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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: 1966383 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cold sweat, Dizziness, Headache, Nausea, Pyrexia, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211125; Test Name: Body temperature; Result Unstructured Data: Test Result:38
CDC Split Type: NOPFIZER INC202101729062

Write-up: Syncope; Cold sweat; Dizziness; Vomiting; Mild fever; Nausea; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: NO-NOMAADVRE-PASRAPP-2021-Uw78qz Regulatory Authority. Other Case identifier(s): NO-NOMAADVRE-E2B_00063516 Regulatory Authority. A 40 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 23Nov2021 00:06 (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: SYNCOPE (medically significant) with onset 25Nov2021, outcome "recovering", described as "Syncope"; COLD SWEAT (non-serious) with onset 25Nov2021, outcome "unknown", described as "Cold sweat"; DIZZINESS (non-serious) with onset 25Nov2021, outcome "not recovered", described as "Dizziness"; VOMITING (non-serious) with onset 25Nov2021, outcome "unknown", described as "Vomiting"; PYREXIA (non-serious) with onset 25Nov2021, outcome "unknown", described as "Mild fever"; NAUSEA (non-serious) with onset 25Nov2021, outcome "unknown", described as "Nausea"; HEADACHE (non-serious) with onset 25Nov2021, outcome "unknown", described as "Headache". The patient reported 2 times syncope the morning after vaccination. The patient underwent the following laboratory tests and procedures: body temperature: (25Nov2021) 38. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1966474 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1013A / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Hyperlipidaemia; Hypertension; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-smoker (10 package years. Ended in 1975.)
Allergies:
Diagnostic Lab Data: Test Name: coronary angiography; Result Unstructured Data: Test Result:normal; Test Name: MRI; Result Unstructured Data: Test Result:please see below; Comments: myocarditis in the basal inferolateral wall; Test Name: troponin; Result Unstructured Data: Test Result:please see below; Comments: She has some dynamic changes in troponin levels.
CDC Split Type: SEPFIZER INC202101730750

Write-up: Myocarditis; booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB. Regulatory number: SE-MPA-2021-095315 (RA). Other Case identifier(s): SE-VISMA-1638197687883 (RA). A 76-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), administration date 25Nov2021 (Lot number: 1F1013A) as dose 3, (booster) single for COVID-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (ongoing); "Hypertension" (ongoing); "Hyperlipidaemia" (ongoing); "Ex-smoker", stop date: 1975, notes: 10 package years. Ended in 1975. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (2nd dose, manufacturer unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 25Nov2021, outcome "unknown", described as "booster"; MYOCARDITIS (hospitalization) with onset 26Nov2021, outcome "not recovered", described as "Myocarditis". The patient underwent the following laboratory tests and procedures: angiogram: normal; magnetic resonance imaging: please see below, notes: myocarditis in the basal inferolateral wall; troponin: please see below, notes: She has some dynamic changes in troponin levels. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1968362 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-04
Onset:2021-11-25
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: Electrocardiogram ST segment; Result Unstructured Data: Test Result:elevation
CDC Split Type: AUPFIZER INC202101741078

Write-up: Electrocardiogram ST segment elevation; Pericarditis/Chest pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 677044 Regulatory Authority. A 17-year-old male patient received bnt162b2 (COMIRNATY), administration date 04Nov2021 (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: ELECTROCARDIOGRAM ST SEGMENT ELEVATION (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Electrocardiogram ST segment elevation"; PERICARDITIS (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Pericarditis/Chest pain". The patient underwent the following laboratory tests and procedures: electrocardiogram st segment: (25Nov2021) elevation. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1968457 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Extensive swelling of vaccinated limb, Injection site reaction, Malaise, Myalgia, Nausea, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Fever; Muscle pain; Extensive swelling of the arm; Nausea; Chills; Worst was the terrible pain in my arm, as if it had been torn off. I couldn''t dangle or use it; Injection site response; Feeling unwell; This case was received via Regulatory Authority (Reference number: BE-FAMHP-DHH-N2021-110111) on 13-Dec-2021 and was forwarded to Moderna on 13-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Muscle pain), EXTENSIVE SWELLING OF VACCINATED LIMB (Extensive swelling of the arm), NAUSEA (Nausea), CHILLS (Chills), PAIN IN EXTREMITY (Worst was the terrible pain in my arm, as if it had been torn off. I couldn''t dangle or use it), INJECTION SITE REACTION (Injection site response) and MALAISE (Feeling unwell) in a 39-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004730) for COVID-19 vaccination. No Medical History information was reported. On 25-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion disability), MYALGIA (Muscle pain) (seriousness criterion disability), EXTENSIVE SWELLING OF VACCINATED LIMB (Extensive swelling of the arm) (seriousness criterion disability), NAUSEA (Nausea) (seriousness criterion disability), CHILLS (Chills) (seriousness criterion disability), PAIN IN EXTREMITY (Worst was the terrible pain in my arm, as if it had been torn off. I couldn''t dangle or use it) (seriousness criterion disability), INJECTION SITE REACTION (Injection site response) (seriousness criterion disability) and MALAISE (Feeling unwell) (seriousness criterion disability). On 29-Nov-2021, PYREXIA (Fever), MYALGIA (Muscle pain), EXTENSIVE SWELLING OF VACCINATED LIMB (Extensive swelling of the arm), NAUSEA (Nausea), CHILLS (Chills), PAIN IN EXTREMITY (Worst was the terrible pain in my arm, as if it had been torn off. I couldn''t dangle or use it), INJECTION SITE REACTION (Injection site response) and MALAISE (Feeling unwell) was resolving. No concomitant medication was reported. No treatment medication was reported. Patient says, worst was the terrible pain in her arm , she could not dangle or use it , as if it had been torn off. Company comment: This regulatory authority case concerns a 39-year-old female patient with no relevant medical history who experienced serious unexpected events of pyrexia, myalgia, extensive swelling of vaccinated limb, nausea, chills, pain in extremity, injection site reaction and malaise. The events occurred on the same day after the first dose of the mRNA-1273 . Patient reported that out of all symptoms, the pain in her arm was the worst and she could not dangle or use it and felt like it was torn off. The rechallenge was not applicable since due to lack of information on the second dose, no rechallenge could be done and thus, recurrence was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2021: Translation document received on 16-Dec-2021. Translated event verbatim updated.; Sender''s Comments: This regulatory authority case concerns a 39-year-old female patient with no relevant medical history who experienced serious unexpected events of pyrexia, myalgia, extensive swelling of vaccinated limb, nausea, chills, pain in extremity, injection site reaction and malaise. The events occurred on the same day after the first dose of the mRNA-1273 . Patient reported that out of all symptoms, the pain in her arm was the worst and she could not dangle or use it and felt like it was torn off. The rechallenge was not applicable since due to lack of information on the second dose, no rechallenge could be done and thus, recurrence was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1968520 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN ABZ5320 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Muscle spasms, Nausea, Pyrexia, Tachycardia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TIROSINT
Current Illness: Food allergy; Hypothyreosis; Perfume sensitivity; Pollen allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHJNJFOC20211230993

Write-up: CRAMPS; TACHYCARDIA; CHILLS; NAUSEA; FEVER; This spontaneous report received from a consumer Via a Regulatory Authority (Swiss Agency Therapeutic Product, CH-SM-2021-29612) and concerned a 46 year old female. The patient''s weight was 68 kilograms, and height was 165 centimeters. The patient''s concurrent conditions included: hypothyreosis, pollen allergy, food allergy, and perfume sensitivity. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin not reported, batch number: ABZ5320 expiry: UNKNOWN) dose was not reported,1 total, administered on 25-NOV-2021 for an unspecified indication. Concomitant medications included levothyroxine sodium for hypothyreosis. On 25-NOV-2021, the patient experienced cramps, tachycardia, chills, nausea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramps, tachycardia, chills, nausea, and fever. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20211230993-COVID-19 VACCINE AD26.COV2.S-Cramps, Tachycardia. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20211230993-COVID-19 VACCINE AD26.COV2.S-Chills, Nausea, Fever. These events are labeled per RSI and are therefore considered potentially related.


VAERS ID: 1969125 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 31101TB / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Immunisation
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Disorder pancreas; Food allergy; Gastrectomy; Hay fever; Peanut allergy; Splenectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101742768

Write-up: booster; Anaphylactic shock; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: DE-PEI-CADR2021206303. Other Case identifier(s): DE-CADRPEI-2021206303, DE-PEI-202100232559. A 42 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: 31101TB) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "peanut allergy" (unspecified if ongoing); "No stomach" (unspecified if ongoing); "no spleen" (unspecified if ongoing); "Chronic pancreas problems" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Hay fever" (unspecified if ongoing); "food allergies" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "booster"; ANAPHYLACTIC SHOCK (medically significant) with onset 25Nov2021, outcome "recovering", described as "Anaphylactic shock". The event "anaphylactic shock" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of anaphylactic shock included medication treatment, emergency set, infusion and continued treatment over the weekend with celestone and citerizine. Relatedness: Comirnaty / Anaphylactic shock / Regulatory Authority: D. Unclassifiable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969268 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-11-25
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5436 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PLANTABEN [PLANTAGO OVATA]; MAGNOGENE [MAGNESIUM CHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (No symptoms. It was detected by a PCR test)
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: PCR; Test Result: Positive
CDC Split Type: ESPFIZER INC202101743160

Write-up: Acute pericarditis; Fatigue; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority-WEB. The reporter is the patient. Regulatory number: ES-AEMPS-1062849 (RA). A 46 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 23Jun2021 (Lot number: FC5436) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: May2020 (unspecified if ongoing), notes: No symptoms. It was detected by a PCR test. Concomitant medication(s) included: PLANTABEN [PLANTAGO OVATA] taken for constipation, start date: 02Nov2021, stop date: 26Nov2021; MAGNOGENE [MAGNESIUM CHLORIDE] taken for constipation, start date: 02Nov2021, stop date: 26Nov2021. The following information was reported: PERICARDITIS (medically significant) with onset 25Nov2021, outcome "recovering", described as "Acute pericarditis"; FATIGUE (medically significant) with onset 25Nov2021, outcome "unknown", described as "Fatigue". The events "acute pericarditis" and "fatigue" were evaluated at the physician office visit. 30Nov2021: Telephone consultation: Refer that yesterday went to the hospital for Pericarditis and Fatigue, not fever. The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (May2021) positive. Therapeutic measures were taken as a result of pericarditis. Treatment was Colchicina SEID 0.5 mg tablets 1-1-1 / Ibuprofeno 600 mg 40 tablets 1-1-1 / Omeprazole 20 mg tablets 1-0-0. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969359 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1019A / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactoid reaction, Angioedema, Aphonia, Immunisation, Interchange of vaccine products, Lip swelling, Off label use, Pharyngeal paraesthesia
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101734089

Write-up: Delayed anaphylactoid reaction; angiodema; swelling of the lip; tingling of the throat; loss of voice; off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the Regulatory Authority. Regulatory number: FR-AFSSAPS-TO20219177 (RA). A 65 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Lot number: 1F1019A) at the age of 65 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 X; MANUFACTURER UNKNOWN (where X=1, 2, or number unknown)), for COVID-19 immunisation; Covid-19 vaccine (DOSE X; MANUFACTUERER UNKNOWN (where X=1, 2, or number unknown)), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 25Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; ANAPHYLACTOID REACTION (medically significant) with onset 26Nov2021, outcome "recovered" (27Nov2021), described as "Delayed anaphylactoid reaction"; ANGIOEDEMA (medically significant) with onset 26Nov2021, outcome "unknown", described as "angiodema"; APHONIA (non-serious) with onset 25Nov2021, outcome "unknown", described as "loss of voice"; LIP SWELLING (non-serious) with onset 26Nov2021, outcome "unknown", described as "swelling of the lip"; PHARYNGEAL PARAESTHESIA (non-serious) with onset 26Nov2021, outcome "unknown", described as "tingling of the throat". The events "delayed anaphylactoid reaction", "angiodema", "loss of voice", "swelling of the lip" and "tingling of the throat" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of anaphylactoid reaction, angioedema, aphonia, lip swelling, pharyngeal paraesthesia. Clinical course details: Referral to doctor on duty via the Emergency call, emergency injection of solumedrol and prescription of cortidoide treatment for 4 days. Suspicion of angioedema. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1969436 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, EGFR status assay, Immunisation, Inflammation, Renal tubular necrosis, SARS-CoV-2 test, Transplant rejection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Renovascular disorders (broad), Tubulointerstitial diseases (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LOPERAMIDE; SIMVASTATIN; ATROPINE SULFATE; MYFORTIC; LANSOPRAZOLE; ADCAL D3; PROGRAF; FIASP; FERROUS SULFATE; RISEDRONATE SODIUM; TOUJEO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Diabetic retinopathy; Dyspepsia; Gastroparesis; Immunosuppression; Kidney transplant; Osteopenia; Pancreas transplant; Transplant (Recently had a bone marrow transplant or taking medicines following a transplant (e.g. kidney); Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: creatinine test; Result Unstructured Data: Test Result:70-85 umol/L; Test Date: 20211201; Test Name: creatinine test; Result Unstructured Data: Test Result:412 umol/L; Test Name: potassium; Result Unstructured Data: Test Result:6.7 mmol/L; Test Name: eGFR; Result Unstructured Data: Test Result:$g 60; Test Name: eGFR; Result Unstructured Data: Test Result:11; Test Date: 20211205; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101776997

Write-up: Booster; Graft rejection; acute tubular necrosis; Antibody-mediated rejection; interstitial inflammation; This is a spontaneous report received from contactable reporter(s) (Other HCP) from the Regulatory Authority-WEB. Regulatory number: GB-MHRA-WEBCOVID-202112061246416810-ERCSY. Other Case identifier(s): GB-MHRA-ADR 26295451. A 38 year-old male patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (unknown if ongoing); "Transplant" (unknown if ongoing), notes: Recently had a bone marrow transplant or taking medicines following a transplant (e.g. kidney; "kidney transplant", start date: 2015 (unspecified if ongoing); "pancreas transplant" (unspecified if ongoing); "Gastroparesis" (unspecified if ongoing); "Diabetic retinopathy" (unspecified if ongoing); "Immunosuppression" (unspecified if ongoing); "Dyspepsia" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Type 1 diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: LOPERAMIDE taken for impaired gastric emptying; SIMVASTATIN; ATROPINE SULFATE taken for diabetic retinopathy; MYFORTIC taken for immunosuppression, start date: 10Jul2017; LANSOPRAZOLE taken for dyspepsia; ADCAL D3 taken for osteopenia; PROGRAF taken for immunosuppression, start date: 20Jul2017; FIASP taken for type 1 diabetes mellitus; FERROUS SULFATE, start date: 02Mar2020; RISEDRONATE SODIUM taken for osteopenia; TOUJEO taken for type 1 diabetes mellitus. Vaccination history included: Bnt162b2 (Dose-1), for COVID-19 immunization; Bnt162b2 (Dose-2), for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; TRANSPLANT REJECTION (hospitalization, medically significant) with onset 2021, outcome "not recovered", described as "Graft rejection"; RENAL TUBULAR NECROSIS (hospitalization, medically significant) with onset 2021, outcome "recovered" (2021), described as "acute tubular necrosis"; TRANSPLANT REJECTION (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Antibody-mediated rejection"; INFLAMMATION (hospitalization, medically significant) with onset 2021, outcome "recovered" (2021), described as "interstitial inflammation". The patient underwent the following laboratory tests and procedures: blood creatinine: (unspecified date) 70-85 umol/l; (01Dec2021) 412 umol/l; blood potassium: (unspecified date) 6.7 mmol/L; egfr status assay: (unspecified date) $g 60; (unspecified date) 11; sars-cov-2 test: (05Dec2021) negative, notes: No - Negative COVID-19 test. Clinical course: Patient was not had symptoms associated with COVID-19. Simultaneous kidney & pancreas transplant 2015 (early pancreatic graft failure). Stable kidney function with baseline creatinine of 70-85 umol/L, eGFR$g 60. Routine pre-clinic bloods from 01/12/21 showed creatinine = 412 umol/L, potassium = 6.7 mmol/L & eGFR = 11. Renal graft biopsy on 02/12/21. The overall appearances are those of a moderate cellular rejection (Banff 1B). There was moderate oedema and active interstitial inflammation (mostly plasma cells with some eosinophils and lymphocytes) with marked tubulitis and positive C4d. Features of antibody mediated rejection are seen with prominent peritubular capillaries some containing neutrophil polymorphs and plasma cells. There is associated acute tubular necrosis. It would be important to check the DSA. Patient was not tested positive for COVID-19 since having the vaccine. Patient report not relate to possible blood clots or low platelet counts. Patient report not relate 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: 1969595 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Loss of consciousness, SARS-CoV-2 test
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), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Tested negative for COVID-19
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Passed out; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26317412) on 12-Dec-2021 and was forwarded to Moderna on 12-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 61-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria medically significant and life threatening). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Tested negative for COVID-19. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant history was not reported. The treatment history was not provided. Patient is not tested positive for COVID-19 since having the vaccine, not enrolled in clinical trial. Company comment This case concerns a 61-year-old female patient, with no reported medical history, who experienced the unexpected serious event of LOSS OF CONSCIOUSNESS. The event occurred on the following day after the administration of the third dose of mRNA-1273 vaccine. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) had resolved with sequelae. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 61-year-old female patient, with no reported medical history, who experienced the unexpected serious event of LOSS OF CONSCIOUSNESS. The event occurred on the following day after the administration of the third dose of mRNA-1273 vaccine. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) had resolved with sequelae. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1969727 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Myalgia, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Coughing; Muscle ache; Throat pain; This case was received via Regulatory Authroity (Reference number: GB-MHRA-ADR 26324050) on 12-Dec-2021 and was forwarded to Moderna on 12-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Throat pain), COUGH (Coughing) and MYALGIA (Muscle ache) in a 56-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 16-Mar-2021 to an unknown date for Vaccination. On 25-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (Throat pain) (seriousness criterion medically significant). On 26-Nov-2021, the patient experienced COUGH (Coughing) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL PAIN (Throat pain), COUGH (Coughing) and MYALGIA (Muscle ache) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medications were not reported. Patient has not had symptoms associated with COVID-19 and not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial On an unknown date patient undergone Six lateral flow tests which had given negative results. Company comment: This is a regulatory authority case concerning a 56-year-old female patient with no medical history reported, who experienced oropharyngeal pain, cough and myalgia. The events occurred approximately 1 day 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.; Sender''s Comments: This is a regulatory authority case concerning a 56-year-old female patient with no medical history reported, who experienced oropharyngeal pain, cough and myalgia. The events occurred 1 day 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: 1969909 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-11-25
   Days after vaccination:175
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: 20211125; Test Name: Covid-19 PCR test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101745197

Write-up: COVID testing PCR positive; had COVID testing PCR positive; stomach pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient of an unspecified age received bnt162b2 (BNT162B2), administration date 03Jun2021 (Batch/Lot number: unknown) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset 25Nov2021, outcome "unknown", described as "COVID testing PCR positive"; VACCINATION FAILURE (medically significant) with onset 25Nov2021, outcome "unknown", described as "had COVID testing PCR positive"; ABDOMINAL PAIN UPPER (non-serious) with onset 25Nov2021, outcome "unknown", described as "stomach pains". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Nov2021) positive. Details were reported as follows: "Am reporting that I have had COVID testing PCR positive Thursday 25Nov (Symptomatic headache, runny nose, sore throat, loss taste/smell, sickness, stomach pains, fatigue)" The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1970016 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005244 / UNK - / OT

Administered by: Unknown       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: ITMODERNATX, INC.MOD20214

Write-up: Loss of consciousness, syncope; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-816167) on 13-Dec-2021 and was forwarded to Moderna on 13-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness, syncope) in a 55-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005244) for COVID-19 vaccination. No Medical History information was reported. On 24-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness, syncope) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness, syncope) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant drug information provided. No treatment drug information provided. Company comment: This regulatory case concerns a 55-year-old female patient, with no reported medical history, who experienced the serious (medically significant) unexpected event of SYNCOPE. The event occurred 1 day after receiving a dose of mRNA-1273 which dose number is unknown. The rechallenge is not applicable since there is missing information about further dosing. The event was resolved at the time of the report and no further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This regulatory case concerns a 55-year-old female patient, with no reported medical history, who experienced the serious (medically significant) unexpected event of SYNCOPE. The event occurred 1 day after receiving a dose of mRNA-1273 which dose number is unknown. The rechallenge is not applicable since there is missing information about further dosing. The event was resolved at the time of the report and no further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 1970074 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram thorax, Diffuse alveolar damage, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Respiratory fatigue
SMQs:, Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211128; Test Name: Thorax CAT; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Test Name: Oxygen Saturation; Test Result: 82 %
CDC Split Type: ITPFIZER INC202101743229

Write-up: Respiratory fatigue; Fever; Oxygen saturation low; Bilateral alveolitis with diffuse contiguous-confluent areas of pulmonary thickening.; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency WEB. Regulatory number: IT-MINISAL02-817228 (MINISAL02). A 16 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 23Nov2021 10:21 (Lot number: FG3739, Expiration Date: 31Mar2022) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: RESPIRATORY FATIGUE (hospitalization) with onset 25Nov2021, outcome "recovering", described as "Respiratory fatigue"; PYREXIA (hospitalization) with onset 25Nov2021, outcome "recovering", described as "Fever"; OXYGEN SATURATION DECREASED (hospitalization) with onset 25Nov2021, outcome "recovering", described as "Oxygen saturation low"; DIFFUSE ALVEOLAR DAMAGE (medically significant), outcome "unknown", described as "Bilateral alveolitis with diffuse contiguous-confluent areas of pulmonary thickening.". The patient underwent the following laboratory tests and procedures: computerised tomogram thorax: (28Nov2021) unknown results; oxygen saturation: (unspecified date) 82 %. Therapeutic measures were taken as a result of respiratory fatigue, pyrexia, oxygen saturation decreased. Reporter Comment: Fever and worsening respiratory distress occurred 2 days after administration of the first dose of Pfizer''s Covid vaccine. Bilateral diffuse alveolitis with Oxygen Saturation: 82%. Transferred immediately to intensive care. Additional information: Actions taken (Admission to paediatrics and immediately afterwards to resuscitation. On treatment with high-flow oxygen, Cancidas, Tazocin, Targosid, Urbason, Antra, Clexane). Patient Transferred immediately to intensive care. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Fever and worsening respiratory distress occurred 2 days after administration of the first dose of Pfizer''s Covid vaccine. Bilateral diffuse alveolitis with Oxygen Saturation: 82%. Transferred immediately to intensive care.


VAERS ID: 1970097 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1016A / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Asthenia, Electrocardiogram
SMQs:, Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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: Hypertension
Allergies:
Diagnostic Lab Data: Test Name: cardiogram; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: ITPFIZER INC202101745723

Write-up: Arrhythmias and severe asthenia after Comirnaty vaccine; Arrhythmias and severe asthenia after Comirnaty vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: IT-MINISAL02-817591. A 42 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 19Nov2021 (Lot number: 1F1016A) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant), ASTHENIA (non-serious) all with onset 25Nov2021, outcome "recovering" and all described as "Arrhythmias and severe asthenia after Comirnaty vaccine". The patient underwent the following laboratory tests and procedures: electrocardiogram: unknown results. Clinical course also included Impact on quality of life (6/10), diagnostic examination - cardiogram. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1970208 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1008A / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Immunisation, Malaise, Myalgia, Pyrexia, SARS-CoV-2 test, Syncope, Vaccination site erythema, Vaccination site inflammation, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Disease risk factor
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: pyrexia; Result Unstructured Data: Test Result:39.9 Centigrade; Test Date: 202101; Test Name: pyrexia; Result Unstructured Data: Test Result:39.9 Centigrade; Test Date: 20211125; Test Name: pyrexia; Result Unstructured Data: Test Result:38 tot 40.5 Centigrade; Comments: fever; Test Date: 20200421; Test Name: corona, confirmmed with test; Result Unstructured Data: Test Result:Positive,
CDC Split Type: NLPFIZER INC202101736772

Write-up: booster; Generalized joint pain; Reaction at or around the injection site: heat; Reaction at or around the injection site: itching; Reaction at or around the injection site: swelling, occurring within a week of vaccination; Malaise; Fatigue; Reaction at or around the injection site: redness; Inflammatory reaction at the reaction site: redness, warmth, swelling, occurring within a week of vaccination; Myalgia; Fever: 38 to 40.5 degrees Celsius; Chills; Syncope; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Agency-WEB. The reporter is the patient. Regulatory number: NL-LRB-00721106 (LRB). A 63 year-old female patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: 1F1008A) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 21Apr2020 (unspecified if ongoing); "Disease risk factor" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Biontech/pfizer vaccin (comirnaty), administration date: 29Jan2021, for covid-19 immunisation, reaction(s): "High fever 39.9", "chills", "tremors", "a lot of nerve pain", "loss of strength in my vaccinated arm"; Biontech/pfizer vaccin (comirnaty), administration date: 08Jan2021, for covid-19 immunisation, reaction(s): "General malaise", "chills", "fever 39.9 degrees". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; SYNCOPE (medically significant), outcome "recovered", described as "Syncope"; ARTHRALGIA (non-serious), outcome "recovering", described as "Generalized joint pain"; CHILLS (non-serious) with onset 25Nov2021, outcome "recovered", described as "Chills"; VACCINATION SITE WARMTH (non-serious), outcome "not recovered", described as "Reaction at or around the injection site: heat"; VACCINATION SITE PRURITUS (non-serious), outcome "not recovered", described as "Reaction at or around the injection site: itching"; VACCINATION SITE SWELLING (non-serious), outcome "not recovered", described as "Reaction at or around the injection site: swelling, occurring within a week of vaccination"; MALAISE (non-serious), outcome "recovering", described as "Malaise"; PYREXIA (non-serious) with onset 25Nov2021, outcome "recovered", described as "Fever: 38 to 40.5 degrees Celsius"; FATIGUE (non-serious), outcome "recovering", described as "Fatigue"; VACCINATION SITE ERYTHEMA (non-serious), outcome "not recovered", described as "Reaction at or around the injection site: redness"; VACCINATION SITE INFLAMMATION (non-serious), outcome "not recovered", described as "Inflammatory reaction at the reaction site: redness, warmth, swelling, occurring within a week of vaccination"; MYALGIA (non-serious), outcome "recovering", described as "Myalgia". The patient underwent the following laboratory tests and procedures: body temperature: (Jan2021) 39.9 Centigrade; (Jan2021) 39.9 Centigrade; (25Nov2021) 38 tot 40.5, notes: fever; sars-cov-2 test: (21Apr2020) positive,. Therapeutic measures were taken as a result of arthralgia, malaise, pyrexia, myalgia. Treatment: Generalized joint pain is treated with Paracetamol, malaise is treated with Paracetamol, myalgia is treated with Paracetamol 1 gr 4 x dd 1 and pyrexia is treated with Paracetamol. Sender''s Diagnosis: Injection site inflammation No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101777533 the same reporter/patient, different event/ 2nd dose;NL-PFIZER INC-202101777534 the same reporter/patient, different event/ 1st dose


