA (medically significant) with onset 22Nov2021 10:06, outcome "recovering", described as "facial angioedema"; CHEST DISCOMFORT (medically significant) with onset 22Nov2021 10:06, outcome "recovering", described as "Chest discomfort"; PERIORBITAL OEDEMA (medically significant) with onset 22Nov2021 10:06, outcome "recovering", described as "Periorbital oedema"; THROAT TIGHTNESS (medically significant) with onset 22Nov2021 10:06, outcome "recovering", described as "Throat tightness". The events "anaphylactic reaction", "facial angioedema", "chest discomfort", "periorbital oedema" and "throat tightness" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: scan: (22Nov2021) nil compromised respiratory. Therapeutic measures were taken as a result of anaphylactic reaction, angioedema, chest discomfort, periorbital oedema, throat tightness. Additional information: Reporters description of AEFI: 2 minutes after vaccination experienced tongue swelling, dry cough , facial angioedema. Obs - see scanned data. Nil compromised respiratory. Adrenaline 0.3ml ( 1:1000) ( B 950013 exp 11/21) given imL deltoid, as per instructions. Symptoms eased by 1008 am, obs remained stable, still slight cough . Symptoms started to return at 10.17 am. Adrenaline 0.3m ( 1:1000) as perr previous batch, given im right deltoid. Symptoms improved at 1021 am, however given adrenaline nebuliser at 1023am( 0.5ml in 5ml saline ). Nebulise complete at 10.30 am , with some ease in symptoms. However some swelling at back of tongue and chest tightness. Transferred to ED for observation at 1040 hrs. Needing further dose of adrenaline in ED, given by ED staff. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1978276 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Cough, Hyperhidrosis, Musculoskeletal pain, Nausea, Pyrexia, Rhabdomyolysis, Vomiting
SMQs:, Rhabdomyolysis/myopathy (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (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: Test Name: CK; Result Unstructured Data: Test Result:$g30000; Test Name: CK; Result Unstructured Data: Test Result:28,000
CDC Split Type: NZPFIZER INC202101760408

Write-up: Rhabdomyolysis; Cough; Hyperhidrosis; Musculoskeletal pain; Nausea; Pyrexia; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-052098 (MedSafe AEFI Case Number). A 24 year-old male patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: RHABDOMYOLYSIS (hospitalization, medically significant) with onset 22Nov2021, outcome "recovering", described as "Rhabdomyolysis"; COUGH (hospitalization) with onset 22Nov2021, outcome "recovering", described as "Cough"; HYPERHIDROSIS (hospitalization) with onset 22Nov2021, outcome "recovering", described as "Hyperhidrosis"; MUSCULOSKELETAL PAIN (hospitalization) with onset 22Nov2021, outcome "recovering", described as "Musculoskeletal pain"; NAUSEA (hospitalization) with onset 22Nov2021, outcome "recovering", described as "Nausea"; PYREXIA (hospitalization) with onset 22Nov2021, outcome "recovering", described as "Pyrexia"; VOMITING (hospitalization) with onset 22Nov2021, outcome "recovering", described as "Vomiting". The patient underwent the following laboratory tests and procedures: blood creatine phosphokinase: $g30000; 28,000.The patient was at the gym on Tuesday he changed his routine but denies that he was doing any excessive lifting. The patient had been doing a leg work out. He presented two days ago with thigh pain and dark urine with a CK of 28,000. The patient had increased his oral intake but started to feel unwell since Wednesday, today he had subjective fevers and sweats. The patient continues to had dark urine but denies any dysuria. The patient had complained of slight cough with a headache (nil meningism). Th patient also had nausea and vomiting today and had not been out of the city. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1978313 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Blood pressure measurement, Bronchospasm, Dyspnoea, Nervousness, Oxygen saturation, Tachycardia, Tachypnoea, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:stable; Test Name: O2 sats; Result Unstructured Data: Test Result:stable
CDC Split Type: NZPFIZER INC202101760466

Write-up: Anxiety; Bronchospasm; Slightly tachycardic; tachypnoeic; she had widespread wheeze; felt like she was shaking all over and then found it hard to breathe; felt like she was shaking all over and then found it hard to breathe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-051712 (MedSafe AEFI Case Number). A 59 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (hospitalization) with onset 22Nov2021 12:15, outcome "recovered" (2021), described as "Anxiety"; BRONCHOSPASM (hospitalization) with onset 22Nov2021 12:15, outcome "recovered" (2021), described as "Bronchospasm"; TACHYCARDIA (hospitalization) with onset 22Nov2021 12:15, outcome "recovered" (2021), described as "Slightly tachycardic"; TACHYPNOEA (hospitalization) with onset 22Nov2021 12:15, outcome "recovered" (2021), described as "tachypnoeic"; WHEEZING (hospitalization) with onset 22Nov2021 12:15, outcome "recovered" (2021), described as "she had widespread wheeze"; DYSPNOEA (hospitalization), NERVOUSNESS (hospitalization) all with onset 22Nov2021 12:15, outcome "recovered" (2021) and all described as "felt like she was shaking all over and then found it hard to breathe". The patient underwent the following laboratory tests and procedures: blood pressure measurement: stable; oxygen saturation: stable. Clinical course: Reporters description of AEFI: felt like she was shaking all over and then found it hard to breathe. When examined at 1255 she had widespread wheeze and was tachypnoeic. Slightly tachycardic but blood pressure and O2 sats stable. No swelling/angioedema. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1978336 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Lymphadenopathy, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101765241

Write-up: Pirexia; Tremor; Lymphadenopathy cervical/ Lymphadenopathy axillary; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority-WEB. Regulatory number: PT-INFARMED-J202111-2062. A 53 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 (Lot number: FF2382) as dose 3 (booster), 0.3ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (Dose 1, 0.3 mL single, Batch/lot number: not reported), for covid-19 immunization; Comirnaty (Dose 2, 0.3 mL single, Batch/lot number: not reported), for covid-19 immunization. The following information was reported: PYREXIA (disability) with onset 23Nov2021, outcome "not recovered", described as "Pirexia"; TREMOR (disability) with onset 23Nov2021, outcome "not recovered", described as "Tremor"; LYMPHADENOPATHY (disability) with onset 23Nov2021, outcome "not recovered", described as "Lymphadenopathy cervical"; LYMPHADENOPATHY (disability) with onset 23Nov2021, outcome "not recovered", described as "Lymphadenopathy axillary"; IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "Booster". Therapeutic measures were taken as a result of pyrexia, tremor, lymphadenopathy, lymphadenopathy. Clinical course: Specific treatment of the reaction with anti-inflammatory action was implemented in 6 hours, but the reaction persists. A history of reaction with previous doses of the suspected vaccine is unknown. No history of adverse reaction to other drugs is known. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1979653 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-22
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Subdural haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (broad)

Life 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: ESPFIZER INC202101773390

Write-up: Intracranial subdural haematoma, Right fronto-parietal subdural hematoma; Progressive loss of strength in the left half of the body; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: ES-AEMPS-1065712 (RA). A 75 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 12Nov2021 (Lot number: Unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SUBDURAL HAEMATOMA (hospitalization) with onset 22Nov2021, outcome "recovering", described as "Intracranial subdural haematoma, Right fronto-parietal subdural hematoma"; ASTHENIA (non-serious), outcome "unknown", described as "Progressive loss of strength in the left half of the body". Therapeutic measures were taken as a result of subdural haematoma. Clinical course was reported as on 22Nov2021, patient had no known trauma and was presented with a progressive loss of strength in left half of the body. Patient had required hospital admission for surgical drainage of the hematoma and was recovering as of 04Dec2021. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1979782 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Asthenia, Blood creatine phosphokinase, Blood electrolytes, Blood pressure measurement, Body temperature, C-reactive protein, Cardiac tamponade, Chest pain, Discomfort, Echocardiogram, Electrocardiogram, Full blood count, Heart rate, Hepatic cytolysis, Immunisation, Loss of consciousness, Malaise, Pyrexia, Renal function test, Tachycardia, Troponin
SMQs:, Torsade de pointes/QT prolongation (broad), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial septal defect repair
Allergies:
Diagnostic Lab Data: Test Date: 20211201; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:4; Test Date: 20211201; Test Name: creatine kinase; Result Unstructured Data: Test Result:Negative; Test Date: 20211201; Test Name: Electrolyte balance; Result Unstructured Data: Test Result:Normal; Test Date: 20211201; Test Name: Blood pressure; Result Unstructured Data: Test Result:13/9; Comments: no drop in blood pressure while lying down; Test Date: 20211122; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade; Comments: fever; Test Date: 20211201; Test Name: C-reactive protein; Result Unstructured Data: Test Result:42; Test Date: 20211201; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:circumferential pericardial effusion 20 mm in; Comments: latero-left ventricle, 20 mm in apical, 16 mm in latero-right ventricle and 20 mm in latero-right atrium. Paradoxical septum, slight right ventricle and right atrium collapse. latero-left ventricle, 20 mm in apical, 16 mm in latero-right ventricle and 20 mm in latero-right atrium. Paradoxical septum, slight right ventricle and right atrium collapse. Inferior vena cava dilated to 30 mm, noncompliant, significant mitral flow variation; Test Date: 20211201; Test Name: Electrocardiography; Result Unstructured Data: Test Result:Sinus rhythm 85 bpm; Comments: normal QRS complexes, slight inferior ST depression; Test Date: 20211201; Test Name: Blood count; Result Unstructured Data: Test Result:Normal; Test Date: 20211201; Test Name: Heart rate; Result Unstructured Data: Test Result:90-100 bpm; Comments: Tachycardia; Test Date: 20211201; Test Name: Hepatic cytolysis; Result Unstructured Data: Test Result:x3; Test Date: 20211201; Test Name: Renal function; Result Unstructured Data: Test Result:Good; Test Date: 20211201; Test Name: Troponin; Result Unstructured Data: Test Result:6$g 9
CDC Split Type: FRPFIZER INC202101779477

Write-up: Pericardial tamponade; Booster; Loss of consciousness; 6 episodes of malaise; Tachycardia at 90-100 bpm; Chest pain; Feeling of discomfort; fever 39 C; Asthenia; This is a spontaneous report received from a contactable reporter (Pharmacist) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-MP20219038. A 48 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Atrial septal defect repair", start date: 2016 (not ongoing). The patient''s concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; COVID-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 22Nov2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 22Nov2021, outcome "unknown", described as "fever 39 C"; ASTHENIA (non-serious) with onset 22Nov2021, outcome "unknown", described as "Asthenia"; CHEST PAIN (non-serious) with onset 27Nov2021, outcome "unknown", described as "Chest pain"; DISCOMFORT (non-serious) with onset 27Nov2021, outcome "unknown", described as "Feeling of discomfort"; MALAISE (non-serious) with onset 01Dec2021, outcome "unknown", described as "6 episodes of malaise"; TACHYCARDIA (non-serious) with onset 01Dec2021, outcome "unknown", described as "Tachycardia at 90-100 bpm"; LOSS OF CONSCIOUSNESS (medically significant) with onset 01Dec2021, outcome "unknown", described as "Loss of consciousness"; CARDIAC TAMPONADE (hospitalization) with onset 02Dec2021, outcome "recovering", described as "Pericardial tamponade". The patient was hospitalized for immunisation, cardiac tamponade (start date: Dec2021, discharge date: 07Dec2021). The patient underwent the following laboratory tests and procedures: body temperature: (22Nov2021) 39 Centigrade, notes: fever; alanine aminotransferase: (01Dec2021) 4; blood creatine phosphokinase: (01Dec2021) negative; blood electrolytes: (01Dec2021) normal; blood pressure measurement: (01Dec2021) 13/9, notes: no drop in blood pressure while lying down; C-reactive protein: (01Dec2021) 42; echocardiogram: (01Dec2021) circumferential pericardial effusion 20 mm in, notes: latero-left ventricle, 20 mm in apical, 16 mm in latero-right ventricle and 20 mm in latero-right atrium. Paradoxical septum, slight right ventricle and right atrium collapse. latero-left ventricle, 20 mm in apical, 16 mm in latero-right ventricle and 20 mm in latero-right atrium. Paradoxical septum, slight right ventricle and right atrium collapse. Inferior vena cava dilated to 30 mm, noncompliant, significant mitral flow variation; electrocardiogram: (01Dec2021) sinus rhythm 85 bpm, notes: normal QRS complexes, slight inferior ST depression; full blood count: (01Dec2021) normal; heart rate: (01Dec2021) 90-100 bpm, notes: Tachycardia; hepatic cytolysis: (01Dec2021) x3; renal function test: (01Dec2021) good; troponin: (01Dec2021) 6$g 9. Therapeutic measures were taken as a result of cardiac tamponade which included Colchimax, Aspirin and Acupan (if needed). Clinical course: HISTORY OF THE DISEASE: Pfizer vaccine 3rd dose on 22Nov, since then fever 39 C, important asthenia. 27Nov2021: on exertion, chest pain and feeling of discomfort, improved after stopping exertion. 01Dec2021: chest pain and 6 episodes of malaise with loss of consciousness preceded by prodromes. Examination: chest pain increased on deep inspiration, relieved by bending forward. Blood pressure 13/9, no drop in blood pressure while lying down, tachycardia at 90-100 bpm. Eupnoeic on oxygen with nasal cannulas. No right or left heart failure signs. Regular heart sounds, no murmurs, no audible rubbing. Electrocardiography: Sinus rhythm 85 bpm, normal QRS complexes, slight inferior ST depression. Transthoracic echocardiography: circumferential pericardial effusion 20 mm in latero-left ventricle, 20 mm in apical, 16 mm in latero-right ventricle and 20 mm in latero-right atrium. Paradoxical septum, slight right ventricle and right atrium collapse. Inferior vena cava dilated to 30 mm, noncompliant, significant mitral flow variation. Preserved left ventricular ejection fraction, no disturbance of segmental or global kinetics except paradoxical septum. Low left ventricular filling pressures. No significant aortic or mitral valve disease. Good right ventricle function. Blood test: Troponin 6$g 9, creatine kinase negative, C-reactive protein 42, alanine aminotransferase 4, hepatic cytolysis x3, good renal function, no electrolyte disorders, normal blood count Outcome: abundant pericardial effusion with echographic and clinical signs of poor tolerance (malaise), post vaccination against COVID a Pericardial drainage of haematic fluid, 500 ml removed, disappearance of the pericardial effusion on transthoracic echocardiography. Initiation of a treatment with Colchimax 1 tablet/day, Aspirin 1G x3/day, Acupan if needed. 02Dec2021 1st day post drainage, improvement. Preserved left ventricular ejection fraction, non-dilated non-hypertrophied left ventricle. No disorders of segmental motion. No significant mitral or aortic valvular disease. Normal left ventricular filling pressures. Right chambers not dilated. Good right ventricle function, tricuspid annular plane systolic excursion 19 mm and S waves at 13 cm/s. Compliant 22 mm inferior vena cava. No recorded tricuspid regurgitation; latero-right ventricle effusion 3 mm in diastole and maximum 8 mm. No apical or left chambers effusion. No impact on the right chambers. No impact on the mitral flow. On-site pericardial drainage which yielded 300 cc of liquid. 07Dec normal pericardium, discharged from hospital. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1979790 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Pregnancy test urine
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage; Pregnancy; Termination of pregnancy - medical (early 2021 pregnancy with Down''s syndrome)
Allergies:
Diagnostic Lab Data: Test Date: 20211111; Test Name: urine test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101773544

