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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: 1924136 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20211206775

Write-up: ABDOMINAL PAIN; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300121862] concerned a 57 year old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for an unspecified indication. (Dose number in series 1). No concomitant medications were reported. On 17-NOV-2021, the patient experienced abdominal pain, fever and was hospitalized (date unspecified). The number of days hospitalized was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and abdominal pain. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20211206775-Covid-19 vaccine ad26.cov2.s-Abdominal pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20211206775-Covid-19 vaccine ad26.cov2.s-Fever. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1926123 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Erythema, Fatigue, Feeling hot, Headache, Hypersensitivity, Influenza, Nasal dryness, Nasopharyngitis, Pain in extremity, Rhinorrhoea, Sinus disorder, Throat irritation
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (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: Medical History/Concurrent Conditions: Drug allergy (allergic to paracetamol, ibuprofen. Novaminsulfone)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101644390

Write-up: allergy symptoms; Head like a Cooking pot; redness all over the body; flu symptoms less; a bit more runny nose; cold symptoms; tired; quickly chilled; nasal Sinus dryness; nasal Sinus dryness; itchy throat; headache; aching limbs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): 101281 (Biontech). A 43 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Drug Allergie" (unspecified if ongoing), notes: allergic to paracetamol, ibuprofen. Novaminsulfone. The patient''s concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (medically significant), outcome "recovering", described as "allergy symptoms"; FEELING HOT (medically significant), outcome "recovering", described as "Head like a Cooking pot"; ERYTHEMA (medically significant), outcome "recovering", described as "redness all over the body"; FATIGUE (non-serious) with onset 17Nov2021, outcome "recovering", described as "tired"; CHILLS (non-serious) with onset 17Nov2021, outcome "recovering", described as "quickly chilled"; NASAL DRYNESS (non-serious), SINUS DISORDER (non-serious) all with onset 17Nov2021, outcome "recovering" and all described as "nasal Sinus dryness"; THROAT IRRITATION (non-serious) with onset 17Nov2021, outcome "recovering", described as "itchy throat"; HEADACHE (non-serious) with onset 17Nov2021, outcome "recovering", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021, outcome "recovering", described as "aching limbs"; INFLUENZA (non-serious), outcome "recovering", described as "flu symptoms less"; RHINORRHOEA (non-serious), outcome "recovering", described as "a bit more runny nose"; NASOPHARYNGITIS (non-serious), outcome "recovering", described as "cold symptoms". Therapeutic measures were taken as a result of hypersensitivity, feeling hot, erythema, fatigue, chills, nasal dryness, sinus disorder, throat irritation, headache, pain in extremity, influenza, rhinorrhoea, nasopharyngitis. Clinical courses: He was at noon vaccinated and was immediately tired, then quickly chilled. A short time later he had nasal Sinus dryness and itchy throat. Then were the sinuses closed, he had a headache and aching limbs, but no fever. The weekend was the flu symptoms less, but then came the allergy symptoms. Head like a Cooking pot, central headache and redness all over the body. Not treated with cortisone 100mg (now it is tapered off) after the treatment on 21Nov2021 he felt much better and on 22Nov2021 the reddening was almost gone. Yet some reddening, a bit more runny nose and cold symptoms, but otherwise nothing he was in the intensive care unit and not against vaccination, but because of his allergies he had concerns. Regarding the 2nd vaccination, his family doctor now wants him to have an accompanying one Give cortisone therapy a second vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1926485 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Fatigue, Headache, Migraine, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637572

Write-up: exhausted/I''ve been very drained; headache; Generalized muscle aches; Migraine; Chest tightness/Have been feeling chesty ever since, chest feels tight and cool and I''ve been very drained; 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-APPCOVID-20211121162044 (RA). Other Case identifier(s): GB-MHRA-ADR 26232623 (RA). A 25 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Past drug history included: Yazmin for contraceptive pill. Vaccination history included: Covid-19 vaccine (Dose-1, MANUFACTURE UNKNWON), for Covid-19 immunisation. The following information was reported: HEADACHE (medically significant) with onset 17Nov2021, outcome "unknown", described as "headache"; MYALGIA (medically significant) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Generalized muscle aches"; MIGRAINE (medically significant) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Migraine"; CHEST DISCOMFORT (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Chest tightness/Have been feeling chesty ever since, chest feels tight and cool and I''ve been very drained"; FATIGUE (medically significant), outcome "unknown", described as "exhausted/I''ve been very drained". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient reported No covid before hand, had 1st vaccine. On the second I was fine the day of but the day after I couldn''t get out of bed with a bad headache and body aches. Day after I was physically exhausted but the aches wore off eventually. Have been feeling chesty ever since, chest feels tight and cool and I''ve been very drained. In my chest it feels like I''ve done a lot of exercise but I have done no exercise. Patient had no known allergies. Patient had not had symptoms associated with COVID-19 Patient was not pregnant, Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926486 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-14
Onset:2021-11-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Haemorrhage, Influenza, Muscle spasms, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210621; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101637765

Write-up: ache; flu symptoms; cramps; fever; Shivers and fever; heavy bleeding; Heavy bleeding and awful pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-APPCOVID-20211121192944 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26232818 (MHRA). A 29 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 14Nov2021 (Batch/Lot number: unknown) at the age of 29 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 21Jun2021, stop date: 30Jun2021. The patient''s concomitant medications were not reported. The following information was reported: PAIN (medically significant), outcome "recovered", described as "ache"; INFLUENZA (medically significant), outcome "recovered", described as "flu symptoms"; MUSCLE SPASMS (medically significant), outcome "recovered", described as "cramps"; PYREXIA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "fever"; HAEMORRHAGE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "heavy bleeding"; PAIN (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Heavy bleeding and awful pain"; CHILLS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Shivers and fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jun2021) yes - positive covid-19 test. Clinical course: She felt a bit off not too bad Monday/Tuesday. Wednesday evening come on her period and since then it has been horrendous bleeding and cramps. She had never experience in her 17 years of periods. Since the middle of the night last night has been a constant ache which is scaring her. Worth nothing she had a baby 11 weeks ago but have already had a period that was ok. Today about 2 hours ago went hot, then absolutely freezing and awful flu symptoms. Taken covid test and negative. She was not pregnant. She was not currently breastfeeding. She was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926510 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NO BATCH NUMBER / UNK LA / OT
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. NO BATCH NUMBER / UNK RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Chills, Disturbance in attention, Feeling hot, Headache, Hyperaesthesia, Malaise, Musculoskeletal stiffness, Nausea, Neck pain, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Arthritis (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: Crohn''s disease (Controlled successfully by diet); Sulfonamide allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSEQIRUS202106763

Write-up: Back, shoulder and neck stiffness and ache; Back, shoulder and neck stiffness and ache; Back, shoulder and neck stiffness and ache; Feeling hot; Poor concentration; Back, shoulder and neck stiffness and ache; Chills; Feeling lousy; Nausea; Sensitive scalp; Intermittent sharpe jab pain (1 second) left temple and about 2.5 inches above; Intermittent sharp jab pain; This spontaneous case was retrieved on 23-Nov-2021 from regulatory authority (reference number: GB-MHRA-EYC 00266955), reported by other non-healthcare professional and concerned a 61-year-old, male patient. The patient''s medical history included sulfonamide allergy and Chron''s disease. The patient''s concomitant medications were not reported. On 16-Nov-2021, the patient was vaccinated with Flucelvax Tetra (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: parenteral, anatomical location: right arm, dose: not reported) for flu vaccination. The batch number was not reported. On the same day, the patient was vaccinated with non-company, co-suspect COVID-19 mRNA Vaccine BNT162b2 (Tozinameran; route of administration: parenteral, anatomical location: left arm, dose: not reported) for Covid-19 vaccination. The batch number was not reported. On 17-Nov-2021, right after receiving Flucelvax Tetra and non-company, co-suspect COVID-19 mRNA Vaccine BNT162b2, the patient developed intermittent sharp jab pain for one second and about 2.5 inches above. The jab pain lasted for about 1 second at a variable frequency of about 10 to 60 seconds. Closing eyes tight sometimes caused pain at the site. The patient also developed sensitive scalp. On an unspecified date, an unknown amount of time after receiving Flucelvax Tetra and non-company, co-suspect COVID-19 mRNA Vaccine BNT162b2, the patient experienced back, shoulder and neck stiffness and ache, nausea, chill and she was feeling hot, feeling lousy with poor concentration. Temperature was taken and it was normal. At the time of initial reporting, the patient was recovering from the events of ''increased skin sensitivity'', ''vaccination site pain'' and ''headache''. The outcome of all other events was unknown. The reporter did not provide a causality assessment. All events were assessed as serious due to the seriousness criterion of medical significance. Company comment: One day after receiving Flucelvax Tetra and non-company, co-suspect COVID-19 Vaccine, the patient developed intermittent vaccination site pain and sensitive scalp. An unknown amount of time after vaccination, the patient experienced back, shoulder and neck stiffness and ache, nausea, chill and she was feeling hot, feeling lousy with poor concentration. Due to suggestive time relationship, causality is assessed as possibly related for vaccination site pain and sensitive scalp. Causality is unassessable for remaining events, due to unclear time relationship.; Sender''s Comments: One day after receiving Flucelvax Tetra and non-company, co-suspect COVID-19 Vaccine, the patient developed intermittent vaccination site pain and sensitive scalp. An unknown amount of time after vaccination, the patient experienced back, shoulder and neck stiffness and ache, nausea, chill and she was feeling hot, feeling lousy with poor concentration. Due to suggestive time relationship, causality is assessed as possibly related for vaccination site pain and sensitive scalp. Causality is unassessable for remaining events, due to unclear time relationship.


VAERS ID: 1926512 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Body temperature; Result Unstructured Data: Test Result:Increased
CDC Split Type: GBPFIZER INC202101646341

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-RA-EYC 00266980 (RA). Other Case identifier(s): GB-RA-ADR 26231682 (RA). A 67 year-old female patient received bnt162b2 (COMIRNATY), parenteral, administration date 17Nov2021 (Lot number: FL1939) at the age of 67 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Ill-defined disorder" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOL taken for ill-defined disorder. The following information was reported: DIZZINESS (medically significant) with onset 17Nov2021, outcome "recovering", described as "dizziness"; VOMITING (medically significant) with onset 17Nov2021, outcome "recovering", described as "causing vomiting"; PYREXIA (medically significant) with onset 17Nov2021, outcome "recovering", described as "high temperature"; HEADACHE (medically significant) with onset 17Nov2021, outcome "recovering", described as "headache". Dizziness causing vomiting, high temperature and headache. The patient underwent the following laboratory tests and procedures: body temperature: (17Nov2021) increased. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926540 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Headache, Immunisation, Interchange of vaccine products, Myalgia, Off label use, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life 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 INC202101629465

Write-up: Chronic headaches; Fever; Generalised muscle aches; Armpit pain; Off label use; Interchange of vaccine; Booster; This is a spontaneous report received from a contactable reporter(Consumer or other non HCP) from the regulatory authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202111191645413040-AWRSE (MHRA). Other Case identifier: GB-MHRA-ADR 26228660 (MHRA). A 67-year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 67 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 astrazeneca (Dose 1); Covid-19 vaccine astrazeneca (Dose 2). The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Chronic headaches"; PYREXIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Fever"; MYALGIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Generalised muscle aches"; AXILLARY PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Armpit pain". Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926542 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH H44751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Chills, Dyspnoea, Gastrooesophageal reflux disease, Immunisation, Interchange of vaccine products, Off label use, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)); Radiotherapy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101646531

Write-up: chills; vomiting; Fever; Shortness of breath; acid reflux; Generalised chest pains; patient has not previously received the full primary immunization series of BNT162b2 vaccination/third dose on 17Nov2021; patient has not previously received the full primary immunization series of BNT162b2 vaccination/third dose on 17Nov2021; patient has not previously received the full primary immunization series of BNT162b2 vaccination/third dose on 17Nov2021; 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-202111191842274610-U73ZT (MHRA). Other Case identifier(s): GB-MHRA-ADR 26230231 (MHRA). A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: h44751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2008 (unknown if ongoing); "Radiotherapy", start date: 2008 (unknown if ongoing); "Neoplasm" (unknown if ongoing), notes: Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy). The patient''s concomitant medications were not reported. 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 patient had not previously received the full primary immunization series of BNT162b2 vaccination. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "patient has not previously received the full primary immunization series of BNT162b2 vaccination/third dose on 17Nov2021"; CHILLS (medically significant), outcome "not recovered", described as "chills"; VOMITING (medically significant), outcome "not recovered", described as "vomiting"; CHEST PAIN (medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Generalised chest pains"; PYREXIA (medically significant), outcome "unknown", described as "Fever"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath"; GASTROOESOPHAGEAL REFLUX DISEASE (medically significant), outcome "unknown", described as "acid reflux". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Clinical course: The patient had chest pains associated with violent acid reflux. The chest pain were milder after vomiting. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926545 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chest pain, Fatigue, Myocarditis, Pericarditis, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE; TESTOGEL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646352

Write-up: Fatigue/unusual tiredness; Chest pain; Swelling; myocarditis; pericarditis; Armpit pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). The reporter is the patient. Regulatory number: -MHRA-WEBCOVID-202111201041276170-2XIO5 (RA). Other Case identifier(s): RA-ADR 26231197 (RA). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FK9413) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE; TESTOGEL. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: AXILLARY PAIN (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Armpit pain"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; SWELLING (medically significant), outcome "unknown", described as "Swelling"; MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis". Patient armpit on the side of the injection site had been swollen and painful since the day after the vaccine. Chest pain and fatigue. Report related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. No diagnosis was made by a medical professional. No blood tests, such as for certain proteins (called troponin) that signal heart muscle damage were taken. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926593 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH(OR M?)4751 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Hypoaesthesia, Immunisation, Interchange of vaccine products, Limb discomfort, Off label use, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Metastatic neoplasm; Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)); Neoplasm (neoplasm malignant free since 2015)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101637948

Write-up: Heaviness in arm; Numbness of fingers; Leg pain; Backache; pain in 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 Authority (RA). Regulatory number: -MHRA-WEBCOVID-202111211159582120-660KE (RA). Other Case identifier(s): -MHRA-ADR 26232413 (RA). A 65-year-old female patient received BNT162B2 (COMIRNATY, formulation: Solution for injection), administered in arm left, administration date 17Nov2021 (Lot number: FH(or M?)4751) at the age of 65 years as dose 3 (booster), single for COVID-19 immunisation. . Relevant medical history included: "Metastatic neoplasm" (unspecified if ongoing); "Neoplasm" (unspecified if ongoing), notes: Recently had treatment for cancer, leukaemia, or lymphoma (radiotherapy or chemotherapy); "neoplasm" (unspecified if ongoing), notes: neoplasm malignant free since 2015. Concomitant medication(s) included: INFLUENZA VIRUS, administration date Nov2021. Past drug history included: Letrozole, stop date: Jul2019. Vaccination history included: COVID-19 vaccine (first dose; lot number: unknown; MANUFACTURER UNKNOWN), for COVID-19 immunisation; COVID-19 vaccine (second dose; lot number: unknown; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant) with onset 18Nov2021, outcome "recovering", described as "pain in arm"; LIMB DISCOMFORT (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Heaviness in arm"; HYPOAESTHESIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Numbness of fingers"; PAIN IN EXTREMITY (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Leg pain"; BACK PAIN (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Backache". Clinical course: Reaction definitely due to booster vac - in left arm - and not flu vac - right arm. Cant control fingers to type or hold/control anything with left hand. Backache and pain in left thigh. Left leg not strong. More or less debilitated down entire left side of body. Had booster on 17th, pain in arm on 18th. Serious side effects as described above started 20th. It was reported that, the patient has not tested positive for COVID-19 since having the vaccine. Unsure if patient had symptoms associated with COVID-19. Not had a COVID-19 test. She was not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information expected.