VAERS ID: 1970239 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0004 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Facial asymmetry, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101759291

Write-up: RASHES; dizziness; vomiting; LEFT SIDE FACIAL ASYMMETRY; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300123244. A 32 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: PCB0004) at the age of 32 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: RASH (medically significant) with onset 25Nov2021 13:00, outcome "recovered", described as "RASHES"; DIZZINESS (medically significant) with onset 25Nov2021 13:00, outcome "recovered", described as "dizziness"; VOMITING (medically significant) with onset 25Nov2021 13:00, outcome "recovered", described as "vomiting"; FACIAL ASYMMETRY (medically significant) with onset 25Nov2021 13:00, outcome "recovered", described as "LEFT SIDE FACIAL ASYMMETRY". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1972128 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, Chest X-ray, Chest X-ray abnormal, Chest pain, Echocardiogram, Echocardiogram abnormal, Electrocardiogram, Electrocardiogram abnormal, Myocarditis, Troponin I, Troponin I abnormal, Troponin T, Troponin T increased
SMQs:, Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: Chest X-ray; Result Unstructured Data: Test Result:unknown results; Test Date: 20211125; Test Name: C-reactive protein; Result Unstructured Data: Test Result:increased; Test Date: 20211125; Test Name: Echocardiogram; Result Unstructured Data: Test Result:unknown results; Test Date: 20211125; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:unknown results; Test Date: 20211125; Test Name: Troponin I; Result Unstructured Data: Test Result:unknown results; Test Date: 20211125; Test Name: Troponin T; Result Unstructured Data: Test Result:increased
CDC Split Type: AUPFIZER INC202101740518

Write-up: Myocarditis; C-reactive protein increased; Chest X-ray; Chest pain; Echocardiogram; Electrocardiogram; Troponin I; Troponin T increased; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 674836 (RA ADR#). A 12 year-old male patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (first dose), administration date: 29Oct2021, for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant) with onset 25Nov2021, outcome "recovering", described as "Myocarditis"; C-REACTIVE PROTEIN INCREASED (non-serious) with onset 25Nov2021, outcome "recovering", described as "C-reactive protein increased"; CHEST X-RAY ABNORMAL (non-serious) with onset 25Nov2021, outcome "recovering", described as "Chest X-ray"; CHEST PAIN (non-serious) with onset 25Nov2021, outcome "recovering", described as "Chest pain"; ECHOCARDIOGRAM ABNORMAL (non-serious) with onset 25Nov2021, outcome "recovering", described as "Echocardiogram"; ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 25Nov2021, outcome "recovering", described as "Electrocardiogram"; TROPONIN I ABNORMAL (non-serious) with onset 25Nov2021, outcome "recovering", described as "Troponin I"; TROPONIN T INCREASED (non-serious) with onset 25Nov2021, outcome "recovering", described as "Troponin T increased". The patient underwent the following laboratory tests and procedures: chest x-ray: (25Nov2021) unknown results; c-reactive protein: (25Nov2021) increased; echocardiogram: (25Nov2021) unknown results; electrocardiogram: (25Nov2021) unknown results; troponin i: (25Nov2021) unknown results; troponin t: (25Nov2021) increased. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1972435 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRP9 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Echocardiogram, Electrocardiogram, Myocarditis, Pericardial effusion, Troponin, Troponin increased, Vaccination site swelling
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Prolactinoma (with therapy by cabergolin (this under regular echocardiography control))
Allergies:
Diagnostic Lab Data: Test Date: 20211129; Test Name: echo; Result Unstructured Data: Test Result:mild pericardial effusion, troponin in decline; Comments: discharge in the evening, with the diagnosis of vaccine-related myocarditis; Test Date: 20211129; Test Name: ECG; Result Unstructured Data: Test Result:abnormal; Test Date: 20211129; Test Name: troponin; Result Unstructured Data: Test Result:increased
CDC Split Type: DEPFIZER INC202101753681

Write-up: Diagnosed myocarditis with mild course (increased troponin, mild pericardial effusion, chest pain); Diagnosed myocarditis with mild course (increased troponin, mild pericardial effusion, chest pain); Injection site swelling and pain; Diagnosed myocarditis with mild course (increased troponin, mild pericardial effusion, chest pain); This is a spontaneous report received from a non-contactable reporter(s) (Physician) from Regulatory Authority-WEB. Regulatory number: DE-PEI-CADR2021210263 . Other Case identifier(s): DE-CADRPEI-2021210263, DE-PEI-202100262155. A 24 year-old female patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: SCRP9) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Prolactinoma" (unspecified if ongoing), notes: with therapy by cabergolin (this under regular echocardiography control). The patient''s concomitant medications were not reported. The following information was reported: PERICARDIAL EFFUSION (hospitalization, medically significant), MYOCARDITIS (hospitalization, medically significant), TROPONIN INCREASED (hospitalization) all with onset 25Nov2021, outcome "not recovered" and all described as "Diagnosed myocarditis with mild course (increased troponin, mild pericardial effusion, chest pain)"; VACCINATION SITE SWELLING (hospitalization) with onset 25Nov2021, outcome "not recovered", described as "Injection site swelling and pain". The patient underwent the following laboratory tests and procedures: echocardiogram: (29Nov2021) mild pericardial effusion, troponin in decline, notes: discharge in the evening, with the diagnosis of vaccine-related myocarditis; electrocardiogram: (29Nov2021) abnormal; troponin: (29Nov2021) increased. Therapeutic measures were taken as a result of pericardial effusion, myocarditis, vaccination site swelling, troponin increased. Clinical course:25Nov2012 - The first symptoms of chest pain were relieved.26/27Nov2021 No symptoms.28Nov2021, early morning: Upper abdominal/back pain, sensation of pressure on chest, burning chest pain. 28Nov Course: Chest burning/back pain. 29Nov Medical visit, abnormal ECG, increased troponin- hospitalization KH, echo there (mild pericardial effusion, troponin in decline, discharge in the evening, with the diagnosis of vaccine-related myocarditis. 30Nov Sick leave for 2 weeks, Ibuprofen/Strict physical rest, symptoms still present 01Dec Slight decrease in symptoms, fatigue, exhaustion, in case of mild stress (sitting up, walking for short distances) still leads to pain. Causality for the events Pericardial effusion; Injection site swelling; Myocarditis; Troponin increased were reported as Unclassifiable. sender''s comment: Do you or the person affected have any known allergies? If so, which ones? No No follow-up attempts are possible. No further information is expected.


VAERS ID: 1972588 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Body temperature, Heavy menstrual bleeding, Immunisation, Immunisation reaction, Lymphadenopathy, Pyrexia, Rheumatoid arthritis, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREDNISOLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis (under corticosteroid therapy)
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: body temperature; Result Unstructured Data: Test Result:39.7 Centigrade; Test Date: 20201220; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101755228

Write-up: Booster; Rheumatoid arthritis flare up; Pain in the right armpit; large lymph nodes; fever up to 39.7 C; Reactogenicity event; Excessive menstruation; This is a spontaneous report received from a contactable Consumer from the regulatory authority-WEB. Regulatory number: FR-AFSSAPS-LY202112950. A 53 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Batch/Lot number not provided) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Progressive rheumatoid arthritis", notes: under corticosteroid therapy. Concomitant medication included: PREDNISOLONE. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; RHEUMATOID ARTHRITIS (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Rheumatoid arthritis flare up"; AXILLARY PAIN (non-serious) with onset 25Nov2021, outcome "unknown", described as "Pain in the right armpit"; LYMPHADENOPATHY (non-serious) with onset 25Nov2021, outcome "unknown", described as "large lymph nodes"; PYREXIA (non-serious) with onset 25Nov2021, outcome "recovered" (2021), described as "fever up to 39.7 C"; IMMUNISATION REACTION (non-serious) with onset 25Nov2021, outcome "not recovered", described as "Reactogenicity event"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 25Nov2021, outcome "not recovered", described as "Excessive menstruation". 4h post injection, the patient reports the occurrence of pain in the right armpit with large lymph nodes + Fever up to 39.7 C which has now disappeared. Big attack of polyarthritis (hands, elbows, feet) Very painful and disabling. On 26Nov2021: Unexpected onset of very heavy periods (though pre-menopausal). As of 28Nov2021: not restored. The patient underwent the following laboratory tests and procedures: body temperature: (25Nov2021) 39.7 Centigrade; sars-cov-2 test: (20Dec2020) negative. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1972696 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dysstasia, Fall, Headache, Hypersomnia, Magnetic resonance imaging, Pain, Pain in extremity, Paraesthesia, Vaccination site bruising
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EZETROL; EPLERENONE; CARVEDILOL; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20211129; Test Name: MRI; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202101758855

Write-up: Crushing Headache; painful feet; difficult to stand on; falling around; slept from the early hours to 11.30 the rest of the day; Pins and needles; body was in a lot of pain; bruise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-EYC 00268538. Other Case identifier(s): GB-MHRA-ADR 26299028. A 74 year-old male patient received bnt162b2 (COMIRNATY), parenteral, administration date 25Nov2021 (Batch/Lot number: unknown) at the age of 74 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Mar2020 (not ongoing); "Stroke" (not ongoing). Concomitant medication(s) included: EZETROL; EPLERENONE; CARVEDILOL; CLOPIDOGREL. It was reported as patient take a lot other medicines at the moment because they were for problems to be dealt with and anyhow, he was getting tired whilst reporting so he had to wrap up). The following information was reported: HEADACHE (medically significant) with onset 25Nov2021, outcome "recovered with sequelae" (25Nov2021), described as "Crushing Headache"; PAIN IN EXTREMITY (medically significant) with onset 25Nov2021, outcome "unknown", described as "painful feet"; PARAESTHESIA (medically significant) with onset 2021, outcome "unknown", described as "Pins and needles"; PAIN (medically significant) with onset 2021, outcome "unknown", described as "body was in a lot of pain"; VACCINATION SITE BRUISING (medically significant) with onset 2021, outcome "unknown", described as "bruise"; DYSSTASIA (medically significant) with onset 25Nov2021, outcome "unknown", described as "difficult to stand on"; FALL (medically significant) with onset 2021, outcome "unknown", described as "falling around"; HYPERSOMNIA (medically significant) with onset 2021, outcome "unknown", described as "slept from the early hours to 11.30 the rest of the day". The events "crushing headache", "painful feet", "pins and needles", "body was in a lot of pain", "bruise", "difficult to stand on", "falling around" and "slept from the early hours to 11.30 the rest of the day" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (29Nov2021) unknown results. The clinical course was reported as: The patient had a crushing headache at the same time as painful feet which he found difficult to stand on. Pins and needles where present at various parts of the body in particular with feet. As he got out of bed ended up falling around the room knocking stuff off the side table, he needed to go down stairs so he had to cling to the banister to manage his self "desent". His body was in a lot of pain so after he had made a phone call, he went back to bed to see if he could sleep the pain off. He slept from the early hours to 11:30 the rest of the day he just did nothing. He spoke to his doctor and she told everyone was like that, he felt sorry but he did not believe that. The following day was better but he still was not himself. It was reported as in the interest of reporting as feedback that on the following Monday 29Nov2021, he had an magnetic resonance imaging (MRI) scan which had to be abandoned half way through. Incidentally his vaccination left him with an initial bruise 3 inches long and 3/4 wide, at the time of this report, it was not so long but was bit wider. The patient just recently had a stroke and he hopes this information was useful. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1972767 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest pain, Dyspnoea, Electrocardiogram, Fatigue, Headache, Immunisation, Interchange of vaccine products, Malaise, Nausea, Off label use, Oxygen saturation, Palpitations, Pulmonary function test, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:ok; Test Date: 2021; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:ok; Test Date: 2021; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:ok; Test Date: 2021; Test Name: Lung function tests; Result Unstructured Data: Test Result:ok; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101758853

Write-up: Breathlessness; Nausea; Head pain; Chest pain; Patient received first and second dose of Non Pfizer vaccine and booster dose of COMIRNATY vaccine; Patient received first and second dose of Non Pfizer vaccine and booster dose of COMIRNATY vaccine; Patient received booster dose of COMIRNATY vaccine; Fatigue/unusual tiredness; Heart palpitations; Vomiting; Felt sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112070921350120-SLY1U (RA). Other Case identifier(s): GB-MHRA-ADR 26297883 (RA). A 57 year-old male patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE NUMBER UNKNOWN), administration date: 04Mar2021, for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (disability, medically significant), INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) all with onset 25Nov2021, outcome "unknown" and all described as "Patient received first and second dose of Non Pfizer vaccine and booster dose of COMIRNATY vaccine"; IMMUNISATION (disability, medically significant) with onset 25Nov2021, outcome "unknown", described as "Patient received booster dose of COMIRNATY vaccine"; DYSPNOEA (disability, medically significant) with onset 01Dec2021, outcome "recovered" (02Dec2021), described as "Breathlessness"; NAUSEA (disability, medically significant) with onset 01Dec2021, outcome "recovered" (02Dec2021), described as "Nausea"; HEADACHE (disability, medically significant) with onset 01Dec2021, outcome "recovered" (02Dec2021), described as "Head pain"; CHEST PAIN (disability, medically significant) with onset 01Dec2021, outcome "recovered" (02Dec2021), described as "Chest pain"; FATIGUE (disability, medically significant) with onset 2021, outcome "unknown", described as "Fatigue/unusual tiredness"; PALPITATIONS (disability, medically significant) with onset 2021, outcome "unknown", described as "Heart palpitations"; VOMITING (disability, medically significant) with onset 2021, outcome "unknown", described as "Vomiting"; MALAISE (disability, medically significant) with onset 2021, outcome "unknown", described as "Felt sick". The events "breathlessness", "nausea", "head pain", "chest pain", "fatigue/unusual tiredness", "heart palpitations", "vomiting" and "felt sick" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) ok; electrocardiogram: (2021) ok; oxygen saturation: (2021) ok; pulmonary function test: (2021) ok; sars-cov-2 test: (unspecified date) no - negative covid-19 test. Clinical course reported as follows: The patient woke up on the morning of the 1st, feeling like the patient had a hangover, as the day progressed, the patient felt worse, but could not explain how the patient felt, just strange by 17:00 the patient was getting short of breath, struggling to hold a conversation, go upstairs, shower. By about 10pm, the patient had severe shortness of breath, the patient could not walk across a room, lay down, talk, the patient felt sick, by the time the patient got to a sink the patient thought was going to die. Wife wanted to take the patient to accident and emergency (A&E) but the patient knew the patient would not be able to get to the car, and the patient wouldn''t let her call an ambulance, but wish the patient had. This continued to 07:00 ish on the 2nd. The patient then started to feel better, able to walk around a bit better, and as the day progressed felt better. After a bit of research thought it may be a reaction to the vaccine so called General practitioner (GP) and he wanted to see the patient straight away 17:00. The symptoms did not lead to a hospital stay. The symptoms were a diagnosis made by a medical professional. The patient was happy to contact GP. There we''re not any blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. It was reported as none if the patient had any other recent or ongoing illness. The patient had 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: 1972919 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Immunisation, Interchange of vaccine products, Off label use, Pruritus, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: CETIRIZINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101758697

Write-up: Giant hives; Primary immunisation series: non-Pfizer manufacturer; Booster: COMIRNATY; Primary immunisation series: non-Pfizer manufacturer; Booster: COMIRNATY; Patient received booster dose of COMIRNATY; hives; persistent itch; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory number: GB-MHRA-WEBCOVID-202112081108048250-3BR4O (MHRA). Other Case identifier: GB-MHRA-ADR 26306757 (MHRA). A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: Fl1939) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: CETIRIZINE. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE,Lot Number: unknown, Route of administration: unspecified, Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, SINGLE,Lot Number: unknown, Route of administration: unspecified, Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 25Nov2021, outcome "unknown" and all described as "Primary immunisation series: non-Pfizer manufacturer; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Patient received booster dose of COMIRNATY"; URTICARIA (medically significant) with onset 2021, outcome "not recovered", described as "hives"; ANGIOEDEMA (medically significant) with onset 26Nov2021, outcome "not recovered", described as "Giant hives"; PRURITUS (medically significant) with onset 2021, outcome "not recovered", described as "persistent itch". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of urticaria, angioedema, pruritus and included treatment with certirizine hydroloride 10 mg (MANUFACTURER UNKNOWN). Clinical course: The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1972964 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Diarrhoea, Immunisation, Product use issue, SARS-CoV-2 test, Stool analysis
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211015; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 2021; Test Name: Stool sample; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101758675

Write-up: Diarrhoea; COMIRNATY was administered on same day when Influenza vaccine was administered; The patient received third/booster dose of COMIRNATY; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from a Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112081548230030-UEZTS. Other Case identifier(s): GB-MHRA-ADR 26308697. A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VIRUS), administration date 25Nov2021 (Batch/Lot number: unknown) for immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. 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 25Nov2021, outcome "unknown", described as "The patient received third/booster dose of COMIRNATY"; DIARRHOEA (medically significant) with onset 01Dec2021, outcome "recovered" (06Dec2021), described as "Diarrhoea"; PRODUCT USE ISSUE (non-serious) with onset 25Nov2021, outcome "unknown", described as "COMIRNATY was administered on same day when Influenza vaccine was administered". The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results; sars-cov-2 test: (15Oct2021) no - negative covid-19 test; stool analysis: (2021) unknown results. Patient had 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: 1973395 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6270 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Hypoaesthesia, Immunisation, Lumbar puncture, Myalgia, Paraparesis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: rachicentesis; Result Unstructured Data: Test Result:no results
CDC Split Type: ITPFIZER INC202101742592

Write-up: progressive paraparesis with suspected S. Guillan Barre; Progressive lower limb hypostenia up to the upper thoracic level; Progressive lower limb hypostenia with hypoesthesia up to the upper thoracic level; diffuse myalgias; booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from a regulatory authority. Regulatory number: IT-MINISAL02-817346 (RA). A 56 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 19:37 (Lot number: FG6270, Expiration Date: 31Mar2022) as dose 3 (booster), 0.3 ml, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown, Primary immunisation completed), for covid-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown, Primary immunisation completed), for covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 25Nov2021, outcome "unknown", described as "booster"; PARAPARESIS (hospitalization, medically significant) with onset 27Nov2021, outcome "unknown", described as "progressive paraparesis with suspected S. Guillan Barre"; ASTHENIA (hospitalization) with onset 27Nov2021, outcome "unknown", described as "Progressive lower limb hypostenia up to the upper thoracic level"; HYPOAESTHESIA (hospitalization) with onset 27Nov2021, outcome "unknown", described as "Progressive lower limb hypostenia with hypoesthesia up to the upper thoracic level"; MYALGIA (hospitalization) with onset 27Nov2021, outcome "unknown", described as "diffuse myalgias". The patient underwent the following laboratory tests and procedures: lumbar puncture: no results. Therapeutic measures were taken as a result of paraparesis, asthenia, hypoaesthesia, myalgia. Additional information: The patient is subjected to rachicentesis and cortisone therapy and Immunoglobulins intravenously. Denies any noteworthy medical conditions. No follow-up attempts are possible. No further information is expected. .


VAERS ID: 1973681 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Nausea, Oxygen saturation, Oxygen saturation decreased, Syncope, Vital signs measurement
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:80/50 mmHg; Comments: after vaccination; Test Date: 20211125; Test Name: 02 saturation; Test Result: 87 %; Comments: after vaccination; Test Date: 20211125; Test Name: vital signs; Result Unstructured Data: Test Result: within normal limits.
CDC Split Type: PHPFIZER INC202101759003

Write-up: FAINTING; NAUSEA; Lightheadedness; Oxygen saturation decreased; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300122626 (RA). A 19 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 10:55 (Batch/Lot number: unknown) at the age of 19 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 25Nov2021 11:10, outcome "recovered" (25Nov2021 12:15), described as "FAINTING"; OXYGEN SATURATION DECREASED (medically significant) with onset 25Nov2021, outcome "unknown", described as "Oxygen saturation decreased"; NAUSEA (medically significant) with onset 25Nov2021 11:10, outcome "recovered" (25Nov2021 12:15), described as "NAUSEA"; DIZZINESS (medically significant) with onset 25Nov2021, outcome "unknown", described as "Lightheadedness". The events "fainting", "oxygen saturation decreased", "nausea" and "lightheadedness" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (25Nov2021) 80/50 mmHg, notes: after vaccination; oxygen saturation: (25Nov2021) 87%, notes: after vaccination; vital signs measurement: (25Nov2021) within normal limits. Therapeutic measures were taken as a result of syncope, oxygen saturation decreased, nausea, dizziness and included intravenous fluids (IVF) and oxygen. Clinical course: Patient verbalized that he only had cereals during his breakfast. 12:15 pm vital signs was re checked, within normal limits. Patient was sent home after. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1973732 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FIT4752 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Nasopharyngitis, 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 INC202101759409

Write-up: Fainting; Cold; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300123488. A 15 year-old male patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Lot number: FIT4752) 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: SYNCOPE (medically significant) with onset 25Nov2021 18:00, outcome "recovered", described as "Fainting"; NASOPHARYNGITIS (non-serious) with onset 25Nov2021 18:00, outcome "recovered", described as "Cold". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1973778 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32025BD / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate
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: 20211125; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:160/110 mmHg; Comments: pre-vaccination; Test Date: 20211125; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:186/113 mmHg; Comments: post vaccination; Test Date: 20211125; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:170/80 mmHg; Comments: repeat measurement after being advised to rest.; Test Date: 20211125; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: pre-vaccination; Test Date: 20211125; Test Name: Heart rate; Result Unstructured Data: Test Result:137; Comments: bpm pre-vaccination; Test Date: 20211125; Test Name: Heart rate; Result Unstructured Data: Test Result:134; Comments: bpm post-vaccination
CDC Split Type: PHPFIZER INC202101760098

Write-up: Elevated BP/160/110 mmHg, 186/113 mmHg; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300124628 (PHFDA). A 36 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Lot number: 32025BD) at the age of 36 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 25Nov2021, outcome "recovered" (25Nov2021), described as "Elevated BP/160/110 mmHg, 186/113 mmHg". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (25Nov2021) 160/110 mmHg, notes: pre-vaccination; (25Nov2021) 186/113 mmHg, notes: post vaccination; (25Nov2021) 170/80 mmHg, notes: repeat measurement after being advised to rest; body temperature: (25Nov2021) 36.3 Centigrade, notes: pre-vaccination; heart rate: (25Nov2021) 137, notes: bpm pre-vaccination; (25Nov2021) 134, notes: bpm post-vaccination. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1974924 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Immunisation, Malaise, Myalgia, Nausea, Pyrexia, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101779469

Write-up: Booster; Fatigue; Nausea; Feeling unwell; Shivering; Headache; Muscle pain; Joint pain; Injection site reaction; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency WEB. Regulatory number: BE-FAMHP-DHH-N2021-109970 (RA). A 35 year-old female patient received BNT162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3, 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; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: IMMUNISATION (disability), described as "Booster"; FATIGUE (disability); NAUSEA (disability); MALAISE (disability), described as "Feeling unwell"; CHILLS (disability), described as "Shivering"; HEADACHE (disability); MYALGIA (disability), described as "Muscle pain"; ARTHRALGIA (disability), described as "Joint pain"; VACCINATION SITE REACTION (disability, described as "Injection site reaction"; PYREXIA (disability), described as "Fever" all with onset 25Nov2021, outcome "recovered" (26Nov2021). Therapeutic measures were not taken as a result of immunisation, fatigue, nausea, malaise, chills, headache, myalgia, arthralgia, vaccination site reaction, pyrexia. Reporter Comment: Treatment - No Evolution of the ADR - Recovery No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Treatment - No Evolution of the ADR - Recovery


VAERS ID: 1975095 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Immunisation, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101761975

Write-up: Headache; Myalgia; Chills; Feeling unwell; Fatigue; Booster; This is a spontaneous report received from a contactable reporter from the Regulatory Authority. Regulatory number: BE-FAMHP-DHH-N2021-110187. A 29 year-old male patient received bnt162b2, administration date 25Nov2021 (Lot number: FH8469) as dose 3, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/lot:EM0477), administration date: 14Jan2021, for COVID-19 immunisation; BNT162B2 (Dose 2, Batch/lot:EK9788), administration date: 04Feb2021, for COVID-19 immunisation. The following information was reported: immunization with onset 25Nov2021, outcome unknown; headache, myalgia, chills, malaise and fatigue Therapeutic measures were not taken as a result of headache, myalgia, chills, malaise, fatigue. Reporter Comment: Treatment � No. Evolution of the ADR - Restored: 2 days. ADR time relationship - Complaints started in the evening of 26Nov2021. No follow-up attempts are possible. No further information is expected. Reporter''s Comments: Treatment � No. Evolution of the ADR - Restored: 2 days. ADR time relationship - complaints started in the evening of 26Nov2021.