Write-up: Early miscarriage; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-NT20215470 (RA). A 41 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 20Nov2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Spontaneous miscarriage", start date: Aug2021 (unspecified if ongoing); "early 2021 pregnancy with Down''s syndrome summer 2021 with medical termination of pregnancy", start date: 2021 (unspecified if ongoing), notes: early 2021 pregnancy with Down''s syndrome; "early 2021 pregnancy with Down''s syndrome summer 2021 with medical termination of pregnancy", start date: 2021 (unspecified if ongoing). Date of last menstrual period: 16Oct2021. The patient was 5 weeks pregnant at the time of exposure to bnt162b2. The patient was 5 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 23Jul2022. The patient''s concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 22Nov2021, outcome "recovered" (23Nov2021), described as "Early miscarriage". The pregnancy resulted in spontaneous abortion. The patient underwent the following laboratory tests and procedures: pregnancy test urine: (11Nov2021) positive. Additional information: Two days after vaccination, the patient had an early spontaneous miscarriage on the night of 22Nov2021 to 23Nov2021. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1979882 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Blood test, Body temperature, Coma scale, Dizziness, Dysarthria, Electrocardiogram, Facial paralysis, Gastrointestinal examination, Heart rate, Hypertriglyceridaemia, Immunisation, Ischaemic stroke, Magnetic resonance imaging, Neurological examination, Oxygen saturation, Physical examination, Pulmonary physical examination, Rheumatological examination, Skin test, Urological examination, Vertigo
SMQs:, Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Vestibular disorders (narrow), Lipodystrophy (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: PRAVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of prostate; Alcohol abuse (Alcohol consumption: at least 2 glasses of red wine per meal.); Ex-tobacco user (Smoking cessation 30 years ago.); Forestier disease; Hypercholesterolaemia
Allergies:
Diagnostic Lab Data: Test Name: hemoglucotest; Result Unstructured Data: Test Result:114 g/l; Test Name: Blood pressure; Result Unstructured Data: Test Result:198/85 mmHg; Test Name: blood test; Result Unstructured Data: Test Result:normal; Test Name: Temperature; Result Unstructured Data: Test Result:36.9 degree Centigrade; Test Name: Glasgow score at 15; Result Unstructured Data: Test Result:Normal alertness; Comments: (Glasgow score 15), no headache. Visual field intact, no oculomotor disorder. Pupils equal, round and receptive to light. No sensory-motor deficit, no segmental ataxia. Fluent, informative and coherent speech, good temporal and spatial orientation. Minimal dysarthria (1).; Test Name: Stroke Scale at 1; Result Unstructured Data: Test Result:Doubts about fresh frozen plasma on the left. No; Comments: Doubts about fresh frozen plasma on the left. No sensory-motor deficit. No clear dysarthria. Clinicians suggest right lateropontine ischemic stroke due to proximal basilar trunk stenosis, probably atheromatous in origin. Proximal basilar trunk stenosis over 9 mm extended to intracranial segments of both vertebral arteries.; Test Name: Electrocardiography; Result Unstructured Data: Test Result:sinus, hyperleft QRS axis at -45� on bifascicular; Comments: sinus, hyperleft QRS axis at -45degree on bifascicular block (Hepatitis B antigen + complete Right bundle branch block), isolated negative T wave in V1, Corrected QT interval 461 ms.; Test Name: Gastrointestinal findings; Result Unstructured Data: Test Result:Nothing to Report; Test Name: heart rate; Result Unstructured Data: Test Result:69/min; Test Name: hypertriglyceridemia; Result Unstructured Data: Test Result:2.37 g/l; Test Name: Magnetic resonance imaging; Result Unstructured Data: Test Result:unknown; Test Date: 20211123; Test Name: Magnetic resonance imaging; Result Unstructured Data: Test Result:unknown; Comments: brain and supra-aortic trunks; Test Name: Intracranial vascular findings; Result Unstructured Data: Test Result:stenosis of the basilar trunk extended over 9; Comments: stenosis of the basilar trunk extended over 9 mm of the proximal 1/3 with irregular appearance of the distal 1/3 as well as of the termination of the 2 vertebrae, especially on the left. The carotid axes are patent, with no stenosis detected.; Test Name: Oxygen saturation; Test Result: 97 %; Comments: On room air; Test Name: General; Result Unstructured Data: Test Result:good general condition; Comments: No superficial lymphadenopathy palpated. Extracellular dehydration. Cardiological findings: regular heart sounds, with no heart murmur or carotid artery murmur. No signs of cardiac insufficiency. No chest pain or palpitation. Palpable peripheral pulses (right pedal pulses decreased). Bilateral venous insufficiency, more significant on the left.; Test Name: Pneumological findings; Result Unstructured Data: Test Result:no functional signs.; Comments: no functional signs. Clear and symmetrical pulmonary auscultation; Test Name: Rheumatological findings; Result Unstructured Data: Test Result:joints normal; Comments: joints normal, no clinical evidence of Horton''s disease; Test Name: Skin; Result Unstructured Data: Test Result:no suspicious lesions.; Comments: Presence of white matter hypersignals in relation to mild vasculodegenerative leukopathy; Test Name: Urological examination; Result Unstructured Data: Test Result:Nothing to Report.
CDC Split Type: FRPFIZER INC202101773564

Write-up: Ischemic stroke; booster; dysarthria; facial paralysis; vertigo; lightheadedness; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: FR-AFSSAPS-RS20214031. A 74 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Adenocarcinoma of prostate" (unspecified if ongoing); "Forestier disease" (unspecified if ongoing); "Hypercholesterolaemia" (unspecified if ongoing); "Alcohol abuse" (unspecified if ongoing), notes: Alcohol consumption: at least 2 glasses of red wine per meal.; "Ex-tobacco user" (unspecified if ongoing), notes: Smoking cessation 30 years ago. Concomitant medication(s) included: PRAVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 22Nov2021, outcome "unknown", described as "booster"; ISCHAEMIC STROKE (hospitalization, medically significant) with onset 23Nov2021, outcome "recovering", described as "Ischemic stroke"; FACIAL PARALYSIS (medically significant) with onset 23Nov2021 13:00, outcome "unknown", described as "facial paralysis"; VERTIGO (non-serious) with onset 23Nov2021 09:30, outcome "unknown", described as "vertigo"; DIZZINESS (non-serious) with onset 23Nov2021 09:30, outcome "unknown", described as "lightheadedness"; DYSARTHRIA (non-serious) with onset 23Nov2021 13:00, outcome "unknown", described as "dysarthria". The patient underwent the following laboratory tests and procedures: blood glucose: (unspecified date) 114 g/l; blood pressure measurement: (unspecified date) 198/85 mmHg; blood test: (unspecified date) normal; body temperature: (unspecified date) 36.9 degree; coma scale: (unspecified date) normal alertness, notes: (Glasgow score 15), no headache. Visual field intact, no oculomotor disorder. Pupils equal, round and receptive to light. No sensory-motor deficit, no segmental ataxia. Fluent, informative and coherent speech, good temporal and spatial orientation. Minimal dysarthria (1); (unspecified date) doubts about fresh frozen plasma on the left. no, notes: Doubts about fresh frozen plasma on the left. No sensory-motor deficit. No clear dysarthria. Clinicians suggest right lateropontine ischemic stroke due to proximal basilar trunk stenosis, probably atheromatous in origin. Proximal basilar trunk stenosis over 9 mm extended to intracranial segments of both vertebral arteries; electrocardiogram: (unspecified date) sinus, hyperleft qrs axis at -45� on bifascicular, notes: sinus, hyperleft QRS axis at -45degree on bifascicular block (Hepatitis B antigen + complete Right bundle branch block), isolated negative T wave in V1, Corrected QT interval 461 ms; gastrointestinal examination: (unspecified date) nothing to report; heart rate: (unspecified date) 69/min; hypertriglyceridaemia: (unspecified date) 2.37 g/l; magnetic resonance imaging: (unspecified date) unknown; (23Nov2021) unknown, notes: brain and supra-aortic trunks; neurological examination: (unspecified date) stenosis of the basilar trunk extended over 9, notes: stenosis of the basilar trunk extended over 9 mm of the proximal 1/3 with irregular appearance of the distal 1/3 as well as of the termination of the 2 vertebrae, especially on the left. The carotid axes are patent, with no stenosis detected; oxygen saturation: (unspecified date) 97 %, notes: On room air; physical examination: (unspecified date) good general condition, notes: No superficial lymphadenopathy palpated. Extracellular dehydration. Cardiological findings: regular heart sounds, with no heart murmur or carotid artery murmur. No signs of cardiac insufficiency. No chest pain or palpitation. Palpable peripheral pulses (right pedal pulses decreased). Bilateral venous insufficiency, more significant on the left; pulmonary physical examination: (unspecified date) no functional signs., notes: no functional signs. Clear and symmetrical pulmonary auscultation; rheumatological examination: (unspecified date) joints normal, notes: joints normal, no clinical evidence of Horton''s disease; skin test: (unspecified date) no suspicious lesions., notes: Presence of white matter hypersignals in relation to mild vasculodegenerative leukopathy; urological examination: (unspecified date) nothing to report.. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1980102 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Chest crushing, Chest pain, Dizziness, Electrocardiogram, Electrocardiogram T wave abnormal, Fatigue, Fibrin D dimer, Fibrin D dimer increased, Full blood count, Headache, Immunisation, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (broad), Vestibular disorders (broad), Arthritis (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Psoriasis (Psoriasis treated with methotrexate.); Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:NSR with non specific T wave abnormality; Test Date: 2021; Test Name: D-dimer; Result Unstructured Data: Test Result:positive 0.59; Test Date: 2021; Test Name: Full blood count test; Result Unstructured Data: Test Result:showed MCV of 103.7 and MCH of 35.9; Test Date: 20211212; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Inconclusive test
CDC Split Type: GBPFIZER INC202101780147

Write-up: Chest pain; Chest crushing; Headache; Nausea; Vomiting; Dizziness; Weakness; Tiredness; Aching joints; Dose number 3 (BOOSTER); D-dimer positive 0.59; non specific T wave abnormality; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority; GB-MHRA-WEBCOVID-202112122038041230-CYV9B. Other Case identifier(s): GB-MHRA-ADR 26325213. A female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis; "Psoriasis" (unspecified if ongoing), notes: Psoriasis treated with methotrexate. The patient''s concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19 Inconclusive test. Patient is not enrolled in clinical trial. Past drug history included: Methotrexate for Psoriasis, not been taking since had vaccine. Vaccination history included: Bnt162b2 (DOSE 2, Lot number: UNKNOWN), for COVID-19 immunisation; Bnt162b2 (DOSE 1, Lot number: UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability, medically significant) with onset 22Nov2021, outcome "unknown", described as "Dose number 3 (BOOSTER)"; CHEST PAIN (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Chest pain"; CHEST CRUSHING (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Chest crushing"; HEADACHE (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Headache"; NAUSEA (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Nausea"; VOMITING (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Vomiting"; DIZZINESS (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Dizziness"; ASTHENIA (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Weakness"; FATIGUE (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Tiredness"; ARTHRALGIA (disability, medically significant) with onset 23Nov2021, outcome "not recovered", described as "Aching joints"; FIBRIN D DIMER INCREASED (disability, medically significant) with onset 2021, outcome "unknown", described as "D-dimer positive 0.59"; ELECTROCARDIOGRAM T WAVE ABNORMAL (disability, medically significant) with onset 2021, outcome "unknown", described as "non specific T wave abnormality". All events were evaluated at the emergency room visit. Patient attended emergency department (ED) today with all the symptoms listed above. Symptoms started to day after receiving the Pfizer booster injection. Returning to the department tomorrow for CTPA and possible ECHO. The patient underwent the following laboratory tests and procedures: electrocardiogram (ECG): (2021) Normal sinus rhythm (NSR) with non specific t wave abnormality; D-dimer: (2021) positive 0.59; full blood count (FBC): (2021) showed MCV of 103.7 and MCH of 35.9; COVID-19 virus test: (12Dec2021) inconclusive test. Therapeutic measures were taken as a result of fibrin d dimer increased included given Tinzaparin. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1980222 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye pain, Immunisation, Interchange of vaccine products, Iritis, Ocular hyperaemia, Off label use, Pain, Photophobia, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Ocular infections (broad), Medication errors (broad), COVID-19 (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 Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101788769

Write-up: Iritis/ inflammation in eye; Vaginal bleeding; The patient received the primary immunization series with AZ vaccine; The patient received the primary immunization series with AZ vaccine; The patient received booster dose; pain; Pain, redness and sensitivity to light in eye; Pain, redness and sensitivity to light in eye; Pain, redness and sensitivity to light in eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112132015062220-79H8V (RA). Other Case identifier(s): GB-MHRA-ADR 26329448 (RA). A 28 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. . The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient was not not currently breastfeeding. The patient last menstrual date was 10Nov2021. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 2), administration date: 2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 1), administration date: 2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 22Nov2021, outcome "unknown" and all described as "The patient received the primary immunization series with AZ vaccine"; IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "The patient received booster dose"; VAGINAL HAEMORRHAGE (medically significant) with onset 24Nov2021, outcome "recovered" (24Nov2021), described as "Vaginal bleeding"; EYE PAIN (medically significant), OCULAR HYPERAEMIA (medically significant), PHOTOPHOBIA (medically significant) all with onset 2021, outcome "unknown" and all described as "Pain, redness and sensitivity to light in eye"; IRITIS (medically significant) with onset 26Nov2021, outcome "not recovered", described as "Iritis/ inflammation in eye" got progressively worse over a couple of days, called emergency and told to go to emergency, inflammation found and treated with Maxidex for 5 weeks and Mydrilate for 5 days; PAIN (medically significant) with onset 2021, outcome "not recovered", described as "pain". The events "pain, redness and sensitivity to light in eye" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The patient was not tested positive for COVID-19 since having the vaccine. Therapeutic measures were taken as a result of eye pain, ocular hyperaemia, photophobia, iritis. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1980364 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6270 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Immunisation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (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? No
Previous Vaccinations:
Other Medications: EUTIROX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Microangiopathy (amyloid spells (TFNE) in amyloid microangiopathy with cortical hydrosis neodiagnosis); Superficial siderosis of central nervous system
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101774181

Write-up: Right parietal intraparenchymal cerebral haemorrhage with hemoventricle; BOOSTER; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: IT-MINISAL02-818504. A 73 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 (Lot number: FG6270) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Microangiopathy" (unknown if ongoing), notes: amyloid spells (TFNE) in amyloid microangiopathy with cortical hydrosis neodiagnosis; "Superficial siderosis of central nervous system", start date: 01Oct2021 (unknown if ongoing). Concomitant medication(s) included: EUTIROX. Vaccination history included: Comirnaty (Dose 1, Lot: unknown), for COVID-19 immunisation; Comirnaty (Dose 2, Lot: unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant, life threatening) with onset 22Nov2021, outcome "unknown", described as "BOOSTER"; CEREBRAL HAEMORRHAGE (hospitalization, medically significant, life threatening) with onset 26Nov2021, outcome "not recovered", described as "Right parietal intraparenchymal cerebral haemorrhage with hemoventricle". Therapeutic measures were taken as a result of cerebral haemorrhage. Reporter Comment: Same vaccination as previous doses. Reason for recall: Other or not known. - The flu vaccination was not carried out. Predisposing conditions: amyloid spells in amyloid microangiopathy with cortical hydrosis neodiagnosis (Oct2021). No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Same vaccination as previous doses. Reason for recall: Other or not known. - The flu vaccination was not carried out. Predisposing conditions: amyloid spells in amyloid microangiopathy with cortical hydrosis neodiagnosis (Oct2021)


VAERS ID: 1980375 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1006A / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101774158

Write-up: Nausea; Dizziness; Asthenia; Shivers; FARO This is a non-interventional study report from the Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-818787 (RA). A 57 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left (left shoulder), administration date 22Nov2021 08:51 (Lot number: 1F1006A, Expiration Date: 31Dec2021) at the age of 57 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty ((BIONTECH MANUFACTURING GMBH) (J07BX03), 09:10, batch FG3739 Right arm.), administration date: 29Oct2021, for COVID-19 vaccination. The following information was reported: NAUSEA (hospitalization) with onset 22Nov2021, outcome "recovering", described as "Nausea"; DIZZINESS (hospitalization) with onset 22Nov2021, outcome "recovering", described as "Dizziness"; ASTHENIA (hospitalization) with onset 22Nov2021, outcome "recovering", described as "Asthenia"; CHILLS (hospitalization) with onset 22Nov2021, outcome "recovering", described as "Shivers". The events "nausea", "dizziness", "asthenia" and "shivers" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of nausea, dizziness, asthenia, chills included Levosulpiride (LEVOPRAID); Ketorolac tromethamine (TORADOL), Paracetamol (TACHIPIRINA). The reporter''s assessment of the causal relationship of the "nausea", "dizziness", "asthenia" and "shivers" with the suspect product(s) bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Reporter Comment: The suspected Adverse Drug Reaction was observed during the analysis of adverse drug reactions in the Emergency Room. The patient received the 1 dose of vaccine on 29Oct2021, 09:10, batch FG3739, expiry date not available, right arm. No follow-up attempts are possible. No further information is expected. Sender''s Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1980451 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4092 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Chest pain, Immunisation, Magnetic resonance imaging heart, Myocarditis, Troponin
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METOPROLOL; DOXAZOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: Angiography; Result Unstructured Data: Test Result:Open coronary vessels.; Test Date: 20211122; Test Name: Magnetic resonance imaging heart; Result Unstructured Data: Test Result:Findings compatible with myocarditis.; Test Date: 20211122; Test Name: Troponin; Result Unstructured Data: Test Result:2225 ng/L
CDC Split Type: NOPFIZER INC202101779929