VAERS ID: 1926596 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 47438XX312 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Fatigue, Immunisation, Insomnia, Myocarditis, Tinnitus
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hearing impairment (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Cardiomegaly; Myocarditis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101637951

Write-up: Sleep difficult; Chest pain; Fatigue/unusual tiredness; Myocarditis; Tinnitus; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111211207365810-J2VKI (MHRA). Other Case identifier: GB-MHRA-ADR 26232411 (MHRA). A 47-year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: 47438xx312) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: ''Cardiomegaly'' (unspecified if ongoing); ''High blood pressure'' (unspecified if ongoing); ''myocarditis'' (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose No-1), for COVID-19 immunization; Bnt162b2 (Dose No-2), for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant) with onset 19Nov2021, outcome ''not recovered'', described as ''Myocarditis''; IMMUNISATION (medically significant) with onset 17Nov2021, outcome ''unknown'', described as ''Booster''; TINNITUS (medically significant) with onset 17Nov2021, outcome ''not recovered'', described as ''Tinnitus''; INSOMNIA (medically significant), outcome ''unknown'', described as ''Sleep difficult''; CHEST PAIN (medically significant), outcome ''unknown'', described as ''Chest pain''; FATIGUE (medically significant), outcome ''unknown'', described as ''Fatigue/unusual tiredness''. Patient has not tested positive for COVID-19 since having the vaccine. Clinical course: the patient''s tinnitus became oppressive the evening of the dose and has not subsided. Making sleep difficult. Chest pain very similar to previous occurrence of myocarditis (which was resolved).


VAERS ID: 1926686 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Interchange of vaccine products, Malaise, Myalgia, Off label use
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101637920

Write-up: Unwell; Muscle pain; Tiredness; 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-202111212211264670-TZPXT (RA). Other Case identifier(s): GB-RA-ADR 26232947 (RA). A 62-year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Inflammatory bowel disease" (unspecified if ongoing), notes: Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis); "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef... The patient''s concomitant medications were not reported. 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 patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The following information was reported: OFF LABEL USE (disability) with onset 17Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 17Nov2021, outcome "unknown", described as "Booster"; MYALGIA (disability) with onset 18Nov2021, outcome "recovering", described as "Muscle pain"; FATIGUE (disability) with onset 18Nov2021, outcome "recovering", described as "Tiredness"; MALAISE (disability), outcome "recovering", described as "Unwell" Clinical course: It was reported that patient was unable to function had to stay indoors and mostly sleeping. The patient has not tested positive for COVID-19 since having the vaccine.Patient not had symptoms associated with COVID-19. Not had a COVID-19 test. The Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926691 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Immunisation, Interchange of vaccine products, Malaise, 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637791

Write-up: Arthritic-like pain; I am not well; Patient received first dose of Pfizer vaccine, second dose of ASTRAZENECA vaccine and booster dose of COMIRNATY; Patient received first dose of Pfizer vaccine, second dose of ASTRAZENECA vaccine and booster dose of COMIRNATY; Patient received third (booster) dose of COMIRNATY; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111212243580990-7YNNY. Other Case identifier(s): GB-MHRA-ADR 26232980. A 54 year-old male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca, administration date: 18Feb2021, for COVID-19 vaccination; Comirnaty (DOSE 1, SINGLE, Lot number: FF8288), administration date: 18Feb2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 2021, outcome "unknown" and all described as "Patient received first dose of Pfizer vaccine, second dose of ASTRAZENECA vaccine and booster dose of COMIRNATY"; IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "Patient received third (booster) dose of COMIRNATY"; ARTHRALGIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Arthritic-like pain"; MALAISE (medically significant) with onset 2021, outcome "unknown", described as "I am not well". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. "I am reacting to my Covid Pfizer Booster shot I am not well after 2 weeks." Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report does not relate to possible inflammation of the heart. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926731 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FX0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspepsia, Eructation, Fatigue, Headache, Immunisation, Interchange of vaccine products, Neck pain, Off label use, Pain, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), 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: GLUCOPHAGE S; RAMIPRIL; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Essential hypertension; Influenza immunization; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101646329

Write-up: pain in chest; Heartburn; Eructation/belching; off label use; Interchange of vaccine products; Booster; Tiredness; aching all over; headache; neck pain; 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-202111220908418480-NONGW (RA). Other Case identifier(s): GB-MHRA-ADR 26233829 (RA). A 36 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY,PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Nov2021 (Lot number: FX0596) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing); "Essential hypertension" (unspecified if ongoing); "Influenza immunization" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medications included: GLUCOPHAGE S taken for type 2 diabetes mellitus; RAMIPRIL taken for essential hypertension, start date: 03Jul2021; INFLUENZA A(H5N1) VACCINE taken for influenza immunisation, administration date 27Sep2021; SERTRALINE taken for depression, start date: 2020. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 06Mar2021, for COVID-19 vaccination; Covid-19 vaccine astrazeneca (Dose 2), administration date: 27Apr2021, for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; FATIGUE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Tiredness"; PAIN (medically significant) with onset 17Nov2021, outcome "recovered" (Nov2021), described as "aching all over"; HEADACHE (medically significant) with onset 17Nov2021, outcome "recovered" (Nov2021), described as "headache"; NECK PAIN (medically significant) with onset 17Nov2021, outcome "recovered" (Nov2021), described as "neck pain"; CHEST PAIN (medically significant) with onset 21Nov2021, outcome "unknown", described as "pain in chest"; DYSPEPSIA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Heartburn"; ERUCTATION (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Eructation/belching". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of chest pain, dyspepsia, eructation. Clinical course included On the day of the vaccination was initially fine with no symptoms but the afternoon of the vaccine started to feel extremely tired, aching all over, headache, neck pain, this seems to resolve after 24 hours except the tiredness. Then 3 days later starting with pain in chest feeling like heartburn and excessive belching, did not respond to gaviscon or other antacids. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926746 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Hyperhidrosis, Immunisation, Interchange of vaccine products, Mouth ulceration, Nausea, Off label use, Pain, Vomiting
SMQs:, Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Medication errors (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: CITALOPRAM; LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646379

Write-up: Mouth ulceration; Fatigue; Vomiting; Shivers; Drenching sweats; Nausea; Stomach ache; General body pain; Head pain; 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-202111221020185610-B8ZV9 (RA). Other Case identifier(s): GB-MHRA-ADR 26234011 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FL1939) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response and i... Concomitant medication(s) included: CITALOPRAM; LANSOPRAZOLE. Past drug history included: Qvar; Bricanyl. Vaccination history included: Covid-19 vaccine astrazeneca (1st dose), administration date: 29Apr2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (2nd dose), administration date: 02Oct2021, for COVID-19 immunisation. The following information was reported: CHILLS (medically significant) with onset 18Nov2021, outcome "recovered" (21Nov2021), described as "Shivers"; HYPERHIDROSIS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Drenching sweats"; NAUSEA (medically significant) with onset 18Nov2021, outcome "recovering", described as "Nausea"; ABDOMINAL PAIN UPPER (medically significant) with onset 18Nov2021, outcome "recovering", described as "Stomach ache"; PAIN (medically significant) with onset 18Nov2021, outcome "recovering", described as "General body pain"; HEADACHE (medically significant) with onset 18Nov2021, outcome "recovering", described as "Head pain"; MOUTH ULCERATION (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Mouth ulceration"; FATIGUE (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Fatigue"; VOMITING (medically significant) with onset 18Nov2021, outcome "recovered" (Nov2021), described as "Vomiting". Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial Reaction. Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)?: "No". No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926783 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Catarrh, Chills, Cough, Dry mouth, Fatigue, Glossodynia, Lymphadenopathy, Oral mucosal erythema, Oropharyngeal pain, Pain, Palpitations, Peak expiratory flow rate decreased, Productive cough, Rhinorrhoea, SARS-CoV-2 test, Sneezing, Throat irritation, Upper-airway cough syndrome
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: ACRIVASTINE; CLENIL MODULITE; VENTOLIN ACCUHALER
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Asthma; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101646510

Write-up: Postnasal drip; Catarrh; Sputum; Glands swollen; Chills; Fatigue; Ache; Redness mouth; Coughing; Heart racing; Itchy throat; Sore throat; Stinging tongue; Sneezing; Runny nose; Peak flow decreased; Dry mouth; This is a spontaneous report received from a contactable consumer from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111221326175970-PFJCF (RA). Other Case identifier(s): GB-MHRA-ADR 26234649 (RA). A 42 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK0596) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started, Unsure when symptoms stopped; "Allergy" (unspecified if ongoing). Concomitant medications included: ACRIVASTINE taken for hypersensitivity, start date: Jan2021; CLENIL MODULITE taken for asthma, start date: 01Oct2021; VENTOLIN ACCUHALER taken for asthma, start date: 05Sep2021. The following information was reported: ORAL MUCOSAL ERYTHEMA (medically significant) with onset 17Nov2021, outcome "recovering", described as "Redness mouth"; COUGH (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Coughing"; PALPITATIONS (medically significant) with onset 17Nov2021, outcome "recovering", described as "Heart racing"; THROAT IRRITATION (medically significant) with onset 17Nov2021, outcome "recovering", described as "Itchy throat"; OROPHARYNGEAL PAIN (medically significant) with onset 17Nov2021, outcome "recovering", described as "Sore throat"; GLOSSODYNIA (medically significant) with onset 17Nov2021, outcome "recovered (Nov2021)", described as "Stinging tongue"; SNEEZING (medically significant) with onset 17Nov2021, outcome "recovered (Nov2021)", described as "Sneezing"; RHINORRHOEA (medically significant) with onset 17Nov2021, outcome "recovered (Nov2021)", described as "Runny nose"; PEAK EXPIRATORY FLOW RATE DECREASED (medically significant) with onset 17Nov2021, outcome "recovering", described as "Peak flow decreased"; DRY MOUTH (medically significant) with onset 17Nov2021, outcome "recovered (Nov2021)", described as "Dry mouth"; LYMPHADENOPATHY (medically significant) with onset 18Nov2021, outcome "recovering", described as "Glands swollen"; CHILLS (medically significant) with onset 18Nov2021, outcome "recovered (Nov2021)", described as "Chills"; FATIGUE (medically significant) with onset 18Nov2021, outcome "recovering", described as "Fatigue"; PAIN (medically significant) with onset 18Nov2021, outcome "recovering", described as "Ache"; UPPER-AIRWAY COUGH SYNDROME (medically significant) with onset 19Nov2021, outcome "recovering", described as "Postnasal drip"; CATARRH (medically significant) with onset 18Nov2021, outcome "recovering", described as "Catarrh"; PRODUCTIVE COUGH (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Sputum". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (13Jul2021) positive, notes: Yes - Positive COVID-19 test. 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 inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926784 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Headache, Immunisation, Interchange of vaccine products, Malaise, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (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: AMLODIPINE; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart rate abnormal
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101646177

Write-up: Feeling unwell; Feeling of total lack of energy; Headache; Tiredness; Off label use; Interchange of vaccine products; Booster; Pain in arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111221328082690-ARMLI (RA). Other Case identifier(s): GB-MHRA-ADR 26234574 (RA). A 64-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on 17Nov2021 (Lot Number: FK9413), at the age of 64 years old, as 3rd single dose (booster), for COVID-19 immunization. Medical history included heart rate abnormal. The patient previously received COVID-19 VACCINE ASTRAZENECA, dose 1 on 27Feb2021, and COVID-19 VACCINE ASTRAZENECA, dose 2 on 15May2021, for COVID-19 immunization. Concomitant medication included amlodipine for heart rate, and ramipril for heart rate. The patient had not had symptoms associated with COVID-19, had not tested positive for COVID-19 since having the vaccine, and was not enrolled in clinical trial. The patient experienced pain in arm on 17Nov2021, and feeling unwell, feeling of total lack of energy, headache, and tiredness all on 18Nov2021. A COVID-19 test on an unspecified date was negative. The patient recovered from pain in arm on 20Nov2021, but had not recovered from feeling unwell, feeling of total lack of energy, headache, and tiredness. The case was reported as serious by the regulatory authority since involving a medically important condition. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926841 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Delirium, Diplegia, Hyperhidrosis, Immunisation, Influenza like illness, Interchange of vaccine products, Lethargy, Monoplegia, Off label use, Panic reaction, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Medication errors (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body Temperature; Result Unstructured Data: Test Result:High; Test Date: 20211120; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646409

Write-up: Drenching sweats; Delirious; Shivering; Lethargic; Flu like symptoms; Paralysis arm; Paralysis legs; panic; 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 (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111221732438360-8TRKR (MHRA). Other Case identifier(s): GB-MHRA-ADR 26235256 (MHRA). A 62 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: fk0596) at the age of 62 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 - manufacturer unknown (DOSE 1. BATCH/LOT NUMBER: UNKNOWN), for COVID-19 vaccination; Covid-19 vaccine - manufacturer unknown (DOSE 2. BATCH/LOT NUMBER: UNKNOWN), for COVID-19 vaccination. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; HYPERHIDROSIS (medically significant) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "Drenching sweats"; DELIRIUM (medically significant) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Delirious"; CHILLS (medically significant) with onset 17Nov2021, outcome "recovered" (19Nov2021), described as "Shivering"; LETHARGY (medically significant) with onset 17Nov2021, outcome "recovering", described as "Lethargic"; INFLUENZA LIKE ILLNESS (medically significant) with onset 17Nov2021, outcome "recovered" (19Nov2021), described as "Flu like symptoms"; MONOPLEGIA (medically significant) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Paralysis arm"; DIPLEGIA (medically significant) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Paralysis legs"; PANIC REACTION (medically significant) with onset 17Nov2021, outcome "unknown", described as "panic". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) high; sars-cov-2 test: (20Nov2021) no - negative covid-19 test. Therapeutic measures were taken as a result of influenza like illness. clinical course: Within 12 hours of receiving the booster all the above symptoms started. The patient said: ''My experience was extremely scary as I was unable to move my arms and legs for some time. I was very delirious and in a state of panic. For all the flu like symptoms I took paracetamol to easy the pain and to bring my temperature down. Other than the lethargy I feel I have now made a good recovery.'' No follow-up attempts are possible. No further information is expected.


VAERS ID: 1926845 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5475 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Facial paralysis, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646296

Write-up: Palsy Bells; Off label use; interchange of vaccine products; Booster; facial paralysis; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority). Regulatory number: GB-MHRA-WEBCOVID-202111221749109610-NDU2V (RA). Other Case identifier(s): GB-MHRA-ADR 26235230 (RA). A 69 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK5475) at the age of 69 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, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (dose2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Developed facial paralysis a couple of days after vaccine . Patient has not tested positive for COVID-19 since having the vaccine. The following information was reported: OFF LABEL USE (disability, medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) with onset 17Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (disability, medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; FACIAL PARALYSIS (disability, medically significant) with onset 2021, outcome "unknown", described as "facial paralysis"; BELL''S PALSY (disability, medically significant) with onset 20Nov2021, outcome "not recovered", described as "Palsy Bells". No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926850 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AZATHIOPRINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease Crohns; Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646364

Write-up: Pins and needles; 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-202111221805291720-4DERS. Other Case identifier(s): GB-MHRA-ADR 26235327. A 40 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: Not known) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Inflammatory bowel disease" (unspecified if ongoing), notes: Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis); "Disease Crohns" (unspecified if ongoing). Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medication(s) included: AZATHIOPRINE taken for crohn''s disease; INFLUENZA VIRUS, administration date 17Nov2021. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1 (batch/lot number: Not known)), administration date: 05Mar2021, 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) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; PARAESTHESIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Pins and needles". Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926969 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Lymphadenopathy, Pain, Product use issue, SARS-CoV-2 test
SMQs:, Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101697702

Write-up: Tired; Aching; Patient received booster dose of COMIRNATY; Glands swollen/swollen gland in armpit; COMIRNATY was administered on same day when Influenza vaccine was administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). The reporter is the patient. Regulatory number: GB-RA-WEBCOVID-202111291123127720-0FXL4 (RA). Other Case identifier(s): GB-RA-ADR 26264887 (RA). A 56 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 17Nov2021 (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: INFLUENZA VIRUS taken for immunisation, administration date 17Nov2021. Vaccination history included: Bnt162b2 (DOSE 2, SINGLELot number: UNKNOWN Route of administration: Unspecified), for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLELot number: UNKNOWN Route of administration: Unspecified), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Patient received booster dose of COMIRNATY"; LYMPHADENOPATHY (medically significant) with onset 17Nov2021, outcome "recovered" (20Nov2021), described as "Glands swollen/swollen gland in armpit"; PRODUCT USE ISSUE (non-serious) with onset 17Nov2021, outcome "unknown", described as "COMIRNATY was administered on same day when Influenza vaccine was administered"; FATIGUE (non-serious) with onset 18Nov2021, outcome "recovered" (19Nov2021), described as "Tired"; PAIN (non-serious) with onset 18Nov2021, outcome "recovered" (19Nov2021), described as "Aching". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. Upon having COVID booster and flu vaccine on 17 November 2021, the patient had swollen gland in the armpit on the left side that is the arm in which the COVID booster was given. It lasted 3 days. The patient was also tired and aching on the day after the booster which lasted one day only. The 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: 1928220 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F10014A / UNK - / IM
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / IM

