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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: 1991092 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   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 30150BA / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Dermatosis, Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dermatosis; Velo-cardio-facial syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC202101822763

Write-up: erythroid dermatosis which exacerabated after the vaccine; erythroid dermatosis which exacerabated after the vaccine; Erythema / Redness; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 18236-12 (COFEPRIS). A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Nov2021 (Lot number: 30150BA, Expiration Date: 30Nov2021) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cardiofacial syndrome" (unspecified if ongoing); "erythroid dermatosis" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: DERMATOSIS (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 18Nov2021, outcome "unknown" and all described as "erythroid dermatosis which exacerabated after the vaccine"; ERYTHEMA (non-serious) with onset 18Nov2021, outcome "unknown", described as "Erythema / Redness". Patient with diagnosis of erythroid dermatosis which exacerabated after the vaccine without data of hemodynamic alterations. Patient was in observation 30 min. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1991258 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   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 FJ8760 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101805060

Write-up: FAINTING; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from Regulatory Authority. Regulatory number: PH-PHFDA-300125857. A 14 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: FJ8760) at the age of 14 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 18Nov2021 15:00, outcome "recovered" (18Nov2021 15:10), described as "FAINTING". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1991271 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-01
Onset:2021-11-18
   Days after vaccination:48
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: Cough, Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: 20211202; Test Name: Oxygen saturation; Test Result: 83 %; Test Date: 20211202; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:73-77 %; Test Date: 20211202; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:Low
CDC Split Type: PHPFIZER INC202101805287

Write-up: Oxygen saturation low; Difficulty of breathing; Cough; Fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300126178. A 27 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date Oct2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Aug2021 (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: COUGH (hospitalization) with onset 18Nov2021, outcome "recovering", described as "Cough"; PYREXIA (hospitalization) with onset 18Nov2021, outcome "recovering", described as "Fever"; DYSPNOEA (hospitalization) with onset 25Nov2021, outcome "recovering", described as "Difficulty of breathing"; OXYGEN SATURATION DECREASED (hospitalization) with onset 02Dec2021, outcome "recovering", described as "Oxygen saturation low". The patient underwent the following laboratory tests and procedures: oxygen saturation: (02Dec2021) 83 %; (02Dec2021) 73-77 %; oxygen saturation: (02Dec2021) low. Therapeutic measures were taken as a result of dyspnoea. It was reported that, on 24Nov2021, cough improved, still with on and off fever and on 25Nov2021, dob/ sob, neb given every 8 hours. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1991316 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-11-18
   Days after vaccination:131
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C17-05 / 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: PTJNJFOC20211259277

Write-up: This spontaneous report received from a health care professional by a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202112-959) on 28-DEC-2021 concerned a 29-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 (dose number in series 1) (suspension for injection, intramuscular, batch number: 21C1705 expiry: UNKNOWN) 0.5 ml, 1 total administered on 10-JUL-2021 for covid-19 immunisation. The drug start period (latency) was 131 days. No concomitant medications were reported. On 18-NOV-2021, the patient experienced vaccination failure (dose number in series 1). The action taken with covid-19 vaccine was not applicable. The patient recovered from vaccination failure on 04-DEC-2021. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint, and reference number requested.


VAERS ID: 1991477 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-30
Onset:2021-11-18
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood pressure measurement, Body temperature, C-reactive protein, Chest discomfort, Chest pain, Coma scale, Dyspnoea, Fibrin D dimer, Heart rate, Oxygen saturation, Respiratory rate, Troponin I, White blood cell count
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life 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: 20211118; Test Name: Creatinine; Test Result: 0.74 mg/dl; Test Date: 20211118; Test Name: Blood pressure; Result Unstructured Data: Test Result:130/90 mmHg; Test Date: 20211118; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 20211118; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:E4V5M6; Test Date: 20211118; Test Name: C-reactive protein; Result Unstructured Data: Test Result:3.33 mg/l; Test Date: 20211118; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:less than 0.19; Comments: mg/L feu; Test Date: 20211118; Test Name: Heart rate; Result Unstructured Data: Test Result:75; Comments: Units:{beats}/min; Test Date: 20211118; Test Name: O2 saturation; Test Result: 100 %; Test Date: 20211118; Test Name: Respiratory rate; Result Unstructured Data: Test Result:18; Comments: Units:{breaths}/min; Test Date: 20211118; Test Name: Troponin I; Result Unstructured Data: Test Result:less than 0.0023 ng/ml; Test Date: 20211118; Test Name: White blood cells; Result Unstructured Data: Test Result:7.27 x10 3/mm3
CDC Split Type: TWPFIZER INC202101832537

Write-up: CHEST PAIN; CHEST TIGHTNESS; DIFFICULTY BREATHING; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014541 (Regulatory Authority). Other Case identifier(s): TW-Fosun-2021FOS006884 (RA). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100014541. A 24-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number was not reported) on 30-Oct-2021 via intramuscular at 0.3 ml with unspecified dosing frequency for COVID-19 immunization. No medical history and using adverse reaction history. Concomitant medication and past product were not reported. The patient experienced difficulty breathing chest pain and chest tightness on 18-Nov-2021. On 18-Nov-2021, the patient started to chest pain since around 7:30 in the morning and also felt dyspnea. No fever, no cough, no nausea or vomiting, no cold sweating, no abdominal pain, no backpain. The patient came to the hospital for a diagnosis, mainly complained chest pain and chest tightness. Life signs: Glasgow coma scale (GCS): E4V5M6; Blood pressure (BP): 130/90 mmHg; Heart Rate (HR):75 times/min; Respiratory rate (RR): 18 times/min; Body temperature (BT): 36.8 Centigrade; O2 saturation (SPO2): 100%. White blood cells (WBC): 7.27x1000/UL. Tropo-i: <0.0023 ng/ml; C-reactive protein (CRP) (quantitative): 3.33 mg/L; D-Dimer: <0.19mg/L feu; Creatinine: 0.74 mg/dl. Physician gave the patient oral medicine after diagnosis. After the diagnosis, the patient''s condition was stabilized and adjusted. The physician notified the vaccine adverse reactions. The patient was discharged with oral medicine: DepyRetin 1 Tab PRN (6) and Inderal 1 Tab PRN (total 6). Difficulty breathing chest pain and chest tightness met the seriousness criterion of Other Medically Important Condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. Drug: Comirnaty Causality Assessments: Chest tightness Difficulty breathing; chest pain Per Reporter= Possible Per Company (BioNTech) = Possible Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE.


VAERS ID: 1991555 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nausea, Tachycardia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Dehydration (broad)

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

Write-up: Tachycardia; Nausea; vomiting; This regulatory authority case was reported by an other health care professional and describes the occurrence of TACHYCARDIA (Tachycardia), NAUSEA (Nausea) and VOMITING (vomiting) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. Concurrent medical conditions included Hypertension (HTN (hypertension)). On 15-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 18-Nov-2021, the patient experienced TACHYCARDIA (Tachycardia) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). At the time of the report, TACHYCARDIA (Tachycardia), NAUSEA (Nausea) and VOMITING (vomiting) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Patient was performed laboratory test that include GCS:E4V5M6; BP: 133 / 69 mmHg; HR:150 beats / minute; RR:28 breaths / minute; BT:39.9?; SpO2:95%, WBC 15.59x1000/uL. BNP=75.1 pg/mL; Lactate=3.12 m mol/L; Lipase=9.8 U/L; Tropo-I=0.0397 ng/mL; CRP (quantification) = 405.42 mg/L; D-Dimer=2.51 mg/L FEU; Creatinine=1.24 mg/dL. Bil (Total)= 0.97 mg/dL. COVID-19 PCR test Negative. On November 18, 2021, patient came to the emergency department of our hospital for treatment with the chief complaint of upper respiratory infection and relevant symptoms (running nose and cough), fever and dyspnea. On November 15, patient received the first dose of Moderna vaccine. Upon examination by the physician, patient said he had a fever for 3 days. On November 15, patient received the first dose of Moderna, and had fever, dyspnea, mild cough and vomit several times with general weakness. Upon examination, patient''s condition was unstable, so the patient was advised by physician to be hospitalized for treatment. As the relevance to adverse reactions of COVID-19 vaccine cannot be excluded, the nurse reported adverse reactions of the vaccine. On November 26, 2021, patient''s condition improved upon hospitalization and treatment. The physician allowed patient to be discharged from the hospital. The patient was transferred to the outpatient department for follow-up and treatment. The follow-up care was as follows On December 9, 2021, we called the patient, but no one answered the phone. On December 9, 2021, the patient said he had a fever or vomiting after receiving the vaccine, so he went to Hospital for treatment and was diagnosed with infection and inflammation caused by kidney stones. The patient had a surgery in November. Now the patient is discharged from the hospital with stable conditions, so the case is closed. Company Comment This is a regulatory case concerning a 60-year-old female patient with medical history of hypertension, who experienced the serious unexpected per severity events of tachycardia, nausea and vomiting. The events occurred approximately 4 days after the first dose of mRNA-1273 vaccine administration. The events were assessed as related, per temporal association with the product administration. The medical history of hypertension was considered as a contributory factor for event of tachycardia. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 60-year-old female patient with medical history of hypertension, who experienced the serious unexpected per severity events of tachycardia, nausea and vomiting. The events occurred approximately 4 days after the first dose of mRNA-1273 vaccine administration. The events were assessed as related, per temporal association with the product administration. The medical history of hypertension was considered as a contributory factor for event of tachycardia. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1991569 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-31
Onset:2021-11-18
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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: Thrombocytopenia; This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOCYTOPENIA (Thrombocytopenia) in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 31-Oct-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. On 18-Nov-2021, the patient experienced THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criterion hospitalization). At the time of the report, THROMBOCYTOPENIA (Thrombocytopenia) was resolving. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications are provided . No treatment medications are provided.On July 12, 2021, the patient received the first dose and the on October 31, 2021,the second dose of COVID-19 Moderna vaccine. November 15, 2021 According to the patient, he was in his usual state of health until he received COVID vaccination on October 31, 2021. Mild, dull bilateral flank pain developed afterwards but he didn''t pay much attention to it since it was tolerable. However, the pain aggravated and radiated to abdominal area on November 15. Dark, tea-color urine was also noted. He was then brought to a local hospital for help where non-contrast abdominal CT revealed a hypodense, heterogenous, cyctic lesion over pancreatic head with pancreatic duct dilatation. He was then referred to our hospital for further evaluation and management. November 18, 2021 Upon initial medical encounter, he denied fever, chills, cough, chest pain, chest tightness, diarrhea, dysuria, skin rashes, joint pain or conscious disturbance. Nausea with vomitting for one time was noted at ER. Physical examination showed consciousness was clear, no pale conjunctiva, no icteric sclera, clear breath sound, regular heart beat, no murmur, palpable hard, soft abdomen without rebounding pain and muscle guarding. Knocking pain over bilateral lower back was noted. Under the impression of pancreatic head mass, he is admitted for further evaluation and management. November 19, 2021 After admission, MRI was arranged for structural check, general surgeon was consulted for possible Whipple surgery. High CEA level, slight elevated bilirubin level was noticed. November 22, 2021 Persistent low back pain was complaint and analgesics was given. Company comment includes This case concerns a 59-year-old male patient with no relevant medical history who experienced serious due to hospitalization, unexpected events of special interest (ADR) thrombocytopenia. The event occurred approximately 18 days after the 2nd dose of the mRNA-1273. Reportedly, 15 days after vaccination, the patient had bilateral, mild, dull flank pain that further aggravated and radiated to abdominal area with dark tea colored urine. The patient was admitted to a hospital and abdominal CT showed cystic pancreatic head lesion with pancreatic duct dilation. The patient also had one occurrence of nausea and vomiting. The provided clinical course does not mention thrombocytopenia. The rechallenge was not applicable since due to occurence after the second dose , no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 59-year-old male patient with no relevant medical history who experienced serious due to hospitalization, unexpected events of special interest (ADR) thrombocytopenia. The event occurred approximately 18 days after the 2nd dose of the mRNA-1273. Reportedly, 15 days after vaccination, the patient had bilateral, mild, dull flank pain that further aggravated and radiated to abdominal area with dark tea colored urine. The patient was admitted to a hospital and abdominal CT showed cystic pancreatic head lesion with pancreatic duct dilation. The patient also had one occurrence of nausea and vomiting. The provided clinical course does not mention thrombocytopenia. The rechallenge was not applicable since due to occurence after the second dose , no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1991591 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Skin rashes (non-injection site); Neuralgia (pain along a nerve pathway); This regulatory authority case was reported by an other health care professional and describes the occurrence of RASH (Skin rashes (non-injection site)) and NEURALGIA (Neuralgia (pain along a nerve pathway)) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced RASH (Skin rashes (non-injection site)) (seriousness criterion medically significant) and NEURALGIA (Neuralgia (pain along a nerve pathway)) (seriousness criterion medically significant). At the time of the report, RASH (Skin rashes (non-injection site)) and NEURALGIA (Neuralgia (pain along a nerve pathway)) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medication was not reported. The treatment medication was not reported. 16 December 2021 The patient said that tinnitus occurred in the left ear after received the Moderna vaccine on November 18, and redness and blisters occurred on the right side of the back on November 27. December 10, 2021 After the second shot, the tinnitus turned into neuralgia, which induced herpes zoster, and then the patient was hospitalized .Hospital for about 5 to 6 days then Patient had been discharged and the symptoms was improving. The patient was informed of the matter on drug injury relief application. Company comment: This case concerns a 58-year-old, male patient with no medical history reported, who experienced the unexpected events of rash and neuralgia. The events occurred on the same day after the second dose of mRNA-1273. As reported, the patient said that tinnitus occurred in the left ear after he received the Moderna vaccine and redness and blisters occurred on the right side of the back on 9 days later. After the second shot, the tinnitus turned into neuralgia, which induced herpes zoster, and then the patient was hospitalized for about 5 to 6 days. The patient had been eventually discharged and the symptoms was improving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Events were captured as per provided information by the Regulatory authority.; Sender''s Comments: This case concerns a 58-year-old, male patient with no medical history reported, who experienced the unexpected events of rash and neuralgia. The events occurred on the same day after the second dose of mRNA-1273. As reported, the patient said that tinnitus occurred in the left ear after he received the Moderna vaccine and redness and blisters occurred on the right side of the back on 9 days later. After the second shot, the tinnitus turned into neuralgia, which induced herpes zoster, and then the patient was hospitalized for about 5 to 6 days. The patient had been eventually discharged and the symptoms was improving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Events were captured as per provided information by the Regulatory authority.


VAERS ID: 1991995 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   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 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Nausea, Pain, Pyrexia, Vaccination site movement impairment, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101799180

Write-up: Severe whole-body pain, extreme on vaccinated arm - can hardly move; extreme on vaccinated arm - can hardly move; Severe whole body pain; fatigue; Fever; Headache; Nausea; Chills; 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-2021-062165. A 17 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm, administration date 18Nov2021 12:30 (Lot number: Unknown) at the age of 17 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: PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Severe whole body pain"; FATIGUE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "fatigue"; PYREXIA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Nausea"; CHILLS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset 18Nov2021 15:00, outcome "not recovered", described as "Severe whole-body pain, extreme on vaccinated arm - can hardly move "; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) with onset 18Nov2021, outcome "not recovered", described as "extreme on vaccinated arm - can hardly move". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Additional Information:Severe whole body pain, extreme on vaccinated arm - can hardly move - even lying down suffering fatigue, headache, nausea, fever, chills First vaccination at 12:30 p.m., Nov. 18, 2021. Pain in arm started at 3 p.m.


VAERS ID: 1992218 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   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 FE8244 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Eye disorder, Feeling hot, Hypertensive crisis, Immunisation
SMQs:, Anticholinergic syndrome (broad), Hypertension (narrow), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101809585

Write-up: new short attack; RR at episode 212/110 for several hours.; Feeling hot; Lightheadedness; Visual disturbance in both eyes approx. 5 sec; booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority-WEB. Regulatory number: AT-BASGAGES-2021-075806. A 65-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: FE8244) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome unknown, described as booster; HYPERTENSIVE CRISIS (medically significant) with onset 06Dec2021, outcome recovered (Dec2021), described as new short attack; HYPERTENSIVE CRISIS (medically significant) with onset 29Nov2021, outcome recovered (2021), described as RR at episode 212/110 for several hours.; FEELING HOT (non-serious) with onset 29Nov2021, outcome not recovered, described as Feeling hot; DIZZINESS (non-serious) with onset 29Nov2021, outcome not recovered, described as Lightheadedness; EYE DISORDER (non-serious) with onset 29Nov2021, outcome recovered (2021), described as Visual disturbance in both eyes approx. 5 sec. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1993047 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCVY8 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Immunisation, Interchange of vaccine products, Off label use, Pyrexia, Seizure, Urine analysis
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artery dissection (stent); Cerebral haemorrhage (haemorrhages of lateral ventricles and posterior horns, treated with hemicraniectomy); Contusion (cerebral contusions, lung-liver-spleen contusion); Epilepsy (epilepsy after traumatic brain injury); Hemiparesis (right); Multiple fractures ((face, skull base fracture, rib series fracture, 2nd cervical vertebra)); Polytrauma; Road traffic accident; Traumatic brain injury
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unremarkable; Comments: with regard to infections; Test Name: body temperature increased; Result Unstructured Data: Test Result:38 degrees Centigrade; Comments: until today; Test Date: 20211118; Test Name: body temperature increased; Result Unstructured Data: Test Result:40.3 degrees Centigrade; Comments: within 20 minutes; Test Name: urine test; Result Unstructured Data: Test Result:unremarkable; Comments: despite SPK
CDC Split Type: DEPFIZER INC202101809731

Write-up: off label use; interchange of vaccine products; booster; Seizures as a result of fever; Pyrexia; 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-CADR2021208314. Other Case identifier(s): DE-CADRPEI-2021208314, DE-PEI-202100259277. A 28 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: SCVY8) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Road traffic accident", start date: 2011, stop date: 2011; "polytrauma", start date: 2011 (unspecified if ongoing); "traumatic brain injury", start date: 2011 (unspecified if ongoing); "contusions", start date: 2011 (unspecified if ongoing), notes: cerebral contusions,, lung-liver-spleen contusion; "haemorrhages of lateral ventricles and posterior horns", start date: 2011 (unspecified if ongoing), notes: haemorrhages of lateral ventricles and posterior horns, treated with hemicraniectomy; "multiple fractures", start date: 2011 (unspecified if ongoing), notes: (face, skull base fracture, rib series fracture, 2nd cervical vertebra); "artery dissection" (unspecified if ongoing), notes: stent; "right-sided hemiparesis" (unspecified if ongoing); "epilepsy" (unspecified if ongoing), notes: epilepsy after traumatic brain injury. The patient''s concomitant medications were not reported. Past drug history included: Ciprofloxacin, reaction(s): "hives". Vaccination history included: Covid-19 vaccine moderna (dose 1, single), administration date: 22Mar2021, for covid-19 immunisation, reaction(s): "No adverse reaction"; Covid-19 vaccine moderna (dose 2, single), administration date: 28Apr2021, for covid-19 immunisation, reaction(s): "No adverse reaction". The following information was reported: OFF LABEL USE (hospitalization), outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization), outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (hospitalization), outcome "unknown", described as "booster"; SEIZURE (hospitalization, medically significant) with onset 18Nov2021 08:50, outcome "recovered" (18Nov2021), described as "Seizures as a result of fever"; PYREXIA (hospitalization) with onset 18Nov2021 08:30, outcome "not recovered", described as "Pyrexia". The events "seizures as a result of fever" and "pyrexia" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unremarkable, notes: with regard to infections; body temperature: (unspecified date) 38 degrees, notes: until today; (18Nov2021) 40.3 degrees, notes: within 20 minutes; urine analysis: (unspecified date) unremarkable, notes: despite SPK. Therapeutic measures were taken as a result of seizure, pyrexia. Clinical course: On 18Nov2021 8.30 a.m. the patient had sudden fever of 40.3 degrees within 20 minutes, epileptic seizure, status: first focal then generalized. Emergency ambulance transport to the hospital, blood values unremarkable with regard to infections, urine status unremarkable despite SPK. 5 hours later, no fever and discharged into his care. Since then the patient had been taking paracetamol 500mg up to 4 times a day. Nevertheless, the temperature had always been up to 38 degrees until the date of reporting. Result of Assessment: A. Consistent causal association to immunization. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1993352 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   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 - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hemiparaesthesia, Immunisation, Joint ankylosis, Malaise
SMQs:, Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Tinnitus (after second dose)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101800429

