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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: 1957597 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL5324 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, C-reactive protein, Chest pain, Dizziness, Echocardiogram, Electrocardiogram, Hypoaesthesia, Immunisation, Nausea, Troponin, Troponin increased, X-ray
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TRAMADOL HEXAL; ZOLPIDEM STADA; ALVEDON
Current Illness: Back pain (ongoing for several years); Thrombocytosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: CRP; Result Unstructured Data: Test Result:Normal; Test Date: 20211121; Test Name: echocardiogram; Result Unstructured Data: Test Result:Normal; Test Date: 20211121; Test Name: ECG; Result Unstructured Data: Test Result:Normal; Test Date: 20211121; Test Name: troponin; Result Unstructured Data: Test Result:Increased; Comments: dynamics of troponin; Test Date: 20211121; Test Name: coronary artery X-ray; Result Unstructured Data: Test Result:Normal
CDC Split Type: SEPFIZER INC202101719415

Write-up: NSTEMI; booster; troponin increased; central chest pain; numbness in her left arm; nausea; dizziness; This is a spontaneous report received from a contactable reporter (physician) from the regulatory authority-WEB. Regulatory number: SE-MPA-2021-094573 (MPA). Other Case identifier(s): SE-VISMA-1637670961312 (VISMA). A 78-year-old female patient received BNT162b2 (COMIRNATY, solution for injection), administration date 19Nov2021 (lot number FL5324) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "back pain" (ongoing), notes: ongoing for several years; and "thrombocytosis", start date: 2013 (ongoing). Concomitant medications included: TRAMADOL HEXAL, start date: 25May2010; ZOLPIDEM STADA, start date: 12Feb2014; ALVEDON, start date: 11Jun2018. Vaccination history included: Covid-19 vaccine (dose 1, primary immunization series complete but unknown manufacturer), for covid-19 immunisation; and Covid-19 vaccine (dose 2, primary immunization series complete but unknown manufacturer), for covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; ACUTE MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 20Nov2021, outcome "recovering", described as "NSTEMI"; CHEST PAIN (non-serious) with onset 2021, outcome "recovered" (2021), duration 20 min, described as "central chest pain"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "recovered" (2021), duration 20 min, described as "numbness in her left arm"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), duration 20 min, described as "nausea"; DIZZINESS (non-serious) with onset 2021, outcome "recovered" (2021), duration 20 min, described as "dizziness"; TROPONIN INCREASED (non-serious) with onset 21Nov2021, outcome "unknown", described as "troponin increased". The events "NSTEMI", "central chest pain", "numbness in her left arm", "nausea" and "dizziness" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: CRP: (21Nov2021) normal; echocardiogram: (21Nov2021) normal; electrocardiogram: (21Nov2021) normal; troponin: (21Nov2021) increased, notes: dynamics of troponin; coronary artery x-ray: (21Nov2021) normal. Therapeutic measures were taken as a result of acute myocardial infarction which included Trombyl and Brilique. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1957636 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Palpitations, Thrombocytopenia
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Shortness of breath, palpitations, thrombocytopenia; Shortness of breath, palpitations, thrombocytopenia; Shortness of breath, palpitations, thrombocytopenia; This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOCYTOPENIA (Shortness of breath, palpitations, thrombocytopenia), DYSPNOEA (Shortness of breath, palpitations, thrombocytopenia) and PALPITATIONS (Shortness of breath, palpitations, thrombocytopenia) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced THROMBOCYTOPENIA (Shortness of breath, palpitations, thrombocytopenia) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath, palpitations, thrombocytopenia) (seriousness criterion medically significant) and PALPITATIONS (Shortness of breath, palpitations, thrombocytopenia) (seriousness criterion medically significant). At the time of the report, THROMBOCYTOPENIA (Shortness of breath, palpitations, thrombocytopenia), DYSPNOEA (Shortness of breath, palpitations, thrombocytopenia) and PALPITATIONS (Shortness of breath, palpitations, thrombocytopenia) 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. Concomitant product use was not provided by the reporter. It was stated that the patient received second dose of Moderna vaccine on 16 November 2021 and developed fever, chills, nausea, vomiting and chest distress that night. The patient thought that they were common side effects of the vaccine. Patient developed wheezing after slight movements, as well as nausea and palpitations in the morning, 18 November 2021. On 19 November 2021, patient visited the emergency room of Hospital because of aggravated wheezing. Most of data of the patient were normal but had low WBC. The doctor of the emergency room didn''t prescribed medicines, and the patient was sent to Hospital for further examinations. On 22 November 2021, the patient still had wheezing, nausea, vomiting, palpitations and would be visiting the Department of Hematology of Hospital again. Patient did not have a history of chronic diseases.Whether it''s related to the vaccine was not sure. Company comment: This case concerns a 43-year-old female patient with relevant medical history who experienced serious unexpected events of thrombocytopenia, dyspnea, palpitations. The events occurred approximately 3 days after the 2nd dose of the mRNA-1273 .Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 43-year-old female patient with relevant medical history who experienced serious unexpected events of thrombocytopenia, dyspnea, palpitations. The events occurred approximately 3 days after the 2nd dose of the mRNA-1273 .Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1957641 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-28
Onset:2021-11-19
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? 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); This regulatory authority case was reported by an other health care professional and describes the occurrence of RASH (Skin rashes (non-injection site)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced RASH (Skin rashes (non-injection site)) (seriousness criterion hospitalization). At the time of the report, RASH (Skin rashes (non-injection site)) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported. Past medical history of the patient included Gastric ulcer. November 19, 2021 The patient is a 67-year-old female. Past medical history includes gastric ulcer. On November 6, the patient said that small rashes appeared on her back and hands two days after patient received the second dose of Moderna vaccine on October 28, and then rashes extended to all over the body with small blisters. patient first visited another hospital, but thought the results were not good after taking drugs, so she came to the Dermatology Department of this hospital, where the physician recommended hospitalization for treatment. On November 15, as patient''s condition stabilized, she was discharged and followed up via outpatient service.The follow-up care was as follows November 24, 2021 The patient recovered (having received the second dose) Company Comment: This case concerns a 67-year-old, female subject with no relevant medical history, who experienced the serious (seriousness criterion= Caused/Prolonged Hospitalization) unexpected event of Rash. The event, which caused/prolonged hospitalization, occurred 2 days after the second dose of mRNA 1273 Vaccine. The patient said that two days after she received the second dose of mRNA 1273 Vaccine, small rashes appeared on her back and hands which then extended to all over the body with small blisters. She visited a hospital, but thought the results were not good after taking drugs. This prompted consult to the Dermatology Department of the reporting hospital, where the physician recommended hospitalization for treatment. At the time of the report, the outcome of the event was Recovering/Resolving. Rechallenge was not applicable as there is no available information regarding an additional dose. The benefit-risk relationship of mRNA 1273 Vaccine is not affected by this report; Sender''s Comments: This case concerns a 67-year-old, female subject with unknown medical history, who experienced the serious (seriousness criterion= Caused/Prolonged Hospitalization) unexpected event of Rash. The event, which caused/prolonged hospitalization, occurred 3 days after the second dose of mRNA 1273 Vaccine. The patient said that two days after she received the second dose of mRNA 1273 Vaccine, small rashes appeared on her back and hands which then extended to all over the body with small blisters. She visited a hospital, but thought the results were not good after taking drugs. This prompted consult to the Dermatology Department of the reporting hospital, where the physician recommended hospitalization for treatment. At the time of the report, the outcome of the event was Recovering/Resolving. Rechallenge was not applicable as there is no available information regarding an additional dose. The benefit-risk relationship of mRNA 1273 Vaccine is not affected by this report


VAERS ID: 1957661 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-04
Onset:2021-11-19
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 082F218-CDC / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Deep vein thrombosis; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082F218-CDC) for COVID-19 vaccination. No Medical History information was reported. On 04-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion hospitalization). At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication were provided Company comment: This regulatory authority case concerns a 70-year-old male patient, with no relevant medical history reported, who experienced the serious (hospitalization) unexpected AESI of DEEP VEIN THROMBOSIS. The event occurred approximately 1 months and 15 days after receiving the second dose of mRNA-1273. The rechallenge is not applicable since no information about further dosing was disclosed. Patient was admitted due to deep vein thrombosis of the left leg and at the time of the report was already discharged and recovering. No treatment information was provided. The benefit-risk relation ship of mRNA-1273 is not affected by this report. .; Sender''s Comments: This regulatory authority case concerns a 70-year-old male patient, with no relevant medical history reported, who experienced the serious (hospitalization) unexpected AESI of DEEP VEIN THROMBOSIS. The event occurred approximately 1 months and 15 days after receiving the second dose of mRNA-1273. The rechallenge is not applicable since no information about further dosing was disclosed. Patient was admitted due to deep vein thrombosis of the left leg and at the time of the report was already discharged and recovering. No treatment information was provided. The benefit-risk relation ship of mRNA-1273 is not affected by this report.


VAERS ID: 1957663 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Headache; Muscle pain; Chills; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Dec-2021 and was forwarded to Moderna on 08-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and PYREXIA (Fever) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion hospitalization), MYALGIA (Muscle pain) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization) and PYREXIA (Fever) (seriousness criterion hospitalization). At the time of the report, HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and PYREXIA (Fever) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. On November 19, 2021, the patient developed fever, chills, headache, bone pain, chest pain and systemic soreness after receiving Moderna''s vaccine on November 18, 2021. On November 19, 2021 The patient visited the hospital because his symptoms did not improve, and was then admitted to the hospital for treatment. On November 26, 2021, the patient said he had not develop any symptoms, after the first dose of the vaccine, and developed fever, systemic weakness and pain at the vaccination site after the second dose. Now patient symptoms had improved, and will continue to follow up on this. The patient was living in Wanluan Township, Pingtung County, so the report record was sent there. November 26, 2021 The case will be closed after the hospital uploads the medical record. Treatment information was not provided. Company Comment This case concerns a 36-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of headache, myalgia, chills and pyrexia. The events occurred 1 day after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. 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 36-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of headache, myalgia, chills and pyrexia. The events occurred 1 day after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1957683 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Herpes zoster
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20214

Write-up: Zoster on the right face; This regulatory authority case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (Zoster on the right face) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced HERPES ZOSTER (Zoster on the right face) (seriousness criterion hospitalization). At the time of the report, HERPES ZOSTER (Zoster on the right face) 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. The patient received second dose of Moderna vaccine on 19-Nov-2021. She experienced itchiness on the right side of her face 3 days ago, but she did not pay attention to it, as she thought that it was due to wearing of mask. After which, the patient had pain with an intermittent stinging sensation and the pain extended to her right ear and was not alleviated even after resting. The patient started to develop red rashes, blisters and swelling on the right side of her face. She still did not seek treatment. As she experienced severe stinging pain and constant throbbing pain. She was unable to eat then she sought medical attention at the Emergency Department of the hospital. The system review showed no fever, no cough, no shortness of breath, no vomiting, no abdominal pain and no melena. Patent had right face and ear tenderness, erythema, swelling, blisters formation. She had impression of Herpes zoster over face and ear. The patient was hospitalized for further treatment and her son informed that patient was currently hospitalized for treatment and the symptoms began to resolve after drug therapy. Lab tests includes: Leukocytosis: no, Glucose: 117 mg/dl, RFT, LFT normal, ECG: LAE, and CXR: cardiomegaly, pain assessment: 8 points , T: 36.4 degree Celsius, P:93/min, R: 16/min. BP: 146/80 mmHg and SaO2: 99 Percentage Concomitant medications were not reported. Treatment details were not provided. Company comment: This is a regulatory authority case concerning a 70-year-old, female patient with no reported medical history, who experienced the unexpected serious event of herpes zoster (herpes zoster over right face, ear) which resulted to hospitalization. The event herpes zoster (herpes zoster over right face, ear) occurred the same day with the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 70-year-old, female patient with no reported medical history, who experienced the unexpected serious event of herpes zoster (herpes zoster over right face, ear) which resulted to hospitalization. The event herpes zoster (herpes zoster over right face, ear) occurred the same day with the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1958753 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Generalised tonic-clonic seizure, Immunisation
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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: Epilepsy (Generalized)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101728291

Write-up: Grand times seizure; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: AT-BASGAGES-2021-062440. A 53 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FF2834) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "epilepsy" (unspecified if ongoing), notes: Generalized. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, UNKNOWN MANUFACTURER), for covid-19 immunisation; Covid-19 vaccine (dose 2, UNKNOWN MANUFACTURER), for covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 19Nov2021, outcome "unknown", described as "Booster"; GENERALISED TONIC-CLONIC SEIZURE (hospitalization, medically significant) with onset 20Nov2021, outcome "recovered" (2021), described as "Grand times seizure". Additional information: The casual relationship of Comirnaty and Convulsion grand mal assessed as Possible by the health care professional. Reporter Comment: Treatment of side effect 1: observance No follow-up attempts are possible. No further information is expected.


VAERS ID: 1959097 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G044A / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Facial paresis
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101728246

Write-up: This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority. Regulatory number: AT-BASGAGES-2021-062794 (BASGAGES). A 38 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Formulation: solution for injection, Lot number: 1G044A) at the age of 38 years as dose1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported.The following information was reported: FACIAL PARESIS (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Right peripheral facial paralysis ".No follow-up attempts are possible. No further information is expected.


VAERS ID: 1959678 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Menopause
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101730672

Write-up: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), via the regulatory authority (CZ-CZSUKL-21012414). A 51-year-old female patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), intramuscularly, on Nov 19, 2021, single dose, for COVID-19 immunisation. Medical history included menopause (ongoing). There were no concomitant medications. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (primary immunization series complete but unknown manufacturer), for COVID-19 immunization. The patient reported immunization/booster (medically significant), onset Nov 19, 2021, with outcome of unknown; and postmenopausal hemorrhage/postmenopausal bleeding (medically significant), onset Nov 21, 2021, with outcome of not recovered. Clinical information: A female patient experienced an adverse reaction after being vaccinated with the third dose of Comirnaty (Nov 19, 2021). Menstrual bleeding appeared the day after the vaccination, even though the patient was in menopause and no longer had periods. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.


VAERS ID: 1959750 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101733894

Write-up: Limited thumb sensitivity; Trembling of the fingers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: CZ-CZSUKL-21012542 (RA). A 34 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: Unknown) at the age of 34 years 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: Covid-19 vaccine (1st dose, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: HYPOAESTHESIA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Limited thumb sensitivity"; TREMOR (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Trembling of the fingers". Clinical course: finger tremors on the side of vaccine application. The thumb still has strange sensitivity. All the symptoms are still present and have not faded away. The reporter does not wish to contact the physician. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1959752 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pain, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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: 20211119; Test Name: Body temperature; Result Unstructured Data: 38.5 Cel
CDC Split Type: CZJNJFOC20211236622

Write-up: SYNCOPE; FEVER; PANTALGIA; This spontaneous report received from a consumer via a Regulatory Authority [CZ-CZSUKL-21012748] concerned a 53 year old female of an unspecified race and ethnic origin. The patient''s weight was 65 kilograms, and height was 173 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) 1 dosage forms, 1 total was administered on 19-NOV-2021 for covid-19 immunization. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 19-NOV-2021, the patient experienced pantalgia and fever. Laboratory data included: Body temperature (NR: not provided) 38.5 Celsius. On 20-NOV-2021, the patient experienced syncope. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pantalgia, and fever on 21-NOV-2021, and syncope on 20-NOV-2021. This report was serious (Other Medically Important Condition).


VAERS ID: 1959753 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Epigastric discomfort, Pain in extremity, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Comments: no allergy no diagnosed diseases
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Body temperature; Result Unstructured Data: greater than or equal to 38 Cel
CDC Split Type: CZJNJFOC20211236534

Write-up: Syncope; Pain in extremity; Gastric irritation; Fever; Rigoring; This spontaneous report received from a consumer via a Regulatory Authority [CZ-CZSUKL-21012793] concerned a 29 year old female with unspecified race, and ethnicity. The patient''s weight was 56 kilograms, and height was 165 centimeters. The patient''s past medical history included: covid-19, and other pre-existing medical conditions included: no allergy no diagnosed diseases. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown expiry: unknown) 1 dosage forms, 1 total administered on 19-NOV-2021 for covid-19 immunisation (dose series number 1). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 19-NOV-2021, the patient had syncope, pain in extremity, gastric irritation, fever, rigoring. Laboratory data included: Body temperature (NR: not provided) greater than or equal to 38 Cel. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 22-NOV-2021, was recovering from pain in extremity, gastric irritation, and rigoring, and the outcome of syncope was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1960192 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Medication errors (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: ASPIRIN; ATORVASTATIN; CARVEDILOL; ENALAPRIL; OMEPRAZOL.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211201; Test Name: COVID-19 virus test; Test Result: Negative .
CDC Split Type: GBPFIZER INC202101732145

Write-up: Blood pressure; 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. Regulatory number: GB-MHRA-WEBCOVID-202112031936316870-6XTQC. Other Case identifier(s): GB-MHRA-ADR 26288208 (MHRA). A 43 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN; ATORVASTATIN; CARVEDILOL; ENALAPRIL; OMEPRAZOL. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; BLOOD PRESSURE MEASUREMENT (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Blood pressure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Dec2021) negative. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine.Patient is not enrolled in clinical trial.Reaction 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: 1960266 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Menstrual disorder, Polymenorrhoea
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101732079

Write-up: shortening of usual 28 day cycle; Menstrual cycle abnormal/ Changed menstrual cycle; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112041555383670-ANC1R (RA). Other Case identifier(s): GB-MHRA-ADR 26289065 (RA). A 37 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 18Mar2020 (ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunisation; Bnt162b2 (Dose: 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; MENSTRUAL DISORDER (medically significant) with onset 01Dec2021, outcome "not recovered", described as "Menstrual cycle abnormal/ Changed menstrual cycle"; POLYMENORRHOEA (medically significant), outcome "unknown", described as "shortening of usual 28 day cycle". Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Changed menstrual cycle - shortening of usual 28 day cycle. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report did not relate to possible blood clots, low platelets counts, myocarditis or pericarditis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1960370 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Fatigue, Illness, Immunisation
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101731519

Write-up: felt severely bloated; got sick; painful upper stomach in the middle; felt very tired; Upset gastrointestinal; 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-202112051429447450-TKW6E (RA). Other Case identifier(s): GB-MHRA-ADR 26291540 (RA). A 60 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK0596) 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, MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (2ND DOSE, MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; ABDOMINAL DISCOMFORT (medically significant) with onset 01Dec2021, outcome "recovered with sequelae" (03Dec2021), described as "Upset gastrointestinal"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "felt severely bloated"; ILLNESS (non-serious), outcome "unknown", described as "got sick"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "painful upper stomach in the middle"; FATIGUE (non-serious), outcome "unknown", described as "felt very tired". Clinical course: The patient felt severely bloated, and also got sick. The patient had never been like that before. It was painful upper stomach in the middle and felt very tired. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1960413 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-26
Onset:2021-11-19
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Blood test, Dizziness, Electrocardiogram, Fatigue, Heart rate, Heart rate increased, Oxygen saturation, Palpitations, SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (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:
Allergies:
Diagnostic Lab Data: Test Name: glucose; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Test Name: blood pressure; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Test Name: blood tests; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Test Name: ECG; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Test Date: 20211119; Test Name: HEART RATE; Result Unstructured Data: Test Result:140; Comments: heart rate at 140 just standing up; Test Name: blood oxygen; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101731524

Write-up: heart palpitations; shaking; light headedness; tiredness; Heart rate high; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112052312245700-IHVEA (RA). Other Case identifier: GB-MHRA-ADR 26293375 (RA). A 18-year-old male patient received bnt162b2 (COMIRNATY), administration date 26Oct2021 (Lot number: FH8469) as dose 2, 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, unknown manufacturer), for COVID-19 IMMUNISATION. The following information was reported: PALPITATIONS (medically significant), outcome "not recovered", described as "heart palpitations"; TREMOR (medically significant), outcome "not recovered", described as "shaking"; DIZZINESS (medically significant), outcome "not recovered", described as "light headedness"; FATIGUE (medically significant), outcome "not recovered", described as "tiredness"; HEART RATE INCREASED (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Heart rate high". The patient underwent the following laboratory tests and procedures: blood glucose: (unspecified date) unknown results; blood pressure measurement: (unspecified date) unknown results; blood test: (unspecified date) unknown results; electrocardiogram: (unspecified date) unknown results; heart rate: (19Nov2021) 140, notes: heart rate at 140 just standing up; oxygen saturation: (unspecified date) unknown results; sars-cov-2 test: (unspecified date) no - negative covid-19 test. Clinical course: Patient not had symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since the vaccination. Patient was not enrolled in clinical trial. The reporter did not consider relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1960517 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Suspected COVID-19 (Has long covid)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Rigors; Muscle pain; High temperature; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26297199) on 07-Dec-2021 and was forwarded to Moderna on 07-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature), CHILLS (Rigors) and MYALGIA (Muscle pain) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Suspected COVID-19 (Has long covid) since 18-Jan-2021. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (Rigors) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). On 22-Nov-2021, PYREXIA (High temperature) had resolved. At the time of the report, CHILLS (Rigors) and MYALGIA (Muscle pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. It was stated that the patient experienced very high temperature of 38.9 for two days, severe rigors and muscle pain and spasms. Company comment: This regulatory authority case concerns a 44-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) events of Pyrexia, Chills and Myalgia after mRNA- 1273 Moderna vaccine. The events occurred approximately 1 day after the third dose of mRNA- 1273 vaccine (dosage unknown). Pyrexia, Chills and Myalgia are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. At the time of the report, the events had resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 44-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Pyrexia, Chills and Myalgia after mRNA- 1273 Moderna vaccine. The events occurred approximately 1 day after the third dose of mRNA- 1273 vaccine (dosage unknown). Pyrexia, Chills and Myalgia are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. At the time of the report, the events had resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 1960738 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Peripheral swelling, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: ELTROXIN; NORIDAY [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy (Face and tongue have swollen before, reaction to medication)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101728967