VAERS ID: 1975368 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FM3289 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Fatigue, Headache, Hypertension, Immunisation, Pyrexia, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: AROMASIN; ELTHYRONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Barlow''s syndrome (in remission); Breast cancer
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: BEPFIZER INC202101762025

Write-up: Booster; Tachycardia; Shivering; Exhaustion; Headache; Fever 38C; Hypertension; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-110353 (RA). A 48 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FM3289) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2014 (unspecified if ongoing); "Barlow''s disease" (unspecified if ongoing), notes: in remission. Concomitant medication(s) included: AROMASIN; ELTHYRONE. Vaccination history included: Comirnaty (Dose 2, Lot: EK9788), administration date: 23Feb2021, for COVID-19 immunisation; Comirnaty (Dose 1, Lot: EJ6134), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; TACHYCARDIA (disability) with onset 25Nov2021, outcome "recovered", described as "Tachycardia"; CHILLS (disability) with onset 25Nov2021, outcome "recovered", described as "Shivering"; FATIGUE (disability) with onset 25Nov2021, outcome "recovered", described as "Exhaustion"; HEADACHE (disability) with onset 25Nov2021, outcome "recovered with sequelae", described as "Headache"; PYREXIA (disability) with onset 25Nov2021, outcome "recovered", described as "Fever 38C"; HYPERTENSION (disability) with onset 25Nov2021, outcome "recovered", described as "Hypertension"; FATIGUE (disability) with onset 25Nov2021, outcome "recovered with sequelae", described as "Fatigue". The patient underwent the following laboratory tests and procedures: body temperature: (25Nov2021) 38 Centigrade. Therapeutic measures were taken as a result of tachycardia, chills, fatigue, headache, pyrexia, hypertension, fatigue. No follow up attempts are possible. No further information is expected; Reporter''s Comments: Treatment - Yes dafalgan rest total temporary incapacity Evolution of the ADR - Recovered with sequelae: fatigue and headaches Situations - Other: no idea ADR time relationship - it got better after a few days but still fatigue, headaches and high blood pressure ADR description - fever 38 exhaustion headache hypertension tachycardia


VAERS ID: 1975584 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH P-FK8911 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chills, Extensive swelling of vaccinated limb, Headache, Immunisation, Lymphadenopathy, Vaccination site reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101762563

Write-up: Swollen axillary lymph nodes +++ for almost 3 days; Chills: a few hours; Extended swelling of the arm; Axillary nodes painful for almost 3 days; Headache; Injection site reaction; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-110167. A 34-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administration date 25Nov2021 (Lot number: P-FK8911) at an unspecified age, as dose 3, (booster) single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose, lot: EP9598), administration date: 23Feb2021, for covid-19 immunisation; Comirnaty (2nd dose, lot: ER2659), administration date: 16Mar2021, for covid-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 25Nov2021, outcome "unknown", described as "booster"; LYMPHADENOPATHY (disability) with onset 26Nov2021, outcome "recovered" (29Nov2021), described as "Swollen axillary lymph nodes +++ for almost 3 days"; CHILLS (disability) with onset 26Nov2021, outcome "recovered" (26Nov2021), described as "Chills: a few hours"; EXTENSIVE SWELLING OF VACCINATED LIMB (disability) with onset 26Nov2021, outcome "recovered" (29Nov2021), described as "Extended swelling of the arm"; AXILLARY PAIN (disability) with onset 26Nov2021, outcome "recovered" (29Nov2021), described as "Axillary nodes painful for almost 3 days"; HEADACHE (disability) with onset 26Nov2021, outcome "recovered" (2021), described as "Headache"; VACCINATION SITE REACTION (disability) with onset 26Nov2021, outcome "recovered" (29Nov2021), described as "Injection site reaction". Therapeutic measures were not taken as a result of lymphadenopathy, chills, extensive swelling of vaccinated limb, axillary pain, headache, vaccination site reaction. Reporter''s Comment: Chills only lasted a few hours No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Chills only lasted a few hours


VAERS ID: 1976572 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Influenza like illness, Retching, Tinnitus
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZJNJFOC20211246593

Write-up: FLU-LIKE SYMPTOMS; EAR HISSING; DRY HEAVES; This spontaneous report received from a consumer by a Regulatory Authority (regulatory authority, CZ-CZSUKL-21013011) was received on 21-DEC-2021 and concerned a 25 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (Solution for injection, intramuscular, batch number and expiry: unknown) 1 total administered on 25-NOV-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 25-NOV-2021, the patient experienced flu-like symptoms (head pain, chills, fever, malaise, weakness), ear hissing and dry heaves. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu-like symptoms, ear hissing and dry heaves. This report was serious (Other Medically Important Condition).


VAERS ID: 1977186 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-25
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Fatigue, Feeling abnormal, Immunisation, Interchange of vaccine products, Lymph node pain, Lymphadenopathy, Off label use, Syncope, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADCAL D3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Broken wrist; Comments: None - apart from broken wrist in 2019 Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data: Test Name: Blood Pressure; Result Unstructured Data: Test Result:Unknown; Test Name: full blood test; Result Unstructured Data: Test Result:Unknown
CDC Split Type: GBPFIZER INC202101768697

Write-up: Off label Use; Interchange of vaccine products; Booster; Felt tired; lymph nodes were swollen; Fainting; Vertigo; Lymph node pain; Fuzzy head; 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-WEBCOVID-202112081803567110-5XQDN. Other Case identifier(s): GB-MHRA-ADR 26310479. A 65 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Broken wrist", start date: 2019 (unspecified if ongoing). Concomitant medication(s) included: ADCAL D3 taken for blood calcium, start date: 01Apr2019; INFLUENZA VIRUS, administration date 06Oct2021. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 26Feb2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), administration date: 14May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label Use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; SYNCOPE (medically significant) with onset 26Nov2021, outcome "recovered" (26Nov2021), described as "Fainting"; VERTIGO (medically significant) with onset 26Nov2021, outcome "recovered" (06Dec2021), described as "Vertigo"; LYMPH NODE PAIN (medically significant) with onset 26Nov2021, outcome "recovered" (06Dec2021), described as "Lymph node pain"; FEELING ABNORMAL (medically significant) with onset 25Nov2021, outcome "recovered" (06Dec2021), described as "Fuzzy head"; FATIGUE (medically significant), outcome "unknown", described as "Felt tired"; LYMPHADENOPATHY (medically significant), outcome "unknown", described as "lymph nodes were swollen". The patient underwent the following laboratory tests and procedures: blood pressure measurement: unknown; blood test: unknown. Clinical course: Fainted 24 hrs after jab - was out shopping. After recovering I went to bed but had severe vertigo and my lymph nodes were swollen. Felt tired and had a fuzzy head for 10 days. 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; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1977910 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Immunisation, Pain, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101806205

Write-up: Dose number 3; pain; period following each dose of the vaccine has been heavier and caused a lot more pain than usual; period following each dose of the vaccine has been heavier and caused a lot more pain than usual; caused to vomit; blood has flooded a few times; 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-202112152139365110-WV5JO (RA). Other Case identifier(s): GB-MHRA-ADR 26341269 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing). The patient''s concomitant medications were not reported. The patient did not have symptoms associated with COVID-19 and was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE,Lot Number: UNKNOWN), administration date: 18Mar2021, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered", "Menstrual cramp", "Bleeding menstrual heavy"; Bnt162b2 (DOSE 1, SINGLE,Lot Number: UNKNOWN), administration date: 01Jan2021, for COVID-19 immunisation, reaction(s): "Bleeding menstrual heavy", "Menstrual cramp", "Menstrual flow altered". The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Dose number 3"; PAIN (medically significant) with onset 2021, outcome "recovering", described as "pain"; DYSMENORRHOEA (medically significant), HEAVY MENSTRUAL BLEEDING (medically significant) all with onset 2021, outcome "unknown" and all described as "period following each dose of the vaccine has been heavier and caused a lot more pain than usual"; VOMITING (medically significant) with onset 2021, outcome "unknown", described as "caused to vomit"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 2021, outcome "unknown", described as "blood has flooded a few times". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative covid-19 test. The clinical course was reported as follows: the patient had noticed that her period following each dose of the vaccine had been heavier and had caused a lot more pain than usual. The periods gradually got better however she would then have received another dose and the cycle would have started again. The patient had 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.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101841394 same patient/drug/different dose/ event;GB-PFIZER INC-202101841395 same patient/drug/different dose/ event


VAERS ID: 1978051 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-11-25
   Days after vaccination:255
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER PV46672 / 1 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER PV46684 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEURONTIN; SERTRALINE [SERTRALINE HYDROCHLORIDE]
Current Illness: Penicillin allergy
Preexisting Conditions: Comments: Allergic reaction to penicillin, I take neurontin 300mg brisk upper plantars Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210307; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Nausea; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25001879) on 15-Dec-2021 and was forwarded to Moderna on 15-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Co-suspect products included non-company products COVID-19 VACCINE (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination and COVID-19 VACCINE (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. Allergic reaction to penicillin, I take neurontin 300mg brisk upper plantars Patient has not had symptoms associated with COVID-19. Concurrent medical conditions included Penicillin allergy. Concomitant products included SERTRALINE HYDROCHLORIDE (SERTRALINE [SERTRALINE HYDROCHLORIDE]) from 19-Nov-2021 to an unknown date for Anxiety, GABAPENTIN (NEURONTIN) from 01-Mar-2013 to an unknown date for an unknown indication. On 15-Mar-2021, the patient received first dose of COVID-19 VACCINE (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 22-May-2021, the patient received second dose of COVID-19 VACCINE (COVID-19 VACCINE ASTRAZENECA) (unknown route) UNK, Dose 2. On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 28-Nov-2021, NAUSEA (Nausea) and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-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. No treatment drugs were reported Patient is allergic to pencilline Patient take neurontin 300mg brisk upper plantars Patient has not had symptoms associated with COVID-19 Minerva interuterine coil for menopause Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Indication for NEURONTIN was Wear and tear neurological Company Comment: This case concerns a 57 year-old female patient with no reported relevant medical history who experienced the unexpected serious event of nausea and headache 1 day after vaccination with mRNA-1273 vaccine, taken as a third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 57 year-old female patient with no reported relevant medical history who experienced the unexpected serious event of nausea and headache 1 day after vaccination with mRNA-1273 vaccine, taken as a third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1978312 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Anaphylactic reaction, Chest discomfort, Depressed level of consciousness, Dizziness, Feeling of body temperature change, Hypoaesthesia, Nausea, Oxygen saturation, Throat tightness, Tremor, Vaccination site pain, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (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 (narrow), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: O2 sats; Test Result: 98 %; Comments: at 24mins after vaccination
CDC Split Type: NZPFIZER INC202101760465

Write-up: Anaphylactic reaction; Depressed level of consciousness; Agitation; Chest discomfort; Dizziness; Feeling of body temperature change; Hypoaesthesia; Injection site pain; Nausea; Throat tightness; Tremor; Wheezing; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: AEFI-A-051568 (MedSafe AEFI Case Number). A 36 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (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: ANAPHYLACTIC REACTION (medically significant) with onset 25Nov2021 17:40, outcome "recovered" (2021), described as "Anaphylactic reaction"; DEPRESSED LEVEL OF CONSCIOUSNESS (medically significant) with onset 25Nov2021 17:40, outcome "recovering", described as "Depressed level of consciousness"; AGITATION (medically significant) with onset 25Nov2021 17:40, outcome "recovering", described as "Agitation"; CHEST DISCOMFORT (medically significant) with onset 25Nov2021 17:40, outcome "recovering", described as "Chest discomfort"; DIZZINESS (medically significant) with onset 25Nov2021 17:40, outcome "recovering", described as "Dizziness"; FEELING OF BODY TEMPERATURE CHANGE (medically significant) with onset 25Nov2021 17:40, outcome "recovering", described as "Feeling of body temperature change"; HYPOAESTHESIA (medically significant) with onset 25Nov2021 17:40, outcome "recovering", described as "Hypoaesthesia"; VACCINATION SITE PAIN (medically significant) with onset 25Nov2021 17:40, outcome "recovering", described as "Injection site pain"; NAUSEA (medically significant) with onset 25Nov2021 17:40, outcome "recovering", described as "Nausea"; THROAT TIGHTNESS (medically significant) with onset 25Nov2021 17:40, outcome "recovering", described as "Throat tightness"; TREMOR (medically significant) with onset 25Nov2021 17:40, outcome "recovering", described as "Tremor"; WHEEZING (medically significant) with onset 25Nov2021 17:40, outcome "recovering", described as "Wheezing". The patient underwent the following laboratory tests and procedures: oxygen saturation: (25Nov2021) 98 %, notes: at 24mins after vaccination. Additional information: Reporters description of AEFI: - Hot arm occurring immediately at site of vaccination, Chest tightness and stridor began 7 to 9mins after injection, Patient describing swelling of throat at 16mins after injection, Adrenaline (BN:950013 - EXP:11/2021) (o.5mL 1:1000) administered 18mins after injection, Improvement in sx within 1min of administering adrenaline. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1978343 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-11-25
   Days after vaccination:169
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD986 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211125; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive IU international unit (s)
CDC Split Type: PTJNJFOC20211248526

Write-up: VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory Authority (PT-INFARMED-T202112-552) on 22-DEC-2021 and concerned a 52 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: XD986 expiry: UNKNOWN) 0.5 ml, dose number in series was 1, administered 1 in total on 09-JUN-2021 for covid-19 immunisation. The drug start period (latency) was 169 days. No concomitant medications were reported. On 25-NOV-2021, the patient experienced vaccination failure (dose number in series was 1). Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive IU international unit (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint, and reference number requested.


VAERS ID: 1979446 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Dyspnoea, Fatigue, Headache, Myalgia, Pain in extremity, Pyrexia, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: Body temperature; Result Unstructured Data: Test Result:38.8 Centigrade
CDC Split Type: BEPFIZER INC202101774282

Write-up: Shortness of breath; Pain in arm; Fever 38,8; Fatigue; Headache; Arthralgia; Myalgia; vaccination site reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-110022 (RA). A 26 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FH8469) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (disability) with onset 25Nov2021, outcome "recovering", described as "Shortness of breath"; PAIN IN EXTREMITY (disability) with onset 25Nov2021, outcome "recovering", described as "Pain in arm"; PYREXIA (disability) with onset 25Nov2021, outcome "recovering", described as "Fever 38,8"; FATIGUE (disability) with onset 25Nov2021, outcome "recovering", described as "Fatigue"; HEADACHE (disability) with onset 25Nov2021, outcome "recovering", described as "Headache"; ARTHRALGIA (disability) with onset 25Nov2021, outcome "recovering", described as "Arthralgia"; MYALGIA (disability) with onset 25Nov2021, outcome "recovering", described as "Myalgia"; VACCINATION SITE REACTION (disability) with onset 25Nov2021, outcome "recovering", described as "vaccination site reaction". The patient underwent the following laboratory tests and procedures: body temperature: (25Nov2021) 38.8 Centigrade. Therapeutic measures were taken as a result of pain in extremity, pyrexia, fatigue, headache, arthralgia, myalgia, vaccination site reaction. Reporter Comment: Treatment: Ibuprofen. Evolution of the ADR: Healing. Situations: Other: not mentioned. ADR description: Severe muscle aches, fever (38.8), arm pain plus shortness of breath and breathlessness. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment: Ibuprofen. Evolution of the ADR: Healing. Situations: Other: not mentioned. ADR description: Severe muscle aches, fever (38.8), arm pain plus shortness of breath and breathlessness.


VAERS ID: 1979857 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-05
Onset:2021-11-25
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Antithrombin III, Blood creatinine, Blood disorder, Blood fibrinogen, Blood pressure measurement, Cardiolipin antibody negative, Cerebral venous thrombosis, Cerebrovascular accident, Cluster headache, Coagulation test, Computerised tomogram, Electrocardiogram, Factor II mutation, Factor V Leiden mutation, Full blood count, HIV test, Heart rate, Hepatitis B virus test, Hepatitis C virus test, Immunology test, Janus kinase 2 mutation, Lumbar puncture, Magnetic resonance imaging head, Neurological examination, Oedema peripheral, Prothrombin level, Seizure, Thrombophlebitis, Vital signs measurement
SMQs:, Cardiac failure (broad), Angioedema (broad), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Headache (no medical history of venous thromboembolism)
Allergies:
Diagnostic Lab Data: Test Date: 20211126; Test Name: antithrombin III; Result Unstructured Data: Test Result:Pending; Test Date: 20211126; Test Name: Serum creatinine; Result Unstructured Data: Test Result:Normal; Test Date: 20211126; Test Name: Thrombocytopaenia; Result Unstructured Data: Test Result:normal protein C/S; Test Date: 20211126; Test Name: Fibrinogen; Result Unstructured Data: Test Result:unknown results; Test Date: 20211126; Test Name: Blood pressure; Result Unstructured Data: Test Result:110/55 mmHg; Test Date: 20211126; Test Name: Anticardiolipids; Result Unstructured Data: Test Result:Negative; Test Date: 20211126; Test Name: NIHSS; Result Unstructured Data: Test Result:0; Comments: Stroke Scale score; Test Date: 20211126; Test Name: headaches evaluated; Result Unstructured Data: Test Result:7/10; Test Date: 20211126; Test Name: Coagulation assessment; Result Unstructured Data: Test Result:Normal; Comments: Coagulation assessment (including prothrombin time, partial thromboplastin time, fibrinogen); Test Date: 20211126; Test Name: Brain computed tomography; Result Unstructured Data: Test Result:cerebral thrombophlebitis of the right sinus; Comments: no hemorrhagic/oedematous change; Test Date: 20211126; Test Name: Electrocardiography; Result Unstructured Data: Test Result:normal; Test Date: 20211126; Test Name: mutation of factor II; Result Unstructured Data: Test Result:None; Test Date: 20211126; Test Name: Factor V Leiden mutation; Result Unstructured Data: Test Result:None; Test Date: 20211126; Test Name: blood count with platelets; Result Unstructured Data: Test Result:355 g/l; Test Date: 20211126; Test Name: heart rate; Result Unstructured Data: Test Result:70; Comments: BPM; Test Date: 20211126; Test Name: Hepatitis B virus; Result Unstructured Data: Test Result:Negative; Test Date: 20211126; Test Name: Hepatitis C Virus; Result Unstructured Data: Test Result:Negative; Test Date: 20211126; Test Name: Human Immunodeficiency Virus; Result Unstructured Data: Test Result:Negative; Test Date: 20211126; Test Name: Anti beta2-glycoprotein 1; Result Unstructured Data: Test Result:Negative; Test Date: 20211126; Test Name: Janus Kinase 2 gene mutation; Result Unstructured Data: Test Result:Pending; Test Date: 20211126; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:Normal; Test Date: 20211126; Test Name: Brain MRI; Result Unstructured Data: Test Result:cerebral thrombophlebitis of the right sinus; Comments: without hemorrhagic/oedematous change; Test Date: 20211126; Test Name: Neurological exam; Result Unstructured Data: Test Result:Normal; Comments: neurological exam was normal without sensory or motor deficit or pyramidal anomaly; Test Date: 20211126; Test Name: Oedematous; Result Unstructured Data: Test Result:No change; Test Date: 20211126; Test Name: Prothrombin time; Result Unstructured Data: Test Result:unknown results; Test Date: 20211126; Test Name: Febrile results; Result Unstructured Data: Test Result:Afebrile; Comments: On admission the patient was afebrile; Test Date: 20211126; Test Name: Cerebral thrombophlebitis; Result Unstructured Data: Test Result:Cerebral thrombophlebitis of the right sinus; Comments: without hemorrhagic/oedematous change; Test Date: 20211126; Test Name: Vitals monitoring; Result Unstructured Data: Test Result:No abnormalities; Comments: no rhythm abnormalities detected
CDC Split Type: FRPFIZER INC202101779404

Write-up: Cerebral venous thrombosis; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-PO20215638 (RA). A 30 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 05Nov2021 (Batch/Lot number: unknown) as dose 2, 0.3 ml single for COVID-19 immunisation; ethinylestradiol (ETHINYLESTRADIOL), oral from 19Nov2021 (Batch/Lot number: unknown) to 26Nov2021 at 30 ug 1x/day for contraception; levonorgestrel (LEVONORGESTREL), oral from 19Nov2021 (Batch/Lot number: unknown) to 26Nov2021 at 150 ug 1x/day for contraception. Relevant medical history included: "Tesnion headache" (unspecified if ongoing), notes: no medical history of venous thromboembolism; "Contraception" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Povidone excipient k 90; Lactose monohydrate; Saccharose; Talc; Ethinylestradiol; Macrogol 6000; Levonorgestrel; Povidone excipient k 25, start date: 19Nov2021. Vaccination history included: Comirnaty (Dose 1, Single, Strength: 0.3ml, Route of Administration: Intramuscular), administration date: 14Oct2021, for COVID-19 immunisation. The following information was reported: CEREBRAL VENOUS THROMBOSIS (hospitalization) with onset 25Nov2021, outcome "recovered" (01Dec2021), described as "Cerebral venous thrombosis". The patient was hospitalized for cerebral venous thrombosis (start date: 26Nov2021). The patient underwent the following laboratory tests and procedures: antithrombin iii: (26Nov2021) pending; blood creatinine: (26Nov2021) normal; blood disorder: (26Nov2021) normal protein c/s; blood fibrinogen: (26Nov2021) unknown results; blood pressure measurement (55-110): (26Nov2021) 110/55 mmHg; cardiolipin antibody negative: (26Nov2021) negative; cerebrovascular accident: (26Nov2021) 0, notes: Stroke Scale score; cluster headache (7-10): (26Nov2021) 7/10; coagulation test: (26Nov2021) normal, notes: Coagulation assessment (including prothrombin time, partial thromboplastin time, fibrinogen); computerised tomogram: (26Nov2021) cerebral thrombophlebitis of the right sinus, notes: no hemorrhagic/oedematous change; electrocardiogram: (26Nov2021) normal; factor ii mutation: (26Nov2021) none; factor v leiden mutation: (26Nov2021) none; full blood count (normal low range 355): (26Nov2021) 355 g/l; heart rate: (26Nov2021) 70, notes: BPM; hepatitis b virus test: (26Nov2021) negative; hepatitis c virus test: (26Nov2021) negative; hiv test: (26Nov2021) negative; immunology test: (26Nov2021) negative; janus kinase 2 mutation: (26Nov2021) pending; lumbar puncture: (26Nov2021) normal; magnetic resonance imaging head: (26Nov2021) cerebral thrombophlebitis of the right sinus, notes: without hemorrhagic/oedematous change; neurological examination: (26Nov2021) normal, notes: neurological exam was normal without sensory or motor deficit or pyramidal anomaly; oedema peripheral: (26Nov2021) no change; prothrombin level: (26Nov2021) unknown results; seizure: (26Nov2021) afebrile, notes: On admission the patient was afebrile; thrombophlebitis: (26Nov2021) cerebral thrombophlebitis of the right sinus, notes: without hemorrhagic/oedematous change; vital signs measurement: (26Nov2021) no abnormalities, notes: no rhythm abnormalities detected. The action taken for ethinylestradiol and levonorgestrel was dosage permanently withdrawn on 26Nov2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1979888 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCVD1 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood electrolytes, Blood fibrinogen, Blood glucose, Blood pressure measurement, Body temperature, C-reactive protein, Coagulation test, Dysarthria, Electrocardiogram, Fibrinolysis, Full blood count, Heart rate, Hemiparesis, Immunisation, Ischaemic stroke, Lipids, Liver function test, Magnetic resonance imaging, Oxygen saturation, SARS-CoV-2 test, Urine analysis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BISOPROLOL; MIANSERIN; MONOPROST; TRANSIPEG [MACROGOL]; ZOPICLONE; KARDEGIC; PRADAXA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Accelerated hypertension; Cataract; Cognitive disorders (early cognitive disorders); Cognitive disturbance; Glaucoma; Hip replacement (Left total hip replacement(2013)); PTHrP
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Electrolytes; Result Unstructured Data: Test Result:Sodium 139 mmol/L; Comments: Sodium 139 mmol/L; potassium 4.3 mmol/L, urea 6.3 mmol/L, creatinine 75 micrometermol/L. Estimated creatinine clearance 62 mL/min (Chronic Kidney Disease Epidemiology Collaboration) Protein 71 g/L. Troponin 14 pmol/L. Glycated haemoglobin 5.7 %. Thyroid stimulating hormone 2.03 micrometerU/ml. - Blood glucose 1.2 g/L; Test Date: 2021; Test Name: Fibrinogen; Result Unstructured Data: Test Result:2.56 g/l; Test Date: 2021; Test Name: blood glucose; Result Unstructured Data: Test Result:1.42 g/l; Test Date: 20211128; Test Name: blood glucose; Result Unstructured Data: Test Result:balanced g/l; Comments: balanced fasting blood glucose; Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:119/97 mmHg; Test Date: 20211128; Test Name: Blood pressure; Result Unstructured Data: Test Result:Normal mmHg; Test Date: 2021; Test Name: Temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 2021; Test Name: Coagulation; Result Unstructured Data: Test Result:Prothrombin time [PT] 91 %; Comments: Prothrombin time [PT] 91 %, activated partial thromboplastin time [PTT] ratio 0.88; Test Date: 2021; Test Name: C-reactive protein; Result Unstructured Data: Test Result:4.8 mg/l; Test Date: 2021; Test Name: Electrocardiography; Result Unstructured Data: Test Result:Sinus rhythm, PR interval normal; Comments: Sinus rhythm, PR interval normal, left axis deviation, no bundle branch block, no repolarisation disorders. Left anterior hemiblock.; Test Date: 2021; Test Name: D-dimers; Result Unstructured Data: Test Result:11.74 micrometerg/mL; Test Date: 2021; Test Name: Complete blood count; Result Unstructured Data: Test Result:haemoglobin 13.2 g/dL; Comments: haemoglobin 13.2 g/dL, haematocrit 39.9 %, mean corpuscular volume 96 fL, platelets 234 G/L, white blood cells 7.8 G/L.; Test Date: 2021; Test Name: heart rate; Result Unstructured Data: Test Result:70 bpm; Test Date: 2021; Test Name: Lipid tests; Result Unstructured Data: Test Result:total cholesterol 1.4 g/L; Comments: total cholesterol 1.4 g/L, triglycerides 0.84 g/L, high density lipoprotein 0.38 g/L, low density lipoprotein 0.86 g/L.; Test Date: 2021; Test Name: Liver function tests; Result Unstructured Data: Test Result:total bilirubin 13 micrometermol/L; Comments: total bilirubin 13 micrometermol/L, conjugated bilirubin 4 micrometermol/L, unconjugated bilirubin 8 micrometermol/L, aspartate aminotransferase 25 IU/L, alanine aminotransferase 14 IU/L, alkaline phosphatase 56 IU/L, Gamma-glutamyl transpeptidase 22 IU/L. Creatine phosphokinase 102 IU/L.; Test Date: 2021; Test Name: magnetic resonance imaging; Result Unstructured Data: Test Result:National Institutes of Health Stroke Scale 6; Comments: National Institutes of Health Stroke Scale 6: Left central facial palsy +2, dysarthria +1, drop on Barre test +1, drop on left Mingazzini test +1, left lower limb sensory neglect +1, no homonymous lateral hemianopia or hemineglect.; Test Date: 20211126; Test Name: magnetic resonance imaging; Result Unstructured Data: Test Result:Increased signal diffusion; Comments: Increased signal diffusion with contrast medium restriction from the right centrum semiovale, without overt consistency in the fluid-attenuated inversion recovery sequences (increased fluid-attenuated inversion recovery signal intensity consistent with leukoencephalopathy in this area). Vascular occlusion at the junction between segments M1 (proximal segment) and M2 (insular segment), with finding of a thrombus in the susceptibility weighted imaging sequences. No haemorrhagic changes. No midline shift. No hydrocephalus. No significant carotid or vertebral artery stenosis.; Test Date: 2021; Test Name: oxygen saturation; Test Result: 95 %; Comments: oxygen saturation in room air; Test Date: 20211126; Test Name: SARS-Cov-2 test; Test Result: Negative ; Comments: COVID polymerase chain reaction test.; Test Date: 2021; Test Name: Urine dipstick; Result Unstructured Data: Test Result:proteinuria +2; Comments: proteinuria +2. Proteinuria 0.16 g/L. Proteinuria/Creatinuria 0.27 g/g
CDC Split Type: FRPFIZER INC202101773532