Write-up: Hemiparaesthesia; Feeling sick; Ankylosis of ankle; booster; This is a spontaneous report from a contactable consumer and a physician from the Regulatory Agency-WEB. Regulatory number: FR-AFSSAPS-PV20213606. A 75-year-old female patient received BNT162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "tinnitus", start date: 05May2021 (ongoing), after second dose. The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (dose 2, 0.3 ml, intramuscular, lot number: EX0893), administration date: 21Apr2021, for covid-19 immunisation, reaction(s): "tinnitus", "dizziness postural"; Comirnaty (dose 1), for covid-19 immunisation. The following information was reported: immunisation (medically significant) with onset 18Nov2021, outcome "unknown", described as "booster"; hemiparaesthesia (medically significant) with onset 27Nov2021, outcome "recovering", described as "hemiparaesthesia"; malaise (non-serious) with onset 27Nov2021, outcome "recovered" (27Nov2021), described as "feeling sick"; joint ankylosis (non-serious) with onset 27Nov2021, outcome "recovering", described as "ankylosis of ankle". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1993448 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 393269110000011 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cellulitis
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: GBMODERNATX, INC.MOD20213

Write-up: Cellulitis; This case was initially received via regulatory agency (Reference number: GB-MHRA-ADR 26228175) on 29-Nov-2021. The most recent information was received on 14-Dec-2021 and was forwarded to Moderna on 14-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of CELLULITIS (Cellulitis) in a 38-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 39326911000001101) for COVID-19 vaccination. No Medical History information was reported. On 17-Nov-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (Cellulitis) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Treatment details not provided. Concomitant drug details not provided. Company Comment: This is a regulatory case concerning a 38-year-old, female patient with unknown medical history, who experienced the unexpected serious (medically significant) event of cellulitis. The event occurred one day after the second dose of mRNA-1273 vaccine. Localization has not been reported. At the moment of the report, the outcome is not resolved. The rechallenge was unknown since there''s no information about the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting. On 14-DEC-2021, upon internal review, case MOD-2021-416221 was merged with case MOD-2021-399668 as they were determined to be duplicate events. Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Significant Follow Up Appended, indication and senders comment added. Case upgraded to serious as per follow-up source document.; Reporter''s Comments: This case is a master made from existing duplicates by the duplicate management team. The case numbers of the underlying duplicates are in the Other Case Identifiers section.; Sender''s Comments: This is a regulatory case concerning a 38-year-old, female patient with unknown medical history, who experienced the unexpected serious (medically significant) event of cellulitis. The event occurred one day after the second dose of mRNA-1273 vaccine. Localization has not been reported. At the moment of the report, the outcome is not resolved. The rechallenge was unknown since there''s no information about the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1993641 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Intermenstrual bleeding, Off label use, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101805811

Write-up: Intermenstrual bleeding; Off-label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112151840121610-SCSE6. Other Case identifier(s): GB-MHRA-ADR 26340969. A 40 year-old patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; INTERMENSTRUAL BLEEDING (medically significant) with onset 07Dec2021, outcome "recovered" (11Dec2021), described as "Intermenstrual bleeding". Clinical course: Prior to this incident the patient never had any menstrual cycle related problems throughout the whole life. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1993890 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5475 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood test, Cardiac flutter, Chest X-ray, Chills, Electrocardiogram, Immunisation, Interchange of vaccine products, Muscle spasms, Off label use, Palpitations, Paraesthesia, Restless legs syndrome, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown Result; Test Name: chest x- ray; Result Unstructured Data: Test Result:Unknown Result; Test Name: ECG; Result Unstructured Data: Test Result:Unknown Result; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101813680

Write-up: palpitations; rigor; spasm; both legs from the knees down; I was unable to move and was extremely weak.; Rigors; Pins and needles; Cramp in hand; Heart fluttering; Off label; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112161938487600-CUMKJ. Other Case identifier(s): GB-MHRA-ADR 26346681. A female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: fk5475) 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; MANUFACTUERER 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 (hospitalization, medically significant) with onset 18Nov2021, outcome "unknown", described as "Off label"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (hospitalization, medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; PALPITATIONS (hospitalization, medically significant), outcome "recovering", described as "palpitations"; CHILLS (hospitalization, medically significant), outcome "recovering", described as "rigor"; MUSCLE SPASMS (hospitalization, medically significant), outcome "recovering", described as "spasm"; CARDIAC FLUTTER (hospitalization, medically significant) with onset 20Nov2021, outcome "recovering", described as "Heart fluttering"; CHILLS (hospitalization, medically significant) with onset 05Dec2021, outcome "recovered" (05Dec2021), described as "Rigors"; PARAESTHESIA (hospitalization, medically significant) with onset 05Dec2021, outcome "recovered" (05Dec2021), described as "Pins and needles"; MUSCLE SPASMS (hospitalization, medically significant) with onset 05Dec2021, outcome "recovered" (05Dec2021), described as "Cramp in hand"; RESTLESS LEGS SYNDROME (hospitalization, medically significant), outcome "unknown", described as "both legs from the knees down"; ASTHENIA (hospitalization, medically significant), outcome "unknown", described as "I was unable to move and was extremely weak.". The events "off label", "interchange of vaccine products", "booster" were evaluated at the physician office visit. The events "palpitations", "rigor", "spasm", "heart fluttering", "rigors", "pins and needles", "cramp in hand", "both legs from the knees down" and "i was unable to move and was extremely weak." were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: unknown result; chest x-ray: unknown result; electrocardiogram: unknown result; sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: It was reported that the experienced heart fluttering or what he would describe as severe palpitations started two days after receiving the vaccine. She visited GP, then was referred to hospital for ECG. Reportedly, there was rigor, accompanied by severe pins and needles in both forearms and both legs from the knees down. This then caused both hands to severely cramp and spasm, which led to them both locking. She was unable to move and was extremely weak. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1994372 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: HIGH BLOOD PRESSURE; Result Unstructured Data: Test Result:140/90.
CDC Split Type: PHPFIZER INC202101663270

Write-up: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120193 (RA). A 17-year-old adolescent male received a dose (unknown dose number) of intramuscular BNT162B2 (COMIRNATY, solution for injection; Lot PCB0002 expiry information not provided) as a single dose on 18Nov2021 (at 17-years-old) for COVID-19 immunization. There was no medical history or concomitant medications reported. On 18Nov2021 at 11:03, the patient experienced high blood pressure (140/90). The outcome of the event high blood pressure (140/90) was recovered on 18Nov2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1994373 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: HIGH BLOOD PRESSURE; Result Unstructured Data: Test Result:140/90
CDC Split Type: PHPFIZER INC202101663280

Write-up: HIGH BLOOD PRESSURE(140/90); This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120187. A 16-year-old adolescent male received a dose (unknown dose number) of intramuscular BNT162B2 (COMIRNATY, solution for injection; Lot PCB0002 expiry information not provided) as a single dose on 18Nov2021 (at 16-years-old) for COVID-19 immunization. There was no medical history or concomitant medications reported. On 18Nov2021 at 10:46, the patient experienced high blood pressure (140/90). The outcome of the event high blood pressure (140/90) was recovered on 18Nov2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1994374 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Blood pressure; Result Unstructured Data: Test Result:140/90 mmHg; Comments: at 16:22
CDC Split Type: PHPFIZER INC202101663439

Write-up: HIGH BLOOD PRESSURE(140/90); This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300120462. A 16-year-old adolescent male received a dose (unknown dose number) of intramuscular BNT162B2 (COMIRNATY, solution for injection; Lot PCB0002 expiry information not provided) as a single dose on 16Nov2021 for COVID-19 immunization. There was no medical history or concomitant medications reported. On 18Nov2021 at 16:22 (two days after the vaccination), the patient experienced high blood pressure (140/90mmHg). The outcome of the event high blood pressure (140/90) was recovered on 18Nov2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1996261 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Pruritus allergic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN/HIDROCLOROTIAZIDA TECNIGEN; EUTIROX; OMEPRAZOL APOTEX; AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Pain abdominal; Unspecified hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101817554

Write-up: This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: ES-AEMPS-1069333 (RA). A 77-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: FG6273) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history includes Unspecified hypothyroidism, Hypertension, Pain abdominal. Concomitant medication(s) included: LOSARTAN/HIDROCLOROTIAZIDA TECNIGEN taken for hypertension, start date: 24Nov2016; EUTIROX taken for hypothyroidism, start date: 11Dec2020; OMEPRAZOL APOTEX taken for abdominal pain, start date: 11Dec2020; AMLODIPINE taken for hypertension, start date: 20Aug2018. The following information was reported: ANGIOEDEMA (medically significant, life threatening) with onset 18Nov2021, outcome "recovered" (21Nov2021), described as "Allergic angioedema"; URTICARIA (medically significant, life threatening) with onset 18Nov2021, outcome "recovered" (19Nov2021), described as "Acute urticaria"; PRURITUS ALLERGIC (medically significant, life threatening) with onset 18Nov2021, outcome "recovered" (19Nov2021), described as "Pruritus allergic". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1996272 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Echocardiogram, Fibrin D dimer, Immunisation
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Dose 1 : Vaccin Pfizer Comirnaty-30 adulte, le 22/01/2021, Bras gauche, Injection intramusculaire, N� Lot : EJ6795 - Dose 2 : Vaccin Pfizer Comirnaty-30 adulte, le 11/02/2021, Bras gauche, Injection intramuscular, N� Lot : EJ6789
Allergies:
Diagnostic Lab Data: Test Name: Doppler echo; Result Unstructured Data: Test Result:multiple deep vein thrombosis of the right calf; Test Name: D-dimer; Result Unstructured Data: Test Result:more than 5000; Comments: increase
CDC Split Type: FRPFIZER INC202101859984

Write-up: Thrombosis venous deep; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-BR20214248 (RA). A 50 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: FG3739) 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 (Left arm, Intramuscular injection, Lot No .: EJ6795), administration date: 22Jan2021, for COVID-19 immunisation; Comirnaty (Left arm, Injection intramuscular, Lot No: EJ6789), administration date: 11Feb2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, life threatening, medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; DEEP VEIN THROMBOSIS (hospitalization, life threatening, medically significant) with onset 09Dec2021, outcome "not recovered", described as "Thrombosis venous deep". The patient underwent the following laboratory tests and procedures: echocardiogram: multiple deep vein thrombosis of the right calf; fibrin d dimer: more than 5000, notes: increase. Therapeutic measures were taken as a result of deep vein thrombosis. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1996590 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cough, Fatigue, Immunisation, Ischaemic stroke, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? 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: 20211118; Test Name: Fever; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GRPFIZER INC202101817319

Write-up: Ischaemic stroke NOS; Exhaustion; Vomiting; High fever; Deep cough; third dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from the regulatory authority-WEB. Regulatory number: GR-GREOF-202109914. A 90-year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 90 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; MANUFACTUERER UNKNOWN (where X=1, 2, or number unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant, life threatening) with onset 18Nov2021, outcome "unknown", described as "third dose"; ISCHAEMIC STROKE (medically significant, life threatening) with onset 19Nov2021, outcome "recovering", described as "Ischaemic stroke NOS"; FATIGUE (medically significant, life threatening) with onset 18Nov2021, outcome "recovering", described as "Exhaustion"; VOMITING (medically significant, life threatening) with onset 18Nov2021, outcome "recovering", described as "Vomiting"; PYREXIA (medically significant, life threatening) with onset 18Nov2021, outcome "recovering", described as "High fever"; COUGH (medically significant, life threatening) with onset 18Nov2021, outcome "recovering", described as "Deep cough". The patient underwent the following laboratory tests and procedures: body temperature: (18Nov2021) unknown results. Clinical Course: Ten hours after the third dose of the vaccine, the female patient developed high fever, cough (deep), vomiting exhaustion. In addition, 24hours later she suffered from ischaemic stroke. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1996661 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20214

Write-up: 90% vision loss on left eye; This case was received via Regulatory Authority Agency (Reference number: NL-LRB-00729222) 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 VISUAL IMPAIRMENT (90% vision loss on left eye) in a 62-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3001442) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced VISUAL IMPAIRMENT (90% vision loss on left eye) (seriousness criterion disability). At the time of the report, VISUAL IMPAIRMENT (90% vision loss on left eye) had not resolved. No concomitant product use was provided by the reporter. No treatment medications were reported. Company Comment: This case concerns a 62-year-old, male patient with no medical history reported, who experienced the unexpected serious event of Visual impairment (90% vision loss on left eye). The event occurred approximately on the same day after a dose of mRNA-1273 vaccine and had not recovered at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due to disability.; Sender''s Comments: This case concerns a 62-year-old, male patient with no medical history reported, who experienced the unexpected serious event of Visual impairment (90% vision loss on left eye). The event occurred approximately on the same day after a dose of mRNA-1273 vaccine and had not recovered at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due to disability.


VAERS ID: 1998092 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diarrhea; Fever; Laparoscopy; Sickness; Tonsillectomy (remained healthy most of life and the only hospital admission was for a tonsillectomy in early 20s)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Paraesthesia hand; Paraesthesia; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26364374) on 21-Dec-2021 and was forwarded to Moderna on 21-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PARAESTHESIA (Paraesthesia hand) and PARAESTHESIA (Paraesthesia) in a 70-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Sickness, Diarrhea, Fever, Tonsillectomy (remained healthy most of life and the only hospital admission was for a tonsillectomy in early 20s) and Laparoscopy. Previously administered products included for Product used for unknown indication: PENICILLIN; for Period pains: ibuprofen (rarely take any painkillers except Ibuprofen for period pains/contractions which were often extremely severe on day one.). Past adverse reactions to the above products included No adverse event with PENICILLIN and ibuprofen. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced PARAESTHESIA (Paraesthesia hand) (seriousness criterion medically significant) and PARAESTHESIA (Paraesthesia) (seriousness criterion medically significant). At the time of the report, PARAESTHESIA (Paraesthesia hand) and PARAESTHESIA (Paraesthesia) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Reported that first and second dose were of AZ vaccinations. The Moderna vaccination took place at 7.30 pm on 16th Nov. 2021.Patient awoke in the middle of the night with a very bad headache/backache/leg ache and spent a very uncomfortable following day in bed with a slightly raised temperature about 100F. Paracetamol does not very well with patient, but after 24hrs had to take some to get rid of the headache. patient had the second and third jabs in right arm as left arm has never settled down. Now Patient has tingling in Left arm and pins and needles in hand at least six times a day, probably more. Patient often feel as if she was running a temperature, feel feverish, joint pains, tiredness etc. but on taking her temperature it is just below normal. The side effects patient felt at the beginning seem to come and go now fairly often in a very watered-down fashion. Patient had a severe reaction to one and only flu jab in Dec. 2019. Patient may have the new flu jab in January but not at all keen to feel unwell again so soon. Patient was allergic to penicillin and have generally reacted quite strongly to jabs all her life. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial Company Comment This case concerns a 70-year-old female patient with no relevant medical history, who experienced the serious unexpected event of Paraesthesia. The events occurred 2 days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as medically significant and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 70-year-old female patient with no relevant medical history, who experienced the serious unexpected event of Paraesthesia. The events occurred 2 days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as medically significant and retained for consistency with the RA report.


VAERS ID: 2000687 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-11-18
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C16-03 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20211267007

Write-up: VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202112-1488) on 31-DEC-2021 and concerned a 30 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: 21C16-03 expiry: unknown) 0.5 ml, 1 total, administered on 18-AUG-2021 for covid-19 immunisation. The Drug Start Period was 92 days. No concomitant medications were reported. On 18-NOV-2021, the patient experienced vaccination failure. 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 patient recovered from vaccination failure on 29-NOV-2021. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Reporter''s Comments: Other info-no records


VAERS ID: 2002598 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Myocardial infarction
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (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 INC202101836180

Write-up: Myocardial infarction; Cough; Dyspnoea; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 682516. A 58 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: MYOCARDIAL INFARCTION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Myocardial infarction"; COUGH (non-serious) with onset 18Nov2021, outcome "unknown", described as "Cough"; DYSPNOEA (non-serious) with onset 18Nov2021, outcome "unknown", described as "Dyspnoea". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2002618 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-19
Onset:2021-11-18
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Flatulence, Hypoaesthesia, Joint noise, Paraesthesia, Photosensitivity reaction, Pneumonia
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101836476

Write-up: Pneumonia; Flatulence; Hypoaesthesia; Joint noise; Paraesthesia; Photosensitivity reaction; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 684220. A 57 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Oct2021 (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: 14Sep2021, for COVID-19 immunisation. The following information was reported: PNEUMONIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Pneumonia"; FLATULENCE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Flatulence"; HYPOAESTHESIA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Hypoaesthesia"; JOINT NOISE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Joint noise"; PARAESTHESIA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Paraesthesia"; PHOTOSENSITIVITY REACTION (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Photosensitivity reaction". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2003256 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-11-18
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1H048A / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myasthenia gravis; Neuropathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101830420

Write-up: Unconsciousness; Seizure; 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-202100267472 (PEI). A 72-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Sep2021 (Lot number: 1H048A) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "myasthenia gravis" (unspecified if ongoing); "neuropathy" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "drug allergy". Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown), for COVID-19 immunisation. The following information was reported: LOSS OF CONSCIOUSNESS (hospitalization) with onset 18Nov2021, outcome "recovered" (2021), described as "Unconsciousness"; SEIZURE (hospitalization) with onset 18Nov2021, outcome "recovered" (2021), described as "Seizure". The patient was hospitalized for loss of consciousness, seizure (start date: 2021). The PEI assessment for all the events with the suspect product Comirnaty was B. Indeterminate. Sender''s comment: The patient has a history of basic disease myasthenia gravis, and concomitant disease neuropathy. The patient has allergies to amoxicillin.


VAERS ID: 2003556 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E024A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (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: Medical History/Concurrent Conditions: Chronic pain; Depression; Heart disease congenital; Hypertension; Osteoporosis; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101827810

Write-up: Dyspnoea; pulmonary embolism; 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-CADR2021205495. Other Case identifier(s): DE-CADRPEI-2021205495 , DE-PEI-202100231952). An 83-year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: 1E024A) as dose number unknown, 0.3ml single for COVID-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "congenital heart disease (CHD)" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "chronic pain syndrome" (unspecified if ongoing); "Depression" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DYSPNOEA (hospitalization) with onset 18Nov2021, outcome "recovering", described as "Dyspnoea"; PULMONARY EMBOLISM (medically significant) with onset 2021, outcome "unknown", described as "pulmonary embolism". The patient was hospitalized for dyspnoea (start date: 2021). The patient had no known allergy. They assessed the causal relationship between bnt162b2 and dyspnoea was A (Consistent causal association to immunization). Sender Comment: Relatedness of drug to Dyspnoea Source of assessment: Result of Assessment: A. Consistent causal association to immunization No follow-up attempts are needed. No further information is expected.