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? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypercholesterolaemia; Hypertension arterial; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESGLAXOSMITHKLINEES202124

Write-up: Herpes zoster/ LEFT SIDE; This case was reported by a physician via regulatory authority and described the occurrence of herpes zoster in a 82-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Influenza Vaccine Quadrivalent Pre-Filled Syringe Device) injection syringe for prophylaxis and TOZINAMERAN (COMIRNATY) (batch number 1F10014A, expiry date unknown) for prophylaxis. Previously administered products included COMIRNATY (0.3ml dose received intramuscularlyon 30th April 2021, batch EW6362) and COMIRNATY (0.3ml dose received intramuscularlyon 9th April 2021, batch EW2239). Concurrent medical conditions included arterial hypertension, osteoporosis and hypercholesterolemia. On 16th November 2021, the patient received Fluarix Quadrivalent 2021-2022 season (intramuscular) .5 ml, Influenza Vaccine Quadrivalent Pre-Filled Syringe Device and COMIRNATY (intramuscular) .3 ml. On 17th November 2021, 1 days after receiving Fluarix Quadrivalent 2021-2022 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device, the patient experienced herpes zoster (serious criteria other: serious as per reporter). On an unknown date, the outcome of the herpes zoster was recovering/resolving. It was unknown if the reporter considered the herpes zoster to be related to Fluarix Quadrivalent 2021-2022 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. This report is made without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The age at vaccination was unknown. On 17th November 2021, 1 day after receiving COMIRNATY, the patient experienced herpes zoster. It was unknown if the reporter considered the herpes zoster to be related to COMIRNATY. The TTO for event was reported as 2 days as per drug event mapping but was captured as 1 d ay as per reported suspect and event onset date The 2 doses of COMIRNATY were reported as suspect but were captured as history as they were taken more than 3 months before the onset of AE. Initial information was reported by physician via regulatory authority on 30th November 2021: herpes zoster LEFT SIDE


VAERS ID: 1928248 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

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

Write-up: nausea; Headache; fatigue; Muscle fatigue; Fever chills; Migraine type headaches; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26245604) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (nausea), HEADACHE (Headache), FATIGUE (fatigue), MUSCLE FATIGUE (Muscle fatigue), PYREXIA (Fever chills) and MIGRAINE (Migraine type headaches) in a 55-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced MIGRAINE (Migraine type headaches) (seriousness criterion medically significant). On 18-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced MUSCLE FATIGUE (Muscle fatigue) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (nausea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (fatigue) (seriousness criterion medically significant). On 21-Nov-2021, PYREXIA (Fever chills) had resolved. At the time of the report, NAUSEA (nausea), HEADACHE (Headache) and FATIGUE (fatigue) outcome was unknown, MUSCLE FATIGUE (Muscle fatigue) was resolving and MIGRAINE (Migraine type headaches) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment information was not provided. List of concomitant medication were not given. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Within 12 hours of booster was awakened by severe headache and uncontrollable shivers. Intense headache pain over one eye. Company Comment : This case concerns a 55-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of nausea, headache, fatigue, muscle fatigue, pyrexia and migraine. The events occurred between 1 and an unknown number of days after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. 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 meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 55-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of nausea, headache, fatigue, muscle fatigue, pyrexia and migraine. The events occurred between 1 and an unknown number of days after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. 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 meet the criteria to be medically significant.


VAERS ID: 1929704 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-11-17
   Days after vaccination:187
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP6775 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Injection site pain, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Extravasation events (injections, infusions and implants) (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANTUS; METFORMIN; NORVASC; RAMIPRIL; VITAMINE B12
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic; Hypertension; Iron deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Covid test; Result Unstructured Data: Test Result:Positive; Comments: Quarantined until 27Nov2021
CDC Split Type: CAPFIZER INC202101624679

Write-up: Injection pain site; diagnosed with Covid-19; diagnosed with Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient. A 47 year-old male patient received bnt162b2 (COMIRNATY), administration date 23Apr2021 (Lot number: EP6775) as dose 1, single and administration date 14May2021 (Lot number: EP6775) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hight blood pressure" (unspecified if ongoing); "Diabetic" (unspecified if ongoing); "Iron deficiency" (unspecified if ongoing). Concomitant medication(s) included: LANTUS taken for diabetes mellitus (ongoing); METFORMIN taken for diabetes mellitus (ongoing); NORVASC taken for hypertension (ongoing); RAMIPRIL taken for hypertension (ongoing); VITAMINE B12 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with Covid-19" (17Nov2021); INJECTION SITE PAIN (non-serious), outcome "recovered", described as "Injection pain site". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) positive, notes: Quarantined until 27Nov2021. On 19Nov2021, patient was diagnosed positive Covid after feeling sick. On 17Nov2021, consumer complained of scratchy throat, flulike symptoms, body pain, headache, eyes irritated, cough, diarrhea, fever. Headache not going away, Tylenol helped and he experienced Lost sense of taste for 48 hours. He spoke to his HCP about symptoms. On 22nov2021, investigation from the product quality group was received. 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 complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type.The final scope was determined to be the associated lot(s) of the reported lot EP6775. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Follow-up (22Nov2021 and 25Nov2021): This is a follow-up report from product quality group providing investigation results. This is a spontaneous report received from a contactable reporter. Updated information included: Relevant medical history(Hight blood pressure, Diabetic and Iron deficiency), Lab tests( Covid test - Positive, 17Nov2021),Dose details( 1st dose- 23Apr2021 and 14May2021, Lot no - EP6775), Concomitant drugs( Lantus insulin, Metformin, Norvasc and Ramipril), new event for Injection pain site(Onset: After both 1st and 2nd dose, Outcome: Recovered) Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.


VAERS ID: 1930274 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Rash erythematous
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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101654594

Write-up: Red rash; Booster; This is a spontaneous report received from a contactable reporter (Other health care professional) from the Regulatory Authority. Regulatory number: GB-MHRA-APPCOVID-202111240147292530-XKPLN (MHRA). Other Case identifiers: GB-MHRA-ADR 26240977 (RA). A 57 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: Unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Patient did not had symptoms associated with COVID-19 nor had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Concomitant medication included: INFLUENZA VIRUS, administration date 17Nov2021. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: Not known), for COVID-19 immunisation; Bnt162b2 (Dose 2, Single, Lot number: Not known), for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 17Nov2021, outcome "unknown", described as "Booster"; RASH ERYTHEMATOUS (disability) with onset 22Nov2021, outcome "recovering", described as "Red rash". Therapeutic measures were taken as a result of rash erythematous which included treatment with oral anti-histamine and steroid cream. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930353 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Headache, Immunisation, Interchange of vaccine products, Lymphadenopathy, Lymphoedema, Myalgia, Off label use, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rib excision
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101646129

Write-up: Swollen lymph nodes; lymphoedema; Axilla still swollen and tender; sore arm; joint pain; muscle pain; high temperature/ Fever; Pain; Headache; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111220740550340-EIXTJ. Other Case identifier: GB-MHRA-ADR 26233512. A female patient of an unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 17Nov2021 (Lot Number: FK9413) as Dose 3 (Booster), single for COVID-19 immunisation.The patient medical history included an operation to have rib removed. Concomitant medication included influenza vaccine taken for immunisation from 02Oct2021. Historical vaccine included COVID-19 VACCINE ASTRAZENECA, dose 1 on 19Mar2021 and dose 2 on 18May2021 for COVID-19 immunization. The patient experienced muscle pain, high temperature/fever, pain, headache on 18Nov2021; swollen lymph nodes on 19Nov2021. Additional information: sore arm after 12 hours then at 20 hours high temperature, joint and muscle pain with headache this lasted 36 hours but then swollen axilla on RHS, lymphoedema did have op to have rib removed through this axilla 12 years ago so possible interference with lymph drainage. Was also painful along with arm. First time had injection in Right arm last 3 in left arm. Axilla still swollen and tender but resolving. Called 111 for advice 48 hours ago still no call back. The events were considered medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date. The patient has recovered from the events, fever, pain, headache, sore arm, muscle pain and joint pain on 20Nov2021; and recovering from swollen lymph nodes, lymphoedema, & axilla still swollen and tender. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930378 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Diabetes mellitus inadequate control, Fatigue, Immunisation, Off label use
SMQs:, Hyperglycaemia/new onset diabetes mellitus (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: INSULIN ASPART; INSULIN GLARGINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coeliac disease; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef.); Suspected COVID-19; Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Blood glucose; Result Unstructured Data: Test Result:unpredictable/uncontrollable
CDC Split Type: GBPFIZER INC202101646472

Write-up: Feel exhausted; Blood glucose/very unpredictable/uncontrollable blood sugars; Off label use; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111221321493740-QGHVQ (MHRA). Other Case identifier(s): GB-MHRA-ADR 26234578 (MHRA). A 50 year-old patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Coeliac disease" (unspecified if ongoing); "Suspected COVID-19", start date: 10Feb2020, stop date: 20Feb2020; "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef.; "type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation, administration date 15Nov2021; INSULIN ASPART taken for type 1 diabetes mellitus; INSULIN GLARGINE taken for type 1 diabetes mellitus. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; DIABETES MELLITUS INADEQUATE CONTROL (medically significant) with onset 19Nov2021, outcome "recovering", described as "Blood glucose/very unpredictable/uncontrollable blood sugars"; FATIGUE (medically significant), outcome "unknown", described as "Feel exhausted". The patient underwent the following laboratory tests and procedures: blood glucose: (19Nov2021) unpredictable/uncontrollable. Clinical course: The patient have had several days of very unpredictable/uncontrollable blood sugars, swinging from hypo to hyper and often not responding as expected either to doses of insulin to bring it down, or to sugar to bring it up. The patient felt exhausted and quite ''out of it'' though that would be expected if the patient had these swings anyway, so not sure if that is a side effect or just because of the sugar swings. Patient is not enrolled in clinical trial. Not had a COVID-19 test No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930393 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Bone pain, Diarrhoea, Fatigue, Immunisation, Interchange of vaccine products, Myalgia, Off label use, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s disease (not currently taking any medication); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646142

Write-up: Persistent vomiting; diarrhea; severe pain in joints; Muscle pain; Pain bone; Fever; fatigue; Patient received first and second dose of Non Pfizer vaccine and booster dose of COMIRNATY; Patient received first and second dose of Non Pfizer vaccine and booster dose of COMIRNATY; Patient received first and second dose of Non Pfizer vaccine and booster dose of COMIRNATY; This is a spontaneous report received from a contactable consumer from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111221759432200-TU4YX. Other Case identifier: GB-MHRA-ADR 26235272. A 58 year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number: FH3220), administration date 17Nov2021 at 11:00 (at the age of 58 years) as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: suspected COVID-19 from 10Sep2021 and unsure when did the symptoms stop; and Crohn''s disease, patient was not taking any medication for it as azathioprine was damaging her liver and then could not see consultant because of pandemic, so currently she has no other medication. There were no concomitant medications. Vaccination history included: dose 1 and dose 2 of COVID-19 vaccine (Primary Immunization series complete but unknown manufacturer), both received on unknown date for COVID-19 immunization. The following information was reported: OFF LABEL USE, INTERCHANGE OF VACCINE PRODUCTS, IMMUNISATION all with onset 17Nov2021, outcome "unknown" and all described as "Patient received first and second dose of Non Pfizer vaccine and booster dose of COMIRNATY"; PYREXIA with onset 17Nov2021 20:45, outcome "recovered" (Nov2021), described as "Fever"; FATIGUE with onset 17Nov2021, outcome "not recovered"; ARTHRALGIA with onset 18Nov2021 08:00, outcome "unknown", described as "severe pain in joints"; MYALGIA with onset 18Nov2021 08:00, outcome "recovering", described as "Muscle pain"; VOMITING with onset 18Nov2021 22:00, outcome "recovered" (20Nov2021), described as "Persistent vomiting"; DIARRHOEA with onset 18Nov2021 22:00, outcome "not recovered", described as "diarrhea"; BONE PAIN with onset 18Nov2021, outcome "recovering", described as "Pain bone". The events were reported as serious per other medically important condition. The clinical course was reported as follows: Had vaccine 11:00 Wednesday. Started with fever 20:45 Wednesday. Severe pain in muscles and joints began 08:00 Thursday, paracetamol not helping. Diarrhoea and vomiting started 22:00 Thursday. Fatigue so bad had to stay in bed Wednesday night to Sunday 12:00. Still got diarrhoea. Never had such severe vaccine reaction. Still feel very fatigued and diarrhoea Monday. Patient has 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). The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (12Sep2021) No - Negative COVID-19 test. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930429 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast pain, Breast tenderness, Menstruation delayed, SARS-CoV-2 test
SMQs:, Lipodystrophy (broad), Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211111; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654426

Write-up: Never been so sore before; incredibly soft boobs since second jab; Delayed period; 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-202111230920364800-WVMSE (regulatory authority). Other Case identifier(s): GB-MHRA-ADR 26237164 (regulatory authority). A female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (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: Covid-19 vaccine (Dose 1, Single, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MENSTRUATION DELAYED (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Delayed period"; BREAST PAIN (medically significant), outcome "unknown", described as "Never been so sore before"; BREAST TENDERNESS (medically significant), outcome "unknown", described as "incredibly soft boobs since second jab". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course: Period had never come. Also have had incredibly soft boobs since second jab. Never had been so sore before. Was very worried as currently trying for children. Patient not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report did not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1930460 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101654451

Write-up: Faint; felt light headed; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111231226330630-A7EOK. Other Case identifier(s): GB-MHRA-ADR 26238423. A 14 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The following information was reported: SYNCOPE (medically significant) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Faint"; DIZZINESS (non-serious) with onset 17Nov2021, outcome "unknown", described as "felt light headed". It was further reported that approximately five minutes post vaccination the young person felt light headed and fainted. Young person was sitting on a chair and was assisted by nursing staff to the crash mat where he promptly awake once lay flat. Legs elevated on a chair. Once young person felt well enough he was assisted back onto chair and given a small drink of water to sip. Approximately 30 minutes post faint young person felt well enough to return to class. No report was related to possible blood clots or low platelet counts. No report was related to possible myocarditis or pericarditis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930505 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cough, Fatigue, Feeling cold, Headache, Immunisation, Influenza like illness, Interchange of vaccine products, Malaise, Off label use, Pain, Product use issue, Rhinorrhoea, SARS-CoV-2 test, Sneezing
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), 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: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain tumour operation (I had a brain tumour (haemangioblastoma) removed in 1998.); Corneal transplant (Low dose steroid eye drops - one drop daily - following cornea transplant in 2019.); Pleurisy (had pleurisy around 7 years ago.)
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654661