Write-up: Booster; Myocarditis; Acute chest pain; Chest pain with radiation to left arm; This is a spontaneous report received from a contactable reporter(Physician) from the Agency Regulatory Authority-WEB. Regulatory number: NO-NOMAADVRE-FHI-2021-U93ywj Regulatory Authority. Other Case identifier(s): NO-NOMAADVRE-E2B_00063942 Regulatory Authority. An 86 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: FH4092) as dose 3, (booster) single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). The patient was previously mainly healthy, according to the reporter. Concomitant medication included: METOPROLOL; DOXAZOSIN. Vaccination history included: Comirnaty (1st dose, lot number: EJ6789, intramuscular), administration date: 17Feb2021, for covid-19 Immunisation; Comirnaty (2nd dose, lot number: EP9605, intramuscular), administration date: 10Mar2021, for Covid-19 immunization.The following information was reported: IMMUNISATION (hospitalization, medically significant), outcome "unknown", described as "Booster"; MYOCARDITIS (hospitalization, medically significant) with onset 22Nov2021, outcome "recovering", described as "Myocarditis"; CHEST PAIN (hospitalization) with onset 22Nov2021, outcome "recovering", described as "Acute chest pain"; CHEST PAIN (hospitalization) with onset 22Nov2021, outcome "recovering", described as "Chest pain with radiation to left arm". The patient was hospitalized for myocarditis, chest pain, chest pain (start date: 22Nov2021). The patient underwent the following laboratory tests and procedures: angiogram: (22Nov2021) open coronary vessels.; magnetic resonance imaging heart: (22Nov2021) findings compatible with myocarditis.; troponin: (22Nov2021) 2225 ng/L. The Agency assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. Reporter''s comments: NSTEMI was suspected, but after investigations the patient was diagnosed with myocarditis. According to the reporter, the event is considered as related to vaccination. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: NSTEMI was suspected, but after investigations the patient was diagnosed with myocarditis. According to the reporter, the event is considered as related to vaccination.


VAERS ID: 1980487 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-22
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SDFE2 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dyspepsia, Heart rate, Malaise, Tachycardia, Urinary incontinence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Dehydration (broad)

Life Threatening? Yes
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 Date: 20211122; Test Name: Heart rate; Result Unstructured Data: Test Result:140; Comments: Units:(beats)/min
CDC Split Type: ROPFIZER INC202101776795

Write-up: This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority . The reporter is the patient. Regulatory number: RO-NMA-2021-SPCOV15355 (NMA). A 35 year-old male patient received bnt162b2 (COMIRNATY), administration date 15Nov2021 (Lot number: SDFE2) as dose 2, single for COVID-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (DOSE 1, Batch/lot number: FL5324), administration date: 25Oct2021, for COVID-19 immunisation, reaction(s): "Weakness". The following information was reported: TACHYCARDIA (life threatening) with onset 22Nov2021, outcome "not recovered", described as "Tachycardia (heart rate = 140 per minute)"; URINARY INCONTINENCE (life threatening) with onset 22Nov2021, outcome "not recovered", described as "Urinary incontinence"; MALAISE (life threatening) with onset 22Nov2021, outcome "not recovered", described as "Feeling sick"; ASTHENIA (life threatening) with onset 22Nov2021, outcome "not recovered", described as "Weakness generalised"; DYSPEPSIA (life threatening) with onset 22Nov2021, outcome "not recovered", described as "Indigestion". The events "tachycardia", "urinary incontinence", "feeling sick", "weakness generalised" and "indigestion" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: heart rate: (22Nov2021) 140, notes: Units:(beats)/min. Therapeutic measures were taken as a result of tachycardia, urinary incontinence, malaise, asthenia, dyspepsia with Anxiar. The patient was not diagnosed with SARS-CoV-2 infection before or after vaccination. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : RO-PFIZER INC-202101774893 same patient, different event, different vaccine doses


VAERS ID: 1980494 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-08
Onset:2021-11-22
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL5324 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac telemetry, Electrocardiogram, Myocarditis, Syncope, Troponin, Ultrasound chest
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), 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: MELATONIN AGB; INTUNIV; MIDAZOLAM ACCORD
Current Illness: ADHD; Intellectual disability
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: telemetry monitoring; Result Unstructured Data: Test Result:No severe arrhythmia; Comments: No severe arrhythmia during telemetry monitoring so far.; Test Name: ECG; Result Unstructured Data: Test Result:No obvious changes; Test Name: Troponin; Result Unstructured Data: Test Result:42 ng/L; Comments: A Troponin increase that remains; Test Date: 20211128; Test Name: Troponin; Result Unstructured Data: Test Result:74 ng/L; Test Date: 20211201; Test Name: Troponin; Result Unstructured Data: Test Result:69 ng/L; Test Name: Ultrasound heart; Result Unstructured Data: Test Result:No obvious changes
CDC Split Type: SEPFIZER INC202101779955

Write-up: Fainting; Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB. Regulatory number: SE-MPA-2021-095577 (RA). Other Case identifier(s): SE-VISMA-1638362557958 (RA). A 14 year-old male patient received bnt162b2 (COMIRNATY), administration date 08Nov2021 (Lot number: FL5324) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (ongoing); "Intellectual disability" (ongoing). Concomitant medication(s) included: MELATONIN AGB, start date: 04Mar2021; INTUNIV, start date: 14May2021; MIDAZOLAM ACCORD, start date: 22Nov2021 08:30, stop date: 22Nov2021. The following information was reported: MYOCARDITIS (hospitalization) with onset 22Nov2021, outcome "not recovered", described as "Myocarditis"; SYNCOPE (hospitalization) with onset 22Nov2021 10:30, outcome "not recovered", described as "Fainting". The patient underwent the following laboratory tests and procedures: cardiac telemetry: (unspecified date) no severe arrhythmia, notes: No severe arrhythmia during telemetry monitoring so far; electrocardiogram: (unspecified date) no obvious changes; troponin: (unspecified date) 42 ng/L, notes: A Troponin increase that remains; (28Nov2021) 74 ng/L; (01Dec2021) 69 ng/L; ultrasound chest: (unspecified date) no obvious changes. Additional information: Fainting on the 22Nov2021 about half past 10. Midazolam prior to dental visit was given at half past 8. CPR alarm. The patient recovered but became absent three more times. Recurrent left-sided chest pain. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1981155 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-21
Onset:2021-11-22
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-12-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

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

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

Write-up: Passed out with no warning signs. Feel heart pain and muscle contractions around the heart. Feels almost like a heart attack is coming on.


VAERS ID: 1982660 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Allodynia, Arthralgia, Blood pressure measurement, Herpes zoster, Hyperaesthesia, Immunisation, Musculoskeletal pain, Neurological examination, Otoscopy, Rash, Vertigo positional, Vestibular function test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Vestibular disorders (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (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: BPPV
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:110/70; Test Name: neurological examination; Result Unstructured Data: Test Result:Normal; Comments: no vestibular sd, no focal MS deficit, muscle stretch reflex + plantar reflex +, normal cranial pairs, no cerebellar syndrome; Test Name: otoscopy; Result Unstructured Data: Test Result:normal; Test Name: The Dix-Hallpike maneuver; Test Result: Negative
CDC Split Type: FRPFIZER INC202101774117

Write-up: skin rash facing left paraC7; BPPV; Herpes zoster; left shoulder blade pain up to the elbow/ left shoulder blade pain up to the elbow/ more of a burning type; left shoulder blade pain up to the elbow/ more of a burning type; allodynia; hyperesthesia; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency WEB. Regulatory number: FR-AFSSAPS-BX202110996 (RA). A 68 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 (Lot number: FG4493) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "BPPV" (unspecified if ongoing). No Covid infection. The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1 (Arm left, Intramuscular, Batch: EX0893)), administration date: 22Apr2021, for COVID-19 immunisation; Comirnaty (Dose 2 (Arm left, Intramuscular, Batch: FA4598)), administration date: 20May2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "Booster"; HERPES ZOSTER (medically significant) with onset 25Nov2021, outcome "recovering", described as "Herpes zoster"; MUSCULOSKELETAL PAIN (medically significant) with onset 25Nov2021, outcome "recovering", described as "left shoulder blade pain up to the elbow/ left shoulder blade pain up to the elbow/ more of a burning type"; ARTHRALGIA (medically significant) with onset 25Nov2021, outcome "recovering", described as "left shoulder blade pain up to the elbow/ more of a burning type"; ALLODYNIA (medically significant) with onset 25Nov2021, outcome "recovering", described as "allodynia"; HYPERAESTHESIA (medically significant) with onset 25Nov2021, outcome "recovering", described as "hyperesthesia"; RASH (medically significant) with onset 30Nov2021, outcome "recovering", described as "skin rash facing left paraC7"; VERTIGO POSITIONAL (medically significant) with onset 30Nov2021, outcome "recovering", described as "BPPV". The events "herpes zoster", "left shoulder blade pain up to the elbow/ left shoulder blade pain up to the elbow/ more of a burning type", "left shoulder blade pain up to the elbow/ more of a burning type", "allodynia", "hyperesthesia", "skin rash facing left parac7" and "bppv" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: 110/70; neurological examination: normal, notes: no vestibular sd, no focal MS deficit, muscle stretch reflex + plantar reflex +, normal cranial pairs, no cerebellar syndrome; otoscopy: normal; vestibular function test: negative. Therapeutic measures were taken as a result of herpes zoster, musculoskeletal pain, arthralgia, allodynia, hyperaesthesia, rash, vertigo positional. On 25Nov2021, onset of left shoulder blade pain up to the elbow, more of a burning type, allodynia, hyperesthesia then on 30Nov2021, patient had skin rash facing left paraC7 - Probable shingles. On 30Nov2021, appearance of atypical BPPV: positional dizziness such as instability. Treatment included Zelitrex + Cicaplast + Versatis, Tanganil. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1982685 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-11-22
   Days after vaccination:143
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: PCR test; Result Unstructured Data: Test Result: unknown results.
CDC Split Type: FRPFIZER INC202101773964

Write-up: Vaccination failure; COVID-19: respiratory distress; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority. The Regulatory Authority number FR-AFSSAPS-LL20217964. A 68 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 02Jul2021 (Lot number: Unknown) as dose 2, single and intramuscular, administration date 08Jun2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported VACCINATION FAILURE (hospitalization, medically significant) with onset 22Nov2021, outcome not recovered; COVID-19 (hospitalization, medically significant) with onset 22Nov2021, outcome not recovered. The patient was hospitalized for vaccination failure, covid-19 (start date: 22Nov2021). On 22Nov2021, male patient presented with respiratory distress. The patient underwent the following laboratory tests and procedures sars-cov-2 test (22Nov2021) unknown results. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1982849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7911 / 3 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Pericarditis, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Primary sclerosing cholangitis
Allergies:
Diagnostic Lab Data: Test Date: 20211207; Test Name: sars-cov-2 test; Test Result: Negative.
CDC Split Type: FRPFIZER INC202101782381

Write-up: Pericarditis; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority. The Regulatory Authority number FR-AFSSAPS-TO20219422. A 45 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 22Nov2021 (Lot number: FG7911) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Primary sclerosing cholangitis (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included Comirnaty (1st dose, batch unknown), for covid-19 immunization; Comirnaty (2nd dose, batch unknown), for covid-19 immunization. The following information was reported IMMUNISATION (medically significant) with onset 22Nov2021, outcome unknown; PERICARDITIS (medically significant) with onset 06Dec2021, outcome not recovered. The patient underwent the following laboratory tests and procedures sars-cov-2 test (07Dec2021) negative. Evolution included subject not restored on 08Dec2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1983563 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness postural, Immunisation, Neck pain
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101782436

Write-up: Pain in left side of neck; Feeling dizzy when lying down and getting up from lying position; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) froma regulatory authority. Regulatory number: IE-HPRA-2021-087886. Other Case identifier(s): IE-HPRA-CVARR2021120723109. A 60 year-old male patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE UNKNOWN, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 22Nov2021, outcome "unknown", described as "Booster"; NECK PAIN (disability) with onset 05Dec2021, outcome "not recovered", described as "Pain in left side of neck"; DIZZINESS POSTURAL (disability) with onset 05Dec2021, outcome "not recovered", described as "Feeling dizzy when lying down and getting up from lying position". The symptoms was persisting. Persistent or significant disability/incapacity. Serious details included the patient was sure where the symptoms may lead. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1983678 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1008A / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Dysphagia, Eating disorder, Facial paralysis, Immunisation, Interchange of vaccine products, Musculoskeletal stiffness, Off label use, Speech disorder, Swollen tongue, Tongue discomfort
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hearing impairment (broad), Hypersensitivity (narrow), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic leukaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101779298

Write-up: Difficulty eating, swallowing and speaking; Difficulty eating, swallowing and speaking; Difficulty eating, swallowing and speaking; A paralysis similar to Bell''s Paralysis; A paralysis similar to Bell''s Paralysis/left side of my face started becoming paralysed; Stiff mouth; The same evening sensitive tongue with a thick spot; The same night I had a sensitive tongue and swelling; 1st dose and 2nd dose was Spikevax, 3rd dose was BNT162B2; 1st dose and 2nd dose was Spikevax, 3rd dose was BNT162B2; booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority Regulatory number: NL-LRB-00723927 (LRB). Other Case identifier(s): NL-LRB-00728984 (LRB). A 73-year-old female patient received bnt162b2 (COMIRNATY, strength: 0.3ml), administration date 22Nov2021 (Lot number: 1F1008A, expiration date unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic leukaemia" (ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Spikevax (2nd dose, solution for injection 0.5 ml), administration date: 10May2021, for COVID-19 immunisation; Spikevax (1st dose, solution for injection 0.5 ml), administration date: 08Apr2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 22Nov2021, outcome "unknown" and all described as "1st dose and 2nd dose was Spikevax, 3rd dose was BNT162B2"; IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "booster"; BELL''S PALSY (medically significant) with onset 23Nov2021, outcome "recovering", described as "A paralysis similar to Bell''s Paralysis"; FACIAL PARALYSIS (medically significant) with onset 23Nov2021, outcome "recovering", described as "A paralysis similar to Bell''s Paralysis/left side of my face started becoming paralysed"; TONGUE DISCOMFORT (non-serious) with onset 22Nov2021 (also reported as 23Nov2021), outcome "recovering", described as "The same evening sensitive tongue with a thick spot"; SWOLLEN TONGUE (non-serious) with onset 22Nov2021, outcome "unknown", described as "The same night I had a sensitive tongue and swelling"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 23Nov2021, outcome "unknown", described as "Stiff mouth"; EATING DISORDER (non-serious), DYSPHAGIA (non-serious), SPEECH DISORDER (non-serious), outcome "unknown" and all described as "Difficulty eating, swallowing and speaking". The patient''s symptoms still persist, started after vaccination on 22Nov2021. The prognosis was that full recovery may take some time. Therapeutic measures were taken as a result of bell''s palsy, facial paralysis, tongue discomfort and the treatment included Prednisone. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1985424 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-11-22
   Days after vaccination:97
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Pericarditis
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101789497

Write-up: Pericarditis; Chest pain; Dyspnoea; This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: 677706 (regulatory authority ADR#). A 37 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Pericarditis"; CHEST PAIN (non-serious) with onset 22Nov2021, outcome "not recovered", described as "Chest pain"; DYSPNOEA (non-serious) with onset 22Nov2021, outcome "not recovered", described as "Dyspnoea". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1985565 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-22
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101790263

Write-up: Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 679831 Regulatory Authority. A 15 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Pericarditis". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1985623 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Nausea, Peripheral swelling, Vaccination site reaction, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IMPLANON
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101782894

Write-up: Extended swelling of the arm; Injection site reaction; Nausea; Vomiting; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: BE-FAMHP-DHH-N2021-110301. A 30-year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH8469) as dose 2, single for Covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: IMPLANON. Vaccination history included: Comirnaty (1st dose, batch number: FG7369), administration date: 29Oct2021, for COVID-19 immunisation. The following information was reported: PERIPHERAL SWELLING (disability) with onset 22Nov2021, outcome "recovered" (27Nov2021), described as "Extended swelling of the arm"; VACCINATION SITE REACTION (disability) with onset 22Nov2021, outcome "recovered" (27Nov2021), described as "Injection site reaction"; NAUSEA (disability) with onset 22Nov2021, outcome "recovered" (27Nov2021), described as "Nausea"; VOMITING (disability) with onset 22Nov2021, outcome "recovered" (27Nov2021), described as "Vomiting". Therapeutic measures were taken as a result of nausea and vomiting, treated with Primperan. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment: Primperan Evolution of the ADR: Healing: 6 days (also reported as 5 days) Situations: Other: Side effects of the vaccine ADR description: Vomiting during the week following the injection.