VAERS ID: 2003583 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Osteitis
SMQs:, Osteonecrosis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101827667

Write-up: Bone inflammation; Emergency operation! Tooth extraction. Tubes placed to drain pus from the entire right lower jaw so that it does not run further to the neck and take air.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from a Regulatory Authority. Regulatory number: DE-PEI-CADR2021207183. Other Case identifier(s): DE-CADRPEI-2021207183, DE-PEI-202100233172. A 61 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: OSTEITIS (hospitalization) with onset 18Nov2021, outcome "recovering", described as "Bone inflammation; Emergency operation! Tooth extraction. Tubes placed to drain pus from the entire right lower jaw so that it does not run further to the neck and take air.". Therapeutic measures were taken as a result of osteitis. A Regulatory Authority assessment for Bone inflammation with the suspect product Comirnaty is A. Consistent causal association to immunization. Sender Comment: Do you or the person concerned known of any allergies? If yes, which? No information on risk factors or previous illnesses / / operation, expansion of pus over days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2003631 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E024A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Headache, Hot flush, Influenza like illness, Myalgia, Nausea, Tachycardia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101830641

Write-up: Dyspnoea/ Shortness of breath; Tachycardia/ racing heart; Nausea; Influenza like illness; muscle pain; headache; pain at the injection site; hot flashes; This is a spontaneous report received from a non-contactable reporter (Consumer) from the Regulatory Authority. -WEB. Regulatory number: DE-PEI-CADR2021224538. Other Case identifier(s): DE-CADRPEI-2021224538, DE-PEI-202100277952. A 37-year-old female patient received bnt162b2 (COMIRNATY 0.3 mL), administration date 18Nov2021 (Lot number: 1E024A) 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: DYSPNOEA (hospitalization) with onset 18Nov2021, outcome "recovered with sequelae", described as "Dyspnea/ Shortness of breath"; TACHYCARDIA (hospitalization) with onset 18Nov2021, outcome "recovering", described as "Tachycardia/ racing heart"; NAUSEA (hospitalization) with onset 18Nov2021, outcome "recovering", described as "Nausea"; INFLUENZA LIKE ILLNESS (hospitalization) with onset 18Nov2021, outcome "recovering", described as "Influenza like illness"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; HEADACHE (non-serious), outcome "unknown", described as "headache"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site"; HOT FLUSH (non-serious), outcome "unknown", described as "hot flashes". Also reported "events stop date: 15Dec2021." This report is serious - hospitalization. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2003864 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Blood pressure measurement, Chest discomfort, Dyspnoea, Electrocardiogram, Oxygen saturation, Peripheral coldness, Poor peripheral circulation, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: blood pressure; Result Unstructured Data: Test Result:unknown; Test Date: 20211122; Test Name: electrocardiography; Result Unstructured Data: Test Result:clean; Test Date: 20211122; Test Name: oxygen saturation; Result Unstructured Data: Test Result:unknown
CDC Split Type: FIPFIZER INC202101828029

Write-up: Arrhythmia; Chest pressure sensation; Dyspnoea; Poor peripheral circulation; Cold hands & feet; Tachycardia; 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: FI-FIMEA-20217817. A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: UNKNOWN) at the age of 46 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: ARRHYTHMIA (disability) with onset 18Nov2021, outcome "not recovered", described as "Arrhythmia"; CHEST DISCOMFORT (disability) with onset 18Nov2021, outcome "not recovered", described as "Chest pressure sensation"; DYSPNOEA (disability) with onset 18Nov2021, outcome "not recovered", described as "Dyspnoea"; POOR PERIPHERAL CIRCULATION (disability) with onset 18Nov2021, outcome "not recovered", described as "Poor peripheral circulation"; PERIPHERAL COLDNESS (disability) with onset 18Nov2021, outcome "not recovered", described as "Cold hands & feet"; TACHYCARDIA (disability) with onset 18Nov2021, outcome "not recovered", described as "Tachycardia". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (22Nov2021) unknown; electrocardiogram: (22Nov2021) clean; oxygen saturation: (22Nov2021) unknown. Clinical course: 5-6 hours after the vaccine, breathing difficulties had started and continued till the next day. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2003973 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-11-18
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Heavy menstrual bleeding, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Covid-19; Result Unstructured Data: Test Result:Negative
CDC Split Type: FRPFIZER INC202101830643

Write-up: Asthenia; Arthromyalgia; Menorrhagia; muscle pain in the legs; stiffness; pain was permanent for several days; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority WEB. Regulatory number: FR-AFSSAPS-LY202112822 (AFSSAPS). A 33 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 30Aug2021 (Lot number: FG7387) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: ASTHENIA (medically significant) with onset 18Nov2021, outcome "unknown", described as "Asthenia"; MUSCULOSKELETAL PAIN (non-serious) with onset 18Nov2021, outcome "unknown", described as "Arthromyalgia"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 18Nov2021, outcome "unknown", described as "Menorrhagia"; MYALGIA (non-serious) with onset 18Nov2021, outcome "unknown", described as "muscle pain in the legs"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 18Nov2021, outcome "unknown", described as "stiffness"; PAIN (non-serious) with onset 18Nov2021, outcome "unknown", described as "pain was permanent for several days"; FATIGUE (non-serious) with onset 18Nov2021, outcome "unknown", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Aug2021) negative. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2003992 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-11-18
   Days after vaccination:79
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005285 / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral venous thrombosis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

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

Write-up: Thrombophlebitis cerebral vein; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-MA20215685) on 25-Dec-2021 and was forwarded to Moderna on 25-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of CEREBRAL VENOUS THROMBOSIS (Thrombophlebitis cerebral vein) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005285) for COVID-19 vaccination. Co-suspect product included non-company product ETHINYLESTRADIOL, GESTODENE (CARLIN) for Contraception. The patient''s past medical history included Weight increase, Premenstrual migraine and Acne. Previously administered products included for Product used for unknown indication: Moderna vaccine (Dose 1: Left arm, Intramuscular injection, Lot N: 3003187) on 16-Jul-2021 and Moderna vaccine (Dose 2: Batch number: 3005285) on 31-Aug-2021. Past adverse reactions to the above products included No adverse event with Moderna vaccine and Moderna vaccine. On 31-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient started ETHINYLESTRADIOL, GESTODENE (CARLIN) (Oral) 21 dosage form. On 18-Nov-2021, after starting mRNA-1273 (Spikevax), the patient experienced CEREBRAL VENOUS THROMBOSIS (Thrombophlebitis cerebral vein) (seriousness criteria hospitalization and life threatening). At the time of the report, CEREBRAL VENOUS THROMBOSIS (Thrombophlebitis cerebral vein) had resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication was provided. This is a regulatory case concerning a 26-year-old female patient with no relevant medical history, who experienced the serious life-threatening unexpected AESI event of Cerebral venous thrombosis. The event occurred 2 months, 19 days after the second dose of mRNA-1273 vaccine administration. The event was assessed as related to the product administration. The de-challenge was positive per reporter. The rechallenge was not applicable since the event occurred after the second dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2021: Follow up received. Event outcome and de-challenge was updated.; Sender''s Comments: This is a regulatory case concerning a 26-year-old female patient with no relevant medical history, who experienced the serious life-threatening unexpected AESI event of Cerebral venous thrombosis. The event occurred 2 months, 19 days after the second dose of mRNA-1273 vaccine administration. The event was assessed as related to the product administration. The de-challenge was positive per reporter. The rechallenge was not applicable since the event occurred after the second dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2004004 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7911 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Dose 1 : Vaccin AstraZeneca, le 09/03/2021, Bras gauche, Injection intramusculaire, N� Lot : ABV5045 - Dose 2 : Vaccin AstraZeneca, le 26/05/2021, Bras droit, Injection intramusculaire, N� Lot : ABW0891
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101827725

Write-up: Generalized urticaria; Generalised pruritus; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-MA20215798. A 70 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: FG7911) at the age of 70 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: Vaxzevria (DOSE 1, SINGLE, lot number: ABV5045, Route of administration: Intramuscular, Location: Left arm), administration date: 09Mar2021, for COVID-19 immunisation; Vaxzevria (DOSE 2, SINGLE, lot number: ABW0891, Route of administration: Intramuscular, Location: Right arm), administration date: 26May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; URTICARIA (medically significant) with onset 23Nov2021, outcome "recovered" (30Nov2021), described as "Generalized urticaria"; PRURITUS (medically significant) with onset 23Nov2021, outcome "recovered" (30Nov2021), described as "Generalised pruritus". The events "generalized urticaria" and "generalised pruritus" were evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, pruritus with several antihistamines. Clinical course: Patient had GENERALIZED URTICARIA requiring medical consultation and testing of several antihistamines before regression without sequelae. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2004121 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Arm fracture; Colon adenoma; Disorder personality; Haemorrhoids; Morbid obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20214

Write-up: Embolism pulmonary; Thrombosis of leg deep venous; This case was received via regulatory agency (Reference number: FR-AFSSAPS-RS20214155) on 23-Dec-2021 and was forwarded to Moderna on 23-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEEP VEIN THROMBOSIS (Thrombosis of leg deep venous) and PULMONARY EMBOLISM (Embolism pulmonary) in a 49-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Arm fracture, Haemorrhoids, Disorder personality, Colon adenoma and Morbid obesity. Concurrent medical conditions included Type 2 diabetes mellitus. On 10-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In 2021, the patient experienced DEEP VEIN THROMBOSIS (Thrombosis of leg deep venous) (seriousness criteria hospitalization and medically significant). On 18-Nov-2021, after starting mRNA-1273 (Spikevax), the patient experienced PULMONARY EMBOLISM (Embolism pulmonary) (seriousness criterion hospitalization). At the time of the report, DEEP VEIN THROMBOSIS (Thrombosis of leg deep venous) and PULMONARY EMBOLISM (Embolism pulmonary) was resolving. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication were provided Company Comment: This case concerns a 49-year-old male patient, with medical history of Arm fracture and morbid obesity and Concurrent medical conditions Type 2 diabetes mellitus, who experienced the unexpected serious AESI events of Deep vein thrombosis and Pulmonary embolism. The events occurred on an unknown date after the first dose of mRNA-1273 vaccine. The outcome of the events was reported as recovering. Patients history and concurrent medical conditions remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Seriousness criteria of hospitalization was captured for all reported events according to Regulatory Authority assessment; Sender''s Comments: This case concerns a 49-year-old male patient, with medical history of Arm fracture and morbid obesity and Concurrent medical conditions Type 2 diabetes mellitus, who experienced the unexpected serious AESI events of Deep vein thrombosis and Pulmonary embolism. The events occurred on an unknown date after the first dose of mRNA-1273 vaccine. The outcome of the events was reported as recovering. Patients history and concurrent medical conditions remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Seriousness criteria of hospitalization was captured for all reported events according to Regulatory Authority assessment


VAERS ID: 2004413 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Chest pain, Dyspnoea, Echocardiogram, Fatigue, Fibrin D dimer, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, Palpitations, Pericarditis, Pulmonary embolism, SARS-CoV-2 test, Sinus tachycardia, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma chronic; Ehlers-Danlos syndrome; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:unknown results; Test Name: echocardiogram, 24 hour tape; Result Unstructured Data: Test Result:unknown results; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:D-dimer was higher than 4000; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101822872

Write-up: Fatigue; Chest Pain; Dyspnoea; Heart palpitations; Tachycardia; Suspected PE; Myocarditis; pericarditis; Sinus tachycardia; Fainting/fainting episodes; Shortness of breath; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Other HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112170817483800-8AO8C (RA). Other Case identifier(s): GB-MHRA-ADR 26350060 (RA). A female patient received bnt162b2 (COMIRNATY, reported as COVID-19 MRNA VACCINE BIONTECH), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19" (ongoing), notes: Unsure when symptoms started; "Pregnancy" (unspecified if ongoing); "Chronic asthma" (unspecified if ongoing); "Ehlers Danlos syndrome" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation. 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: OFF LABEL USE (medically significant) with onset 2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "Booster"; SINUS TACHYCARDIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Sinus tachycardia"; SYNCOPE (medically significant) with onset 18Nov2021, outcome "not recovered", described as " Fainting/fainting episodes "; DYSPNOEA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Shortness of breath"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest Pain"; DYSPNOEA (medically significant), outcome "unknown", described as "Dyspnoea"; PALPITATIONS (medically significant), outcome "unknown", described as " Heart palpitations"; TACHYCARDIA (medically significant), outcome "unknown", described as "Tachycardia"; PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "Suspected PE"; MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis". The events "sinus tachycardia", "fainting", "shortness of breath", "fatigue", "chest pain", "dyspnoea", "palpitations", "tachycardia", "suspected pe", "myocarditis" and "pericarditis" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: chest x-ray: unknown results; echocardiogram: unknown results; fibrin d dimer: d-dimer was higher than 4000; sars-cov-2 test: no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This HCP think there was not relate to possible blood clots or low platelet counts, but relate to possible myocarditis or pericarditis. The patient was seen by a cardiologist, not admitted to hospital, no a Chest Computed Tomography carried out, no a Cardiac MRI carried out, no a Cardiac Biopsy performed, no a Coronary angiography carried out. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2004595 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Dyspnoea, Fatigue, Illness, Immunisation, Interchange of vaccine products, Lethargy, Myocarditis, Off label use, Palpitations, Pericarditis, SARS-CoV-2 test, Scan, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: imaging; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101822482

Write-up: possible inflammation of the heart (myocarditis or pericarditis); possible inflammation of the heart (myocarditis or pericarditis); Palpitations/ Heart palpitations; Shortness of breath/ short breath; Racing heart (tachycardia); lethargic; sickness; Fatigue/unusual tiredness; Dose 1 and 2: COVID-19 Vaccine (not BNT162b2); dose 3 (booster): Comirnaty; Dose 1 and 2: COVID-19 Vaccine (not BNT162b2); dose 3 (booster): Comirnaty; booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112171939225610-0GYWV. Other Case identifier: GB-MHRA-ADR 26354418. A female patient received BNT162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 2, manufacturer unknown ), for COVID-19 immunisation; COVID-19 vaccine (DOSE 1, manufacturer unknown ), for COVID-19 immunisation. The patient has not previously received the full primary immunization series of BNT162b2 vaccination. The following information was reported: PALPITATIONS (medically significant), outcome "not recovered", described as "Palpitations/ Heart palpitations"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath/ short breath"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; LETHARGY (medically significant), outcome "unknown", described as "lethargic"; ILLNESS (medically significant), outcome "unknown", described as "sickness"; FATIGUE (medically significant) with onset 2021, outcome "unknown", described as "Fatigue/unusual tiredness". Clinical course: Short breath, palpitations, sickness, lethargic, worn out. Big mistake stake having this jab. The report was related to possible inflammation of the heart (myocarditis or pericarditis). It was unknown whether the symptoms lead to a hospital stay. The diagnosis was made by a medical professional (GP) (evaluated at the physician office visit). There was imaging carried out. There were blood tests taken. The outcome of "possible inflammation of the heart (myocarditis or pericarditis)" was unknown. The patient underwent COVID-19 virus test with result "no - negative COVID-19 test". Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2004900 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vaccination site pain
SMQs:, Arthritis (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Allergies:
Diagnostic Lab Data: Test Date: 20211217; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101822025

Write-up: Joint ache; off label use; Booster; Interchange of vaccine products; Severe arm/joints pain near or around injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112181944125710-9NNIW (RA). Other Case identifier(s): GB-MHRA-ADR 26358510 (RA). A 52 year-old male patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: Fk9413) as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr... The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "off label use"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; ARTHRALGIA (medically significant) with onset 12Dec2021, outcome "not recovered", described as "Joint ache"; VACCINATION SITE PAIN (medically significant) with onset 2021, outcome "unknown", described as "Severe arm/joints pain near or around injection site". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Dec2021) no - negative covid-19 test. Clinical course: The patient had no symptoms associated with COVID-19. The patient was not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2005084 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211110; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101829565

Write-up: uncontrolled bleeding from the nose/Nosebleed; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112191211244080-AZIDC. Other Case identifier: GB-MHRA-ADR 26359748. A male patient received bnt162b2 (COMIRNATY, reported as COVID-19 MRNA VACCINE BIONTECH), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (dose number unknown), administration date: 05Mar2021, for covid-19 immunisation; Covid-19 vaccine (dose number unknown, MANUFACTUERER UNKNOWN), for covid-19 immunisation. Patient has not had symptoms associated with COVID-19. The following information was reported: OFF LABEL USE (hospitalization) with onset 18Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (hospitalization) with onset 18Nov2021, outcome "unknown", described as "Booster"; EPISTAXIS (hospitalization) with onset 18Dec2021, outcome "not recovered", described as "uncontrolled bleeding from the nose/Nosebleed". It was reported that Uncontrolled bleeding from the nose, currently in hospital, cannot stop the bleeding. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Nov2021) negative. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2005110 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hot flushes; Menopausal (for 7-8 years and had previously had hot flushes)
Allergies:
Diagnostic Lab Data: Test Date: 20211127; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101829420

Write-up: barely sleeping; Menopausal hot flushes; Booster; Interchange of vaccine products; Off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112191324232290-UBLOP (MHRA). Other Case identifier(s): GB-MHRA-ADR 26359862 (MHRA). A 63-year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FH3220) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "post menopausal" (unspecified if ongoing), notes: for 7-8 years and had previously had hot flushes; "hot flushes" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. She took 100mcg of levothyroxine per day. Patient has not had symptoms associated with COVID-19. Past drug history included: Levothyroxine. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, lot number PV46672), administration date: 10Mar2021, for COVID-19 Immunisation; Covid-19 vaccine astrazeneca (Dose 2, lot number PV46687), administration date: 20May2021, for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Off label use"; HOT FLUSH (medically significant) with onset 30Nov2021, outcome "not recovered", described as "Menopausal hot flushes"; INSOMNIA (medically significant), outcome "unknown", described as "barely sleeping". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course: She had been post menopausal for 7-8 years and had previously had hot flushes. These have been minimal in the last 12-24 months but since shortly after the booster jab there has been a definite increase in the amount of hot flushes and also the severity of them. So much so that she was barely sleeping. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. Report not relate to possible inflammation of the heart (myocarditis or pericarditis). Not yet contacted her GP but will be doing this week as she had hoped the condition would have eased but it definitely hasn''t. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2006938 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Atrial flutter
SMQs:, Supraventricular tachyarrhythmias (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101836069

Write-up: Atrial fibrillation; Atrial flutter; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 682309 (RA ADR#). A 48 year-old male patient received BNT162B2 (COMIRNATY, solution for injection), administration date 12Nov2021 (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: ATRIAL FIBRILLATION (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Atrial fibrillation"; ATRIAL FLUTTER (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Atrial flutter". The event onset date from the administration of the first dose was 6 days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2007011 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, C-reactive protein, C-reactive protein increased, Fatigue, Fibrin D dimer, Immunisation, Muscular weakness, Myalgia, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AFEBRYL; LORAZETOP; MAGNECAPS MUSCLES
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:strongly increased; Test Name: D-dimer; Result Unstructured Data: Test Result:++; Test Name: VS; Result Unstructured Data: Test Result:strongly increased
CDC Split Type: BEPFIZER INC202101845492

Write-up: C-reactive protein strongly increased; sedimentation rate strongly increased; Myalgia; Arthralgia; Fatigue; severe asthenia; Muscular weakness; Third dose administered; This is a spontaneous report received from a contactable reporter(s) (Physician) from the RA. Regulatory number: BE-FAMHP-DHH-N2021-111431 (RA). A 75 year-old male patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FH8469) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient''s relevant medical history was not reported. Concomitant medication(s) included: AFEBRYL; LORAZETOP 2.5 MG, 1 tablet at bedtime; MAGNECAPS MUSCLES. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (disability) with onset 18Nov2021, outcome "unknown", described as "Third dose administered"; MYALGIA (disability) with onset 02Dec2021, outcome "not recovered", described as "Myalgia"; ARTHRALGIA (disability) with onset 02Dec2021, outcome "not recovered", described as "Arthralgia"; FATIGUE (disability) with onset 02Dec2021, outcome "not recovered", described as "Fatigue"; ASTHENIA (disability) with onset 02Dec2021, outcome "not recovered", described as "severe asthenia"; MUSCULAR WEAKNESS (disability) with onset 02Dec2021, outcome "not recovered", described as "Muscular weakness"; C-REACTIVE PROTEIN INCREASED (non-serious), outcome "unknown", described as "C-reactive protein strongly increased"; RED BLOOD CELL SEDIMENTATION RATE INCREASED (non-serious), outcome "unknown", described as "sedimentation rate strongly increased". The patient underwent the following laboratory tests and procedures: c-reactive protein: strongly increased; fibrin D dimer: ++; red blood cell sedimentation rate: strongly increased. Therapeutic measures lives + afebryl (aspirin) were taken as a result of myalgia, arthralgia, fatigue, asthenia, muscular weakness. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2007183 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E028A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Fibrin D dimer, Fibrin D dimer increased, Headache, Oropharyngeal pain, Pain, Pulmonary embolism, Radioisotope scan, Tachycardia
SMQs:, Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), 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), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birch pollen allergy; Grass allergy
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: D-dimer; Test Result: Positive ; Test Date: 20211126; Test Name: Lung scintigraphy; Result Unstructured Data: Test Result:pulmonary artery embolism; Comments: wedge-shaped perfusion defects (sub) segmental in the left dorsal lower lobe, as well as in the left lower upper lobe anterior
CDC Split Type: DEPFIZER INC202101830898