Write-up: Ischemic stroke; Booster; Hemiparesis (left); Dysarthria; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-RS20214122. A 89 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Lot number: SCVD1) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Cognitive disturbance" (unspecified if ongoing); "PTHrP" (unspecified if ongoing); "Cataract" (unspecified if ongoing); "Accelerated hypertension" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "cognitive disorders" (unspecified if ongoing), notes: early cognitive disorders; "hip replacement", start date: 2013 (unspecified if ongoing), notes: Left total hip replacement(2013). Concomitant medication(s) included: BISOPROLOL; MIANSERIN; MONOPROST; TRANSIPEG [MACROGOL]; ZOPICLONE; KARDEGIC (ongoing); PRADAXA, start date: 02Dec2021 (ongoing). Vaccination history included: Comirnaty (DOSE 1, Date: 14Apr2021, Batch: EW2246), administration date: 14Apr2021, for COVID-19 immunisation; Comirnaty (DOSE 2, Date: 04May2021, Batch ET6956), administration date: 04May2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; ISCHAEMIC STROKE (hospitalization, medically significant) with onset 26Nov2021, outcome "recovering", described as "Ischemic stroke"; HEMIPARESIS (medically significant) with onset 26Nov2021, outcome "unknown", described as "Hemiparesis (left)"; DYSARTHRIA (medically significant) with onset 26Nov2021, outcome "unknown", described as "Dysarthria". The event "ischemic stroke" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood electrolytes: (2021) sodium 139 mmol/l, notes: Sodium 139 mmol/L; potassium 4.3 mmol/L, urea 6.3 mmol/L, creatinine 75 micrometermol/L. Estimated creatinine clearance 62 mL/min (Chronic Kidney Disease Epidemiology Collaboration) Protein 71 g/L. Troponin 14 pmol/L. Glycated haemoglobin 5.7 %. Thyroid stimulating hormone 2.03 micrometerU/ml. - Blood glucose 1.2 g/L; blood fibrinogen: (2021) 2.56 g/l; blood glucose: (2021) 1.42 g/l; (28Nov2021) balanced, notes: balanced fasting blood glucose; blood pressure measurement: (2021) 119/97 mmHg; (28Nov2021) normal; body temperature: (2021) 36.8 Centigrade; coagulation test: (2021) prothrombin time [pt] 91 %, notes: Prothrombin time [PT] 91 %, activated partial thromboplastin time [PTT] ratio 0.88; c-reactive protein: (2021) 4.8 mg/l; electrocardiogram: (2021) sinus rhythm, pr interval normal, notes: Sinus rhythm, PR interval normal, left axis deviation, no bundle branch block, no repolarisation disorders. Left anterior hemiblock; fibrinolysis: (2021) 11.74 micrometerg/ml; full blood count: (2021) haemoglobin 13.2 g/dl, notes: haemoglobin 13.2 g/dL, haematocrit 39.9 %, mean corpuscular volume 96 fL, platelets 234 G/L, white blood cells 7.8 G/L; heart rate: (2021) 70 bpm; lipids: (2021) total cholesterol 1.4 g/l, notes: total cholesterol 1.4 g/L, triglycerides 0.84 g/L, high density lipoprotein 0.38 g/L, low density lipoprotein 0.86 g/L; liver function test: (2021) total bilirubin 13 micrometermol/l, notes: total bilirubin 13 micrometermol/L, conjugated bilirubin 4 micrometermol/L, unconjugated bilirubin 8 micrometermol/L, aspartate aminotransferase 25 IU/L, alanine aminotransferase 14 IU/L, alkaline phosphatase 56 IU/L, Gamma-glutamyl transpeptidase 22 IU/L. Creatine phosphokinase 102 IU/L; magnetic resonance imaging: (2021) national institutes of health stroke scale 6, notes: National Institutes of Health Stroke Scale 6: Left central facial palsy +2, dysarthria +1, drop on Barre test +1, drop on left Mingazzini test +1, left lower limb sensory neglect +1, no homonymous lateral hemianopia or hemineglect; (26Nov2021) increased signal diffusion, notes: Increased signal diffusion with contrast medium restriction from the right centrum semiovale, without overt consistency in the fluid-attenuated inversion recovery sequences (increased fluid-attenuated inversion recovery signal intensity consistent with leukoencephalopathy in this area). Vascular occlusion at the junction between segments M1 (proximal segment) and M2 (insular segment), with finding of a thrombus in the susceptibility weighted imaging sequences. No haemorrhagic changes. No midline shift. No hydrocephalus. No significant carotid or vertebral artery stenosis; oxygen saturation: (2021) 95 %, notes: oxygen saturation in room air; sars-cov-2 test: (26Nov2021) negative, notes: COVID polymerase chain reaction test; urine analysis: (2021) proteinuria +2, notes: proteinuria +2. Proteinuria 0.16 g/L. Proteinuria/Creatinuria 0.27 g/g. Therapeutic measures were taken as a result of ischaemic stroke. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1980028 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Blood test, C-reactive protein, Computerised tomogram, Decreased appetite, Fatigue, Haemorrhage, Headache, Immunisation, Inflammation, Interchange of vaccine products, Malaise, Nausea, Off label use, Pain, Pallor, Spondylitis, Ultrasound Doppler, Uterine enlargement
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (narrow), Medication errors (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ankylosing spondylitis (50 mg subcutaneous injections); Asthma (steroid Fostair inhaler); Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis or other types of arthritis except osteoarthritis); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 202112; Test Name: blood tests; Result Unstructured Data: Test Result:unknown result; Test Date: 202112; Test Name: CT Scan; Result Unstructured Data: Test Result:showed enlarged uterus; Test Date: 202112; Test Name: C-reactive protein (CRP); Result Unstructured Data: Test Result:60; Comments: on admittance; Test Date: 202112; Test Name: C-reactive protein (CRP); Result Unstructured Data: Test Result:98; Comments: on discharge; Test Date: 202112; Test Name: ultrasound; Result Unstructured Data: Test Result:unknown result
CDC Split Type: GBPFIZER INC202101780211

Write-up: Appetite lost; Inflammation; Nausea; Headache; Fatigue; Abdominal pain; massive blood loss; weak; pain; enlarged uterus; unwell; spondylitis; pale; Dose 1 and Dose 2: unknown manufacturer and Dose 3: Pfizer Covid vaccine; Dose 1 and Dose 2: unknown manufacturer and Dose 3: Pfizer Covid vaccine; dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112121329436280-AYQU3 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26324786 (MHRA). A 46 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) 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 osteoarthritis; "Suspected COVID-19", start date: 05Apr2020 (unspecified if ongoing), notes: Unsure when symptoms stopped; "Asthma" (unspecified if ongoing), notes: steroid Fostair inhaler; "Ankylosing spondylitis" (unspecified if ongoing), notes: 50 mg subcutaneous injections. Patient last menstrual period date was on 05Dec2021. Patient did not have a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. Past drug history included: Fostair for Asthma. Vaccination history included: Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (hospitalization), INTERCHANGE OF VACCINE PRODUCTS (hospitalization) all with onset 25Nov2021, outcome "unknown" and all described as "Dose 1 and Dose 2: unknown manufacturer and Dose 3: Pfizer Covid vaccine"; IMMUNISATION (hospitalization) with onset 25Nov2021, outcome "unknown", described as "dose number 3"; MALAISE (hospitalization) with onset Dec2021, outcome "recovering", described as "unwell"; SPONDYLITIS (hospitalization) with onset Dec2021, outcome "recovering", described as "spondylitis"; PALLOR (hospitalization) with onset Dec2021, outcome "recovering", described as "pale"; ABDOMINAL PAIN (hospitalization) with onset 02Dec2021, outcome "not recovered", described as "Abdominal pain"; NAUSEA (hospitalization) with onset 07Dec2021, outcome "not recovered", described as "Nausea"; HEADACHE (hospitalization) with onset 07Dec2021, outcome "not recovered", described as "Headache"; FATIGUE (hospitalization) with onset 05Dec2021, outcome "not recovered", described as "Fatigue"; DECREASED APPETITE (hospitalization) with onset 07Dec2021, outcome "not recovered", described as "Appetite lost"; INFLAMMATION (hospitalization) with onset 07Dec2021, outcome "not recovered", described as "Inflammation"; HAEMORRHAGE (hospitalization, medically significant) with onset Dec2021, outcome "unknown", described as "massive blood loss"; ASTHENIA (hospitalization) with onset Dec2021, outcome "unknown", described as "weak"; PAIN (hospitalization) with onset Dec2021, outcome "unknown", described as "pain"; UTERINE ENLARGEMENT (hospitalization) with onset Dec2021, outcome "unknown", described as "enlarged uterus". The patient was hospitalized for off label use, interchange of vaccine products, immunisation, malaise, spondylitis, pallor, abdominal pain, nausea, headache, fatigue, decreased appetite, inflammation, haemorrhage, asthenia, pain, uterine enlargement (start date: Dec2021). Patient had well managed anklylosing spondylitis. Day 7 after vaccine, she had period bleeding for 3 days which was normal amount of bleeding then lost for 2 further days massive blood loss which made her nauseous, pale and weak so stayed in bed for 2 days. Patient was not due a period as she had a period a week and a half previous. Day after she felt better then got worse, she was admitted to hospital for 4 days to manage pain. CT Scan showed enlarged uterus, but nothing that would explain pain or other symptoms. CPR levels on admittance were 60 and were 98 on discharge. It seemed the vaccine had triggered her immune system to attack her own body. Patient was still unwell. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent the following laboratory tests and procedures: blood test: (Dec2021) unknown result; computerised tomogram: (Dec2021) showed enlarged uterus; c-reactive protein: (Dec2021) 60, notes: on admittance; (Dec2021) 98, notes: on discharge; ultrasound doppler: (Dec2021) unknown result. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1980055 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-11-25
   Days after vaccination:251
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004737 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER PV46679 / 2 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER 4120Z001 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Chest pain, Dry eye, Dyspnoea, Electrocardiogram, Fatigue, Feeling cold, Feeling hot, Freezing phenomenon, Headache, Hyperhidrosis, Lymphadenopathy, Pain, Pain in extremity, Palpitations, Peripheral coldness, SARS-CoV-2 test, Swelling, Tachycardia, Thirst, Tremor, X-ray
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Corneal disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VITAMIN D NOS; MULTIVITAMIN [VITAMINS NOS]
Current Illness: Mitral regurgitation (Having regular check-ups, so far not had any additional issues regarding this in daily life)
Preexisting Conditions: Medical History/Concurrent Conditions: Coarctation of the aorta (Operated on as a child); Herpes simplex type II
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: no indication on infection, inflammation, myocardi; Test Name: ECG; Result Unstructured Data: a bit uneven; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test; Test Name: X-ray; Result Unstructured Data: Normal
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Pain in arm; Feeling of warmth; Feeling cold; Racing heart (tachycardia); Swelling; Heart palpitations; Pain; feel extremely exhausted; Freezing phenomenon; Shortness of breath; Shaking inside; Swollen lymph nodes; Sweaty; Dry eye; Fatigue; Chest burning; Chest pain; Cold hands; Increased thirst; Headache; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26325005) on 14-Dec-2021 and was forwarded to Moderna on 14-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DRY EYE (Dry eye), FATIGUE (Fatigue), THIRST (Increased thirst), CHEST PAIN (Chest burning), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Pain in arm), FEELING HOT (Feeling of warmth), FEELING COLD (Feeling cold), TACHYCARDIA (Racing heart (tachycardia)), SWELLING (Swelling), PALPITATIONS (Heart palpitations), PAIN (Pain), PERIPHERAL COLDNESS (Cold hands), FATIGUE (feel extremely exhausted), HYPERHIDROSIS (Sweaty), DYSPNOEA (Shortness of breath), FREEZING PHENOMENON (Freezing phenomenon), LYMPHADENOPATHY (Swollen lymph nodes), HEADACHE (Headache) and TREMOR (Shaking inside) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004737) for COVID-19 vaccination. Co-suspect products included non-company products COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. The patient''s past medical history included Coarctation of the aorta (Operated on as a child) and Herpes simplex type II. Previously administered products included for Product used for unknown indication: ACICLOVIR. Past adverse reactions to the above products included Herpes simplex type II with ACICLOVIR. Concurrent medical conditions included Mitral regurgitation (Having regular check-ups, so far not had any additional issues regarding this in daily life). Concomitant products included VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 19-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 22-May-2021, the patient received second dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced THIRST (Increased thirst) (seriousness criteria hospitalization, disability and medically significant) and HEADACHE (Headache) (seriousness criteria hospitalization, disability and medically significant). On 26-Nov-2021, the patient experienced DRY EYE (Dry eye) (seriousness criteria hospitalization, disability and medically significant), FATIGUE (Fatigue) (seriousness criteria hospitalization, disability and medically significant), CHEST PAIN (Chest burning) (seriousness criteria hospitalization, disability and medically significant), PERIPHERAL COLDNESS (Cold hands) (seriousness criteria hospitalization, disability and medically significant), HYPERHIDROSIS (Sweaty) (seriousness criteria hospitalization, disability and medically significant), LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criteria hospitalization, disability and medically significant) and TREMOR (Shaking inside) (seriousness criteria hospitalization, disability and medically significant). 26-Nov-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criteria hospitalization, disability and medically significant). On 27-Nov-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criteria hospitalization, disability and medically significant). On 28-Nov-2021, the patient experienced FREEZING PHENOMENON (Freezing phenomenon) (seriousness criteria hospitalization, disability and medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criteria hospitalization, disability and medically significant), FEELING HOT (Feeling of warmth) (seriousness criteria hospitalization, disability and medically significant), FEELING COLD (Feeling cold) (seriousness criteria hospitalization, disability and medically significant), TACHYCARDIA (Racing heart (tachycardia)) (seriousness criteria hospitalization, disability and medically significant), SWELLING (Swelling) (seriousness criteria hospitalization, disability and medically significant), PALPITATIONS (Heart palpitations) (seriousness criteria hospitalization, disability and medically significant), PAIN (Pain) (seriousness criteria hospitalization, disability and medically significant) and FATIGUE (feel extremely exhausted) (seriousness criteria hospitalization, disability and medically significant). On 26-Nov-2021, HEADACHE (Headache) had resolved. On 28-Nov-2021, FREEZING PHENOMENON (Freezing phenomenon) had resolved. On 29-Nov-2021, DYSPNOEA (Shortness of breath) and LYMPHADENOPATHY (Swollen lymph nodes) had resolved. At the time of the report, DRY EYE (Dry eye), FATIGUE (Fatigue), THIRST (Increased thirst), CHEST PAIN (Chest burning) and CHEST PAIN (Chest pain) had not resolved, PAIN IN EXTREMITY (Pain in arm), FEELING HOT (Feeling of warmth), FEELING COLD (Feeling cold), TACHYCARDIA (Racing heart (tachycardia)), SWELLING (Swelling), PALPITATIONS (Heart palpitations) and PAIN (Pain) outcome was unknown, PERIPHERAL COLDNESS (Cold hands), FATIGUE (feel extremely exhausted) and HYPERHIDROSIS (Sweaty) was resolving and TREMOR (Shaking inside) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) no indication on infection, inflammation, myocardi. On an unknown date, Electrocardiogram: abnormal (abnormal) a bit uneven. On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. On an unknown date, X-ray: normal (normal) Normal. Day 2 to 4, patient had only in bed fatigue, shortness of breath, shaky, chest pains, small burning in the chest, cold hands arms, coldness in chest, swollen lymph nodes, sore arm where vaccine was taken, sweaty from time to time, feel heart-pounding, maybe a bit uneven from time to time. On day 5 to 9, feeling tired but better. On day 9 to 11, patient started to walk and socialize a bit, feeling burning point at left chest (5-6 inch from collarbone and one inch to the left) when moving more, lasting 2-4 hours in general once or twice each day. On day 12, patient had burning in chest during the night to morning day 12. On day 13, felt slightly better energy and pain-wise, hurting sore. On day 14, patient walked home 30-40 minutes from x-ray (normally quite active, often exercise, do long walks, and run). Felt extremely exhausted, cannot fully walk at normal pace, rested at home. On day 15, had fatigue, start having chest pains. Chest pains increase, feel swollen and sore at left side and arm, pain at back, under the arm, shoulder, arm, intense needle/electric chest pains that last shortly, and burning sensation as before at same location. Cannot get up from bed. Patient felt warm in the area and try to cool it down with hands and a glass of water, sweaty from time to time. On day 16, symptoms as the day before but gets lighter during the day. Tired, sore at arm, side sorter pains in chest here and there. Need air, go for a very slow-paced walk, and sit outside for a little while. On day 17, more or less the same had dry eyes, headache, increased thirst, tachycardia. Laboratory data was mentioned as general practitioner took oxygen and blood pressure and both was normal. Patient went to accident and emergency to do the tests. Flow tests performed negative, Treatment drugs paracetamol, ibuprofen for pain. Patient did not had symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since having the vaccine. Company comment: This regulatory authority case concerns a 33-year-old female patient with no relevant medical history and previous administration of COVID-19 vaccine AstraZeneca, who experienced serious unexpected events of dry eye, fatigue, thirst, chest pain, pain in extremity, feeling hot, feeling cold, tachycardia, swelling, palpitations, pain, peripheral coldness, fatigue, hyperhidrosis, dyspnoea, freezing phenomenon, lymphadenopathy, headache and tremor. The events occurred approximately 1-4 days after the third dose of the mRNA-1273 respectively .The rechallenge was not applicable since due to occurrence after the third dose , no rechallenge was done and recurrence was not applicable. The regulatory authority assessed the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow up received included Past medical history updated, past drug added, Concomitant medication were updated, concomitant medication updated to co-suspect, I narrative updated.; Sender''s Comments: This regulatory authority case concerns a 33-year-old female patient with no relevant medical history and previous administration of COVID-19 vaccine AstraZeneca, who experienced serious unexpected events of dry eye, fatigue, thirst, chest pain, pain in extremity, feeling hot, feeling cold, tachycardia, swelling, palpitations, pain, peripheral coldness, fatigue, hyperhidrosis, dyspnoea, freezing phenomenon, lymphadenopathy, headache and tremor. The events occurred approximately 1-4 days after the third dose of the mRNA-1273 respectively .The rechallenge was not applicable since due to occurrence after the third dose , no rechallenge was done and recurrence was not applicable. The regulatory authority assessed the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1980217 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Infectious mononucleosis, Product use issue, SARS-CoV-2 test, Tonsillitis
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20211203; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101788627

Write-up: Tonsillitis; Glandular fever; Patient received booster dose of Comirnaty; The patient received Influenza vaccine same day with third (booster) dose of BNT162B2; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112131809232990-UB9IU. Other Case identifier(s): GB-MHRA-ADR 26328970. A 22 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation, administration date 25Nov2021. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 25Nov2021, outcome "unknown", described as "Patient received booster dose of Comirnaty"; TONSILLITIS (hospitalization, medically significant) with onset 29Nov2021, outcome "recovered" (08Dec2021), described as "Tonsillitis"; INFECTIOUS MONONUCLEOSIS (hospitalization, medically significant) with onset 29Nov2021, outcome "not recovered", described as "Glandular fever"; PRODUCT USE ISSUE (non-serious) with onset 25Nov2021, outcome "unknown", described as "The patient received Influenza vaccine same day with third (booster) dose of BNT162B2". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Dec2021) no - negative covid-19 test. Clinical course: The patient had no symptoms associated with COVID-19. The patient was not currently breastfeeding. The patient was not enrolled in clinical trial. The patient had not tested positive for COVID-19 since having the vaccine. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). It was reported that the patient needed antibiotics and hospitalization to resolve, founded LTFs to be increased. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1980224 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Gait inability, Immunisation, Joint swelling, Myocarditis, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101788828

Write-up: with swollen; myocarditis; Knee pain; could not walk and stand; Swollen joint; 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-202112132033283530-3O5YR (RA). Other Case identifier(s): GB-MHRA-ADR 26329461 (RA). A 58 year-old male patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FH3220) 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: Bnt162b2 (Dose 1, Single, Lot no. Unknown), for COVID-19 Immunisation; Bnt162b2 (Dose 2, Single, Lot no. Unknown), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "booster"; PERIPHERAL SWELLING (medically significant), outcome "not recovered", described as "with swollen"; MYOCARDITIS (medically significant), outcome "not recovered", described as "myocarditis"; JOINT SWELLING (medically significant) with onset 28Nov2021, outcome "not recovered", described as "Swollen joint"; ARTHRALGIA (medically significant), outcome "not recovered", described as "Knee pain"; GAIT INABILITY (medically significant), outcome "unknown", described as "could not walk and stand". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient had swollen, painful left knee joint and getting worse,could not walk and stand. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1980339 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOLIPAXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Connective tissue disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101773651

Write-up: painful; Enlarged lymph nodes under left arm; Enlarged lymph nodes under left arm. Visibly swollen and tender / very uncomfortable; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: IE-HPRA-2021-087401. Other Case identifier(s): IE-HPRA-CVARR2021112722881. A 44 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FH8469) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Connective tissue disorder" (unspecified if ongoing). Concomitant medication(s) included: MOLIPAXIN. Vaccination history included: Comirnaty (Dose 2, lot number: UNKNOWN, Lot number:FH8469), administration date: 11Jun2021, for COVID-19 Immunisation; Comirnaty (Dose 1), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 26Nov2021, outcome "not recovered", described as "Enlarged lymph nodes under left arm"; LYMPH NODE PAIN (medically significant) with onset 26Nov2021, outcome "not recovered", described as "Enlarged lymph nodes under left arm. Visibly swollen and tender / very uncomfortable"; PAIN (non-serious), outcome "unknown", described as "painful". It was further stated that patient reported reaction is painful and worrying Symptoms persisting. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1981514 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Erythema, Feeling hot, Immunisation, Positron emission tomogram, Pruritus, Swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NICORETTE
Current Illness:
Preexisting Conditions: Cervical cancer; Penicillin allergy; Smoker
Allergies:
Diagnostic Lab Data: Test Name: PET scan; Result Unstructured Data: Test Result: Results unknown.
CDC Split Type: BEPFIZER INC202101777792

Write-up: Booster; Anaphylaxis; Redness; Swelling; Itching; Feeling hot; This is a spontaneous report received from a contactable other HCP from the Regulatory Authority. The Regulatory Authority number BE-FAMHP-DHH-N2021-109909. A 38-year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FH8469) at the age of 38 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included penicillin allergy (unspecified if ongoing); cervical cancer (unspecified if ongoing); Smoker (unspecified if ongoing). Concomitant medication included NICORETTE. Vaccination history included Covid-19 vaccine (DOSE 1, MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Influvac tetra, for flu immunisation. The following information was reported IMMUNISATION (medically significant) with onset 25Nov2021, outcome unknown; ANAPHYLACTIC REACTION (medically significant) with onset 25Nov2021, outcome unknown; ERYTHEMA (non-serious) with onset 25Nov2021, outcome unknown; SWELLING (non-serious) with onset 25Nov2021, outcome unknown; PRURITUS (non-serious) with onset 25Nov2021, outcome unknown; FEELING HOT (non-serious) with onset 25Nov2021, outcome unknown. The patient underwent the following laboratory tests and procedures PET scan: results unknown. Therapeutic measures were taken as a result of anaphylactic reaction, erythema, swelling, pruritus, and feeling hot. Treatment - Yes cetirizine started. Evolution of the ADR included Examinations - would be reported to oncologist. ADR description - One and a half hours after injection, redness, swelling, feeling of heat, itching all over the trunk, arms and face appear. No complaints of breathing. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1981524 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Immunisation, Lymphadenopathy, Malaise, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101779587

Write-up: Nausea; Shivering; Myalgia; Malaise; Swollen lymph node under the armpit; Headache; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: BE-FAMHP-DHH-N2021-110025 (RA). A 39 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FH8469) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1), for Covid-19 immunisation; Comirnaty (dose 2), for Covid-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 25Nov2021, outcome "unknown", described as "Booster"; NAUSEA (disability) with onset 26Nov2021, outcome "not recovered", described as "Nausea"; CHILLS (disability) with onset 26Nov2021, outcome "not recovered", described as "Shivering"; MYALGIA (disability) with onset 26Nov2021, outcome "not recovered", described as "Myalgia"; MALAISE (disability) with onset 26Nov2021, outcome "not recovered", described as "Malaise"; LYMPHADENOPATHY (disability) with onset 26Nov2021, outcome "not recovered", described as "Swollen lymph node under the armpit"; HEADACHE (disability) with onset 26Nov2021, outcome "not recovered", described as "Headache". Therapeutic measures were not taken as a result of nausea, chills, myalgia, malaise, lymphadenopathy, headache. Evolution of the adverse drug reaction was no improvement. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1982490 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, Blood pressure measurement, Blood thyroid stimulating hormone, C-reactive protein, Cardiac telemetry, Echocardiogram, Ejection fraction, Electrocardiogram, Heart rate, Immunisation, Supraventricular tachycardia, Troponin T
SMQs:, Supraventricular tachyarrhythmias (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: GANGIDEN; ELTROXIN; LAMICTAL; ATORVASTATIN 1A FARMA; LEVETIRACETAM ACCORD; MULTI-VITAMINS VITAFIT; TRUXAL [CHLORPROTHIXENE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Epilepsy; Hypercholesterolaemia; Hypometabolism; Sedative therapy; Vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: Creatinine; Result Unstructured Data: Test Result:107; Comments: Unit not specified; Test Date: 202111; Test Name: Potassium; Result Unstructured Data: Test Result:4.6; Comments: Unit not specified; Test Date: 202111; Test Name: Blood pressure; Result Unstructured Data: Test Result:125/75 mmHg; Comments: (Following treatment of SVT); Test Date: 20211127; Test Name: Blood pressure; Result Unstructured Data: Test Result:101/55 mmHg; Comments: (At hospitalisation); Test Date: 202111; Test Name: TSH; Result Unstructured Data: Test Result:Normal; Test Date: 202111; Test Name: Cardiac telemetry; Result Unstructured Data: Test Result:Sinus rhythm with frequency of 96; Comments: Beats per minute; Test Date: 202111; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Normal; Test Date: 202111; Test Name: Echocardiography; Result Unstructured Data: Test Result:No apparent cardiac valve pathology; Comments: (During SVT); Test Date: 202111; Test Name: Echocardiography; Result Unstructured Data: Test Result:Well functioning left ventricle; Comments: (During SVT); Test Date: 202111; Test Name: Ejection fraction; Result Unstructured Data: Test Result:Normal, 55 %; Comments: (During SVT); Test Date: 202111; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Supraventricular tachycardia (SVT); Comments: measured to 145 per minute; Test Date: 202111; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:No ischaemia or stress; Test Date: 20211127; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Narrow QRS-complexes; Test Date: 20211127; Test Name: Pulse rate; Result Unstructured Data: Test Result:145 Beats per minute; Comments: (At hospitalisation); Test Date: 202111; Test Name: Troponin T; Result Unstructured Data: Test Result:88; Comments: Unit not specified
CDC Split Type: DKPFIZER INC202101774368