VAERS ID: 1985627 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Burning sensation, Chills, Diarrhoea, Fatigue, Gastrointestinal disorder, Headache, Hyperhidrosis, Malaise, Myalgia, Pain in extremity, Paraesthesia, Purpura, Pyrexia, Skin disorder, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: AMLOR; BISOPROLOL; AERIUS [DESLORATADINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (with hospitalization from Jun24 to 31 70% lung affected)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101782932

Write-up: intestinal problems/bowel problems; Fatigue; Perspiration excessive; Pain in arm; Headache; Shivering; Fever; Muscle pain; Purpura; forearm hives; Burning sensation; Tingling; Malaise; Diarrhea; Skin disorder; Arthralgia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: BE-FAMHP-DHH-N2021-110321 (FAMHP). A 52-year-old male patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Lot number: FH8469) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: 17Jun2021 (unspecified if ongoing), notes: with hospitalization from Jun24 to 31 70% lung affected. Concomitant medication(s) included: AMLOR; BISOPROLOL; AERIUS [DESLORATADINE]. Past drug history included: Penicillin nos, reaction(s): "anaphylactic shock". The following information was reported: GASTROINTESTINAL DISORDER (disability) with onset 22Nov2021, outcome "recovering", described as "intestinal problems/bowel problems"; FATIGUE (disability) with onset 22Nov2021, outcome "recovering", described as "Fatigue"; HYPERHIDROSIS (disability) with onset 22Nov2021, outcome "recovering", described as "Perspiration excessive"; PAIN IN EXTREMITY (disability) with onset 22Nov2021, outcome "recovering", described as "Pain in arm"; HEADACHE (disability) with onset 22Nov2021, outcome "recovering", described as "Headache"; CHILLS (disability) with onset 22Nov2021, outcome "recovering", described as "Shivering"; PYREXIA (disability) with onset 22Nov2021, outcome "recovering", described as "Fever"; MYALGIA (disability) with onset 22Nov2021, outcome "recovering", described as "Muscle pain"; PURPURA (disability) with onset 22Nov2021, outcome "recovering", described as "Purpura"; URTICARIA (disability) with onset 22Nov2021, outcome "recovering", described as "forearm hives"; BURNING SENSATION (disability) with onset 22Nov2021, outcome "recovering", described as "Burning sensation"; PARAESTHESIA (disability) with onset 22Nov2021, outcome "recovering", described as "Tingling"; MALAISE (disability) with onset 22Nov2021, outcome "recovering", described as "Malaise"; DIARRHOEA (disability) with onset 22Nov2021, outcome "recovering", described as "Diarrhea"; SKIN DISORDER (disability) with onset 22Nov2021, outcome "recovering", described as "Skin disorder"; ARTHRALGIA (disability) with onset 22Nov2021, outcome "recovering", described as "Arthralgia". Therapeutic measures were not taken as a result of gastrointestinal disorder, fatigue, hyperhidrosis, pain in extremity, headache, chills, pyrexia, myalgia, purpura, urticaria, burning sensation, paraesthesia, malaise, diarrhoea, skin disorder, arthralgia. Reporter Comment: Medical conditions: hypersensitivity and excessive immune reaction (allergy subject anaphylactic shock penicillin). Still intestinal problems and ongoing fatigue and sweating. Arm pain the first day, and head nights Monday through Friday: chills then fever and muscle pain and fatigue until Saturday, as well as profuse sweating at night Saturday: purpura style forearm hives with burning and tingling sensations; Sunday to this Thursday 02Dec bowel problems, diarrhea bowel disorder.; Reporter''s Comments: Medical conditions: hypersensitivity and excessive immune reaction (allergy subject anaphylactic shock penicillin). Still intestinal problems and ongoing fatigue and sweating. Arm pain the first day, and head nights Monday through Friday: chills then fever and muscle pain and fatigue until Saturday, as well as profuse sweating at night Saturday: purpura style forearm hives with burning and tingling sensations; Sunday to this Thursday 02Dec bowel problems, diarrhea bowel disorder.


VAERS ID: 1985807 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SDEH4 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Embolic cerebral infarction, Immunisation
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT skull; Result Unstructured Data: Test Result:unknown results
CDC Split Type: DEPFIZER INC202101782771

Write-up: Embolic medial infarction; booster; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: DE-PEI-202100270249. An 84-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 (Lot number: SDEH4) at the age of 84 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, single; Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (2nd dose, single; Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 22Nov2021, outcome "unknown", described as "booster"; EMBOLIC CEREBRAL INFARCTION (hospitalization) with onset 28Nov2021, outcome "not recovered", described as "Embolic medial infarction". The patient underwent the following laboratory tests and procedures: computerised tomogram head: unknown results. Sender Comment: Clinical CT skull Relatedness for event Cerebral infarction was assessed as D. Unclassifiable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1985883 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E021A / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Antibody test, Arthritis, C-reactive protein, Erythema nodosum, Inflammation, Laboratory test, Oedema peripheral, Proteinuria, Rheumatoid factor, Rheumatoid factor positive, Urine analysis
SMQs:, Acute renal failure (broad), Cardiac failure (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (narrow), Proteinuria (narrow), Tubulointerstitial diseases (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? 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 Name: CCP; Test Result: Negative ; Test Name: CRP; Result Unstructured Data: Test Result:64 mg/l; Test Name: Lab test; Result Unstructured Data: Test Result:Thrombosis ruled out; Test Date: 20211122; Test Name: Rheumatoid factor; Result Unstructured Data: Test Result:sligtly positive; Test Date: 20211122; Test Name: urine test; Result Unstructured Data: Test Result:11.4; Comments: significant protein excretion in urine, test confirms mild anaemia
CDC Split Type: DEPFIZER INC202101809176

Write-up: Lower leg oedema on both sides; Bilateral ankle arthritis; Inflammation of fatty tissue; Erythema nodosum; significant protein excretion in urine, test confirms mild anaemia; significant protein excretion in urine, test confirms mild anaemia; Rheumatoid factor sligtly positive; This is a spontaneous report received from a contactable reporter(s) (Physician) from License Party. Other Case identifier(s): 109374 (Biontech). A 55 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: 1E021A) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: OEDEMA PERIPHERAL (hospitalization) with onset 22Nov2021, outcome "recovered" (12Dec2021), described as "Lower leg oedema on both sides"; ARTHRITIS (non-serious) with onset 22Nov2021, outcome "recovered" (12Dec2021), described as "Bilateral ankle arthritis"; INFLAMMATION (non-serious) with onset 22Nov2021, outcome "recovered" (12Dec2021), described as "Inflammation of fatty tissue"; ERYTHEMA NODOSUM (non-serious) with onset 22Nov2021, outcome "recovered" (12Dec2021), described as "Erythema nodosum"; PROTEINURIA (non-serious), ANAEMIA (non-serious) all with onset 22Nov2021, outcome "recovered" (12Dec2021) and all described as "significant protein excretion in urine, test confirms mild anaemia"; RHEUMATOID FACTOR POSITIVE (non-serious) with onset 22Nov2021, outcome "recovered" (12Dec2021), described as "Rheumatoid factor sligtly positive". The event "lower leg oedema on both sides" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: antibody test: (unspecified date) negative; c-reactive protein: (unspecified date) 64 mg/l; laboratory test: (unspecified date) thrombosis ruled out; rheumatoid factor: (22Nov2021) sligtly positive; urine analysis: (22Nov2021) 11.4, notes: significant protein excretion in urine, test confirms mild anaemia. Therapeutic measures were taken as a result of oedema peripheral, arthritis, inflammation, erythema nodosum, proteinuria, anaemia, rheumatoid factor positive. The treatment included cortisone, KOXID. Clinical course: Thrombosis clarification in clinic (then ruled out). Bnt162b2 is under agreement with Biontech.


VAERS ID: 1985976 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCWF7 / 3 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Alanine aminotransferase, Angiogram, Aspartate aminotransferase, Blood creatine phosphokinase, Blood creatinine, Body temperature, Catheterisation cardiac, Chest X-ray, Chest pain, Coronary artery stenosis, Echocardiogram, Electrocardiogram, Gamma-glutamyltransferase, Immunisation, Interchange of vaccine products, Investigation, Off label use, Pericardial effusion, Pericarditis, Physical examination, SARS-CoV-2 test positive, Troponin T
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Chronic kidney disease (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ETANERCEPT; PARIET; LOSARTAN; CRESTOR; ALOPURINOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal failure ((Renal chronic failure) RCF stage 3. History of Nephrotic Sd. Cr basal 1.3-1.5); COVID-19 (Covid-19.Admission for NAC COVID-19 March 2020 with neumotorax after discharge, treated with thoracic drainage. 6-8 days of admission PCR + 23Mar2020); Dyslipidaemia; Familial mediterranean fever; Hypertension; Obesity; Secondary amyloidosis
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: GPT; Result Unstructured Data: Test Result:93; Test Date: 20211125; Test Name: Angiography; Result Unstructured Data: Test Result:Good results; Test Date: 20211125; Test Name: GOT; Result Unstructured Data: Test Result:216; Test Date: 20211125; Test Name: Creatine kinase; Result Unstructured Data: Test Result:2265; Test Name: Creatinine; Result Unstructured Data: Test Result:1.9; Comments: at discharge; Test Name: Creatinine; Result Unstructured Data: Test Result:1.51; Comments: at income; Test Date: 20211125; Test Name: Creatinine; Result Unstructured Data: Test Result:2.3; Test Date: 20211125; Test Name: Body temperature; Result Unstructured Data: Test Result:Afebrile; Test Date: 20211125; Test Name: Catheterisation cardiac; Result Unstructured Data: Test Result:Radial (right)D. (Left coronary trunk) TCI without; Comments: lesions. (Anterior descending) DA without injury. Proximal occlusion of (circumflex coronary artery) Cx, with proximal ectasia. Abundant thrombus. Thyrofiban (intracoronary) ic is administered and PCI is realized (percutaneous coronary intervention) with implantation of drug-active Stent ORSIRO 3.5X26 mm with good result. Some residual thrombus so tyrophyban perfusion is left. Dominant right coronary artery without lesions; Test Date: 20211123; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:Cardiomegaly in decubitus. Mild bilateral; Comments: congestion; Test Date: 20211125; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:Portable TTU (transthoracic ultrasound):; Comments: non-dilated VI, concentrically increased thicknesses, (left ventricle ejection fraction) LVEF 40% with lateral and posterior basal and mean akinesia. Remaining preserved contractility. Mild (perdicardial effusion) PE in TTU (transthoracic ultrasound). After percutaneous coronary intervention LVEF 50%; Test Date: 20211125; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:RS with normal PR at 50 bpm. ST elevation; Comments: to 2.5 mm in II, III, aVF and V5-6, descent 5 mm in V1-3; Test Date: 20211125; Test Name: GGT; Result Unstructured Data: Test Result:47; Test Date: 20211125; Test Name: Killip; Result Unstructured Data: Test Result:II; Test Date: 20211125; Test Name: TIMI; Result Unstructured Data: Test Result:III; Comments: Grade 3 (Thrombolysis in myocardial infarction); Test Date: 20211125; Test Name: Physical examination; Result Unstructured Data: Test Result:without data to highlight; Comments: Evolution Hemodynamically stable, asymptomatic after PCI (percutaneous coronary intervention) During his stay in ICU-Co, he remains hemodynamically stable, which allows to initiate ARA II and CA at low doses. Good forced diuresis with furosemide and (saline physiologic serum) SPS performing negative balances. During his stay in the plant he remains stable and asymptomatic.; Test Date: 20210323; Test Name: COVID-19 PCR test positive; Test Result: Positive ; Test Date: 20211125; Test Name: TpnTus; Result Unstructured Data: Test Result:9310
CDC Split Type: ESPFIZER INC202101792620

Write-up: Myocardial infarction acute; Proximal circunflex artery thrombotic occlusion; Pericardial effusion; Pericarditis; Typical chest pain; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB. Regulatory number: ES-AEMPS-1060324 (AEMPS). A 60 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 22Nov2021 (Lot number: SCWF7) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "Familial mediterranean fever" (unspecified if ongoing); "Secondary amyloidosis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "COVID-19", start date: Mar2021 (unspecified if ongoing), notes: Covid-19.Admission for NAC COVID-19 March 2020 with neumotorax after discharge, treated with thoracic drainage., 6-8 days of admission, PCR + 23Mar2020; "Chronic renal failure" (unspecified if ongoing), notes: (Renal chronic failure) RCF stage 3. History of Nephrotic Sd. Cr basal 1.3-1.5; "Dyslipidaemia" (unspecified if ongoing). Concomitant medication(s) included: ETANERCEPT; PARIET; LOSARTAN; CRESTOR; ALOPURINOL. Vaccination history included: Vaxzevria (DOSE 1, Lot # ABW0411, Route of administration not provided, Anatomical location not provided), administration date: 15Apr2021, for COVID-19 IMMUNISATION; Vaxzevria (DOSE 2, Lot # not provided, CANCELLED), administration date: 04Oct2021, for COVID-19 IMMUNISATION. The following information was reported: OFF LABEL USE (medically significant) with onset 22Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "Booster"; ACUTE MYOCARDIAL INFARCTION (hospitalization, medically significant, life threatening) with onset 25Nov2021, outcome "recovering", described as "Myocardial infarction acute"; CORONARY ARTERY STENOSIS (medically significant) with onset 25Nov2021, outcome "recovering", described as "Proximal circunflex artery thrombotic occlusion"; PERICARDIAL EFFUSION (medically significant) with onset 25Nov2021, outcome "recovering", described as "Pericardial effusion"; PERICARDITIS (medically significant) with onset 25Nov2021, outcome "recovering", described as "Pericarditis"; CHEST PAIN (non-serious) with onset 25Nov2021, outcome "recovering", described as "Typical chest pain". The event "typical chest pain" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: (25Nov2021) 93; angiogram: (25Nov2021) good results; aspartate aminotransferase: (25Nov2021) 216; blood creatine phosphokinase: (25Nov2021) 2265; blood creatinine: (unspecified date) 1.9, notes: at discharge; (unspecified date) 1.51, notes: at income; (25Nov2021) 2.3; body temperature: (25Nov2021) afebrile; catheterisation cardiac: (25Nov2021) radial (right)d. (left coronary trunk) tci without, notes: lesions. (Anterior descending) DA without injury. Proximal occlusion of (circumflex coronary artery) Cx, with proximal ectasia. Abundant thrombus. Thyrofiban (intracoronary) ic is administered and PCI is realized (percutaneous coronary intervention) with implantation of drug-active Stent ORSIRO 3.5X26 mm with good result. Some residual thrombus so tyrophyban perfusion is left. Dominant right coronary artery without lesions; chest x-ray: (23Nov2021) cardiomegaly in decubitus. mild bilateral, notes: congestion; echocardiogram: (25Nov2021) portable ttu (transthoracic ultrasound):, notes: non-dilated VI, concentrically increased thicknesses, (left ventricle ejection fraction) LVEF 40% with lateral and posterior basal and mean akinesia. Remaining preserved contractility. Mild (perdicardial effusion) PE in TTU (transthoracic ultrasound). After percutaneous coronary intervention LVEF 50%; electrocardiogram: (25Nov2021) rs with normal pr at 50 bpm. st elevation, notes: to 2.5 mm in II, III, aVF and V5-6, descent 5 mm in V1-3; gamma-glutamyltransferase: (25Nov2021) 47; investigation: (25Nov2021) ii; (25Nov2021) iii, notes: Grade 3 (Thrombolysis in myocardial infarction); physical examination: (25Nov2021) without data to highlight, notes: Evolution Hemodynamically stable, asymptomatic after PCI (percutaneous coronary intervention) During his stay in ICU-Co, he remains hemodynamically stable, which allows to initiate ARA II and CA at low doses. Good forced diuresis with furosemide and (saline physiologic serum) SPS performing negative balances. During his stay in the plant he remains stable and asymptomatic; sars-cov-2 test positive: (23Mar2021) positive; troponin t: (25Nov2021) 9310. Therapeutic measures were taken as a result of acute myocardial infarction, coronary artery stenosis, pericardial effusion, pericarditis, chest pain. Additional information: typical chest pain at rest at 15:00. He had been in the field in the morning, asymptomatic arriving at the room with 2 hours of evolution of symptoms. Physical Scan without data to highlight. Evolution Hemodynamically stable, asymptomatic after PCI (percutaneous coronary intervention), it passes to the Coronary Unit for surveillance and treatment. During his stay in ICU-Co (Intensive Care Unit-Coronary), he remains hemodynamically stable, which allows to initiate ARA II (Angiotensin-II receptor antagonists or blockers) and CA at low doses. Presents episode of chest pain compatible with pericarditis post Myocardial infarction acute so colchicine and AAS 500 mg are initiated with disappearance of pain. INFERO-postero-lateral (ST elevation myocardial infarction) STEMI. Killip II. Proximal (circumflex artery) Cx thrombotic occlusion. Primary (percutaneous coronary intervention) PCI with drug-active stent implantation. Bolus + (Tyrofiban) TFB infusion. No (myocardial infarction) MI. 2nd DOSE of ASTRA-ZENECA 04-10-2021 cancelled.