Write-up: Ache/ painful pulling and stinging left thoracic region, radiating to the throat; Ache/ painful pulling and stinging left thoracic region, radiating to the throat; Ache/ painful pulling and stinging left thoracic region, radiating to the throat; Fatigue; Headache; Dyspnoea; Tachycardia; pulmonary artery embolism; positive D-dimer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory authority. A 34-year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: 1E028A) as dose number unknown, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "grasses allergy" (unspecified if ongoing); "birch allergy" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: HEADACHE (hospitalization) with onset 20Nov2021, outcome "recovering", described as "Headache"; DYSPNOEA (hospitalization) with onset 20Nov2021, outcome "not recovered", described as "Dyspnoea"; CHEST PAIN (hospitalization), PAIN (hospitalization), OROPHARYNGEAL PAIN (hospitalization) all with onset 22Nov2021, outcome "recovering" and all described as "Ache/ painful pulling and stinging left thoracic region, radiating to the throat"; FATIGUE (hospitalization) with onset 20Nov2021, outcome "not recovered", described as "Fatigue"; TACHYCARDIA (hospitalization) with onset 18Nov2021, outcome "not recovered", described as "Tachycardia"; PULMONARY EMBOLISM (medically significant) with onset 26Nov2021, outcome "unknown", described as "pulmonary artery embolism"; FIBRIN D DIMER INCREASED (medically significant) with onset 25Nov2021, outcome "unknown", described as "positive D-dimer". The event "positive d-dimer" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: D-dimer: (25Nov2021) positive; radioisotope scan: (26Nov2021) pulmonary artery embolism, notes: wedge-shaped perfusion defects (sub) segmental in the left dorsal lower lobe, as well as in the left lower upper lobe anterior. Additional information: No risk factors or previous illnesses. 25Nov2021 emergency admission to the monitoring station with positive D-dimer. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2007307 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1010A / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Dyspnoea, Headache, Limb discomfort, Nausea, Palpitations, Syncope, Tachycardia, Vaccination site pain, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma; Allergy to animal; House dust allergy; Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101830653

Write-up: Dyspnoea/sudden shortness of breath; Arrhythmia; Tachycardia; Headache; Nausea; Vomiting; Palpitations; Limb discomfort; Injection site pain; Fainted; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: DE-PEI-CADR2021224893 (Agency). Other Case identifier(s): DE-CADRPEI-2021224893 (Agency Webportal), DE-PEI-202100278375 (Agency). A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: 1F1010A) as dose 1,single for covid-19 immunisation. Relevant medical history included: "Allergic asthma" (unspecified if ongoing); "House dust" (unspecified if ongoing); "animal hair" (unspecified if ongoing); "pollen" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (hospitalization) with onset 19Nov2021, outcome "recovered" (01Dec2021), described as "Limb discomfort"; VACCINATION SITE PAIN (hospitalization) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "Injection site pain"; DYSPNOEA (hospitalization) with onset 19Nov2021, outcome "recovered" (05Dec2021), described as "Dyspnoea/sudden shortness of breath"; ARRHYTHMIA (hospitalization) with onset 19Nov2021, outcome "recovered" (05Dec2021), described as "Arrhythmia"; TACHYCARDIA (hospitalization) with onset 19Nov2021, outcome "recovered" (05Dec2021), described as "Tachycardia"; HEADACHE (hospitalization) with onset 19Nov2021, outcome "recovered" (05Dec2021), described as "Headache"; NAUSEA (hospitalization) with onset 19Nov2021, outcome "recovered" (05Dec2021), described as "Nausea"; VOMITING (hospitalization) with onset 19Nov2021, outcome "recovered" (05Dec2021), described as "Vomiting"; PALPITATIONS (hospitalization) with onset 19Nov2021, outcome "recovered" (05Dec2021), described as "Palpitations"; SYNCOPE (medically significant), outcome "unknown", described as "Fainted". Therapeutic measures were taken as a result of syncope and included "resuscitation". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2007366 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30891TB / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cartilage injury, Fatigue, Headache, Immunisation
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101838454

Write-up: Booster; Fatigue; Cartilage injury; Headache; This is a study report from the regulatory authority-WEB. Regulatory number: DE-SVPEI-202100935607 (regulatory authority). A 30 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 22:34 (Lot number: 30891TB) at the age of 30 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 (1st dose,0.3 ml, intramuscular, batch/lot# EX3510, 12:27), administration date: 21Apr2021, for COVID-19 immunisation, reaction(s): "vaccination site pain", "Headache"; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 18Nov2021 22:34, outcome "unknown", described as "Booster"; FATIGUE (hospitalization) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Fatigue"; CARTILAGE INJURY (hospitalization) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Cartilage injury"; HEADACHE (non-serious), outcome "recovering", described as "Headache". Regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and event Headache and Cartilage injury as D. Unclassifiable. Regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and event Fatigue as B. Indeterminate. The reporter''s assessment of the causal relationship of the "booster", "fatigue", "cartilage injury" and "headache" with the suspect product(s) bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information in the case provided, the causal association between the events Fatigue, Cartilage injury, Headache, Booster and the suspect drug BNT162B2 cannot be excluded considering plausible drug-event temporal association. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-202101884523 same patient, different dose, events


VAERS ID: 2007657 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Grip strength decreased, Muscular weakness, Neuropathy peripheral, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLIN; AMLODIPINE; FLUOXETIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Hypertension; Ill-defined disorder; Obsessive-compulsive disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101838515

Write-up: Neuropathy NOS; severe constant burning pain from the site radiating to fingers; severe constant burning pain from the site radiating to fingers; weakness in wrist/fingers/grip; weakness in wrist/fingers/grip; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-EYC 00269594 (RA). Other Case identifier(s): GB-MHRA-ADR 26364088 (RA). A 60 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "dyslipidaemia" (unspecified if ongoing); "OCD" (unspecified if ongoing); "Ill-defined disorder" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLIN taken for ill-defined disorder; AMLODIPINE taken for ill-defined disorder; FLUOXETIN taken for ill-defined disorder. Past drug history included: Penicillin, reaction(s): "allergy: rash". The following information was reported: NEUROPATHY PERIPHERAL (disability, medically significant) with onset 18Nov2021, outcome "not recovered", described as "Neuropathy NOS"; VACCINATION SITE PAIN (disability), BURNING SENSATION (disability) all with onset 18Nov2021, outcome "not recovered" and all described as "severe constant burning pain from the site radiating to fingers"; MUSCULAR WEAKNESS (disability), GRIP STRENGTH DECREASED (disability) all with onset 18Nov2021, outcome "not recovered" and all described as "weakness in wrist/fingers/grip". Clinical course: Within hours of vaccine administration into left arm, patient experienced severe constant burning pain from the site radiating to fingers, had noted weakness in wrist/fingers/grip. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2008084 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood bilirubin, Blood bilirubin increased, Blood test, Breast cancer, Hepatic enzyme, Hepatic enzyme increased, Hepatitis, Immunisation, Interchange of vaccine products, Off label use, Platelet count, Platelet count increased, SARS-CoV-2 test
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Acute pancreatitis (broad), Biliary system related investigations, signs and symptoms (narrow), Breast malignant tumours (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), 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: PALBOCICLIB
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy))
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Bilirubin; Result Unstructured Data: Test Result:elevated; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: liver enzymes; Result Unstructured Data: Test Result:elevated; Test Name: blood platelets; Result Unstructured Data: Test Result:elevated; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101839410

Write-up: breast cancer; elevated blood platelets; elevated liver enzymes; inflammation of the liver; Bilirubin elevated; Off label use; Interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112201400573050-BHCPD (RA). Other Case identifier(s): GB-MHRA-ADR 26364365 (RA). A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Lot number: FL1939) as dose 3 (booster), single for covid-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Relevant medical history included: "Neoplasm" (unspecified if ongoing), notes: Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy). Concomitant medication(s) included: PALBOCICLIB taken for breast cancer, start date: 02Jan2018. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE NUMBER: UNKNOWN), administration date: 24Apr2021, for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER: UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "booster"; BREAST CANCER (medically significant), outcome "not recovered", described as "breast cancer"; BLOOD BILIRUBIN INCREASED (medically significant) with onset 18Nov2021, outcome "recovered" (16Dec2021), described as "Bilirubin elevated"; PLATELET COUNT INCREASED (medically significant), outcome "unknown", described as "elevated blood platelets"; HEPATIC ENZYME INCREASED (medically significant), outcome "unknown", described as "elevated liver enzymes"; HEPATITIS (medically significant), outcome "unknown", described as "inflammation of the liver". The patient was receiving targeted therapy for breast cancer. The patient also took letrozole medication. The patient had regular blood tests for inflammation of the liver and medication had to be suspended because of elevated blood platelets and elevated liver enzymes. The patient underwent the following laboratory tests and procedures: blood bilirubin: (18Nov2021) elevated; blood test: (unspecified date) unknown results; hepatic enzyme: (unspecified date) elevated; platelet count: (unspecified date) elevated; sars-cov-2 test: (unspecified date) no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2009737 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Pericarditis, Ultrasound Doppler
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: cardiac ultrasound; Result Unstructured Data: Test Result:Unknown results; Test Name: electrocardiogram; Result Unstructured Data: Test Result:Unknown results; Test Name: coloured Doppler scan; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GRPFIZER INC202101830692

Write-up: Pericarditis; acute retrosternal pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from the regulatory authority-WEB. Regulatory number: GR-GREOF-202109950. A 14-year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 14 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURE UNKNOWN), for COVID-19 immunisation. The following information was reported: PERICARDITIS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Pericarditis"; CHEST PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "acute retrosternal pain". The patient underwent the following laboratory tests and procedures: echocardiogram: unknown results; electrocardiogram: unknown results; ultrasound doppler: unknown results. Therapeutic measures were taken as a result of pericarditis, chest pain and included treatment with Algofren 400mg for 10 days. Clinical course: On 03Dec2021, the cardiologist diagnosed the pericarditis. More specifically, the pericardium had a small quantity of fluid in the posterior wall of the left ventricle with a size of 0.1mm. Until 07Dec2021 the retro cisternal pain remained. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2009799 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-11-18
   Days after vaccination:135
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood pressure fluctuation, Chest discomfort, Hypertension, Hypoaesthesia, Inappropriate schedule of product administration, Lichen planus, Magnetic resonance imaging head, Muscular weakness, Musculoskeletal chest pain, Specialist consultation, Thirst
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Cardiomyopathy (broad), Medication errors (narrow), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Dyslipidemia
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Liposuction; Stress (On 2 occasions she experienced great stress several years ago, due to a robbery at work); Uterine myomectomy
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: MRI brain; Result Unstructured Data: Test Result:no clear pathomorphological substrate was found...; Comments: no clear pathomorphological substrate was found to explain the etiology of right arm weakness.; Test Date: 20211105; Test Name: Cardiac examination; Result Unstructured Data: Test Result:in notes; Comments: occasionally exerts pressure surges, blushes, she has chest pressure
CDC Split Type: HRPFIZER INC202101830872

Write-up: Hypoaesthesia of right arm; Increased thirst; Pain right in the area of the costal arch; there is a feeling of painful tightness and pain in the area of the right costal arch, and the right lumbar region; Numbness of the right hand and forearm lasting up to 2h; Occasional pressure spikes, what the patient also notice after the 1st dose of Comirnaty vaccine.; Right arm weakness and right arm hypoaesthesia; Lumbar pain right; Lichen planus; Unregulated hypertension; inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Physician). Regulatory number: HR-HALMED-300052858 (HALMED). Other Case identifier(s): 10-782-419-988 (UMCPRS). A 50-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 06Jul2021 (Lot number: FD6840) as dose 2, 0.3 ml, single for covid-19 immunisation; amlodipine besilate, indapamide, perindopril arginine (TRIPLIXAM), oral from 10Nov2021 (Lot number: unknown) to 16Nov2021 at 1 DF 1x/day for hypertension; moxonidine (PHYSIOTENS), oral from 10Nov2021 (Lot number: unknown) to 16Nov2021 at 0.4 mg 1x/day for hypertension. Relevant medical history included: "Appendectomy", stop date: 2003; "Dyslipidemia" (ongoing); "Uterine myomectomy", start date: 2013 (not ongoing); "Arterial hypertension", start date: 2005 (ongoing); "Liposuction", stop date: 2020; "Stress" (unspecified if ongoing): On 2 occasions she experienced great stress several years ago, due to a robbery at work. The patient''s concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "allergy". Vaccination history included: Comirnaty (1st dose, 0.3 ml, intramuscular, lot FA7083, she noticed a sudden appearance of blisters and redness, and itchy skin of the forearms and lower legs, and shortly afterwards the whole back. She describes that after scratching, there are scarring marks on the skin, which are still visible today), administration date: 25May2021, for Covid-19 immunisation, reaction(s): "Lichen planus", "Hypertension". The following information was reported: HYPOAESTHESIA (hospitalization, medically significant) with onset 18Nov2021, outcome "recovering", described as "Hypoaesthesia of right arm"; THIRST (hospitalization, medically significant) with onset 18Nov2021, outcome "recovering", described as "Increased thirst"; MUSCULOSKELETAL CHEST PAIN (hospitalization, medically significant) with onset 18Nov2021, outcome "recovering", described as "Pain right in the area of the costal arch"; CHEST DISCOMFORT (hospitalization, medically significant) with onset 18Nov2021, outcome "recovering", described as "there is a feeling of painful tightness and pain in the area of the right costal arch, and the right lumbar region"; HYPOAESTHESIA (hospitalization, medically significant) with onset 18Nov2021, outcome "unknown", described as "Numbness of the right hand and forearm lasting up to 2h"; BLOOD PRESSURE FLUCTUATION (hospitalization, medically significant) with onset 18Nov2021, outcome "unknown", described as "Occasional pressure spikes, what the patient also notice after the 1st dose of Comirnaty vaccine."; MUSCULAR WEAKNESS (hospitalization, medically significant) with onset 18Nov2021, outcome "recovering", described as "Right arm weakness and right arm hypoaesthesia"; BACK PAIN (hospitalization, medically significant) with onset 18Nov2021, outcome "recovering", described as "Lumbar pain right"; LICHEN PLANUS (medically significant), outcome "recovering", described as "Lichen planus"; HYPERTENSION (medically significant), outcome "recovering", described as "Unregulated hypertension"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "inappropriate schedule of vaccine administered". The patient was hospitalized for hypoaesthesia, thirst, musculoskeletal chest pain, chest discomfort, hypoaesthesia, blood pressure fluctuation, muscular weakness, back pain (start date: 19Nov2021, discharge date: 23Nov2021, hospitalization duration: 4 day(s)). The event "lichen planus" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging head: (2021) no clear pathomorphological substrate was found..., notes: no clear pathomorphological substrate was found to explain the etiology of right arm weakness; specialist consultation: (05Nov2021) in notes, notes: occasionally exerts pressure surges, blushes, she has chest pressure. The action taken for amlodipine besilate, indapamide, perindopril arginine and moxonidine was dosage permanently withdrawn on 16Nov2021. Therapeutic measures were taken as a result of lichen planus, hypertension. Clinical course: On 06Jul2021, she received the 2nd dose of Comirnaty vaccine, after which the same problems are still present, as well as after the 1st dose. Due to these changes, it was controlled by a dermatologist, understood as "Lichen planus", corticosteroid treatment has been tried locally, but it has so far had no therapeutic effect. During the summer, the changes spontaneously partially regressed, but since the autumn they have been exacerbating again, with an additional deterioration from around 10Nov2021, when in therapy introduced Triplixam and Physiotens. Antihypertensive therapy was corrected for unregulated blood pressure values, with occasional pressure spikes, which the patient also noticed after the 1st dose of Comirnaty vaccine. From 16Nov2021, discontinued Triplixam and Physiotens therapy, and currently has the impression that the changes are in partial regression. From 18Nov2021 around noon the patient states that she felt a prick under her right costal arch, describes it as a non-specific discomfort without nausea and vomiting, accompanied by a feeling of heightened thirst. Later, there was a feeling of painful tightness and pain in the area of the right costal arch, and the right lumbar region, it intensifies when turning the torso, and the difficulties persist when admission. On the same day, numbness of the right hand and forearm occurred, which lasted up to 2 hours, without motor weakness. The ailments receded spontaneously. On the day of her admission to the Department of Neurology, she has been feeling numbness in her right hand since morning, and motor weakness in her right hand, and things fell out of her hands. No similar problems have occurred in the past. The patient has been hospitalized from 19Nov to 23Nov2021 at the Department of Neurology, during which time there was a regression of motor weakness of the right arm, but the hypoaesthesia of the right forearm remains. The performed treatment, which included MR of the brain and cervical spine, did not find a clear pathomorphological substrate that could explain the etiology of right arm weakness. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : HR-PFIZER INC-202101880442 same reporter/patient/drug, different dose/events


VAERS ID: 2010924 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Ataxia, Brain stem infarction, Computerised tomogram, Contusion, Echocardiogram, Fall, General physical health deterioration, Immunisation, Magnetic resonance imaging, Physical examination
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Eliquis; ATORVASTATIN MEPHA; ELTROXIN; DUTASTERIDE;TAMSULOSIN; VI-DE 3; CANDESARTAN SANDOZ
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (regular alcohol consumption); Atrial flutter (Typical atrial flutter (ED 09Aug2021)); Bladder carcinoma (Complaint and relapse-free state after pTa G2 bladder carcinoma (ED Mar2015)); Chronic renal failure (Chronic renal failure KDiGO G2 - 3a); Delirium (Mixed hypo- and hyperactive delirium (ED 11Nov2021)); Persistent atrial fibrillation (status after persistent atrial fibrillation (ED Feb2020)); Subdural hematoma (Mini-craniotomy and hematoma evacuation on the left for a recurrent subdural hematoma on the left)
Allergies:
Diagnostic Lab Data: Test Name: Computed tomography; Result Unstructured Data: Test Result:a branch stenosis of the left vertebral artery; Test Name: echocardiographic; Result Unstructured Data: Test Result:were the same compared to the previous examination; Comments: The echocardiographic findings were the same compared to the previous examination in Jun2021; Test Name: MRI; Result Unstructured Data: Test Result:an acute pontine infarction paramedian left; Comments: with little haemorrhagic transformation; Test Name: clinical examination; Result Unstructured Data: Test Result:trunk instability; Comments: discrete weakness of the right arm and leg, and ataxia in the finger-nose test and in the right knee-heel test.
CDC Split Type: CHPFIZER INC202101880968

Write-up: Fall; thoracic contusion at the right lower ribcage; Pontine infarction; Ataxia; Reduced general condition; weakness; received 3rd dose; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: CH-SM-2021-28841. A 77 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation; apixaban (ELIQUIS, 5 mg), first regimen oral (Batch/Lot number: unknown) till 20Nov2021 at 5 mg 2x/day (1-0-1-0) and second regimen oral since 23Nov2021 (Batch/Lot number: unknown) at 5 mg 2x/day (1-0-1-0) for anticoagulant therapy. Relevant medical history included: "Delirium", start date: 11Nov2021 (unspecified if ongoing), notes: Mixed hypo- and hyperactive delirium (ED 11Nov2021); "Atrial flutter", start date: 09Aug2021 (unspecified if ongoing), notes: Typical atrial flutter (ED 09Aug2021); "status after persistent atrial fibrillation", start date: Feb2020 (unspecified if ongoing), notes: status after persistent atrial fibrillation (ED Feb2020); "Chronic renal failure" (unspecified if ongoing), notes: Chronic renal failure KDiGO G2 - 3a; "Subdural haematoma", start date: May2016 (unspecified if ongoing), notes: Mini-craniotomy and hematoma evacuation on the left for a recurrent subdural hematoma on the left; "Bladder cancer", start date: Mar2015 (unspecified if ongoing), notes: Complaint and relapse-free state after pTa G2 bladder carcinoma (ED Mar2015); "Alcohol abuse" (unspecified if ongoing), notes: regular alcohol consumption. Concomitant medication(s) included: ATORVASTATIN MEPHA (ongoing); ELTROXIN (ongoing); DUTASTERIDE;TAMSULOSIN (ongoing); VI-DE 3 (ongoing); CANDESARTAN SANDOZ (ongoing). Vaccination history included: Comirnaty (1st dose), for Covid-19 immunisation; Comirnaty (2nd dose), for Covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, disability, medically significant) with onset 18Nov2021, outcome "unknown", described as "received 3rd dose"; GENERAL PHYSICAL HEALTH DETERIORATION (hospitalization, disability, medically significant) with onset 19Nov2021, outcome "recovering", described as "Reduced general condition"; ASTHENIA (hospitalization, disability, medically significant) with onset 19Nov2021, outcome "recovering", described as "weakness"; FALL (hospitalization, disability, medically significant) with onset 20Nov2021, outcome "not recovered", described as "Fall"; CONTUSION (hospitalization, disability, medically significant) with onset 20Nov2021, outcome "not recovered", described as "thoracic contusion at the right lower ribcage"; BRAIN STEM INFARCTION (hospitalization, disability, medically significant) with onset 20Nov2021, outcome "not recovered", described as "Pontine infarction"; ATAXIA (hospitalization, disability, medically significant) with onset 20Nov2021, outcome "unknown", described as "Ataxia". The patient was hospitalized for immunisation, general physical health deterioration, asthenia, fall, contusion, brain stem infarction, ataxia (start date: 20Nov2021, discharge date: 26Nov2021, hospitalization duration: 6 day(s)). The patient underwent the following laboratory tests and procedures: computerised tomogram: a branch stenosis of the left vertebral artery; echocardiogram: were the same compared to the previous examination, notes: The echocardiographic findings were the same compared to the previous examination in Jun2021; magnetic resonance imaging: an acute pontine infarction paramedian left, notes: with little haemorrhagic transformation; physical examination: trunk instability, notes: discrete weakness of the right arm and leg, and ataxia in the finger-nose test and in the right knee-heel test. The action taken for apixaban was dosage permanently withdrawn. Clinical course: After the booster vaccination, the patient suffered from increasing weakness and general condition deterioration on 19Nov021. On 20Nov2021, the patient was unable to get out of bed due to weakness, attempted to do so anyway and fell with impact against the rollator, sustaining a thoracic contusion at the right lower ribcage. The patient stated that there was no head impact and that he was not unconscious. As a result, the patient was hospitalised via ambulance on 20Nov2021. On admission to hospital, the patient presented in a reduced general condition and hemodynamically stable. The clinical examination revealed trunk instability, discrete weakness of the right arm and leg, and ataxia in the finger-nose test and in the right knee-heel test. Computed tomography revealed a branch stenosis of the left vertebral artery. MRI scan revealed an acute pontine infarction paramedian left (with little haemorrhagic transformation). The echocardiographic findings were the same compared to the previous examination in Jun2021. The treating medical team interpreted the fall event in the context of trunk instability after acute pontine infarction. A conservative therapy was initiated. It should also be taken into account that the patient was taking a therapy with Eliquis (apixaban). Eliquis was paused on hospital admission and restarted at the same dosage on the evening of 23Nov2021. The primary reporting centre stated that permanent damage or disability was to be assumed as a consequence of the possible ADR in this patient. On 26Nov2021, the patient was discharged from hospital to rehabilitation in an improved condition. Sender''s comment: CAUSALITY: If there is a temporal connection for Comirnaty 3rd and Eliquis as well as other possible causes, we classify the causality of both Comirnaty 3rd and Eliquis for the occurrence of the suspected ADR as possible. A causal relationship between Comirnaty, Eliquis and Pontine infarction, Asthenia, Fall, Reduced general condition was assessed by Regulatory Authority as being possible. Regulatory Authority assessed this case as serious with seriousness criterion/criteria Hospitalization, Disabling, Other medically important condition. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2010950 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-11-18
   Days after vaccination:269
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101866291