Write-up: Swollen arm and arm pit; Swollen arm; Arm pit sore / arm pit is sore (arm injection in); booster; 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-2021-087079 (RA). Other Case identifier(s): IE-HPRA-CVARR2021112022748 (RA). A 42 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH0114) at the age of 42 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: Face and tongue have swollen before, reaction to medication. Concomitant medication(s) included: ELTROXIN; NORIDAY [ETHINYLESTRADIOL;LEVONORGESTREL]. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer for Dose 1), for COVID-19 Immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer for Dose 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; SWELLING (medically significant) with onset 20Nov2021, outcome "unknown", described as "Swollen arm and arm pit"; PERIPHERAL SWELLING (medically significant) with onset 20Nov2021, outcome "unknown", described as "Swollen arm"; AXILLARY PAIN (medically significant) with onset 20Nov2021, outcome "unknown", described as "Arm pit sore / arm pit is sore (arm injection in)". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1960746 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Loss of personal independence in daily activities
SMQs:, Dementia (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 INC202101729111

Write-up: WAS WALKING 10 000 STEPS A DAY AS AVERAGE. FOR NOW I STOPPED, I PREFER TO AVOID ANY EFFORTS / AVOID STRONG EFFORT AND BIG EMOTIONS; STRONG HEART BEATING LIKE AFTER SPORT EXERCISES AT REST / HEART BEATING IS STRONGER THAN BEFORE GETTING MY FIRST INJECTION / NOT FASTER, JUST I FEEL MY PULSE ALMOST ALL THE TIME; 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-2021-087164. Other Case identifier(s): IE-HPRA-CVARR2021112222807. A 39 year-old male patient received bnt162b2 (COMIRNATY), administration date 15Nov2021 (Lot number: FH0114) 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: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (medically significant), outcome "unknown", described as "WAS WALKING 10 000 STEPS A DAY AS AVERAGE. FOR NOW I STOPPED, I PREFER TO AVOID ANY EFFORTS / AVOID STRONG EFFORT AND BIG EMOTIONS"; CARDIAC DISORDER (medically significant) with onset 19Nov2021, outcome "unknown", described as "STRONG HEART BEATING LIKE AFTER SPORT EXERCISES AT REST / HEART BEATING IS STRONGER THAN BEFORE GETTING MY FIRST INJECTION / NOT FASTER, JUST I FEEL MY PULSE ALMOST ALL THE TIME". Clinical course: The reporter commented that they don''t do sport but they can compare it with heart beating like just after sport exercise. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1961028 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0003 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Myocarditis, Off label use, Ultrasound scan
SMQs:, Cardiomyopathy (broad), Medication errors (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: Crohn''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ultrasound heart; Result Unstructured Data: Test Result:Results of the investigations are missing
CDC Split Type: SEPFIZER INC202101730909

Write-up: Myocarditis; 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: SE-MPA-2021-095401 (RA). Other Case identifier(s): SE-VISMA-1638273773991 (RA). A 26-year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: PCB0003) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Crohn''s disease" (ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Spikevax (Dose 1), administration date: 02Aug2021, for covid-19 immunisation; Spikevax (Dose 2, D2: 3005697), administration date: 08Sep2021, for covid-19 immunisation. The following information was reported: OFF LABEL USE (hospitalization) with onset 19Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (hospitalization) with onset 19Nov2021, outcome "unknown", described as "booster"; MYOCARDITIS (hospitalization) with onset 25Nov2021, outcome "recovering", described as "Myocarditis". The patient underwent the following laboratory tests and procedures: ultrasound scan: results of the investigations are missing.


VAERS ID: 1962659 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Inflammation, Psoriasis, SARS-CoV-2 test, Swelling, Thermal burns of eye, Vision blurred
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210812; 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: Blurry vision; Swelling; Eye burns; Inflammation; Psoriasis; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26306736) on 09-Dec-2021 and was forwarded to Moderna on 09-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), PSORIASIS (Psoriasis), INFLAMMATION (Inflammation), SWELLING (Swelling) and THERMAL BURNS OF EYE (Eye burns) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 16-Nov-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PSORIASIS (Psoriasis) (seriousness criteria disability and medically significant). On 30-Nov-2021, the patient experienced INFLAMMATION (Inflammation) (seriousness criteria disability and medically significant). On 01-Dec-2021, the patient experienced SWELLING (Swelling) (seriousness criteria disability and medically significant) and THERMAL BURNS OF EYE (Eye burns) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced VISION BLURRED (Blurry vision) (seriousness criteria disability and medically significant). At the time of the report, VISION BLURRED (Blurry vision), PSORIASIS (Psoriasis), INFLAMMATION (Inflammation), SWELLING (Swelling) and THERMAL BURNS OF EYE (Eye burns) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant Medication use information was not provided by reporter. Treatment Medication use information was not provided by reporter. Patient were experienced with Numb toes. Patient was not had symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 32-year-old male patient, with no relevant medical history, who experienced the serious unexpected events of VISION BLURRED, PSORIASIS, THERMAL BURNS OF EYE, INFLAMMATION and SWELLING. The event PSORIASIS occurred three days after the second dose of mRNA-1273. The event INFLAMMATION occurred fourteen days after the second dose of the mRNA-1273. The events THERMAL BURNS OF EYE and SWELLING occurred fifteen days on the second dose of the mRNA-1273. The event VISION BLURRED occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered as not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.; Sender''s Comments: This case concerns a 32-year-old male patient, with no relevant medical history, who experienced the serious unexpected events of VISION BLURRED, PSORIASIS, THERMAL BURNS OF EYE, INFLAMMATION and SWELLING. The event PSORIASIS occurred three days after the second dose of mRNA-1273. The event INFLAMMATION occurred fourteen days after the second dose of the mRNA-1273. The events THERMAL BURNS OF EYE and SWELLING occurred fifteen days on the second dose of the mRNA-1273. The event VISION BLURRED occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered as not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.


VAERS ID: 1964210 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Adjusted calcium, Blood triglycerides, C-reactive protein, Immunisation, Lipase, Magnetic resonance imaging pancreas, Pancreatitis acute, Ultrasound scan
SMQs:, Acute pancreatitis (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: COVERAM; ASPIRINE; ROSUVASTATIN; CALCIMAGON D3; INDERAL; FLECTOR TISSUGEL; VITAMINE B12
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute pancreatitis (A diagnosis of severe acute pancreatitis (Balthazar E according to surgeons) was retained); Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20211127; Test Name: Adjusted calcium; Result Unstructured Data: Test Result:in the norm; Test Name: Triglicerides; Result Unstructured Data: Test Result:1.9 mmol/L; Comments: in the norm; Test Date: 20211127; Test Name: C-reactive protein; Result Unstructured Data: Test Result:not provided; Test Date: 20211129; Test Name: C-reactive protein; Result Unstructured Data: Test Result:not provided; Test Date: 20190529; Test Name: Lipase; Result Unstructured Data: Test Result:not provided; Test Date: 20211127; Test Name: Lipase; Result Unstructured Data: Test Result:not provided; Test Date: 20211129; Test Name: Magnetic resonance imaging pancreas; Result Unstructured Data: Test Result:Conclusion: Acute cephalic pancreatitis of Balthaz; Comments: Conclusion: Acute cephalic pancreatitis of Balthazar D stage grafting onto a known chronic pancreatitis with pseudocyst of the corporeal / caudal pancreatic compartment and accompanied by segmental portal hypertension. Non-occlusive thrombosis of the right portal vein extending into the right sectoral branch and into the segmental portal vein of segment VI; Test Name: Ultrasound; Result Unstructured Data: Test Result:No lithiasis or dilation of the bile ducts seen
CDC Split Type: CHPFIZER INC202101762487

Write-up: Pancreatitis acute; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: CH-SM-2021-29124. A 82 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 82 years as dose 3 (booster), single for covid-19 immunisation; amlodipine besilate, indapamide, perindopril arginine (COVERAM PLUS), oral, administration date Oct2021 (Batch/Lot number: unknown) as 1 DF for hypertension. Relevant medical history included: "severe acute pancreatitis", start date: Jan2019, stop date: Jan2019, notes: A diagnosis of severe acute pancreatitis (Balthazar E according to surgeons) was retained; "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: COVERAM taken for hypertension, start date: 2019, stop date: Oct2021; ASPIRINE taken for hypertension; ROSUVASTATIN, start date: 2019; CALCIMAGON D3; INDERAL; FLECTOR TISSUGEL; VITAMINE B12. Vaccination history included: Comirnaty (Dose 1), administration date: 2021, for Covid-19 immunization; Comirnaty (Dose 2), administration date: 2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; PANCREATITIS ACUTE (hospitalization, medically significant) with onset 27Nov2021, outcome "not recovered", described as "Pancreatitis acute". The patient was hospitalized for pancreatitis acute (start date: 27Nov2021). Patient admitted on 27Nov2021 shortly after midnight for reported events. A few hours earlier patient had fatty meal (fish with a lot of butter) and Greasy food (chocolate) the previous few days. No notion of alcoholism (drinks about 3 glasses of wine per week). Received 3 doses of the Comirnaty vaccine without consecutive general complaints (no fever). A diagnosis of Balthazar E pancreatitis of probably drug origin - atorvastatin versus hydrochlorothiazide - appears on the discharge letter. Medicines prescribed by the attending physician obtained by phone from the doctor''s office on 29Nov2021. A causal relationship between Comirnaty and Pancreatitis acute was assessed as being possible. case considered as serious as per the reporter. The patient underwent the following laboratory tests and procedures: adjusted calcium: (27Nov2021) in the norm; blood triglycerides: (unspecified date) 1.9 mmol/L, notes: in the norm; c-reactive protein: (27Nov2021) not provided; (29Nov2021) not provided; lipase: (29May2019) not provided; (27Nov2021) not provided; magnetic resonance imaging pancreas: (29Nov2021) conclusion: acute cephalic pancreatitis of balthaz, notes: Conclusion: Acute cephalic pancreatitis of Balthazar D stage grafting onto a known chronic pancreatitis with pseudocyst of the corporeal / caudal pancreatic compartment and accompanied by segmental portal hypertension. Non-occlusive thrombosis of the right portal vein extending into the right sectoral branch and into the segmental portal vein of segment VI; ultrasound scan: (unspecified date) no lithiasis or dilation of the bile ducts seen. The action taken for amlodipine besilate, indapamide, perindopril arginine was dosage permanently withdrawn on 26Nov2021. Therapeutic measures were taken as a result of pancreatitis acute. Reporter Comment: Conclusion: unlikely implication of current treatments in severe acute pancreatitis (very rare side effect, little suggestive time relationship). Possible implication of the Comirnaty vaccine (3rd dose) (reported cases, plausible temporal relationship). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Conclusion: unlikely implication of current treatments in severe acute pancreatitis (very rare side effect, little suggestive time relationship). Possible implication of the Comirnaty vaccine (3rd dose) (reported cases, plausible temporal relationship).; Sender''s Comments: Linked Report(s) : CH-PFIZER INC-202101789308 same patient, different suspect product


VAERS ID: 1964549 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1015A / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Bradyphrenia, Carotid arteriosclerosis, Computerised tomogram head, Disorientation, Electrocardiogram, Immunisation, Memory impairment, Physical examination, Scan brain, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement; Hyperlipidemia; Hypertension arterial; Ischemia; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Blood test; Result Unstructured Data: Test Result:Normal; Test Date: 20211119; Test Name: Tomography of brain; Result Unstructured Data: Test Result:Atheromatosis; Comments: Atheromatosis of the left vertebral and carotid siphons. Sequelae of chronic ischemia. Hemorrhagic cause is ruled out for its current clinical picture.; Test Date: 20211119; Test Name: ECG; Result Unstructured Data: Test Result:Normal; Comments: sinus rhythm unchanged from baseline.; Test Date: 20211119; Test Name: Exploration; Result Unstructured Data: Test Result:Conscious, time-oriented; Comments: does not recognize her daughter, Bradyphrenia; Test Date: 20211119; Test Name: Scan brain; Result Unstructured Data: Test Result:No acute pathology
CDC Split Type: ESPFIZER INC202101729038

Write-up: Booster; Atheromatosis of the left vertebral and carotid siphons; Syncope of vagal profile; Disorientation; Vomited; Bradyphrenia; does not recognize her daughter; This is a spontaneous report received from a contactable reporter (physician) from the regulatory authority; the Regulatory report number is ES-AEMPS-1061029 (AEMPS). A 75-year-old female patient received the third dose of bnt162b2 (COMIRNATY), intramuscular on 19Nov2021 (batch/lot number: 1F1015A) at the age of 75 years old, as DOSE 3 (BOOSTER), 0.3 mL SINGLE for COVID-19 immunization. Relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing); "Aortic valve replacement" (unspecified if ongoing); "Hypertension arterial" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "chronic ischemia" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty [second dose, intramuscular, (batch/lot number: EY7015) as DOSE 2, 0.3 mL SINGLE], administration date: 06May2021, for COVID-19 immunization; Comirnaty [first dose, intramuscular, (batch/lot number: EW9127) as DOSE 1, 0.3 mL SINGLE], administration date: 15Apr2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown," described as "Booster"; CAROTID ARTERIOSCLEROSIS (medically significant) with onset 19Nov2021, outcome "unknown," described as "Atheromatosis of the left vertebral and carotid siphons"; SYNCOPE (medically significant) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Syncope of vagal profile"; DISORIENTATION (medically significant) with onset 19Nov2021, outcome "unknown," described as "Disorientation"; VOMITING (medically significant) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Vomited"; BRADYPHRENIA (medically significant) with onset 19Nov2021, outcome "unknown," described as "Bradyphrenia"; MEMORY IMPAIRMENT (medically significant) with onset 19Nov2021, outcome "unknown," described as "does not recognize her daughter." The patient underwent the following laboratory tests and procedures: blood test: (19Nov2021) normal; Tomography of brain (computerised tomogram head): (19Nov2021) atheromatosis, notes: Atheromatosis of the left vertebral and carotid siphons. Sequelae of chronic ischemia. Hemorrhagic cause is ruled out for its current clinical picture; ECG (electrocardiogram): (19Nov2021) normal, notes: sinus rhythm unchanged from baseline; Exploration (physical examination): (19Nov2021) conscious, time-oriented, notes: does not recognize her daughter, Bradyphrenia; and scan brain: (19Nov2021) no acute pathology. Additional information: No chest pain, no dyspnea, or other symptoms. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1964599 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-19
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101730119

Write-up: Headache; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority-WEB. The reporter is the patient. Regulatory number: FI-FIMEA-20217288 (RA). A 23-year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 2021 (Lot number: UNKNOWN) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pollen allergy" (unspecified if ongoing). The patient''s concomitant medications were not reported. On 19Nov2021, the patient experienced headache. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1964723 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1006A / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Impaired work ability, Influenza like illness, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210428; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101730572

Write-up: Influenza like illness; headaches; fever; aches and pains; severe stomach ache; diarrhoea; Was unable to go to work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: FR-AFSSAPS-LL20217845 (AFSSAPS). A 27 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 18Nov2021 (Lot number: 1F1006A) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (medically significant) with onset 19Nov2021, outcome "recovering", described as "Influenza like illness"; HEADACHE (non-serious) with onset 19Nov2021, outcome "unknown", described as "headaches"; PYREXIA (non-serious) with onset 19Nov2021, outcome "unknown", described as "fever"; PAIN (non-serious) with onset 19Nov2021, outcome "unknown", described as "aches and pains"; ABDOMINAL PAIN UPPER (non-serious) with onset 19Nov2021, outcome "unknown", described as "severe stomach ache"; DIARRHOEA (non-serious) with onset 19Nov2021, outcome "unknown", described as "diarrhoea"; IMPAIRED WORK ABILITY (non-serious) with onset 19Nov2021, outcome "unknown", described as "Was unable to go to work". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Apr2021) positive. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1965034 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Chest discomfort, Chest pain, Dizziness, Dyspnoea, Headache, Heart rate, Oxygen saturation, Somnolence, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Blood pressure; Result Unstructured Data: Test Result:unknown results; Test Date: 20211119; Test Name: Body temperature; Result Unstructured Data: Test Result:unknown results; Test Date: 20211119; Test Name: Pulse rate; Result Unstructured Data: Test Result:unknown results; Test Date: 20211119; Test Name: O2 saturation; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202101628909

Write-up: Chest tightness; Shortness of breath/ breath shortness; Dizzy; Weakness; Chest pain; Headache; Tachycardic; unable to keep her eyes open; A 15 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH4751) at the age of 15 years as dose 1, single for covid-19 immunisation; mestranol, norethisterone (Batch/Lot number: unknown). The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (medically significant) with onset 19Nov2021, outcome "unknown", described as "Chest tightness"; DYSPNOEA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Shortness of breath/ breath shortness"; DIZZINESS (medically significant) with onset 19Nov2021, with a reported stop date of 19Nov2021, outcome "not recovered", described as "Dizzy"; ASTHENIA (medically significant) with onset 19Nov2021, with a reported stop date of 19Nov2021, outcome "not recovered", described as "Weakness"; CHEST PAIN (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Chest pain"; HEADACHE (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Headache"; TACHYCARDIA (medically significant) with onset 19Nov2021, outcome "unknown", described as "Tachycardic"; SOMNOLENCE (medically significant) with onset 19Nov2021, outcome "unknown", described as "unable to keep her eyes open". The events "chest tightness", "shortness of breath/ breath shortness", "dizzy", "weakness", "chest pain", "headache", "tachycardic" and "unable to keep her eyes open" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (19Nov2021) unknown results; body temperature: (19Nov2021) unknown results; heart rate: (19Nov2021) unknown results; oxygen saturation: (19Nov2021) unknown results. The action taken for mestranol, norethisterone was unknown. Therapeutic measures were taken as a result of chest discomfort, dyspnoea, dizziness, asthenia, chest pain, headache, tachycardia. Patient attended a clinic for their routine Covid-19 Vaccination as per national 12-15 years old school''s vaccination program. Post vaccination, the patient complained of feeling dizzy and weak. The patient was also unable to keep her eyes open. The patient was taken to the resuscitation area, her legs were raised; while in the resuscitation area, the patient complained of chest tightness, headaches, and shortness of breath. The father of the patient was called to the school as the symptoms worsened. The patient was found to be tachycardic. The observations were completed, which included blood pressure, pulse, temperature and O2 saturation measurements. An ambulance was called, and patient was taken to hospital. Patient has not tested positive for COVID-19 since having the vaccine was not enrolled in clinical trial; the report was not related to possible myocarditis or pericarditis. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1965140 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH CH4751 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Dyspnoea, Electrocardiogram, Fatigue, Headache, Oropharyngeal pain, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Food allergy
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:normal; Test Date: 20211124; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101731817

Write-up: Fatigue extreme/fatigue; Breathlessness; Heart pounding; Headache; Sore throat; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority (UK-MHRA). The reporter is the parent. Regulatory number: GB-MHRA-WEBCOVID-202112041747090520-9W4OT (MHRA). Other Case identifier(s): GB-MHRA-ADR 26289192 (MHRA). A 15 year-old male patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: CH4751) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Food allergy" (unspecified if ongoing). The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The following information was reported: HEADACHE (disability, medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Headache"; OROPHARYNGEAL PAIN (disability, medically significant) with onset 19Nov2021, outcome "not recovered", described as "Sore throat"; FATIGUE (disability, medically significant) with onset 20Nov2021, outcome "not recovered", described as "Fatigue extreme/fatigue"; DYSPNOEA (disability, medically significant) with onset 20Nov2021, outcome "not recovered", described as "Breathlessness"; PALPITATIONS (disability, medically significant) with onset 20Nov2021, outcome "not recovered", described as "Heart pounding". On Friday 19/11, the patient had a headache and sore throat. Over the weekend of 20-21/11 he started suffering with extreme fatigue and breathlessness and pounding heart on exertion (exertion being moving from room to room, showering, brushing hair, moving arm to write while sitting down). He has not improved in the two weeks since, still has sore throat as well as fatigue, breathlessness, pounding heart. He has been seen by paediatricians at RMCH who tested bloods and ECG and found no abnormalities. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The events "headache", "sore throat", "fatigue extreme/fatigue", "breathlessness" and "heart pounding" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) normal; electrocardiogram: (2021) normal; sars-cov-2 test: (24Nov2021) no - negative covid-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1965352 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Diarrhoea, Dyspnoea, Eye pain, Fatigue, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INSULIN HUMAN; LISINOPRIL; METFORMIN; QUININE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal; Cramps leg; Diabetic
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101739410