Write-up: coughing; flu-like; like a very bad cold; feeling dreadful; Sneezing; Runny nose; Cough; Headache; Tiredness/exhaustion; Ache; Shoulder soreness; Product use for unapproved combination; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111231804327650-TEVFJ. Other Case identifier(s): GB-MHRA-ADR 26240122. A 51 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Pleurisy" (unspecified if ongoing), notes: had pleurisy around 7 years ago.; "cornea transplant", start date: 2019 (unspecified if ongoing), notes: Low dose steroid eye drops - one drop daily - following cornea transplant in 2019.; "brain tumour (haemangioblastoma) removed", start date: 1998 (unspecified if ongoing), notes: I had a brain tumour (haemangioblastoma) removed in 1998. Concomitant medication(s) included: INFLUENZA VIRUS, administration date 17Nov2021. Past drug history included: Depo-medrone. Vaccination history included: COVID-19 vaccine astrazeneca (Dose 1, Single, Batch/Lot number: Unknown), administration date: 2021, for COVID-19 immunisation, reaction(s): "exhausted", "flu-like", "achey"; COVID-19 vaccine (Dose: 2, Single, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; COUGH (medically significant), outcome "recovering", described as "coughing"; SNEEZING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Sneezing"; RHINORRHOEA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Runny nose"; COUGH (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Cough"; INFLUENZA LIKE ILLNESS (medically significant), outcome "unknown", described as "flu-like"; PRODUCT USE ISSUE (non-serious) with onset 17Nov2021, outcome "unknown", described as "Product use for unapproved combination"; PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Ache"; FEELING COLD (medically significant), outcome "unknown", described as "like a very bad cold"; HEADACHE (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Headache"; FATIGUE (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Tiredness/exhaustion"; MALAISE (medically significant), outcome "unknown", described as "feeling dreadful"; ARTHRALGIA (medically significant) with onset 17Nov2021, outcome "recovered" (19Nov2021), described as "Shoulder soreness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Nov2021) no - negative COVID-19 test. Therapeutic measures: paracetamol and ibuprofen were taken as a result of cough, sneezing, rhinorrhoea, cough, influenza like illness, pain, feeling cold, headache, fatigue, malaise, arthralgia. Clinical Course: Following COVID booster and flu jag (at the same time - first time had flu jag) felt achey, exhausted and flu-like for 2 days (following first COVID jag) but started sneezing on top of the aches etc on Saturday night (day 3 following jags). This led to a runny nose, continued aches, coughing and generally feeling dreadful - like a very bad cold - with headaches and exhaustion. Had signs of improvement tonight (day 6 following jags, spent the past 6 days in bed, or on the couch in dressing gown, being looked after). The patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No details of any relevant investigations or tests conducted was provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930535 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-06
Onset:2021-11-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Chest pain, Dyspnoea, Pleurisy
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: GBPFIZER INC202101654519

Write-up: Pleurisy; Chest pain; hurts to breath; random onset of back and chest pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111232142278940-5ZCDD. Other Case identifier(s): GB-MHRA-ADR 26240552. A 35 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 06Nov2021 (Lot number: FH8469) 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: BACK PAIN (medically significant) with onset 2021, outcome "not recovered", described as "random onset of back and chest pains"; PLEURISY (medically significant) with onset 17Nov2021, outcome "recovered" (22Nov2021), described as "Pleurisy"; CHEST PAIN (medically significant) with onset 2021, outcome "not recovered", described as "Chest pain"; DYSPNOEA (medically significant) with onset 2021, outcome "unknown", described as "hurts to breath". The events "random onset of back and chest pains", "pleurisy", "chest pain" and "hurts to breath" were evaluated at the physician office visit. Therapeutic measures were taken as a result of back pain, pleurisy, chest pain, dyspnoea. Clinical course: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. Random onset of back and chest pains, hurts to breath. Seen GP and told its Pleurisy and been on antibiotics. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1930544 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Dizziness, Headache, Immunisation, Influenza like illness, Interchange of vaccine products, Muscular weakness, Off label use, Pain, SARS-CoV-2 test, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (narrow), 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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654558

Write-up: Had a short bout of vertigo; Sudden weakness in legs while walking; 3rd dose was administered, and the patient has not previously received the full primary immunization series of BNT162B2 vaccination; 3rd dose was administered, and the patient has not previously received the full primary immunization series of BNT162B2 vaccination; 3rd dose was administered, and the patient has not previously received the full primary immunization series of BNT162B2 vaccination; Continued throbbing head which eases during day; Flu-like aching; General discomfort; Lightheaded feeling occasionally when standing; Aching; This is a spontaneous report received from a contactable consumer from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111232306527140-OFOQF. Other Case identifier(s): GB-MHRA-ADR 26240937. A 68-year-old patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH4751) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Vaccination history included: COVID-19 vaccine astrazeneca (Dose 1, Batch/lot: Unknown), administration date: 24Feb2021, for COVID-19 Immunization; COVID-19 vaccine astrazeneca (Dose 2, Batch/lot: Unknown), administration date: 14May2021, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "3rd dose was administered, and the patient has not previously received the full primary immunization series of BNT162B2 vaccination"; MUSCULAR WEAKNESS (medically significant) with onset 21Nov2021, outcome "recovered" (21Nov2021), described as "Sudden weakness in legs while walking"; VERTIGO (medically significant) with onset 23Nov2021, outcome "recovered" (2021), described as "Had a short bout of vertigo"; HEADACHE (medically significant) with onset 2021, outcome "recovering", described as "Continued throbbing head which eases during day"; INFLUENZA LIKE ILLNESS (medically significant) with onset 2021, outcome "recovering", described as "Flu-like aching"; DISCOMFORT (medically significant) with onset 2021, outcome "unknown", described as "General discomfort"; DIZZINESS (medically significant) with onset 2021, outcome "unknown", described as "Lightheaded feeling occasionally when standing"; PAIN (medically significant) with onset 2021, outcome "unknown", described as "Aching". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. Clinical course reported as: Sudden weakness in legs while walking 4 days after booster jab. Recovered after short rest. Later had continued throbbing head which eases during day. General discomfort and aching. Lightheaded feeling occasionally when standing. Had a short bout of vertigo on day 6 but recovered after sitting. Throbbing head although less frequent still persists. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1930565 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Chills, Feeling abnormal, Headache, Migraine, Pyrexia, SARS-CoV-2 test, Vertigo
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis (take riveroxaban blood thinner as suffer with deep vein thrombosis); Lymphedema
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: chills; shivering; hours; days; headache; covid; Vertigo; Migraine headache; This case was received via regulatory authority on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (chills), CHILLS (shivering), FEELING ABNORMAL (hours), PYREXIA (days), HEADACHE (headache), VERTIGO (Vertigo), MIGRAINE (Migraine headache) and COVID-19 (covid) in a 55-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Deep vein thrombosis (take riveroxaban blood thinner as suffer with deep vein thrombosis). Previously administered products included for Deep vein thrombosis: RIVAROXABAN. Past adverse reactions to the above products included No adverse event with RIVAROXABAN. Concurrent medical conditions included Lymphedema. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced VERTIGO (Vertigo) (seriousness criterion medically significant) and MIGRAINE (Migraine headache) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant), CHILLS (shivering) (seriousness criterion medically significant), FEELING ABNORMAL (hours) (seriousness criterion medically significant), PYREXIA (days) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant) and COVID-19 (covid) (seriousness criterion medically significant). On 21-Nov-2021, VERTIGO (Vertigo) and MIGRAINE (Migraine headache) was resolving. At the time of the report, CHILLS (chills), CHILLS (shivering), FEELING ABNORMAL (hours), PYREXIA (days), HEADACHE (headache) and COVID-19 (covid) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications reported by reporter. Patient was suffering with shivering and chills for 48 hours. Headache for 4 days and finally covid arm for 4 days. Patient has not tested positive for COVID-19 since having the vaccine. No treatment medications provided by the reporter. Company Comment This case concerns a 55-year-old, female patient with relevant medical history of deep vein thrombosis and lymphoedema, who experienced the unexpected events of chills, feeling abnormal, pyrexia, headache, vertigo, migraine and COVID-19 (AESI). The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. 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 meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 55-year-old, female patient with relevant medical history of deep vein thrombosis and lymphoedema, who experienced the unexpected events of chills, feeling abnormal, pyrexia, headache, vertigo, migraine and COVID-19 (AESI). The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. 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 meet the criteria to be medically significant.


VAERS ID: 1930610 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 3 - / OT

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

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.MOD20213

Write-up: headache; Headache fullness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26252746) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache fullness) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003651) for an unknown indication. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced HEADACHE (Headache fullness) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant). On 20-Nov-2021, HEADACHE (Headache fullness) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant product use was not provided by the reporter. Patient had headache unable to get out of bed felt like had be hit by a lorry. Very very sore arm & very swollen. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. Company Comment: This case concerns a 51-year-old female subject, with no medical history reported, who experienced the unexpected and serious event of Headache. The event is unexpected as it is retained as serious per the source document Authority reporting. The event occurred the same day after the booster dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. 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 subject, with no medical history reported, who experienced the unexpected and serious event of Headache. The event is unexpected as it is retained as serious per the source document Authority reporting. The event occurred the same day after the booster dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1930690 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Coordination abnormal, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

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

Write-up: Numbness facial; Incoordination; This case was received via RA (Reference number: GB-MHRA-ADR 26258380) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of COORDINATION ABNORMAL (Incoordination) and HYPOAESTHESIA (Numbness facial) in a 75-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced COORDINATION ABNORMAL (Incoordination) (seriousness criterion medically significant). On 19-Nov-2021, the patient experienced HYPOAESTHESIA (Numbness facial) (seriousness criterion medically significant). On 19-Nov-2021, COORDINATION ABNORMAL (Incoordination) had resolved. On 21-Nov-2021, HYPOAESTHESIA (Numbness facial) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported. No Treatment medications were provided. Patient had no co-ordination at night, no better on the thursday, developed numbness to left side of face on friday, all these symtpoms settled down over the weekend and was feeling back to normal on 25 Nov 2021 Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. It was reported that the report was not related to possible blood clots or low platelet counts or possible myocarditis or pericarditis . Company comment: This regulatory case concerns a 77-year-old, female patient with no reported medical history, who experienced the unexpected, serious (IME) events of coordination abnormal and hypoaesthesia. The patient experienced the same night after third dose of mRNA-1273 vaccine, no coordination and developed two days after vaccination numbness to left side of face. She was feeling back to normal 8 days after vaccination. Regulatory authority captured the rechallenge as unknown, however no information about further dosing is disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.; Sender''s Comments: This regulatory case concerns a 77-year-old, female patient with no reported medical history, who experienced the unexpected, serious (IME) events of coordination abnormal and hypoaesthesia. The patient experienced the same night after third dose of mRNA-1273 vaccine, no coordination and developed two days after vaccination numbness to left side of face. She was feeling back to normal 8 days after vaccination. Regulatory authority captured the rechallenge as unknown, however no information about further dosing is disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.


VAERS ID: 1930692 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GABAPENTIN; SERTRALINE; SIMVASTATIN
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.MOD20213

Write-up: Incontinence; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26258564) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INCONTINENCE (Incontinence) in a 71-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concomitant products included SERTRALINE from 2001 to an unknown date for Mood depression, GABAPENTIN from 2019 to an unknown date for Neck pain, SIMVASTATIN from 2020 to an unknown date for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced INCONTINENCE (Incontinence) (seriousness criterion medically significant). On 18-Nov-2021, INCONTINENCE (Incontinence) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no-negative covid-19 test (Negative) No-Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The patient woke up soaking wet. She continued incontinence during the next day. The patient been in remission since May 2020. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment medications were reported. The reporter did not provide causality assessment for the reported event. Company comment: This case concerns a 71-year-old female patient with no medical history provided, who experienced the serious unexpected event of Incontinence. The event occurred one day after the patient had received the third dose of the mRNA-1273 vaccine. The event resolved during the next day and no further information regarding the clinical course of the event was provided. The re-challenge and action taken with the suspect product were retained as unknown (in line with the source document), even though could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine and no additional doses are planned. The patient''s elderly age and use of concomitant medication Sertraline are considered as a risk factors for the reported event. The benefit-risk relationship of the MRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 71-year-old female patient with no medical history provided, who experienced the serious unexpected event of Incontinence. The event occurred one day after the patient had received the third dose of the mRNA-1273 vaccine. The event resolved during the next day and no further information regarding the clinical course of the event was provided. The re-challenge and action taken with the suspect product were retained as unknown (in line with the source document), even though could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine and no additional doses are planned. The patient''s elderly age and use of concomitant medication Sertraline are considered as a risk factors for the reported event. The benefit-risk relationship of the MRNA-1273 vaccine is not affected by this report.


VAERS ID: 1930731 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Agitation, Arthralgia, Headache, Nausea, Night sweats, Pain in extremity, Pruritus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypersensitivity (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: Low grade lymphoma (Have low grade lymphoma, no treatment necessary. Being monitored.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: night sweats; joint pain; nausea; swollen upper arm; agitation; extreme head and face pain; Head pain; This case was received via RA (Reference number: GB-MHRA-ADR 26262142) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Head pain), NIGHT SWEATS (night sweats), ARTHRALGIA (joint pain), NAUSEA (nausea), PAIN IN EXTREMITY (swollen upper arm), AGITATION (agitation) and PRURITUS (extreme head and face pain) in an 80-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concurrent medical conditions included Low grade lymphoma (Have low grade lymphoma, no treatment necessary. Being monitored.). On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced HEADACHE (Head pain) (seriousness criterion medically significant). On an unknown date, the patient experienced NIGHT SWEATS (night sweats) (seriousness criterion medically significant), ARTHRALGIA (joint pain) (seriousness criterion medically significant), NAUSEA (nausea) (seriousness criterion medically significant), PAIN IN EXTREMITY (swollen upper arm) (seriousness criterion medically significant), AGITATION (agitation) (seriousness criterion medically significant) and PRURITUS (extreme head and face pain) (seriousness criterion medically significant). At the time of the report, HEADACHE (Head pain) was resolving and NIGHT SWEATS (night sweats), ARTHRALGIA (joint pain), NAUSEA (nausea), PAIN IN EXTREMITY (swollen upper arm), AGITATION (agitation) and PRURITUS (extreme head and face pain) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication information was mentioned by reporter. Patient reported that Patient experienced Extreme head and face pain, just starting to recover, Pain in neck glands, teeth, jaw behind eyes and Swollen upper arm, Agitation, fatigued but sometimes unable to sleep. Patient experienced Really bad night sweats, changing nightwear several times a night and sometimes bedding. This was like having a smaller dose of Covid which Patient had in March 2020. No treatment medication information was mentioned by reporter Company Comment: This case concerns a 80-year-old patient of unknown gender with relevant medical history of Low grade lymphoma, who experienced the unexpected serious events of Headache approximately 1 day after the third dose of mRNA-1273 Vaccine. The events Night sweats, Arthralgia, Nausea, Pain in extremity, Agitation and Pruritus occurred on an unknown date. At the time of report the outcome was Resolving for Headache and resolved for the other events. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The patient''s medical history of Low grade lymphoma, remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 80-year-old patient of unknown gender with relevant medical history of Low grade lymphoma, who experienced the unexpected serious events of Headache approximately 1 day after the third dose of mRNA-1273 Vaccine. The events Night sweats, Arthralgia, Nausea, Pain in extremity, Agitation and Pruritus occurred on an unknown date. At the time of report the outcome was Resolving for Headache and resolved for the other events. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The patient''s medical history of Low grade lymphoma, remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1930921 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK8562 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure systolic, Body temperature, Chest discomfort, Heart rate, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis (The patient experienced anaphylaxis due to ant sting.); Ant sting (The patient experienced anaphylaxis due to ant sting.)
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:82 mmHg; Test Date: 20211117; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:100 mmHg; Comments: After giving Adrenaline 0.5mg intramuscular; Test Date: 20211117; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20211117; Test Name: pulse rate; Result Unstructured Data: Test Result:72/min; Comments: regular; Test Date: 20211117; Test Name: SPO2; Test Result: 97 %
CDC Split Type: JPPFIZER INC202101650212

Write-up: Anaphylaxis; chest discomfort; blood pressure decreased; Blood pressure systolic 82mmHg; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: v21131421. A 35 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 09:35 (Lot number: FK8562, Expiration Date: 30Apr2022) at the age of 35 years as dose 2, single for covid-19 immunisation. Body temperature before vaccination was 36.7 degrees centigrade. 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 experienced drug eruption due to Toledomin before. The patient experienced anaphylaxis due to ant sting. Relevant medical history included: "anaphylaxis" (unspecified if ongoing), notes: The patient experienced anaphylaxis due to ant sting.; "ant sting" (unspecified if ongoing), notes: The patient experienced anaphylaxis due to ant sting. The patient''s concomitant medications were not reported. Past drug history included: Toledomin, reaction(s): "drug eruption". Vaccination history included: Covid-19 vaccine (dose 1, Manufacturer Unknown), for covid-19 immunisation. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 17Nov2021 09:45, outcome "recovering", described as "Anaphylaxis"; CHEST DISCOMFORT (medically significant) with onset 17Nov2021 09:45, outcome "recovering", described as "chest discomfort"; BLOOD PRESSURE DECREASED (medically significant) with onset 17Nov2021 09:45, outcome "recovering", described as "blood pressure decreased"; BLOOD PRESSURE SYSTOLIC (medically significant) with onset 17Nov2021 09:45, outcome "recovering", described as "Blood pressure systolic 82mmHg". The events "anaphylaxis", "chest discomfort", "blood pressure decreased" and "blood pressure systolic 82mmhg" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure systolic: (17Nov2021) 82 mmHg; (17Nov2021) 100 mmHg, notes: After giving Adrenaline 0.5mg intramuscular; body temperature: (17Nov2021) 36.7 Centigrade, notes: before vaccination; heart rate: (17Nov2021) 72/min, notes: regular; oxygen saturation: (17Nov2021) 97 %. Therapeutic measures were taken as a result of anaphylactic reaction, chest discomfort, blood pressure decreased, blood pressure systolic and included treatment with Adrenaline 0.5mg intramuscular. Clinical course: On 17Nov2021 at 09:35 (the day of the vaccination), the patient received the second dose. On 17Nov2021 at 09:45 (10 minutes after the vaccination), the patient experienced anaphylaxis. On 18Nov2021 (1 day after the vaccination), the outcome of the event was recovering. The course of the event was as follows: 10 minutes after the vaccination, the patient experienced chest discomfort, blood pressure decreased (Blood pressure systolic 82mmHg). Pulse rate 72/min, regular, SPO2 97%. After giving Adrenaline 0.5mg intramuscular, blood pressure systolic became 100mmHg but chest discomfort continued. The patient was emergency transferred to the privacy hospital. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1931042 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH IF1014A / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Eye swelling, Protein urine, Renal disorder
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Proteinuria (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101644497

Write-up: kidneys are being damaged; protein through urine; have swelling in eyes; This is a spontaneous report received from a contactable consumer or other non HCP from medical information team. The reporter is the patient. A 31 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: IF1014A) at the age of 31 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: RENAL DISORDER (medically significant) with onset 17Nov2021, outcome "not recovered", described as "kidneys are being damaged"; PROTEIN URINE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "protein through urine"; EYE SWELLING (medically significant) with onset 17Nov2021, outcome "not recovered", described as "have swelling in eyes". Follow-up attempts are completed. No further information is expected.