Write-up: Supraventricular tachycardia (SVT) with narrow QRS-complexes; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: DK-DKMA-WBS-0092309 (RA). Other Case identifier(s): DK-DKMA-ADR 26276011 (RA). A 51-year-old male patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FE7053, Expiration Date: 30Nov2021) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypercholesterolaemia" (unspecified if ongoing); "Hypometabolism" (unspecified if ongoing); "Constipation" (unspecified if ongoing); "Epilepsy" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing); "Sedative therapy" (unspecified if ongoing). Concomitant medication(s) included: GANGIDEN taken for constipation, start date: 11Jul2018; ELTROXIN taken for hypometabolism, start date: 08May2014; LAMICTAL taken for epilepsy, start date: 14Dec2016; ATORVASTATIN 1A FARMA taken for hypercholesterolaemia, start date: 04Nov2019; LEVETIRACETAM ACCORD taken for epilepsy, start date: 08May2014; MULTI-VITAMINS VITAFIT taken for vitamin d deficiency, start date: 01Dec2016; TRUXAL [CHLORPROTHIXENE] taken for sedative therapy, start date: 08May2014. Vaccination history included: Comirnaty (2nd dose), administration date: 30Mar2021, for COVID-19 immunisation; Comirnaty (1st dose), administration date: 08Mar2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, life threatening) with onset 25Nov2021, outcome "unknown", described as "Booster"; SUPRAVENTRICULAR TACHYCARDIA (hospitalization, life threatening) with onset 27Nov2021, outcome "recovered" (Nov2021), described as "Supraventricular tachycardia (SVT) with narrow QRS-complexes". The patient was hospitalized for supraventricular tachycardia (start date: 27Nov2021). The patient underwent the following laboratory tests and procedures: blood creatinine: (Nov2021) 107, notes: Unit not specified; blood potassium: (Nov2021) 4.6, notes: Unit not specified; blood pressure measurement: (Nov2021) 125/75 mmHg, notes: (Following treatment of SVT); (27Nov2021) 101/55 mmHg, notes: (At hospitalisation); blood thyroid stimulating hormone: (Nov2021) normal; cardiac telemetry: (Nov2021) sinus rhythm with frequency of 96, notes: Beats per minute; c-reactive protein: (Nov2021) normal; echocardiogram: (Nov2021) no apparent cardiac valve pathology, notes: (During SVT); (Nov2021) well functioning left ventricle, notes: (During SVT); ejection fraction: (Nov2021) normal, 55 %, notes: (During SVT); electrocardiogram: (Nov2021) supraventricular tachycardia (svt), notes: measured to 145 per minute; (Nov2021) no ischaemia or stress; (27Nov2021) narrow qrs-complexes; heart rate: (27Nov2021) 145 beats per minute, notes: (At hospitalisation); troponin t: (Nov2021) 88, notes: Unit not specified. Therapeutic measures were taken as a result of supraventricular tachycardia. Clinical Course: It was reported that the patient was treated with carotid sinus massage on both sides due to the Supraventricular tachycardia, but this had no effect. Following this, the patient was treated with Adenosine 6 mg intravenously due to the Supraventricular tachycardia, which also did not have any effect. The patient''s Tachycardia supraventricular finally converted following treatment with Adenosine 12 mg intravenously. When the patient was well-being, the patient received a single ordination of Metoprolol 50 mg, which is to be continued on a daily basis as an anti-arrhythmic prophylaxis. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1982493 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Heart rate, Immunisation, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PROCORALAN; ENANTYUM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: BPM; Result Unstructured Data: Test Result:170; Comments: bpm
CDC Split Type: ESPFIZER INC202101775396

Write-up: tachycardia; booster; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. Regulatory number: ES-AEMPS-1059417 (AEMPS). A 44-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 25Nov2021 (Lot number: Unknown) as dose 3, 0.3 ml, single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medications included: ivabradine hydrochloride (PROCORALAN) taken for sinus tachycardia, start date: 15Dec2020; dexketoprofen trometamol (ENANTYUM) taken for headache. Vaccination history included: Covid-19 vaccine (Dose 1; Manufactuerer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2; Manufactuerer Unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "booster"; TACHYCARDIA (medically significant) with onset 26Nov2021, outcome "recovered" (duration was 1 day), described as "tachycardia". The events "booster" and "tachycardia" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate increased: 170, notes: bpm. Therapeutic measures were taken as a result of tachycardia. Punctually for sinus tachycardia (maximum 130 bpm) diagnosed as sinus tachycardia not appropriate by Cardiology. Description of the treatment followed for the adverse reaction: ivabradine hydrochloride (PROCORALAN) 7.5 mg, lorazepam 1 mg. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1982548 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Immunisation, Influenza like illness, Malaise, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ROSUVASTATIN; UTROGESTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic fatigue syndrome; Fibromyalgia
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101779482

Write-up: Chills; General flu feeling; Headache; feeling unwell; Myalgia; Fever; joint pain; Fatigue; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: BE-FAMHP-DHH-N2021-110004 (RA). A 47 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic fatigue syndrome" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; UTROGESTAN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for Covid-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 25Nov2021, outcome "unknown", described as "booster"; CHILLS (disability) with onset 26Nov2021, outcome "unknown", described as "Chills"; INFLUENZA LIKE ILLNESS (disability) with onset 26Nov2021, outcome "unknown", described as "General flu feeling"; HEADACHE (disability) with onset 26Nov2021, outcome "unknown", described as "Headache"; MALAISE (disability) with onset 26Nov2021, outcome "unknown", described as "feeling unwell"; MYALGIA (disability) with onset 26Nov2021, outcome "unknown", described as "Myalgia"; PYREXIA (disability) with onset 26Nov2021, outcome "unknown", described as "Fever"; ARTHRALGIA (disability) with onset 26Nov2021, outcome "unknown", described as "joint pain"; FATIGUE (disability) with onset 26Nov2021, outcome "unknown", described as "Fatigue". It was unknown if therapeutic measures were taken as a result of chills, influenza like illness, headache, malaise, myalgia, pyrexia, arthralgia, fatigue. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1982549 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Disease recurrence, Extensive swelling of vaccinated limb, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101779568

Write-up: Extensive swelling of the arm; pain in the armpit; pain in the armpit; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-110017. A female patient received BNT162B2 (COMIRNATY), administration date 25Nov2021 (Lot number: FH8469) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose number unknown, manufacturer unknown), for covid-19 immunisation; Vaxzevria (dose number unknown), for covid-19 immunisation, reaction(s): "pain in the armpit", "Swelling". The following information was reported: OFF LABEL USE (disability) with onset 25Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 25Nov2021, outcome "unknown", described as "Booster"; EXTENSIVE SWELLING OF VACCINATED LIMB (disability) with onset 27Nov2021, outcome "recovering", described as "Extensive swelling of the arm"; AXILLARY PAIN (disability), DISEASE RECURRENCE (disability) all with onset 27Nov2021, outcome "recovering" and all described as "pain in the armpit". Therapeutic measures were not taken as a result of extensive swelling of vaccinated limb, axillary pain, disease recurrence. Reporter Comment: ADR description - Swelling and pain in armpit, 48 hours after booster shot with Pfizer. Swelling and pain in the armpit, a few days after vaccination with ASTRA ZENICA. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: ADR description - Swelling and pain in armpit, 48 h after booster shot with pfizer. Swelling and pain in the armpit, a few days after vaccination with astra zenica


VAERS ID: 1982555 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7900 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Extensive swelling of vaccinated limb, Fatigue, Headache, Immunisation, Lymph node pain, Malaise, Myalgia, Nausea, Pyrexia, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101779380

Write-up: booster; Nausea; feeling unwell; Shivering; Fever; Fatigue; Myalgia; Extensive swelling of the arm; Headache; Injection site reaction; Pain in lymph nodes under armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the regulatory authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-110048. A 41 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FG7900) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, LOT: EK9788), administration date: 12Jan2021, for COVID-19 immunisation; Comirnaty (DOSE 2, LOT: EM0477), administration date: 02Feb2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 25Nov2021, outcome "unknown", described as "booster"; NAUSEA (disability) with onset 25Nov2021, outcome "recovered" (28Nov2021), described as "Nausea"; MALAISE (disability) with onset 25Nov2021, outcome "recovered" (28Nov2021), described as "feeling unwell"; CHILLS (disability) with onset 25Nov2021, outcome "recovered" (28Nov2021), described as "Shivering"; PYREXIA (disability) with onset 25Nov2021, outcome "recovered" (28Nov2021), described as "Fever"; FATIGUE (disability) with onset 25Nov2021, outcome "recovered" (28Nov2021), described as "Fatigue"; MYALGIA (disability) with onset 25Nov2021, outcome "recovered" (28Nov2021), described as "Myalgia"; EXTENSIVE SWELLING OF VACCINATED LIMB (disability) with onset 25Nov2021, outcome "recovered" (28Nov2021), described as "Extensive swelling of the arm"; HEADACHE (disability) with onset 25Nov2021, outcome "recovered" (28Nov2021), described as "Headache"; VACCINATION SITE REACTION (disability) with onset 25Nov2021, outcome "recovered" (28Nov2021), described as "Injection site reaction"; LYMPH NODE PAIN (disability) with onset 25Nov2021, outcome "recovered" (28Nov2021), described as "Pain in lymph nodes under armpit". Therapeutic measures were taken as a result of nausea, malaise, chills, pyrexia, fatigue, myalgia, extensive swelling of vaccinated limb, headache, vaccination site reaction, lymph node pain included Paracetamol. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1982785 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-25
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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: Medical History/Concurrent Conditions: Arterial hypertension; Atrial fibrillation; Cardiac insufficiency; CVA; Insufficiency renal
Allergies:
Diagnostic Lab Data: Test Date: 20211206; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101776618

Write-up: Drug ineffective; COVID-19 confirmed by positive COVID-19 test; booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-NT20215604 (RA). A 88 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Lot number: Unknown) as dose 3 (booster), single, intramuscular (Lot number: Unknown) as dose 2, single and intramuscular (Lot number: Unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arterial hypertension" (unspecified if ongoing); "Cardiac insufficiency" (unspecified if ongoing); "Insufficiency renal" (unspecified if ongoing); "CVA" (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant) with onset 06Dec2021, outcome "recovering", described as "Drug ineffective"; COVID-19 (medically significant) with onset 06Dec2021, outcome "recovering", described as "COVID-19 confirmed by positive COVID-19 test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Dec2021) positive. Clinical course: NT2105731. 88-year-old woman living in an institution, presenting a vaccine failure (not serious) against Covid-19 on Day + 11 of a booster dose with COMIRNATY. No immunosuppressive treatment. Associated symptoms: asthenia, hoarse voice. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1982835 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-25
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, COVID-19, Drug ineffective, Fibrin D dimer, Hyponatraemia, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Hyponatraemia/SIADH (narrow), Chronic kidney disease (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial angioplasty; Dyslipidaemia; Hypertension arterial; Obesity; Stent placement
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:68 mg/l; Test Name: D-dimer; Result Unstructured Data: Test Result:1690 ug/ml; Test Name: hyponatremia; Result Unstructured Data: Test Result:131 mmol/L; Test Name: Sars-cov-2 test; Test Result: Positive ; Comments: Variant not known to the patient
CDC Split Type: FRPFIZER INC202101782421

Write-up: Vaccination failure; COVID-19 respiratory infection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the regulatory authority-WEB. Regulatory number: FR-AFSSAPS-ST20214542 (RA). A 73 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date Jun2021 (Lot number: Unknown) as dose 2,0.3 ml single and (Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dyslipidaemia" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Arterial angioplasty" (unspecified if ongoing); "Stent placement" (unspecified if ongoing); "Hypertension arterial" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization) with onset 25Nov2021, outcome "not recovered", described as "Vaccination failure"; COVID-19 (hospitalization) with onset 25Nov2021, outcome "not recovered", described as "COVID-19 respiratory infection". The patient underwent the following laboratory tests and procedures: c-reactive protein: 68 mg/l; fibrin d dimer: 1690 ug/ml; hyponatraemia: 131 mmol/L; sars-cov-2 test: positive, notes: Variant not known to the patient. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: This non-serious case, of the spontaneous notification type, received by fax, was notified by a pharmacist. Clinical summary: Admission on Day 7 of a positive COVID19 patient, patient vaccinated with 2 doses Malaise and loss of consciousness and sepsis starting from the lungs (cough + sputum) Oxygenorequence increase at 50ml / min FiO2 at 80% Transfer to intensive care for the rest of the treatment on26Nov2021. Pneumonia evaluated at 30 to 50% with fibrosing evolution on the ground of destructive emphysematous dystrophic bronchopneumopathy. No pulmonary embolism as of 30Nov2021, non-invasive ventilation and optoflow without intubation. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1982844 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7911 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Cystitis noninfective, Dyspnoea, Fibrin D dimer, Haematuria, Immunisation, Investigation, Pain in extremity, Pulmonary embolism, Ultrasound Doppler, Urethral pain
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MORPHINE SULFATE; ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic interstitial cystitis NOS; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: Pulmonary CT Angiography; Result Unstructured Data: Test Result:bilateral pulmonary embolism; Test Name: Blood test; Result Unstructured Data: Test Result:positive; Comments: A blood test was carried out on an outpatient basis, showing positive D-dimer values; Test Name: Investigation; Result Unstructured Data: Test Result:no proximal deep vein thrombosis; Comments: no proximal deep vein thrombosis; Test Name: Venous Doppler ultrasound; Result Unstructured Data: Test Result:confirmed; Comments: Venous Doppler ultrasound of the lower limbs performed for a pulmonary embolism confirmed on computed tomography (first episode)
CDC Split Type: FRPFIZER INC202101774157

Write-up: Embolism pulmonary; Booster; dyspnoea; calf pain; bladder inflammation; microscopic haematuria; Urethral pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-TO20219362 (RA). A 72 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 25Nov2021 (Lot number: FG7911) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension arterial" (unspecified if ongoing); "Chronic interstitial cystitis NOS" (unspecified if ongoing). Concomitant medication(s) included: MORPHINE SULFATE taken for urethral pain; ELIQUIS, start date: 02Dec2021. Vaccination history included: Comirnaty (Dose 1, Batch/lot number: ER9470, ROA: Intramuscular, Anatomical Location: Left arm), administration date: 31Mar2021, for COVID-19 IMMUNIZATION; Comirnaty (Dose 2, Batch/lot number: ET6956, ROA: Intramuscular, Anatomical Location: Left arm), administration date: 28Apr2021, for COVID-19 IMMUNIZATION. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; PULMONARY EMBOLISM (hospitalization, medically significant) with onset 29Nov2021, outcome "recovering", described as "Embolism pulmonary"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "dyspnoea"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "calf pain"; CYSTITIS NONINFECTIVE (non-serious) with onset 2021, outcome "unknown", described as "bladder inflammation"; HAEMATURIA (non-serious) with onset 2021, outcome "unknown", described as "microscopic haematuria"; URETHRAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "Urethral pain". The patient was hospitalized for pulmonary embolism (start date: 30Nov2021). The patient underwent the following laboratory tests and procedures: angiogram: bilateral pulmonary embolism; fibrin d dimer: positive, notes: A blood test was carried out on an outpatient basis, showing positive D-dimer values; investigation: no proximal deep vein thrombosis, notes: no proximal deep vein thrombosis; ultrasound doppler: confirmed, notes: Venous Doppler ultrasound of the lower limbs performed for a pulmonary embolism confirmed on computed tomography (first episode).Clinical course: Onset of dyspnoea evolving in a context of left calf pain. A blood test was carried out on an outpatient basis, showing positive D-dimer values, for which the patient was referred to the emergency room, where a pulmonary computed tomography angiography was performed, revealing a bilateral pulmonary embolism. Venous Doppler ultrasound of the lower limbs performed for a pulmonary embolism confirmed on computed tomography (first episode). Background of bladder inflammation and microscopic haematuria. Does not walk much because of serious pain (urethra) and on morphine. Left calf pain for a few days Results: no proximal deep vein thrombosis. The female patient has chronic interstitial cystitis representing a chronic inflammatory syndrome, which reduced her mobility since she has pain due to this cystitis which may be related to this pulmonary embolism. Discharged on 02Dec2021 with the following in addition to her usual treatment: ELIQUIS 5 mg, 2 tablets morning and 2 tablets evening. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1983474 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-11-25
   Days after vaccination:255
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER PV46689 / UNK - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER 4120Z001 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise, 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: INFLUENZA VIRUS; INFLUENZA VIRUS; CANDESARTAN; FLUNARIZINE; HYDROXYZINE; RIZATRIPTAN; SOLIFENACIN
Current Illness: Headache (Persistent daily headache)
Preexisting Conditions: Medical History/Concurrent Conditions: Tethered cord syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20201029; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Feeling unwell; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26338370) on 16-Dec-2021 and was forwarded to Moderna on 16-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell) in a 58-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. Co-suspect products included non-company products COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. The patient''s past medical history included Tethered cord syndrome. Concurrent medical conditions included Headache (Persistent daily headache). Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 09-Dec-2020 to an unknown date, INFLUENZA VACCINE (INFLUENZA VIRUS), CANDESARTAN from 01-Feb-2020 to an unknown date, FLUNARIZINE from 14-Feb-2020 to an unknown date, HYDROXYZINE from 01-Sep-2019 to an unknown date, RIZATRIPTAN from 01-Nov-2020 to an unknown date and SOLIFENACIN from 01-Jul-2020 to an unknown date for an unknown indication. On 15-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 24-May-2021, the patient received dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced MALAISE (Feeling unwell) (seriousness criterion medically significant). On 26-Nov-2021, MALAISE (Feeling unwell) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2020, 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. Patient not had symptoms associated with COVID-19. No treatment information was provided by the reporter. Patient had not tested positive for COVID-19 since had the vaccine Patient was not enrolled in clinical trial. Company Comment: This case concerns a 58-year-old male patient with a relevant medical history of Persistent daily headache, who experienced the serious unexpected event of Malaise. The event occurred on the same day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The medical history of Persistent daily headache remains a confounder. The event doesn''t seem to be serious by medical judgement and from a clinical or regulatory standpoint, but it was assessed as serious as per regulatory authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender''s Comments: This case concerns a 58-year-old male patient with a relevant medical history of Persistent daily headache, who experienced the serious unexpected event of Malaise. The event occurred on the same day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The medical history of Persistent daily headache remains a confounder. The event doesn''t seem to be serious by medical judgement and from a clinical or regulatory standpoint, but it was assessed as serious as per regulatory authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 1983517 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Immunisation, Interchange of vaccine products, Lip swelling, Off label use, Paraesthesia oral
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypertension (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: Blood pressure; Result Unstructured Data: Test Result:182/106
CDC Split Type: IEPFIZER INC202101773924

Write-up: Off label use; Interchange of vaccine products; Booster; BLOOD PRESSURE RAISED 182/106 / ABOVE THERAPEUTIC NORM; LIPS A BIT SWOLLEN AND TINGLING; LIPS A BIT SWOLLEN AND TINGLING; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Agency Regulatory Authority-WEB. Regulatory number: IE-HPRA-2021-087372. A 54 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FH8469) at the age of 54 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure abnormal" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Vaxzevria (Dose 1, batch number: unspecified, No reaction was noted), administration date: 19Feb2021, for COVID-19 immunisation; Vaxzevria (Dose 2, batch number: unspecified, No reaction was noted), administration date: 27May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 25Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; BLOOD PRESSURE INCREASED (medically significant) with onset 25Nov2021, outcome "unknown", described as "BLOOD PRESSURE RAISED 182/106 / ABOVE THERAPEUTIC NORM"; LIP SWELLING (medically significant), PARAESTHESIA ORAL (medically significant) all with onset 25Nov2021, outcome "recovered" (25Nov2021) and all described as "LIPS A BIT SWOLLEN AND TINGLING". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (25Nov2021) 182/106. Therapeutic measures were not taken as a result of lip swelling, paraesthesia oral. Clinical course: 15 minutes later on 25Nov2021, the patient''s lips became a bit swollen and were tingling and their blood pressure raised to 182/106 (units unspecified). The patient''s blood pressure was reported as above the therapeutic norm. The tingling and swelling resolved after 15 minutes and the duration of the reaction was reported as 30 minutes. The patient was medical assessed and no treatment was administered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1983547 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Arthralgia, Chest X-ray, Chest pain, Immunisation, Interchange of vaccine products, Off label use, Painful respiration, Troponin
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Arthritis (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown results; Comments: Results were not provided; Test Name: Troponin; Result Unstructured Data: Test Result:Unknown results; Comments: Results were not provided
CDC Split Type: IEPFIZER INC202101773981

Write-up: it felt like heart related pain / pain so severe; intermittent chest pain in upper left chest that turned to persistent chest pain of upper left chest and into left shoulder with an additional stabbing pain left of sternum when taking deep breath in; intermittent chest pain in upper left chest that turned to persistent chest pain of upper left chest and into left shoulder with an additional stabbing pain left of sternum when taking deep breath in; intermittent chest pain in upper left chest that turned to persistent chest pain of upper left chest and into left shoulder with an additional stabbing pain left of sternum when taking deep breath in; 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 WEB. Regulatory number: IE-HPRA-2021-087732. Other Case identifier(s): IE-HPRA-CVARR2021120323029. A 30 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: FH8469) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Past drug history included: Vaxzevria for COVID-19 immunization, notes: Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S). No previous covid infection. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: Mar2021, for COVID-19 immunization; Covid-19 vaccine astrazeneca (Dose 2), administration date: Jun2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 25Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "booster"; ANGINA PECTORIS (medically significant) with onset 29Nov2021, outcome "not recovered", described as "it felt like heart related pain / pain so severe"; CHEST PAIN (medically significant), ARTHRALGIA (medically significant), PAINFUL RESPIRATION (medically significant) all with onset 29Nov2021, outcome "not recovered" and all described as "intermittent chest pain in upper left chest that turned to persistent chest pain of upper left chest and into left shoulder with an additional stabbing pain left of sternum when taking deep breath in". The events "it felt like heart related pain / pain so severe", "intermittent chest pain in upper left chest that turned to persistent chest pain of upper left chest and into left shoulder with an additional stabbing pain left of sternum when taking deep breath in", "intermittent chest pain in upper left chest that turned to persistent chest pain of upper left chest and into left shoulder with an additional stabbing pain left of sternum when taking deep breath in" and "intermittent chest pain in upper left chest that turned to persistent chest pain of upper left chest and into left shoulder with an additional stabbing pain left of sternum when taking deep breath in" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: chest x-ray: unknown results, notes: Results were not provided; troponin: unknown results, notes: Results were not provided. Therapeutic measures were taken as a result of angina pectoris, chest pain, arthralgia, painful respiration. Treatment includes Nurofen. Clinical course: The patient had Intermittent chest pain in upper left chest that turned to persistent chest pain of upper left chest and into left shoulder with an additional stabbing pain left of sternum when taking deep breath in. It felt like heart related pain. Medically significant. Serious details includes Pain so severe it required A&E assessment. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1983557 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Bedridden, Body temperature, Chills, Hyperhidrosis, Immunisation, Loss of personal independence in daily activities, Malaise, Nausea, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: Body temperature; Result Unstructured Data: Test Result:didn''t go lower than 38; Test Date: 20211125; Test Name: Body temperature; Result Unstructured Data: Test Result:temp was 39+; Test Date: 20211127; Test Name: Body temperature; Result Unstructured Data: Test Result:temp was still at 39+; Test Date: 20211128; Test Name: Body temperature; Result Unstructured Data: Test Result:normal at 38; Test Date: 20211130; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: IEPFIZER INC202101782482

Write-up: Unable to leave bed or lift my phone due to the pain in wrist; Later i began vomiting / this continued until friday afternoon; Very weak / couldn''t leave my room till monday was too weak to walk; Arm is still quite tender but improved; Could barely move in the bed / in terrible pain all night; Woke with bad rigors/sweating; Severe joint pain to ankles/knees/wrists mainly / painful joints; Sweating / sweated through 5 sets of pjs in 1 day due to temp; Temp was 39+ /temp didn''t go lower than 38 / sweated through 5 sets of pjs in 1 day due to temp / saturday temp was still at 39+; Felt very unwell / sick; Still feel nauseous/queasy and fragile; Unable to leave bed or lift my phone due to the pain in wrist / couldn''t leave my room till monday was too weak to walk; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority-WEB. Regulatory number: IE-HPRA-2021-087809 (RA). Other Case identifier(s): IE-HPRA-CVARR2021120623078 (RA). A 32 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FH0114) at the age of 32 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 (Dose 2, Primary Immunization series complete but unknown manufacturer), administration date: Jan2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; BEDRIDDEN (medically significant) with onset 25Nov2021 23:00, outcome "recovered" (Dec2021), described as "Unable to leave bed or lift my phone due to the pain in wrist"; VOMITING (medically significant) with onset 25Nov2021 23:00, outcome "recovered" (Dec2021), described as "Later i began vomiting / this continued until friday afternoon"; ASTHENIA (medically significant) with onset 25Nov2021 23:00, outcome "recovered" (Dec2021), described as "Very weak / couldn''t leave my room till monday was too weak to walk"; PAIN IN EXTREMITY (medically significant) with onset 25Nov2021 23:00, outcome "recovered" (Dec2021), described as "Arm is still quite tender but improved"; PAIN (medically significant) with onset 25Nov2021 23:00, outcome "recovered" (Dec2021), described as "Could barely move in the bed / in terrible pain all night"; CHILLS (medically significant) with onset 25Nov2021 23:00, outcome "recovered" (Dec2021), described as "Woke with bad rigors/sweating"; ARTHRALGIA (medically significant) with onset 25Nov2021 23:00, outcome "recovered" (Dec2021), described as "Severe joint pain to ankles/knees/wrists mainly / painful joints"; HYPERHIDROSIS (medically significant) with onset 25Nov2021 23:00, outcome "recovered" (Dec2021), described as "Sweating / sweated through 5 sets of pjs in 1 day due to temp"; PYREXIA (medically significant) with onset 25Nov2021 23:00, outcome "recovered" (Dec2021), described as "Temp was 39+ /temp didn''t go lower than 38 / sweated through 5 sets of pjs in 1 day due to temp / saturday temp was still at 39+"; MALAISE (medically significant) with onset 25Nov2021 23:00, outcome "recovered" (Dec2021), described as "Felt very unwell / sick"; NAUSEA (medically significant) with onset 25Nov2021 23:00, outcome "recovered" (Dec2021), described as "Still feel nauseous/queasy and fragile"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (medically significant) with onset 25Nov2021 23:00, outcome "recovered" (Dec2021), described as "Unable to leave bed or lift my phone due to the pain in wrist / couldn''t leave my room till monday was too weak to walk". The patient underwent the following laboratory tests and procedures: body temperature: (25Nov2021) didn''t go lower than 38; (25Nov2021) temp was 39+; (27Nov2021) temp was still at 39+; (28Nov2021) normal at 38; sars-cov-2 test: (30Nov2021) negative. Therapeutic measures were taken as a result of bedridden, vomiting, asthenia, pain in extremity, pain, chills, arthralgia, hyperhidrosis, pyrexia, malaise, nausea, loss of personal independence in daily activities and included treatment with ibuprofen (NUROFEN), cyclizine (VALOID), codeine phosphate;paracetamol (SOLPADOL), electrolytes, and freeze gel. Patient reported that occupation health kept in touch the week following reaction. General practitioner (GP) also phone to check how the patient was doing. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : -HPRA-2021-065193