VAERS ID: 1986097 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-22
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1003A / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ankylosing spondylitis, Fatigue, SARS-CoV-2 test
SMQs:, Arthritis (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Ankylosing spondylitis (few rare outbreaks located on one side of the pelvis)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: SARS-CoV-2 Test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101782455

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the . Regulatory number: FR-AFSSAPS-PC20215327 (AFSSAPS). A 53 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: 1F1003A) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Axial ankylosing spondylitis", start date: 1992 (ongoing), notes: few rare outbreaks located on one side of the pelvis; "Arterial hypertension", start date: 2017 (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Advil for ankylosing spondylitis/ outbreak, notes: few rare outbreaks located on one side of the pelvis. Patient had axial ankylosing spondylitis (1992) and very little active for 15 years, a few rare outbreaks located on one side of the pelvis, treated with a single intake of Advil, which was enough to stop the outbreak. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant) with onset 22Nov2021, outcome "recovering", described as "Spondylitis ankylosing aggravated"; FATIGUE (medically significant) with onset 2021, outcome "unknown", described as "pains led to a general state of great fatigue". From 22Nov2021 (to 26Nov2021, as reported), occurrence of massive flare-ups of ankylosing spondylitis from the ankles to the nape of the neck and on both sides: legs, thighs, hips, pelvis, shoulder blades, lower back. The patient has never had a similar relapse in 29 years. These pains led to a general state of great fatigue. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) negative. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1986432 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Hypokinesia, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vertigo
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Asthma; Depression
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101788499

Write-up: lack of energy; difficult to work; Vertigo; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112131603396880-4QDD2 (RA). Other Case identifier(s): GB-MHRA-ADR 26328619 (RA). A 44 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca, for COVID-19 immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 22Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "Booster"; ASTHENIA (medically significant), outcome "not recovered", described as "lack of energy"; VERTIGO (medically significant) with onset 10Dec2021, outcome "not recovered", described as "Vertigo"; HYPOKINESIA (medically significant), outcome "unknown", described as "difficult to work". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of vertigo. Clinical course: Patient last menstrual period date was provided as 10Dec2021. Patient had asthma, depression/anxiety. Patient has not had symptoms associated with COVID-19, not tested positive for COVID-19 since having the vaccine, was not pregnant, not currently breastfeeding and was not enrolled in clinical trial. Patient had Lack of energy. Finding it difficult to work. Patient was Prescribed prochlorperazine 5mg 3x per day problem getting worse awaiting doctor. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1986538 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dermatitis allergic, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20211213; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101788679

Write-up: Allergic rash; off label use; Interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The Regulatory Authority number GB-MHRA-WEBCOVID-202112140017462030-K45JA, other case identifier(s) GB-MHRA-ADR 26329822. A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Lot number: Not known) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Past drug history included Citalopram; Omeprazole. Vaccination history included Covid-19 vaccine astrazeneca (dose 1), administration date: 04Mar2021, for covid-19 immunisation; Covid-19 vaccine astrazeneca (dose 2), administration date: 20May2021, for covid-19 immunisation. The following information was reported OFF LABEL USE (medically significant) with onset 22Nov2021, outcome unknown; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Nov2021, outcome unknown; IMMUNISATION (medically significant) with onset 22Nov2021, outcome unknown; DERMATITIS ALLERGIC (medically significant) with onset 06Dec2021, outcome recovering. The event allergic rash was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures sars-cov-2 test (13Dec2021) no - negative covid-19 test. Therapeutic measures were taken as a result of dermatitis allergic. Patient had a rash which mainly appeared on her chest, upper back, neck, shoulders, and arms. Patient had been prescribed Anti-histamine tablets and Calamine Lotion, and the Condition appears to be improving. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). Photos of the Rash were sent to GP. Patient had not had symptoms associated with COVID-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1986555 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Medication errors (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101796957

Write-up: Shingles; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112140719550260-SWTAE (RA). Other Case identifier(s): GB-MHRA-ADR 26330399 (RA). A 70 year-old male patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing), notes: Study details: (Privacy). Patient had no symptoms associated with COVID-19 and had not tested positive for COVID-19 since having the vaccine. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE: 01, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE: 02, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 22Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "Booster"; HERPES ZOSTER (medically significant) with onset 27Nov2021, outcome "not recovered", described as "Shingles". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The report of the patient was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1986574 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Influenza, Lethargy, Renal pain, SARS-CoV-2 test
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101796583

Write-up: Kidney pain; Flu; Headache; Lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory authority. A 58 year-old male patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. The following information was reported: HEADACHE (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Headache"; LETHARGY (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Lethargy"; INFLUENZA (medically significant) with onset 29Nov2021, outcome "recovering", described as "Flu"; RENAL PAIN (medically significant) with onset 30Nov2021, outcome "not recovered", described as "Kidney pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The patient had not been tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1987104 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201212; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Rash all over; This case was received via recent authority (Reference number: GB-MHRA-ADR 26357208) on 19-Dec-2021 and was forwarded to Moderna on 19-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash all over) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced RASH (Rash all over) (seriousness criterion medically significant). On 02-Dec-2021, RASH (Rash all over) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Dec-2020, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. List of concomitant medication were not given. Patient had hives and rash. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This regulatory case concerns a 32-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected event of RASH. The event occurred one day after receiving a third dose of mRNA-1273. No information about previous vaccination schedule has been provided. The rechallenge is captured as unknown as per the Regulatory Authority assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness is captured as provided by the RA.; Sender''s Comments: This regulatory case concerns a 32-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected event of RASH. The event occurred one day after receiving a third dose of mRNA-1273. No information about previous vaccination schedule has been provided. The rechallenge is captured as unknown as per the Regulatory Authority assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness is captured as provided by the RA.


VAERS ID: 1987238 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Immunisation, Pain
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101798844

Write-up: BOOSTER; DIZZINESS; PAIN; GENERALIZED WEAKNESS; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: IE-HPRA-2021-087929. Other Case identifier(s): IE-HPRA-CVARR2021120823130. A 30 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 30 years as dose number unknown (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "BOOSTER"; DIZZINESS (medically significant) with onset 22Nov2021, outcome "recovered" (24Nov2021), described as "DIZZINESS"; PAIN (medically significant) with onset 22Nov2021, outcome "recovered" (24Nov2021), described as "PAIN"; ASTHENIA (medically significant) with onset 22Nov2021, outcome "recovered" (24Nov2021), described as "GENERALIZED WEAKNESS". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1987360 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1005A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101792666

Write-up: BOOSTER; Dolore nel sito di iniezione ; Linfoadenopatia ascellare sinistra; Dolore nel sito di iniezione ; Linfoadenopatia ascellare sinistra; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the Regulatory Authority, number: IT-MINISAL02-820088 (MINISAL02). A 28 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 (Lot number: 1F1005A) at the age of 28 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE, BATCH/LOT NO EL1484 of 30Apr2021), administration date: 05Jan2021, for Covid-19 Immunization; Comirnaty (DOSE 2, SINGLE, BATCH/LOT NO EJ6136 of 30Apr2021), administration date: 26Jan2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "BOOSTER"; AXILLARY PAIN (medically significant), LYMPHADENOPATHY (medically significant) all with onset 22Nov2021, outcome "recovering" and all described as "Dolore nel sito di iniezione ; Linfoadenopatia ascellare sinistra". Reporter Comment: Reportercomment: The adverse reaction to the third dose occurred on 22Nov2021 at 17:00. The first dose was administered on 05Jan2021 with batch EL1484 of 30Apr2021. The second dose was administered on 26Jan2021 with batch EJ6136 of 30Apr2021. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Reportercomment: The adverse reaction to the third dose occurred on 22Nov2021 at 17:00. The first dose was administered on 05Jan2021 with batch EL1484 of 30Apr2021. The second dose was administered on 26Jan2021 with batch EJ6136 of 30Apr2021.


VAERS ID: 1987464 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005702 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Echocardiogram, Electrocardiogram, Myocarditis, Pyrexia, Troponin I
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: 36.8 degree Celsius; Test Date: 20211125; Test Name: Echocardiogram test; Result Unstructured Data: No significant abnormalities; Test Date: 20211125; Test Name: Electrocardiogram test; Result Unstructured Data: No significant abnormalities; Test Date: 20211125; Test Name: Troponin I; Result Unstructured Data: 325 picogram per millilitre; Test Date: 20211125; Test Name: Troponin I; Result Unstructured Data: 1560.20 picogram per millilitre
CDC Split Type: JPMODERNATX, INC.MOD20214

Write-up: Suspected acute myocarditis; Pyrexia; This case was received via Agency Regulatory Authority(Reference number: 2021TJP135609) on 16-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This case was received via Regulatory Authority (Reference number: 2021TJP135609) on 16-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the Regulatory Authority (Ref, v21132201). On an unknown date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.8 degrees Celsius. On 22-Nov-2021, at 16:00, the patient received the 2nd dose of this vaccine. Pyrexia developed. The patient took an antipyretic. On 23-Nov-2021, pyrexia improved. On 25-Nov-2021, at 07:30, the patient was urgently transported to the hospital as he was aware of left chest pain. Blood test showed elevated troponin I of 325 pg/mL. Acute myocarditis was suspected, so the patient was referred to the reporting hospital. Electrocardiogram and echocardiogram test showed no significant abnormalities, but troponin I was further elevated to 1,560.2 pg/mL; thus, the patient was hospitalized for follow-up. On 27-Nov-2021, the patient was discharged from the hospital as the symptoms were resolving. The outcome of pyrexia and suspected acute myocarditis 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: 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 21-year-old, male patient with no relevant medical history reported, who experienced the expected event of myocarditis. The event occurred 3 days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1987578 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32025BD / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:141/90 mmHg; Comments: PRE-VACCINATION BP; Test Date: 20211122; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:150/80 mmHg; Comments: POST-VACCINATION BP
CDC Split Type: PHPFIZER INC202101713393

Write-up: Elevated BP; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300121897. A 16 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 (Lot number: 32025BD) at the age of 16 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 22Nov2021, outcome "recovered" (22Nov2021), described as "Elevated BP". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (22Nov2021) 141/90 mmHg, notes: PRE-VACCINATION BP; (22Nov2021) 150/80 mmHg, notes: POST-VACCINATION BP. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1987585 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8773 / UNK - / IM

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Malaise, Pain, 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? 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 INC202101760488

Write-up: This is a spontaneous report received from a contactable other HCP, via the regulatory authority (PH-PHFDA-300124838). A 14-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# FH8773), at the age of 14, intramuscularly, on Nov 22, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. The patient reported malaise/body malaise (hospitalization, medically significant), onset Nov 22, 2021, at 15:00, with outcome of unknown; chest pain (hospitalization, medically significant), onset Nov 24, 2021, at 03:00, with outcome of unknown; pyrexia/fever (hospitalization, medically significant), onset Nov 23, 2021, at 06:00, with outcome of unknown; and pain/body aches, with outcome unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1987679 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG8643 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Back pain, Blood test, Body temperature, Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram, Fatigue, Hyperacusis, Limb discomfort, Lymphadenopathy, Nasopharyngitis, Pyrexia, Tachycardia, Tremor, Underdose, Urticaria, Vision blurred
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? Yes
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: Drug allergy (Neo-braderol tablets, Cherry Strephen, Brufen syrup and Klacid tablets); Food allergy; Polyethylene glycol allergy
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown results; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever; Test Date: 20211210; Test Name: echocardiogram; Result Unstructured Data: Test Result:unknown results; Test Name: electrocardiogram; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: PTPFIZER INC202101785851