VAERS ID: 1932102 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Pruritus, Thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARATYNE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101648063

Write-up: Thrombosis; Fatigue; Pruritus; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 666632 Regulatory Authority. A 49-year-old female patient received BNT162B2 (COMIRNATY, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: CLARATYNE. The following information was reported: THROMBOSIS (medically significant) with onset 17Nov2021, outcome "recovered" (Nov2021), described as "Thrombosis"; FATIGUE (non-serious) with onset 17Nov2021, outcome "recovered" (Nov2021), described as "Fatigue"; PRURITUS (non-serious) with onset 17Nov2021, outcome "recovered" (Nov2021), described as "Pruritus". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1933141 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101648384

Write-up: Generalised tonic-clonic seizure; Syncope; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 667041 (TGA ADR#). A 19 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (medically significant) with onset 17Nov2021, outcome "recovered", described as "Generalised tonic-clonic seizure"; SYNCOPE (medically significant) with onset 17Nov2021, outcome "recovered", described as "Syncope". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1933152 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Rash
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101648454

Write-up: anaphylactic reaction; rash; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. A 12 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 17Nov2021, outcome "recovered", described as "anaphylactic reaction"; RASH (non-serious) with onset 17Nov2021, outcome "recovered", described as "rash". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1933154 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspraxia, Headache, Loss of consciousness, Neck pain, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101648469

Write-up: Loss of consciousness; Dyspraxia; Headache; Neck pain; Tremor; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 667392 (TGA ADR#). A 25 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Loss of consciousness"; DYSPRAXIA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Dyspraxia"; HEADACHE (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Headache"; NECK PAIN (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Neck pain"; TREMOR (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Tremor". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1933186 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101648735

Write-up: pulmonary embolism; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 668257 Regulatory Authority. A 35 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (medically significant) with onset 17Nov2021, outcome "unknown", described as "pulmonary embolism". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1933560 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Myalgia, Tachypnoea, Vaccination site erythema, Vaccination site swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to metals (nickel); Hay fever; Iron deficiency (not yet clarified, but suspected); Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101667875

Write-up: Swelling and redness; rapid superficial respiration; Swelling and redness; Headache; Myalgia; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: CH-SM-2021-28699. A 21 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 21 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Allergy to metals" (unspecified if ongoing), notes: nickel; "hay fever" (unspecified if ongoing); "smoker" (unspecified if ongoing); "Iron deficiency" (unspecified if ongoing), notes: not yet clarified, but suspected. The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1 (batch number unknown)), for COVID-19 immunisation; Comirnaty (dose 2 (batch number unknown)), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; VACCINATION SITE ERYTHEMA (medically significant), VACCINATION SITE SWELLING (medically significant) all with onset 18Nov2021, outcome "recovering" and all described as "Swelling and redness"; HEADACHE (medically significant) with onset 17Nov2021, outcome "recovered" (22Nov2021), described as "Headache"; MYALGIA (medically significant) with onset 17Nov2021, outcome "recovered" (20Nov2021), described as "Myalgia"; TACHYPNOEA (medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "rapid superficial respiration". Source of assessment: SM, Method of assessment: regulatory authority Assessment, Drug result: Probable/Likely. The case is serious and unlabelled. Due to temporal relationship and the known safety profile of the vaccine, the causality is assessed as probable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1933655 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-11-17
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: PCR test positive; Test Result: Positive
CDC Split Type: CZPFIZER INC202101657787

Write-up: mild symptoms of cold; Vaccination Failure; PCR test positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient. An 18 year-old male patient received bnt162b2 (COMIRNATY), administration date 25Jun2021 (Batch/Lot number: unknown) as DOSE 2, SINGLE and administration date 04Jun2021 (Batch/Lot number: unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient did not diagnose with COVID-19. The following information was reported: VACCINATION FAILURE (medically significant) with onset 17Nov2021, outcome "recovering", described as "Vaccination Failure"; COVID-19 (medically significant) with onset 17Nov2021, outcome "recovering", described as "PCR test positive"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "mild symptoms of cold". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1933697 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-11-17
   Days after vaccination:174
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D014A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101665667

Write-up: myocardial infarction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): 102294 (Biontech). A 78 year-old male patient received bnt162b2 (COMIRNATY), administration date 27May2021 (Lot number: 1D014A) 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, lot number: EX3599), administration date: 28Apr2021, for COVID-19 immunisation. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 17Nov2021, outcome "unknown", described as "myocardial infarction". Therapeutic measures were taken as a result of myocardial infarction. Treated by HCP. BNT162B2 is under agreement with Biontech.


VAERS ID: 1933989 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response e.g. immunodef); Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20211010; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654372

Write-up: extremely fatigued; Headache; the patient received a third/booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111231138177330-1XO7N (MHRA). Other Case identifier(s): GB-MHRA-ADR 26237998 (MHRA). A 48 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response e.g. immunodef; "Type 1 Diabetes" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "the patient received a third/booster dose"; HEADACHE (medically significant) with onset 22Nov2021, outcome "recovered" (23Nov2021), described as "Headache"; FATIGUE (medically significant), outcome "unknown", described as "extremely fatigued". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Oct2021) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of headache took ibuprofen. Clinical course: Sharp pain in right frontal lobe unlike any headache experienced previously. Which symptoms were relieved but next day extremely fatigued. There was no report related to possible inflammation of the heart (myocarditis or pericarditis). Patient not had tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1934051 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deafness, Immunisation, Interchange of vaccine products, Off label use, Tinnitus
SMQs:, Hearing impairment (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clot blood; Pulmonary embolism
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101670794

Write-up: This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111252040504960-TND4R. Other Case identifier(s): GB-MHRA-ADR 26253647. A 65 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clot blood" (unspecified if ongoing); "Pulmonary embolism" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE,Lot Number: UNKNOWN, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, SINGLELot Number: UNKNOWN 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), IMMUNISATION (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "patient received third (booster) dose of BNT162b2/previously received two doses of COVID-19 vaccine, at least one is non-Pfizer COVID-19 Vaccine"; DEAFNESS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Intermittent deafness in both ears"; TINNITUS (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Tinnitus". The week after injection, patient still got intermittent deafness and slight tinnitus. The patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient had not tested positive for COVID-19 since having had the vaccine. The patient was not enrolled in clinical trial. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1934108 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Headache, Myalgia, Nausea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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.MOD20213

Write-up: stomach pain; Stomach ache; Nausea; Headache; Muscle pain; Joint pain; Chills; Tiredness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26262437) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL PAIN UPPER (Stomach ache), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Tiredness) in a 55-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) (seriousness criterion medically significant). On 19-Nov-2021, ABDOMINAL PAIN UPPER (Stomach ache), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Tiredness) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication information provided No treatment medication information provided. Within two and a half hours nausea, stomach pain, headache, muscle pain, joint pain and chills Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. It was reported that the report is not related to possible inflammation of the heart (myocarditis or pericarditis). Company comment This case concerns a 55-year-old female patient with no relevant medical history reported, who experienced the serious unexpected events of Abdominal pain upper, nausea, headache, myalgia, arthralgia, chills, fatigue. The events occurred the same day after the third dose of mRNA-1273 and most of them recovered. The rechallenge is unknown, according to SD. 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 55-year-old female patient with no relevant medical history reported, who experienced the serious unexpected events of Abdominal pain upper, nausea, headache, myalgia, arthralgia, chills, fatigue. The events occurred the same day after the third dose of mRNA-1273 and most of them recovered. The rechallenge is unknown, according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1934125 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER PW40167 / 3 - / -
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER UNK / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Illness, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Osteoporosis; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr); Comments: RA, allergies, Osteoporosis Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211130; Test Name: COVID-19 virus test; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: GBGLAXOSMITHKLINEGB202124

Write-up: hours; vomiting; nausea; fatigue; diarrhea; Sickness; Case received by GSK via on 2nd December 2021: This case was reported by a consumer via regulatory authority and described the occurrence of spaced out in a 65-year-old female patient who received DTPa-IPV (DTPa-IPV) for prophylaxis. Co-suspect products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (batch number PW40167, expiry date unknown) for prophylaxis. Previously administered products included COVID-19 VACCINE ASTRAZENECA (dose received on 30th January 2021). Concurrent medical conditions included osteoporosis, clinical trial participant and rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr). Additional patient notes included RA, allergies, Osteoporosis Patient has not had symptoms associated with COVID-19. On an unknown date, the patient received DTPa-IPV (unknown). On 17th November 2021, the patient received the 3rd dose of COVID-19 VACCINE ASTRAZENECA (unknown). On 17th November 2021, unknown after receiving DTPa-IPV, the patient experienced sickness (serious criteria other: Serious as per reporter). On an unknown date, the patient experienced spaced out (serious criteria other: Serious as per reporter), vomiting (serious criteria other: Serious as per reporter), nausea (serious criteria other: Serious as per reporter), fatigue (serious criteria other: Serious as per reporter) and diarrhea (serious criteria other: Serious as per reporter). On an unknown date, the outcome of the spaced out, vomiting, nausea, fatigue and diarrhea were recovering/resolving and the outcome of the sickness was not recovered/not resolved. It was unknown if the reporter considered the spaced out, vomiting, nausea, fatigue, diarrhea and sickness to be related to DTPa-IPV. Additional details were reported as follows: The age at vaccination was unknown. On 30th November 2021, Covid 19 test was performed and result was reported as negative. In November 2021, unknown after receiving DTPa-IPV, the patient experienced spaced out, vomiting, booster, nausea, fatigue and diarrhea. On 17th November 2021, less than a day after receiving COVID-19 VACCINE ASTRAZENECA, the patient experienced sickness. In November 2021, less than 2 weeks after receiving COVID-19 VACCINE ASTRAZENECA, the patient experienced spaced out, booster and fatigue. In November 2021, 3 hours after receiving COVID-19 VACCINE ASTRAZENECA, the patient experienced vomiting, nausea and diarrhea. It was unknown if the reporter considered the spaced out, vomiting, booster, nausea, fatigue, diarrhea and sickness to be related to COVID-19 VACCINE ASTRAZENECA. Note: TTO for COVID-19 VACCINE ASTRAZENECA was reported as 1 day however it was captured as less than a day as per vaccination date. The event was reported as Booster, however Booster should not be considered as an adverse event. Hence it was retained in narrative only Initial information received from consumer via regulatory authority on 2nd December 2021: Hours, vomiting, booster, nausea, fatigue, diarrhea and sickness. Case narrative: Vomiting 3 hours after vaccine booster, followed by diarrhoea and nausea. Loss of appetite and extreme fatigue. Still continuing 13 days after booster Patient has not tested positive for COVID-19 since having the vaccine Clinical trial participant Reaction Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "No"


VAERS ID: 1934133 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Immunisation, Joint stiffness, Pain in extremity
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADCAL D3; ALENDRONIC ACID; AMLODIPINE BESYLATE; ATORVASTATIN; FEXOFENADINE HYDROCHLORIDE; LANSOPRAZOLE; NAPROXEN; TAMSULOSIN HYDROCHLORIDE OD; PREDNISOLONE; VITAMIN D 3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure management; Cholesterol normal; Enlarged prostate; Osteoarthritis (Also re recent tests have Osteoarthritis.); Osteoporosis; Pain; Polymyalgia rheumatica (Blood test Doctor informed me suspected Polymyalgia Rheumatica.); Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Stomach ulcer; Swollen mouth
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Stiff joint; my top of arms and shoulders extremely sore especially my right side; my top of arms and shoulders extremely sore especially my right side; Booster; RA This is a solicited report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA) for a sponsored program. Regulatory number: RA-YCVM-202102172138395130 (RA). Other Case identifier(s): GB-RA-ADR 26243207 (RA). A 67 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH3220) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...; "en-larged prostate", start date: 21Apr2021 (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing), notes: Also re recent tests have Osteoarthritis.; "Osteoporosis" (unspecified if ongoing); "Blood pressure management" (unspecified if ongoing); "Cholesterol normal" (unspecified if ongoing); "Swollen mouth" (unspecified if ongoing); "Stomach ulcer" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Suspected Polymyalgia rheumatica" (unspecified if ongoing), notes: Blood test Doctor informed me suspected Polymyalgia Rheumatica. Concomitant medication(s) included: ADCAL D3 taken for osteoarthritis, start date: 28Jul2021; ALENDRONIC ACID taken for osteoporosis, start date: 28Jul2021; AMLODIPINE BESYLATE taken for blood pressure management, start date: 15May2019; ATORVASTATIN taken for blood cholesterol normal; FEXOFENADINE HYDROCHLORIDE taken for mouth swelling; LANSOPRAZOLE taken for gastric ulcer, start date: 05May2021, stop date: 20Sep2021; NAPROXEN taken for pain, start date: 05May2021, stop date: 15Sep2021; TAMSULOSIN HYDROCHLORIDE OD taken for prostatomegaly, start date: 23Oct2021; PREDNISOLONE taken for polymyalgia rheumatica, start date: 21Apr2021; VITAMIN D 3 taken for osteoarthritis, start date: 26Jul2021. Vaccination history included: Bnt162b2 (DOSE 1; Batch/lot number: EK4244), administration date: 12Feb2021, for COVID-19 immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; JOINT STIFFNESS (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Stiff joint"; ARTHRALGIA (medically significant), PAIN IN EXTREMITY (medically significant) all with onset 19Nov2021, outcome "not recovered" and all described as "my top of arms and shoulders extremely sore especially my right side". Clinical course: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. enlarged prostate on the21Apr2021 re blood test Doctor informed me suspected Polymyalgia Rheumatica Also re recent tests have Osteoarthritis. On the 19Nov2021 his top of arms and shoulders extremely sore especially his right side, to date cannot dress properly or drive a car as he cannot raise or use his right arm. Pain has eased as long as he does not use his right arm which he find it disabling. Patient was not enrolled in clinical trial. The reporters assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment."; Sender''s Comments: Based on the close temporal association, the relationship between the events arthralgia, joint stiffness and pain in extremity and the use of Suspect product BNT162b2 cannot be fully excluded. The event immunization is assessed in context of the event that occurred after the use of suspect product BNT162b2 Booster dose.