VAERS ID: 1983608 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1020A / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Fall, Immunisation, Loss of consciousness, Pyrexia, Syncope, 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), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy (LIDOCAINA); Tumor (Carcinoma - soggetto vulnerabile)
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: Blood sampling; Result Unstructured Data: Test Result:consistent; Comments: On 25Nov2021 the patient reports consistent blood sampling at 7:30 before breakfast.; Test Date: 20211125; Test Name: Body temperature; Result Unstructured Data: Test Result:40 Centigrade
CDC Split Type: ITPFIZER INC202101774216

Write-up: Booster; Blackout; Tremor; Hyperpyrexia/ the body temperature rose to 40 degree Celsius; Falling; The temperature drops, but shortly afterwards she faints; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: IT-MINISAL02-818575 (MINISAL02). A 76 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 10:00 (Lot number: 1F1020A) at the age of 76 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Drug allergy" (unknown if ongoing), notes: LIDOCAINA; "Tumor" (unknown if ongoing), notes: Carcinoma - soggetto vulnerabile. The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (COMIRNATY (BIONTECH MANUFACTURING GMBH) (J07BX03), DOSE 2, SINGLE), administration date: 30Apr2021, for COVID-19 immunisation, reaction(s): "No adverse drug reaction"; Comirnaty (COMIRNATY (BIONTECH MANUFACTURING GMBH) (J07BX03), DOSE 1, SINGLE), administration date: 09Apr2021, for COVID-19 immunisation, reaction(s): "No adverse drug reaction". The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; LOSS OF CONSCIOUSNESS (medically significant) with onset 25Nov2021, outcome "recovering", described as "Blackout"; SYNCOPE (medically significant) with onset 2021, outcome "unknown", described as "The temperature drops, but shortly afterwards she faints"; TREMOR (medically significant) with onset 25Nov2021, outcome "recovering", described as "Tremor"; PYREXIA (medically significant) with onset 25Nov2021, outcome "recovering", described as "Hyperpyrexia/ the body temperature rose to 40 degree Celsius"; FALL (medically significant) with onset 2021, outcome "unknown", described as "Falling". The patient underwent the following laboratory tests and procedures: blood test: (25Nov2021) consistent, notes: On 25Nov2021 the patient reports consistent blood sampling at 7:30 before breakfast; body temperature: (25Nov2021) 40 Centigrade. Therapeutic measures were taken as a result of pyrexia. Clinical course: In the evening and during the night, the body temperature rose to 40 degrees Celsius. Strong tremors. The following day, the lady took Paracetamol 1,000mg. The temperature dropped, but shortly afterwards she fainted. Loss of consciousness. The lady lived alone. She woke up on the floor bewildered and noticed overturned chairs on the ground. Even the water bottle had spilled all over the floor. The patient reported that she ''crawled'' to reach the phone and call for help. Influence of reaction on quality of life: 10. She used Arnica ointment after falling. She informed her general practitioner. Reporter Comment: Vulnerable patient No follow-up attempts are possible. No further information is expected.


VAERS ID: 1983699 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3219 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chills, Diabetes mellitus, Dyspnoea, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Immunisation, Nodal rhythm, Troponin
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Disorders of sinus node function (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic dilatation; Ileostomy; Malignant tumour excision; Postoperative ileus (with reoperation.); Rectal cancer (Dukes A. no need for adjuvant radiation-/chemotherapy.); Ventricular hypertrophy
Allergies:
Diagnostic Lab Data: Test Date: 201805; Test Name: Echocardiography; Result Unstructured Data: Test Result:Moderate left ventricular; Comments: hypertrophy with normal left ventricular function. Slightly dilated aorta ascendens.; Test Date: 20211127; Test Name: ECG; Result Unstructured Data: Test Result:Nodal replacement rhythm.; Comments: No signs of ischemia. Sinus rhythm with AV block grade 1.; Test Date: 201805; Test Name: Holter monitoring; Result Unstructured Data: Test Result:No bradycardia or high grade block.; Test Date: 20211127; Test Name: Cardiac troponin; Result Unstructured Data: Test Result:39; Test Date: 20211127; Test Name: Cardiac troponin; Result Unstructured Data: Test Result:47; Test Date: 20211127; Test Name: Cardiac troponin; Result Unstructured Data: Test Result:43
CDC Split Type: NOPFIZER INC202101776717

Write-up: chest pressure/feeling of pressure over his chest; chills; dyspnoea; immunisation; diabetes mellitus; Nodal replacement rhythm; This is a spontaneous report received from a contactable reporter (Physician) from the Regulatory Authority-WEB. Regulatory number: NO-NOMAADVRE-FHI-2021-Uqgqgy (NOMA). Other Case identifier(s): NO-NOMAADVRE-E2B_00063592 (NOMA). A 76-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Lot number: FH3219) at the age of 76 years as dose 3, (booster) single for COVID-19 immunization. Relevant medical history included: "Rectal cancer", start date: Nov2017 (unspecified if ongoing) Dukes A with radical surgery with ileostomy (on unknown date) and no need for adjuvant radiation/chemotherapy. He also had postoperative ileus with reoperation on unknown date. The patient''s concomitant medications were not reported. In May 2018, echocardiogram showed moderate left ventricular hypertrophy with normal left ventricular function. Slightly dilated aorta ascendens with no bradycardia or high-grade block on Holter monitoring. Vaccination history included: COVID-19 Vaccine [dose 1 and dose 2 (manufacturer and lot number unknown)], for COVID-19 Immunization. Then, received the booster dose of bnt162b2 (COMIRNATY) on 25Nov2021. Two days after vaccination with booster dose (27Nov2021), he was hospitalized due to a feeling of pressure over his chest, dyspnoea, as well as chills. The patient was also diagnosed with diabetes mellitus (started on unknown date) during the current hospital stay. It was also noted that the patient had nodal replacement rhythm (started on 25Nov2021) on ECG on 27Nov2021 with no signs of ischemia. Sinus rhythm with AV block grade 1. Troponin had no dynamic rise and fall as 29, 47 and 43 on 27Nov2021. It was also reported that nodal replacement rhythm was reported as serious (medically significant). The patient recovered from nodal replacement rhythm on 26Nov2021 while unknown for the remaining events. The Center assessed the causal relationship between bnt162b2 (COMIRNATY) and Nodal rhythm as Possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1983734 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-11-25
   Days after vaccination:107
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C10-04 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20211252196

Write-up: This spontaneous report received from a health care professional by a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202112-2110) on 23-DEC-2021 and concerned a 21-year-old male of unknown 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 (suspension for injection, intramuscular, batch number: 21C1004 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 10-AUG-2021 for covid-19 immunisation (Dose number in series 1). No concomitant medications were reported. On 25-NOV-2021, the patient experienced vaccination failure. The action taken with covid-19 vaccine was not applicable. The patient recovered from vaccination failure on 06-DEC-2021. This report was serious. This report was associated with a product quality complaint. Reporter''s Comments: Other information: sensitive information redacted; psychiatry.


VAERS ID: 1983757 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-01
Onset:2021-11-25
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0003 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: SEPFIZER INC202101776896

Write-up: blood clot; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority-WEB. Regulatory number: SE-MPA-2021-095012 (MPA). Other Case identifier(s): SE-VISMA-1637882152402 (MPA). A 12 year-old female patient received bnt162b2 (COMIRNATY), administration date Nov2021 (Lot number: PCB0003) 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, manufacturer unknown), for COVID-19 immunisation. The following information was reported: THROMBOSIS (medically significant) with onset 25Nov2021, outcome "recovering", described as "blood clot". It was reported that suspected adverse event was blood clot starting approximately 1 week after dose 2 vaccination. The event "blood clot" was evaluated at the physician office visit. The report indicated that the boy (unspecified, as reported) was in contact with health care providers. Case was assessed as serious. The Medical Products Agency assesses suspected event blood clot as serious, important medical event while the reporter indicated as non-serious.


VAERS ID: 1985372 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Dyspnoea, Heart rate increased, Hyperthyroidism, Immunisation, Thyroid function test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hyperthyroidism (narrow), Other ischaemic heart disease (narrow), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211126; Test Name: heart rate increased; Result Unstructured Data: Test Result:Resting heart rate at 140; Test Date: 20211126; Test Name: Thyroid function test; Result Unstructured Data: Test Result:Suspected hyperthyroidism; Comments: increased
CDC Split Type: ATPFIZER INC202101782656

Write-up: suspected hyperthyroidism; Heart piercing; Resting heart rate at 140; Shortness of breath; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: AT-BASGAGES-2021-063266 (RA). A 21 year-old male patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FE7051) at the age of 21 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 (COVID-19 VACCINE-MANUFACTURER UNKNOWN, dose 1, single), for covid-19 immunization; Covid-19 vaccine (COVID-19 VACCINE-MANUFACTURER UNKNOWN, dose 2, single), for covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 25Nov2021, outcome "unknown", described as "booster"; HYPERTHYROIDISM (hospitalization, medically significant) with onset 26Nov2021, outcome "unknown", described as "suspected hyperthyroidism"; ANGINA PECTORIS (hospitalization, medically significant) with onset 26Nov2021, outcome "unknown", described as "Heart piercing"; HEART RATE INCREASED (hospitalization) with onset 26Nov2021, outcome "unknown", described as "Resting heart rate at 140"; DYSPNOEA (hospitalization) with onset 26Nov2021, outcome "unknown", described as "Shortness of breath". The patient underwent the following laboratory tests and procedures: heart rate increased: (26Nov2021) resting heart rate at 140; thyroid function test: (26Nov2021) suspected hyperthyroidism, notes: increased. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1985520 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram, Electrocardiogram T wave inversion, Feeling of body temperature change, Pain in extremity, Rhinorrhoea, Tachycardia, Troponin
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (broad), Tendinopathies and ligament disorders (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Electrocardiogram T wave inversion; Test Date: 20211125; Test Name: Troponin; Result Unstructured Data: Test Result:unknown results
CDC Split Type: AUPFIZER INC202101789965

Write-up: Electrocardiogram T wave inversion; Chest pain; Feeling of body temperature change; Pain in extremity; Rhinorrhoea; Tachycardia; Troponin; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 678799 Regulatory Authority. A 42 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (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: ELECTROCARDIOGRAM T WAVE INVERSION (medically significant) with onset 25Nov2021, outcome "recovering", described as "Electrocardiogram T wave inversion"; CHEST PAIN (non-serious) with onset 25Nov2021, outcome "recovering", described as "Chest pain"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 25Nov2021, outcome "recovering", described as "Feeling of body temperature change"; PAIN IN EXTREMITY (non-serious) with onset 25Nov2021, outcome "recovering", described as "Pain in extremity"; RHINORRHOEA (non-serious) with onset 25Nov2021, outcome "recovering", described as "Rhinorrhoea"; TACHYCARDIA (non-serious) with onset 25Nov2021, outcome "recovering", described as "Tachycardia"; TROPONIN (non-serious) with onset 25Nov2021, outcome "recovering", described as "Troponin". The patient underwent the following laboratory tests and procedures: electrocardiogram: (25Nov2021) electrocardiogram t wave inversion; troponin: (25Nov2021) unknown results. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1985549 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-25
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Deep vein thrombosis, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101790137

Write-up: Deep vein thrombosis; Chest pain; Dyspnoea; This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: 679697 Regulatory Authority. A 31 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Deep vein thrombosis"; CHEST PAIN (non-serious) with onset 25Nov2021, outcome "not recovered", described as "Chest pain"; DYSPNOEA (non-serious) with onset 25Nov2021, outcome "not recovered", described as "Dyspnoea". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1985600 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness, Headache, Hypoaesthesia, Hypoaesthesia oral, Immunisation, Interchange of vaccine products, Migraine with aura, Off label use
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Medication errors (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101782621

Write-up: Off label use; Interchange of vaccine products; Booster; Headache; Migraine aura; Numbness of face, hand, fingers; Numbness of tongue; vision partially lost, unable to see words/letters; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-110051. A 51 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included: Vaxzevria (1st dose), for COVID-19 immunisation, reaction(s): "Vision loss", "Headache", "Numbness of face, hand, fingers", "Numbness of tongue", "Migraine aura"; Vaxzevria (2nd dose), for COVID-19 immunisation, reaction(s): "Vision loss", "Headache", "Numbness of face, hand, fingers", "Numbness of tongue", "Migraine aura". The following information was reported: OFF LABEL USE (disability) with onset 25Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 25Nov2021, outcome "unknown", described as "Booster"; HEADACHE (disability) with onset 25Nov2021, outcome "recovering", described as "Headache"; MIGRAINE WITH AURA (disability) with onset 25Nov2021, outcome "recovering", described as "Migraine aura"; HYPOAESTHESIA (disability) with onset 25Nov2021, outcome "recovering", described as "Numbness of face, hand, fingers"; HYPOAESTHESIA ORAL (disability) with onset 25Nov2021, outcome "recovering", described as "Numbness of tongue"; BLINDNESS (disability, medically significant) with onset 25Nov2021, outcome "recovering", described as "vision partially lost, unable to see words/letters". Therapeutic measures were not taken as a result of headache, migraine with aura, hypoaesthesia, hypoaesthesia oral, blindness. However, it was also reported that the stop date of the events was 26Nov2021 (possibly discrepant). Reporter Comment: Treatment - No Evolution of the ADR - Recovering Situations - Other: Suspected reaction to vaccine. Same with 2 vaccines Astra zeneca ADR description - On administration of vaccine, felt directly in head. 5 min later first symptoms of migraine with aura. Numbness of face, tongue, hand, fingers, vision partially lost, unable to see words/letters. Attack after attack. Until late at night. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Treatment - No Evolution of the ADR - Recovering Situations - Other: Suspected reaction to vaccine. Same with 2 vaccines Astra zeneca ADR description - On administration of vaccine, felt directly in head. 5 min later first symptoms of migraine with aura. Numbness of face, tongue, hand, fingers, vision partially lost, unable to see words/letters. Attack after attack. Until late at night.


VAERS ID: 1985612 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7369 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Cold sweat, Fatigue, Headache, Immunisation, Interchange of vaccine products, Malaise, Myalgia, Nausea, Off label use, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (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? 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: Abstains from alcohol; Arthritis (multiple autoimmune diseases); Crohn''s disease (multiple autoimmune diseases); Influenza-like symptoms (Possible COVID 6 weeks before vaccination (influenza syndrome, not tested)); Non-tobacco user; Pancreatitis (multiple autoimmune diseases); Suspected COVID-19 (Possible COVID 6 weeks before vaccination (influenza syndrome, not tested))
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101782594

Write-up: Nausea; Headache; Fatigue; Malaise; off label use; Interchange of vaccine products; booster; Fever; Shivering; Cold sweat; Myalgia; Arthralgia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: BE-FAMHP-DHH-N2021-110240 (RA). A 39-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), administration date 25Nov2021 14:00 (Lot number: FG7369) as dose 3 ( booster), single for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19" (unspecified if ongoing), "Influenza-like symptoms" (unspecified if ongoing), notes: Possible COVID 6 weeks before vaccination (influenza syndrome, not tested); "pancreatitis" (unspecified if ongoing), "arthritis" (unspecified if ongoing), "crohn''s disease" (unspecified if ongoing), notes: multiple autoimmune diseases; "no alcohol" (unspecified if ongoing); "no tobacco" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Vaxzevria (DOSE 1), administration date: 01Mar2021 and Vaxzevria (DOSE 2), administration date: 25May2021, both for COVID-19 immunisation, with reaction(s): "localized deltoid pain" (First 2 Astra Zeneca doses without adverse effects (localized deltoid pain)). The following information was reported: OFF LABEL USE (disability) with onset 25Nov2021, described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 25Nov2021, described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 25Nov2021, described as "booster"; PYREXIA (disability) with onset 25Nov2021, outcome "recovering", described as "Fever"; CHILLS (disability) with onset 25Nov2021, outcome "recovering", described as "Shivering"; COLD SWEAT (disability) with onset 25Nov2021, outcome "recovering", described as "Cold sweat"; MYALGIA (disability) with onset 25Nov2021, outcome "recovering", described as "Myalgia"; ARTHRALGIA (disability) with onset 25Nov2021, outcome "recovering", described as "Arthralgia"; NAUSEA (disability) with onset 26Nov2021, outcome "recovering", described as "Nausea"; HEADACHE (disability) with onset 26Nov2021, outcome "recovering", described as "Headache"; FATIGUE (disability) with onset 26Nov2021, outcome "recovering", described as "Fatigue"; MALAISE (disability) with onset 26Nov2021, outcome "recovering", described as "Malaise". The patient took diclofenac (retard, 75 mg) 1x as a treatment for the events. Reporter Comment: Treatment: Diclofenac retard 75 mg, 1x. Evolution of the ADR: Recovering. ADR description: Vaccination around 2pm on 25Nov, fever, chills, cold sweats, pain on the night of 25-26 until mid-day on 26. Nausea headache the evening of 26, fatigue, and malaise from 26 to 30. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment: Diclofenac retard 75 mg, 1x. Evolution of the ADR: Recovering. ADR description: Vaccination around 2pm on 25Nov, fever, chills, cold sweats, pain on the night of 25-26 until mid-day on 26. Nausea headache the evening of 26, fatigue, and malaise from 26 to 30.


VAERS ID: 1985635 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7369 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Immunisation
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATACAND PLUS; CRESTOR; SIPRALEXA; EZETROL; METFORMINE [METFORMIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101792731

Write-up: Fatigue/exhausted; Headache; Shivering; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: BE-FAMHP-DHH-N2021-110473. A 67-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), administration date 25Nov2021 10:00 (Lot number: FG7369) at the age of 67 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Alcohol occasionally" (unspecified if ongoing). Concomitant medications included: ATACAND PLUS; CRESTOR; SIPRALEXA; EZETROL; METFORMINE [METFORMIN]. Vaccination history included: Comirnaty (lot number: EP2166), administration date: 11Mar2021 as dose 1, single for COVID-19 immunisation; Comirnaty (lot number: ER9480), administration date: 01Apr2021 as dose 2, single for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 25Nov2021 10:00, outcome "unknown", described as "Booster"; FATIGUE (disability) with onset 25Nov2021 17:00, outcome "recovered" (26Nov2021 17:00), described as "Fatigue/exhausted"; HEADACHE (disability) with onset 25Nov2021 17:00, outcome "recovered" (26Nov2021 17:00), described as "Headache"; CHILLS (disability) with onset 25Nov2021 17:00, outcome "recovered" (26Nov2021 17:00), described as "Shivering". Therapeutic measures were taken as a result of fatigue, headache, chills with Dafalgan and Biofenac. ADR description: Vaccination at 10 a.m. Side effects at 5 p.m. for 24 hours straight. Patient had headache, felt exhausted and shivering.


VAERS ID: 1985875 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Echocardiogram, Electrocardiogram, Gait disturbance, Hypertension, Muscular weakness, Palpitations, Paraesthesia, Pulse abnormal, Restlessness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Operation NOS (post operative treatmtent included long term cortisone administration.)
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:146/86 mmHg; Test Date: 20211206; Test Name: blood pressure; Result Unstructured Data: Test Result:187/110 mmHg; Test Date: 20211206; Test Name: echo; Result Unstructured Data: Test Result:performed; Comments: exclusion of myocardial infarction; Test Date: 20211206; Test Name: ecg; Result Unstructured Data: Test Result:performed; Comments: exclusion of myocardial infarction
CDC Split Type: DEPFIZER INC202101795552

Write-up: Blood pressure of 187/110 and rapid pulse; Blood pressure of 187/110 and rapid pulse; Heart pounding / stumbling a few hours after 1. vaccination; I can''t calm down day and night and my hands and legs have been tingling; I can''t calm down day and night and my hands and legs have been tingling; weak hands and legs; difficulty walking; dizziness; 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): 109583 (Biontech nr), 109056 (Biontech nr). A 49-year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; diclofenac sodium (DICLOFENAC SODIUM), since 02Dec2021 (Batch/Lot number: unknown) at 75 mg (75 mg syringe) for back pain; dexamethasone (DEXAMETHASONE), since 02Dec2021 (Batch/Lot number: unknown) at 8 mg (8 mg syringe) for back pain. Relevant medical history included: "operation" (unspecified if ongoing), notes: post operative treatmtent included long term cortisone administration. The patient''s concomitant medications were not reported. The following information was reported: PALPITATIONS (hospitalization) with onset 25Nov2021, outcome "unknown", described as "Heart pounding / stumbling a few hours after 1. vaccination"; HYPERTENSION (hospitalization), PULSE ABNORMAL (hospitalization), outcome "unknown" and all described as "Blood pressure of 187/110 and rapid pulse"; RESTLESSNESS (non-serious), PARAESTHESIA (non-serious), outcome "not recovered" and all described as "I can''t calm down day and night and my hands and legs have been tingling"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "weak hands and legs"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "difficulty walking"; DIZZINESS (non-serious), outcome "not recovered", described as "dizziness". The patient was hospitalized for palpitations, pulse abnormal (start date: 06Dec2021); the patient was hospitalized for hypertension (start date: 06Dec2021). The patient underwent the following laboratory tests and procedures: blood pressure measurement: (unspecified date) 146/86 mmHg; (06Dec2021) 187/110 mmHg; echocardiogram: (06Dec2021) performed, notes: exclusion of myocardial infarction; electrocardiogram: (06Dec2021) performed, notes: exclusion of myocardial infarction. Therapeutic measures were taken as a result of palpitations, hypertension, pulse abnormal. Other clinical course: Dexamethason 8mg / Diclofenac 75mg , "Neuraltreatment" with 2 syringes 7 days after vaccination on 02Dec2021 administered as combination in hip by General practitioner for chronic back pain. Since that day patient was feeling bad, treatment after hospitalization included betablocking agents (metoprolol succinate 23.75mg), which would not help, Pharmacist and cardiologist stated to expect a decreased immune response. Last night (12Dec2021) again loud pounding of heart, slept only for 1.5 hours; before very sporty person., had a rather low blood pressure before. BNT162B2 is under agreement with Biontech SE. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1985988 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG9428 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Immunisation, Interchange of vaccine products, Off label use, Pain, Pustule
SMQs:, Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101782605

Write-up: Herpes zoster; Off-label use; Interchange of vaccine products; Booster; I have pustules (10-12) distributed from the height of the scapula to the bottom of the navel; I''m better after two weeks of pain.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from the regulatory authority. The reporter is the patient. Regulatory number: ES-AEMPS-1066287. A 69 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 25Nov2021 (Lot number: FG9428) as dose 2 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine janssen (Dose 1. Batch/lot number: 21C10-04. Intramuscular.), administration date: 01May2021, for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 25Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; HERPES ZOSTER (medically significant) with onset 26Nov2021, outcome "recovering", described as "Herpes zoster"; PUSTULE (non-serious) with onset 2021, outcome "unknown", described as "I have pustules (10-12) distributed from the height of the scapula to the bottom of the navel"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "I''m better after two weeks of pain." It was reported that it was a herpes zoster that affects his back and left side. He had been diagnosed and treated online by a family emergency physician in another community, who sent a prescription to the pharmacy on call to give me the medications with which he has treated / supervised me. The Patient had no COVID-19. No follow-up attempts are possible. No further information is expected


VAERS ID: 1986192 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4571 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Feeling hot, Mobility decreased, Muscle spasms, Pain in extremity, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple sclerosis.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101796834

Write-up: Hot feeling generalized; sore arm as expected; Right leg feels like it''s been punched and is quite sore.; spasms in legs and to a lesser extent in arms when turning over.; After a couple of hours more I was able to move with limited mobility out of the bedroom; during night shakes for about 2 hours; no strength or power in legs and arms requiring assistance to get to sit on the edge of the bed; This is a spontaneous report received from a contactable reporter(Consumer) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-APPCOVID-20211125154648 . Other Case identifier(s): GB-MHRA-ADR 26253042 . A male patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: FH4571) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). 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: FEELING HOT (disability) with onset 25Nov2021, outcome "recovering", described as "Hot feeling generalized"; PAIN IN EXTREMITY (disability) with onset 2021, outcome "not recovered", described as "sore arm as expected"; PAIN IN EXTREMITY (disability) with onset 2021, outcome "unknown", described as "Right leg feels like it''s been punched and is quite sore."; MUSCLE SPASMS (disability) with onset 2021, outcome "unknown", described as "spasms in legs and to a lesser extent in arms when turning over."; MOBILITY DECREASED (disability) with onset 2021, outcome "unknown", described as "After a couple of hours more I was able to move with limited mobility out of the bedroom"; TREMOR (disability) with onset 2021, outcome "recovered" (2021), described as "during night shakes for about 2 hours"; ASTHENIA (disability) with onset 2021, outcome "unknown", described as "no strength or power in legs and arms requiring assistance to get to sit on the edge of the bed". Clinical Course: The patient had sore arm as expected, during night shakes for about 2 hours, spasms in legs and to a lesser extent in arms when turning over. Legs ''cooking'' and difficult to move. Right leg feels like it had been punched and was quite sore. When trying to get out of bed, almost no strength or power in legs and arms requiring assistance to get to sit on the edge of the bed. After an hour or he was able to move to a chair but needed a bottle to urinate. After a couple of hours more he was able to move with limited mobility out of the bedroom. The patient had Multiple Sclerosis which reduces mobility to a degree but this pretty much immobilised him. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No details provided of any relevant investigations or tests conducted No follow-up attempts are possible. No further information is expected.