Write-up: Vaccination failure; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: DE-PEI-202100276848 Regulatory Authority. A 90 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Mar2021 (Lot number: BEP2163) at the age of 89 years as dose 2,single and intramuscular, administration date 22Feb2021 (Lot number: EJ6789) 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: DRUG INEFFECTIVE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Vaccination failure"; SUSPECTED COVID-19 (medically significant) with onset 18Nov2021, outcome "unknown", described as "COVID-19". Clinical Information: Reporter provided the relatedness of drug to reaction(s)/event assessed by Regulatory Authority was: B. Indeterminate for vaccination failure and as B. Indeterminate for covid-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2011916 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Burning sensation, Dermatitis, Immunisation, Interchange of vaccine products, Irritability, Off label use, Rash macular, SARS-CoV-2 test, Skin irritation
SMQs:, Severe cutaneous adverse reactions (broad), Peripheral neuropathy (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: CETIRIZINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioedema; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data: Test Date: 20211202; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101851711

Write-up: extreme irritation/Skin irritation; extreme irritation/Skin irritation; initially as spots which became like small blisters and then red tops; initially as spots which became like small blisters and then red tops; Burning sensation in bath water; Skin inflammation; off label use; Interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112221323542200-UUDB6 (RA). Other Case identifier(s): GB-MHRA-ADR 26378466 (RA). A 75-year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...; "angioedema" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE taken for angioedema, start date: Oct2015. Past drug history included: Nizatidine; Rivaroxaban. 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: OFF LABEL USE (medically significant) with onset 18Nov2021, described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 18Nov2021, described as "booster"; SKIN IRRITATION (medically significant), IRRITABILITY (medically significant), outcome "not recovered" and all described as "extreme irritation/Skin irritation"; DERMATITIS (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Skin inflammation"; BLISTER (medically significant), RASH MACULAR (medically significant), outcome "unknown" and all described as "initially as spots which became like small blisters and then red tops"; BURNING SENSATION (medically significant), outcome "unknown", described as "Burning sensation in bath water". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Dec2021) negative, notes: No - Negative COVID-19 test. Clinical course: Displayed initially as spots which became like small blisters and then red tops. Began on the lower legs and gradually progressed to the lower back, neck and arms and the upper back. Extreme irritation. Burning sensation in bath water. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2011989 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Epistaxis, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Blood; Result Unstructured Data: Test Result:Unknown result; Test Date: 20211221; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101851737

Write-up: Nose bleeds; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112222013117710-DC2N1. Other Case identifier: GB-MHRA-ADR 26381557. A 67 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE UNKNOWN), administration date: 15Feb2021; Covid-19 vaccine (DOSE UNKNOWN; MANUFACTURER UNKNOWN), for covid-19 immunization. Patient has not had symptoms associated with COVID-19. The following information was reported: OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; EPISTAXIS (medically significant) with onset 01Dec2021, outcome "recovering", however, event stop date was reported as 21Dec2021 described as "Nose bleeds". It was reported that nose bleeds between 01:00 and 06:00. 01De2021 for 10 minutes, 11Dec2021 for 10 minutes, 17Dec2021 for 5 minutes and 1 hour. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unknown result; sars-cov-2 test: (21Dec2021) no - negative covid-19 test. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2012699 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure decreased, Hyperhidrosis, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Blood pressure decreased; Fainting; Perspiration excessive; Fever; This case was received via the RA (Reference number: GR-GREOF-202109970) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (Blood pressure decreased) and SYNCOPE (Fainting) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE SODIUM (THYROHORMONE), IRBESARTAN (APROVEL), NEBIVOLOL HYDROCHLORIDE (LOBIVON) and PRAVASTATIN SODIUM (PRANALIP) for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced BLOOD PRESSURE DECREASED (Blood pressure decreased) (seriousness criterion medically significant) and SYNCOPE (Fainting) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (Perspiration excessive) and PYREXIA (Fever). On 18-Nov-2021, BLOOD PRESSURE DECREASED (Blood pressure decreased) and SYNCOPE (Fainting) had resolved. At the time of the report, HYPERHIDROSIS (Perspiration excessive) and PYREXIA (Fever) had resolved. Medical history was not provided. No treatment medication was provided. Company Comment: This case concerns a 68-year-old female patient with concomitant use of Irbesartan and Nebivolol Hydrochloride, who experienced the events of Blood pressure decreased and Syncope. The events occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Non serious events of Hyperhidrosis and Pyrexia were also reported with unknown dates. Concomitant use of blood pressure control medications could remain a confounder for event of Blood pressure decreased, which could be contributory to Syncope. Events seriousness assessed 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 68-year-old female patient with concomitant use of Irbesartan and Nebivolol Hydrochloride, who experienced the events of Blood pressure decreased and Syncope. The events occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Non serious events of Hyperhidrosis and Pyrexia were also reported with unknown dates. Concomitant use of blood pressure control medications could remain a confounder for event of Blood pressure decreased, which could be contributory to Syncope. Events seriousness assessed 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: 2012758 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Extrasystoles, Immunisation
SMQs:, Anaphylactic reaction (broad), Tachyarrhythmia terms, nonspecific (narrow), 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:
CDC Split Type: IEPFIZER INC202101830504

Write-up: Missed beats; Chest heaviness; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory authority. A 52 year-old male patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose1 MANUFACTURE UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (dose 2 MANUFACTURE UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; EXTRASYSTOLES (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Missed beats"; CHEST DISCOMFORT (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Chest heaviness". Therapeutic measures were taken as a result of extrasystoles, chest discomfort under cardiac review No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2013024 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1006A / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Blood pressure measurement, Chest pain, Electrocardiogram, Feeling of body temperature change, Heart rate, Immunisation, Malaise, Oxygen saturation, Pain, Pain in extremity, Paraesthesia, Physical examination, Vaccination site pain, Vertigo
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: arterial blood gas analysis; Result Unstructured Data: Test Result:unknown results; Test Name: Blood pressure; Result Unstructured Data: Test Result:115/70 mmHg; Test Name: electrocardiogram; Result Unstructured Data: Test Result:unknown results; Test Name: heart rate; Result Unstructured Data: Test Result:112; Comments: beats per minute; Test Name: saturation; Test Result: 98 %; Test Name: general examination; Result Unstructured Data: Test Result:rhythmic, valid tones; Comments: rhythmic, valid tones, apparently free pauses; diffuse vesicular murmur, absence of added pathological noises; treatable abdomen, not painful or tender on superficial and deep palpation; peristalsis present; no declivous edema; radial pulses present.
CDC Split Type: ITPFIZER INC202101817474

Write-up: Pain at injection site; Vertigo; hot/ cold feeling; chest pain radiating to the arm; tingling in limbs; general malaise; chest pain radiating to the arm; chest pain radiating to the arm; Booster; FARO This is a non-interventional study report from the Regulatory Authority. Regulatory number: IT-MINISAL02-820940 (MINISAL02). A 40 year-old female subject received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 14:58 (Lot number: 1F1006A, Expiration Date: 31Dec2021) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The subject''s relevant medical history and concomitant medications were not reported. Vaccination history included: Vaxzevria (ex covid-19 vaccine astrazeneca) (astrazeneca ab) (j07bx03) (1st dose, 3:48 pm, lot ABV2856, left arm.), administration date: 24Feb2021, for COVID-19 immunisation; Vaxzevria (ex covid-19 vaccine astrazeneca) (astrazeneca ab) (j07bx03) (2nd dose, 4:32 pm, lot ABX1506, left arm.), administration date: 13May2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 18Nov2021, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "Pain at injection site"; VERTIGO (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "Vertigo"; FEELING OF BODY TEMPERATURE CHANGE (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "hot/ cold feeling"; CHEST PAIN (hospitalization), PAIN (hospitalization), PAIN IN EXTREMITY (hospitalization) all with onset 19Nov2021, outcome "not recovered" and all described as "chest pain radiating to the arm"; PARAESTHESIA (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "tingling in limbs"; MALAISE (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "general malaise". The events "pain at injection site", "vertigo", "hot/ cold feeling", "chest pain radiating to the arm", "tingling in limbs", "general malaise", "chest pain radiating to the arm" and "chest pain radiating to the arm" were evaluated at the emergency room visit. The suspected Adverse Drug Reactions (ADR) was observed as part of the analysis of adverse drug reactions in the emergency room. The subject underwent the following laboratory tests and procedures: blood gases: unknown results; blood pressure measurement: 115/70 mmHg; electrocardiogram: unknown results; heart rate: 112, notes: beats per minute; oxygen saturation: 98 %; physical examination: rhythmic, valid tones, notes: rhythmic, valid tones, apparently free pauses; diffuse vesicular murmur, absence of added pathological noises; treatable abdomen, not painful or tender on superficial and deep palpation; peristalsis present; no declivous edema; radial pulses present. Therapeutic measures were taken as a result of vaccination site pain, vertigo, feeling of body temperature change, chest pain, paraesthesia, malaise, pain, pain in extremity.Therapy administered: Pantorc (1 vial) + Levopraid (2 vials) + Toradol (1 vial) + physiological solution 250 ml. Recommended: Tachipirin 1 g as needed). The reporter''s assessment of the causal relationship of the "booster", "pain at injection site", "vertigo", "hot/ cold feeling", "chest pain radiating to the arm", "tingling in limbs" and "general malaise" with the suspect product(s) bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on limited information in the case , a possible causal association between the reported events Vaccination site pain, Immunisation ,vertigo, feeling of body temperature changes, chest pain , pain , malaise paraesthesia ,pain in extremity and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 2013159 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1016A / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Confusional state, Immunisation, Local anaesthesia, Muscle rigidity, Myelitis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101845203

Write-up: dorsal myelitis; Increasing mental confusion and asthenia with muscle rigidity and skin anaesthesia from the lower limbs to the submammary groove; Increasing mental confusion and asthenia with muscle rigidity and skin anaesthesia from the lower limbs to the submammary groove; Increasing mental confusion and asthenia with muscle rigidity and skin anaesthesia from the lower limbs to the submammary groove; Increasing mental confusion and asthenia with muscle rigidity and skin anaesthesia from the lower limbs to the submammary groove; booster; This is a spontaneous report received from a contactable reporter (Physician) from the regulatory authority-WEB. Regulatory number: IT-MINISAL02-822796 (regulatory authority). A 57 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 18Nov2021 (Lot number: 1F1016A, Expiration Date: 30Apr2022) as dose 3 (booster),0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE, LOT NUMBER EJ6797, EXPIRATION DATE 30APR2021, LEFT DELTOID, TIME OF VACCINATION 10:05), administration date: 16Jan2021, for COVID-19 immunisation; Comirnaty (DOSE 2, SINGLE, LOT NUMBER EK9788, EXPIRATION DATE 31MAY2021 , LEFT DELTOID, TIME OF VACCINATION 10:18), administration date: 06Feb2021, for COVID-19 immunisation. The following information was reported: MYELITIS (hospitalization, medically significant), outcome "unknown", described as "dorsal myelitis"; CONFUSIONAL STATE (medically significant), LOCAL ANAESTHESIA (medically significant), ASTHENIA (medically significant), MUSCLE RIGIDITY (medically significant) all with onset 20Nov2021, outcome "not recovered" and all described as "Increasing mental confusion and asthenia with muscle rigidity and skin anaesthesia from the lower limbs to the submammary groove"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "booster". Therapeutic measures were taken as a result of myelitis included steroid therapy. It took after admission to neurology unit with diagnosis of dorsal myelitis. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2015213 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004669 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Creatinine renal clearance, Diarrhoea, Dyspnoea, Hypotension, Nausea, Tachycardia, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ischaemic cardiomyopathy
Allergies:
Diagnostic Lab Data: Test Name: Creatinine renal clearance; Result Unstructured Data: TEST 10011371 (24.1) 99 �mol/l (20211118): The creatinine was 99 at the time of reporting (probably �mol/l).; Test Date: 20211118; Test Name: Creatinine renal clearance; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive
CDC Split Type: CHMODERNATX, INC.MOD20214

Write-up: nausea; vomiting; diarrhoea; thoracic pressure; tachycardia; hypotension; shortness of breath; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Dec-2021 and was forwarded to Moderna on 28-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting), DIARRHOEA (diarrhoea), CHEST PAIN (thoracic pressure), TACHYCARDIA (tachycardia), HYPOTENSION (hypotension) and DYSPNOEA (shortness of breath) in a 79-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3004669) for SARS-CoV-2 immunisation. The patient''s past medical history included Ischaemic cardiomyopathy. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced NAUSEA (nausea) (seriousness criteria hospitalization and medically significant), VOMITING (vomiting) (seriousness criteria hospitalization and medically significant), DIARRHOEA (diarrhoea) (seriousness criteria hospitalization and medically significant), CHEST PAIN (thoracic pressure) (seriousness criteria hospitalization and medically significant), TACHYCARDIA (tachycardia) (seriousness criteria hospitalization and medically significant), HYPOTENSION (hypotension) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (shortness of breath) (seriousness criteria hospitalization and medically significant). At the time of the report, NAUSEA (nausea), VOMITING (vomiting), DIARRHOEA (diarrhoea), CHEST PAIN (thoracic pressure), TACHYCARDIA (tachycardia), HYPOTENSION (hypotension) and DYSPNOEA (shortness of breath) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, Creatinine renal clearance: inconclusive (Inconclusive) Inconclusive. On an unknown date, Creatinine renal clearance: 99 TEST 10011371 (24.1) 99 �mol/l (20211118): The creatinine was 99 at the time of reporting (probably �mol/l).. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter considered NAUSEA (nausea), VOMITING (vomiting), DIARRHOEA (diarrhoea), CHEST PAIN (thoracic pressure), TACHYCARDIA (tachycardia), HYPOTENSION (hypotension) and DYSPNOEA (shortness of breath) to be possibly related. It was verbally reported that, the patient received the third Spikevax vaccination subcutaneously on 17.11.2021 for immunization against Covid-19 (Covid-19 booster, lot. 3004669). The next day there was progressive stress dyspnea with Nausea/Emesis and Diarrhea, as well as an intermittent sensation of thoracic pressure. These complaints lasted about 2 hours. The patient was hospitalized the same day. An electrocardiography performed in hospital showed ventricular tachycardia as the cause of discomfort. This was also hemodynamically relevant with hypotension at 70/40 mmHg. A scar in ischemic cardiopathy was assumed to be an etiology, but a consequence of booster vaccination against Covid-19 was also discussed in differential diagnosis. none allergies were known. Nicotine or alcohol consumption was not reported. No evidence of virus hepatitis or liver disease. The patient was not taking any new medication recently. The habitual medication is unknown. We do not have any further relevant information on this case. Company comment: This is a regulatory case concerning a 79 year-old, male patient with a history of Ischaemic cardiomyopathy, who experienced the serious (due to medically important condition and hospitalization) unexpected, according CCDS, events of nausea, vomiting, Diarrhoea, chest pain, tachycardia, hypotension and dyspnoea. The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. The outcome of the events was reported as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the third dose. The medical history, of Ischaemic cardiomyopathy and patient�s advanced age remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 79 year-old, male patient with a history of Ischaemic cardiomyopathy, who experienced the serious (due to medically important condition and hospitalization) unexpected, according CCDS, events of nausea, vomiting, Diarrhoea, chest pain, tachycardia, hypotension and dyspnoea. The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. The outcome of the events was reported as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the third dose. The medical history, of Ischaemic cardiomyopathy and patient�s advanced age remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2015273 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-11
Onset:2021-11-18
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SDEH4 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bursitis, Immunisation
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101859623

Write-up: booster; Increasing pain left. UA shoulder neck: inpatient admission; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: DE-PEI-202100279422 (Agency). A 96 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 11Nov2021 (Lot number: SDEH4) at the age of 96 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown), for covid-19 immunisation; Covid-19 vaccine (2nd dose, manufacturer unknown), for covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization), outcome "unknown", described as "booster"; BURSITIS (hospitalization) with onset 18Nov2021, outcome "not recovered", described as "Increasing pain left. UA shoulder neck: inpatient admission". Therapeutic measures were taken as a result of bursitis. Clinical course: This report is non-serious. Event assessment: Agency / Comirnaty / Shoulder bursitis / D. Unclassifiable. Sender comment: Hospital diagnosis (report attached): Pre-septic clinical picture with acute thrombocytopenia with synovitis/bursitis of the left shoulder, unclear cause of the infection. Therapy: Shoulder joint puncture (left), antibiotics.