VAERS ID: 1934213 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0161 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Facial asymmetry, Headache, Immunisation, Investigation, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ZETIA; GLUCOPHAGE; TRAJENTA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Instrumental Test; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: ITPFIZER INC202101651655

Write-up: Booster; Headache; BUCCAL RHYME DEVIATION/ Facial asymmetry; Postural instability; Vision blurred; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-812024 (MINISAL02). A 40-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: FH0161) at the age of 40 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: ZETIA; GLUCOPHAGE; TRAJENTA. Vaccination history included: Comirnaty (Dose 1), for Covid-19 immunisation; Comirnaty (Dose 2), for Covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 17Nov2021, outcome "unknown", described as "Booster"; HEADACHE (hospitalization) with onset 17Nov2021, outcome "recovering", described as "Headache"; FACIAL ASYMMETRY (hospitalization) with onset 17Nov2021, outcome "recovering", described as "BUCCAL RHYME DEVIATION/ Facial asymmetry"; BALANCE DISORDER (hospitalization) with onset 17Nov2021, outcome "recovering", described as "Postural instability"; VISION BLURRED (hospitalization) with onset 17Nov2021, outcome "recovering", described as "Vision blurred". The events "headache", "buccal rhyme deviation/ facial asymmetry", "postural instability" and "vision blurred" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: unknown results. The patient was kept under observation at the short-term intensive care unit. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1934332 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 11/17/2021; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result: 210/120 mmHg; Comments: at 13:54.
CDC Split Type: PHPFIZER INC202101663174

Write-up: This is a spontaneous report received from a contactable healthcare professional, via the regulatory authority (PH-PHFDA-300119951). A 64-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# PCB0002), at the age of 64, intramuscularly, on Nov 17, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. The patient had increased blood pressure/elevated BP: 210/120 mmHg (medically significant), onset of Nov 17, 2021, at 13:54, with outcome of recovering. The patient underwent the following laboratory tests and procedures: Blood pressure measurement on Nov 17, 2021: 210/120 mmHg, at 13:54. No follow-up attempts possible. No further information expected.


VAERS ID: 1934335 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 11/17/2021; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result: 160/100 mmHg; Comments: at 14:25.
CDC Split Type: PHPFIZER INC202101663235

Write-up: This is a spontaneous report received from a contactable other HCP, via the regulatory authority (PH-PHFDA-300119994). A 52-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# PCB0002), at the age of 52, intramuscularly, on Nov 17, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. The patient had increased blood pressure/elevated BP: 160/100 (medically significant), onset Nov 17, 2021, at 14:25, with outcome of recovered (Nov 17, 2021). The patient underwent the following laboratory tests and procedures: Blood pressure measurement on Nov 17, 2021: 160/100 mmHg, notes: at 14:25. No follow-up attempts possible. No further information expected.


VAERS ID: 1934336 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:150/100 mmHg; Comments: 15:02
CDC Split Type: PHPFIZER INC202101663237

Write-up: ELEVATED BP (150/100); This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120007 (PHFDA). A 30 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: PCB0002) at the age of 30 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 17Nov2021 15:02, outcome "recovered" (17Nov2021), described as "ELEVATED BP (150/100)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (17Nov2021) 150/100 mmHg, notes: 15:02. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1935283 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2; COVID-19 MRNA VACCINE BNT162B2
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: fatigue; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26230107) on 29-Nov-2021 and was forwarded to Moderna on 29-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No medical history was provided by the reporter. . Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 15-Mar-2021 to an unknown date for COVID-19 vaccination, TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) for Vaccination. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (fatigue) (seriousness criterion medically significant). At the time of the report, FATIGUE (fatigue) and PYREXIA (Fever) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment medications were not reported. Company comment: This case concerns a 61-year-old female patient, with no relevant medical history reported, who experienced the serious unexpected events of FATIGUE and PYREXIA. The event PYREXIA occurred on the same day of the third dose of mRNA-1273, and the event FATIGUE occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is 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.; Sender''s Comments: This case concerns a 61-year-old female patient, with no relevant medical history reported, who experienced the serious unexpected events of FATIGUE and PYREXIA. The event PYREXIA occurred on the same day of the third dose of mRNA-1273, and the event FATIGUE occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is 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.


VAERS ID: 1936645 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Lymphadenopathy, Peripheral swelling, Thrombosis
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101649011

Write-up: Thrombosis; Chest pain; Lymphadenopathy; Peripheral swelling; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 668945 Regulatory Authority. A 48 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "not recovered", described as "Thrombosis"; CHEST PAIN (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Chest pain"; LYMPHADENOPATHY (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Lymphadenopathy"; PERIPHERAL SWELLING (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Peripheral swelling". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1936931 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: PCR; Test Result: Positive ; Comments: Ct 25.8
CDC Split Type: DEPFIZER INC202101684328

Write-up: PCR with a positive result; PCR with a positive result; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from License Party. The reporter is the patient. Other Case identifier(s): 102778 (Biontech). A male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: unknown) as dose 3 (booster), single, administration date Feb2021 (Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 23Nov2021, outcome "unknown" and all described as "PCR with a positive result". After mild symptoms, the patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Nov2021) positive, notes: cycle threshold (Ct) 25.8. Bnt162b2 (COMIRNATY) is under agreement with Biontech. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.


VAERS ID: 1937130 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-11-17
   Days after vaccination:99
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101703486

Write-up: Vaccination failure; SARS-CoV-2 test positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority. Regulatory number: FR-AFSSAPS-LL20217821 (RA). Other Case identifier(s): FR-AFSSAPS-2021159202 (RA). A 24 year-old female patient received bnt162b2 (COMIRNATY, Formulation: solution for injection), intramuscular, administration date 10Aug2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 19Jul2021 (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: VACCINATION FAILURE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 17Nov2021, outcome "unknown", described as "SARS-CoV-2 test positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1937243 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH 4651 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphagia, Immunisation, Interchange of vaccine products, Lymphadenopathy, Musculoskeletal stiffness, Off label use
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101661995

Write-up: Swollen lymph nodes; Swallowing difficult; Stiff neck; 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-APPCOVID-202111241920144930-4974T (RA). Other Case identifier(s): GB-MHRA-ADR 26246119 (RA). A 68-year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH 4651) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; INFLUENZA VIRUS taken for antiviral prophylaxis, administration date 17Oct2021. 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) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; MUSCULOSKELETAL STIFFNESS (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Stiff neck"; DYSPHAGIA (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Swallowing difficult"; LYMPHADENOPATHY (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Swollen lymph nodes". Clinical Course: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test and patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial and the report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1937257 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0112 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, Cough, Dry mouth, Gastric disorder, Joint stiffness, Mouth ulceration, Pain, Pain in extremity, Paraesthesia oral, Taste disorder
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEXOFENADINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fish allergy (Allergy to mussels); Latex allergy (Elastoplast)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101661712

Write-up: Joint stiffness; Taste disorder; Slight temperature but no fever; Mouth ulcers; dry mouth; tingly bottom lip; sore arm; general aches; cough; gastric disturbance; 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-EYC 00267237 (RA). Other Case identifier(s): GB-MHRA-ADR 26239951 (RA). A 64 year-old female patient received bnt162b2 (COMIRNATY), parenteral, administration date 17Nov2021 (Lot number: FK0112) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rubber sensitivity" (unknown if ongoing), notes: Elastoplast; "Food allergy" (unknown if ongoing), notes: Allergy to mussels. Concomitant medication(s) included: FEXOFENADINE HYDROCHLORIDE. Past drug history included: Hepatitis vaccine unspecified. The following information was reported: MOUTH ULCERATION (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Mouth ulcers"; DRY MOUTH (medically significant) with onset 17Nov2021, outcome "not recovered", described as "dry mouth"; PARAESTHESIA ORAL (medically significant) with onset 17Nov2021, outcome "not recovered", described as "tingly bottom lip"; PAIN IN EXTREMITY (medically significant) with onset 17Nov2021, outcome "not recovered", described as "sore arm"; PAIN (medically significant) with onset 17Nov2021, outcome "not recovered", described as "general aches"; COUGH (medically significant) with onset 17Nov2021, outcome "not recovered", described as "cough"; GASTRIC DISORDER (medically significant) with onset 17Nov2021, outcome "not recovered", described as "gastric disturbance"; JOINT STIFFNESS (medically significant), outcome "unknown", described as "Joint stiffness"; TASTE DISORDER (medically significant), outcome "unknown", described as "Taste disorder"; BODY TEMPERATURE INCREASED (medically significant), outcome "unknown", described as "Slight temperature but no fever". Clinical course: Mouth became dry approx 6 hours after receiving vaccination. Mouth ulcers developed in lower mouth. Lower lip tingling and feels swollen. Altered taste. Gastric disturbance mucus. Cough. Slight temperature but no fever. General aches & stiff joints. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1937270 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

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

Write-up: PV bleeding since the vaccination; This case was received via Regulatory Authority on 02-Dec-2021 and was forwarded to Moderna on 02-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (PV bleeding since the vaccination) in a 55-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 immunisation. Co-suspect product included non-company product TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) for COVID-19 immunisation.Concurrent medical conditions included Postmenopause. Concomitant products included METFORMIN HYDROCHLORIDE (SUKKARTO) and LEVOTHYROXINE for an unknown indication. On 15-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) (unknown route) 1 dosage form. On an unknown date, TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced VAGINAL HAEMORRHAGE (PV bleeding since the vaccination) (seriousness criterion medically significant). At the time of the report, VAGINAL HAEMORRHAGE (PV bleeding since the vaccination) had not resolved. No treatment medications were reported. Company comment: This is a regulatory authority case concerning a 55-year-old, female patient with medical history of being post menopause, who experienced the unexpected serious (medically significant) event of vaginal bleeding. The event occurred approximately 2 days after the third dose of mRNA 1273 vaccine. Patient was priory vaccinated with two primary doses of Tozinameran and the event also occurred after both of these vaccinations. The bleeding was investigated, and no clear cause was found. The rechallenge is reported as unknown. The vaccine Tozinameran remains a co suspect for the event.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 55-year-old, female patient with medical history of being post menopause, who experienced the unexpected serious (medically significant) event of vaginal bleeding. The event occurred approximately 2 days after the third dose of mRNA 1273 vaccine. Patient was priory vaccinated with two primary doses of Tozinameran and the event also occurred after both of these vaccinations. The bleeding was investigated, and no clear cause was found. The rechallenge is reported as unknown. The vaccine Tozinameran remains a co suspect for the event.The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 1937288 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Fatigue, Pain, Vertigo
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular 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: CINNARIZINE; CLARITHROMYCIN; FENBID [FLURBIPROFEN]; FLUCLOXACILLIN; OLMESARTAN MEDOXOMIL; SIMVASTATIN; TRAMADOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101661526

Write-up: Vertigo; fatigue; acheing; dizziness; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-TPP37311561C9757703YC1637163241346 (RA). Other Case identifier(s): GB-MHRA-ADR 26239944 (RA). A 44 year-old male patient received bnt162b2 (BNT162B2), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: CINNARIZINE, start date: 17Nov2021; CLARITHROMYCIN, start date: 11Oct2021, stop date: 18Oct2021; FENBID [FLURBIPROFEN], start date: 17Nov2021; FLUCLOXACILLIN, start date: 06Oct2021, stop date: 13Oct2021; OLMESARTAN MEDOXOMIL, start date: 30Mar2021; SIMVASTATIN, start date: 30Mar2021; TRAMADOL, start date: 30Mar2021. The following information was reported: FATIGUE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "fatigue"; PAIN (medically significant) with onset 17Nov2021, outcome "not recovered", described as "acheing"; DIZZINESS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "dizziness"; DYSPNOEA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Shortness of breath"; VERTIGO (medically significant), outcome "unknown", described as "Vertigo". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1937314 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6431 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye pain, Headache, Immunisation, Myalgia, SARS-CoV-2 test, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101659170

Write-up: Sore eye; Blurred vision; Headache NOS; patient received the 3rd dose of COMIRNATY; Generalised muscle aches; This is a spontaneous report received from contactable reporters (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111191520365590-OV4MZ. Other Case identifier(s): GB-MHRA-ADR 26228171. A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FG6431) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 16Nov2021 (ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation, reaction: "Suspected COVID-19"; Bnt162b2 (DOSE 2), for COVID-19 immunisation, reaction: "Suspected COVID-19". Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "patient received the 3rd dose of COMIRNATY"; EYE PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Sore eye"; VISION BLURRED (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Blurred vision"; MYALGIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Generalised muscle aches"; HEADACHE (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Headache NOS". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Nov2021) no - negative covid-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1937349 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Hearing impairment (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101661688

Write-up: Palsy Bells; first dose administered on 07Sep2021/second dose administered on 17Nov2021; 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-202111240821409870-ILIAI. Other Case identifier(s): GB-MHRA-ADR 26241801. A 24 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), solution for injection, administration date 17Nov2021 (Lot number: Fh4751) at the age of 24 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), administration date: 07Sep2021, for covid-19 immunization. Went to A&E and was prescribed steroids and eye drops. The following information was reported: BELL''S PALSY (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Palsy Bells"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "first dose administered on 07Sep2021/second dose administered on 17Nov2021". The event "palsy bells" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of bell''s palsy. Clinical course: Patient has not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1937360 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FHU751 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anosmia, Body temperature, Eye swelling, Headache, Ocular hyperaemia, Oropharyngeal pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20191117; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20211117; Test Name: temperature; Result Unstructured Data: Test Result:high
CDC Split Type: GBPFIZER INC202101661608

Write-up: Eyes swollen; Red eye; High temperature; Sore throat; Runny nose; Loss of smell; Headache; 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-202111240925066420-FBQDO (RA). Other Case identifier(s): GB-MHRA-ADR 26242329 (RA). A 13 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FHU751) at the age of 13 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The following information was reported: PYREXIA (medically significant) with onset 17Nov2021, outcome "recovered" (20Nov2021), described as "High temperature"; OROPHARYNGEAL PAIN (medically significant) with onset 17Nov2021, outcome "recovering", described as "Sore throat"; RHINORRHOEA (medically significant) with onset 17Nov2021, outcome "recovering", described as "Runny nose"; ANOSMIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Loss of smell"; HEADACHE (medically significant) with onset 17Nov2021, outcome "recovered" (21Nov2021), described as "Headache"; EYE SWELLING (medically significant) with onset 19Nov2021, outcome "recovering", described as "Eyes swollen"; OCULAR HYPERAEMIA (medically significant) with onset 19Nov2021, outcome "recovering", described as "Red eye". The events "high temperature", "sore throat", "runny nose", "loss of smell", "headache", "eyes swollen" and "red eye" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2019) negative, notes: No - Negative COVID-19 test; body temperature: (17Nov2021) high. Therapeutic measures were taken as a result of pyrexia, oropharyngeal pain, rhinorrhoea, anosmia, headache, eye swelling, ocular hyperaemia. Clinical course: Symptoms worsened every day, contacted GP, Loratidine syrup prescribed, continues with treatment. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1937430 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5475 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Arthritis, Back pain, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Arthritis (narrow), Medication errors (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Knee injury; Pelvic inflammatory disease; Wrist surgery
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101661524

Write-up: back pain; Multiple painful joints; Joint swelling inflammatory; received the third dose; receivd 1st and 2nd dose of COVID-19 vaccine (Manufacturer Unknown) / received the third dose; received the third dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202111241613287700-OCIJ8 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26245105 (MHRA). A 62 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: FK5475) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Joint injury", start date: May2021 (unknown if ongoing); "Surgery to wrist", start date: 2020 (unknown if ongoing); "PID lumbar region" (unknown if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary Immunization series complete but MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, Primary Immunization series complete but MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "received the third dose"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "receivd 1st and 2nd dose of COVID-19 vaccine (Manufacturer Unknown) / received the third dose"; BACK PAIN (medically significant), outcome "not recovered", described as "back pain"; ARTHRALGIA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Multiple painful joints"; ARTHRITIS (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Joint swelling inflammatory". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of back pain, arthralgia, arthritis. Addition information: Patient has not had symptoms associated with COVID-19. Treatment was received included paracetamol. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report as not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1937477 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Intermenstrual bleeding, Off label use, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101662055

Write-up: Off-label use; Interchange of vaccine products; Booster; Spotting menstrual; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111241950248820-BJFSF (MHRA). Other Case identifier(s): GB-MHRA-ADR 26246169 (MHRA). A 51 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 51 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 astrazeneca (Dose 1), administration date: 13Mar2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), administration date: 15May2021, for COVID-19 immunisation. Patient had not had symptoms associated with COVID-19. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; INTERMENSTRUAL BLEEDING (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Spotting menstrual". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Started to bleed within 5 hours of having the booster having not had a bleed for 6 months. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was 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: 1937531 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Fatigue, Headache, Immunisation, Interchange of vaccine products, Off label use, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101661940