Write-up: Sore eyes; Chest pain; Shortness of breath; Tiredness; Diarrhea; 3rd dose has been administered (bnt162b2) and the patient has previously received the full primary immunization series of another vaccine; 3rd dose has been administered (bnt162b2) and the patient has previously received the full primary immunization series of another vaccine; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112061513401870-EEQCK. Other Case identifier(s): GB-MHRA-ADR 26296082. A 62 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetic"; "Blood pressure"; "Cramps leg". Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication(s) included: INSULIN HUMAN taken for diabetes mellitus; LISINOPRIL taken for blood pressure abnormal; METFORMIN taken for diabetes mellitus; QUININE taken for muscle spasms. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 19Nov2021, outcome "unknown" and all described as "3rd dose has been administered (bnt162b2) and the patient has previously received the full primary immunization series of another vaccine"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; FATIGUE (medically significant) with onset 21Nov2021, outcome "recovering", described as "Tiredness"; DIARRHOEA (medically significant) with onset 21Nov2021, outcome "recovered" (22Nov2021), described as "Diarrhea"; CHEST PAIN (medically significant) with onset 22Nov2021, outcome "recovering", described as "Chest pain"; DYSPNOEA (medically significant) with onset 22Nov2021, outcome "recovering", described as "Shortness of breath"; EYE PAIN (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Sore eyes". The events "tiredness", "diarrhea", "chest pain", "shortness of breath" and "sore eyes" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Clinical course: Booster Friday Morning, tired and diarrhea (as reported, pending clarification). Slept Saturday and Sunday, went to work Monday, but still tired and had chest pains, stabbing pains and shortness of breath. Early Tuesday Morning reported to general practitioner (GP), Thursday reported additional symptom of sore eyes. Week 2 still not feeling any better reported to GP. Had following week off referred to Cardiac Clinic. Appointment Wednesday 10:00. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1965407 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Arthritis (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: LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101739003

Write-up: Shoulder soreness; 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 (RA). Regulatory number: GB-MHRA-WEBCOVID-202112062132059350-PMVPI (RA). Other Case identifier(s): GB-MHRA-ADR 26297400 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started, Unsure when symptoms stopped; "Under active thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 26Mar2021, for COVID-19 immunization; Covid-19 vaccine astrazeneca (Dose 2), administration date: 11Jun2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; ARTHRALGIA (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Shoulder soreness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Patient had cramp like feelings in left arm and shoulder where injected (where there is now a white mark) which aches spreading to base of neck and down arm can be severe making it unable to do work etc, worse when bending arm. It was reported that this report was not related to possible inflammation of the heart (myocarditis or pericarditis). When asking for relevant investigations or tests conducted it was reported that "told docs they said this is normal, but I don''t think it is as its totally different to when I had others this is a different debilitating pain". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1965767 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Heart rate, Oropharyngeal pain, SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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: Heart rate; Shakiness; Headache; Throat sore; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26310994) on 10-Dec-2021 and was forwarded to Moderna on 10-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), OROPHARYNGEAL PAIN (Throat sore), HEART RATE (Heart rate) and TREMOR (Shakiness) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and OROPHARYNGEAL PAIN (Throat sore) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced HEART RATE (Heart rate) (seriousness criterion medically significant) and TREMOR (Shakiness) (seriousness criterion medically significant). On 21-Nov-2021, TREMOR (Shakiness) had resolved. On 23-Nov-2021, HEADACHE (Headache), OROPHARYNGEAL PAIN (Throat sore) and HEART RATE (Heart rate) had 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 concomitant medication were reported. No treatment information were reported. Felt worse than when she had pneumonia and pleurisy for 48 hours after my jab Company comment This is a regulatory authority case concerning a female patient of unknown age with no relevant medical history reported, who experienced the serious unexpected, according to CCDS, events of HEADACHE, OROPHARYNGEAL PAIN, TREMOR and another serious event. The events headache and oropharyngeal pain occurred the same day after the third dose of mRNA-1273 vaccine. The event tremor occurred a day after the third dose of mRNA-1273 vaccine. The rechallenge was unknown according to SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory authority case concerning a female patient of unknown age with no relevant medical history reported, who experienced the serious unexpected, according to CCDS, events of HEADACHE, OROPHARYNGEAL PAIN, TREMOR and another serious event. The events headache and oropharyngeal pain occurred the same day after the third dose of mRNA-1273 vaccine. The event tremor occurred a day after the third dose of mRNA-1273 vaccine. The rechallenge was unknown according to SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1965953 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hallucination, Memory impairment, Reading disorder
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (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 INC202101734352

Write-up: memory impairment; Forgetting peoples names / forgetting names of people; Hallucinations, imaging things are moving when they are not; Words suddenly become backwards / sometimes words are reading backwards; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: IE-HPRA-2021-087065 (HPRA). A 24 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: MEMORY IMPAIRMENT (medically significant) with onset 19Nov2021, outcome "unknown", described as "Forgetting peoples names / forgetting names of people"; HALLUCINATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Hallucinations, imaging things are moving when they are not"; READING DISORDER (medically significant) with onset 19Nov2021, outcome "unknown", described as "Words suddenly become backwards / sometimes words are reading backwards"; MEMORY IMPAIRMENT (medically significant), outcome "unknown", described as "memory impairment". Clinical course: The patient was not taking any concomitant medication. The patient did not have any relevant medical history or concurrent conditions. It was also reported that the patient had no history of previous mental health illness or family history of mental illness. 2 days later, on 19/Nov/2021, the patient experienced hallucinations. The patient reported hallucinations, described as ''imagining (imaging) things were moving when they were not'', words suddenly became backwards/read backwards and the patient forgot people''s names. The duration was reported as a few seconds. At the time of reporting, the patient outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : IE-HPRA-2021-087082


VAERS ID: 1965960 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Body temperature, Bone pain, Headache, Immunisation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Osteonecrosis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: The patient did not have any relevant medical history or concurrent conditions.
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Temp; Result Unstructured Data: Test Result:High temperature; Comments: at 09:00
CDC Split Type: IEPFIZER INC202101734029

Write-up: Joint pain / pain spread to shoulder and back; Pain spread to...back on the following day; Bone pain; Headache; Temp; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority. Regulatory number: IE-HPRA-2021-087104 (RA). A 54 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. 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 19Nov2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 20Nov2021 09:00, outcome "not recovered", described as "Temp"; ARTHRALGIA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Joint pain / pain spread to shoulder and back"; HEADACHE (medically significant) with onset 20Nov2021 09:00, outcome "not recovered", described as "Headache"; BACK PAIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Pain spread to...back on the following day"; BONE PAIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Bone pain". The patient underwent the following laboratory tests and procedures: body temperature: (20Nov2021) high temperature, notes: at 09:00. Therapeutic measures were taken as a result of pyrexia, arthralgia, headache, back pain, bone pain. Clinical course: The patient was not taking any concomitant medication. The patient had previously received the first and second doses of Comirnaty. It was reported that 1 day later at 09:00 on 20Nov2021, the patient experienced headache and temperature. On 21Nov2021, the patient experienced bone and joint pain. The reporter stated the pain spread to the shoulder and back on the following day after vaccination. The patient was treated with ibuprofen (brand unspecified). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1966094 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Immunisation
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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101734390

Write-up: NSTEMI Myocardial Infarction; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-816690 (MINISAL02). A 62 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 19Nov2021 (Lot number: Unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "arterial hypertension" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for hypertension. 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 19Nov2021, outcome "unknown", described as "Booster"; ACUTE MYOCARDIAL INFARCTION (hospitalization) with onset 28Nov2021, outcome "unknown", described as "NSTEMI Myocardial Infarction". Reporter Comment: Arterial hypertension in therapy with metoprolol 100 mg No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Arterial hypertension in therapy with metoprolol 100 mg


VAERS ID: 1966192 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0115 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Anaphylactic shock, Blood pressure diastolic, Blood pressure systolic, Dyspnoea, Heart rate, Hyperhidrosis, Lip swelling, Loss of consciousness, Oxygen saturation, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Blood pressure diastolic; Result Unstructured Data: Test Result:80 mmHg; Comments: After ANAPEN administration; Test Date: 20211119; Test Name: Blood pressure diastolic; Result Unstructured Data: Test Result:70 mmHg; Comments: Before ANAPEN administration; Test Date: 20211119; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:90 mmHg; Comments: Before ANAPEN administration; Test Date: 20211119; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:110 mmHg; Comments: After ANAPEN administration; Test Date: 20211119; Test Name: Heart rate; Result Unstructured Data: Test Result:50; Comments: Units:/min Before ANAPEN administration; Test Date: 20211119; Test Name: Heart rate; Result Unstructured Data: Test Result:86; Comments: Units:/min After ANAPEN administration; Test Date: 20211119; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:100; Comments: Units:/100 After ANAPEN administration; Test Date: 20211119; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:99; Comments: Units:/100 Before ANAPEN administration
CDC Split Type: LUPFIZER INC202101728721

Write-up: Shortness of breath; Abdominal pain; Swollen lips; Pallor; Anaphylactic shock; Sweating increased; Loss of consciousness; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency WEB. Regulatory number: LU-ALMPS-202103182 (RA). A 12 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: FK0115) at the age of 12 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: DYSPNOEA (hospitalization) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Shortness of breath"; ABDOMINAL PAIN (hospitalization) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Abdominal pain"; LIP SWELLING (hospitalization) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Swollen lips"; PALLOR (hospitalization) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Pallor"; ANAPHYLACTIC SHOCK (hospitalization, medically significant) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Anaphylactic shock"; HYPERHIDROSIS (hospitalization) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Sweating increased"; LOSS OF CONSCIOUSNESS (hospitalization, medically significant) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Loss of consciousness". The patient underwent the following laboratory tests and procedures: blood pressure diastolic: (19Nov2021) 80 mmHg, notes: After ANAPEN administration; (19Nov2021) 70 mmHg, notes: Before ANAPEN administration; blood pressure systolic: (19Nov2021) 90 mmHg, notes: Before ANAPEN administration; (19Nov2021) 110 mmHg, notes: After ANAPEN administration; heart rate: (19Nov2021) 50, notes: Units:/min Before ANAPEN administration; (19Nov2021) 86, notes: Units:/min After ANAPEN administration; oxygen saturation: (19Nov2021) 100, notes: Units:/100 After ANAPEN administration; (19Nov2021) 99, notes: Units:/100 Before ANAPEN administration. Therapeutic measures were taken as a result of dyspnoea, abdominal pain, lip swelling, pallor, anaphylactic shock, hyperhidrosis, loss of consciousness and included treatment with Anapen. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1966222 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Deafness unilateral, Immunisation
SMQs:, Hearing impairment (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: Hearing aid user
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101726124

Write-up: 3rd vaccine at 12 o''clock in right arm. At about 17 complete deafness in right ear.; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: NL-LRB-00716965. A 77 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 19Nov2021 12:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hearing aid" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (0,3 ml), administration date: 09Apr2021, for Covid-19 immunisation; Comirnaty (0,3 ml), administration date: 14May2021, for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021 12:00, outcome "unknown", described as "Booster"; DEAFNESS UNILATERAL (medically significant) with onset 19Nov2021 17:00, outcome "recovered" (19Nov2021 23:00), described as "3rd vaccine at 12 o''clock in right arm. At about 17 complete deafness in right ear.". No sound perception in the right ear even with hearing aid. No previous covid-19 infection. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1966223 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Burning sensation, Vaccination site discomfort
SMQs:, Peripheral neuropathy (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101726650

Write-up: pain with heartbeat; Burning sensation in the heart; Other reaction at or around the injection site: Stiffness; This is a spontaneous report received from a contactable Consumer from the regulaory authority. Regulatory number: NL-LRB-00717088. A 41 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: Unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Previous COVID-19 infection: No. The following information was reported: ANGINA PECTORIS (medically significant) with onset 19Nov2021, outcome "recovering", described as "pain with heartbeat"; BURNING SENSATION (non-serious) with onset 19Nov2021, outcome "recovering", described as "Burning sensation in the heart"; VACCINATION SITE DISCOMFORT (non-serious) with onset 19Nov2021, outcome "recovering", described as "Other reaction at or around the injection site: Stiffness". Latency of events "pain with heartbeat" and "Burning sensation in the heart" was 30min, latency of event "Other reaction at or around the injection site: Stiffness" was 10min. Reporter Comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Adverse Drug Reaction: Acted right away. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccin (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no Burning sensation in the heart, pain at heartbeat Additional information Adverse Drug Reaction: Acted right away COVID19 Previous COVID-19 infection: No


VAERS ID: 1966315 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ3438 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Immunisation
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: EXELON [RIVASTIGMINE]; TERBINAFIN ORIFARM; CIPRALEX; SELO-ZOK; ATORVASTATIN MYLAN; ALBYL-E
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101730963

Write-up: booster; LACK OF DRUG EFFECT; COVID-19; This is a spontaneous report received from a contactable reporter (Physician) from the Regulatory Authority. The Regulatory Authority number NO-NOMAADVRE-FHI-2021-U3xexy, Other Case identifier(s) NO-NOMAADVRE-E2B_00062629. A 78 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: FJ3438) as dose 3 (booster), single, administration date 12May2021 (Lot number: unknown) as dose 2, single and administration date 30Mar2021 (Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medications included EXELON taken for cognitive disorder; TERBINAFIN ORIFARM; CIPRALEX; SELO-ZOK taken for coronary artery disease; ATORVASTATIN MYLAN taken for hypercholesterolaemia; ALBYL-E. The following information was reported IMMUNISATION (hospitalization), outcome unknown; COVID-19 (hospitalization) with onset 19Nov2021; DRUG INEFFECTIVE (hospitalization) with onset 19Nov2021, outcome recovering. 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 product type. The final scope was determined to be the associated lot(s) of the reported lot FJ3438. 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. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root causes were identified as the complaint was not confirmed. Started with typical symptoms of common cold followed by acute dysfunction that led to hospitalization. 30Nov2021 requested additional information. If new medical information is received, report will be updated. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Started with typical symptoms of common cold followed by acute dysfunction that led to hospitalization. 30Nov2021 requested additional information. If new medical information is received, report will be updated. Linked Report(s): NO-PFIZER INC-202101774620 the same reporter/patient, different event/dose.


VAERS ID: 1966409 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Diarrhoea, Headache, Immunisation, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BILASTINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101691710

Write-up: Diarrhea; Myalgia/muscle pain; Arthralgia/joint pain; Headache; Booster; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-web. This is a report received from the Regulatory Authority. Regulatory Authority Report Number: PT-INFARMED-B202111-2057. A 60 year-old female patient received bnt162b2 (COMIRNATY, Strength 30ug), intramuscular, administration date 19Nov2021 (Lot number: FF2382) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication included: BILASTINE. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; DIARRHOEA (medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Diarrhea"; MYALGIA (medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Myalgia/muscle pain"; ARTHRALGIA (medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Arthralgia/joint pain"; HEADACHE (medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Headache". As a specific treatment for ADRs, ibuprofen was administered orally. Reactions reversed after 2 days. After clinical reassessment of the case, the severity level was changed to Severe, as treatment with ibuprofen was required to reverse the reactions. The reporter''s assessment of the causal relationship of the [diarrhea, myalgia, arthralgia, and headache] with the suspect product was: Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: probable. No follow-up attempts are possible. No further information is expected. Follow-up (06Dec2021). This is a spontaneous follow-up report received from the same contactable pharmacist. Updated information: case upgrading to serious, product dose number, concomitant drug, new event booster added, treatment. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: the causal relationship of the [diarrhea, myalgia, arthralgia, and headache] with the suspect product was: Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: probable.


VAERS ID: 1968299 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-19
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Nephrotic syndrome
SMQs:, Chronic kidney disease (broad), Proteinuria (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101740648

Write-up: Nephrotic syndrome; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 675216 Regulatory Authority. A 31 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: NEPHROTIC SYNDROME (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Nephrotic syndrome". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1968389 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Immunisation, Lymphadenopathy, Myalgia, Nausea, 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101733887

Write-up: Booster; Myalgia; Nausea; Glands swollen; Fatigue; Fever; Headache; Shivering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a Regulatory Authority. Regulatory number: BE-FAMHP-DHH-N2021-109602. A 36 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: Unknown) at the age of 36 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 1, MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (dose 2, MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 19Nov2021, outcome "unknown", described as "Booster"; MYALGIA (disability) with onset 19Nov2021, outcome "unknown", described as "Myalgia"; NAUSEA (disability) with onset 19Nov2021, outcome "unknown", described as "Nausea"; LYMPHADENOPATHY (disability) with onset 19Nov2021, outcome "unknown", described as "Glands swollen" (armpit); FATIGUE (disability) with onset 19Nov2021, outcome "unknown", described as "Fatigue"; PYREXIA (disability) with onset 19Nov2021, outcome "unknown", described as "Fever"; HEADACHE (disability) with onset 19Nov2021, outcome "unknown", described as "Headache"; CHILLS (disability) with onset 19Nov2021, outcome "unknown", described as "Shivering". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1968398 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Malaise, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? 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: BEPFIZER INC202101734028

Write-up: booster; Myalgia; Nausea; Malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-109632. A 53 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH8469) at the age of 53 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 1, MANUFACTURER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 19Nov2021, outcome "unknown", described as "booster"; MYALGIA (disability) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Myalgia"; NAUSEA (disability) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Nausea"; MALAISE (disability) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Malaise". Reporter Comment: Treatment - Evolution of the ADR - Recovered: 2 days No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - Evolution of the ADR - Recovered: 2 days


VAERS ID: 1968467 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ4187 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Localised oedema, Lymphadenopathy, Malaise, Pain, Pyrexia, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101751327

Write-up: fatigue; unwell; pain in the body; pain in the body and joints; swelling of the face; edema in the cervical region; swelling of the face and lymph nodes; fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. A 53 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 15:00 (Lot number: FJ4187) 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: FATIGUE (hospitalization) with onset 19Nov2021 18:00, outcome "unknown", described as "fatigue"; MALAISE (hospitalization) with onset 19Nov2021 18:00, outcome "unknown", described as "unwell"; PAIN (hospitalization) with onset 19Nov2021 18:00, outcome "unknown", described as "pain in the body"; ARTHRALGIA (hospitalization) with onset 19Nov2021 18:00, outcome "unknown", described as "pain in the body and joints"; SWELLING FACE (hospitalization) with onset 19Nov2021 18:00, outcome "unknown", described as "swelling of the face"; LOCALISED OEDEMA (hospitalization) with onset 19Nov2021 18:00, outcome "unknown", described as "edema in the cervical region"; LYMPHADENOPATHY (hospitalization) with onset 19Nov2021 18:00, outcome "unknown", described as "swelling of the face and lymph nodes"; PYREXIA (hospitalization) with onset 19Nov2021 18:00, outcome "recovered" (2021), described as "fever". Therapeutic measures were taken as a result of fatigue, malaise, pain, arthralgia, swelling face, localised oedema, lymphadenopathy, pyrexia which included antihistamines and Prednisolone 40. Clinical course: She was admitted to the PRIVACY and then transferred to the emergency unit of PRIVACY [entry in on Thursday [2nd day] and discharged yesterday (07Dec2021)]. She is taking antihistamines and Prednisolone 40 (she is concerned that Prednisolone has raised her blood pressure and the patient is hypertensive). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information 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: 1969078 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-19
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20214

Write-up: Tachycardia; Dyspnoea; This case was received via regulatory authroity (Reference number: DE-PEI-202100229092) 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 DYSPNOEA (Dyspnoea) and TACHYCARDIA (Tachycardia) in a 38-year-old female patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. No Medical History information was reported. On 21-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced DYSPNOEA (Dyspnoea) (seriousness criterion hospitalization). On 21-Nov-2021, the patient experienced TACHYCARDIA (Tachycardia) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (Dyspnoea) and TACHYCARDIA (Tachycardia) had not resolved. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.; Reporter''s Comments: Are you or the person concerned aware of allergies? If yes, which one? none information on risk factors or pre-existing illnesses; Sender''s Comments: This case concerns a 38-year-old female patient, with no medical history reported, who experienced the serious (hospitalization) unexpected events of Dyspnoea and Tachycardia. The event occurred on the same day after the 3rd doses of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered Not applicable. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1969450 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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: Back pain, Fatigue, Feeling abnormal, Gastric disorder, Headache, Immunisation
SMQs:, Retroperitoneal fibrosis (broad), Dementia (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: Dilated cardiomyopathy; Thyroidectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101739041

Write-up: Fatigue/ Daily intense fatigue; Patient received booster dose of Comirnaty; Headache; Gastric Problems; Backache; Feel Toxic; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202112061658551190-QSBAZ (RA). Other Case identifier(s): GB-MHRA-ADR 26296647 (RA). A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Thyroidectomy" (unspecified if ongoing); "Dilated cardiomyopathy" (unspecified if ongoing). Patient did not have symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown), for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Patient received booster dose of Comirnaty"; HEADACHE (medically significant) with onset 2021, outcome "not recovered", described as "Headache"; FATIGUE (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Fatigue/ Daily intense fatigue"; GASTRIC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Gastric Problems"; BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "Backache"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Feel Toxic". Patient did not have a COVID-19 test. Patient did not test 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: 1969534 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-07
Onset:2021-11-19
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, COVID-19, Cough, Dizziness, Dyspnoea, Peripheral coldness, Peripheral swelling, Pruritus, SARS-CoV-2 test, Tremor
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:goes up; Test Date: 20211119; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101768601