Write-up: Tachycardia; feeling heavy on the back and feeling of limitation of movement on shoulders.; Cold, tremors; Dizziness; Pain under the armpit; Fever; Difficulty breathing; Cold, tremors; Hearing change; Feeling thick, warm lava coming down to the center of the back, associated with stings and burns; Hives on the back and chest; Blurred vision; Too tired; Angioedema in the back; partial administration (0.1 ml) of the suspected drug; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority. -WEB. Regulatory number: PT-INFARMED-M202111-2532. A 41 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 (Lot number: FG8643) as dose 2, 0.1ml single for covid-19 immunisation. Relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: Neo-braderol tablets, Cherry Strephen, Brufen syrup and Klacid tablets; "unspecified foods hypersensitivity" (unspecified if ongoing); "polyethylene glycol" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "Hypersensitivity". Vaccination history included: Comirnaty (1st dose), for Covid-19 immunisation, reaction(s): "hypersensitivity". The following information was reported: VISION BLURRED (congenital anomaly, medically significant) with onset 22Nov2021, outcome "recovered", described as "Blurred vision"; FATIGUE (congenital anomaly, medically significant) with onset 22Nov2021, outcome "recovering", described as "Too tired"; LYMPHADENOPATHY (congenital anomaly, medically significant) with onset 23Nov2021, outcome "recovering", described as "Pain under the armpit"; TACHYCARDIA (congenital anomaly, medically significant), outcome "recovering", described as "Tachycardia"; PYREXIA (congenital anomaly, medically significant) with onset 23Nov2021, outcome "recovering", described as "Fever"; DYSPNOEA (congenital anomaly, medically significant) with onset 23Nov2021, outcome "recovering", described as "Difficulty breathing"; NASOPHARYNGITIS (congenital anomaly, medically significant), TREMOR (congenital anomaly, medically significant) all with onset 23Nov2021, outcome "recovering" and all described as "Cold, tremors"; ANGIOEDEMA (congenital anomaly, medically significant) with onset 22Nov2021, outcome "recovering", described as "Angioedema in the back"; HYPERACUSIS (congenital anomaly, medically significant) with onset 23Nov2021, outcome "recovering", described as "Hearing change"; BACK PAIN (congenital anomaly, medically significant) with onset 23Nov2021, outcome "recovering", described as "Feeling thick, warm lava coming down to the centre of the back, associated with stings and burns"; URTICARIA (congenital anomaly, medically significant) with onset 22Nov2021, outcome "recovering", described as "Hives on the back and chest"; DIZZINESS (congenital anomaly, medically significant) with onset 23Nov2021, outcome "recovering", described as "Dizziness"; UNDERDOSE (congenital anomaly, medically significant) with onset 22Nov2021, outcome "unknown", described as "partial administration (0.1 ml) of the suspected drug"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "feeling heavy on the back and feeling of limitation of movement on shoulders.". The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unknown results; body temperature: (unspecified date) fever; echocardiogram: (10Dec2021) unknown results; electrocardiogram: (unspecified date) unknown results. Therapeutic measures were taken as a result of vision blurred, fatigue, lymphadenopathy, tachycardia, pyrexia, dyspnoea, nasopharyngitis, angioedema, hyperacusis, back pain, urticaria, dizziness, limb discomfort, tremor. Additional information: 30 mcg/0.3 ml, in a 2-dose, for immunization against COVID-19, with a dosage of 0.3 ml. Adverse reactions (ADRs) started 15 minutes after partial administration (0.1 ml) of the suspected medicinal product, and its administration was suspended after observation by the user by the immunoallergenology unit. Previous reactions to the same drug (so that it was administered in a hospital environment) and to other drugs (penicillin) are known. Reported history of allergy to the following medications: Neo-braderol pastilles, Strephen cherry, Brufen syrup and Klacid tablets and unspecified foods. Regarding the medications that cause allergy, it was found that they all have polyethylene glycol in their composition, as well as in the suspected drug (Pfizer vaccine). Reactions improved with discontinuation of the drug Specific treatment of ADRs (Adverse drug reactions) started with 200mg of hydrocortisone and 1 ampoule of clemastin; subsequently uses Lepicortinolo, Singulair (started 2 days before taking the vaccine), Kestin, Biresp inhaler, Ventolin inhaler in SOS, Ben-U-Ron and Sedoxil. Evolution of ADRs: in recovery. Because it presents criteria of severity, it is referred for attribution of causality. ADRs also motivated the stay at home, in bed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Concomitant Medication-aerius Occurred Medication Error?-No Other information-Did skin reaction with urticaria on the back, shoulders and thorax and presents edema at the posterior cervical level at level C7, less than 30 minutes after administration of only 0.1cc of the vaccine at the time of the attempt of the 2nd inoculation. Refers to feeling heavy on the back and feeling of limitation of movement on shoulders.


VAERS ID: 1987737 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SDFE2 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cellulitis, Chest pain, Lymphadenopathy, 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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202101785744

Write-up: Phlegmon; Fever; Lymphadenopathy; Chest pain; This is a spontaneous report received from a contactable reporter (Consumer) from the Agency Regulatory Authority-WEB. The reporter is the patient. Regulatory number: RO-NMA-2021-SPCOV15474 (NMA). A 16 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: SDFE2) as dose 1,single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (hospitalization) with onset 22Nov2021, outcome "recovered" (28Nov2021), described as "Phlegmon"; PYREXIA (hospitalization) with onset 22Nov2021, outcome "recovered" (28Nov2021), described as "Fever"; LYMPHADENOPATHY (hospitalization) with onset 22Nov2021, outcome "recovered" (28Nov2021), described as "Lymphadenopathy"; CHEST PAIN (hospitalization) with onset 22Nov2021, outcome "recovered" (28Nov2021), described as "Chest pain". The patient was hospitalized for cellulitis, pyrexia, lymphadenopathy, chest pain (start date: 2021). Therapeutic measures were taken as a result of cellulitis, pyrexia, lymphadenopathy, chest pain with Injectable antibiotic. The patient was not diagnosed with SARS-CoV-2 infection before/after vaccination. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1987766 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1013A / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Immunisation
SMQs:, Arthritis (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: Ehlers-Danlos syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101785929

Write-up: Joint pain (in both shoulder joints ); Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: SE-MPA-2021-096565 (RA). Other Case identifier(s): SE-VISMA-1638940939293 (RA). A 74 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Lot number: 1F1013A) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ehlers-Danlos syndrome" (ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (2nd dose; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: ARTHRALGIA (disability) with onset 23Nov2021, outcome "not recovered", described as "Joint pain (in both shoulder joints )"; IMMUNISATION (disability) with onset 22Nov2021, outcome "unknown", described as "Booster". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1987919 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-11
Onset:2021-11-22
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / IM

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101842297

Write-up: This is a spontaneous report received from noncontactable healthcare professional via the regulatory authority (TW-TFDA-TVS-1100013875; safety report unique identifier: TW-Fosun-2021FOS006921). A 61-year-old male patient received unknown dose number of Tozinameran (Comirnaty, batch/lot# not reported), intramuscularly, on Nov 11, 2021, single dose, for COVID-19 immunization. Medical history, concomitant medication and past product use not reported. On Nov 22, 2021, patient experienced slight heart muscle pain (other medically important condition). On Nov 19, 2021, due to the events in his left chest, he went to emergency treatment. Patient treated with anti-inflammatory painkillers, antihistamine and muscle relaxants. On Nov 22, 2021, there was slight heart muscle pain, but no symptoms after the doctor made a diagnosis. The action taken for Tozinameran (Comirnaty) regarding the event: not applicable. At the time of the report, the outcome of the event: unknown. Initial report received on Dec 15, 2021. Follow-up closed. No further information possible. Causality Assessments: Drug Comirnaty/Event slight heart muscle pain/Per Reporter: Possible. Per Company (BioNTech SE): Possible. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.


VAERS ID: 1987988 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Palpitations
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101855296

Write-up: PALPITATION; DIZZINESS; CHEST TIGHTNESS; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014209. Other Case identifier(s): TW-Fosun-2021FOS007088. This is a spontaneous report received from a non-contactable HCP received via a regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100014209. A 62-year-old female patient started to receive the 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 21-Nov-2021 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. The patient received the 1st dose of BNT vaccination on 13-Oct-2021. Medical history was not reported. Concomitant medication and past product were not reported. The patient experienced palpitation, dizziness, chest tightness on 22-Nov-2021. At 10:31 of 21-Nov-2021, the patient received the 2nd dose of BNT vaccination at the otorhinolaryngology (ENT) department of a hospital. Since the morning of 22-Nov-2021, the patient experienced sudden palpitation, chest tightness without diaphoresis. The patient went to the emergency room of a hospital and was administered propranolol by oral. Afterwards, the patient was in a stable condition with smooth breathing and discharged from hospital. Palpitation, dizziness, chest tightness 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 recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Causality Assessment for Palpitation, Dizziness, Chest tightness, Per Reporter was Possible, Per Company (BioNTech SE) was Possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1988128 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-22
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure increased, Dyspnoea, Palpitations, Rash
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: TWMODERNATX, INC.MOD20214

Write-up: Skin rashes (non-injection site); Palpitation; Dyspnea; Elevated blood pressure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of RASH (Skin rashes (non-injection site)), PALPITATIONS (Palpitation), DYSPNOEA (Dyspnea) and BLOOD PRESSURE INCREASED (Elevated blood pressure) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 15-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Nov-2021, the patient experienced RASH (Skin rashes (non-injection site)) (seriousness criterion medically significant), PALPITATIONS (Palpitation) (seriousness criterion medically significant), DYSPNOEA (Dyspnea) (seriousness criterion medically significant) and BLOOD PRESSURE INCREASED (Elevated blood pressure) (seriousness criterion medically significant). At the time of the report, RASH (Skin rashes (non-injection site)), PALPITATIONS (Palpitation), DYSPNOEA (Dyspnea) and BLOOD PRESSURE INCREASED (Elevated blood pressure) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. December 6, 2021 On November 15, the patient received the Moderna Covid vaccine. On December 6, the patient visited the Metabolism Clinic due to symptoms of palpitation,breast tightness, and dyspnea, saying skin rash also occurred about one week after the vaccination. The physician referred the patient to the Cardiology Clinic. After the diagnosis and treatment as well as echocardiographic examination, the condition of pericardial effusion was detected. The patient was given anti-inflammatory agents Conicine and Cataflam for oral administration. The follow-up care was as followsDecember 7, 2021 At 13:37, the patient was called, anhe/she asked us to call againafter 14:00. December 7, 2021. At 14:20, the patient was called, and his/her younger sister answered for him, saying that the patient had no history of chronic disease or history of drug allergy, he/she was overweight (BMI: 25.7). After he/she received the first dose of Moderna vaccine on November 15, skin rash occurred about one week later. On December 6, he/she sought medical treatment at the Metabolism Clinic of a Hospital due to palpitation, breast tightness, dyspnea and other symptoms, and was referred to the Cardiology Clinic later. After the diagnosis and treatment as well as Company Comment: This is a regulatory case concerning a 36-year-old, male patient with no medical history, who experienced the unexpected serious events of Rash, Palpitations, Dyspnoea and Blood pressure increased. The events occurred approximately 8 days after the first dose of mRNA-1273 vaccine. Pericardial effusion was detected in echocardiographic examination and was given anti-inflammatory agents Conicine and Cataflam. Underlying pericardial effusion can be contributory to palpitations and dyspnoea. The outcome of the events was reported as not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The events were assessed as serious by the Regulatory Authority.; Sender''s Comments: This is a regulatory case concerning a 36-year-old, male patient with no medical history, who experienced the unexpected serious events of Rash, Palpitations, Dyspnoea and Blood pressure increased. The events occurred approximately 8 days after the first dose of mRNA-1273 vaccine. Pericardial effusion was detected in echocardiographic examination and was given anti-inflammatory agents Conicine and Cataflam. Underlying pericardial effusion can be contributory to palpitations and dyspnoea. The outcome of the events was reported as not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The events were assessed as serious by the Regulatory Authority.


VAERS ID: 1989119 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-02
Onset:2021-11-22
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life 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: ATPFIZER INC202101809615

Write-up: Stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: AT-BASGAGES-2021-063331 (BASGAGES). A 41 year-old female patient received bnt162b2 (COMIRNATY), administration date 02Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization) with onset 22Nov2021, outcome "unknown", described as "Stroke". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1989781 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anhedonia, Bipolar disorder, Depressed mood, Depression, Fear of death, Feeling abnormal, Hypersomnia
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (narrow), 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: LAMOTRIGINE; VELAXIN; KETILEPT
Current Illness: Bipolar affective disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101799158

Write-up: Feeling miserable/feelings of failure; Feeling sad/sadness; Moderately severe depressive episode; Anhedonia/inability to rejoice; Near death experience/feelings near death; Sleep excessive/longer sleep; Worsening of her mental condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient. Regulatory number: CZ-CZSUKL-21012764. A 26 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bipolar affective disorder" (ongoing). Concomitant medication(s) included: LAMOTRIGINE taken for bipolar disorder, start date: 01Feb2013; VELAXIN taken for bipolar disorder, start date: 01Feb2014; KETILEPT taken for bipolar disorder, start date: 01Dec2018. Vaccination history included: Comirnaty (Dose 1, single, route of administration: Intramuscular), administration date: 01Nov2021, for COVID-19 immunisation, reaction(s): "Sleep disturbance", "Increased activity", "Short Manic episode", "Worsening of her mental condition ". The following information was reported: FEELING ABNORMAL (medically significant) with onset 22Nov2021, outcome "recovering", described as "Feeling miserable/feelings of failure"; DEPRESSED MOOD (medically significant) with onset 22Nov2021, outcome "recovering", described as "Feeling sad/sadness"; DEPRESSION (medically significant) with onset 22Nov2021, outcome "recovering", described as "Moderately severe depressive episode"; ANHEDONIA (medically significant) with onset 22Nov2021, outcome "recovering", described as "Anhedonia/inability to rejoice"; FEAR OF DEATH (medically significant) with onset 22Nov2021, outcome "recovering", described as "Near death experience/feelings near death"; HYPERSOMNIA (medically significant) with onset 22Nov2021, outcome "recovering", described as "Sleep excessive/longer sleep"; BIPOLAR DISORDER (non-serious) with onset 2021, outcome "recovering", described as "Worsening of her mental condition". Therapeutic measures (medication) were taken as a result of feeling abnormal, depressed mood, depression, anhedonia, fear of death, hypersomnia, bipolar disorder. After one week the medication was increased, which caused stabilization of the condition. The reporter did not wish to contact a physician. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1989990 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-22
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30891TB / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Immunisation
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Eye infarction; Prostate cancer; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101809747

Write-up: booster; Shingles on the face; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: DE-PEI-CADR2021208581. Other Case identifier(s): DE-CADRPEI-2021208581, DE-PEI-202100259662. An 86 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: 30891TB) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "prostate cancer" (unspecified if ongoing); "stroke", start date: 2018 (unspecified if ongoing); "eye infarction", start date: 2017 (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (2nd dose, MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: HERPES ZOSTER (hospitalization) with onset 22Nov2021, outcome "not recovered", described as "Shingles on the face". Relatedness between COMIRNATY and the event was assessed by Paul-Ehrlich-Institut (PEI) as Consistent causal association to immunization. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1990014 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Depressed level of consciousness, Muscle tightness, Myalgia, Myosclerosis, Somnolence, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma; Heart failure; Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101816518

Write-up: pain at the injection site; tension in the neck muscles (trapezoal contra-site of the vaccine side) hardens and tends to get painful; slight loss of consciousness; tension in the neck muscles (trapezoal contra-site of the vaccine side) hardens and tends to get painful; tension in the neck muscles (trapezoal contra-site of the vaccine side) hardens and tends to get painful; drowsiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): 109877 (Biontech). A female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic asthma" (unspecified if ongoing); "pollen allergy" (unspecified if ongoing); "heart failure" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: MYOSCLEROSIS (medically significant), MUSCLE TIGHTNESS (non-serious), MYALGIA (non-serious) all with onset 22Nov2021, outcome "unknown" and all described as "tension in the neck muscles (trapezoal contra-site of the vaccine side) hardens and tends to get painful"; DEPRESSED LEVEL OF CONSCIOUSNESS (medically significant) with onset 22Nov2021, outcome "unknown", described as "slight loss of consciousness"; SOMNOLENCE (non-serious) with onset 22Nov2021, outcome "unknown", described as "drowsiness"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "pain at the injection site". Clinical course: Additional information : rapidly improving pain at the injection site 2-3 days after primary and second vaccination, less severe after two injections. After 2nd vaccination: irregular occurrence of paraesthesia in the hands and feet; Tingling, painful (like walking on a nail bed) The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101816605 same product and patient, different dose


VAERS ID: 1990048 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disturbance in attention, Dysphagia, Feeling hot, Head discomfort, Hypoaesthesia oral, Limb discomfort, Neuroborreliosis, Off label use, Paraesthesia, Product use issue, Sensory disturbance, Visual impairment
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Neuroborreliosis (for many years)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101824232

Write-up: off-label use; Drug use in unapproved population; Neuroborreliosis; parestesyen on the face; beginning with sensory disturbances over the entire body; oral difficulty swallowing difficulties mouth throat; oral difficulty swallowing difficulties mouth throat like numbness; hot feet; head pressure; Problems with concentration; Visual disturbances; right leg and the right arm were very difficult; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): 109989 (Biontech). A female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic neuroborelliosis" (unspecified if ongoing). Chronic neuroborelliosis for many years without symptoms. Received guidance from general practitioner Globuli. Presentation by an internist.The patient''s concomitant medications were not reported. The following information was reported: OFF LABEL USE (medically significant) with onset 22Nov2021, outcome "unknown", described as "off-label use"; PRODUCT USE ISSUE (medically significant) with onset 22Nov2021, outcome "unknown", described as "Drug use in unapproved population"; NEUROBORRELIOSIS (medically significant) with onset 22Nov2021, Onset Latency 3 hours, outcome "recovering", described as "Neuroborreliosis"; PARAESTHESIA (non-serious) with onset 22Nov2021, outcome "recovering", described as "parestesyen on the face"; SENSORY DISTURBANCE (non-serious) with onset 22Nov2021, outcome "recovering", described as "beginning with sensory disturbances over the entire body"; DYSPHAGIA (non-serious) with onset 22Nov2021, outcome "recovering", described as "oral difficulty swallowing difficulties mouth throat"; HYPOAESTHESIA ORAL (non-serious) with onset 22Nov2021, outcome "recovering", described as "oral difficulty swallowing difficulties mouth throat like numbness"; FEELING HOT (non-serious) with onset 22Nov2021, outcome "recovering", described as "hot feet"; HEAD DISCOMFORT (non-serious) with onset 22Nov2021, outcome "recovering", described as "head pressure"; DISTURBANCE IN ATTENTION (non-serious) with onset 22Nov2021, outcome "recovering", described as "Problems with concentration"; VISUAL IMPAIRMENT (non-serious) with onset 22Nov2021, outcome "recovering", described as "Visual disturbances"; LIMB DISCOMFORT (non-serious) with onset 22Nov2021, outcome "recovering", described as "right leg and the right arm were very difficult". Bnt162b2 (COMIRNATY) is under agreement with Biontech. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : -PFIZER INC-202101833987 baby case