Write-up: Sore throat NOS; Dry cough; Headache; Fatigue; 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 United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202111250653017300-AYGDG (MHRA). Other Case identifier(s): GB-MHRA-ADR 26247931 (MHRA). A 51 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (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 2, SINGLE, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; OROPHARYNGEAL PAIN (medically significant), outcome "recovered", described as "Sore throat NOS"; COUGH (medically significant), outcome "not recovered", described as "Dry cough"; HEADACHE (medically significant), outcome "recovering", described as "Headache"; FATIGUE (medically significant), outcome "not recovered", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient had not symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Her report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1937533 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-04
Onset:2021-11-17
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Contusion, Erythema, Haematemesis, Haemorrhage, Immune thrombocytopenia, Platelet count decreased
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Gastrointestinal haemorrhage (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response); Liver transplant
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:very low platelets
CDC Split Type: GBPFIZER INC202101661856

Write-up: low platelets; lots of mouth ulcers; Covered in small bruise; Small cut bled profusely; Immune thrombocytopenic purpura; Vomiting blood; This is a spontaneous report received from a contactable reporter from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111250728458820-IAD52. Other Case identifier(s): GB-MHRA-ADR 26248036. A 15 year-old male patient received bnt162b2, administration date 04Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Liver transplant" (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The following information was reported: PLATELET COUNT DECREASED (hospitalization), outcome "not recovered", described as "low platelets"; ERYTHEMA (hospitalization), outcome "not recovered", described as "lots of mouth ulcers"; IMMUNE THROMBOCYTOPENIA (hospitalization) with onset 20Nov2021, outcome "not recovered", described as "Immune thrombocytopenic purpura"; HAEMATEMESIS (hospitalization) with onset 17Nov2021, outcome "recovered" (22Nov2021), described as "Vomiting blood"; CONTUSION (hospitalization), outcome "unknown", described as "Covered in small bruise"; HAEMORRHAGE (hospitalization), outcome "unknown", described as "Small cut bled profusely". All events were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: very low platelets. Therapeutic measures were taken as a result of platelet count decreased, erythema, immune thrombocytopenia, haematemesis, contusion, haemorrhage. Clinical course: Covered in small bruise. Lots of mouth ulcers. Small cut bled profusely and took a very long time to stop. Went to ER and had a blood test which came back with very low platelets. Needed to have IV immune booster. Awaiting ultrasound and further tests. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1937564 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Immunisation, Menstruation irregular, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101670405

Write-up: 1 week after my vaccine i started bleeding; Irregular periods; 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-202111251358062940-JW2JK (RA). Other Case identifier(s): GB-MHRA-ADR 26252742 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Patient has not had symptoms associated with COVID-19. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation. 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 17Nov2021, outcome "unknown", described as "Booster"; HAEMORRHAGE (medically significant), outcome "not recovered", described as "1 week after my vaccine i started bleeding"; MENSTRUATION IRREGULAR (non-serious) with onset 25Nov2021, outcome "not recovered", described as "Irregular periods". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: 1 week after vaccine patient started bleeding, she assumed a period induced by the vaccine because she had only started a period 2 weeks previously. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1937567 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Dysstasia, Fall, Gait inability, Immunisation, Interchange of vaccine products, Loss of control of legs, Off label use, Pain in extremity, SARS-CoV-2 test, Sitting disability
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), 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: ALLOPURINOL; CYCLIZINE; GABAPENTIN; IBUPROFEN; OMEPRAZOL; PARACETAMOL; RAMIPRIL; SIMVASTATIN; TADALAFIL; TESTOSTERONE; VITAMIN D [VITAMIN D NOS]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101670726

Write-up: Sitting disability; Loss of energy; Loss of control of legs; Unable to walk; 3rd dose was administered, and the patient has not previously received the full primary immunization series of BNT162B2 vaccination; 3rd dose was administered, and the patient has not previously received the full primary immunization series of BNT162B2 vaccination; 3rd dose was administered, and the patient has not previously received the full primary immunization series of BNT162B2 vaccination; started with sore arm that went across shoulders into other arm; sore arm; fell onto the floor; unable to stand; This is a spontaneous report received from a contactable consumer from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111251420356040-URHGS. Other Case identifier(s): GB-MHRA-ADR 26252845. A 71-year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK0596) at the age of 71-years-old as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Patient has not had symptoms associated with COVID-19. Concomitant medication(s) included: INFLUENZA VIRUS, administration date 27Sep2021; ALLOPURINOL; CYCLIZINE; GABAPENTIN; IBUPROFEN; OMEPRAZOL; PARACETAMOL; RAMIPRIL; SIMVASTATIN; TADALAFIL; TESTOSTERONE; VITAMIN D [VITAMIN D NOS]. Vaccination history included: COVID-19 vaccine astrazeneca (Dose 1), administration date: 04Feb2021, for COVID-19 immunisation; COVID-19 vaccine astrazeneca (Dose 2), administration date: 23Apr2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "3rd dose was administered, and the patient has not previously received the full primary immunization series of BNT162B2 vaccination"; ASTHENIA (medically significant) with onset 19Nov2021, outcome "recovering", described as "Loss of energy"; LOSS OF CONTROL OF LEGS (medically significant) with onset 19Nov2021, outcome "recovering", described as "Loss of control of legs"; GAIT INABILITY (medically significant) with onset 19Nov2021, outcome "recovered" (2021), described as "Unable to walk"; SITTING DISABILITY (medically significant) with onset 21Nov2021, outcome "recovered" (2021), described as "Sitting disability"; ARTHRALGIA (medically significant) with onset 2021, outcome "recovering", described as "started with sore arm that went across shoulders into other arm"; PAIN IN EXTREMITY (medically significant) with onset 2021, outcome "recovering", described as "sore arm"; FALL (medically significant) with onset 2021, outcome "unknown", described as "fell onto the floor"; DYSSTASIA (medically significant) with onset 2021, outcome "unknown", described as "unable to stand". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Apr2021) yes - positive COVID-19 test. Clinical course: Started with sore arm that went across shoulders into other arm, then when in bed at 3.15am tried to get out of bed and fell onto the floor was unable to stand or sit up without help, managed to get to where he could pull himself up off floor but then couldn''t walk, with help finally got back onto the bed until the morning, tried having a shower but fell over in shower cubicle, had problem walking properly for the rest of the day, still a bit unstable now. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1937570 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101670724

Write-up: Headache; patient received third dose of BNT162b2 on 17Nov2021; patient received third dose of BNT162b2 on 17Nov2021; patient received third dose of BNT162b2 on 17Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the regulatory authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202111251445436880-GWFEF (RA). Other Case identifier(s): GB-MHRA-ADR 26252847 (RA). A 66 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH3220) 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, 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. Patient had no symptoms associated with COVID-19, nor had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "patient received third dose of BNT162b2 on 17Nov2021"; HEADACHE (medically significant) with onset 18Nov2021, outcome "recovered" (22Nov2021), described as "Headache". No follow up attempts are possible. No further information is expected.


VAERS ID: 1937678 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Dizziness, Dyspnoea, Faeces discoloured, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Noninfectious diarrhoea (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: LISINOPRIL; MONTELUKAST; PREGABALIN; TRELEGY
Current Illness:
Preexisting Conditions: Comments: No medical history was reported by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Black stools; Abdominal pain; Dizziness; Increased shortness of breath; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26263344) on 29-Nov-2021 and was forwarded to Moderna on 29-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal pain), FAECES DISCOLOURED (Black stools) and DYSPNOEA (Increased shortness of breath) in a 72-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. No medical history was reported by the reporter. Concomitant products included MONTELUKAST for Asthma, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for COPD, LISINOPRIL for Hypertension, PREGABALIN for Prurigo nodularis. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant) and DYSPNOEA (Increased shortness of breath) (seriousness criterion medically significant). On 19-Nov-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced FAECES DISCOLOURED (Black stools) (seriousness criterion medically significant). On 22-Nov-2021, DIZZINESS (Dizziness) had resolved. On 25-Nov-2021, ABDOMINAL PAIN (Abdominal pain) and FAECES DISCOLOURED (Black stools) had resolved. At the time of the report, DYSPNOEA (Increased shortness of breath) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-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 information was not provided by the reporter. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company Comment This case concerns a 72-year-old, female patient with relevant medical history of hypertension, who experienced the unexpected events of dizziness, abdominal pain, faeces decoloured and dyspnoea. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. 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 meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 72-year-old, female patient with relevant medical history of hypertension, who experienced the unexpected events of dizziness, abdominal pain, faeces decoloured and dyspnoea. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. 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 meet the criteria to be medically significant.


VAERS ID: 1938132 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCA0008 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101663134

Write-up: Fainting; This is a spontaneous report received from a contactable reporter (other healthcare professional) from Regulatory Authority. Regulatory number: PH-PHFDA-300119938 (RA). A 17-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: PCA0008) at the age of 17 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. On 17Nov2021 (10:45), the patient experienced fainting. The outcome of event was recovered on 17Nov2021 (11:45). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1938134 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:170/100 mmHg; Comments: 13:27
CDC Split Type: PHPFIZER INC202101663136

Write-up: ELEVATED BP(170/100); Dizziness; DIFFICULTY OF BREATHING; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300119947 (PHFDA). A 40-year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: PCB0002) at the age of 40 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 17Nov2021 13:27, outcome "recovered" (17Nov2021), described as "ELEVATED BP(170/100)"; DIZZINESS (non-serious) with onset 17Nov2021 13:27, outcome "recovered" (17Nov2021), described as "Dizziness"; DYSPNOEA (non-serious) with onset 17Nov2021 13:27, outcome "recovered" (17Nov2021), described as "DIFFICULTY OF BREATHING". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (17Nov2021) 170/100 mmHg, notes: 13:27. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1938135 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:160/100 mmHg; Comments: 13:52
CDC Split Type: PHPFIZER INC202101663144

Write-up: "ELEVATED BP(160/100); This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300119964 (RA). A 34-year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: PCB0002) at the age of 34 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 17Nov2021 13:52, outcome "recovered" (17Nov2021), described as ""ELEVATED BP(160/100)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (17Nov2021) 160/100 mmHg, notes: 13:52.


VAERS ID: 1938136 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32025BD / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Hunger, Loss of consciousness, Pallor, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101663165

Write-up: Near fainting; blocking out; Dizziness; Pale; Minor headache; Hungry; This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300119887 (RA). A 17-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: 32025BD) at the age of 17 years as single dose for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: PRESYNCOPE (medically significant) with onset 17Nov2021 10:25, outcome "recovered" (17Nov2021 11:00), described as "Near fainting"; LOSS OF CONSCIOUSNESS (medically significant) with onset 17Nov2021, outcome "recovering", described as "blocking out"; DIZZINESS (non-serious) with onset 17Nov2021, outcome "recovering", described as "Dizziness"; PALLOR (non-serious) with onset 17Nov2021, outcome "unknown", described as "Pale"; HEADACHE (non-serious) with onset 17Nov2021, outcome "unknown", described as "Minor headache"; HUNGER (non-serious) with onset 17Nov2021, outcome "unknown", described as "Hungry". Therapeutic measures were taken as a result of headache and included treatment with paracetamol 500 mg tab. Clinical course: 20 minutes post innoculation, patient was seen sitting and complained of blocking out and dizziness. Patent was carried to (monitoring) area via wheelchair and was placed on bed via high fowlers position. Patient was conscious, pale and verbalized that she was getting better. Paracetamol 500 mg tab was given due to minor headache. Patient was monitored for 30 minutes and was discharged thereafter after verbalizing she was well and able to walk and was also hungry. Instructions was given to both patient and guardian. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1938139 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Diplopia, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Ocular motility disorders (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101663193

Write-up: Doubling of vision; Chest heaviness; Urticaria; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120078 (RA). A 15 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: PCB0002) at the age of 15 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: DIPLOPIA (medically significant) with onset 17Nov2021 16:00, outcome "recovered" (17Nov2021 19:24), described as "Doubling of vision"; CHEST DISCOMFORT (medically significant) with onset 17Nov2021 16:00, outcome "recovered" (17Nov2021 19:24), described as "Chest heaviness"; URTICARIA (medically significant) with onset 17Nov2021 16:00, outcome "recovered" (17Nov2021 19:24), described as "Urticaria". No follow-up attempts are needed. No further information is expected.


VAERS ID: 1938145 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 310608D / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101663217

Write-up: Loss of consciousness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300119998 (RA). A 14 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: 310608D) at the age of 14 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: LOSS OF CONSCIOUSNESS (medically significant) with onset 17Nov2021, outcome "recovered", described as "Loss of consciousness".


VAERS ID: 1938146 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:170/120 mmHg; Comments: 14:18
CDC Split Type: PHPFIZER INC202101663223

Write-up: ELEVATED BP(170/120); This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300119992 (PHFDA). A 28 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: PCB0002) at the age of 28 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 17Nov2021 14:18, outcome "recovered" (17Nov2021), described as "ELEVATED BP(170/120)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (17Nov2021) 170/120 mmHg, notes: 14:18. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1938147 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:140/100 mmHg; Comments: 14:40
CDC Split Type: PHPFIZER INC202101663224

Write-up: "ELEVATED BP (140/100); This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300119999 (PHFDA). A 52 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: PCB0002) at the age of 52 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 17Nov2021 14:40, outcome "recovered" (17Nov2021), described as ""ELEVATED BP (140/100)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (17Nov2021) 140/100 mmHg, notes: 14:40. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1938149 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8847 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Nasopharyngitis, Nausea, Pyrexia, Seizure, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), 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:
CDC Split Type: PHPFIZER INC202101663230

Write-up: Nausea; Vomiting; Seizure; Colds; Body malaise; Fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120041 RA). A 18 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: FF8847) at the age of 18 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: SEIZURE (medically significant) with onset 17Nov2021 06:00, outcome "recovered" (17Nov2021 07:03), described as "Seizure"; NASOPHARYNGITIS (non-serious) with onset 17Nov2021 06:00, outcome "recovering", described as "Colds"; MALAISE (non-serious) with onset 17Nov2021 06:00, outcome "recovering", described as "Body malaise"; PYREXIA (non-serious) with onset 17Nov2021 06:00, outcome "recovering", described as "Fever"; NAUSEA (non-serious) with onset 17Nov2021 07:00, outcome "unknown", described as "Nausea"; VOMITING (non-serious) with onset 17Nov2021 07:00, outcome "unknown", described as "Vomiting". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1938170 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 321558A / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Blood pressure; Result Unstructured Data: Test Result:150/100 mmHg; Comments: 13:30
CDC Split Type: PHPFIZER INC202101663579

Write-up: Elevated BP; This is a spontaneous report received from a contactable Other Health Professional from Regulatory Authority. Regulatory number: PH-PHFDA-300120637 (PHFDA). A 17 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: 321558A) at the age of 17 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 17Nov2021 13:30, outcome "recovered" (17Nov2021 17:30), described as "Elevated BP". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (17Nov2021) 150/100 mmHg, notes: 13:30.


VAERS ID: 1938179 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32021BD / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101663740

Write-up: Fainting; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120929 (PHFDA). A 16 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: 32021BD) at the age of 16 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 17Nov2021 12:30, outcome "recovered", described as "Fainting"; DIZZINESS (non-serious) with onset 17Nov2021 12:30, outcome "recovered", described as "Dizziness".


VAERS ID: 1938180 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 321558A / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Blood pressure; Result Unstructured Data: Test Result:150/100
CDC Split Type: PHPFIZER INC202101663741

Write-up: Elevated BP; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120937 (PHFDA). A 18 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: 321558A) at the age of 18 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 17Nov2021 10:00, outcome "recovered" (19Nov2021 08:00), described as "Elevated BP". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (17Nov2021) 150/100.


VAERS ID: 1938181 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0004 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101663757

Write-up: Fainting; This is a spontaneous report received from a contactable other hcp from Regulatory Authority. Regulatory number: PH-PHFDA-300121325 (PHFDA). A 13-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: PCB0004) at the age of 13 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: SYNCOPE (medically significant) with onset 17Nov2021 03:10, outcome "recovered" (17Nov2021 04:00), described as "Fainting". No follow-up attempts are possible. No further information expected.