VAERS ID: 2015286 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-11-18
   Days after vaccination:268
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101866186

Write-up: COVID-19; Vaccination failure; 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: DE-PEI-202100284103 Regulatory Authority. A 92 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Feb2021 (Lot number: EL8723) at the age of 92 years as dose 2, single and intramuscular, administration date 02Feb2021 (Lot number: EK9788) 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: SUSPECTED COVID-19 (medically significant) with onset 18Nov2021, outcome "recovering", described as "COVID-19"; DRUG INEFFECTIVE (medically significant) with onset 18Nov2021, outcome "recovering", described as "Vaccination failure". Relatedness of drug to events �Vaccination failure'' and �COVID-19'' as per source of assessment Regulatory Authority was B Indeterminate. Relatedness of drug to events �Vaccination failure'' and �COVID-19'' as per source of assessment Regulatory Authority was B Indeterminate. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2015451 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1010A / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Blood pressure measurement, Epistaxis, Immunisation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease (Stage III)
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:130/80; Test Name: Blood pressure; Result Unstructured Data: Test Result:190/100
CDC Split Type: DEPFIZER INC202101859862

Write-up: Treatment in the hospital for nose bleeding was necessary; After 3rd vaccination with Biontec, blood pressure was significantly higher, instead of 130/80, repeated values of 190/100. Treatment in hospital for nose bleeding was necessary. Outpatient further; Booster; 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: DE-PEI-CADR2021217774 Regulatory Authority. Other Case identifier(s): DE-CADRPEI-2021217774 Regulatory Authority, DE-PEI-202100270476 Regulatory Authority. A 78 year-old male patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: 1F1010A) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic kidney disease" (unspecified if ongoing), notes: Stage III. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, LOT: unknown, unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (2nd dose, LOT: unknown, unknown manufacturer), for covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; ARRHYTHMIA (hospitalization, medically significant) with onset 19Nov2021, outcome "not recovered", described as "After 3rd vaccination with Biontec, blood pressure was significantly higher, instead of 130/80, repeated values of 190/100. Treatment in hospital for nose bleeding was necessary. Outpatient further"; EPISTAXIS (hospitalization), outcome "unknown", described as "Treatment in the hospital for nose bleeding was necessary". The patient underwent the following laboratory tests and procedures: blood pressure measurement: 130/80; 190/100. Therapeutic measures were taken as a result of arrhythmia, epistaxis. Blood pressure fluctuations with need for outpatient and inpatient therapy. Relatedness assessment of event arrhythmia was consistent causal association to immunization, Source of assessment was Regulatory Authority. Regulatory Authority Comment: Do you or the person concerned have any known allergies, If yes, which ones: 0. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2015473 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-11-18
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1436 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bacterial test, Cerebral venous sinus thrombosis, Intracranial pressure increased, Magnetic resonance imaging, Nasopharyngitis, Ocular hyperaemia, Papilloedema, Viral test
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Psoriasis
Allergies:
Diagnostic Lab Data: Test Name: CSF BACTERIA TEST; Result Unstructured Data: Test Result:Bacterial infections excluded by lumbar puncture; Test Name: MRI; Result Unstructured Data: Test Result:diagnosed with venous sinus thrombosis,; Comments: elevated intracranial pressure was measured alongside; Test Name: CSF VIRAL TEST; Result Unstructured Data: Test Result:Viral infections excluded by lumbar puncture
CDC Split Type: DEPFIZER INC202101859630

Write-up: Thrombosis of venous sinuses; Increased intracranial pressure; Papilledema bilateral; red eye; cold; 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 parent. Regulatory number: DE-PEI-CADR2021222575 (RA). Other Case identifier(s): DE-CADRPEI-2021222575 (RA), DE-PEI-202100276475 (RA). A 17 year-old male patient received bnt162b2 (COMIRNATY), administration date 22Sep2021 (Lot number: FC1436) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "psoriasis" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: CEREBRAL VENOUS SINUS THROMBOSIS (hospitalization, medically significant) with onset 21Nov2021, outcome "unknown", described as "Thrombosis of venous sinuses"; INTRACRANIAL PRESSURE INCREASED (hospitalization, medically significant) with onset 21Nov2021, outcome "unknown", described as "Increased intracranial pressure"; PAPILLOEDEMA (hospitalization, medically significant) with onset 21Nov2021, outcome "unknown", described as "Papilledema bilateral"; NASOPHARYNGITIS (non-serious) with onset 18Nov2021, outcome "unknown", described as "cold"; OCULAR HYPERAEMIA (non-serious) with onset 21Nov2021, outcome "unknown", described as "red eye". The events "thrombosis of venous sinuses", "increased intracranial pressure", "papilledema bilateral", "cold" and "red eye" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: bacterial test: bacterial infections excluded by lumbar puncture; magnetic resonance imaging: diagnosed with venous sinus thrombosis,, notes: elevated intracranial pressure was measured alongside; viral test: viral infections excluded by lumbar puncture. Therapeutic measures were taken as a result of cerebral venous sinus thrombosis, intracranial pressure increased, papilloedema. Relatedness of comirnaty to increased intracranial pressure, papilledema, thrombosis of venous sinuses was assessed by RA was unclassifiable. Sender Comment: Do you or the person concerned have any known allergies? If so, which ones? No Information on risk factors or pre-existing conditions None known / Initially, the sinus vein thrombosis in my son was only noticeable due to a red eye on 21Nov2021, which was initially assessed by an ophthalmologist in connection with a cold that had been present for about 3 days. The ophthalmologist noticed bilateral papilloedema and referred my son to PRIVACY hospital for further diagnostic workup, where he was diagnosed with venous sinus thrombosis based on magnetic resonance imaging. Elevated intracranial pressure was measured alongside the findings. Since my son had no infections around or after the time of the second vaccination and since viral and bacterial infections in the cerebrospinal fluid were excluded by lumbar puncture, there is strong suspicion that the event was a consequence of vaccination -even though the vaccination was several weeks before. According to the doctors, the thrombosis is not new, but older - not just a few days old, but rather a few weeks. He is now being treated with heparin. I think it''s important to say that my son didn''t have headaches at the time of the diagnosis. The only symptoms he noticed were cold, which appeared on 18Nov2021, and red eye, which appeared on 21Nov2021. It was lucky that he went to the ophthalmologist and that she investigated so thoroughly. My son also didn''t have any symptoms after the vaccination. Apart from psoriasis, he has no pre-existing condition and has never had thrombosis or similar before. No genetic predisposition is known in the family. He is now undergoing medical assessment for possible predispositions to thrombophilia or similar. The case will also be reported to Regulatory Authority by the doctors. Dosage text: 2


VAERS ID: 2015474 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-11-18
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1436 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bacterial test, Cerebral venous sinus thrombosis, Intracranial pressure increased, Magnetic resonance imaging, Nasopharyngitis, Ocular hyperaemia, Papilloedema, Viral test
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Psoriasis
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: CSF bacteria test; Result Unstructured Data: Test Result:Bacterial infections excluded by lumbar puncture; Test Date: 20211121; Test Name: MRI; Result Unstructured Data: Test Result:diagnosed with venous sinus thrombosis,; Comments: elevated intracranial pressure was measured alongside; Test Date: 20211121; Test Name: CSF virus test; Result Unstructured Data: Test Result:viral and bacterial excluded by lumbar puncture
CDC Split Type: DEPFIZER INC202101859691

Write-up: Thrombosis of venous sinuses; Papilledema bilateral; Increased intracranial pressure; RED EYE; COLD; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP, patient''s parent) from the Regulatory Authority-WEB. Regulatory number: DE-PEI-CADR2021222576 (RA). Other Case identifier(s): DE-CADRPEI-2021222576 (RA), DE-PEI-202100276496 (RA). A 17 year-old male patient received bnt162b2 (COMIRNATY), administration date 22Sep2021 (Lot number: FC1436) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "PSORIASIS" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: CEREBRAL VENOUS SINUS THROMBOSIS (hospitalization) with onset 21Nov2021, outcome "unknown", described as "Thrombosis of venous sinuses"; PAPILLOEDEMA (hospitalization, medically significant) with onset 21Nov2021, outcome "unknown", described as "Papilledema bilateral"; INTRACRANIAL PRESSURE INCREASED (hospitalization, medically significant) with onset 21Nov2021, outcome "unknown", described as "Increased intracranial pressure"; NASOPHARYNGITIS (non-serious) with onset 18Nov2021, outcome "unknown", described as "COLD"; OCULAR HYPERAEMIA (non-serious) with onset 21Nov2021, outcome "unknown", described as "RED EYE". The events "thrombosis of venous sinuses", "papilledema bilateral", "increased intracranial pressure", "cold" and "red eye" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: bacterial test: (21Nov2021) bacterial infections excluded by lumbar puncture; magnetic resonance imaging: (21Nov2021) diagnosed with venous sinus thrombosis, notes: elevated intracranial pressure was measured alongside; viral test: (21Nov2021) viral and bacterial excluded by lumbar puncture. Therapeutic measures were taken as a result of cerebral venous sinus thrombosis, papilloedema, intracranial pressure increased. Clinical course: Initially, the sinus vein thrombosis in the patient was only noticeable due to a red eye on 21Nov2021, which was initially assessed by an ophthalmologist in connection with a cold that had been present for about 3 days. The ophthalmologist noticed bilateral papilloedema and referred the patient to a hospital for further diagnostic workup, where he was diagnosed with venous sinus thrombosis based on magnetic resonance imaging. Elevated intracranial pressure was measured alongside the findings. Since the patient had no infections around or after the time of the second vaccination and since viral and bacterial infections in the cerebrospinal fluid were excluded by lumbar puncture, there is strong suspicion that the event was a consequence of vaccination -even though the vaccination was several weeks before. According to the doctors, the thrombosis is not new, but older - not just a few days old, but rather a few weeks. He was treated with heparin (ongoing). Reporter though it was important to say that the patient didn''t have headaches at the time of the diagnosis. The only symptoms he noticed were cold, which appeared on 18Nov2021, and red eye, which appeared on 21Nov2021. It was lucky that he went to the ophthalmologist and that she investigated so thoroughly. Patient also didn''t have any symptoms after the vaccination. Apart from psoriasis, he has no pre-existing condition and has never had thrombosis or similar before. No genetic predisposition is known in the family. He is now undergoing medical assessment for possible predispositions to thrombophilia or similar. The case will also be reported to RA by the doctors. Relatedness of Comirnaty to Increased intracranial pressure, Papilledema, Thrombosis of venous sinuses assessed by RA is D. unclassifiable.


VAERS ID: 2015711 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1003A / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood calcium, Blood creatinine, Blood potassium, Blood pressure measurement, Blood sodium, Blood thyroid stimulating hormone, Body temperature, C-reactive protein, Computerised tomogram, Dyspnoea exertional, Echocardiogram, Electrocardiogram, Glomerular filtration rate, Haemoglobin, Heart rate, Immunisation, Liver function test, Oxygen saturation, Pericardial effusion, Pericarditis, Platelet count, Pyrexia, SARS-CoV-2 test, Troponin, Ultrasound scan, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EUTHYROX; ROSUVASTATINE ACCORD; KARDEGIC; TAHOR
Current Illness: Dyslipidaemia; Gastrectomy partial (sleeve); Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Blindness, one eye; Central retinal artery occlusion (left blindness)
Allergies:
Diagnostic Lab Data: Test Date: 20211127; Test Name: Cardiac auscultation; Result Unstructured Data: Test Result:Regular; Comments: regular heart sounds, no audible murmurs. No signs of right or left heart failure; Test Date: 20211127; Test Name: blood calcium; Result Unstructured Data: Test Result:2.39 mmol/L; Test Date: 20211127; Test Name: creatinine; Result Unstructured Data: Test Result:64 umol/l; Test Date: 20211127; Test Name: potassium; Result Unstructured Data: Test Result:4.1 mmol/L; Test Date: 20211127; Test Name: blood pressure; Result Unstructured Data: Test Result:102/71 mmHg; Test Date: 20211127; Test Name: sodium; Result Unstructured Data: Test Result:137 mmol/L; Test Date: 20211127; Test Name: TSH; Result Unstructured Data: Test Result:1.1 uiU/mL; Test Date: 20211127; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20211203; Test Name: Thoracic-abdominal-pelvic CT scan with injection; Result Unstructured Data: Test Result:no sign of neoplastic involvement over the entire; Comments: no sign of neoplastic involvement over the entire volume explored. Circumferential pericardial effusion with fluid density and pericardial contrast; Test Date: 20211127; Test Name: CRP; Result Unstructured Data: Test Result:53.7 mg/l; Test Name: Echocardiography; Result Unstructured Data: Test Result:does not show any signs of tamponade; Comments: does not show any signs of tamponade.Circumferential pericardial effusion. Circumferential pericardial effusion. 10 mm lateral-right ventricle compressive on inspiration on the right ventricle 10 mm lateral-left ventricle 10 mm apex Inspiratory variation in transmitral flows Inferior vena cava still thin and respiring cardiac output preserved; Test Date: 20211127; Test Name: ECG; Result Unstructured Data: Test Result:regular sinus rhythm with HR 82/min, normal PR, fi; Comments: regular sinus rhythm, normal PR, fine QRS, no repolarization disorder; Test Date: 20211127; Test Name: GFR; Result Unstructured Data: Test Result:93 ml/min; Test Date: 20211127; Test Name: Hb; Result Unstructured Data: Test Result:13.6 g/dl; Test Name: heart rate; Result Unstructured Data: Test Result:82/ min; Test Date: 20211127; Test Name: heart rate; Result Unstructured Data: Test Result:100 bpm; Test Date: 20211127; Test Name: liver function test; Result Unstructured Data: Test Result:normal; Test Date: 20211127; Test Name: saturation; Test Result: 99 %; Comments: Ambient air; Test Date: 20211127; Test Name: platelets; Result Unstructured Data: Test Result:203 10*6/L; Test Date: 20211128; Test Name: Covid PCR; Test Result: Negative ; Test Date: 20211127; Test Name: troponin; Result Unstructured Data: Test Result:9.92 ng/L; Test Date: 20211127; Test Name: echoscopy; Result Unstructured Data: Test Result:circumferential pericardial effusion; Test Date: 20211127; Test Name: leukocytes; Result Unstructured Data: Test Result:11.6 10*6/L
CDC Split Type: FRPFIZER INC202101859524

Write-up: low fever; booster; against a background of dyspnea on exertion evolving for 15 days; circumferential pericardial effusion; Acute pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-TO20219635 (RA). A 73 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 18Nov2021 (Lot number: 1F1003A) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Dyslipidaemia" (ongoing); "Central retinal artery occlusion" (not ongoing), notes: left blindness; "Hypothyroidism" (ongoing); "Gastrectomy partial", start date: 2011 (ongoing), notes: sleeve; "left blindness" (unspecified if ongoing). No drug allergies. Concomitant medication(s) included: EUTHYROX taken for hypothyroidism; ROSUVASTATINE ACCORD taken for dyslipidaemia; KARDEGIC; TAHOR. Vaccination history included: Covid-19 vaccine (1st dose, UNKNOWN MANUFACTURER), for Covid-19 immunisation; Covid-19 vaccine (2nd dose, UNKNOWN MANUFACTURER), for Covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 18Nov2021, outcome "unknown", described as "booster"; DYSPNOEA EXERTIONAL (hospitalization) with onset 2021, outcome "unknown", described as "against a background of dyspnea on exertion evolving for 15 days"; PERICARDIAL EFFUSION (hospitalization) with onset 2021, outcome "unknown", described as "circumferential pericardial effusion"; PERICARDITIS (hospitalization, medically significant) with onset 27Nov2021, outcome "recovering", described as "Acute pericarditis"; PYREXIA (hospitalization) with onset 27Nov2021, outcome "recovering", described as "low fever". The patient was hospitalized for pericarditis (start date: 27Nov2021, discharge date: 04Dec2021, hospitalization duration: 7 day(s)). The events "circumferential pericardial effusion", "acute pericarditis" and "low fever" were evaluated at the emergency room visit. Cardio management in the context of low fever at 38 � C associated with pericarditis chest pain increased on inspiration and relieved on anteflexion, without orthopnoea, against a background of dyspnoea on exertion evolving for 15 days. An echoscopy revealed a circumferential pericardial effusion, justifying the transfer to intensive care of Cardiology. Transferred by the emergency medical service on 27Nov2021. Pericarditic chest pain, without palpitation, without syncope, with dyspnoea NYHA III. The patient underwent the following laboratory tests and procedures: auscultation: (27Nov2021) regular, notes: regular heart sounds, no audible murmurs. No signs of right or left heart failure; blood calcium: (27Nov2021) 2.39 mmol/L; blood creatinine: (27Nov2021) 64 umol/l; blood potassium: (27Nov2021) 4.1 mmol/L; blood pressure measurement: (27Nov2021) 102/71 mmHg; blood sodium: (27Nov2021) 137 mmol/L; blood thyroid stimulating hormone: (27Nov2021) 1.1 uiU/mL; body temperature: (27Nov2021) 38 Centigrade; computerised tomogram: (03Dec2021) no sign of neoplastic involvement over the entire, notes: no sign of neoplastic involvement over the entire volume explored. Circumferential pericardial effusion with fluid density and pericardial contrast enhancement; c-reactive protein: (27Nov2021) 53.7 mg/l; echocardiogram: (unspecified date) does not show any signs of tamponade, notes: Circumferential pericardial effusion. 10 mm lateral-right ventricle compressive on inspiration on the right ventricle. 10 mm lateral-left ventricle. 10 mm apex. Inspiratory variation in transmitral flows, Inferior vena cava still thin, breathable and respiring, cardiac output preserved; electrocardiogram: (27Nov2021) regular sinus rhythm with hr 82/min, normal pr, fi, notes: regular sinus rhythm, normal PR, fine QRS, no repolarization disorder; glomerular filtration rate: (27Nov2021) 93 ml/min; haemoglobin: (27Nov2021) 13.6 g/dl; heart rate: (unspecified date) 82/ min; (27Nov2021) 100 bpm; liver function test: (27Nov2021) normal; oxygen saturation: (27Nov2021) 99 %, notes: Ambient air; platelet count: (27Nov2021) 203 10*6/L; sars-cov-2 test: (28Nov2021) negative; troponin: (27Nov2021) 9.92 ng/L; ultrasound scan: (27Nov2021) circumferential pericardial effusion; white blood cell count: (27Nov2021) 11.6 10*6/L. DC retained; Pericardial puncture deemed unnecessary. TAP CT scan with injection on 12/03/2021 found: no sign in favor of neoplastic involvement over the whole of the explored volume. Therapeutic measures were taken as a result of dyspnoea exertional, pericardial effusion, pericarditis, pyrexia. Treatment with Aspegic according to the decreasing pattern until 01Sep2022, and IPP until 01Sep2022. Introduction of Colchicine.


VAERS ID: 2015943 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Breast discomfort, Breast pain, Immunisation, Lymph node pain, Lymphadenopathy, SARS-CoV-2 test, Vaccination site pain
SMQs:, Lipodystrophy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101857476

Write-up: Patient had extreme pain in her armpit and then the lymph nodes got swollen under the arm and then the nodes in breast with pain and discomfort; Patient had extreme pain in her armpit and then the lymph nodes got swollen under the arm and then the nodes in breast with pain and discomfort; Patient had extreme pain in her armpit and then the lymph nodes got swollen under the arm and then the nodes in breast with pain and discomfort; Patient had extreme pain in her armpit and then the lymph nodes got swollen under the arm and then the nodes in breast with pain and discomfort; Patient had extreme pain in her armpit and then the lymph nodes got swollen under the arm and then the nodes in breast with pain and discomfort; Patient had extreme pain in her armpit and then the lymph nodes got swollen under the arm and then the nodes in breast with pain and discomfort.; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112241309399810-3U9EB (MHRA). Other Case identifier(s): GB-MHRA-ADR 26392239 (MHRA). A 51 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant), LYMPH NODE PAIN (medically significant), AXILLARY PAIN (medically significant), VACCINATION SITE PAIN (medically significant), BREAST PAIN (medically significant), outcome "recovered" and all described as "Patient had extreme pain in her armpit and then the lymph nodes got swollen under the arm and then the nodes in breast with pain and discomfort"; BREAST DISCOMFORT (medically significant), outcome "recovered", described as "Patient had extreme pain in her armpit and then the lymph nodes got swollen under the arm and then the nodes in breast with pain and discomfort.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test negative. Clinical Course: It was reported that events lasted for 6 weeks then it started to reduce. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016026 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
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, Electrocardiogram, Feeling abnormal, Heart rate, Heart rate decreased, Immunisation, SARS-CoV-2 test, X-ray
SMQs:, Anaphylactic reaction (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), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina attack; ECG
Allergies:
Diagnostic Lab Data: Test Date: 20211211; Test Name: ecg; Result Unstructured Data: Test Result:unknown; Test Date: 20211211; Test Name: Heart rate; Result Unstructured Data: Test Result:heart rate found at 162 BPM; Test Date: 20211211; Test Name: Heart rate; Result Unstructured Data: Test Result:heart rate still high at 140 BPM; Test Date: 20211211; Test Name: Heart rate; Result Unstructured Data: Test Result:Heart rate lower at <100 BPM.; Test Date: 20211211; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20211211; Test Name: X-Ray; Result Unstructured Data: Test Result:unknown
CDC Split Type: GBPFIZER INC202101857583

Write-up: heart rate lower; difficulty breathing; 21 felt very poorly in the morning; Atrial fibrillation; chest pain; 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-202112242315175100-ZTKJN. Other Case identifier(s): GB-MHRA-ADR 26394012. A male patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Angina pectoris", start date: Jul2020 (unspecified if ongoing); "Electrocardiogram" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot number unknown), for covid-19 immunisation; Bnt162b2 (Dose: 2, Lot number unknown), for covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; CHEST PAIN (hospitalization, medically significant) with onset 08Dec2021, outcome "recovering", described as "chest pain"; HEART RATE DECREASED (hospitalization, medically significant), outcome "recovering", described as "heart rate lower"; DYSPNOEA (hospitalization, medically significant), outcome "recovering", described as "difficulty breathing"; FEELING ABNORMAL (hospitalization, medically significant) with onset 11Dec2021, outcome "recovering", described as "21 felt very poorly in the morning"; ATRIAL FIBRILLATION (hospitalization, medically significant) with onset 11Dec2021, outcome "recovered with sequelae" (12Dec2021), described as "Atrial fibrillation". The events "booster", "chest pain", "heart rate lower", "difficulty breathing" and "21 felt very poorly in the morning" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: (11Dec2021) unknown; heart rate: (11Dec2021) heart rate found at 162 bpm; (11Dec2021) heart rate still high at 140 bpm; (11Dec2021) heart rate lower at <100 bpm.; sars-cov-2 test: (11Dec2021) negative, notes: No - Negative COVID-19 test; x-ray: (11Dec2021) unknown. Therapeutic measures were taken as a result of chest pain, heart rate decreased, dyspnoea, feeling abnormal, atrial fibrillation. Clinical course: Patient has not had symptoms associated with COVID-19. Patient discharged that day (11Dec2021) but follow up to be done in a few weeks. administered beta blockers and blood thinners for the next few weeks. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016561 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0002 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101850815

Write-up: Seizure; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300126774 (PHFDA). A 50 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Nov2021 (Lot number: PCB0002) at the age of 50 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: SEIZURE (medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Seizure". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016725 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-11-18
   Days after vaccination:99
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101821215

Write-up: Vaccine failure; COVID-19; This is a spontaneous report received from a contactable reporter (Physician) from the regulatory authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202111-2506. A 28-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 11Aug2021 (Lot number: FF0680, Expiration Date: 31Oct2021) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 18Nov2021, outcome "recovered" (28Nov2021), described as "COVID-19"; DRUG INEFFECTIVE (medically significant) with onset 18Nov2021, outcome "recovered" (28Nov2021), described as "Vaccine failure". Additional information: Non-serious case (as reported). A complete vaccination schedule is unknown, with the notion of "Vaccination failure" 2 months after the first dose. Symptomatology was no information. Information on specific testing with a positive result to the SARS-2 virus is unknown. According to the investigation performed provided on 22Dec2021, it was concluded that for this lot Adverse Event Safety Request for Investigation and/or Lack of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FF0680. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016885 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1014A / 1 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Menstrual disorder
SMQs:

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: PTPFIZER INC202101833114

Write-up: This is a spontaneous report received from a contactable consumer, via the regulatory authority (PT-INFARMED-T202112-447). A 49-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# 1F1014A), intramuscularly, on Nov 15, 2021, 0.3mL, single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications not reported. The patient experienced menstrual disorder/changes in menstrual cycle (medically significant), onset Nov 18, 2021, with outcome of unknown. The event (changes in menstrual cycle) was evaluated at a physician office visit. Additional information: The adverse reaction appeared three days after administration of the suspected drug. No follow-up attempts possible. No further information expected.