VAERS ID: 1986751 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Dizziness, Immunisation, Interchange of vaccine products, Loss of consciousness, Off label use, SARS-CoV-2 test, Syncope, Vertigo
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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211025; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101796639

Write-up: Blacking out; Fainting; Loss of balance; Lightheadedness; Spinning sensation; 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-202112150035100010-V7TPO (RA). Other Case identifier(s): GB-MHRA-ADR 26336760 (RA). A 48 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 25Nov2021 (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. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 12Mar2021, for COVID-19 Immunisation; Covid-19 vaccine astrazeneca (Dose 2), administration date: 2021, for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (disability, medically significant) with onset 25Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) with onset 25Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability, medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; LOSS OF CONSCIOUSNESS (disability, medically significant), outcome "unknown", described as "Blacking out"; SYNCOPE (disability, medically significant), outcome "not recovered", described as "Fainting"; BALANCE DISORDER (disability), outcome "unknown", described as "Loss of balance"; DIZZINESS (disability), outcome "not recovered", described as "Lightheadedness"; VERTIGO (disability), outcome "unknown", described as "Spinning sensation". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Oct2021) negative, notes: No-Negative COVID-19 test. Patient last menstrual period date was 07Dec2021. 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; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1987061 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-01
Onset:2021-11-25
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Menstruation delayed
SMQs:, Fertility 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: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Late period; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26343228) on 17-Dec-2021 and was forwarded to Moderna on 17-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Late period) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 31-Mar-2020 to 17-Apr-2020. On 01-Nov-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced MENSTRUATION DELAYED (Late period) (seriousness criterion medically significant). On 15-Dec-2021, MENSTRUATION DELAYED (Late period) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information provided It was reported that patient period was late by roughly 24 days which was the length of the average cycle. So in effect patient did not ovulate and missed one period. This was not normal for the patient. The patient did not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Reaction: Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: No No treatment medication information provided This case concerns a female patient of an unknown age with medical history of Suspected COVID-19, who experienced the unexpected serious event of Menstruation Delayed, the event was reported as medically significant by the regulatory authority. The events of occurred approximately 24 days after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was reported as unknown by the regulatory authority. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a female patient of an unknown age with medical history of Suspected COVID-19, who experienced the unexpected serious event of Menstruation Delayed, the event was reported as medically significant by the regulatory authority. The events of occurred approximately 24 days after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was reported as unknown by the regulatory authority. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1987252 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214014 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Cough, Pericarditis, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Fever up to 39�C, coughing up to 39�C. From 26/11 onset of continuous oppressive retrosternal pain exacerbated by breathing, supine and lateral decubitus and acupressure: acute pericarditis.; Fever up to 39�C, coughing up to 39�C. From 26/11 onset of continuous oppressive retrosternal pain exacerbated by breathing, supine and lateral decubitus and acupressure: acute pericarditis.; Fever up to 39�C, coughing up to 39�C. From 26/11 onset of continuous oppressive retrosternal pain exacerbated by breathing, supine and lateral decubitus and acupressure: acute pericarditis.; Fever up to 39�C, coughing up to 39�C. From 26/11 onset of continuous oppressive retrosternal pain exacerbated by breathing, supine and lateral decubitus and acupressure: acute pericarditis.; This case was received via the Regulatory Authority (Reference number: IT-MINISAL02-817553) on 14-Dec-2021 and was forwarded to Moderna on 14-Dec-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of PYREXIA (Fever up to 39�C, coughing up to 39�C. From 26/11 onset of continuous oppressive retrosternal pain exacerbated by breathing, supine and lateral decubitus and acupressure: acute pericarditis.), COUGH (Fever up to 39�C, coughing up to 39�C. From 26/11 onset of continuous oppressive retrosternal pain exacerbated by breathing, supine and lateral decubitus and acupressure: acute pericarditis.), CHEST PAIN (Fever up to 39�C, coughing up to 39�C. From 26/11 onset of continuous oppressive retrosternal pain exacerbated by breathing, supine and lateral decubitus and acupressure: acute pericarditis.) and PERICARDITIS (Fever up to 39�C, coughing up to 39�C. From 26/11 onset of continuous oppressive retrosternal pain exacerbated by breathing, supine and lateral decubitus and acupressure: acute pericarditis.) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214014) for COVID-19 immunisation. The patient''s past medical history included Iron deficiency anaemia. On 24-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 25-Nov-2021, the patient experienced PYREXIA (Fever up to 39�C, coughing up to 39�C. From 26/11 onset of continuous oppressive retrosternal pain exacerbated by breathing, supine and lateral decubitus and acupressure: acute pericarditis.) (seriousness criterion hospitalization), COUGH (Fever up to 39�C, coughing up to 39�C. From 26/11 onset of continuous oppressive retrosternal pain exacerbated by breathing, supine and lateral decubitus and acupressure: acute pericarditis.) (seriousness criterion hospitalization), CHEST PAIN (Fever up to 39�C, coughing up to 39�C. From 26/11 onset of continuous oppressive retrosternal pain exacerbated by breathing, supine and lateral decubitus and acupressure: acute pericarditis.) (seriousness criterion hospitalization) and PERICARDITIS (Fever up to 39�C, coughing up to 39�C. From 26/11 onset of continuous oppressive retrosternal pain exacerbated by breathing, supine and lateral decubitus and acupressure: acute pericarditis.) (seriousness criteria hospitalization and medically significant). At the time of the report, PYREXIA (Fever up to 39�C, coughing up to 39�C. From 26/11 onset of continuous oppressive retrosternal pain exacerbated by breathing, supine and lateral decubitus and acupressure: acute pericarditis.), COUGH (Fever up to 39�C, coughing up to 39�C. From 26/11 onset of continuous oppressive retrosternal pain exacerbated by breathing, supine and lateral decubitus and acupressure: acute pericarditis.), CHEST PAIN (Fever up to 39�C, coughing up to 39�C. From 26/11 onset of continuous oppressive retrosternal pain exacerbated by breathing, supine and lateral decubitus and acupressure: acute pericarditis.) and PERICARDITIS (Fever up to 39�C, coughing up to 39�C. From 26/11 onset of continuous oppressive retrosternal pain exacerbated by breathing, supine and lateral decubitus and acupressure: acute pericarditis.) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant intake of EP and iron pill cycles. No batch, expiration and place of administration of the vaccine is not available. Patient discharged with long-term therapy prescription, returns in 1 month per visit. No treatment information was provided. Company comment: This case concerns a 23-year-old female patient, with medical history of iron deficiency anaemia, who experienced the serious (hospitalization) expected AESI of pericarditis and the serious unexpected events of pyrexia, chest pain and cough after a dose of mRNA-1273. The events could be in association with each other. The events occurred two days after vaccination. No information regarding dose number was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reporter''s Comments: 1 dose 20/10 3005698.; Sender''s Comments: This case concerns a 23-year-old female patient, with medical history of iron deficiency anaemia, who experienced the serious (hospitalization) expected AESI of pericarditis and the serious unexpected events of pyrexia, chest pain and cough after a dose of mRNA-1273. The events could be in association with each other. The events occurred two days after vaccination. No information regarding dose number was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1987290 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-25
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1005A / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Incorrect route of product administration, Loss of consciousness, Pyrexia
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), Drug abuse and dependence (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:37.5 Centigrade
CDC Split Type: ITPFIZER INC202101784666

Write-up: Inappropriate route of vaccination; Fainting the next night, that is, 26/2021 for a few seconds.; Fever 37.5 for 1 day.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: IT-MINISAL02-819361 (regulatory authority). A 12 year-old male patient received bnt162b2 (COMIRNATY), buccal, administered in arm left (Lot number: 1F1005A) 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, manufacturer unknown), for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 26Nov2021, outcome "recovering", described as "Fainting the next night, that is, 26/2021 for a few seconds."; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate route of vaccination"; PYREXIA (non-serious) with onset 25Nov2021, outcome "recovering", described as "Fever 37.5 for 1 day.". The events "fainting the next night, that is, 26/2021 for a few seconds." and "fever 37.5 for 1 day." were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: 37.5 Centigrade. Clinical course: Actions taken (Contacted family doctor.) - Impact on quality of life (1/10), Indication for Use in Case, Indication as Reported by the Primary Source Paracetamol normal, Indication for use in the case (Paracetamol normal). A final statement is not entered.


VAERS ID: 1987504 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1008A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cardiac fibrillation, Echocardiogram, Fatigue, Headache, Malaise, Myocarditis
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy multiple (Epoxy, some perfumes, diethyltoluamide); Pollen allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to chemicals (diethyltoluamide); Perfume sensitivity; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:high inflammatory values; Test Name: Echocardiogram; Result Unstructured Data: Test Result:suspected inflammation
CDC Split Type: NLPFIZER INC202101785904

Write-up: Myocarditis; it seemed like my heart was fibrillating or buzzing; Headache; Fatigue; Malaise; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the Regulatory Authority-WEB. Regulatory number: NL-LRB-00721875 (RA). A 45-year-old male patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: 1F1008A) as dose 2, single for COVID-19 immunization. Relevant medical history included: "Allergy multiple" (ongoing), notes: Epoxy, some perfumes, diethyltoluamide; "Suspected COVID-19", start date: 01Apr2020 (unspecified if ongoing); "Pollen allergy" (ongoing); "Perfume allergy" (unspecified if ongoing); "Allergy to chemicals" (unspecified if ongoing), notes: diethyltoluamide. The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), administration date: 03Nov2021, for COVID-19 immunization, reactions: "Fatigue", "Headache". The following information was reported: MYOCARDITIS (hospitalization) with onset 25Nov2021, outcome "recovering", described as "Myocarditis"; CARDIAC FIBRILLATION (medically significant), outcome "unknown", described as "it seemed like my heart was fibrillating or buzzing"; HEADACHE (non-serious), outcome "recovering", described as "Headache"; FATIGUE (non-serious), outcome "recovering", described as "Fatigue"; MALAISE (non-serious), outcome "recovered", described as "Malaise". The patient underwent the following laboratory tests and procedures: blood test: high inflammatory values; echocardiogram: suspected inflammation. Therapeutic measures were taken as a result of myocarditis which included anti-inflammatories. Clinical course: Patient got chest pain a day after vaccination. The patient also experienced fibrillation of the heart. Tests: Echocardiogram showed suspicion of inflammation, blood test showed high inflammation values. Latency of fatigue was 3 hours after start while for other events was 1 day after start. Hospitalization information: Heart inflammation. As reported, "The day after the vaccination, I felt pain near the heart. It was constant and, at times, the sensation spiked. At these times, it seemed like my heart was fibrillating or buzzing. After the 5th day it lessened but didn''t end." Reporter Comment: Past drug therapy Comirnaty: yes ADRs: Yes, headache and extreme fatigue for 1.5 weeks Date: 03Nov2021 Hospitalization information: Heart inflammation The day after the vaccination, I felt pain near the heart. It was constant and, at times, the sensation spiked. At these times, it seemed like my heart was fibrillating or buzzing. After the 5th day it lessened, but didn''t end. confounding factors, allergy: Epoxy, some perfumes, diethyltoluamide and pollen Previous COVID-19 infection: disease symptoms: quite diagnostic procedures: Echocardiogram and blood test. Ultrasound showed the suspected inflammation; blood test showed high inflammatory values.; Reporter''s Comments: Summary of reporter comment: Past Comirnaty 03Nov2021, headache, extreme fatigue 1.5 weeks. Hospitalization info: Heart inflammation. Day after vaccination, felt pain near heart. Constant and at times sensation spiked. Seemed like heart was fibrillating or buzzing. After 5th day it lessened but didn''t end. Confounding factors, allergy: Epoxy, perfumes, diethyltoluamide, pollen. Previous COVID-19 infection: disease symptoms quite. Echocardiogram and blood test showed inflammation.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101842370 same patient, vaccine, different dose and events


VAERS ID: 1987509 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1008A / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT; Result Unstructured Data: Test Result:unknown results; Test Name: EKG; Result Unstructured Data: Test Result:unknown results; Test Name: cardiologist; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC202101793059

Write-up: Cerebral infarction: I had a cerebral infarction 4 days after the vaccination; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. The reporter is the patient. Regulatory number: NL-LRB-00723336. Other Case identifier(s): NL-LRB-00727466. A 86 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: 1F1008A) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose), administration date: 01Apr2021, for COVID-19 immunisation, reaction(s): "No adverse event"; Comirnaty (2nd dose), administration date: 15May2021, for COVID-19 immunisation, reaction(s): "inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (hospitalization, disability, medically significant) with onset 25Nov2021, outcome "unknown", described as "booster"; CEREBRAL INFARCTION (hospitalization, disability, medically significant) with onset 29Nov2021, outcome "unknown", described as "Cerebral infarction: I had a cerebral infarction 4 days after the vaccination". The event "cerebral infarction: i had a cerebral infarction 4 days after the vaccination" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: unknown results; electrocardiogram: unknown results; investigation: unknown results. Clinical course : Information other or disabling information: I think the vaccination is the cause because the same thing happened to a friend. I had a stroke 4 days after the vaccination No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101839906 same patient, different vaccine doses


VAERS ID: 1987740 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-04
Onset:2021-11-25
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN ACA5775 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Hypertension, Monoplegia
SMQs:, Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: ROJNJFOC20211251934

Write-up: ARTERIAL HYPERTENSION; ARM PARALYSIS; ARRHYTHMIA CARDIAC (NOS); This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, RO-NMA-2021-SPCOV15600) on 23-DEC-2021 concerned a 75 year old female. The patient''s weight was 50 kilograms, and height was 167 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: ACA5775 expiry: Unknown), 1st dose 1 dosage forms, 1 in total, administered on 04-NOV-2021 for an unspecified indication (dose number in series 1) . No concomitant medications were reported. On 25-NOV-2021, the patient experienced arterial hypertension, sensory disturbances/paralysis from the elbow to the palm/fingers in the right arm (arm paralysis), and arrhythmia cardiac (NOS). (dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from arterial hypertension, arm paralysis, and arrhythmia cardiac (NOS) on 25-NOV-2021. This report was serious (Other Medically Important Condition).


VAERS ID: 1987900 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Haematemesis, Headache, Tremor, Vision blurred, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101842037

Write-up: unable to focus; VOMIT; DIZZY; HAND SHAKING; VOMITING BLOOD; HEADACHE; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014550. Other Case identifier(s): TW-Fosun-2021FOS006887 (Fosun). A 70 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Batch/Lot number: unknown) at the age of 70 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), for COVID-19 immunization. The patient experienced headache, vomiting blood, hand shaking on 25Nov2021. At 7 PM of 25Nov2021, the patient felt dizzy and wanted to vomit and improved after returning home. At 5 AM of 26Nov2021, the patient went to the toilet, suddenly felt headache, dizziness, hand shake and vomiting (red vomit). The family went to the toilet inspected that the patient was unable to focus, so called ambulance. On an unspecified date, the patient was hospitalized and was currently in the hospital. Events met the seriousness criterion of Hospitalisation. At the time of the report, the outcomes of the events were recovering. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Causality Assessments: Drug: COMIRNATY Shaking of hands, Dizzy, Vomiting blood, Vomiting, Headache Per Reporter = Possible Per Company (BioNTech SE)= Possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1987941 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101855515

Write-up: CHEST TIGHTNESS; This is a spontaneous report received from non-contactable healthcare professional from License Party (BioNTech SE) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014668 (Regulatory Authority). Other Case identifier(s): TW-Fosun-2021FOS007002. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100014668. A 25-year-old male patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 25-Nov-2021 at age of 25-year-old via intramuscular at 0.3 ml with unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history, concomitant medications and past product were not reported. The patient experienced chest tightness on 25-Nov-2021. On 25-Nov-2021, the patient received the 2nd dose of vaccination. On the same day, the patient experienced chest tightness. the patient performed tests and other examinations immediately. On 28-Nov-2021, it was reported that "still in hospital, turn home". Chest tightness met the seriousness criterion of Caused Hospitalization. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE. Causality Assessment: Chest tightness Per Reporter = Possible Per Company (BioNTech SE) = Possible


VAERS ID: 1988045 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-25
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Blood creatinine, Blood glucose, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, Chest pain, Coma scale, Dizziness, Fibrin D dimer, Haemoglobin, Heart rate, Oxygen saturation, Pain assessment, Platelet count, Red blood cell count, Respiratory rate, Troponin I, Vertigo, White blood cell count
SMQs:, Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperthyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: GPT; Result Unstructured Data: Test Result:14 IU/l; Test Date: 20211125; Test Name: Creatinine; Test Result: 0.63 mg/dl; Test Date: 20211125; Test Name: Sugar; Test Result: 133 mg/dl; Test Date: 20211125; Test Name: K; Result Unstructured Data: Test Result:3.3 mmol/L; Test Date: 20211125; Test Name: BP; Result Unstructured Data: Test Result:167/89 mmHg; Test Date: 20211125; Test Name: Sodium; Result Unstructured Data: Test Result:137.6 mmol/L; Test Date: 20211125; Test Name: Blood urea nitrogen; Test Result: 18.4 mg/dl; Test Date: 20211125; Test Name: Body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Test Date: 20211125; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:E4V5M6; Test Date: 20211125; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:0.31 ug/ml; Test Date: 20211125; Test Name: Hemoglobin; Result Unstructured Data: Test Result:13.7 g/dl; Test Date: 20211125; Test Name: Heart rate; Result Unstructured Data: Test Result:74; Comments: Units:{beats}/min; Test Date: 20211125; Test Name: Oxygen saturation; Test Result: 95 %; Test Date: 20211125; Test Name: Pain scale; Result Unstructured Data: Test Result:0 points; Test Date: 20211125; Test Name: Platelet count; Result Unstructured Data: Test Result:204 x10 6/mm3; Test Date: 20211125; Test Name: Red blood cell count; Result Unstructured Data: Test Result:4.73 10*6/uL; Test Date: 20211125; Test Name: Respiratory rate; Result Unstructured Data: Test Result:18; Comments: Units:{breaths}/min; Test Date: 20211125; Test Name: Troponin I; Result Unstructured Data: Test Result:0.006 ng/ml; Test Date: 20211125; Test Name: WBC; Result Unstructured Data: Test Result:6.23 x10 6/mm3
CDC Split Type: TWPFIZER INC202101854872

Write-up: CHEST PAIN; VERTIGO; DIZZINESS; This is a spontaneous report received from non-contactable healthcare professional from License Party (BioNTech SE) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014418 (Regulatory- Authority Center for Disease Control). Other Case identifier(s): TW-Fosun-2021FOS007207. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100014418. A 64-year-old female patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 18-Nov-2021 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history included hyperthyroidism. Concomitant medication and past product were not reported. The patient experienced chest pain, vertigo and dizziness on 25-Nov-2021. On 25-Nov-2021, the patient went to emergency. Differential diagnosis was vertigo and dizziness, blood pressure or heartbeat of the patient had an usual value, blood-based power was stable, and the pain index was 0 points. Chest pain was also reported. Life signed: blood pressure (BP): 167/89 mmHg, heart rate (HR): 74 times/min, respiratory rate (RR): 18 times/minute, body temperature (BT): 35.9 centigrade, oxygen saturation (SPO2): 95 %. Glasgow coma scale (GCS): E4V5M6, white blood cell (WBC): 6.23 x1000/UL, red blood cell (RBC): 4.73 x 10^6/UL, hemoglobin (HGB):13.7 g/dL, platelet count (PLT): 204 x1000/UL, Sugar:133 mg/dl, glutamic-pyruvic transaminase (GPT): 14 IU/L, urea nitrogen (UREA N): 18.4 mg/dl, creatinine 0.63 mg/dl, sodium (Na): 137.6 mmol/L, potassium (K): 3.3 mmol/L, troponin i (Tropo-i): 0.006 ng/ml, D-Dimer: 0.31 ug/ml. Treatments of "Sodium chloride (Sodium Chloride 0.9% 500ml/Bag) 500 ml st IVD 1 day, Diphenhydramine (Diphenhydramine 30mg/1ml/amp) 1 amp st IVP 1 day (aq dest 20ml/ amp) 20 ml st IVP 1 day, Diphenidol HCL (Diphenidol 25mg/Tab) 1 Tab PO TID PC 3 days" were prescribed. On an unknown date , the patient was stabled and discharge. On 29-Nov-2021, symptoms of the patient had been improved. Chest pain, vertigo and dizziness met the seriousness criterion of hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. The outcomes of the events were recovered on an unknown date. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. COMIRNATY is under agreement with BioNTech SE. Causality Assessment: the causality of the events Chest pain, Vertigo, Dizziness was possible per reporter and company (BioNTech No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1988110 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (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: TWPFIZER INC202101854550

Write-up: BELL''S PALSY; This is a spontaneous report received from non-contactable reporter (Other HCP) from License Party (BioNTech) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014761. Other Case identifier(s): TW-Fosun-2021FOS007413. This is a spontaneous report received from a non-contactable HCP received via Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100014761. A 47-year-old male patient started to receive 2nd dose of BNT162B2 (COMIRNATY) (batch number was not reported) on 25-Nov-2021 via intramuscular at DOSE 2, 0.3 ML SINGLE for COVID-19 immunization. The 1st agent was given on an unknown date. The patient had no medical history. Concomitant medications and past product were not reported. The patient experienced bell''s palsy on 25-Nov-2021. On 25-Nov-2021, the patient had inoculation of the second agent BNT vaccine, then the patient started right face palsy at night. On 01-Dec-2021, the doctors prescribed 4 days of Prednisolone 20mg Tid, Methylcobalamin (MethycoBal) 500mcg QID and Tears Naturale 15ml / bot. On 03-Dec-2021, after the medicine treatment, the eyes could already be slightly closed, and the mouth would leak when the patient was drinking water. Bell''s palsy met the seriousness criterion of Other Medically Important Condition. At the time of the report, the outcome of the event was recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Reporter Causality Assessments: Bell''s palsy Possible related to bnt162b2. Company (BioNTech SE) Causality Assessments: Bell''s palsy Possible related to bnt162b2.


VAERS ID: 1988339 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Muscular weakness, Myalgia, Pain in extremity, Pneumonia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

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

Write-up: Muscle pain; Pain of limbs; Pneumonia; Limb weakness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of MYALGIA (Muscle pain), PAIN IN EXTREMITY (Pain of limbs), PNEUMONIA (Pneumonia) and MUSCULAR WEAKNESS (Limb weakness) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 24-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Nov-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Pain of limbs) (seriousness criterion hospitalization), PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and MUSCULAR WEAKNESS (Limb weakness) (seriousness criterion hospitalization). At the time of the report, MYALGIA (Muscle pain), PAIN IN EXTREMITY (Pain of limbs), PNEUMONIA (Pneumonia) and MUSCULAR WEAKNESS (Limb weakness) was resolving. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant Medication use information was not provided by reporter. Treatment Medication use information was not provided by reporter. On 24 November 2021, the patient received moderna vaccine and then had aches and weakness of both reached up to 37.1 Degree Celsius and there was murmured of breath sounded. The patient was hospitalized for treatment. The follow up care was as follows on 6 December 2021, the patient''s wife said that the patient had poor appetite, aches and weakness of lowered limbs and other symptoms successively after receiving the vaccine. The patient fell down at home several times but did not saw a doctor. On 01 December 2021, the patient fell down again, and paid a medical visited to the emergency department of Hospital accompanied by the family member. At present, the patient was admitted to ICU for intubation and observation due to pulmonary edema or pneumonia. The patient''s wife said that it was inconvenient to went out because had a lumbar surgery, but wanted to discuss the illness and transfer with the doctor. We had helped asked about the relevant situation and were told that the patient''s wife could went to the ICU to visit the patient in the evening and called the ward to discuss the relevant matters with the attending physician. The patient''s wife and daughter got it. Company Comment: This is a regulatory case concerning a 74-year-old, male patient with no reported medical history, who experienced the unexpected serious events of Myalgia, Pain in extremity, Pneumonia and Muscular weakness. The events occurred 1 day after the first dose of mRNA-1273 vaccine. 8 days later patient was hospitalized for treatment and was under observation in an ICU continuously. The outcome of the events was reported as recovering. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 74-year-old, male patient with no reported medical history, who experienced the unexpected serious events of Myalgia, Pain in extremity, Pneumonia and Muscular weakness. The events occurred 1 day after the first dose of mRNA-1273 vaccine. 8 days later patient was hospitalized for treatment and was under observation in an ICU continuously. The outcome of the events was reported as recovering. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1989907 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1H049A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Factor V Leiden heterozygote
Allergies:
Diagnostic Lab Data: Test Name: doppler ultrasound; Result Unstructured Data: Test Result:unknown
CDC Split Type: DEPFIZER INC202101798822

Write-up: Deep vein thrombosis; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: DE-PEI-202100274775 . A 24 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Lot number: 1H049A) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "heterozygous Factor V gene mutation" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, Primary Immunization series complete but unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (2nd dose, Primary Immunization series complete but unknown manufacturer), for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "booster"; DEEP VEIN THROMBOSIS (medically significant) with onset 26Nov2021, outcome "not recovered", described as "Deep vein thrombosis". The patient underwent the following laboratory tests and procedures: ultrasound doppler: unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1989984 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 308991TB / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Electrocardiogram, Head injury, Ligament sprain, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Tendinopathies and ligament disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: electrocardiogram; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: DEPFIZER INC202101799017

Write-up: Syncope; Not in a good mood having previously gone unconscious; Ran from the chair, hit their head off the concrete floor; Bruises; Cervical spine and collarbone sprains; This is a spontaneous report received from a non-contactable Consumer from the regulatory authority. Regulatory number: DE-PEI-CADR2021206202 (RA). Other Case identifier(s): DE-CADRPEI-2021206202 (RA Webportal), DE-PEI-202100232371 (RA). A 16 year-old male patient received bnt162b2 (COMIRNATY strength 0.3ml), administration date 25Nov2021 (Lot number: 308991TB) 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 25Nov2021, outcome " not recovered" described as "Syncope"; LOSS OF CONSCIOUSNESS (medically significant) with 25Nov2021, outcome "unknown", described as "Not in a good mood having previously gone unconscious"; HEAD INJURY (non-serious) with onset 2021, outcome "unknown", described as "Ran from the chair, hit their head off the concrete floor"; CONTUSION (non-serious) with onset 2021, outcome "unknown", described as "Bruises"; LIGAMENT SPRAIN (non-serious) with onset 2021, outcome "unknown", described as "Cervical spine and collarbone sprains". The patient underwent the following laboratory tests and procedures: electrocardiogram: unknown results. Therapeutic measures were taken as a result of syncope. Sender comment: Do you or the person concerned have any known allergies? If so, what are they?No.Details or risk factors of previous illnesses:None/restoration of circulatory stability, electrocardiogram carried out, not in a good mood having previously gone unconscious, ran from the chair, hit their head off the concrete floor, bruises, cervical spine and collarbone sprains. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1990054 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCTJ2 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Cardiac function test, Dizziness, Gait disturbance, Headache, Magnetic resonance imaging, Neurological examination
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: cardiological tests; Result Unstructured Data: Test Result:Unknown results; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Test Name: neurological test; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: DEPFIZER INC202101834210

Write-up: severe dizziness; headache; cannot walk alone; balance organ disturbed / weak; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from License Party. The reporter is the parent. Other Case identifier: 110155 (Biontech). A female patient (reporter''s daughter) received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: SCTJ2) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose, Lot number: 1F1021A), administration date: 21Oct2021, for Covid-19 immunization. The following information was reported: DIZZINESS (hospitalization) with onset 25Nov2021, outcome "not recovered", described as "severe dizziness"; HEADACHE (hospitalization) with onset 25Nov2021, outcome "not recovered", described as "headache"; GAIT DISTURBANCE (hospitalization) with onset 25Nov2021, outcome "not recovered", described as "cannot walk alone"; BALANCE DISORDER (hospitalization) with onset 25Nov2021, outcome "not recovered", described as "balance organ disturbed / weak". The patient underwent the following laboratory tests and procedures: cardiological tests: unknown results; magnetic resonance imaging (MRI): unknown results; neurological test: unknown results. Therapeutic measures were taken as a result of dizziness, headache, gait disturbance, balance disorder. Clinical course: Nothing had been going on since second vaccination. She had severe dizziness, headache, could not walk alone, balance organ disturbed/weak. No tryptane, no cortisone, etc. helped. MRI, neurological and cardiological tests are in progress or have already been performed. She was in the hospital for a week, no improvement in sight. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101842551 Same Reporter, different Patient.