VAERS ID: 1991438 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-21
Onset:2021-11-22
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Anti-platelet factor 4 antibody test, Discomfort
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Anti-Pf4 antibody; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: TWPFIZER INC202101834060

Write-up: ACUTE MYOCARDIAL INFARCTION; UNCOMFORTABLE; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party(BioNTech) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014320. Other Case identifier(s): TW-Fosun-2021FOS006819. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100014320. A 48-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number was not reported) on 21Oct2021 via intramuscular at unknown dose with single dose (reported as unspecified dosing frequency) for COVID-19 immunization. Medical history was not reported. Concomitant medication and past product were not reported. The patient experienced acute myocardial infarction on 22Nov2021, uncomfortable on 26Nov2021. At night of 21Oct2021, the patient went to clinic for the BNT vaccine inoculation. On 22Nov2021, the patient was taken to the emergency department due to acute myocardial infarction, accepted emergency heart catheters. The patient was placed the bracket and hospitalized. On 26Nov2021, the patient was discharged, and still felt uncomfortable. On 25Nov2021, upload Anti-Pf4 antibody feelings. On 29Nov2021, upload inspection report. Acute myocardial infarction met the seriousness criterion of Hospitalisation. 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. On 26Nov2021, the patient was discharged. Initial report was received on 15Dec2021. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1991594 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoglycaemia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Hypoglycaemia (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: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Hypoglycemia; This regulatory authority case was reported by an other health care professional and describes the occurrence of HYPOGLYCAEMIA (Hypoglycemia) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. Concurrent medical conditions included Diabetes. On 22-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 22-Nov-2021, the patient experienced HYPOGLYCAEMIA (Hypoglycemia) (seriousness criterion medically significant). At the time of the report, HYPOGLYCAEMIA (Hypoglycemia) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient taken oral hypoglycemic medicine from the clinic to control diabetes for a long time.On November 22, the patient received the first dose of Moderna vaccine at a Public Health Center. On November 22, the patient lost consciousness at home at about 11 PM. Patient family members noticed it, and called emergency services to send the patient to the emergency room of our hospital. Patient blood sugar level was measured by staffers in the ambulance: 26mg/dl. The patient regained consciousness in the emergency room. GCS was E4V5M6; vital signs: BT:35.9?,HR: 100 beats/min, RR: 18 breaths/min, BP: 169/93 mmHg, SPO2: 99%, pain. Score: 0 point. The patient underwent a biochemical blood test, and the results were as follows. The doctor diagnosed her with hypoglycemia, and gave her Dextrose 50% 20ml/amp 4amp ST for treatment and Dextrose 10% 500ml/pack for infusion. Supplementation: November 24, 2021,patient received continuous treatment, and her discomfort was alleviated. The doctor asked her to pay a re-visit to the Department of Metabolism to continuously follow up on her hypoglycemia. After evaluation, the doctor of the Department of Metabolism suspended the former medication of Glimepiride 2mg and metformin 500mg/tab, and prescribed the patient Metformin 500mg BID PO for glucose control, and also taught her family members how to prevent falls and suggested the patient still visit the former clinic for glucose control. December 8, 2021 The doctor called to provide care for the patient, and the patient said she was in stable status and would continue to receive treatment from the doctor. Company comment: This case concerns a 70-year-old female patient with relevant medical history of diabetes mellitus and concurrent use of hypoglycemic drugs (glimepiride 2mg and metformin 500mg/tab), who experienced serious unexpected event of hypoglycemia. The events occurred on the same day after the first dose of the mRNA-1273. Reportedly, the patient lost consciousness after vaccination, so family members called emergency services and the patient was admitted to ER. The patient received Dextrose infusion as a corrective treatment and was switched to metformin 500 mg two times daily instead of previous therapy. The rechallenge was not applicable since due to lack of information on the second dose , no rechallenge was done and recurrence was not applicable. Concurrent use of hypoglycemic is a possible confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 70-year-old female patient with relevant medical history of diabetes mellitus and concurrent use of hypoglycemic drugs (glimepiride 2mg and metformin 500mg/tab), who experienced serious unexpected event of hypoglycemia. The events occurred on the same day after the first dose of the mRNA-1273. Reportedly, the patient lost consciousness after vaccination, so family members called emergency services and the patient was admitted to ER. The patient received Dextrose infusion as a corrective treatment and was switched to metformin 500 mg two times daily instead of previous therapy. The rechallenge was not applicable since due to lack of information on the second dose , no rechallenge was done and recurrence was not applicable. Concurrent use of hypoglycemic is a possible confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1991596 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-22
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoaesthesia, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: Hypertension; Non-smoker; Polycythemia vera
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Numbness of limbs; Limb weakness; This regulatory authority case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Numbness of limbs) and MUSCULAR WEAKNESS (Limb weakness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. Concurrent medical conditions included Hypertension, Polycythemia vera and Non-smoker. On 16-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Nov-2021, the patient experienced HYPOAESTHESIA (Numbness of limbs) (seriousness criterion medically significant) and MUSCULAR WEAKNESS (Limb weakness) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA (Numbness of limbs) and MUSCULAR WEAKNESS (Limb weakness) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Patient was taking Hydroxyurea and Aspirin. The patient said he developed left hand numbness and left lower limb weakness from November 22, one week after vaccination, and the symptoms lasted and did not improve, so he visited the emergency room of our hospital on November 29 for treatment. On 29-NOV-2021 patient visited emergency room for treatment and patient''s GCS was E4V5M6;Body Temperature was 36.4 degree C, Heart rate 90 beats/min, Respiratory rate 20 breaths/min, Blood pressure 163/78 mmHg, SPO2: 94%, and pain score: 0 point. The patient underwent a biochemical blood test, and the results were as follow-.Chest X-ray showed no special findings, and brain CT showed no intracranial bleeding. Patient MRI results showed right middle cerebral artery borderzone territory infarction. After preliminary evaluation, the doctor suspected acute stroke, and suggested the possibility of temporal correlation between these symptoms and Moderna vaccine On 30-NOV-2021 patient visited hospital for subsequent treatment. The doctor gave him 0.9% NaCl 500ml/pack for infusion supplementation, and discharged the patient from the emergency room after the infusion. On 08-DEC-2021 The doctor called to provide care for the patient. The patient said he still had hand numbness and weakness, and had been receiving treatment from the doctor in the Hospital. Patient''s past medical history included Travel history (in the recent three months): None, Drinking: None, Allergy: None, Betel nut: None Company comment: This case concerns a 58-year-old, male patient with medical history pf hypertension and polycythemia vera, who experienced the unexpected events of hypoaesthesia and muscular weakness. The events occurred approximately 6 days after the second dose of mRNA-1273. As reported, the patient developed left hand numbness and left lower limb weakness one week after vaccination, and the symptoms lasted and did not improve, so he visited the emergency room for treatment. Thirteen days after second dose patient''s MRI results showed right middle cerebral artery borderzone territory infarction. After preliminary evaluation, the doctor suspected acute stroke, and suggested the possibility of temporal correlation between these symptoms and Moderna vaccine, as reported. On the following day patient visited hospital for subsequent treatment. The doctor gave 0.9% NaCl 500ml/pack for infusion supplementation, and discharged the patient from the emergency room after the infusion. The patient said he still had hand numbness and weakness. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Events captured as per information provided by Regulatory authority.; Sender''s Comments: This case concerns a 58-year-old, male patient with medical history pf hypertension and polycythemia vera, who experienced the unexpected events of hypoaesthesia and muscular weakness. The events occurred approximately 6 days after the second dose of mRNA-1273. As reported, the patient developed left hand numbness and left lower limb weakness one week after vaccination, and the symptoms lasted and did not improve, so he visited the emergency room for treatment. Thirteen days after second dose patient''s MRI results showed right middle cerebral artery borderzone territory infarction. After preliminary evaluation, the doctor suspected acute stroke, and suggested the possibility of temporal correlation between these symptoms and Moderna vaccine, as reported. On the following day patient visited hospital for subsequent treatment. The doctor gave 0.9% NaCl 500ml/pack for infusion supplementation, and discharged the patient from the emergency room after the infusion. The patient said he still had hand numbness and weakness. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Events captured as per information provided by Regulatory authority.


VAERS ID: 1993037 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E024A / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paresis, Immunisation
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (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: Medical History/Concurrent Conditions: Artificial cardiac pacemaker wearer; Cancer surgery; Colon cancer; Coronary heart disease; Hypertension; Insulin-dependent diabetes mellitus; Liver metastases; Metabolic syndrome; Obesity; Renal insufficiency; Sleep apnoea
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101809251

Write-up: booster; Peripheral facial paresis on the right; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: DE-PEI-CADR2021205058 (RA). Other Case identifier(s): DE-CADRPEI-2021205058 (RA Webportal), DE-PEI-202100230761 (RA). A 73-year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: 1E024A) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "2-vessel coronary heart disease" (unspecified if ongoing); "pacemaker in situ" (unspecified if ongoing); "metabolic syndrome" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "obesity 1�" (unspecified if ongoing); "insulin-dependent diabetes mellitus" (unspecified if ongoing); "renal dysfunction" (unspecified if ongoing); "sleep apnoea" (unspecified if ongoing); "colon cancer", start date: 1996 (not ongoing); "liver metastases" (not ongoing); "liver metastases operation", start date: 1997, stop date: 1997. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; FACIAL PARESIS (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Peripheral facial paresis on the right". Causal relationship between all the events and the administration of CORMINATY was assessed as "A. Consistent causal association to immunization" by the RA. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1993151 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0884 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, C-reactive protein, Computerised tomogram, Cough, Fibrin D dimer, Haemoptysis, Headache, Immunisation, Pulmonary embolism, Pyrexia
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELTROXIN; EZETROL; VAGIFEM
Current Illness: Hypercholesterolaemia; Mucosal dryness; Myxoedema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211207; Test Name: CT scan; Result Unstructured Data: Test Result:Lung embolism; Test Date: 20211207; Test Name: C-reactive protein; Result Unstructured Data: Test Result:<5; Comments: unit not specified; Test Date: 20211207; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:$g2.99; Comments: unit not specified
CDC Split Type: DKPFIZER INC202101809884

Write-up: Coughing with haemoptysis; Coughing with haemoptysis; Lung embolism; Headache started within the first 24 hours after the vaccination; Fever started within the first 24 hours after the vaccination; Joint pain started within the first 24 hours after the vaccination; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: DK-DKMA-WBS-0092783. Other Case identifier(s): DK-DKMA-ADR 26310073. This is a spontaneous case, received on 09Dec2021 from a physician, which describes the occurrence of Fever (Fever started within the first 24 hours after the vaccination), Haemoptysis (Coughing with haemoptysis), Headache (Headache started within the first 24 hours after the vaccination), Joint pain (Joint pain started within the first 24 hours after the vaccination), and Lung embolism (Lung embolism) in a 71 years old female patient, vaccinated with Comirnaty (tozinameran). Concomitant medication included ELTROXIN (LEVOTHYROXINE SODIUM), EZETROL (EZETIMIBE), and VAGIFEM (ESTRADIOL). Past drug included the first vaccination with Comirnaty on 23Apr2021 and the second vaccination with Comirnaty on 14May2021. Patient concurrent conditions included Myxoedema, Hypercholesterolaemia, and Mucosal dryness. There is no information regarding patient medical history. On 22Nov2021 the patient was vaccinated with the third dose Comirnaty (Batch number: FF0884) for COVID-19 immunisation. On 23Nov2021, 1 day after the third vaccination, the patient developed Fever, Headache, and Joint pain. On 27Nov2021, 5 days after the third vaccination, the patient developed Haemoptysis and Lung embolism. The ADRs were by the reporter reported as being life threatening and resulting in hospitalisation on 07Dec2021. The patient is currently being treated with unspecified anticoagulant therapy due to the ADRs. No medical procedure was reported performed. Action taken with Comirnaty was not applicable. The outcome of the ADRs Fever, Headache, Joint pain, and Haemoptysis is unknown. The ADR Lung Embolism was recovered on an unknown date in Dec2021. Test results, 07Dec2021: CT scan, Lung embolism. Fibrin D dimer, $g2.99, unit not specified. C-reactive protein, <5, unit not specified. No Follow-up attempts are possible. No further information is expected.


VAERS ID: 1993169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 9678 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Eyelid oedema, Immunisation, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (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:
CDC Split Type: ESPFIZER INC202101810038

Write-up: Edema palpebral; Swelling face; third dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: ES-AEMPS-1062850. A 30 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 22Nov2021 (Lot number: 9678) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. There was no COVID-19 passed. Past drug history included: Hyaluronic acid, stop date: 2021, for dark circles, notes: 10 months ago in dark circles. Vaccination history included: Covid-19 vaccine (DOSE 1, single, Unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, single, Unknown manufacturer), for COVID-19 immunisation. The patient had no symptoms with the other doses. The following information was reported: IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "third dose"; EYELID OEDEMA (medically significant) with onset 01Dec2021, outcome "not recovered", described as "Edema palpebral"; SWELLING FACE (medically significant) with onset 01Dec2021, outcome "not recovered", described as "Swelling face". Therapeutic measures were taken as a result of eyelid oedema, swelling face. The patient was treated with Urbason 60 mg (milligram). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1993294 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-19
Onset:2021-11-22
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214025 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211201; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: FRMODERNATX, INC.MOD20214

Write-up: Vaccination failure; COVID-19 pneumonitis; This case was received via Regulatory Authority(Reference number: FR-AFSSAPS-MA20215689) on 23-Dec-2021 and was forwarded to Moderna on 23-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonitis) and VACCINATION FAILURE (Vaccination failure) in a 47-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214025) for COVID-19 vaccination. The patient''s past medical history included COVID-19. On 19-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Nov-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonitis) (seriousness criteria hospitalization, medically significant and life threatening) and VACCINATION FAILURE (Vaccination failure) (seriousness criteria hospitalization and life threatening). At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonitis) and VACCINATION FAILURE (Vaccination failure) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information were reported. Rechallenge was done and outcome was unknown. Company comment: This case concerns a 47-year-old, male patient with medical history of COVID 19, who experienced the unexpected events of COVID 19 pneumonia and vaccination failure, which required hospitalization and were considered as life threatening by Regulatory authority. The events occurred approximately 64 days after the second dose of mRNA-1273. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 47-year-old, male patient with medical history of COVID 19, who experienced the unexpected events of COVID 19 pneumonia and vaccination failure, which required hospitalization and were considered as life threatening by Regulatory authority. The events occurred approximately 64 days after the second dose of mRNA-1273. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1993529 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy, Odynophagia, Off label use, Oropharyngeal discomfort, Productive cough
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant (Study details: Children of the 90s)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101805888