Write-up: itchy; Swelling arm; cough; out of breath; Itching; Felt faint; Cold hands and feet; Shaking; SARS-CoV-2 infection; BP goes up; cold feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112090238166130-CXFUK (MHRA). Other Case identifier(s): GB-MHRA-ADR 26311155 (MHRA). A 42 year-old male patient received bnt162b2 (COMIRNATY), administration date 07Nov2021 (Lot number: FK0596) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 18Nov2021 (ongoing). The patient''s concomitant medications were not reported. The patient was not enrolled in clinical trial. The following information was reported: COVID-19 (medically significant) with onset 19Nov2021, outcome "unknown", described as "SARS-CoV-2 infection"; COUGH (medically significant) with onset 06Dec2021 21:41, outcome "unknown", described as "cough"; PERIPHERAL COLDNESS (medically significant) with onset 2021, outcome "unknown", described as "cold feet"; PRURITUS (medically significant) with onset 09Dec2021 01:00, outcome "unknown", described as "itchy"; PRURITUS (medically significant) with onset 06Dec2021, outcome "not recovered", described as "Itching"; PERIPHERAL SWELLING (medically significant) with onset 09Dec2021 01:00, outcome "not recovered", described as "Swelling arm"; DIZZINESS (medically significant) with onset 06Dec2021, outcome "not recovered", described as "Felt faint"; PERIPHERAL COLDNESS (medically significant) with onset 06Dec2021, outcome "not recovered", described as "Cold hands and feet"; TREMOR (medically significant) with onset 06Dec2021, outcome "not recovered", described as "Shaking"; BLOOD PRESSURE INCREASED (medically significant) with onset 2021, outcome "unknown", described as "BP goes up"; DYSPNOEA (non-serious) with onset 06Dec2021 21:41, outcome "unknown", described as "out of breath". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (unspecified date) goes up; sars-cov-2 test: (19Nov2021) positive, notes: Yes - Positive COVID-19 test. Clinical course: The patient was isolated till 29Nov2021. Ongoing cough, out of breath 06Dec2021 21:41, 09Dec2021 1:00 (rang 111) Left forearm starts of itchy, swelling on arm (noticeable by tattoos being raised). Feeling faint Shaking, cold feet and hands. BP goes up Had to concentrate in breathing. Lasts 45-60 minutes. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969605 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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: Abdominal pain upper, Diarrhoea, Headache, Influenza, Nausea, Oropharyngeal pain, Pain, Peripheral coldness, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Ache; Nausea; Flu symptoms; Sore throat; Cold hands; Stomach pain; Diarrhoea; Headache; Feverish; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26317982) on 12-Dec-2021 and was forwarded to Moderna on 12-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache), INFLUENZA (Flu symptoms), OROPHARYNGEAL PAIN (Sore throat), PERIPHERAL COLDNESS (Cold hands), ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhoea), HEADACHE (Headache), PYREXIA (Feverish) and NAUSEA (Nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced INFLUENZA (Flu symptoms) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), PERIPHERAL COLDNESS (Cold hands) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 21-Nov-2021, ABDOMINAL PAIN UPPER (Stomach pain) and DIARRHOEA (Diarrhoea) had resolved. On 22-Nov-2021, OROPHARYNGEAL PAIN (Sore throat), PERIPHERAL COLDNESS (Cold hands), PYREXIA (Feverish) and NAUSEA (Nausea) had resolved. On 23-Nov-2021, INFLUENZA (Flu symptoms) had resolved. At the time of the report, PAIN (Ache) and HEADACHE (Headache) had resolved with sequelae. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Treatment medication were provided No concomitant medication were provided The patient could not move her body - felt like she had been paralysed from the neck down. Patient had not tested positive for COVID-19 since having the vaccine Unsure if patient was enrolled in clinical trial. Patient was not currently breastfeeding. Company comment: This case concerns a 51 year old female patient with no reported medical history who experienced the unexpected events of pain, flu symptoms, abdominal pain and diarrhea 1-2 days after the third dose mRNA 1273 Covid-19 vaccine. The patient could not move her body and felt like she had been paralysed from neck down. Patient also had pyrexia, cold hands, sore throat, and nausea. At the time of report, events abdominal pain, diarrhea, influenza symptoms have resolved, while pain had resolved with sequelae. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 51 year old female patient with no reported medical history who experienced the unexpected events of pain, flu symptoms, abdominal pain and diarrhea 1-2 days after the third dose mRNA 1273 Covid-19 vaccine. The patient could not move her body and felt like she had been paralysed from neck down. Patient also had pyrexia, cold hands, sore throat, and nausea. At the time of report, events abdominal pain, diarrhea, influenza symptoms have resolved, while pain had resolved with sequelae. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 1969736 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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: Hypoaesthesia, Peripheral coldness, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
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: Numbness; Coldness of limbs; This case was received via RA (Reference number: GB-MHRA-ADR 26324172) on 12-Dec-2021 and was forwarded to Moderna on 12-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness) and PERIPHERAL COLDNESS (Coldness of limbs) in a 52-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 04-Feb-2021 to an unknown date for Vaccination. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PERIPHERAL COLDNESS (Coldness of limbs) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA (Numbness) outcome was unknown and PERIPHERAL COLDNESS (Coldness of limbs) 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. Patient stated that she had cold patches over left side of body some numbness. Feeling of weakness of left side of face and left hand. Started to go away until she had booster and back to square one. Patient undergone lab tests include Nerve tests and results were not provided. No treatment medications provided by the reporter. Patient has not tested positive for COVID-19 since having the vaccine. Company comment: This regulatory authority case concerns a 52-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Coldness of limbs and Hypoaesthesia after mRNA- 1273 Moderna vaccine, booster dose of the vaccination schedule. The patient had received prior dose of COVID-19 AstraZeneca vaccine. The onset of the events occurred on the day after the booster dose of mRNA- 1273 vaccine. The patient experienced hypoaesthesia and cold patches over the left side of her body, as well as weakness of the left side of face and left hand. She had experienced this symptoms on an unknown date before booster dose, the events were resolving and worsened after the Moderna booster dose. Nerve conduction studies were performed, but results are not available. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 52-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Coldness of limbs and Hypoaesthesia after mRNA- 1273 Moderna vaccine, booster dose of the vaccination schedule. The patient had received prior dose of COVID-19 AstraZeneca vaccine. The onset of the events occurred on the day after the booster dose of mRNA- 1273 vaccine. The patient experienced hypoaesthesia and cold patches over the left side of her body, as well as weakness of the left side of face and left hand. She had experienced this symptoms on an unknown date before booster dose, the events were resolving and worsened after the Moderna booster dose. Nerve conduction studies were performed, but results are not available. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 1969981 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FM0114 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dental examination, Hyperaesthesia teeth, Immunisation, Toothache, Trigeminal neuralgia
SMQs:, Demyelination (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: Sensitivity of teeth (dental sensitivity on the left side in the weeks before the booster vaccine)
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: Dental examination; Result Unstructured Data: Test Result:no dental cause for pain found; Comments: no dental cause for pain found
CDC Split Type: IEPFIZER INC202101753872

Write-up: Booster; Severe neuralgia type pain on left side of face between ear and midline of lips/severe neuralgia pain jaw after booster; Once this pain eased localised dental sensitivity (Different Pain) worse than previous severity; Once this pain eased localised dental sensitivity (Different Pain) worse than previous severity; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency WEB. Regulatory number: IE-HPRA-2021-087159 (RA). Other Case identifier(s): IE-HPRA-CVARR2021112222802 (RA). A 42 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FM0114) at the age of 42 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Sensitivity of teeth", start date: 2021 (unspecified if ongoing), notes: dental sensitivity on the left side in the weeks before the booster vaccine. There were no concomitant medications. Vaccination history included: Comirnaty (DOSE 1, SINGLE, Lot number: unknown), administration date: 01Feb2021, for COVID-19 immunization; Comirnaty (DOSE 2, SINGLE, Lot number: unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; TRIGEMINAL NEURALGIA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Severe neuralgia type pain on left side of face between ear and midline of lips/severe neuralgia pain jaw after booster"; HYPERAESTHESIA TEETH (medically significant), TOOTHACHE (medically significant) all with onset 19Nov2021, outcome "not recovered" and all described as "Once this pain eased localised dental sensitivity (Different Pain) worse than previous severity". The patient underwent the following laboratory tests and procedures: dental examination: (22Nov2021) no dental cause for pain found, notes: no dental cause for pain found. Therapeutic measures were taken as a result of trigeminal neuralgia, hyperaesthesia teeth, toothache which included anti-inflammatories (not further specified). 120 minutes later, on 19Nov2021, the patient experienced severe neuralgia-type pain on the left side of her face, between her ear and the midline of her lips (also described as severe neuralgia pain in her jaw after the booster). Once this pain eased, she experienced localised dental sensitivity (different pain), worse than previous severity. On 22Nov2021, the patient attended the dentist for an emergency appointment. No dental cause for the pain was found. She was referred to her General Practitioner (GP) and at the time of reporting, was awaiting an appointment. The patient''s symptoms were severe for 36 hours and at the time of reporting, her pain was ongoing. . No follow-up attempts are possible. No further information is expected.


VAERS ID: 1970042 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-30
Onset:2021-11-19
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1016A / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Computerised tomogram head, Depressed level of consciousness, Dysgraphia, Fibrin D dimer, Fibrin D dimer increased, Headache, Hypertension, Specialist consultation, Speech disorder
SMQs:, Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 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:high; Test Name: brain CT scan; Result Unstructured Data: Test Result:negative; Test Name: D dimer; Result Unstructured Data: Test Result:high; Test Name: neurological consultation; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101734774

Write-up: difficulty in speaking, difficulty in writing words, feeling of obtundation; difficulty in speaking, difficulty in writing words, feeling of obtundation; difficulty in speaking, difficulty in writing words, feeling of obtundation; Right frontal-temporal headache tension type; D dimer high; BP high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: IT-MINISAL02-816746 (MINISAL02). A 37-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 30Oct2021 (Lot number: 1F1016A) 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: SPEECH DISORDER (hospitalization), DYSGRAPHIA (hospitalization), DEPRESSED LEVEL OF CONSCIOUSNESS (hospitalization) all with onset 19Nov2021, outcome "not recovered" and all described as "difficulty in speaking, difficulty in writing words, feeling of obtundation"; HEADACHE (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "Right frontal-temporal headache tension type"; FIBRIN D DIMER INCREASED (non-serious), outcome "unknown", described as "D dimer high"; HYPERTENSION (non-serious), outcome "unknown", described as "BP high". The patient was hospitalized for speech disorder, dysgraphia, depressed level of consciousness, headache (hospitalization duration: 1 day(s)). The events "difficulty in speaking, difficulty in writing words, feeling of obtundation" and "right frontal-temporal headache tension type" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: high; computerised tomogram head: negative; fibrin d dimer: high; specialist consultation: unknown results. Therapeutic measures were taken as a result of speech disorder, dysgraphia, depressed level of consciousness, headache. Clinical course: Therapy with Fluxarten 10 mg 1 tablet/ day. Impact on quality of life (7/10). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1972165 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004498 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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: BEMODERNATX, INC.MOD20214

Write-up: Nausea; Chills; Vomiting (3x in the middle of the night and again this morning).; Fatigue; This case was received via Agency Regulatory Authority (Reference number: BE-FAMHP-DHH-N2021-109593) 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 NAUSEA (Nausea), CHILLS (Chills), VOMITING (Vomiting (3x in the middle of the night and again this morning).) and FATIGUE (Fatigue) in a 12-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004498) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion disability), CHILLS (Chills) (seriousness criterion disability), VOMITING (Vomiting (3x in the middle of the night and again this morning).) (seriousness criterion disability) and FATIGUE (Fatigue) (seriousness criterion disability). At the time of the report, NAUSEA (Nausea), CHILLS (Chills), VOMITING (Vomiting (3x in the middle of the night and again this morning).) and FATIGUE (Fatigue) was resolving. Treatment information was not provided. Concomitant medications were not reported. It was reported that patient vomited 3 times in the middle of the night and again the next morning. Company comment: This case concerns a 12-year-old female patient with no medical history provided who experienced serious unexpected events of Nausea, Chills, Vomiting and Fatigue. The events occurred on the same day after the second dose of mRNA-1273. At the time of the report, all the events were resolving and no further information regarding clinical course of the events has been provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Translation received on 17-Dec-2021, includes translated event terms, case summary and reporter comments.; Reporter''s Comments: Treatment - Non Evolution of the ADR - Healing ADR description - Vomiting (3x in the middle of the night and again this morning).; Sender''s Comments: This case concerns a 12-year-old female patient with no medical history provided who experienced serious unexpected events of Nausea, Chills, Vomiting and Fatigue. The events occurred on the same day after the second dose of mRNA-1273. At the time of the report, all the events were resolving and no further information regarding clinical course of the events has been provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1972172 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dizziness, Eye pain, Eyelid pain, Headache, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), 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:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma
Allergies:
Diagnostic Lab Data: Test Name: High fever: 39 degrees; Result Unstructured Data: Test Result:39 Centigrade; Comments: High fever
CDC Split Type: BEPFIZER INC202101753618

Write-up: High fever: 39 degrees; dizzy; Nauseous; Sore eyelids - eyeballs; Headache; Sore eyelids - eyeballs; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority. Regulatory number: BE-FAMHP-DHH-N2021-109728. A 35 year-old male patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Asthmatic - Grass and Tree Pollen" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: PYREXIA (disability) with onset 19Nov2021, outcome "recovering", described as "High fever: 39 degrees"; DIZZINESS (disability) with onset 19Nov2021, outcome "recovering", described as "dizzy"; NAUSEA (disability) with onset 19Nov2021, outcome "recovering", described as "Nauseous"; EYELID PAIN (disability), EYE PAIN (disability) all with onset 19Nov2021, outcome "recovering" and all described as "Sore eyelids - eyeballs"; HEADACHE (disability) with onset 19Nov2021, outcome "recovering", described as "Headache". The patient underwent the following laboratory tests and procedures: body temperature: 39 Centigrade, notes: High fever. Therapeutic measures were not taken as a result of pyrexia, dizziness, nausea, eyelid pain, headache, eye pain. Reporter Comment: Treatment - No Evolution of the ADR - Recovering Situations - None of these options ADR description - High fever: 39 degrees Nauseous and spinning Headache Painful eyelids - eyeballs No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Treatment - No Evolution of the ADR - Recovering Situations - None of these options ADR description - High fever: 39 degrees Nauseous and spinning Headache Painful eyelids - eyeballs


VAERS ID: 1972190 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (before vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101753590

Write-up: Muscle aches; Acute shoulder pain/joint pain; 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-N2021-109966 (FAMHP). An adolescent male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH8469) as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid-19" (unspecified if ongoing), notes: before vaccination. The patient''s concomitant medications were not reported. The following information was reported: MYALGIA (disability) with onset 19Nov2021, outcome "recovered" (23Nov2021), described as "Muscle aches"; ARTHRALGIA (disability) with onset 19Nov2021, outcome "recovered" (23Nov2021), described as "Acute shoulder pain/joint pain". Therapeutic measures were taken as a result of myalgia, arthralgia. Reporter Comment: Treatment - Yes Analgesics Evolution of the ADR - Healing: 4 days ADR description - Acute shoulder pain No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - Yes Analgesics Evolution of the ADR - Healing: 4 days ADR description - Acute shoulder pain


VAERS ID: 1972284 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   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 UNKNOWN / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 antibody test, 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVETIRACETAM
Current Illness: Adenocarcinoma of prostate; Epilepsy; Sleep apnoea syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: anti-N IgG; Test Result: Negative ; Test Date: 20211121; Test Name: anti-S IgG; Test Result: Positive ; Test Date: 20211120; Test Name: smear; Test Result: Positive
CDC Split Type: CHPFIZER INC202101786947

Write-up: SARS-CoV-2 infection despite complete vaccination with Comirnaty; SARS-CoV-2 infection; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. A 83 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: unknown) at the age of 83 years as dose 3 (booster), single, intramuscular, administration date 16Feb2021 (Lot number: unknown) as dose 2, single and intramuscular, administration date 19Jan2021 (Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Prostate cancer" (ongoing); "Epilepsy" (ongoing); "Sleep apnoea syndrome" (ongoing). Concomitant medication(s) included: LEVETIRACETAM. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant) with onset 19Nov2021, outcome "not recovered", described as "SARS-CoV-2 infection despite complete vaccination with Comirnaty"; COVID-19 (hospitalization, medically significant) with onset 19Nov2021, outcome "not recovered", described as "SARS-CoV-2 infection". The events "sars-cov-2 infection despite complete vaccination with comirnaty" and "sars-cov-2 infection" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (21Nov2021) negative; (21Nov2021) positive; sars-cov-2 test: (20Nov2021) positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : CH-PFIZER INC-202101762729 LOE + other events after 3rd dose of vaccine


VAERS ID: 1972918 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Immunisation, Interchange of vaccine products, Myalgia, Off label use, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20211202; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101758703

Write-up: Joint ache; Muscle pain; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; Patient received booster (third) dose; Headache; This is a spontaneous report received from a contactable consumer from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112081107147250-CGICN (RA). Other Case identifier: GB-MHRA-ADR 26306763 (RA). A 62-year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH4751) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing). The patient''s concomitant medications were not reported. 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. he following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 19Nov2021, outcome "unknown" and all described as "Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Patient received booster (third) dose"; HEADACHE (medically significant) with onset 19Nov2021, outcome "recovered" (21Nov2021), described as "Headache"; MYALGIA (medically significant) with onset 20Nov2021, outcome "recovering", described as "Muscle pain"; ARTHRALGIA (medically significant) with onset 21Nov2021, outcome "recovered" (24Nov2021), described as "Joint ache". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (02Dec2021) negative. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1973100 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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: Headache, Immunisation, Interchange of vaccine products, Malaise, Nausea, Off label use, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (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: ALENDRONIC ACID; EVACAL D3; INDAPAMIDE; INFLUENZA VIRUS; LETROZOLE; LEVOTHYROXINE SODIUM; LOSARTAN; NIFEDIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; Blood pressure; Breast cancer; Chemotherapy; Interstitial lung disease; Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)); Radiotherapy; Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20201209; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101768437

Write-up: headache; pain; feeling unwell; Nausea; Painful arm; 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-202112091438158880-ESRLZ (RA). Other Case identifier(s): GB-MHRA-ADR 26312921 (RA). A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Interstitial lung disease" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing); "Radiotherapy" (unspecified if ongoing); "Chemotherapy" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Surgery" (unspecified if ongoing); "Neoplasm" (unspecified if ongoing), notes: Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONIC ACID taken for osteoporosis; EVACAL D3; INDAPAMIDE taken for blood pressure measurement; INFLUENZA VIRUS taken for antiviral prophylaxis, start date: 05Nov2021; LETROZOLE taken for breast cancer, start date: 2017; LEVOTHYROXINE SODIUM; LOSARTAN taken for blood pressure measurement; NIFEDIPINE. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2, MANUCTURER UNKOWN), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant), outcome "not recovered", described as "headache"; PAIN IN EXTREMITY (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Painful arm"; PAIN (medically significant), outcome "not recovered", described as "pain"; MALAISE (medically significant), outcome "not recovered", described as "feeling unwell"; NAUSEA (medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Nausea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Dec2020) positive, notes: Yes - Positive COVID-19 test. Clinical course: It was reported that diagnosed with breast cancer in May 2017, had surgery and radiotherapy and have continued to take Letrozole since and also had breast cancer in the other breast in 1998 and had surgery, chemotherapy and radiotherapy followed by a course of Tamoxifen. The patient taken blood pressure tablets and tablets for arthritis and also suffer with Raynaulds disease. Patient has not had symptoms associated with COVID-19 Nausea, headache and generally feeling unwell for the two days immediately after vaccination. Pain in the arm on day 1 after the vaccination. No further symptoms until 10th day, when the site of the vaccination started to hurt again and two days of nausea and feeling unwell, unable to eat. The pain at the site of vaccination continued to worsen until yesterday (day 20) I was unable to lift my arm or place it in any position without extreme pain in the muscle. It does not hurt to touch the site, but the muscle is extremely painful. The patient had taken one Tamoxifen (last night) to help alleviate the pain, but this had no effect at all. The muscle in my upper right arm is still extremely painful when I try to lift or mover the arm. Otherwise I do not feel ill, apart from a continuous mild headache. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Any relevant investigations or tests conducted was None. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1973171 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FH4751 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, COVID-19, Dizziness, Drug ineffective, Hypoaesthesia, Hypoaesthesia eye, SARS-CoV-2 test, SARS-CoV-2 test negative
SMQs:, Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Corneal disorders (broad), Vestibular disorders (broad), Arthritis (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: METHOTREXATE; PREDNISOLONE; RITUXIMAB
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer surgery; Chemotherapy (In remission now); Ovarian cancer; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr..); Seropositive rheumatoid arthritis; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: lateral tests; Test Result: Positive ; Comments: Lateral tests keep on testing positive; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101770550