VAERS ID: 1990128 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G047A / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Chest pain, Dyspnoea, Inappropriate schedule of product administration, Oral pruritus, Panic reaction, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211126; Test Name: body temperature; Result Unstructured Data: Test Result:37.7 Centigrade
CDC Split Type: FIPFIZER INC202101799367

Write-up: itching symptoms in the mouth; shortness of breath; stinging sensation in the chest; Feverish; Panic reaction; Anaphylactic reaction; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the RA. Regulatory number: FI-FIMEA-20217692 (RA). A 20 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 25Nov2021 (Lot number: 1G047A) at the age of 20 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, single), administration date: 14Oct2021, for covid-19 immunisation, reaction(s): "panic". The following information was reported: PYREXIA (hospitalization, life threatening) with onset 25Nov2021, outcome "recovering", described as "Feverish"; PANIC REACTION (hospitalization, life threatening) with onset 25Nov2021, outcome "recovering", described as "Panic reaction"; ANAPHYLACTIC REACTION (hospitalization, life threatening) with onset 25Nov2021, outcome "recovering", described as "Anaphylactic reaction"; ORAL PRURITUS (hospitalization), outcome "recovering", described as "itching symptoms in the mouth"; DYSPNOEA (hospitalization), outcome "recovering", described as "shortness of breath"; CHEST PAIN (hospitalization), outcome "recovering", described as "stinging sensation in the chest"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 25Nov2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "feverish", "panic reaction", "anaphylactic reaction", "itching symptoms in the mouth", "shortness of breath" and "stinging sensation in the chest" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (26Nov2021) 37.7 Centigrade. Therapeutic measures were taken as a result of pyrexia, panic reaction, anaphylactic reaction, oral pruritus, dyspnoea, chest pain. Clinical course: Anaphylactic reaction from Pfizer Comirnaty vaccine. The patient soon developed itching symptoms in the mouth, shortness of breath and stinging sensation in the chest. Histec 10 mg did not help with the symptoms, and the patient received Epipen 300 micrograms, and an opening drip was put on. In addition, Prednisolone 40 mg was given. On 26Nov2021, the patient also had a temperature reaction, i.e., 37.7 C. The patient was transferred to follow-up care to the hospital. The patient was previously a healthy woman. The first vaccination on 14Oct2021 also caused symptoms and was thought to be a panic type symptom. The patient was recovering from the vaccination reaction. On 29Nov2021, the patient visit the doctor''s office for evaluation. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FI-PFIZER INC-202101808243 Same reporter/patient; different event/dose


VAERS ID: 1990182 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCVDI / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Echocardiogram, Fall, Immunisation, Pain in extremity
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211130; Test Name: Doppler echo; Result Unstructured Data: Test Result:Left sural deep vein thrombosis; Comments: Left sural deep vein thrombosis involving an internal twin vein (5mm) without extension to the rest of the venous today. The inferior vena cava and iliac veins are patent.
CDC Split Type: FRPFIZER INC202101799708

Write-up: Thrombosis venous deep; pain in the left calf; Booster; The patient has fallen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: FR-AFSSAPS-LY202113025 (AFSSAPS). A 67-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 25Nov2021 (Lot number: SCVDI), at the age of 67-years-old, as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown), for covid-19 immunisation; Covid-19 vaccine (2nd dose, manufacturer unknown), for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 25Nov2021, outcome "unknown", described as "Booster"; DEEP VEIN THROMBOSIS (medically significant) with onset 30Nov2021, outcome "recovering", described as "Thrombosis venous deep"; FALL (non-serious) with onset 2021, outcome "unknown", described as "The patient has fallen"; PAIN IN EXTREMITY (non-serious) with onset 30Nov2021, outcome "unknown", described as "pain in the left calf". The events "thrombosis venous deep", "the patient has fallen" and "pain in the left calf" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: echocardiogram (Doppler echo): (30Nov2021) left sural deep vein thrombosis, notes: Left sural deep vein thrombosis involving an internal twin vein (5mm) without extension to the rest of the venous today. The inferior vena cava and iliac veins are patent. Therapeutic measures were taken as a result of deep vein thrombosis. Additional information: On 02Dec2021, the patient had a consultation with an angiologist. Clinically, the patient had flexible calves without edema. There was no popliteal cyst or organized intramuscular hematoma. The patient had an anticoagulant treatment with ELIQUIS 5 for 1 month and wearing of class II elastic compression due to deep vein thrombosis.


VAERS ID: 1990183 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 079F21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness
SMQs:

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

Write-up: Influenza like illness; This case was received via (Reference number: FR-AFSSAPS-LY202113038) on 21-Dec-2021 and was forwarded to Moderna on 21-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Influenza like illness) in a 37-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 079F21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Nov-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Influenza like illness) (seriousness criterion medically significant). At the time of the report, INFLUENZA LIKE ILLNESS (Influenza like illness) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Company comment: This case concerns a 37-year-old female patient with no medical history provided who experienced serious unexpected event of Influenza like illness. The event occurred three days after the second dose of mRNA-1273. At the time of the report, the event was still ongoing and no further information regarding clinical course of the event was provided. As per SD, no rechallenge was done and, therefore, recurrence is not applicable. 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 37-year-old female patient with no medical history provided who experienced serious unexpected event of Influenza like illness. The event occurred three days after the second dose of mRNA-1273. At the time of the report, the event was still ongoing and no further information regarding clinical course of the event was provided. As per SD, no rechallenge was done and, therefore, recurrence is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1990363 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Chest pain, Dyspnoea, Fatigue, Feeling abnormal, Heart rate, Heart rate increased, Immunisation, Malaise, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: CITALOPRAM; DIGOXIN; EDOXABAN; OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety attack; Atrial fibrillation; Chronic atrial fibrillation; Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohnics disease, ulcerative colitis)); Stomach pain
Allergies:
Diagnostic Lab Data: Test Date: 202110; Test Name: heart rate; Result Unstructured Data: Test Result:170 bpm; Test Date: 202110; Test Name: heart rate; Result Unstructured Data: Test Result:205 bpm; Test Date: 202110; Test Name: heart rate; Result Unstructured Data: Test Result:210 bpm; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101796545

Write-up: atrial fibrillation; High pulse rate; Booster; shortness of breath; heart rate increased; chest ache; not well; feeling dull; after the injection within days i was feeling incredibly tired; 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-202112141443431850-P7AL6. Other Case identifier(s): GB-MHRA-ADR 26332724. A 50 year-old male patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "Inflammatory bowel disease" (unspecified if ongoing), notes: Taking medicines for inflammatory bowel disease (Crohnics disease, ulcerative colitis); "Anxiety attack" (unspecified if ongoing); "Chronic atrial fibrillation" (unspecified if ongoing); "Stomach pain" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM taken for anxiety; DIGOXIN taken for atrial fibrillation; EDOXABAN taken for atrial fibrillation; OMEPRAZOL taken for abdominal pain upper. Past drug history included: Buscopan. 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 25Nov2021, outcome "unknown", described as "Booster"; DYSPNOEA (medically significant) with onset 2021, outcome "recovering", described as "shortness of breath"; HEART RATE INCREASED (medically significant) with onset 2021, outcome "recovering", described as "heart rate increased"; CHEST PAIN (medically significant) with onset 2021, outcome "recovering", described as "chest ache"; ATRIAL FIBRILLATION (medically significant), outcome "recovering", described as "atrial fibrillation"; FATIGUE (medically significant) with onset 2021, outcome "recovering", described as "after the injection within days i was feeling incredibly tired"; HEART RATE INCREASED (medically significant) with onset 27Nov2021, outcome "recovering", described as "High pulse rate"; MALAISE (medically significant) with onset 2021, outcome "unknown", described as "not well"; FEELING ABNORMAL (medically significant) with onset 2021, outcome "unknown", described as "feeling dull". The patient underwent the following laboratory tests and procedures: heart rate: (Oct2021) 170 bpm; (Oct2021) 205 bpm; (Oct2021) 210 bpm; sars-cov-2 test: (unspecified date) negative, notes: No - Negative COVID-19 test. Clinical course: It was reported that since 27th November 2021 the patients daily heart rate has increased into the boundaries of late 90''s/100''s . Prior to this had been 80-mid 90''s. During Exercise on the same route he took in October 2021, his heart rate increased to 205-210 max bpm (recorded on different devices) and the average heart rate for the ride was 170bpm. After the injection within days, he was feeling incredibly tired dull, chest ache, out of breath and not well. His heart rate was increased. Currently his GP had doubled his intake of Digoxin to 250mg from 125mg. This had resulted in him feeling better. When reduced to 125mg for a test period, he had shortness of breath, chest ache, and fatigue, so the symptoms returned. Currently in 3 days of 250mg and he was feeling a lot better. Reportedly he had permanent Atrial Fibrillation. He has been cycling without any issue prior to the Booster. He had never had a 200+ BPM heart rate at all since switching to Digoxin. All these symptoms occurred after the booster. He was in a good managed state, and the only change to medication was the booster. Patient was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. 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: 1990579 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PNEUMOCOCCAL POLYSACCHARIDE VACCINE; GLUCOPHAGE; BETA-PROGRANE; BIKTARVY; JARDIANCE; NITROLINGUAL; EVACAL D3; HUMULINE; OZEMPIC; NEURONTIN; INDAPAMIDE; CETIRIZINE HYDROCHLORIDE; AMITRIPTYLINE; PRAVASTATIN SODIUM; RAMIPRIL; ISOSORBIDE-5-MONO
Current Illness: HIV positive (HIV-positive with symptoms or reduction in immune response)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201227; Test Name: COVID-19 virus test; Test Result: Positive; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: vomiting; Pain; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26344359) on 19-Dec-2021 and was forwarded to Moderna on 19-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (vomiting), PYREXIA (Fever) and PAIN (Pain) in a 53-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included HIV positive (HIV-positive with symptoms or reduction in immune response). Concomitant products included PNEUMOCOCCAL VACCINE POLYSACCH (PNEUMOCOCCAL POLYSACCHARIDE VACCINE) from 06-Oct-2021 to 06-Oct-2021 for HIV status, METFORMIN HYDROCHLORIDE (GLUCOPHAGE), PROPRANOLOL HYDROCHLORIDE (BETA-PROGRANE), BIKTARVY, EMPAGLIFLOZIN (JARDIANCE), GLYCERYL TRINITRATE (NITROLINGUAL), CALCIUM CARBONATE, COLECALCIFEROL (EVACAL D3), INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULINE), SEMAGLUTIDE (OZEMPIC), GABAPENTIN (NEURONTIN), INDAPAMIDE, CETIRIZINE HYDROCHLORIDE, AMITRIPTYLINE, PRAVASTATIN SODIUM, RAMIPRIL, ISOSORBIDE-5-MONONITRATE, OMEPRAZOLE and ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication. On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PYREXIA (Fever) (seriousness criterion disability). On an unknown date, the patient experienced VOMITING (vomiting) (seriousness criterion disability) and PAIN (Pain) (seriousness criterion disability). On 05-Dec-2021, PYREXIA (Fever) had resolved with sequelae. At the time of the report, VOMITING (vomiting) had not resolved and PAIN (Pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2020, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. No treatment drug was provided by reporter. Patient had Fever, severe body pain, vomiting, temperature up to 37.7C Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Company comment: This case concerns a 53-year-old female patient with medical history of HIV positive, who experienced the serious unexpected events of vomiting, pyrexia and pain after the third dose of mRNA-1273. The event pyrexia occurred the next day after vaccination and lasted for 10 days. Patient�s polypharmacy remains a confounder for the event vomiting. Underlying patient�s disease could be considered a confounding factor for the event pyrexia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender''s Comments: This case concerns a 53-year-old female patient with medical history of HIV positive, who experienced the serious unexpected events of vomiting, pyrexia and pain after the third dose of mRNA-1273. The event pyrexia occurred the next day after vaccination and lasted for 10 days. Patient�s polypharmacy remains a confounder for the event vomiting. Underlying patient�s disease could be considered a confounding factor for the event pyrexia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1991096 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2595 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Eyelid oedema, Face oedema, Heart rate, Hypertension, Lip oedema, Oxygen saturation, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atopy (unspecified atopy In treatment for allergology with vaccines in childhood); Food allergy
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: Blood pressure; Result Unstructured Data: Test Result:159/107 mmHg; Test Date: 20211125; Test Name: Blood pressure; Result Unstructured Data: Test Result:121/71 mmHg; Test Date: 20211125; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20211125; Test Name: Heart rate; Result Unstructured Data: Test Result:92; Test Date: 20211125; Test Name: Heart rate; Result Unstructured Data: Test Result:62; Test Date: 20211125; Test Name: Oxygen saturation; Test Result: 99 %; Test Date: 20211125; Test Name: Oxygen saturation; Test Result: 99 %; Test Date: 20211125; Test Name: Breathing frequency; Result Unstructured Data: Test Result:2; Test Date: 20211125; Test Name: Breathing frequency; Result Unstructured Data: Test Result:16
CDC Split Type: MXPFIZER INC202101822792

Write-up: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 18266-12 (COFEPRIS). A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 25Nov2021 (Lot number: FF2595, Expiration Date: 01Feb2022) at the age of 21 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "History of allergy to seafood, peach and pork." (unspecified if ongoing); "atopy" (unspecified if ongoing), notes: unspecified atopy In treatment for allergology with vaccines in childhood. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 , MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: LIP OEDEMA (hospitalization, medically significant) with onset 25Nov2021, outcome "recovered" (25Nov2021), described as "lip edema"; EYELID OEDEMA (hospitalization, medically significant) with onset 25Nov2021, outcome "recovered" (25Nov2021), described as "bilateral eyelids edema"; FACE OEDEMA (hospitalization, medically significant) with onset 25Nov2021, outcome "recovered" (25Nov2021), described as "facial edema"; HYPERTENSION (hospitalization, medically significant) with onset 25Nov2021, outcome "recovered" (25Nov2021), described as "Blood pressure 159/107". The patient was hospitalized for lip oedema, eyelid oedema, face oedema, hypertension (start date: 25Nov2021, discharge date: 25Nov2021, hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: blood pressure measurement: (25Nov2021) 159/107 mmHg; (25Nov2021) 121/71 mmHg; body temperature: (25Nov2021) 36.4 Centigrade; heart rate: (25Nov2021) 92; (25Nov2021) 62; oxygen saturation: (25Nov2021) 99 %; (25Nov2021) 99 %; respiratory rate: (25Nov2021) 2; (25Nov2021) 16. Therapeutic measures were taken as a result of lip oedema, eyelid oedema, face oedema, hypertension. Clinical course: Qx (surgeries) and hematrasfusions (blood transfusions) denied. She was brought by module Privacy as started 10-15 min after the second dose of pfizer with lip edema as well as bilateral eyelids edema with difficulty opening them. No glossitis, denies difficulty swallowing, foreign body sensation, itching rash or chest tightness. Was admitted to privacy with blood pressure 159/107, heart rate 92, breathing frequency 2, oxygen saturation 99% temperature 36.4 weight 60 kg height 1.80. Patient was calm, conscious, oriented, stable, only with facial edema without airway compromise, cardiac sinus rhythm rs by telemetry, clean cs ps (pulmonary fields) no aggregates, no dermatological data or angioedema. Proceeded to canalize hartman solution 500 cc. intravenous-diphenhydramine 4 ml intravenous du (only dose) hydrocortsiona 100 mg intravenous with reduction of facial edema, no extra symptoms were added. after 1:30 of observation patient was discharged, blood pressure 121/71, heart rate 62, breathing frequency 16, oxygen saturation 99%. Family member administered treatment prior to medical attention? No. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1991218 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, Gingival bleeding, Haemorrhage in pregnancy, Maternal exposure during pregnancy, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gingival disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CHOLINE; FOLIC ACID; CALCIUM+MAGNESIUM; IODIDE; VITAMIN D WITH OMEGA 3; MULTIVITAMINS [VITAMINS NOS]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101799054

Write-up: Vaginal bleeding; bleeding from the gums when flossing; Bleeding from the abdomen and other mucous membranes during pregnancy; nosebleeds; Maternal exposure during pregnancy, second trimester; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. The reporter is the patient. Regulatory number: NO-NOMAADVRE-PASRAPP-2021-Upywn1. Other Case identifier(s): NO-NOMAADVRE-E2B_00064614. A 29 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 25Nov2021 19:05 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history was not reported. The patient was 27 weeks pregnant at the event onset. Concomitant medication(s) included: CHOLINE; FOLIC ACID; CALCIUM+MAGNESIUM; IODIDE; VITAMIN D WITH OMEGA 3; MULTIVITAMINS [VITAMINS NOS] reported as Gevita multi vegan. The following information was reported: HAEMORRHAGE IN PREGNANCY (medically significant) with onset 30Nov2021, outcome "recovered" (01Dec2021), described as "Bleeding from the abdomen and other mucous membranes during pregnancy"; EPISTAXIS (non-serious) with onset 30Nov2021, outcome "recovered", described as "nosebleeds"; VAGINAL HAEMORRHAGE (non-serious) with onset 01Dec2021, outcome "recovered" (01Dec2021), described as "Vaginal bleeding"; GINGIVAL BLEEDING (non-serious) with onset 30Nov2021, outcome "recovered", described as "bleeding from the gums when flossing"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 25Nov2021 19:05, outcome "unknown", described as "Maternal exposure during pregnancy, second trimester". The Center did not provide a causality assessment. Clinical course: The patient added that nose bleed never happened before. Gum bleeding usually never happens due to daily flossing. Vaginal bleeding happened three times during 3 hours. She discovered it on the toilet paper when she went to the bathroom. This was the first time the patient has bled throughout the pregnancy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Contact with healthcare professionals: Nurse. On 30Nov2021, the patient developed NOSE BLEED, which has never happened before. She also experienced GUM BLEEDING when flossing. This usually never happens due to daily flossing. On 01Dec2021, the patient experienced VACINAL BLEEDING with fresh blood three times during 3 hours (HAEMORRHAGE IN PREGNANCY). This was the first time the patient has bled throughout the pregnancy.


VAERS ID: 1991262 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 22756 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest pain, Chills, Headache, Pruritus, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211129; Test Name: body temperature; Result Unstructured Data: Test Result:Fever greater or equal to 38 degree Centigrade; Comments: 23:50.
CDC Split Type: PHPFIZER INC202101805132

Write-up: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300125711 (RA). A 49-year-old female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Lot number: 22756) at the age of 49 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: CHEST PAIN (hospitalization) with onset 29Nov2021 23:50, outcome "recovering", described as "CHEST PAIN"; CHILLS (hospitalization) with onset 29Nov2021 23:50, outcome "recovering", described as "Chills"; PYREXIA (hospitalization) with onset 29Nov2021 23:50, outcome "recovering", described as "Fever greater or equal to 38 degree centigrade"; HEADACHE (hospitalization) with onset 25Nov2021 13:00, outcome "recovering", described as "Headache"; PRURITUS (hospitalization) with onset 25Nov2021 13:00, outcome "recovering", described as "Itching"; RASH (hospitalization) with onset 29Nov2021 23:53, outcome "recovering", described as "Skin rash". The patient underwent the following laboratory tests and procedures: body temperature: (29Nov2021) fever greater or equal to 38 degrees, notes: 23:50. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1991280 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32021BD / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Rash, Somnolence, Urticaria, Vital signs measurement
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: vital sign; Result Unstructured Data: Test Result:unknown results
CDC Split Type: PHPFIZER INC202101805413

Write-up: Rash all over the body; Generalized skin rashes; Drowsiness sensation; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300126473. A 15 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 23Nov2021 (Lot number: 32021BD) 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: URTICARIA (hospitalization, medically significant) with onset 25Nov2021 19:00, outcome "recovering", described as "Rash all over the body"; RASH (hospitalization, medically significant) with onset 25Nov2021, outcome "unknown", described as "Generalized skin rashes"; SOMNOLENCE (hospitalization, medically significant) with onset 25Nov2021, outcome "unknown", described as "Drowsiness sensation". The patient underwent the following laboratory tests and procedures: vital signs measurement: unknown results (vital signs checked and recorded). Therapeutic measures were taken as a result of urticaria, rash, somnolence.The patient noticed some rashes but no consultation was done. She consulted last on 25Nov2021 with chief complaint of generalized skin rashes. The patient had the urticarial rash on both hands after the vaccination. On the day of consultation, she had increased generalized urticarial rash and drowsiness sensation. Heplock was inserted, IV and IM medication was given. The Laboratory results were seen by the physician (unspecified) and Home meds were instructed, also advised not to eat food that may trigger allergy. She was discharged ambulatory accompanied by relatives (as reported). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1991282 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-21
Onset:2021-11-25
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH B1060BD / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cough, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101805457

Write-up: Weakness; Cough; Dyspnea; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300126600. A 74 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 21Oct2021 (Lot number: B1060BD) at the age of 74 years as dose 2, single and intramuscular, administration date 02Sep2021 (Lot number: FD0350) 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: COUGH (hospitalization) with onset 25Nov2021, outcome "recovering", described as "Cough"; DYSPNOEA (hospitalization) with onset 25Nov2021, outcome "recovering", described as "Dyspnea"; ASTHENIA (hospitalization) with onset 09Dec2021, outcome "recovering", described as "Weakness". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1991458 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Chest discomfort, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101832515

Write-up: SUSPECTED ANGINA; CHEST TIGHTNESS; DIFFICULTY BREATHING; This is a spontaneous report received from non-contactable healthcare professional from Regulatory Authority via License Party (BIONTECH). Regulatory number: TW-TFDA-TVS-1100014375 Agency Regulatory Authority. Other Case identifier(s): TW-Fosun-2021FOS006849 Regulatory Authority. A 40-year-old female patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch num-ber was not reported) on 25-Nov-2021 via intramuscular at unknown dose with unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on an unknown date. The patient had no chronic history. Concomitant medication and past product were not reported. The patient ex-perienced chest tightness and difficulty breathing on 25-Nov-2021, experienced suspected angina on 26-Nov-2021. At 11:30 am of 25-Nov-2021, the patient had chest tightness and breathing was difficult after received the second dose of the Biontech Covid-19 vaccine. At 16:23 pm of 26-Nov-2021, the pa-tient went to the hospital emergency for treatment (not specified). The patient was diagnosed sus-pected angina. The patient was admitted to hospital. Everything to check was normal in the hospital, there were no obvious abnormalities. In the morning of 27-Nov-2021, the patient was stable and dis-charged after hospitalization. Chest tightness, difficulty breathing and suspected angina met the seri-ousness criterion of hospitalisation. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the chest tightness and diffi-culty breathing were recovered, the outcome of the suspected angina was unknown. Causality Assessments: Drug: COMIRNATY, Anginal pain, Difficulty breathing, Chest tightness, Per Re-porter = Possible, Per Company (BioNTech)= Possible Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Comirnaty is under agreement with Biontech.


VAERS ID: 1991460 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-11-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Asthma, Hyperventilation, Interchange of vaccine products, Off label use
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Medication errors (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101832510

Write-up: OFF LABEL USE; INTERCHANGE OF VACCINE PRODUCTS; SEVERE ALLERGIC REACTION; asthma; breathing abnormal; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014390. Other Case identifier(s): TW-Fosun-2021FOS006852 . A 43-year-old female patient started to receive 2nd dose of (COMIRNATY) (batch number was not reported) on 25-Nov-2021 (age at the vaccination was 43-year-old) via intramuscular at 0.3 ml with unspecified dosing frequency for COVID-19 immunization (interchange of vaccine products) (off label use). The 1st dose was re-ceived on 30-Jul-2021. Medical history and concomitant medication were not reported. Past product included one dose of AstraZeneca COVID-19 vaccine received on 30-Jul-2021. The patient experienced severe allergic reaction on 25-Nov-2021. On 30-Jul-2021, the patient received the first dose of COVID-19 AZ vaccine. Dyspnea immediately occurred after 4 minutes. Considering the patient''s vital signs were stable, The physician sent the patient to the emergency room (ER) for further evaluation. Treatments of "chlorpheniramine st inj 5 mg/1 ml im st and methasone inj 5 mg/1 ml/vl im st" were prescribed. On 25-Nov-2021, the patient went to the emergency because there were immediately, asthma, breathing abnormal, and blood oxygen concentrations after inoculation of BNT vaccine second dose. And the patient returned home after rest. Severe allergic reaction met the seriousness criterion of life threatening. The action taken for (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Causality Assessments: Anaphylactic reaction,Interchange of vaccine products, Off label use Per Reporter= Possible Per Company (BioNTech) = Possible


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