VAERS ID: 1938257 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3: 023F21A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: FACIAL SWELLING CONTRIBUTED TO BREATHING DIFFICULTIES; SEVERE SWELLING OF ENTIRE FACE; This case was received via Agency (Reference number: SE-MPA-2021-094222) on 30-Nov-2021 and was forwarded to Moderna on 30-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (FACIAL SWELLING CONTRIBUTED TO BREATHING DIFFICULTIES) and SWELLING FACE (SEVERE SWELLING OF ENTIRE FACE) in a 47-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3: 023F21A) for an unknown indication. No Medical History information was reported. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced DYSPNOEA (FACIAL SWELLING CONTRIBUTED TO BREATHING DIFFICULTIES) (seriousness criterion medically significant) and SWELLING FACE (SEVERE SWELLING OF ENTIRE FACE) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (FACIAL SWELLING CONTRIBUTED TO BREATHING DIFFICULTIES) and SWELLING FACE (SEVERE SWELLING OF ENTIRE FACE) was resolving. No concomitant medications were reported No treatment medications were reported Company comment: This is a regulatory authority case concerning a 47-year-old female patient with no medical history reported, who experienced unexpected events of Dyspnoea and swelling face. The events occurred 2 days after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Translated document was received on 03-Dec-2021. Event verbatim was updated.; Sender''s Comments: This is a regulatory authority case concerning a 47-year-old female patient with no medical history reported, who experienced unexpected events of Dyspnoea and swelling face. The events occurred 2 days after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1938974 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-11-17
   Days after vaccination:261
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER PV46669 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Headache, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Comments: No medical history was reported by the reporter
Allergies:
Diagnostic Lab Data: Test Date: 20200907; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Cough; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26273420) on 02-Dec-2021 and was forwarded to Moderna on 02-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and COUGH (Cough) in a 62-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. No medical history was reported by the reporter. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) for an unknown indication. On 01-Mar-2021, the patient received dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 20-May-2021, received dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced COUGH (Cough) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) and COUGH (Cough) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2020, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment medication information was not provided by the reporter. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient not had symptoms associated with COVID-19. Company comment This case concerns a 62-year-old male patient with no relevant medical history reported, who experienced the serious unexpected events of headache and cough. The event headache occurred on the next day after the third dose of mRNA-1273 (previously received 2 doses of AstraZeneca). The event cough occurred approximately 2 days after the third dose of mRNA-1273. The events are recovering. The rechallenge is unknown according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 62-year-old male patient with no relevant medical history reported, who experienced the serious unexpected events of headache and cough. The event headache occurred on the next day after the third dose of mRNA-1273 (previously received 2 doses of AstraZeneca). The event cough occurred approximately 2 days after the third dose of mRNA-1273. The events are recovering. The rechallenge is unknown according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1939192 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-05
Onset:2021-11-17
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Depression, Hyperhidrosis, Myalgia, Restlessness
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Tendinopathies and ligament disorders (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: Medical History/Concurrent Conditions: Lyme borreliosis (Lyme Borreliose)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101665286

Write-up: Restlessness; Sweating attack; Generalised muscle aches; Anxiety state; Depression; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: AT-BASGAGES-2021-062381 (RA). A 49 year-old male patient received bnt162b2 (COMIRNATY), administration date 05Nov2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme borreliosis" (unknown if ongoing), notes: Lyme Borreliose. The patient''s concomitant medications were not reported. The following information was reported: RESTLESSNESS (medically significant) with onset 17Nov2021, outcome "recovered", described as "Restlessness"; HYPERHIDROSIS (medically significant) with onset 17Nov2021, outcome "recovered", described as "Sweating attack"; MYALGIA (medically significant) with onset 17Nov2021, outcome "recovered", described as "Generalised muscle aches"; ANXIETY (medically significant) with onset 17Nov2021, outcome "recovered", described as "Anxiety state"; DEPRESSION (medically significant) with onset 17Nov2021, outcome "recovered", described as "Depression". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1939195 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Pulmonary embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101719777

Write-up: Thrombosis, bilateral pulmonary embolism; Thrombosis, bilateral pulmonary embolism; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: -BASGAGES-2021-063146 (BASGAGES). A 76 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (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 (MANUFACTURE UNKNOWN. DOSE 1 SINGLE), for COVID-19 immunisation, reaction(s): "no adverse event"; Covid-19 vaccine (MANUFACTURE UNKNOWN DOSE 2 SINGLE), for COVID-19 immunisation, reaction(s): "no adverse event". The following information was reported: PULMONARY EMBOLISM (hospitalization, life threatening), THROMBOSIS (hospitalization, life threatening) all with onset 18Nov2021, outcome "unknown" and all described as "Thrombosis, bilateral pulmonary embolism"; IMMUNISATION (hospitalization, life threatening) with onset 17Nov2021, outcome "unknown", described as "Booster". Therapeutic measures were taken as a result of pulmonary embolism, thrombosis. Reporter Comment: Treatment of the side effect 1: Hospitalization, No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Treatment of the side effect 1: Hospitalization,


VAERS ID: 1939275 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-11-17
   Days after vaccination:168
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Investigation, Overdose, Pain in extremity
SMQs:, Embolic and thrombotic events, venous (narrow), Drug abuse and dependence (broad), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: investigation; Result Unstructured Data: Test Result:Thrombosis of the right internal saphenous vein; Comments: over its entire course
CDC Split Type: CHPFIZER INC202101701889

Write-up: Deep vein thrombosis; overdose; Pain in extremity; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: CH-SM-2021-28684 (RA). A 61-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 02Jun2021 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single and intramuscular, administration date 02Jun2021 (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: PAIN IN EXTREMITY (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Pain in extremity"; DEEP VEIN THROMBOSIS (medically significant), outcome "not recovered", described as "Deep vein thrombosis"; OVERDOSE (non-serious), outcome "unknown", described as "overdose". The patient underwent the following laboratory tests and procedures: investigation: thrombosis of the right internal saphenous vein, notes: over its entire course. Additional information: The patient received Comirnaty (COVID-19 vaccine), a dosage of 0.6 millilitre. A causal relationship between COMIRNATY and Deep vein thrombosis, Pain in extremity was assessed as being Possible. This case was reported as serious Other medically important condition. Sender''s comments: The case is serious and unlabelled. 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: 1939281 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Pruritus, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-LISINOPRIL; DIAMICRON; NIFEDIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adipositas; Diabetes; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101710326

Write-up: booster; Fever; face; massive pruritus; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: CH-SM-2021-28980 (RA). A 76 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: Unknown) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: CO-LISINOPRIL, start date: 31Oct2016; DIAMICRON, start date: 08Jun2015; NIFEDIPINE, start date: 24Sep2020. Vaccination history included: Comirnaty (dose 1 (batch unknown)), administration date: 19Feb2021, for COVID-19 immunisation, reaction(s): "Urticaria"; Comirnaty (dose 2 (batch unknown)), administration date: 19Mar2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; PYREXIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Fever"; URTICARIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "face"; PRURITUS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "massive pruritus". Additional information:Source of assessment: SM, Method of assessment: Regulatory authority Assessment, Drug result: Possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''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.; Sender''s Comments: Linked Report(s) : CH-PFIZER INC-202101756735 the same patient, different dose


VAERS ID: 1940583 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCTD6 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Neck pain, Vaccination site pain
SMQs:, Arthritis (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: FRPFIZER INC202101665599

Write-up: pain in the left arm; pain in the neck on the left side; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-BS20212163 (RA). A 37 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 17Nov2021 (Lot number: SCTD6) at the age of 37 years 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 (1st dose of vaccine, MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: VACCINATION SITE PAIN (medically significant) with onset 17Nov2021, outcome "unknown", described as "pain in the left arm"; NECK PAIN (medically significant) with onset 17Nov2021, outcome "unknown", described as "pain in the neck on the left side". The events "pain in the left arm" and "pain in the neck on the left side" were evaluated at the physician office visit. No COVID history. No COVID test.The doctor prescribes a two-day leave from work.


VAERS ID: 1940827 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-11-17
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood lactic acid, Cardiomyopathy, Echocardiogram, Erythema multiforme, Hypotension, Myocarditis, Pericarditis, SARS-CoV-2 test, Troponin
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Cardiomyopathy (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal pain; Coryzal symptoms (4 day history of coryzal symptoms some red eyes leading up to admission); Rash (short history of rash, Rash on extensor surfaces, lower limbs, hands in and around mouth); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Lactic Acid Blood Test; Result Unstructured Data: Test Result:lactataemia; Test Date: 20211117; Test Name: TTE; Result Unstructured Data: Test Result:LVEF 10-15 %; Comments: with lactataemia and AKI; Test Date: 20211117; Test Name: COVID PCR; Test Result: Negative ; Test Date: 20211119; Test Name: cardiac troponin; Result Unstructured Data: Test Result:95 ng/L; Comments: Raised
CDC Split Type: GBPFIZER INC202101670685

Write-up: Cardiomyopathy; Hypotension; pericarditis; Myocarditis MIS-A; erythema multiforme; This is a spontaneous report received from a contactable reporter(Pharmacist) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111251000175020-CLPYO. Other Case identifier(s): GB-MHRA-ADR 26248786. A 17 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "coryzal symptoms" (unspecified if ongoing), notes: 4 day history of coryzal symptoms, some red eyes leading up to admission; "abdominal pain D&V", start date: 01Jul2021 (unspecified if ongoing); "rash" (unspecified if ongoing), notes: short history of rash, Rash on extensor surfaces, lower limbs, hands in and around mouth, "COVID symptoms", start date: Jan2021 (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: CARDIOMYOPATHY (hospitalization, medically significant) with onset 17Nov2021, outcome "recovering", described as "Cardiomyopathy"; HYPOTENSION (hospitalization, medically significant) with onset 17Nov2021, outcome "unknown", described as "Hypotension"; PERICARDITIS (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "pericarditis"; MYOCARDITIS (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Myocarditis MIS-A"; ERYTHEMA MULTIFORME (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "erythema multiforme". The patient was hospitalized for cardiomyopathy, hypotension, pericarditis, myocarditis, erythema multiforme (start date: 17Nov2021). The events "cardiomyopathy", "hypotension", "pericarditis", "myocarditis mis-a" and "erythema multiforme" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood lactic acid: (unspecified date) lactataemia; echocardiogram: (17Nov2021) lvef 10-15, notes: with lactataemia and AKI; sars-cov-2 test: (17Nov2021) negative; troponin (0-13): (19Nov2021) 95 ng/L, notes: Raised. Therapeutic measures were taken as a result of cardiomyopathy, hypotension, erythema multiforme. Clinical course: Previously fit and well . Attended ED 17.11.21 where profoundly hypotensive requiring admission to ICU. Initially covered for meningoencephalitis. TTE revealed LVEF 10-15% with lactataemia and AKI Transferred for further management on 19.11.2021 - received pulsed IV methylprednisolone and IV anakinra. Improving haemodynamically and extubated 24.11. Patient had not tested positive for COVID-19 since having the vaccine and Unsure if patient is enrolled in clinical trial. The report did not relate to possible blood clots or low platelet counts. The report related to possible myocarditis or pericarditis. Relevant investigations or tests conducted 18.1 HHV6 DNA detected, Not detected: HHV7 parvovirus B19, entrovirus RNA, VZV DNA, HSV 1/2. The patient was admitted to hospital and was still in hospital. The patient was seen by a cardiologist. Myocarditis MIS-A and erythema multiforme presumed as part of unifying diagnosis. Methylprednisolone and anakinra was given as treatment. No Cardiac MRI, Coronary angiography, Cardiac Biopsy was done and the patient was not asymptomatic. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1940997 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, Loss of consciousness, Off label use, Product use issue, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101675342

Write-up: Blackout; Vaso-vagal faint; Without warning fell to the ground; Off label use; Drug use in unapproved population; This is a spontaneous report received from a contactable reporter (Physician) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111261331498370-9EMYC (MHRA). Other Case identifier: GB-MHRA-ADR 26257050. A 26 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing). Patient had no symptoms associated with COVID-19, not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine and unsure if patient was enrolled in clinical trial. Concomitant medication included: INFLUENZA VIRUS taken for immunisation, administration date 23Sep2021. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 23Nov2021, outcome "recovered" (23Nov2021), described as "Blackout"; SYNCOPE (medically significant) with onset 23Nov2021, outcome "recovered" (23Nov2021), described as "Vaso-vagal faint"; FALL (non-serious) with onset 23Nov2021, outcome "recovered" (23Nov2021), described as "Without warning fell to the ground"; OFF LABEL USE (non-serious) with onset 17Nov2021, outcome "unknown", described as "Off label use"; PRODUCT USE ISSUE (non-serious) with onset 17Nov2021, outcome "unknown", described as "Drug use in unapproved population". Clinical course: Without warning fell to the ground while walking from front door to garden gate. Next thing was lying on ground with family calling her name. Felt OK 5 mins later. Sounds like vaso-vagal faint but further tests due to exclude other causes such as cardiac drop attack. 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-202101684153 baby case


VAERS ID: 1941167 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5475 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Condition aggravated, Immunisation, Joint lock, Joint noise, Movement disorder, X-ray
SMQs:, Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Osteoarthritis knee; Pain; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: Xray; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202101675539

Write-up: couldn''t straighten leg; clicking sensation on right side of knee.; knee pain; When walking sharp intense pain incidents causing knee to buckle. Gradually worsening over the following days; Knee lock; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111271739432210-TPPQZ. Other Case identifier(s): GB-MHRA-ADR 26262362. A male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK5475) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pain" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing); "grade 3/4 pattelofemoral oa knee" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation, administration date 29Sep2021. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization; Bnt162b2 (Dose 2, single), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; JOINT LOCK (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Knee lock"; MOVEMENT DISORDER (medically significant), outcome "unknown", described as "couldn''t straighten leg"; JOINT NOISE (medically significant), outcome "unknown", described as "clicking sensation on right side of knee."; ARTHRALGIA (medically significant), outcome "recovering", described as "knee pain"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "When walking sharp intense pain incidents causing knee to buckle. Gradually worsening over the following days". The patient underwent the following laboratory tests and procedures: x-ray: unknown results. Clinical course: The patient had Type 2 diabetes and grade 3/4 pattelofemoral oa knee, which had been significantly pain free for 2 years, so the onset of new pain issues immediately following the booster indicated a potential vaccine side effect to him. Patient had not symptoms associated with COVID-19 and not had a COVID-19 test. Right knee pain. Initial pain started in bed -couldn''t straighten leg and clicking sensation on right side of knee. When walking sharp intense pain incidents causing knee to buckle. Gradually worsening over the following days. Consultation with GP on 24Nov2021 and referral made for Xray. Patient was not enrolled in clinical trial. No follow-up attempts were possible. No further information was expected.


VAERS ID: 1941489 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hypotension, Malaise, Swollen tongue, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to vaccine (The patient has previously reacted to either DPT or MMR vaccine (she is not sure which one she got).); Gestational diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101665386

Write-up: FEELING OF SWELLING OF TONGUE; DIZZINESS; FEELING UNWELL; URTICARIAL RASH; HYPOTENSION; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency. Regulatory number: NO-NOMAADVRE-FHI-2021-Ud9w51 (NOMA). Other Case identifier(s): NO-NOMAADVRE-E2B_00061835 (NOMA). A 38 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 12:00 (Lot number: FJ5782) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gestational diabetes" (unspecified if ongoing); "Allergy to vaccine" (unspecified if ongoing), notes: The patient has previously reacted to either DPT or MMR vaccine (she is not sure which one she got). The patient''s concomitant medications were not reported. The following information was reported: SWOLLEN TONGUE (hospitalization) with onset 17Nov2021, outcome "recovered", described as "FEELING OF SWELLING OF TONGUE"; DIZZINESS (hospitalization) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "DIZZINESS"; MALAISE (hospitalization) with onset 17Nov2021, outcome "recovered", described as "FEELING UNWELL"; URTICARIA (hospitalization) with onset 17Nov2021, outcome "recovering", described as "URTICARIAL RASH"; HYPOTENSION (hospitalization) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "HYPOTENSION". Reporter Comment: 23Nov2021 RELIS: requested additional information. If new medical information is received, report will be updated. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: 23Nov2021 RELIS: requested additional information. If new medical information is received, report will be updated.


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