Write-up: Glands swollen; Off label use; Interchange of vaccine products; Booster; painful swallowing; minimal discomfort in throat; phlegm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112151028191260-ULTGI. Other Case identifier(s): GB-MHRA-ADR 26338444. A 63 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing), notes: Study details: Children of the 90s. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Concomitant medication(s) included: FLUCELVAX TETRA [INFLUENZA VACCINE INACT SAG 4V] taken for immunisation, administration date 19Oct2021. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, Lot Number: PV46671), administration date: 05Mar2021, for COVID-19 Immunization; Covid-19 vaccine astrazeneca (Dose 2, Lot Number: PV46693), administration date: 21May2021, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 22Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 24Nov2021, outcome "recovering", described as "Glands swollen"; ODYNOPHAGIA (medically significant) with onset 2021, outcome "recovering", described as "painful swallowing"; OROPHARYNGEAL DISCOMFORT (medically significant) with onset 2021, outcome "unknown", described as "minimal discomfort in throat"; PRODUCTIVE COUGH (medically significant) with onset 2021, outcome "unknown", described as "phlegm". Therapeutic measures were taken as a result of lymphadenopathy, odynophagia, oropharyngeal discomfort, productive cough, which included self medication with paracetamol. Clinical course: Patient experienced swollen gland in left side of neck and painful swallowing ( like swallowing broken glass) for 7 days. The pain subsided and went after a further 7 days but still have minimal discomfort in throat and phlegm.. Patient has not tested positive for COVID-19 since having the vaccine. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1993573 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-11-22
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Gait disturbance, Muscle spasms, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101806102

Write-up: cramp; Could not walk unaided; Muscular pain in right calf; This is a spontaneous report received from a contactable reporter(Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112151451320430-P3INB (RA). Other Case identifier(s): GB-MHRA-ADR 26339331 (RA). A 48 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 09Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The following information was reported: MYALGIA (medically significant) with onset 22Nov2021, outcome "recovering", described as "Muscular pain in right calf"; MUSCLE SPASMS (medically significant) with onset 03Dec2021, outcome "unknown", described as "cramp"; GAIT DISTURBANCE (medically significant) with onset Dec2021, outcome "recovering", described as "Could not walk unaided ". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: Tolerable muscular pain in the right calf (vaccine administered on the left arm) for over a week, followed by a cramp-like event while running on 03Dec2021. Could not walk unaided for a few days. Never experienced anything like it. Two weeks later, patient was able to walk, pain was diminishing but persists especially at night. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1994181 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Immunisation, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101810288

Write-up: This is a spontaneous report received from contactable reporter (Other HCP) from the regulatory authority. Regulatory number: IE-HPRA-2021-087925 (RA). Other Case identifier(s): IE-RA-CVARR2021120823127 (RA). A 40 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3(booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1), for COVID-19 Immunisation; Comirnaty (DOSE 2), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "Booster"; VOMITING (medically significant) with onset 22Nov2021, outcome "recovered", described as "VOMITING"; ASTHENIA (medically significant) with onset 22Nov2021, outcome "recovered", described as "GENERALIZED WEAKNESS"; DIZZINESS (medically significant) with onset 22Nov2021, outcome "recovered", described as "DIZZINESS"; VACCINATION SITE PAIN (medically significant) with onset 22Nov2021, outcome "recovered", described as "PAIN IN THE SITE". Time to onset of reaction was immediate. Patient was instructed to have rest. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1994182 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Dizziness, Immunisation, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101809607

Write-up: Booster; Dizziness; Underarm swelling; Underarm swelling, pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority. Regulatory number: IE-HPRA-2021-087928 (HPRA). Other Case identifier(s): IE-HPRA-CVARR2021120823129 (HPRA). A 50 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 50 years as dose number unknown (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER: UNKNOWN, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "Booster"; DIZZINESS (medically significant) with onset 22Nov2021, outcome "recovered" (24Nov2021), described as "Dizziness"; SWELLING (medically significant) with onset 22Nov2021, outcome "recovered" (24Nov2021), described as "Underarm swelling"; AXILLARY PAIN (medically significant) with onset 22Nov2021, outcome "recovered" (24Nov2021), described as "Underarm swelling, pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1994186 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-03
Onset:2021-11-22
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Peripheral swelling, Subclavian vein thrombosis
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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: CRESTOR; PREDNISONE; CATASART; BISOPROLOL; ROMEP; CALCICHEW D3; NATRILIX [INDAPAMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Giant cell arteritis; Hypertension; Mobitz type II; Pacemaker insertion (cardiac)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101830822

Write-up: Booster; SWELLING OF LT ARM; SWELLING OF LT ARM, VENOUS THROMBUS IN SUBCLAVIAN VEIN; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory agency-WEB. Regulatory number: IE-HPRA-2021-087981. Other Case identifier(s): IE-HPRA-CVARR2021120923152. A 74 year-old female patient received bnt162b2 (COMIRNATY), administration date 03Nov2021 (Lot number: FH0114) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Giant cell arteritis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Mobitz type II" (unspecified if ongoing); "Pacemaker insertion (cardiac)" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; PREDNISONE; CATASART; BISOPROLOL; ROMEP; CALCICHEW D3; NATRILIX [INDAPAMIDE]. Vaccination history included: Comirnaty (dose 1), for COVID-19 immunisation, reaction(s): "No adverse event"; Comirnaty (dose 2), for COVID-19 immunisation, reaction(s): "No adverse event". The following information was reported: IMMUNISATION (hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (hospitalization, disability, medically significant, life threatening) with onset 22Nov2021, outcome "not recovered", described as "SWELLING OF LT ARM"; SUBCLAVIAN VEIN THROMBOSIS (hospitalization, disability, medically significant, life threatening) with onset 22Nov2021, outcome "not recovered", described as "SWELLING OF LT ARM, VENOUS THROMBUS IN SUBCLAVIAN VEIN". Therapeutic measures were taken as a result of immunisation, peripheral swelling, subclavian vein thrombosis. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1994204 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211129; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown Results; Comments: x2, results not available; Test Date: 20211129; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:confirmed the thrombosis
CDC Split Type: ISPFIZER INC202101810243

Write-up: patient suffered from a thrombosis. It was reported that the patient was diagnosed with DVT in left arm/Thrombus; booster; This is a spontaneous report received from a contactable reporter(s) (Physician) Regulatory number: IS-IMA-7483. A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Lot number: Unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose number unknown (Information on previous doses not available), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "booster"; DEEP VEIN THROMBOSIS (medically significant) with onset 29Nov2021, outcome "not recovered", described as "patient suffered from a thrombosis. It was reported that the patient was diagnosed with DVT in left arm/Thrombus". The patient underwent the following laboratory tests and procedures: blood test: (29Nov2021) unknown results, notes: x2, results not available; ultrasound scan: (29Nov2021) confirmed the thrombosis. The reporter assessed the event as serious due to being medically important. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1994376 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypotension, Incorrect route of product administration, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Drug abuse and dependence (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: PHPFIZER INC202101804608

Write-up: Fainting; Hypotension; Inappropriate route of vaccination; This is a spontaneous report received from a contactable Other Health Professional from Regulatory Authority. Regulatory number: PH-PHFDA-300125104 . A 15-year-old female patient (unknown if pregnant) received BNT162B2 (COMIRNATY; lot number and expiration date were not reported), intradermal on 22Nov2021 (at the age of 15-years-old) as dose number unknown, single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 22Nov2021 11:05, outcome "recovered" (22Nov2021 12:10), described as "Fainting"; HYPOTENSION (medically significant) with onset 22Nov2021 11:05, outcome "recovered" (22Nov2021 12:10), described as "Hypotension"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "Inappropriate route of vaccination".


VAERS ID: 1996675 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-11-22
   Days after vaccination:118
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C16-01 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive lu international unit
CDC Split Type: PTJNJFOC20211263961

Write-up: VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202112-1481) on 30-DEC-2021 and concerned a 26 year old of unspecified sex. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series was 1) (suspension for injection, intramuscular, batch number: 21C16-01 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 27-JUL-2021 for covid-19 immunisation. Drug start period was 118 days. No concomitant medications were reported. On 22-NOV-2021, the patient experienced vaccination failure. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive lu international unit(s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination failure on 25-NOV-2021. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 2002788 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-22
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101836165

Write-up: Bell''s palsy; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 682540 . A 20-year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BELL''S PALSY (medically significant) with onset 22Nov2021, outcome "unknown", described as "Bell''s palsy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2003222 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN ABZ320 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Cardiac function test, Chest X-ray, Chest pain, Circulatory collapse, Dyspnoea, Electrocardiogram, Gastrointestinal examination, Influenza like illness, Palpitations, Physical examination, Pulmonary pain, Pulmonary physical examination, Puncture site pain, Vertigo
SMQs:, Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Amblyopia; Ferropenic anaemia (monitored at Hematology); Overweight; Penicillin allergy (and allergic to Deoxymykoin); Pollen allergy; Psoriasis; Recurrent UTI
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (mild symptoms); Hospitalisation (approximately at 1 year of age, unconsciousness and convulsions few hours after a vaccination)
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: Body temperature; Result Unstructured Data: 39 C; Test Date: 20211206; Test Name: Blood test; Result Unstructured Data: without anything suspicious; Test Date: 20211206; Test Name: Pulmonary physical examination; Result Unstructured Data: symmetric breathing; Test Date: 20211206; Test Name: Physical examination; Result Unstructured Data: without swelling; Test Date: 20211206; Test Name: ECG; Result Unstructured Data: waiting for the result; Test Date: 20211206; Test Name: Thorax X-ray; Result Unstructured Data: norm; Test Date: 20211206; Test Name: Gastrointestinal examination; Result Unstructured Data: without pathological findings; Test Date: 20211206; Test Name: Cardiac function test; Result Unstructured Data: regular heartbeat
CDC Split Type: CZJNJFOC20220101437

Write-up: BREATHLESSNESS; VERTIGO; CHEST ACHE; PUNCTURE SITE PAIN; CHEST BURNING; HEART POUNDING; PULMONARY PAIN; FLU-LIKE SYMPTOMS; COLLAPSE VASOMOTOR; This spontaneous report received from a physician by a Regulatory Authority (regulatory authority, CZ-CZSUKL-21013764) on 03-JAN-2022 concerned a 44 year old female. The patient''s weight was 84 kilograms, and height was 180 centimeters. The patient''s past medical history included: covid-19, and hospitalisation, and concurrent conditions included: recurrent UTI (Urinary tract infection), overweight, psoriasis, ferropenic anaemia, penicillin allergy, amblyopia, and pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: ABZ320, expiry: unknown) 1 dosage forms, 1 total, administered on 21-NOV-2021 for covid-19 vaccination. No concomitant medications were reported. On 22-NOV-2021, the patient experienced breathlessness, vertigo, chest ache, puncture site pain, chest burning, heart pounding, pulmonary pain, flu-like symptoms, and collapse vasomotor. On 06-DEC-2021, Laboratory data included: Blood test (NR: not provided) results without anything suspicious, Cardiac function test (NR: not provided) regular heartbeat, pulse 80/min, ECG (electrocardiogram) (NR: not provided) waiting for the result, Gastrointestinal examination (NR: not provided) without pathological findings, Physical examination (NR: not provided) lower extremities without swelling, Pulmonary physical examination (NR: not provided) symmetric breathing, clear, without side phenom, and Thorax X-ray (NR: not provided) norm (normal). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breathlessness, pulmonary pain, and collapse vasomotor, had not recovered from chest ache, and the outcome of vertigo, puncture site pain, chest burning, heart pounding and flu-like symptoms was not reported. This report was serious (Other Medically Important Condition, and Life Threatening).


VAERS ID: 2003561 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCVTS / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Atrial fibrillation, Heart rate, Tachyarrhythmia
SMQs:, Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Tachyarrhythmia terms, nonspecific (narrow), Hypokalaemia (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 Name: heart rate; Result Unstructured Data: Test Result:180/min
CDC Split Type: DEPFIZER INC202101817097

Write-up: tachyarrhythmia absoluta with atrial fibrillation; tachyarrhythmia absoluta with atrial fibrillation; Arrhythmia; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the WEB. Regulatory number: DE-PEI-CADR2021205732 (PEI). Other Case identifier(s): DE-CADRPEI-2021205732 (PEI Webportal), DE-PEI-202100231912 (PEI). A 62 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: SCVTS) as dose number unknown,single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: ARRHYTHMIA (hospitalization, medically significant) with onset 22Nov2021, outcome "recovered" (2021), described as "Arrhythmia"; ATRIAL FIBRILLATION (hospitalization, medically significant), TACHYARRHYTHMIA (hospitalization, medically significant), outcome "unknown" and all described as "tachyarrhythmia absoluta with atrial fibrillation". The patient underwent the following laboratory tests and procedures: heart rate: 180/min. Therapeutic measures were taken inpatient stay with apixaban, bisoprolol fumarate as a result of arrhythmia, atrial fibrillation, atrial fibrillation. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No Information on risk factors or previous illnesses none / tachyarrhythmia absoluta with atrial fibrillation (HR: 180 / min). Inpatient stay, medication: apixaban, bisoprolol fumarate. The PEI assessment with suspect product Comirnaty is A. Consistent causal association to immunization for event Arrhythmia No follow-up attempts are possible. No further information is expected.


VAERS ID: 2003584 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1022A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Chest discomfort, Chest pain, Dizziness, Electrocardiogram, Palpitations
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:suspected arrhythmia
CDC Split Type: DEPFIZER INC202101833028

Write-up: Arrhythmia; Palpitations; Pressure on the chest; Dizziness; Stinging in the chest; This is a spontaneous report received from a non-contactable consumer from the regulatory authority. Regulatory number: DE-PEI-CADR2021207486. Other Case identifier(s): DE-CADRPEI-2021207486, DE-PEI-202100233849. A 40 year-old male patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Lot number: 1F1022A) as dose number unknown, 0.3ml single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Arrhythmia"; PALPITATIONS (non-serious) with onset 22Nov2021, outcome "not recovered", described as "Palpitations"; CHEST DISCOMFORT (non-serious) with onset 22Nov2021, outcome "not recovered", described as "Pressure on the chest"; DIZZINESS (non-serious) with onset 22Nov2021, outcome "not recovered", described as "Dizziness"; CHEST PAIN (non-serious) with onset 22Nov2021, outcome "not recovered", described as "Stinging in the chest". The events "pressure on the chest", "dizziness" and "stinging in the chest" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: suspected arrhythmia. Additional information: The patient stated, "The next day after the vaccination the symptoms came. I waited and then went to see the doctor. EKG is suspicious for arrhythmia. I should wait and see if it goes away." Relatedness of drug to reactions/events, Comirnaty/ Arrhythmia/ PEI/ A. Consistent causal association to immunization Sender''s comments: Are you or the person concerned known of any allergies? If yes, which? No. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2003692 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 31101TB / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Pulmonary embolism, Vaccination site pain, Vaccination site swelling
SMQs:, Embolic and thrombotic events, venous (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101838565

Write-up: Pulmonary embolism; Injection site pain; Inappropriate schedule of vaccine administered; Injection site swelling; Swollen lymph nodes/ Lymphadenopathy axillary; SAFEVAC 2.0 This is a non-interventional study report from the regulatory authority. Regulatory number: DE-SVPEI-202100935603. A 57 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 18:10 (Lot number: 31101TB) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, 0.3 ml single, intramuscular, lot number: EX8679), administration date: 14May2021, for covid-19 immunisation, reaction(s): "vaccination site pain", "Covid-19", "drug ineffective". The following information was reported: PULMONARY EMBOLISM (hospitalization) with onset 29Nov2021, outcome "recovering", described as "Pulmonary embolism"; VACCINATION SITE SWELLING (non-serious) with onset 2021, outcome "recovering", described as "Injection site swelling"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovering", described as "Swollen lymph nodes/ Lymphadenopathy axillary"; VACCINATION SITE PAIN (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Injection site pain"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Nov2021 18:10, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The patient was hospitalized for pulmonary embolism (start date: 2021). Relatedness of drug Comirnaty to event: Injection site swelling, Injection site pain/Source of assessment: RA/Result of Assessment: B. Indeterminate. Relatedness of drug Comirnaty to event: Pulmonary embolism, Swollen lymph nodes, Lymphadenopathy axillary/Source of assessment: RA/Result of Assessment: D. Unclassifiable. The reporter''s assessment of the causal relationship of the "pulmonary embolism", "injection site swelling", "swollen lymph nodes/ lymphadenopathy axillary" and "injection site pain" with the suspect product(s) bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and events 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.


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