VAERS ID: 2016891 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-11-18
   Days after vaccination:212
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: Positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202101867499

Write-up: Vaccine failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-520 (INFARMED). A 87 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 20Apr2021 (Lot number: ER7812) at the age of 87 years as dose 1, 0.3ml,single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Vaccine failure"; COVID-19 (medically significant) with onset 18Nov2021, outcome "unknown", described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive, notes: Positive Iu international unit(s). Clinical course: The reporter''s assessment of the causal relationship of the [Drug ineffective, COVID-19] with the suspect product was: Source of assessment: Reporter, Method of assessment: Unknown, Result of Assessment: Possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016907 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-11-18
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211118; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: IU international unit(s)
CDC Split Type: PTPFIZER INC202101840330

Write-up: COVID-19; Vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the RA and product quality group. Regulatory number: PT-INFARMED-T202112-747. A 53 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 30Jun2021 (Lot number: FD8274) as dose 2, 0.3 ml single and intramuscular, administration date 02Jun2021 (Lot number: FD1921, Expiration Date: 30Sep2021) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 18Nov2021, outcome "recovered" (02Dec2021), described as "COVID-19"; VACCINATION FAILURE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Vaccination failure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive, notes: IU international unit(s). Reporter Comment: Other information-no records The reporter''s assessment of the causal relationship of the [Vaccination failure] with the suspect product was: possible, Method of assessment: unknown. The other hcp considered the Case as non-serious. Investigation results from product quality group on 25Dec2021 included: Conclusions regarding bnt162b2 (COMIRNATY, Batch/Lot Number: FD1921, expiration date: 30Sep2021). Conclusion from the division was: "For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 6078283 (see File attachment in this investigation record) The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FD1921 A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed." According to complaint investigation from regarding bnt162b2 (COMIRNATY, Batch/Lot Number: FD8274, expiration date: unknown). Conclusion from division was: "The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FD8274. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed." No follow-up attempts are possible. No further information is expected. ; Reporter''s Comments: Other information-no records


VAERS ID: 2016908 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-11-18
   Days after vaccination:107
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211118; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202101840348

Write-up: Vaccination failure; Vaccination failure; This is a spontaneous report received from a contactable reporter (Other HCP) from the RA and product quality group. Regulatory number: PT-INFARMED-T202112-748. A 42 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 03Aug2021 (Lot number: FE8235, Expiration Date: 30Nov2021) as dose 2, 0.3 ml single and intramuscular, administration date 06Jul2021 (Lot number: FE6029) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Nov2021, outcome "recovered" (26Nov2021) and all described as "Vaccination failure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive, notes: Positive Iu international unit(s). The reporters assessment of the casual relationship of the (Vaccination failure) with the suspect product was: Source of assessment: reporter, Method of assessment: Unknown, Result of Assessment: Possible. For Lot FE8235&FE6029: Conclusion from division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 6269565 (see File attachment in this investigation record). The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FE8235&FE6029. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Reporter Comment: Other information-no records No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016920 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-11-18
   Days after vaccination:135
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6029 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211118; Test Name: SARS-CoV-2 test; Test Result: Positive; Comments: IU international unit(s).
CDC Split Type: PTPFIZER INC202101861590

Write-up: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PT-INFARMED-T202112-884 (RA). A 45-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 06Jul2021 (Lot number: FE6029) as dose 2, 0.3ml single and intramuscular, administration date 08Jun2021 (Lot number: FD1921) as dose 1, 0.3ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 18Nov2021, outcome "recovered" (26Nov2021), described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive, notes: IU international unit(s). The reporter''s assessment of the causal relationship of the [Vaccination failure, COVID-19] with the suspect product was Source of assessment: Reporter, Method of assessment: Unknown, Result of Assessment: Possible Reporter Comment: Other information-without records. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016922 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-11-18
   Days after vaccination:150
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211118; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: PTPFIZER INC202101862323

Write-up: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority. WEB and product quality group. Regulatory number: PT-INFARMED-T202112-886. A 58 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 21Jun2021 (Lot number: FC5435) as dose 2, 0.3 ml, single and intramuscular, administration date 24May2021 (Lot number: FA7083) as dose 1, 0.3 ml, single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Nov2021, outcome "recovered" (26Nov2021), described as "Vaccination failure"; COVID-19 (medically significant) with onset 18Nov2021, outcome "recovered" (26Nov2021), described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive. The health authority assessment of the causal relationship of the (Vaccination failure) with the suspect product was: Source of assessment: Reporter, Method of assessment: Unknown, Result of assessment: Possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016923 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-11-18
   Days after vaccination:132
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: PTPFIZER INC202101874389

Write-up: This is a spontaneous report received from a contactable reporter (Other healthcare professional) from Regulatory Authority and. Regulatory number: PT-INFARMED-T202112-895 (RA). A 51-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 09Jul2021 (Lot number: FE1573) as dose 2, 0.3ml, single and intramuscular, administration date 11Jun2021 (Lot number: FA4632) as dose 1, 0.3ml, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Nov2021, outcome "recovered" (27Nov2021), described as "Vaccination failure"; COVID-19 (medically significant) with onset 18Nov2021, outcome "recovered" (27Nov2021), described as "COVID-19". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016925 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-11-18
   Days after vaccination:90
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4721 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211118; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Iu(s)
CDC Split Type: PTPFIZER INC202101846975

Write-up: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter (Other HCP) from the Agency Regulatory Authority-WEB. Regulatory number: PT-INFARMED-T202112-899 Regulatory Authority. A 20-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular, administration date 20Aug2021 (Lot number: FE4721) as dose 2, 0.3 ml single and intramuscular, administration date 24Jul2021 (Lot number: FF0688) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Nov2021, outcome "recovered" (23Nov2021), described as "Vaccination failure"; COVID-19 (medically significant) with onset 18Nov2021, outcome "recovered" (23Nov2021), described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Nov2021) positive, notes: Iu(s). The reporter assessed the case as non-serious. Regulatory Authority provided investigational results on 25Dec2021 for BNT162B2 (COMIRNATY, Batch/Lot Number: FF0688, expiration date: Not provided). Conclusion from Agency division was: The Investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FF0688. A Complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The Manufacturing process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Regulatory Authority provided investigational results on 25Dec2021 for BNT162B2 (COMIRNATY, Batch/Lot Number: FE4721, expiration date: Not provided). Conclusion from Agency division was: The Investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FE4721. A Complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The Manufacturing process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. The reporter''s assessment of the causal relationship of Vaccination failure with the suspect product was: Source of assessment: reporter, Method of assessment: Unknown, Result of Assessment: possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016930 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-11-18
   Days after vaccination:124
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211118; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: PTPFIZER INC202101846970

Write-up: Vaccination failure; Vaccination failure; This is a spontaneous report received from a contactable reporter (Other HCP) from the Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-941. A 46 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Jul2021 (Lot number: FF0688) as dose 2, 0.3 ml single and intramuscular, administration date 19Jun2021 (Lot number: FC5435, Expiration Date: 30Sep2021) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Nov2021, outcome "recovered" (26Nov2021) and all described as "Vaccination failure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive. The reporter''s assessment of the causal relationship of the (Vaccination failure) with the suspect product was: Source of assessment: Reporter, Method of assessment: Unknown, Result of assessment Possible. Non-serious case with PT-INFARMED-T202112-941. Product Quality Group provided investigational results on 25Dec2021 for BNT162b2: Regarding complaint about bnt162b2 (COMIRNATY, Batch/Lot Number: FF0688, expiration date: Unknown). Conclusion from RA division was: The complaint for PFIZERBIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FF0688. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. According to complaint investigation from RA regarding complaint about bnt162b2 (COMIRNATY, Batch/Lot Number: FC5435, expiration date: 30Sep2021). Conclusion from RA division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the RA-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced RA ID resulted in the following conclusion: Reference RA ID 6141289 (see File attachment in this investigation record) The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FC5435. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Reporter Comment: Other information-no records No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information-no records


VAERS ID: 2020068 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-09
Onset:2021-11-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Headache, Hypertension, Insomnia, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad)

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

Write-up: Palpitation; Pain chest; Headache; Hypertension arterial; Insomnia; This case was received (Reference number: FR-AFSSAPS-AN20214720) on 28-Dec-2021 and was forwarded to Moderna on 28-Dec-2021. This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Palpitation), CHEST PAIN (Pain chest), HEADACHE (Headache), HYPERTENSION (Hypertension arterial) and INSOMNIA (Insomnia) in a 39-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 09-Nov-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced PALPITATIONS (Palpitation) (seriousness criterion medically significant), CHEST PAIN (Pain chest) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), HYPERTENSION (Hypertension arterial) (seriousness criterion medically significant) and INSOMNIA (Insomnia) (seriousness criterion medically significant). At the time of the report, PALPITATIONS (Palpitation), CHEST PAIN (Pain chest), HEADACHE (Headache), HYPERTENSION (Hypertension arterial) and INSOMNIA (Insomnia) had not resolved. No relevant concomitant and treatment medications were reported.; Sender''s Comments: This case concerns a 39-year-old female patient with with no previous relevant medical history reported, who experienced the serious unexpected events of Palpitations, Chest pain, Headache, Hypertension and Insomnia. The events occurred 9 days after the second dose of COVID-19 Vaccine Moderna (mRNA-1273). Events seriousness assessed 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: 2020191 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Dizziness, Gastrointestinal haemorrhage, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Vestibular disorders (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: AMITRIPTYLINE; CETIRIZINE; COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA; MELOXICAM; OMEPRAZOLE; ZAPAIN
Current Illness: Irritable bowel syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis (Anaphylaxis worsened in 2021); Colonoscopy; Dermatitis (Take antihistamines every day to prevent contact dermatitis.); Polyp removal (batch of benign polyps removed)
Allergies:
Diagnostic Lab Data: Test Date: 20211116; 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: experienced stomach cramps; dizzy; GI bleed; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26401411) on 28-Dec-2021 and was forwarded to Moderna on 28-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (experienced stomach cramps), DIZZINESS (dizzy) and GASTROINTESTINAL HAEMORRHAGE (GI bleed) in a 46-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Colonoscopy, Anaphylaxis (Anaphylaxis worsened in 2021), Dermatitis (Take antihistamines every day to prevent contact dermatitis.) and Polyp removal (batch of benign polyps removed) on 14-Feb-2021. Concurrent medical conditions included Irritable bowel syndrome. Concomitant products included CETIRIZINE from 01-Jan-2020 to an unknown date for Allergy, OMEPRAZOLE from 01-Feb-2021 to an unknown date for GI pain, AMITRIPTYLINE from 01-Jun-2018 to an unknown date for Nerve pain, MELOXICAM from 01-Feb-2021 to an unknown date and CODEINE PHOSPHATE, PARACETAMOL (ZAPAIN) from 01-Jun-2016 to an unknown date for Pain, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 27-Feb-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced GASTROINTESTINAL HAEMORRHAGE (GI bleed) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (experienced stomach cramps) (seriousness criterion medically significant) and DIZZINESS (dizzy) (seriousness criterion medically significant). On 21-Nov-2021, GASTROINTESTINAL HAEMORRHAGE (GI bleed) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (experienced stomach cramps) and DIZZINESS (dizzy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced felt dizzy and fatigued. Patient experienced stomach cramps, urgent diarrhoea, fresh blood on wiping, mixture of fresh and clotted blood in bowl. Patient stopped taking Meloxicam immediately and carried on taking omeprazole. Stomach cramps and several bloody diarrhoea episodes a day but after 24 hours more like coffee grounds, less fresh blood. Patient had Irritable bowel syndrome. Second colonoscopy and batch of benign polyps removed on 14 Feb 2021. Anaphylaxis worsened in 2021. Take antihistamines every day to prevent contact dermatitis. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment medications provided by the reporter. Report not related to possible inflammation of the heart myocarditis or pericarditis.; Reporter''s Comments: The medical history, of Concurrent medical condition of Irritable bowel syndrome remains a confounder; Sender''s Comments: This is a regulatory authority case concerning a 46-year-old, female patient with Concurrent medical condition of Irritable bowel syndrome, who experienced the unexpected serious events of Stomach cramps, Dizzy and GI Bleed. The events occurred approximately on the same day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events stomach cramps and Dizzy were reported as resolved. The medical history, of Concurrent medical condition of Irritable bowel syndrome remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 2020413 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-11-18
   Days after vaccination:71
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005696 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, N-terminal prohormone brain natriuretic peptide, Troponin T
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: NT-proBNP; Result Unstructured Data: 130 pg/ml Iu international unit(s); Test Date: 20211125; Test Name: Troponin T; Result Unstructured Data: 461 ng/L Iu international unit(s)
CDC Split Type: PTMODERNATX, INC.MOD20214

Write-up: Myopericarditis; This case was received via Regulatory Authority Agency (Reference number: PT-INFARMED-T202111-2304) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myopericarditis) in a 34-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3005885 and 3005696) for COVID-19 vaccination. Concurrent medical conditions included Smoker. On 08-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Oct-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced MYOCARDITIS (Myopericarditis) (seriousness criterion hospitalization). At the time of the report, MYOCARDITIS (Myopericarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Nov-2021, N-terminal prohormone brain natriuretic peptide: 130 pg/ml iu international unit(s) (High) 130 pg/ml Iu international unit(s). On 25-Nov-2021, Troponin T: 461 ng/l iu international unit(s) (High) 461 ng/L Iu international unit(s). For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant Elements: Healthy Concomitant product use was not provided by the reporter. No treatment information was provided. This case concerns a 34-year-old male patient with no relevant medical history, who experienced the unexpected serious adverse event of special interest, Myocarditis, the event caused hospitalization for the patient as reported by the regulatory authority. The event of Myocarditis occurred approximately 1 month after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was reported as not applicable by the regulatory authority. N-terminal prohormone brain natriuretic peptide and Troponin T labs showed high results. No clinical or treatment details were given. It is reported that the event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Reporter''s comments: Healthy young woman, had a first dose without any intercurrences, 2nd dose at 04-Oct-2021. On 18-Nov-2021 thoracalgia had started. On 25-Nov-2021, admitted due to myopericarditis (suggestive ECG, characteristic MRI, elevated troponin). No concomitant drugs and no identification to date of another causative agent.; Sender''s Comments: This case concerns a 34-year-old male patient with no relevant medical history, who experienced the unexpected serious adverse event of special interest, Myocarditis, the event caused hospitalization for the patient as reported by the regulatory authority. The event of Myocarditis occurred approximately 1 month after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was reported as not applicable by the regulatory authority. N-terminal prohormone brain natriuretic peptide and Troponin T labs showed high results. No clinical or treatment details were given. It is reported that the event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2022324 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SDCN1 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Deafness, Immunisation, Magnetic resonance imaging
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic sclerosis; Hypercholesterolemia; Mitral valve insufficiency; Tinnitus
Allergies:
Diagnostic Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:exclusion of Acoustic Neuroma; Comments: MRI exclusion of Acoustic Neuroma (?).
CDC Split Type: DEPFIZER INC202101861655

Write-up: Hearing loss / After 3rd vaccination massive increase of symptoms; Hearing loss / After 3rd vaccination massive increase of symptoms; 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-202100283859 (RA). A 65 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: SDCN1) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "carotid sclerosis" (unspecified if ongoing); "mitral valve insufficiency" (unspecified if ongoing); "tinnitus" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (Dose number: 1, lot number: EX8679, intramuscular), administration date: 05May2021, for COVID-19 immunisation; Comirnaty (Dose number: 2, lot number: 1D014A, intramuscular), administration date: 02Jun2021, for COVID-19 immunisation, reaction(s): "Sudden hearing loss". The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; DEAFNESS (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 19Nov2021, outcome "recovered" (2021) and all described as "Hearing loss / After 3rd vaccination massive increase of symptoms". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: exclusion of acoustic neuroma, notes: MRI exclusion of Acoustic Neuroma (?). Sender''s comments: Three vaccinations: 8 days after the second vaccination, hearing loss on the left with spontaneous conversion under 1x prednisolone IV. Afterwards it occurred several times and subsided without medical support with a decreasing tendency. MRI exclusion of Acoustic Neuroma (?). After 3rd vaccination massive increase of symptoms. 16Dec2021: approximately 10 days after the 3rd vaccination, the complaints had clearly subsided; patient no longer noticed any hearing loss symptoms; tinnitus almost at the (reduced) level of the last years. Pre-existing conditions: Hypercholesterolemia, carotid sclerosis, mitral valve insufficiency. Relatedness of drug to reaction(s)/event(s): Reaction(s) / Event(s) Assessed: Condition worsened. Source of assessment: RA. Result of Assessment: B. Indeterminate. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202200003926 same patient/vaccine, different dose/events


VAERS ID: 2022333 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-11-18
   Days after vaccination:268
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101865424

Write-up: suspected COVID-19; Drug Ineffective; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: DE-PEI-202100284105 (PEI). A 87 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Feb2021 (Lot number: EL8723) at the age of 86 years as dose 2, single and intramuscular, administration date 02Feb2021 (Lot number: EK9788) 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: SUSPECTED COVID-19 (medically significant) with onset 18Nov2021, outcome "recovering", described as "suspected COVID-19"; DRUG INEFFECTIVE (medically significant) with onset 18Nov2021, outcome "recovering", described as "Drug Ineffective". Additional information: Substance / Specified Substance Name - mRNA TOZINAMERAN. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2022336 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-11-18
   Days after vaccination:268
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, General physical health deterioration, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101865536

Write-up: General condition worsened; Vaccination failure; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. -WEB and product quality group. Regulatory number: DE-PEI-202100284110. A 84 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Feb2021 (Lot number: EL8723) at the age of 83 years as dose 2, single and intramuscular, administration date 02Feb2021 (Lot number: EK9788) 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: DRUG INEFFECTIVE (medically significant) with onset 18Nov2021, outcome "recovering", described as "Vaccination failure"; SUSPECTED COVID-19 (medically significant) with onset 18Nov2021, outcome "recovering", described as "COVID-19"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "General condition worsened". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2022337 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-11-18
   Days after vaccination:268
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101865532

Write-up: Vaccination failure/Drug ineffective; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the RA. Regulatory number: DE-PEI-202100284111. A 61 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Feb2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single and intramuscular, administration date 02Feb2021 (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: DRUG INEFFECTIVE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Vaccination failure/Drug ineffective"; SUSPECTED COVID-19 (medically significant) with onset 18Nov2021, outcome "unknown", described as "COVID-19". The PEI assessment with suspect product Comirnaty is B. Indeterminate for events COVID-19 and vaccination failure. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2022341 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-11-18
   Days after vaccination:268
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101866391

Write-up: COVID-19; Vaccination failure; This is a spontaneous report received from a non-contactable reporter(Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: DE-PEI-202100284115. A 84-year-old male patient received BNT162b2 (COMIRNATY), intramuscular, on 23Feb2021 (Lot number: EL8723) at the age of 83 years as 2nd single dose, and intramuscular, on 02Feb2021 (Lot number: EK9788) at the age of 83 years, as 1st single dose, for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. COVID-19/vaccination failure were reported with onset date 18Nov2021. Symptoms included weakness, and general condition deterioration. The event was considered a medically important condition. The patient was recovering from the event. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2022748 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201020; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: pain in chest; Acute chest pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26408419) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Acute chest pain) and CHEST PAIN (pain in chest) in a 2-month-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced CHEST PAIN (Acute chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (pain in chest) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Acute chest pain) had not resolved and CHEST PAIN (pain in chest) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2020, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Patient experienced pain in back. Treatment medication was not provided by the reporter. Company comment This case concerns a 2-month-old female patient, with no reported relevant medical history, who experienced the unexpected serious event of CHEST PAIN. The event occurred approximately 8 days after the administration of the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Patient�s age was reported as 2-month- old and was retained as such. It is reported that patient�s weight is 106 kg and patient�s height is 157 cm.; Sender''s Comments: This case concerns a 2-month-old female patient, with no reported relevant medical history, who experienced the unexpected serious event of CHEST PAIN. The event occurred approximately 8 days after the administration of the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Patient�s age was reported as 2-month- old and was retained as such. It is reported that patient�s weight is 106 kg and patient�s height is 157 cm.