Write-up: drug ineffective; SARS-CoV-2 infection; Numbness facial; Eye numbness; Dizziness; Joint pain; 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-202112101050396390-AGXJR (RA). Other Case identifier(s): GB-MHRA-ADR 26317731 (RA). A 36 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH4751) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ovarian cancer", start date: Jan2020 (unspecified if ongoing); "Chemotherapy", start date: Mar2020, stop date: Jun2020, notes: In remission now; "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "Rheumatoid arthritis", start date: May2015 (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr..; "Seropositive rheumatoid arthritis" (unspecified if ongoing); "ovarian cancer operation", start date: Feb2020 (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis, start date: 15Nov2017; PREDNISOLONE taken for rheumatoid arthritis, start date: 15Aug2020; RITUXIMAB taken for rheumatoid arthritis, start date: 15Oct2020. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 08Dec2021, outcome "unknown", described as "drug ineffective"; COVID-19 (medically significant) with onset 08Dec2021, outcome "unknown", described as "SARS-CoV-2 infection"; ARTHRALGIA (medically significant) with onset 19Nov2021, outcome "recovering", described as "Joint pain"; HYPOAESTHESIA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Numbness facial"; HYPOAESTHESIA EYE (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Eye numbness"; DIZZINESS (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Dizziness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Lateral tests keep on testing positive; sars-cov-2 test negative: negative, notes: No - Negative COVID-19 test. The patient lateral tests keep on testing positive, but PCR was negative. GP advised that clearly there was something. Effects should wear off. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1973176 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FH4751 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic; Coeliac disease; Immunodeficiency (Had an illness or condition, which reduced the immune response (e.g. immunodeficiency)).
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101770421

Write-up: diagnosed shingles/severe pain started in back of eye/inflammation; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; The patient received third/booster as COMIRNATY; This is a spontaneous report received from a contactable reporter (Consumer, patient) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112101618342540-LCQFD (MHRA). Other Case identifier(s): GB-MHRA-ADR 26319577 (MHRA). A 37 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: Fh4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Coeliac disease" (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Had an illness or condition, not listed above, which reduced the immune response (e.g. immunodeficiency); "Asthmatic" (unspecified if ongoing). Patient did not have symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation, administration date 25Sep2021. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 2, SINGLE, Lot Number: UNKNOWN), administration date: 21May2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 1, SINGLE, Lot Number: UNKNOWN), administration date: 06Mar2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (disability), INTERCHANGE OF VACCINE PRODUCTS (disability) all with onset 19Nov2021, outcome "unknown" and all described as "Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY"; IMMUNISATION (disability) with onset 19Nov2021, outcome "unknown", described as "The patient received third/booster as COMIRNATY"; OPHTHALMIC HERPES ZOSTER (disability) with onset 02Dec2021, outcome "recovering", described as "diagnosed shingles/severe pain started in back of eye/inflammation". The event "diagnosed shingles/severe pain started in back of eye/inflammation" was evaluated at the physician office visit and emergency room visit. Patient developed severe pain started in back of eye, then referred to eye specialised by general practitioner (GP) on 03Dec2021 who prescribed steroid drops for inflammation. It got worse over the weekend. Marks on face started on Sunday 05Dec2021. He went to accident and emergency (A&E) on 06Dec2021 who referred him to eye clinic who diagnosed shingles. Proper treatment prescribed and situation was resolving at the reporting date. Follow up appointment 14Dec2021. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative covid-19 test. Patient did not test positive for COVID-19 since having the vaccine. Therapeutic measures were taken as a result of ophthalmic herpes zoster.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: 1973384 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005887 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: ITMODERNATX, INC.MOD20214

Write-up: SEVERE HEADACHE RESISTANT DRUG, IMPORTANT PRESSURE RISE STILL PERSISTENT FORCED TO THERAPY; SEVERE HEADACHE RESISTANT DRUG, IMPORTANT PRESSURE RISE STILL PERSISTENT FORCED TO THERAPY; This case was initially received via Regulatory Agency (Reference number: IT-MINISAL02-815941) on 10-Dec-2021. The most recent information was received on 14-Dec-2021 and was forwarded to Moderna on 14-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of HYPERTENSION (SEVERE HEADACHE RESISTANT DRUG, IMPORTANT PRESSURE RISE STILL PERSISTENT FORCED TO THERAPY) and HEADACHE (SEVERE HEADACHE RESISTANT DRUG, IMPORTANT PRESSURE RISE STILL PERSISTENT FORCED TO THERAPY) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005887) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced HYPERTENSION (SEVERE HEADACHE RESISTANT DRUG, IMPORTANT PRESSURE RISE STILL PERSISTENT FORCED TO THERAPY) (seriousness criterion hospitalization) and HEADACHE (SEVERE HEADACHE RESISTANT DRUG, IMPORTANT PRESSURE RISE STILL PERSISTENT FORCED TO THERAPY) (seriousness criterion hospitalization). At the time of the report, HYPERTENSION (SEVERE HEADACHE RESISTANT DRUG, IMPORTANT PRESSURE RISE STILL PERSISTENT FORCED TO THERAPY) and HEADACHE (SEVERE HEADACHE RESISTANT DRUG, IMPORTANT PRESSURE RISE STILL PERSISTENT FORCED TO THERAPY) had not resolved. mRNA-1273 (Spikevax) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug information was provided. On 23rd November patient experienced headache had hypertensive peak 190 by 110, patient had mute history. Patient was hospitalized. Patient was discharged after 6 hours on 23rd November due to headache, PA had 110 by 90.Treatment Medication use information was provided by reporter that includes tablespoon with amlodipine 5mg, ketorolac, paracetamol, discharged on 25th November 26th November due to headache, patient had PA 150 by 90 treated with Ramipril 5mg, discharged after 2 hours. The laboratory exam were done that includes ECG brain and the result were found normal, CT tests done, and the result were found Unknown. Normal neurological EO was done. Company Comment This case concerns a 48-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of hypertension and headache. The events occurred 1 day after an unknown number of doses of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Significant information added in I narrative.; Reporter''s Comments: HOLTER PRESSURE PROGRAMMED FOR 30/11, CARDIAC HOLTER PROGRAMMED FOR 29/11; Sender''s Comments: This case concerns a 48-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of hypertension and headache. The events occurred 1 day after an unknown number of doses of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1973626 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-08
Onset:2021-11-19
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Paraesthesia, Seizure
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101760238

Write-up: Seizure; Hypoaesthesia; tingling of knees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-050467 (RA AEFI Case Number). A 14 year-old female patient received bnt162b2 (COMIRNATY), administration date 08Oct2021 (Batch/Lot number: unknown) 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, single), for COVID-19 immunization. The following information was reported: SEIZURE (hospitalization, medically significant) with onset 19Nov2021 22:26, outcome "recovering", described as "Seizure"; HYPOAESTHESIA (hospitalization) with onset 19Nov2021 22:26, outcome "recovering", described as "Hypoaesthesia"; PARAESTHESIA (hospitalization) with onset 19Nov2021 22:26, outcome "recovering", described as "tingling of knees". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1973722 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-19
Onset:2021-11-19
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCV002 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation reaction, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101759319

Write-up: Delayed thrombocytopenia; reactogenic reaction; Delayed thrombocytopenia; reactogenic reaction; This is a spontaneous report received from a contactable reporter (Physician) from Regulatory Authority. Regulatory number: PH-PHFDA-300123476 (PHFDA). A 17-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Oct2021 (Lot number: PCV002) at the age of 17 years 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: THROMBOCYTOPENIA (medically significant), IMMUNISATION REACTION (medically significant) all with onset 19Nov2021, outcome "unknown" and all described as "Delayed thrombocytopenia; reactogenic reaction". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1973795 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-19
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH6387 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Heart rate, Heart rate increased, Myocarditis, Ventricular tachycardia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Heart rate; Result Unstructured Data: Test Result:increased
CDC Split Type: PHPFIZER INC202101760482

Write-up: Chest pain; MYOCARDITIS: SEVERE ADVERSE REACTION TO COVID VACCINE VENTRICULAR TACHYCARDIA; MYOCARDITIS: SEVERE ADVERSE REACTION TO COVID VACCINE VENTRICULAR TACHYCARDIA; Vomiting; Heart rate increased; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300124824. A 12 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 10Nov2021 (Lot number: FH6387) at the age of 12 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: MYOCARDITIS (medically significant) with onset 19Nov2021, outcome "recovering", VENTRICULAR TACHYCARDIA (medically significant) with onset 19Nov2021, outcome "unknown" and all described as "MYOCARDITIS: SEVERE ADVERSE REACTION TO COVID VACCINE VENTRICULAR TACHYCARDIA"; VOMITING (non-serious) with onset 19Nov2021, outcome "unknown", described as "Vomiting"; HEART RATE INCREASED (non-serious) with onset 19Nov2021, outcome "unknown", described as "Heart rate increased"; CHEST PAIN (non-serious), outcome "unknown", described as "Chest pain". The patient underwent the following laboratory tests and procedures: heart rate: (19Nov2021) increased. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1973857 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FL5324 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amnesia, Confusional state, Headache, Immunisation, Time perception altered
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101753988

Write-up: Wrong time perception; Confusion; Headache; Memory loss; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: SE-MPA-2021-095217 Regulatory Authority. A 75 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FL5324) 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, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; TIME PERCEPTION ALTERED (medically significant) with onset 20Nov2021 08:30, outcome "recovered" (20Nov2021 14:00), described as "Wrong time perception"; CONFUSIONAL STATE (medically significant) with onset 20Nov2021 08:30, outcome "recovered" (20Nov2021 14:00), described as "Confusion"; HEADACHE (medically significant) with onset 20Nov2021 08:30, outcome "recovered" (20Nov2021 14:00), described as "Headache"; AMNESIA (medically significant) with onset 20Nov2021 08:30, outcome "recovered" (20Nov2021 14:00), described as "Memory loss". Clinical course: the day after the vaccination, the woman ate breakfast and went to bed in the armchair for a while and when she woke up she was confused, had memory loss, did not know where she was nor whether it was morning or evening, but these symptoms then disappeared in the afternoon and lasted between 8.30 and about 14.00. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1974737 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FJ3438 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Immunisation, Malaise, Myalgia, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic 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? 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 INC202101761938

Write-up: Fever; Shivering; Injection site reaction; Headache; Arthralgia; Myalgia; Malaise; Fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-109809. A 39 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FJ3438) 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 1, Primary Immunization series complete but unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (dose number 2, Primary Immunization series complete but unknown manufacturer), for covid-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 19Nov2021, outcome "unknown", described as "Booster"; PYREXIA (disability) with onset 20Nov2021, outcome "recovering", described as "Fever"; CHILLS (disability) with onset 20Nov2021, outcome "recovering", described as "Shivering"; VACCINATION SITE PAIN (disability) with onset 20Nov2021, outcome "recovering", described as "Injection site reaction"; HEADACHE (disability) with onset 20Nov2021, outcome "recovering", described as "Headache"; ARTHRALGIA (disability) with onset 20Nov2021, outcome "recovering", described as "Arthralgia"; MYALGIA (disability) with onset 20Nov2021, outcome "recovering", described as "Myalgia"; MALAISE (disability) with onset 20Nov2021, outcome "recovering", described as "Malaise"; FATIGUE (disability) with onset 20Nov2021, outcome "recovering", described as "Fatigue". Therapeutic measures were taken as a result of pyrexia, chills, vaccination site pain, headache, arthralgia, myalgia, malaise, fatigue. Clinical Information: It was reported that, stop date for events Injection site reaction, Fever, Malaise, Shivering, Fatigue, Arthralgia, Myalgia, Headache was 23Nov2021. Reporter Comment: Treatment - Yes paracetamol Evolution of the ADR - Healing; Reporter''s Comments: Treatment - Yes paracetamol Evolution of the ADR - Healing


VAERS ID: 1974778 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FG7369 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101761960

Write-up: Nausea; Dizziness; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-109815 (FAMHP). A 73-year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FG7369) 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 (2nd dose, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (1st dose, manufacturer unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 19Nov2021, outcome "unknown", described as "Booster"; NAUSEA (disability) with onset 23Nov2021, outcome "not recovered", described as "Nausea"; DIZZINESS (disability) with onset 23Nov2021, outcome "not recovered", described as "Dizziness". Therapeutic measures were taken as a result of nausea, dizziness. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - Yes Preparation of medication to help. Evolution of the ADR - ADR description - Vertiges


VAERS ID: 1976556 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30044980 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
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: Hypertension (Controlled hypertension via perindopril).
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20214

Write-up: Fatigue; Frissons; Joint Pain; Headache; Malaise; This case was received via Regulatory Agency (Reference number: BE-FAMHP-DHH-N2021-109619) 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 FATIGUE (Fatigue), CHILLS (Frissons), ARTHRALGIA (Joint Pain), HEADACHE (Headache) and MALAISE (Malaise) in a 68-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 30044980) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (Controlled hypertension via perindopril). On 19-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion disability), CHILLS (Frissons) (seriousness criterion disability), ARTHRALGIA (Joint Pain) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability) and MALAISE (Malaise) (seriousness criterion disability). At the time of the report, FATIGUE (Fatigue), CHILLS (Frissons), ARTHRALGIA (Joint Pain), HEADACHE (Headache) and MALAISE (Malaise) had not resolved. Company comment: This is a regulatory case concerning a 68-year-old male patient with hypertension, who experienced the serious events fatigue, chills, arthralgia, headache and malaise, with impossibility to work. The events occurred between the same and the day after receiving the third dose of mRNA-1273. Events seriousness (Disability) captured as per Regulatory Authority assessment in Source Document. The benefit-risk relationship of mRNA-1273 is not affected by this report. No Concomitant medications were reported. No Treatment information was reported. The Patient stated that he didn''t experience any ADE after first 2 doses. Patient experienced Malaise, difficulty standing, difficulty thinking and obligation to lie down but these discomforts passed away after 2 hours of sleep. Next day he experienced general inflammation of all joints, and intense fatigue with impossibility of work Third dose administered Intense fatigue and joint inflammation are always needed. Sender''s Comments: Company comment: This is a regulatory case concerning a 68-year-old male patient with hypertension, who experienced the serious events fatigue, chills, arthralgia, headache and malaise, with impossibility to work. The events occurred between the same and the day after receiving the third dose of mRNA-1273. Events seriousness (Disability) captured as per Regulatory Authority assessment in Source Document. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1976582 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthritis, Rheumatoid arthritis
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; METHOTREXATE; PREDNISOLON [PREDNISOLONE]; FOLSAEURE; NOVALGIN [METAMIZOLE SODIUM]
Current Illness: Seropositive rheumatoid arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101762803

Write-up: Rheumatoid arthritis flare up; Rheumatoid arthritis flare up; This is a spontaneous report received from a non-contactable reporter(s) (Physician) Regulatory number: DE-DCGMA-21194917. Other Case identifier(s): DE-PEI-202100262370. A 70 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: Unknown) at the age of 70 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Seropositive rheumatoid arthritis", start date: Oct2021 (ongoing). Concomitant medication(s) included: PANTOZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE], start date: Oct2021; METHOTREXATE, start date: Oct2021; PREDNISOLON [PREDNISOLONE], start date: 09Nov2021; FOLSAEURE, start date: Oct2021; NOVALGIN [METAMIZOLE SODIUM], start date: Oct2021. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), ARTHRITIS (medically significant) all with onset 19Nov2021, outcome "not recovered" and all described as "Rheumatoid arthritis flare up". Therapeutic measures were taken as a result of rheumatoid arthritis, arthritis. Reporter Comment: Measures: Prednisolone increased No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Measures: Prednisolone increased


VAERS ID: 1976603 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCTD6 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Borrelia test, Computerised tomogram head, Facial paralysis, Magnetic resonance imaging
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Borrelia serology; Result Unstructured Data: Test Result:in blood negative; Test Name: cCT; Result Unstructured Data: Test Result:oB with exclusion bleeding or space requirement; Test Name: cMRI; Result Unstructured Data: Test Result:with detection of facial neuritis
CDC Split Type: DEPFIZER INC202101762754

Write-up: Facial paresis left, a.e. idiopathic; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: DE-PEI-202100266114 (PEI). A 44 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 12Nov2021 (Lot number: SCTD6) at the age of 44 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: FACIAL PARALYSIS (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Facial paresis left, a.e. idiopathic". The patient underwent the following laboratory tests and procedures: borrelia test: in blood negative; computerised tomogram head: ob with exclusion bleeding or space requirement; magnetic resonance imaging: with detection of facial neuritis. EEG planned on 07Dec2021, further laboratory oB. Exclusion of Lyme disease, herpes zoster, apoplex, intracranial RF (Rheumatoid factor), mumps Reaction(s) / Event(s) Assessed Facial palsy Source of assessment PEI Result of Assessment D. Unclassifiable No follow-up attempts are possible. No further information is expected.


VAERS ID: 1976841 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 SCRP9 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Fall, Hypoaesthesia, Immunisation, Nausea, Pain in extremity, SARS-CoV-2 test, Sticky skin
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MILNANEURAX; OLMESARTAN MEDOXOMIL; VERAPAM
Current Illness: Polyneuropathy (Mild polyneuropathy since 1918)
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Blood pressure high; Foot discomfort; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20211128; Test Name: Biotech; Test Result: Negative ; Comments: Technique: Nasal Swab; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Unknown; Comments: Since the vaccination, has the patient been tested for COVID-19?: Yes
CDC Split Type: DEPFIZER INC202101774476

Write-up: Fall; severe pain in the right leg/pain in right foot/pain in arms; Pain in the shoulders and arms; Sticks in toes and fingertips; Dizziness; Nausea; No Feeling in the right leg; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 19Nov2021 10:00 (Lot number: SCRP9) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Minor stroke", start date: 2015, stop date: 2015; "Mild polyneuropathy" (ongoing), notes: Mild polyneuropathy since 1918; "High blood pressure" (unspecified if ongoing); "feeling disorders in the feet" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: MILNANEURAX; OLMESARTAN MEDOXOMIL; VERAPAM. Vaccination history included: Comirnaty (Dose 2; Lot No:1D014A;via unknown route in arm left; time: 11:00), administration date: 25May2021, when the patient was 66 years old, for COVID-19 Immunisation, reaction(s): "Dizziness", "severe pain in the right shoulder", "Upper arm", "Numbness of the left hand and face", "Numbness of the left hand and face", "pain of the tongue"; Comirnaty (Dose 1; Lot No: ET3045; via unknown route in arm left; time: 09:00), administration date: 13Apr2021, when the patient was 66 years old, for COVID-19 Immunisation, reaction(s): "severe pain in the re.foot", "left tibia", "prick in the toes and numbness", "prick in the toes and numbness". The following information was reported: IMMUNISATION (disability) with onset 19Nov2021 10:00, outcome "unknown", described as "Booster"; HYPOAESTHESIA (disability) with onset 19Nov2021 11:00, outcome "unknown", described as "No Feeling in the right leg"; FALL (disability), outcome "unknown", described as "Fall"; PAIN IN EXTREMITY (disability), outcome "unknown", described as "severe pain in the right leg/pain in right foot/pain in arms"; ARTHRALGIA (disability), outcome "unknown", described as "Pain in the shoulders and arms"; STICKY SKIN (disability), outcome "unknown", described as "Sticks in toes and fingertips"; DIZZINESS (disability), outcome "unknown", described as "Dizziness"; NAUSEA (disability), outcome "unknown", described as "Nausea". The events "no feeling in the right leg", "fall", "severe pain in the right leg/pain in right foot/pain in arms", "pain in the shoulders and arms", "sticks in toes and fingertips", "dizziness" and "nausea" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Nov2021) negative, notes: Technique: Nasal Swab; (unspecified date) unknown, notes: Since the vaccination, has the patient been tested for COVID-19?: Yes. Therapeutic measures were not taken as a result of hypoaesthesia, fall, pain in extremity, arthralgia, sticky skin, dizziness, nausea.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101785790 same patient/drug, different dose/events;DE-PFIZER INC-202101785791 same patient/drug, different dose/events


VAERS ID: 1977064 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-11-19
   Days after vaccination:171
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Computerised tomogram thorax, 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? Yes
Office Visit? No
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: Test Date: 20211201; Test Name: Computed tomography angiography of the pulmonary arteries; Result Unstructured Data: Test Result: around 50%; Comments: Extensive to severe parenchymal involvement of COVID-19 pneumonia, estimated to be around 50%. Absence of pulmonary embolism, the right ventricle / left ventricle ratio is around 1; Test Date: 20211129; Test Name: SARS-CoV-2 RT-PCR; Test Result: Positive; Comments: positive with the presence of the DELTA variant; Test Date: 20211119; Test Name: Test SARS-CoV-2; Test Result: Positive.
CDC Split Type: FRPFIZER INC202101773429

Write-up: drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority. The Regulatory Authority number FR-AFSSAPS-RE20213020. A 54 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Manufacturer Unknown), for COVID-19 vaccination. The following information was reported DRUG INEFFECTIVE (hospitalization, medically significant) with onset 19Nov2021, outcome recovered (2021); COVID-19 (hospitalization, medically significant) with onset 19Nov2021, outcome recovered (2021). The patient was hospitalized for drug ineffective, covid-19 (start date: 29Nov2021, discharge date: 03Dec2021, hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures computerised tomogram thorax: (01Dec2021) around 50%, Extensive to severe parenchymal involvement of COVID-19 pneumonia, estimated to be around 50%. Absence of pulmonary embolism, note that the right ventricle / left ventricle ratio is around 1; sars-cov-2 test (29Nov2021) positive, positive with the presence of the DELTA variant; (19Nov2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The Clinical Course as No usual treatment. Patient not considered to be at risk of developing a severe form of COVID-19. In June 2021 Second intramuscular injection by COMIRNATY (batch number unknown). On 18Nov2021 experienced Appearance of a cough, ageusia, and fever. On 19Nov2021 PCR positive for COVID-19. On 24Nov2021 Prescription of antibiotic therapy, corticosteroids, and VENTOLINE. On 29Nov2021, Patient hospitalized for SARS-CoV-2 pulmonary infection with worsening dyspnea with 80% desaturation. Initiation of oxygen therapy and LOVENOX. Patient discharged from hospitalization on 03Dec2021. 29Nov2021: SARS-CoV-2 RT-PCR positive with the presence of the DELTA variant. ADDITIONAL EXAM from 01Dec2021 reported as Computed tomography angiography of the pulmonary arteries Extensive to severe parenchymal involvement of COVID-19 pneumonia, estimated to be around 50%. Absence of pulmonary embolism, that the right ventricle / left ventricle ratio is around 1. Patient was recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1977074 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-19
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1015A / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypertensive crisis
SMQs:, Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101764110

Write-up: Crisis hypertensive; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory authority. A 54 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 10Nov2021 (Lot number: 1F1015A) 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, Left arm, Intramuscular injection, Lot: 1F1003A), administration date: 20Oct2021, for COVID-19 immunisation. The following information was reported: HYPERTENSIVE CRISIS (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Crisis hypertensive". The event "crisis hypertensive" was evaluated at the physician office visit. Therapeutic measures were taken as a result of hypertensive crisis. Additional information: COVID test was reportedly unknown. The event required consultation and Nicardipine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1977104 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Peripheral swelling, Skin warm, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101768817

Write-up: Booster; Hives on arm 5 inches under injection site.; hives; Hives on arm 5 inches under injection site.; 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: GB-MHRA-EYC 00268611. Other Case identifier(s): GB-MHRA-ADR 26308335. A 61 year-old female patient received bnt162b2 (COMIRNATY), parenteral, administration date 16Nov2021 (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, 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"; PERIPHERAL SWELLING (medically significant), SKIN WARM (medically significant) all with onset 19Nov2021, outcome "recovered" (22Nov2021) and all described as "Hives on arm 5 inches under injection site."; URTICARIA (medically significant) with onset 19Nov2021, outcome "recovered" (22Nov2021), described as "hives". Clinical course: Red marks appeared on my arm approx 5 inches under the injection site, the marks got worse and ended up as a red mass approx 2 inches across. This was red and swollen and hot to the touch. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1977178 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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: Arrhythmia, Chest pain, Dizziness, Dyspnoea, Electrocardiogram, Fatigue, Headache, Loss of consciousness, Malaise, Myocarditis, Palpitations, Pericarditis, Pyrexia, SARS-CoV-2 test, Skin burning sensation, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy (anaphylaxis)
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis
Allergies:
Diagnostic Lab Data: Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211119; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101769930

Write-up: Still feeling unwell with dizzy spells; Headache; Chest pain; Burning skin; Fever; Generally unwell; Lost consciousness; Fainting; pericarditis; myocarditis; Fatigue/unusual tiredness; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Arrhythmia; This is a spontaneous report received from a contactable reporter(Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112081647008530-OVGQT (RA). Other Case identifier(s): GB-MHRA-ADR 26309299 (RA). A 29 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anaphylactic reaction" (not ongoing); "Drug hypersensitivity" (ongoing), notes: anaphylaxis. Patient had no symptoms associated with COVID-19 . Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (hospitalization, disability, medically significant) with onset 19Nov2021, outcome "recovered with sequelae" (2021), described as "Lost consciousness"; SYNCOPE (hospitalization, disability, medically significant) with onset 2021, outcome "unknown", described as "Fainting"; PERICARDITIS (hospitalization, disability, medically significant) with onset 2021, outcome "unknown", described as "pericarditis"; MYOCARDITIS (hospitalization, disability, medically significant) with onset 2021, outcome "unknown", described as "myocarditis"; DIZZINESS (hospitalization, disability, medically significant) with onset 19Nov2021, outcome "recovered with sequelae" (2021), described as "Still feeling unwell with dizzy spells"; HEADACHE (hospitalization, disability, medically significant) with onset 19Nov2021, outcome "recovering", described as "Headache"; CHEST PAIN (hospitalization, disability, medically significant) with onset 19Nov2021, outcome "recovering", described as "Chest pain"; SKIN BURNING SENSATION (hospitalization, disability, medically significant) with onset 19Nov2021, outcome "recovered" (2021), described as "Burning skin"; PYREXIA (hospitalization, disability, medically significant) with onset 19Nov2021, outcome "recovered" (2021), described as "Fever"; MALAISE (hospitalization, disability, medically significant) with onset 19Nov2021, outcome "not recovered", described as "Generally unwell"; FATIGUE (hospitalization, disability, medically significant) with onset 2021, outcome "unknown", described as "Fatigue/unusual tiredness"; DYSPNOEA (hospitalization, disability, medically significant) with onset 2021, outcome "unknown", described as "Shortness of breath"; PALPITATIONS (hospitalization, disability, medically significant) with onset 2021, outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (hospitalization, disability, medically significant) with onset 2021, outcome "unknown", described as "Racing heart (tachycardia)"; ARRHYTHMIA (hospitalization, disability, medically significant) with onset 2021, outcome "unknown", described as "Arrhythmia". The patient was hospitalized for loss of consciousness, syncope, pericarditis, dizziness, headache, chest pain, skin burning sensation, pyrexia, malaise, fatigue, dyspnoea, palpitations, tachycardia, arrhythmia (start date: 2021, discharge date: 2021, hospitalization duration: 2 day(s)); for myocarditis (start date: 2021, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: electrocardiogram: (unspecified date) unknown results; sars-cov-2 test: (19Nov2021) no - negative covid-19 test. Clinical course: Arrhythmia when assessed by paramedics. The patient was still feeling unwell with dizzy spells. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms led to a hospital stay for 2 days. It was unknown if the diagnosis made by a medical professional and unknown if any blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1977554 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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: Headache, Immunisation, Influenza, Interchange of vaccine products, Neck mass, Off label use, Sleep disorder due to general medical condition, insomnia type
SMQs:, Medication errors (broad), Infective pneumonia (broad), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CODEINE; DIAZEPAM; GABAPENTIN; PARACETAMOL; TRAMADOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder (The patient had a rare heart condition, swelling of the heart sack and causing a low immune system (close to is Bornholms disease).); Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i..); Palpitations
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101770200

Write-up: Neck mass/ Painful lump on back of the head on the right and near the neck; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; Patient received the third (booster) dose; Flu; Headache; Wake up in agony/got about 4hrs sleep per night at best; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112111814324430-NMJAG (MHRA). Other Case identifier(s): GB-MHRA-ADR 26323944 (MHRA). A 38 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart disorder" (unspecified if ongoing), notes: The patient had a rare heart condition, swelling of the heart sack and causing a low immune system (close to is Bornholms disease).; "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response and i..; "Palpitations" (unspecified if ongoing). Concomitant medication(s) included: CODEINE taken for cardiac disorder, start date: 19Nov2021; DIAZEPAM taken for cardiac disorder, start date: 19Nov2021; GABAPENTIN taken for cardiac disorder, start date: 19Nov2021; PARACETAMOL taken for cardiac disorder, start date: 19Nov2021; TRAMADOL taken for cardiac disorder, start date: 19Nov2021. Vaccination history included: Flu jab (influenza vaccine) (The patient had other jabs like flu Jabs with no issues.), for Immunization, reaction(s): "No adverse event"; Covid-19 vaccine (DOSE 2, SINGLE,Lot Number: UNKNOWN, Route of administration: unspecified Primary Immunization series complete but unknown manufacturer. Small lump on the left side on the back of head near neck.), for COVID-19 immunisation, reaction(s): "Neck mass"; Covid-19 vaccine (DOSE 1, SINGLE,Lot Number: UNKNOWN, Route of administration: unspecified Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (hospitalization, medically significant), INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant) all with onset 19Nov2021, outcome "unknown" and all described as "Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY"; IMMUNISATION (hospitalization, medically significant) with onset 19Nov2021, outcome "unknown", described as "Patient received the third (booster) dose"; INFLUENZA (hospitalization, medically significant) with onset 2021, outcome "recovering", described as "Flu"; NECK MASS (hospitalization, medically significant) with onset 21Nov2021, outcome "not recovered", described as "Neck mass/ Painful lump on back of the head on the right and near the neck"; HEADACHE (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Headache"; SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Wake up in agony/got about 4hrs sleep per night at best". The patient was hospitalized for off label use, interchange of vaccine products, immunisation, influenza, neck mass, headache, sleep disorder due to general medical condition, insomnia type (start date: 2021). The event "headache" was evaluated at the emergency room visit. Clinical course: The lump grew over night to around the size of a table spoon. When there''s any pressure applied to the lump the patient get instant headache. If the patient bend over his neck hurts and also get a headache, When the patient go to bed and try to sleep of he roll over and the back of his head rolls over the pillow, the patient get an instant headache and wake up in agony. The patient got about 4hrs sleep per night at best. All because of this lump. The patient did get a small lump on the left side on the back of his head near his neck when he had my 2nd COVID injection, This caused extreme headaches and a visit to A&E. The lump went after 2 weeks. The lump the patient has at the moment on the back of his head on the right and near his neck he has had for more than he expected. The patient didn''t understand why it''s only the COVID injections that are giving him these extremely painful lumps that also like giving me instant headache and pain if touched. The patient has other jabs like flu Jabs with no issues.Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1978247 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Pleuritic pain
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101760261

Write-up: Chest discomfort; worse on position change pain in L upper chest; pleuritic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-050823 (Case Number). A 15 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 15 years 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, SINGLE), for COVID-19 immunization. The following information was reported: CHEST DISCOMFORT (hospitalization) with onset 19Nov2021 14:16, outcome "unknown", described as "Chest discomfort"; CHEST PAIN (hospitalization) with onset 19Nov2021 14:16, outcome "unknown", described as "worse on position change pain in L upper chest"; PLEURITIC PAIN (hospitalization) with onset 19Nov2021 14:16, outcome "unknown", described as "pleuritic". Reporters description of AEFI: Friday evening developed pleuritic and worse on position change pain in L upper chest. Non radiating. Non migrating. No LRTI symptoms No fevers No trauma No cough. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1979482 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-19
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Exercise tolerance decreased, Fatigue, Immunisation, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101779747

Write-up: booster; Exercise capacity decreased; Severe fatigue; Edema of lower extremities; Aching in knees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the WEB CZ-CZSUKL-21012636. The reporter is the patient. A 27 year-old female patient received bnt162b2 (COMIRNATY), intramuscular (Lot number: Unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (1st dose), for COVID-19 immunization; Comirnaty (2nd dose), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; EXERCISE TOLERANCE DECREASED (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Exercise capacity decreased"; FATIGUE (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Severe fatigue"; OEDEMA PERIPHERAL (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Edema of lower extremities"; ARTHRALGIA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Aching in knees". Patient notes: Medical history: not specified. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1979601 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214015 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Respiration abnormal
SMQs:, Acute central respiratory depression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (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: DEMODERNATX, INC.MOD20214

Write-up: headache, earache, armpit lymph node painful, joint and muscle pain, chills, nausea, diarrhea, kidney pain, eye pain,; liver pain with vomiting of yellow fluid; This case was received via Agency (Reference number: DE-PEI-202100230010) 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 ARRHYTHMIA (headache, earache, armpit lymph node painful, joint and muscle pain, chills, nausea, diarrhea, kidney pain, eye pain,) and RESPIRATION ABNORMAL (liver pain with vomiting of yellow fluid) in a 53-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214015) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced ARRHYTHMIA (headache, earache, armpit lymph node painful, joint and muscle pain, chills, nausea, diarrhea, kidney pain, eye pain,) (seriousness criterion hospitalization) and RESPIRATION ABNORMAL (liver pain with vomiting of yellow fluid) (seriousness criterion hospitalization). On 21-Nov-2021, ARRHYTHMIA (headache, earache, armpit lymph node painful, joint and muscle pain, chills, nausea, diarrhea, kidney pain, eye pain,) and RESPIRATION ABNORMAL (liver pain with vomiting of yellow fluid) was resolving. No concomitant medication was provided by reporter. No treatment drug was provided by reporter. Patient had allergy for gluten, angora, chemical hair color, earlier hay fever (no longer present). Complete bed rest, exhaustion, loss of appetite, feeling of having to breathe against resistance, mild arrythmia and dizziness, neural pain, vomiting, joint and Muscle pain with headache (symptoms rising and at the same time) adding diarrhea . Slightly attenuating from day three symptoms but totally exhausted. Company comment: This is a regulatory case concerning a 53-year-old, female patient with no medical history reported, who experienced the serious unexpected , according RA, AESI of Arrythmia and the serious unexpected event of Respiration abnormal. The event occurred approximately the same day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due Hospitalization.; Sender''s Comments: This is a regulatory case concerning a 53-year-old, female patient with no medical history reported, who experienced the serious unexpected , according RA, AESI of Arrythmia and the serious unexpected event of Respiration abnormal. The event occurred approximately the same day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due Hospitalization.


VAERS ID: 1979792 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 1F1003A / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebellar syndrome, Cerebrovascular accident, Immunisation
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), Noninfectious encephalitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ascending aortic dilatation; Epilepsy (stable controlled)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101809952

Write-up: Syndrome cerebellar; CVA/stroke; booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-NT20215657. A 78 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: 1f1003a) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing), notes: stable controlled; "Ascending aortic dilatation" (unspecified if 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 (life threatening) with onset 19Nov2021, outcome "unknown", described as "booster"; CEREBELLAR SYNDROME (medically significant, life threatening) with onset 29Nov2021, outcome "unknown", described as "Syndrome cerebellar"; CEREBROVASCULAR ACCIDENT (medically significant, life threatening) with onset 29Nov2021, outcome "unknown", described as "CVA/stroke".


VAERS ID: 1979848 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-11-19
   Days after vaccination:96
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive disorders; Diabetes mellitus; Fibrillation atrial; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101779883

Write-up: Covid-19 infection; Vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: FR-AFSSAPS-PC20215334 (AFSSAPS). A 90-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15Aug2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Fibrillation atrial" (unspecified if ongoing); "Cognitive disorders" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "Vaccination failure"; COVID-19 (hospitalization) with onset 20Nov2021, outcome "unknown", described as "Covid-19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) positive. Clinical course: Vaccine failure in a female patient vaccinated with two doses of COVID-19 vaccines. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1979900 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-15
Onset:2021-11-19
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Electrocardiogram, Hypertension, Investigation, Myocardial necrosis marker, SARS-CoV-2 test, Sinus tachycardia, Tachycardia, Ultrasound scan
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Hypertension (narrow), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hyperprolactinemia
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Normal; Test Name: electrocardiography; Result Unstructured Data: Test Result:no other abnormality observed except sinus tachyca; Test Name: HTA flare-up; Result Unstructured Data: Test Result:(21/12); Test Name: cardiac enzyme; Result Unstructured Data: Test Result:Normal cardiac enzymes; Test Date: 20210921; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Name: tachycardia; Result Unstructured Data: Test Result:between 120 and 150; Test Name: heart ultrasound; Result Unstructured Data: Test Result:no visible abnormality; Comments: no other abnormality observed except sinus tachycardia
CDC Split Type: FRPFIZER INC202101773442

Write-up: Tachycardia sinus; Arterial hypertension; Chest tightness of; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) Regulatory number: FR-AFSSAPS-TS20216058. A 54 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15Oct2021 (Lot number: FF2382) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 21Sep2021 (not ongoing); "Hyperprolactinemia" (ongoing). The patient''s concomitant medications were not reported. Past drug history included: Dostinex for Hyperprolactinemia. The following information was reported: SINUS TACHYCARDIA (disability) with onset 19Nov2021, outcome "recovering", described as "Tachycardia sinus"; HYPERTENSION (disability) with onset 19Nov2021, outcome "recovering", described as "Arterial hypertension"; CHEST DISCOMFORT (non-serious) with onset 19Nov2021, outcome "recovering", described as "Chest tightness of". The events "tachycardia sinus", "arterial hypertension" and "chest tightness of" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) normal; electrocardiogram: (unspecified date) no other abnormality observed except sinus tachyca; investigation: (unspecified date) (21/12) (HTA flare-up); myocardial necrosis marker: (unspecified date) normal cardiac enzymes; sars-cov-2 test: (21Sep2021) positive; tachycardia: (unspecified date) between 120 and 150; ultrasound scan: (unspecified date) no visible abnormality, notes: no other abnormality observed except sinus tachycardia. Therapeutic measures were taken as a result of sinus tachycardia, hypertension, chest discomfort. Clinical course: Information contained in the statement: "Occurred at place of work. Being IDE, consultation in the emergency room then attending physician then cardiologist who set up the symptomatic treatment. Synthesis carried out by the CRPV: In total, grade III hypertension flare-up, sinus tachycardia and chest tightness, approximately 1 month after a 1st dose of Comirnaty, of favourable course in progress after introduction of propranolol. Echo normal heart and biological balance. Notion of COVID infection 1 month before vaccination.A drug was coded in terms of substance if the commercial name was not known.Accountability without prejudice to the elements of investigations that may be carried out as part of legal or amicable compensation procedures.Therapy 1985; 40:111-8. Symptomatic treatment initiated: AVLOCARDYL. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1980060 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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, Heart rate, Heart rate increased, Immunisation, Insomnia, Interchange of vaccine products, Malaise, Off label use, Oxygen saturation, Oxygen saturation decreased, Pain in extremity, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Infective pneumonia (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: INFLUENZA VIRUS; APIXABAN; BISOPROLOL FUMARATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; TIA
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:68 resting; Test Date: 20211211; Test Name: Heart rate; Result Unstructured Data: Test Result:120 bpm; Test Date: 20211211; Test Name: oxygen; Result Unstructured Data: Test Result:89; Test Date: 20211212; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101780136

Write-up: Heart rate 120 bpm; Feel unwell; Shivers; Aching limbs; Could not sleep; oxygen 89; 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 number 3 (booster); 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: GB-MHRA-WEBCOVID-202112121710286620-CA5YS. Other Case identifier(s): GB-MHRA-ADR 26324974. A 66 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "TIA" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation; APIXABAN taken for transient ischaemic attack, start date: 08Aug2016; BISOPROLOL FUMARATE taken for atrial fibrillation, start date: 16Jan2017. Vaccination history included: Covid-19 vaccine (DOSE 2, MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, 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 19Nov2021, outcome "unknown" and all described as "Dose 1 and Dose 2: Non-Pfizer Covid vaccine and Dose 3: Comirnaty"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Dose number 3 (booster)"; HEART RATE INCREASED (medically significant) with onset 11Dec2021, outcome "not recovered", described as "Heart rate 120 bpm"; MALAISE (medically significant) with onset 11Dec2021, outcome "unknown", described as "Feel unwell"; CHILLS (medically significant) with onset 11Dec2021, outcome "unknown", described as "Shivers"; PAIN IN EXTREMITY (medically significant) with onset 11Dec2021, outcome "unknown", described as "Aching limbs"; INSOMNIA (medically significant) with onset 11Dec2021, outcome "unknown", described as "Could not sleep"; OXYGEN SATURATION DECREASED (medically significant) with onset 11Dec2021, outcome "unknown", described as "oxygen 89". The clinical course reported as had a cup of tea, started to feel unwell, shivers, aching limbs. Slept from 5 till 9.00pm. Went to bed, tested heart rate throughout the night because she couldn''t sleep. Heart rate 120 bpm, oxygen 89. Normal rate was 68 resting. The patient underwent the following laboratory tests and procedures: heart rate: (2021) 68 resting; (11Dec2021) 120 bpm; oxygen saturation: (11Dec2021) 89; COVID-19 virus test: (12Dec2021) no - negative covid-19 test. Patient has not 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: 1980336 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FH8469 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immune thrombocytopenic purpura
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101773648

Write-up: Booster; Swelling between neck and shoulder; 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: IE-HPRA-2021-087318 (RA). Other Case identifier(s): IE-HPRA-CVARR2021112522852 (RA). A 55 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH8469) as dose number unknown (booster) single for covid-19 immunisation. Relevant medical history included: "Immune thrombocytopenic purpura" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTUERER UNKNOWN (where X=1, 2, or number unknown)), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; SWELLING (medically significant) with onset 2021, outcome "unknown", described as "Swelling between neck and shoulder". Clinical course: patient stated that I''ve a bleeding disorder called ITP. I received the booster vaccination 19Nov. I have a swelling between my neck and shoulder. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1980380 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-11-19
   Days after vaccination:287
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Pneumonia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 RT-PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101785626

Write-up: bilateral pneumonia with positive PCR test for sars-cov-2; bilateral pneumonia with positive PCR test for sars-cov-2; bilateral pneumonia with positive PCR test for sars-cov-2; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB and product quality group. Regulatory number: IT-MINISAL02-819128 (MINISAL02). A 85 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 05Feb2021 (Lot number: EK9788) as dose 2, 0.3 ml, single and administration date 15Jan2021 (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: COVID-19 (hospitalization), VACCINATION FAILURE (hospitalization), PNEUMONIA (hospitalization) all with onset 19Nov2021, outcome "unknown" and all described as "bilateral pneumonia with positive PCR test for sars-cov-2". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. For this lot adverse event safety request for investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5648370 (see File attachment in this investigation record) The complaint for adverse event/LOE of "PFIZER BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product. Previously Completed Inv:5649768. PR Link (Previously Investigated CR):5649718. The lot number for bnt162b2 (dose 1), was not provided and will be requested during follow up.


VAERS ID: 1981467 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FH0161 / 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? 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: ATPFIZER INC202101779737

Write-up: BOOSTER; Shingles; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: AT-BASGAGES-2021-065098. A 62 year-old female patient received bnt162b2 (COMIRNATY), administration date 11Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 19Nov2021 (Lot number: FH0161) 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 (first dose), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "BOOSTER"; HERPES ZOSTER (medically significant) with onset 2021, outcome "recovering", described as "Shingles". The event "shingles" was evaluated at the physician office visit. Therapeutic measures were taken as a result of herpes zoster. Clinical course: In the meantime the same patient has developed shingles again after the 3rd vaccination with Comirnaty. The shingles was in better condition with outpatient therapy, the patient has no rel. Basic illnesses, no stat. The stay and start of the shingles were 12 days after the 3rd vaccination. Herpes zoster onset date after 3rd vaccination: 01Dec2021. Sender''s comments: comment: Follow-up information has been requested. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101719943 Pfizer Inc


VAERS ID: 1982261 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCTR1 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time ratio, Alanine aminotransferase, Aspartate aminotransferase, Basophil percentage, Blood creatine phosphokinase, Blood pressure measurement, Body temperature, C-reactive protein, Chest X-ray, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Eosinophil percentage, Fatigue, Fibrin D dimer, Haemoglobin, Heart rate, International normalised ratio, Lymphocyte percentage, Magnetic resonance imaging heart, Monocyte percentage, Myocarditis, Myoglobin blood, N-terminal prohormone brain natriuretic peptide, Neutrophil percentage, Oxygen saturation, Platelet count, Prothrombin time, Red blood cell count, Troponin I, White blood cell count
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Non-tobacco user
Preexisting Conditions: Medical History/Concurrent Conditions: Macrolide antibiotic resistance
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: APTT; Test Result: 25.6 s; Test Date: 20211121; Test Name: Activated partial thromboplastin time ratio; Test Result: 98 %; Test Date: 20211121; Test Name: SGPT; Result Unstructured Data: Test Result:0.94; Comments: Units:ukat/L; Test Date: 20211121; Test Name: Glutamic-oxaloacetic transferase; Result Unstructured Data: Test Result:2.07; Comments: Units:ukat/L; Test Date: 20211121; Test Name: Glutamic-oxaloacetic transferase; Result Unstructured Data: Test Result:2.43; Comments: Units:ukat/L; Test Date: 20211121; Test Name: Basophil percentage; Test Result: 0.4 %; Test Date: 20211121; Test Name: Creatine kinase; Result Unstructured Data: Test Result:13.97; Comments: Units:ukat/L; Test Date: 20211121; Test Name: Creatine kinase; Result Unstructured Data: Test Result:23.63; Comments: Units:ukat/L; Test Date: 20211121; Test Name: Blood pressure; Result Unstructured Data: Test Result:130/85 mmHg; Test Date: 20211121; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20211121; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown results; Comments: bronchovascular lining accentuated perihilently; Test Date: 20211121; Test Name: C-reactive protein; Result Unstructured Data: Test Result:93.8 mg/l; Test Date: 20211121; Test Name: C-reactive protein; Result Unstructured Data: Test Result:93.8 mg/l; Comments: 93.8 mg/L; 77.5 mg/L; Test Date: 20211121; Test Name: Echocardiography; Result Unstructured Data: Test Result:Normal; Comments: Hypertrofic left ventricle with picture of myocardial infiltration, EF 62%, PE- small behind left ventricle no more than 5 mm. Picture of perimyocarditis with myocardial infiltration of left ventricle with good function of left ventricle. There is insignificant pericardial effusion. Normal pulmonary flow. There is suspected pericarditic change on EKG rest curve; Test Date: 20211122; Test Name: Echocardiography; Result Unstructured Data: Test Result:7; Comments: PE- behind left ventricle max 7 mm; Optically better finding of myocard of left ventricle; normal size and function of left ventricle, insignificant progression of effusionbehind left ventricle; Test Date: 20211123; Test Name: Echocardiography; Result Unstructured Data: Test Result:Normal; Comments: Normal size and function of left ventricle, just narrow hem PV behind left ventricle. Control ECG curve in regression, without arhythmia normal conversion times.; Test Date: 20211121; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:regular; Comments: heart rate regular, rhythm sinus, hearbeat 87/min, AQRS 30 grade, PQ 0,09s, QTc 0,39s ST elevation in leads I and aVL no more than 1mm. T negative in V1, without ES, without hypertrophia; Test Date: 20211121; Test Name: Eosinophil percentage; Test Result: 0.1 %; Test Date: 20211121; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:428 mg/l; Test Date: 20211121; Test Name: Hemoglobin; Result Unstructured Data: Test Result:166 g/l; Test Date: 20211121; Test Name: Heart rate; Result Unstructured Data: Test Result:107; Comments: Units:/min; Test Date: 20211121; Test Name: INR; Result Unstructured Data: Test Result:1.22; Test Date: 20211121; Test Name: INR; Result Unstructured Data: Test Result:1.22; Test Date: 20211121; Test Name: Lymphocyte percentage; Test Result: 11.5 %; Test Date: 20211124; Test Name: Magnetic resonance imaging heart; Result Unstructured Data: Test Result:Normal; Comments: no significant finding, all parameters are in norm; Test Date: 20211121; Test Name: Monocyte percentage; Test Result: 11 %; Test Date: 20211121; Test Name: Myoglobin blood; Result Unstructured Data: Test Result:152.4 ug/L; Test Date: 20211121; Test Name: Neutrophil percentage; Test Result: 77 %; Test Date: 20211121; Test Name: NT-proBNP; Result Unstructured Data: Test Result:1300 pg/mL; Test Date: 20211121; Test Name: Oxygen saturation; Test Result: 97 %; Test Date: 20211121; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:234 x10 9/l; Test Date: 20211121; Test Name: Quick''s test; Test Result: 12.8 s; Test Date: 20211121; Test Name: Red blood cell count; Result Unstructured Data: Test Result:5.52 x10 12/l; Test Date: 20211121; Test Name: Cardiac troponin I; Result Unstructured Data: Test Result:27057 ng/L; Test Date: 20211121; Test Name: Cardiac troponin I; Result Unstructured Data: Test Result:10601 ng/L; Test Date: 20211121; Test Name: White blood cell count; Result Unstructured Data: Test Result:14.6 x10 9/l
CDC Split Type: CZPFIZER INC202101774134

Write-up: Acute myopericarditis; chest pain; difficulties breathing; tired; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: CZ-CZSUKL-21012503. A 18 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: SCTR1) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Non-tobacco user" (ongoing); "Allergy macrolide antibiotics" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset 19Nov2021, outcome "unknown", described as "Acute myopericarditis"; CHEST PAIN (hospitalization, medically significant) with onset 19Nov2021, outcome "unknown", described as "chest pain"; DYSPNOEA (hospitalization, medically significant) with onset 19Nov2021, outcome "unknown", described as "difficulties breathing"; FATIGUE (hospitalization, medically significant) with onset 19Nov2021, outcome "unknown", described as "tired". The patient was hospitalized for myocarditis (start date: 21Nov2021, discharge date: 22Nov2021, hospitalization duration: 1 day(s)); the patient was hospitalized for chest pain, dyspnoea, fatigue (start date: 21Nov2021, discharge date: 22Nov2021, hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: activated partial thromboplastin time: (21Nov2021) 25.6 seconds; activated partial thromboplastin time ratio: (21Nov2021) 98 %; alanine aminotransferase: (21Nov2021) 0.94, notes: Units:ukat/L; aspartate aminotransferase: (21Nov2021) 2.07, notes: Units:ukat/L; (21Nov2021) 2.43, notes: Units:ukat/L; basophil percentage: (21Nov2021) 0.4 %; blood creatine phosphokinase: (21Nov2021) 13.97, notes: Units:ukat/L; (21Nov2021) 23.63, notes: Units:ukat/L; blood pressure measurement: (21Nov2021) 130/85 mmHg; body temperature: (21Nov2021) 36.5 Centigrade; chest x-ray: (21Nov2021) unknown results, notes: bronchovascular lining accentuated perihilently; c-reactive protein: (21Nov2021) 93.8 mg/l; c-reactive protein (93.8-77.5): (21Nov2021) 93.8 mg/l, notes: 93.8 mg/L; 77.5 mg/L; echocardiogram: (21Nov2021) normal, notes: Hypertrofic left ventricle with picture of myocardial infiltration, EF 62%, PE- small behind left ventricle no more than 5 mm. Picture of perimyocarditis with myocardial infiltration of left ventricle with good function of left ventricle. There is insignificant pericardial effusion. Normal pulmonary flow. There is suspected pericarditic change on EKG rest curve; (22Nov2021) 7, notes: PE- behind left ventricle max 7 mm; Optically better finding of myocard of left ventricle; normal size and function of left ventricle, insignificant progression of effusionbehind left ventricle; (23Nov2021) normal, notes: Normal size and function of left ventricle, just narrow hem PV behind left ventricle. Control ECG curve in regression, without arhythmia normal conversion times; electrocardiogram: (21Nov2021) regular, notes: heart rate regular, rhythm sinus, hearbeat 87/min, AQRS 30 grade, PQ 0,09s, QTc 0,39s ST elevation in leads I and aVL no more than 1mm. T negative in V1, without ES, without hypertrophia; eosinophil percentage: (21Nov2021) 0.1 %; fibrin d dimer: (21Nov2021) 428 mg/l; haemoglobin: (21Nov2021) 166 g/l; heart rate: (21Nov2021) 107, notes: Units:/min; international normalised ratio: (21Nov2021) 1.22; (21Nov2021) 1.22; lymphocyte percentage: (21Nov2021) 11.5 %; magnetic resonance imaging heart: (24Nov2021) normal, notes: no significant finding, all parameters are in norm; monocyte percentage: (21Nov2021) 11 %; myoglobin blood: (21Nov2021) 152.4 ug/L; neutrophil percentage: (21Nov2021) 77 %; n-terminal prohormone brain natriuretic peptide: (21Nov2021) 1300 pg/mL; oxygen saturation: (21Nov2021) 97 %; platelet count: (21Nov2021) 234 x10 9/l; prothrombin time: (21Nov2021) 12.8 seconds; red blood cell count: (21Nov2021) 5.52 x10 12/l; troponin i: (21Nov2021) 27057 ng/L; (21Nov2021) 10601 ng/L; white blood cell count: (21Nov2021) 14.6 x10 9/l. Therapeutic measures were taken as a result of myocarditis, chest pain, dyspnoea, fatigue. Clinical course: One day after the vaccination, the patient was tired and in the evening he started having difficulties breathing and chest pain. On 21Nov2021 It got worse and there was a rapid worsening of his condition, both chest pain and breathlessness. The patient was hospitalized on the same day. The patient was not coughing and does not have sniffles. He did not undergo COVID-19 and while hospitalized he had negative antigen test. He negates higher exertion before and after the vaccination. He did not have tick nor was he sick. Therapy: Drip infusion, Novalgin, Amoksilav, Ibalgin. The patient was admitted for shortness of breath which lasted for 3 days and chest pain following vaccination with the first dose of Comirnaty vaccine. Parenterally administrated Amoksiklav, regularly administer non-steroidal anti-inflammatory drugs. The second day of controls with a decrease in Troponin I, NT-proBNP 1300 ng/L. The picture of non-specific ECG changes persists. On the third day, a control ECHO was performed, still good left ventricular function, without progression of the effusion. Elevations of the ST segment in leads I and aVL up to 1 mm persist on the control ECG. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1982754 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypotension, Inappropriate schedule of product administration, Presyncope, SARS-CoV-2 test, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: blood pressure; Result Unstructured Data: Test Result:78/138; Test Date: 20211119; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101779069

Write-up: Syncope vasovagal; vagal malaise; hypotension; convulsions; First dose 10Jul2021 and second dose 19Nov2021; This is a spontaneous report from a contactable pharmacist from the WEB. Regulatory number: FR-AFSSAPS-LY202112688. A 17-year-old female patient received BNT162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: FG7911) at the age of 17 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (first dose, right arm, intramuscular injection, lot number: FF2834), administration date: 10Jul2021, for covid-19 immunization. The following information was reported: syncope (hospitalization) with onset 19Nov2021, outcome "recovered", described as "syncope vasovagal"; presyncope (hospitalization) with onset 19Nov2021, outcome "recovered", described as "vagal malaise"; hypotension (hospitalization) with onset 19Nov2021, outcome "recovered", described as "hypotension"; seizure (hospitalization) with onset 19Nov2021, outcome "recovered", described as "convulsions"; inappropriate schedule of product administration (non-serious) with onset 19Nov2021, outcome "unknown", described as "first dose 10Jul2021 and second dose 19Nov2021". The patient was hospitalized for syncope, presyncope, hypotension, seizure (start date: 19Nov2021). The events "syncope vasovagal", "vagal malaise", "hypotension" and "convulsions" were evaluated at the emergency room visit. Within 15 min (time frame reported as 15 minutes), patient had onset of vagal malaise with hypotension measured at the pharmacy without further information, transported to emergency by the fire brigade. Fire brigade called and admitted her to hospital. On admission, no symptoms, blood pressure 78/138, returned home. Vagal discomfort initially then onset of convulsions. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (19Nov2021) 78/138; Sars-Cov-2 test: (19Nov2021) negative. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1982770 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Aphasia, Computerised tomogram abdomen, Diarrhoea, Hemianopia, Immunisation, Ischaemic stroke, Magnetic resonance imaging, Pyrexia, SARS-CoV-2 test, Visual field defect
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: abdominal CT scan; Result Unstructured Data: Test Result:abscessed left diverticular sigmoiditis; Test Name: MRI; Result Unstructured Data: Test Result:unknown results; Test Date: 20211121; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101779484

Write-up: fever; diarrhoea; abdominal pain in the left flank and left hypochondrium; Ischaemic stroke with regressive phasic disorders; complete aphasia and lack of words; right lateral homonymous hemianopia (HLH); bilateral loss of the same visual hemifield; booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB. Regulatory number: FR-AFSSAPS-MP20218906 (RA). A 75 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (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; MANUFACTUERER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 19Nov2021, outcome "unknown", described as "booster"; ISCHAEMIC STROKE (hospitalization) with onset 21Nov2021, outcome "recovered with sequelae" (2021), described as "Ischaemic stroke with regressive phasic disorders"; APHASIA (hospitalization) with onset 21Nov2021, outcome "recovered with sequelae" (2021), described as "complete aphasia and lack of words"; HEMIANOPIA (hospitalization) with onset 21Nov2021, outcome "recovered with sequelae" (2021), described as "right lateral homonymous hemianopia (HLH)"; VISUAL FIELD DEFECT (hospitalization) with onset 21Nov2021, outcome "recovered with sequelae" (2021), described as "bilateral loss of the same visual hemifield"; PYREXIA (hospitalization), outcome "unknown", described as "fever"; DIARRHOEA (hospitalization), outcome "unknown", described as "diarrhoea"; ABDOMINAL PAIN (hospitalization), outcome "unknown", described as "abdominal pain in the left flank and left hypochondrium". The patient underwent the following laboratory tests and procedures: computerised tomogram abdomen: (unspecified date) abscessed left diverticular sigmoiditis; magnetic resonance imaging: (unspecified date) unknown results; sars-cov-2 test: (21Nov2021) negative. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1982804 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 1F1003A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SYMBICORT TURBUHALER; SPIRIVA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive bronchopneumopathy (COPD stage 3); Emphysema
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101782476

Write-up: Pulmonary embolism; Fatigue; Booster; 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: FR-AFSSAPS-PC20215315 (RA). A 62 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Lot number: 1F1003A) at the age of 62 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic obstructive bronchopneumopathy" (unspecified if ongoing), notes: COPD stage 3; "Severe emphysema" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT TURBUHALER; SPIRIVA. 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 19Nov2021, outcome "unknown", described as "Booster"; PULMONARY EMBOLISM (hospitalization, medically significant) with onset 21Nov2021, outcome "recovering", described as "Pulmonary embolism"; FATIGUE (hospitalization) with onset 21Nov2021, outcome "recovering", described as "Fatigue". The events "pulmonary embolism" and "fatigue" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) negative. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1983128 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Swelling, Vaginal haemorrhage
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: armpit swelling; Vaginal bleeding; Swelling; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26337619) 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 VAGINAL HAEMORRHAGE (Vaginal bleeding), SWELLING (Swelling) and SWELLING (armpit swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING (armpit swelling) (seriousness criterion medically significant). On 21-Nov-2021, VAGINAL HAEMORRHAGE (Vaginal bleeding) had resolved. On 25-Nov-2021, SWELLING (Swelling) had resolved. At the time of the report, SWELLING (armpit swelling) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. No concomitant medication was reported. Treatment information was not provided by reporter. It was reported patient experienced armpit swelling and was very sore and lasted several days, Vaginal bleeding was heavy but just for one day. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.; Sender''s Comments: This case concerns a female patient with no relevant medical history, who experienced the unexpected events of Vaginal hemorrhage and Armpit Swelling. Armpit swelling occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19 vaccine); while vaginal bleeding occurred 2 days after the third dose . The rechallenge was not applicable as events occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 1983673 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Dysphagia, Fatigue, Gait inability, Headache, Malaise, Myalgia, Nausea, Oropharyngeal pain, Pharyngitis, Pyrexia, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Body temperature; Result Unstructured Data: Test Result:38 to 40.5 Centigrade
CDC Split Type: NLPFIZER INC202101777435

Write-up: Syncope(turn eyes away, fall away); Tremor; Nausea; Pain in the joints; Sore throat, unable to swallow; throat infection; Sore throat, unable to swallow; Cold shivers; Headache; Fever: 38 to 40.5 degrees Celsius; can''t walk anymore; Myalgia; Not feeling well; Fatigue; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority-WEB. Regulatory number: NL-LRB-00723544. A 74 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FG6273) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose), administration date: 28Oct2021, for COVID-19 immunisation. The following information was reported: SYNCOPE (medically significant) with onset 19Nov2021, outcome "recovering", described as "Syncope(turn eyes away, fall away)"; TREMOR (non-serious) with onset 19Nov2021, outcome "recovering", described as "Tremor"; NAUSEA (non-serious) with onset 19Nov2021, outcome "recovering", described as "Nausea"; ARTHRALGIA (non-serious) with onset 19Nov2021, outcome "recovered" (28Nov2021), described as "Pain in the joints"; OROPHARYNGEAL PAIN (non-serious), DYSPHAGIA (non-serious) all with onset 19Nov2021, outcome "recovering" and all described as "Sore throat, unable to swallow"; PHARYNGITIS (non-serious) with onset 19Nov2021, outcome "recovering", described as "throat infection"; CHILLS (non-serious) with onset 19Nov2021, outcome "recovering", described as "Cold shivers"; HEADACHE (non-serious) with onset 19Nov2021, outcome "recovering", described as "Headache"; PYREXIA (non-serious) with onset 19Nov2021, outcome "recovering", described as "Fever: 38 to 40.5 degrees Celsius"; GAIT INABILITY (non-serious) with onset 19Nov2021, outcome "recovering", described as "can''t walk anymore"; MYALGIA (non-serious) with onset 19Nov2021, outcome "recovered" (28Nov2021), described as "Myalgia"; MALAISE (non-serious) with onset 19Nov2021, outcome "recovering", described as "Not feeling well"; FATIGUE (non-serious) with onset 19Nov2021, outcome "recovering", described as "Fatigue". The patient underwent the following laboratory tests and procedures: body temperature: (19Nov2021) 38 to 40.5. Therapeutic measures were taken as a result of chills, headache, nausea, pyrexia, syncope, throat infection, sore throat, unable to swallow, tremor and unable to walk were treated with antibiotics and painkillers; fatigue, generalized joint pain, malaise and myalgia were treated with painkillers. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1984220 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-19
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20211255628

Write-up: SWOLLEN LYMPH NODES; This spontaneous report received from a consumer by a Regulatory Authority (EVHUMAN Vaccines, DE-PEI-CADR2021214945) on 24-DEC-2021 concerned a 42 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 15-NOV-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 19-NOV-2021, the patient experienced swollen lymph nodes. On an unspecified date, the patient was hospitalized. Number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen lymph nodes. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1984246 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-19
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTJNJFOC20211256697

Write-up: DRUG INEFFECTIVE; This spontaneous report received from a health care professional by a Regulatory Authority (LT-SMCA-6801N) on 27-DEC-2021 concerned a 40 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) .5 ml, dose number in series was 1, 1 in total, start therapy date was not reported for covid-19. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 19-NOV-2021, the patient experienced drug ineffective (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from drug ineffective. This report was serious (Other Medically Important Condition). This case was associated with a product quality complaint and reference number was requested.


VAERS ID: 1985685 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-19
   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 - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Rash maculo-papular, Rash pustular
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101793696

Write-up: Maculo-papular exanthema; Pustules in the thorax, abdomen and all four extremities and tense palmar-plantar bubbles; SARS-Cov-2 vaccine received during pregnancy; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: CH-SM-2021-29721 (RA). A 38 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 38 years 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, single IM, Duration of drug administration 1 minute), administration date: 2021, for COVID-19 immunisation. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (hospitalization, medically significant) with onset 2021, outcome "recovering", described as "SARS-Cov-2 vaccine received during pregnancy"; RASH MACULO-PAPULAR (hospitalization, medically significant) with onset 19Nov2021, outcome "recovering", described as "Maculo-papular exanthema"; RASH PUSTULAR (hospitalization, medically significant) with onset 19Nov2021, outcome "recovering", described as "Pustules in the thorax, abdomen and all four extremities and tense palmar-plantar bubbles". Additional Information: A causal relationship between Comirnaty and Maculopapular rash, Rash vesiculopustular, Maternal exposure during pregnancy, third trimester was assessed by Regulatory Authority according to WHO as being possible. Discrepant information: a patient (Female), age: 37 Year (born: Privacy). Maternal exposure during pregnancy, third trimester stop date 16Nov2021, outcome: recovering Sender''s comments: The case is serious and labelled. Due to temporal relationship and the known safety profile of the vaccine, the causality is assessed as possible. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1985859 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Immunisation
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: DEPFIZER INC202101783067

Write-up: Stroke with loss of speech; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: DE-PEI-CADR2021204243. Other Case identifier(s): DE-CADRPEI-2021204243, DE-PEI-202100229970. An 82 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (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 (1st dose, manufacturer unknown), for covid-19 immunisation; Covid-19 vaccine (2nd dose, manufacturer unknown), for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant, hospitalization) with onset 19Nov2021, outcome "unknown", described as "booster"; CEREBROVASCULAR ACCIDENT (medically significant, hospitalization) with onset 21Nov2021, outcome "not recovered", described as "Stroke with loss of speech". Sender Comment: Currently in the hospital Result of assessment for Apoplectic fit / / A. Consistent causal association to immunization. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1986193 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004673 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hypoaesthesia, Illness, Pain in extremity, Peripheral swelling, Rash, SARS-CoV-2 test, Tremor, Vision blurred
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211129; 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: Rash; Sickness; Numbness; Headache; Leg pain; Swelling arm; Shakiness; Blurry vision; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26274394) 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 RASH (Rash), ILLNESS (Sickness), HYPOAESTHESIA (Numbness), HEADACHE (Headache), PAIN IN EXTREMITY (Leg pain), VISION BLURRED (Blurry vision), PERIPHERAL SWELLING (Swelling arm) and TREMOR (Shakiness) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004673) for COVID-19 vaccination. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 14-Dec-2020 to an unknown date for COVID-19 vaccination. On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced VISION BLURRED (Blurry vision) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced RASH (Rash) (seriousness criteria hospitalization and medically significant), ILLNESS (Sickness) (seriousness criteria hospitalization and medically significant), HYPOAESTHESIA (Numbness) (seriousness criteria hospitalization and medically significant), HEADACHE (Headache) (seriousness criteria hospitalization and medically significant), PAIN IN EXTREMITY (Leg pain) (seriousness criteria hospitalization and medically significant), PERIPHERAL SWELLING (Swelling arm) (seriousness criteria hospitalization and medically significant) and TREMOR (Shakiness) (seriousness criteria hospitalization and medically significant). At the time of the report, RASH (Rash), ILLNESS (Sickness), HYPOAESTHESIA (Numbness), HEADACHE (Headache), PERIPHERAL SWELLING (Swelling arm) and TREMOR (Shakiness) had resolved, PAIN IN EXTREMITY (Leg pain) was resolving and VISION BLURRED (Blurry vision) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment product was not provided by the reporter Company comment. This regulatory authority case concerns a 22-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of vision blurred, pain in extremity, illness, hypoaesthesia, peripheral swelling, tremor, rash, and headache. The events rash and headache are unexpected as they are retained as serious per the source document Authority reporting. The event vision blurred occurred on the same day after the administration of one dose (unknown dosage) of mRNA-1273 vaccine, considered as third dose of COVID-19 vaccine schedule. The patient received previously two doses of Pfizer Biontech COVID-19 vaccine. The date of onset of the events pain in extremity, illness, hypoaesthesia, peripheral swelling, tremor, rash, and headache was not reported. At the time of the report the outcome of vision blurred had not resolved, pain in extremity was resolving, and illness, hypoaesthesia, peripheral swelling, tremor, rash, and headache had resolved. The events were assessed by Regulatory Authority as serious by important medical event and hospitalization criteria; however, no details on hospitalization dates and/or clinical course were provided in the source document. Ten days after vaccination with mRNA-1273, SARS-CoV-2 test was performed with a negative result. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 22-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of vision blurred, pain in extremity, illness, hypoaesthesia, peripheral swelling, tremor, rash, and headache. The events rash and headache are unexpected as they are retained as serious per the source document Authority reporting. The event vision blurred occurred on the same day after the administration of one dose (unknown dosage) of mRNA-1273 vaccine, considered as third dose of COVID-19 vaccine schedule. The patient received previously two doses of Pfizer Biontech COVID-19 vaccine. The date of onset of the events pain in extremity, illness, hypoaesthesia, peripheral swelling, tremor, rash, and headache was not reported. At the time of the report the outcome of vision blurred had not resolved, pain in extremity was resolving, and illness, hypoaesthesia, peripheral swelling, tremor, rash, and headache had resolved. The events were assessed by Regulatory Authority as serious by important medical event and hospitalization criteria; however, no details on hospitalization dates and/or clinical course were provided in the source document. Ten days after vaccination with mRNA-1273, SARS-CoV-2 test was performed with a negative result. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1986404 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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: Fatigue, Immunisation, Jaundice, Muscular weakness, Neuralgia, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACICLOVIR; AMITRIPTYLINE; BECONASE; CO-CODAMOL; CYCLIZINE; GABAPENTIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinosinusitis; Blister; Dizziness; Fatigue; Jaundice (two further attacks of jaundice both happened after efforts to reduce her weight and immunisations); Nerve pain
Allergies:
Diagnostic Lab Data: Test Date: 20200817; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101788863

Write-up: fatigue; Pain nerve; Fever chills; Tachycardia; Booster; jaundice; Loss of power in limbs; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202112131333355930-KOP7T, Safety Report Unique Identifier GB-MHRA-ADR 26328487. A 49-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (COMIRNATY; Batch/Lot Number: unknown), via an unspecified route of administration on 19Nov2021 as a single dose for COVID-19 immunisation. Medical history included jaundice from 2007 (two further attacks of jaundice both happened after efforts to reduce her weight and immunisations), nerve pain from 2007, water blister from 2007, fatigue, dizziness, and allergic rhinosinusitis. The patient had no symptoms associated with COVID-19. The patient was not breastfeeding at the time of this report and not enrolled in clinical trial. Concomitant medications included aciclovir (MANUFACTURER UNKNOWN) from 11Jul2009, amitriptyline (MANUFACTURER UNKNOWN) from 16Sep2009 for pain management, beclometasone dipropionate (BECONASE) for allergic rhinosinusitis, codeine phosphate/paracetamol (CO-CODAMOL), cyclizine (MANUFACTURER UNKNOWN) from 2015 for dizziness, and gabapentin (MANUFACTURER UNKNOWN) from Dec2010 for pain management. The patient previously received both first and second doses of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient previously received hepatitis b vaccine (MANUFACTURER UNKNOWN). The patient previously took tetanus vaccine (MANUFACTURER UNKNOWN). On 17Aug2020, the patient underwent COVID-19 virus test, and the result was negative. The patient has had ongoing health problems since 2007 when she developed jaundice and severe nerve pain along with water blister type spots. The jaundice resolved, however the neurological symptoms and fatigue continued. She had two further attacks of jaundice both happened after efforts to reduce her weight and immunisations (hep b booster and tetanus). The patient experienced jaundice and loss of power in limbs on unspecified date in 2021. The patient also experienced pain nerve, fatigue, fever chills, and tachycardia on 20Nov2021. The events were considered disabling/incapacitating. Course of events as follows: since having the 3rd injection of Pfizer, her health condition has deteriorated. Her nerve pain has increased. She had loss of power in her limbs and terrible fatigue. She has chosen not to go to her GP''s. The outcome of jaundice, pain nerve, and tachycardia was recovering; for fatigue and fever chills was not recovered, while for loss of power in limbs was unknown. 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: 1986500 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), 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? 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: 20210910; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101788637

Write-up: Asthma; Dose 1 and Dose 2, non Pfizer COVID-19 vaccine; Dose 3: COMIRNATY; Dose 1 and Dose 2, non Pfizer COVID-19 vaccine; Dose 3: COMIRNATY; Third dose of COMIRNATY; hives; This is a spontaneous report received from a contactable consumer from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112132012198960-Q6Z8O. Other Case identifier(s): GB-MHRA-ADR 26329351. A 65-year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FK9413) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. It was unsure if patient had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTUERER UNKNOWN, non-Pfizer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTUERER UNKNOWN, non-Pfizer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 19Nov2021, outcome "unknown" and all described as "Dose 1 and Dose 2, non Pfizer COVID-19 vaccine; Dose 3: COMIRNATY"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Third dose of COMIRNATY"; URTICARIA (medically significant) with onset 2021, outcome "not recovered", described as "hives"; ASTHMA (medically significant) with onset 22Nov2021, outcome "recovered" (04Dec2021), described as "Asthma". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (10Sep2021) No - Negative COVID-19 test. Therapeutic measures were taken as a result of urticaria, asthma. The patient took a course of steroids for her asthmas x 12 days; antihistamines taken for hives continuing as not fully resolved. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1986727 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye pain, Fat necrosis, Headache, Joint stiffness, Muscle spasms, Muscular weakness, Musculoskeletal stiffness, Myalgia, Pain, Rash macular, SARS-CoV-2 test, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; IBUPROFEN; DICLOFENAC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic pain; Fat necrosis; Immunodeficiency ((Taking other treatments or medicines, not listed above, known to lower the immune response and I)); Inflammatory pain; Muscle wasting; Muscle weakness; Skin damage
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101796866

Write-up: Muscle pain; Stiffness; Muscle cramp; Head pain; Hives; Stiff joint; Red blotches; Eye pain; Fat necrosis; Chronic pain; Skin weakness; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112142152345270-YPVCS (RA). Other Case identifier(s): GB-MHRA-ADR 26336134 (RA). A 49 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH4751) at the age of 49 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Muscle weakness", start date: 2020 (unspecified if ongoing); "Fat necrosis", start date: 2020 (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing), notes: (Taking other treatments or medicines, not listed above, known to lower the immune response and I); "Muscle wastage" (unspecified if ongoing); "Chronic pain", start date: 2020 (unspecified if ongoing); "Inflammatory pain" (unspecified if ongoing); "Skin temperature/skin thermal damage", start date: 2020 (unspecified if ongoing). Patient had not tested positive for COVID-19 since having the vaccine, was not enrolled in clinical trial, not had symptoms associated with COVID-19, was not breastfeeding at the time of report. Patient''s last menstrual period was on 18Nov2021. Concomitant medication(s) included: AMITRIPTYLINE taken for pain, start date: 18Dec2020; IBUPROFEN taken for inflammatory pain, start date: 26Jul2021, stop date: 05Oct2021; DICLOFENAC taken for pain, start date: 07Oct2021. The following information was reported: MYALGIA (disability, medically significant) with onset 19Nov2021, outcome "not recovered", described as "Muscle pain"; MUSCULOSKELETAL STIFFNESS (disability, medically significant) with onset 19Nov2021, outcome "recovering", described as "Stiffness"; MUSCLE SPASMS (disability, medically significant) with onset 19Nov2021, outcome "not recovered", described as "Muscle cramp"; HEADACHE (disability, medically significant) with onset 19Nov2021, outcome "recovering", described as "Head pain"; URTICARIA (disability, medically significant) with onset 19Nov2021, outcome "recovering", described as "Hives"; JOINT STIFFNESS (disability, medically significant) with onset 19Nov2021, outcome "recovered with sequelae" (2021), described as "Stiff joint"; RASH MACULAR (disability, medically significant) with onset 19Nov2021, outcome "recovered with sequelae" (2021), described as "Red blotches"; EYE PAIN (disability, medically significant) with onset 19Nov2021, outcome "recovered with sequelae" (2021), described as "Eye pain"; FAT NECROSIS (disability, medically significant) with onset 2021, outcome "recovering", described as "Fat necrosis"; PAIN (disability, medically significant) with onset 2021, outcome "recovering", described as "Chronic pain"; MUSCULAR WEAKNESS (medically significant, disability) with onset 2021, outcome "recovering", described as "Skin weakness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) no - negative COVID-19 test. Clinical course: Reaction started 1 to 2 hours after vaccine given, stiffness and muscle pains started 4 hours later, had chronic pain, muscle weakness and skin weakness and fat necrosis as effect from thermal injury since 2020, on diclofenac and amitriptyline before vaccine given. The report did not relate to inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1987181 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Coagulation factor, Inappropriate schedule of product administration, Investigation, Liver function test, Pain in extremity, Renal function test, SARS-CoV-2 test, Thyroid function test
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN B12 [CYANOCOBALAMIN]
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions: Medical History/Concurrent Conditions: Vitamin deficiency
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: Clotting factors; Result Unstructured Data: Test Result:Unknown results; Test Name: Vitamin test; Result Unstructured Data: Test Result:Unknown results; Test Name: Liver test; Result Unstructured Data: Test Result:Unknown results; Test Name: kidneys test; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Test Name: Thyroid test; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101819902

Write-up: achy legs; Inappropriate schedule of vaccine administered; 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. A 37 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vitamin deficiency" (unspecified if ongoing); "Suspected COVID-19" (ongoing), notes: Unsure when symptoms started. Patient last menstrual period date: 2021. Concomitant medication(s) included: VITAMIN B12 [CYANOCOBALAMIN] taken for hypovitaminosis, start date: 05Jul2021, stop date: 08Nov2021. Vaccination history included: Comirnaty (DOSE 1), administration date: 19Sep2021, for COVID-19 immunisation, reaction(s): "burning sensation", "Bruising of leg", "Fatigue/unusual tiredness". The following information was reported: PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "achy legs"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The patient underwent the following laboratory tests and procedures: blood test: unknown results; coagulation factor: unknown results; investigation: unknown results; liver function test: unknown results; renal function test: unknown results; sars-cov-2 test: negative; thyroid function test: unknown results. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101788174 same patient/drug/different dose/ event


VAERS ID: 1987230 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-19
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epididymal cyst, Epididymitis, Neuralgia, Paraesthesia, Prostatic pain, Prostatitis, SARS-CoV-2 test, Testicular pain
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), COVID-19 (broad), Sexual dysfunction (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: 20211110; Test Name: COVID-19 antigen test; Test Result: Negative ; Comments: negative antibody test 1 week before vaccination
CDC Split Type: IEPFIZER INC202101782682

Write-up: Sharp nerve pains in hands, feet and random parts of arms, progressively getting worse, also was not there before vaccine.; Tingling in hands and feet; Developed from pain in prostate to currently pain in prostate and testicles; Cyst in epididymis; Developed from pain in prostate to currently pain in prostate and testicles; Prostatitis, spreading to testicles causing epididymtis; Prostatitis, spreading to testicles causing epididymtis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: IE-HPRA-2021-087479 (HPRA). Other Case identifier(s): IE-HPRA-CVARR2021112922923 (HPRA). A 30 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. It was reported that the patient did not have any history of COVID-19 infection. The following information was reported: TESTICULAR PAIN (medically significant), PROSTATIC PAIN (medically significant) all with onset 19Nov2021, outcome "not recovered" and all described as "Developed from pain in prostate to currently pain in prostate and testicles"; EPIDIDYMAL CYST (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Cyst in epididymis"; EPIDIDYMITIS (medically significant), PROSTATITIS (medically significant) all with onset 19Nov2021, outcome "not recovered" and all described as "Prostatitis, spreading to testicles causing epididymtis"; NEURALGIA (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Sharp nerve pains in hands, feet and random parts of arms, progressively getting worse, also was not there before vaccine."; PARAESTHESIA (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Tingling in hands and feet". It was reported that the patient had never experienced the symptoms before and they had only appeared after the vaccine.The patient''s doctor had advised him that the prostatitis, spreading to testicles, causing epididymitis, which was described as having developed from pain in prostate to current pain in prostate and testicles, and a cyst in epididymis should resolve itself, but may require treatment with antibiotics, should it not resolve whereas patient did not receive treatment for tingling in hands and feet, and sharp nerve pains in hands, feet and random parts of arms, which was described as progressively getting worse. The events "developed from pain in prostate to currently pain in prostate and testicles", "cyst in epididymis", "developed from pain in prostate to currently pain in prostate and testicles", "prostatitis, spreading to testicles causing epididymtis" and "prostatitis, spreading to testicles causing epididymtis" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Nov2021) negative, notes: negative antibody test 1 week before vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1987416 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood phosphorus, Blood phosphorus decreased, Body temperature, Cough, Hyperventilation, Hypoaesthesia, Nausea, Respiratory alkalosis, Tetany
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypokalaemia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (Patient had a history of asthma.); Hyperpnoea (Since the patient had experienced several paroxysms of hyperpnoea)
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: phosphorus level; Result Unstructured Data: Test Result:low; Test Date: 20211119; Test Name: body temperature; Result Unstructured Data: Test Result:no pyrexia Centigrade; Comments: When body temperature was measured at the time of emergency outpatient visit.
CDC Split Type: JPPFIZER INC202101815780

Write-up: queasy; cough; Numbness symptoms; tetany; Hyperpnoea; low phosphorus level; acute respiratory alkalosis; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from Regulatory Authority. Regulatory number: v21132673 (regulatory authority (RA)). A 28 year-old (reported as 28-year and 6-month-old) female patient received BNT162b2 (COMIRNATY, Solution for injection), administration date 19Nov2021 16:00 (Batch/Lot number: unknown) at the age of 28 years (age at the vaccination) as dose 2, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing), notes: Patient had a history of asthma.; "hyperpnoea" (unspecified if ongoing), notes: Since the patient had experienced several paroxysms of hyperpnoea. There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) as follows: The patient had a history of asthma. There was an inhalation of Symbicort. The patient''s concomitant medications were not reported. Past drug history included: Inhalation of symbicort, notes: There was an inhalation of Symbicort. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: NAUSEA (medically significant) with onset 19Nov2021, outcome "unknown", described as "queasy"; COUGH (medically significant) with onset 19Nov2021, outcome "unknown", described as "cough"; HYPOAESTHESIA (medically significant) with onset 19Nov2021, outcome "unknown", described as "Numbness symptoms"; TETANY (medically significant) with onset 19Nov2021, outcome "unknown", described as "tetany"; HYPERVENTILATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Hyperpnoea"; BLOOD PHOSPHORUS DECREASED (medically significant) with onset 19Nov2021, outcome "unknown", described as "low phosphorus level"; RESPIRATORY ALKALOSIS (medically significant) with onset 19Nov2021, outcome "unknown", described as "acute respiratory alkalosis". On 19Nov2021 (the day of vaccination), the patient experienced Queasy. The course of the event was as follows: On 19Nov2021 at around 16:00, the patient received COVID-19 vaccine (reported as COVID-19 vaccine). During the follow-up, the patient experienced queasy and asked for an emergency request. There was no pyrexia when body temperature was measured at the time of emergency outpatient visit. After arriving at the emergency outpatient, queasy and cough gradually improved on 19Nov2021. Numbness symptoms were considered to be tetany due to Hyperpnoea on 19Nov2021. The patient had experienced several times of hyperpnoea attack in the past, and was it triggered by vaccination. The low phosphorus level was considered caused by acute respiratory alkalosis, which due to hyperpnoea. The patient was scheduled to go back home. The reporting pharmacist classified the event as non-serious and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporter commented as follows: On 19Nov2021 at around 16:00, the patient received COVID-19 vaccine (reported as COVID-19 vaccine). During the follow-up, the patient experienced queasy and asked for an emergency request. There was no pyrexia when body temperature was measured at the time of emergency outpatient visit. After arriving at the emergency outpatient, queasy and cough gradually improved. Numbness symptoms were considered to be tetany due to Hyperpnoea. The patient had experienced several times of hyperpnoea attack in the past, and was it triggered by vaccination. The low phosphorus level was considered caused by acute respiratory alkalosis, which due to hyperpnoea. The patient was scheduled to go back home. The events "queasy", "cough", "numbness symptoms", "tetany", "hyperpnoea", "low phosphorus level" and "acute respiratory alkalosis" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood phosphorus: (19Nov2021) low; body temperature: (19Nov2021) no pyrexia, notes: When body temperature was measured at the time of emergency outpatient visit. The outcome of the events was unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.


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