VAERS ID: 2023329 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Fatigue, Headache, Hyperhidrosis, Influenza like illness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Suspected COVID-19 (Unsure when symptoms started)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Chest pain; sweating; flu like symptoms; Fever; Fatigue/unusual tiredness; headache; Feverish; High temperature; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26411440) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (High temperature), PYREXIA (Fever), PYREXIA (Feverish), FATIGUE (Fatigue/unusual tiredness) and HEADACHE (headache) in a 36-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started) on 12-Mar-2019. On 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant), HYPERHIDROSIS (sweating) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). On 21-Nov-2021, PYREXIA (High temperature) and PYREXIA (Feverish) had resolved. At the time of the report, CHEST PAIN (Chest pain), PYREXIA (Fever) and FATIGUE (Fatigue/unusual tiredness) outcome was unknown and HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Approx 6-8hrs after vaccine patient had high fever, night sweating and flu like symptoms including headache approximately after 6-8 hours vaccination. Patient also had tight chest feeling ,strange but very mild chest pain which reported to doctor was not checked. No concomitant was provided. Patient had not tested positive for COVID-19 since the vaccine Patient was not enrolled in clinical trial Patient reported that patient had inflammation of the heart. Patient was told to look after symptoms. No treatment information was provided. Company comment This case concerns a 36-year-old male patient, with no reported medical history, who experienced the unexpected serious events of CHEST PAIN, HYPERHIDROSIS, INFLUENZA LIKE ILLNESS, PYREXIA, PYREXIA, FATIGUE and HEADACHE. The events occurred on the same day of the administration of the second dose of mRNA-1273 vaccine. Patient reported that patient had inflammation of the heart. Patient was told to look after symptoms. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 36-year-old male patient, with no reported medical history, who experienced the unexpected serious events of CHEST PAIN, HYPERHIDROSIS, INFLUENZA LIKE ILLNESS, PYREXIA, PYREXIA, FATIGUE and HEADACHE. The events occurred on the same day of the administration of the second dose of mRNA-1273 vaccine. Patient reported that patient had inflammation of the heart. Patient was told to look after symptoms. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023903 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1013A / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Arthralgia, Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased, Immunisation, Investigation, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Arthritis (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SIMVASTATIN SANDOZ; FINASTERID STADA; ALFUZOSIN STADA; TROMBYL; TESTOGEL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:150/80; Comments: Increased. His normal blood pressure is around 115-120/60-70; Test Name: Heart rate; Result Unstructured Data: Test Result:elevated resting heart rate; Comments: about 10 beats; Test Name: Heart rate; Result Unstructured Data: Test Result:Previously, he reported his heart rate on Applewat; Comments: Previously, he reported his heart rate on Applewatch below 45 beats for at least 10 minutes on 5-20 occasions per night.; Test Name: Heart rate; Result Unstructured Data: Test Result:Only on one occasion has the pulse been below 45 i; Comments: Only on one occasion has the pulse been below 45 in recent weeks.; Test Date: 20211203; Test Name: Tachycardia; Result Unstructured Data: Test Result:he had an uncomfortable tachycardia (120 beats/mi; Comments: he had an uncomfortable tachycardia (120 beats/min) during sedentary rest, which lasted for about 20 minutes.; Test Date: 20211217; Test Name: Tachycardia; Result Unstructured Data: Test Result:he had an uncomfortable tachycardia (120 beats/mi; Comments: he had an uncomfortable tachycardia (120 beats/min) during sedentary rest, which lasted for about 20 minutes.
CDC Split Type: SEPFIZER INC202101868218

Write-up: Arrhythmia; Tachycardia; Heart rate increased; Increased blood pressure; Joint pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) from the Regulatory Authority-WEB. Regulatory number: SE-MPA-2021-098914. Other Case identifier(s): SE-VISMA-1639996962572. A 72-year-old male patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: 1F1013A) as dose 3, single for covid-19 immunisation. The patient relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN SANDOZ, start date: 01Jan2021, stop date: 20Dec2021; FINASTERID STADA, start date: 01Jan2021, stop date: 20Dec2021, ALFUZOSIN STADA, start date: 01Jan2021, stop date: 20Dec2021, TROMBYL, start date: 01Jan2021, stop date: 20Dec2021; TESTOGEL, start date: 01Jan2021, stop date: 20Dec2021. 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 18Nov2021, outcome "unknown", described as "Booster", ARRHYTHMIA (medically significant) with onset 03Dec2021, outcome "not recovered", described as "Arrhythmia", TACHYCARDIA (non-serious) with onset 03Dec2021, outcome "not recovered", described as "Tachycardia", HEART RATE INCREASED (non-serious) with onset 03Dec2021, outcome "not recovered", described as "Heart rate increased", BLOOD PRESSURE INCREASED (non-serious) with onset 03Dec2021, outcome "not recovered", described as "Increased blood pressure", ARTHRALGIA (non-serious) with onset 25Nov2021, outcome "not recovered", described as "Joint pain". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (unspecified date) 150/80, notes: Increased. His normal blood pressure is around 115-120/60-70; heart rate: (unspecified date) elevated resting heart rate notes: about 10 beats; (unspecified date) previously, he reported his heart rate on applewat, notes: Previously, he reported his heart rate on Applewatch below 45 beats for at least 10 minutes on 5-20 occasions per night; (unspecified date) only on one occasion has the pulse been below 45 i, notes: Only on one occasion has the pulse been below 45 in recent weeks; investigation: (03Dec2021) he had an uncomfortable tachycardia (120 beats/mi, notes: he had an uncomfortable tachycardia (120 beats/min) during sedentary rest, which lasted for about 20 minutes; (17Dec2021) he had an uncomfortable tachycardia (120 beats/mi, notes: he had an uncomfortable tachycardia (120 beats/min) during sedentary rest, which lasted for about 20 minutes. Clinical Course: When the patient felt his pulse, he noticed several extra beats for at least half an hour after the tachycardia stopped. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2023931 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101868571

Write-up: CHEST PAIN; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from Regulatory Authority. This is a spontaneous report received from a non-contactable HCP from Regulatory authority. A 30-year-old male patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number was not reported) on 15-Nov-2021 via intramuscular at unknown dose with unspecified dosing frequency for COVID-19 immunization. The first agent was received on an unknown date. Medical history included chronic heart disease. Concomitant medications and past product were not reported. The patient experienced chest pain on 18-Nov-2021. On 15-Nov-2021, the patient received the second agent of BNT vaccine. On 18-Nov-2021, the patient started a symptom of chest pain. Because the symptoms had not improved, the patient went to the hospital. At 07:35, the patient was given treatment as "sodium chloride (isotonic) 0.9% 500 ml bit drop and Ketorolac inj. 30 mg pin agent". At 09:09, the patient felt not suitable, so the doctor gave the patient Bokey, Magnesium Oxide and MORPIDE as oral drugs. On 23-Nov-2021, it was reported that the patient had chronic heart disease and was easy to develop chest distress. The patient currently improved after the medical treatment. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was recovered on an unknown date. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible Bnt162b2 (COMIRNATY) is under agreement with the Agency Causality assessment: the causality between the event Chest pain and the suspect product was Possible per reporter and Company. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2023932 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Headache, Pyrexia, Respiration abnormal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Vestibular disorders (broad), Respiratory failure (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101866661

Write-up: CHEST TIGHTNESS; BREATHING WAS NOT SMOOTH AND BREATHE ABNORMAL WHEN WALKING; HEADACHE; FEVER; DIZZINESS; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014252 (regulatory authority). Other Case identifier(s): TW-Fosun-2021FOS007116 (RA). This is a spontaneous report received from a non-contactable HCP received via the regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100014252. A 36-year-old female patient started to receive the 1st dose of Tozinameran (COMIRNATY) (batch number was not reported) on 17-Nov-2021 via intramuscular at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication and past product were not reported. The patient experienced fever, breathing was not smooth and breathe abnormal when walking, dizziness and headache on 18-Nov-2021, experienced chest tightness on 19-Nov-2021. On 17-Nov-2021, the patient received 1st dose of BNT vaccine. On 18-Nov-2021, the patient experienced fever, breathing was not smooth, breathe abnormal when walking, dizziness and headache. On 19-Nov-2021, the patient had headache, fever, dizziness and chest tightness. Then the patient went to the emergency department of a hospital due to the above symptoms, and was administrated with diphenhydramine injection after the diagnosis and treatment. At the time of the report, the outcomes of the events were recovering. Initial report was received on 15-Dec-2021. Follow-up closed, no further information is possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE


VAERS ID: 2025884 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-06
Onset:2021-11-18
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1010A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alcohol poisoning, Injury, Pathological fracture
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Osteoporosis/osteopenia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101873203

Write-up: MTK-V spontaneous fracture (shaft) after minimal trauma 2 months after the 2nd Biontech vaccination; MTK-V spontaneous fracture (shaft) after minimal trauma 2 months after the 2nd Biontech vaccination; only slightly drunk; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: DE-PEI-CADR2021206185 (RA). Other Case identifier(s): DE-CADRPEI-2021206185 (RA Webportal), DE-PEI-202100232603 (RA). An 18 year-old female patient received BNT162B2 (COMIRNATY, solution for injection), administration date 06Oct2021 (Lot number: 1F1010A) as dose 2, 0.3 ml single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no osteoporosis in the family or evidence of osteoporosis in the personal history or risk factors for it. Vaccination history included: COVID-19 vaccine (1st dose, manufacturer unknown), for COVID-19 immunisation. The following information was reported: PATHOLOGICAL FRACTURE (hospitalization), INJURY (hospitalization) all with onset 18Nov2021, outcome "not recovered" and all described as "MTK-V spontaneous fracture (shaft) after minimal trauma 2 months after the 2nd Biontech vaccination"; ALCOHOL POISONING (non-serious) with onset 18Nov2021, outcome "unknown", described as "only slightly drunk". The course of the events was as follows: MTK-V fracture (shaft) after minimal trauma: only slightly drunk, jumped off the floor while sitting, possibly with a slightly outwardly rotated foot then cracked it. currently pDMS intact, slight reddening of it on the back of the foot. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2026118 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCA0004 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure abnormal, Body temperature, C-reactive protein, Coma scale, Computerised tomogram, Computerised tomogram head, Confusional state, Fall, Hypocalcaemia, Immunisation, Laboratory test, Lung disorder, Oxygen saturation, Status epilepticus
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypertension (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Tumour lysis 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Depressive state; Hypertension arterial; Mitral incompetence; Secondary epilepsy; Vascular dementia.
Preexisting Conditions: Medical History/Concurrent Conditions: CVA.
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:100/65; Test Name: Fever; Result Unstructured Data: Test Result:38.5 degree; Test Name: Fever; Result Unstructured Data: Test Result:38.4 degree; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:8; Test Name: Thoracic-abdominal-pelvic computed tomography; Result Unstructured Data: Test Result:small focus of middle lobe aspiration pneumonia; Comments: due to the patient''s position; Test Name: computed tomography; Result Unstructured Data: Test Result:cerebral vascular accident stable; Comments: Left inferior temporal and right occipital sequelae of the cerebral vascular accident stable. No intracranial bleeding or subdural hematoma.; Test Date: 20201020; Test Name: computed tomography; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Test Name: C-reactive protein; Result Unstructured Data: Test Result:18; Test Name: Lab test; Result Unstructured Data: Test Result:hypocalcaemia; Test Name: Saturation; Result Unstructured Data: Test Result:99 %; Comments: in ambient air
CDC Split Type: FRPFIZER INC202101874131

Write-up: Status epilepticus; pneumopathy; hypocalcaemia; fell; confusion; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority. Regulatory number: FR-AFSSAPS-BS20212560 (Regulatory Authority). Other Case identifier(s): FR-AFSSAPS-2021172241 (Regulatory Authority). A 78 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 18Nov2021 (Lot number: PCA0004) as dose 3 (booster),single for covid-19 immunisation. Relevant medical history included: "Mitral incompetence" (ongoing); "Secondary epilepsy", start date: 2020 (ongoing); "Hypertension arterial" (ongoing); "Vascular dementia" (ongoing); "Depressive state" (ongoing); "CVA", start date: Oct2021 (not ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose), administration date: 02Apr2021, for Covid-19 immunization; Comirnaty (2nd dose), administration date: 26Apr2021, for Covid-19 immunization, reaction(s): "major asthenia". Day 0, during the night of 18 to 19Nov2021, The patient fell. Day 1, on 19Nov2021, he experienced a status epilepticus in a context of 38.5� fever. He was taken care of by the emergency room. On admission: fever 38.4�, Glasgow Coma Scale 8, Saturation 99% in ambient air, blood pressure 100/65, intravenous injection of rivotril 1 mg and paracetamol 1g. On the lab tests: C-reactive protein 18, hypocalcaemia. A computed tomography scan of the brain was performed and found to be unremarkable: Left inferior temporal and right occipital sequelae of the cerebral vascular accident stable compared to the 20Oct2020 scan. No intracranial bleeding or subdural hematoma. Thoracic-abdominal-pelvic computed tomography: Onset of a small focus of middle lobe aspiration pneumonia due to the patient''s position. Therapeutic measures were taken as a result of status epilepticus, fall, lung disorder, hypocalcaemia, confusional state. Medical treatment: DI HYDAN 150 x3. Medical Care: hydration, initiation of KEPPRA and AUGMENTIN, calcium supplementation. Outcome on 20Nov2021 (Day 2): Persistent state of confusion with some fasciculations of the left hand, patient awake with emotional lability. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; STATUS EPILEPTICUS (hospitalization) with onset 19Nov2021, outcome "recovered", described as "Status epilepticus"; FALL (hospitalization) with onset 18Nov2021, outcome "unknown", described as "fell"; LUNG DISORDER (hospitalization) with onset 19Nov2021, outcome "unknown", described as "pneumopathy"; HYPOCALCAEMIA (hospitalization) with onset 19Nov2021, outcome "unknown", described as "hypocalcaemia"; CONFUSIONAL STATE (medically significant) with onset 20Nov2021, outcome "unknown", described as "confusion". The patient was hospitalized for status epilepticus, fall, lung disorder, hypocalcaemia (start date: 19Nov2021). The events "status epilepticus", "fell", "pneumopathy" and "hypocalcaemia" were evaluated at the emergency room visit. Neurologist''s opinion: Coma episode due to infection, including pneumopathy and hypo-Calcemia in a patient with dementia of vascular origin. 21Nov2021: No recurrence of the crisis. Favourable outcome with return to his usual state. No recurrence of convulsions under KEPPRA at a dose of 1 gr morning and evening, No follow-up attempts are possible. No further information is expected. Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202200008780 Second dose


VAERS ID: 2026494 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101877713

Write-up: Itchy rash; 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-202112290654111040-KFGRY. Other Case identifier(s): GB-MHRA-ADR 26406518. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FK0596) 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 Not had a COVID-19 test. 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 18Nov2021, outcome "unknown", described as "Booster"; RASH PRURITIC (medically significant) with onset 15Dec2021, outcome "not recovered", described as "Itchy rash". Detail clinical course was reported as became patient was aware of itches around body mid December which gradually have become more widespread with a rash. Called 111 on 28/12/21 as itching now unbearable. Received creams and strong antihistamine prescription only strength. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No relevant investigations or tests conducted. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029310 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Headache, Hypokalaemia, Immunisation, Muscle spasms, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Other ischaemic heart disease (narrow), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CARDIL [DILTIAZEM HYDROCHLORIDE]; CHLORZOXAZON; ESTRING; LASIX [FUROSEMIDE]; ESTROGEL; MONOPROST; GLYTRIN MET; IMDUR; PRASUGREL KRKA; NEXIUM [ESOMEPRAZOLE SODIUM]; KODEIN ALTERNOVA; MIRENA; KALEORID; PAMOL; HJERTEMAGNYL [ACETYLSALICYLIC ACI
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Anticoagulant therapy; Glaucoma; Heart disorder; Hypercholesterolaemia; Pain; Peptic ulcer; Sleeplessness
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: Hypokalaemia; Result Unstructured Data: Test Result:Slight low potassium; Comments: Slight low potassium
CDC Split Type: DKPFIZER INC202101879245

Write-up: Angina pectoris; Tingling; Muscle cramps; Headache; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: DK-DKMA-WBS-0092120 (RA). Other Case identifier(s): DK-DKMA-ADR 26264787 (RA). A 55 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FE7053, Expiration Date: 30Nov2021) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Angina pectoris" (unspecified if ongoing); "Sleeplessness" (unspecified if ongoing); "Heart disorder" (unspecified if ongoing); "Anticoagulant therapy" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "Peptic ulcer" (unspecified if ongoing); "Hypercholesterolaemia" (unspecified if ongoing). Concomitant medication(s) included: CARDIL [DILTIAZEM HYDROCHLORIDE] taken for angina pectoris, start date: 01Mar2018; CHLORZOXAZON taken for muscle relaxant therapy, start date: 11Jun2021; ESTRING taken for hormone therapy, start date: 25Mar2020; LASIX [FUROSEMIDE] taken for diuretic therapy, start date: 16Feb2017; ESTROGEL taken for hormone therapy, start date: 10Nov2020; MONOPROST taken for glaucoma, start date: 15Oct2021; GLYTRIN MET taken for cardiac disorder, start date: 17Aug2016; IMDUR taken for angina pectoris, start date: 09Dec2020; PRASUGREL KRKA taken for cardiac disorder, start date: 06Dec2020; NEXIUM [ESOMEPRAZOLE SODIUM] taken for peptic ulcer, start date: 01Mar2018; KODEIN ALTERNOVA taken for pain, start date: 01Aug2019; MIRENA taken for hormone therapy, start date: 10Nov2020; KALEORID taken for mineral supplementation, start date: 04Nov2016; PAMOL taken for pain, start date: 24Oct2017; HJERTEMAGNYL [ACETYLSALICYLIC ACID] taken for anticoagulant therapy, start date: 24Feb2015; CIRCADIN taken for insomnia, start date: 08Jan2018; REPATHA taken for hypercholesterolaemia, start date: 19Oct2020; MORFIN ALTERNOVA taken for pain, start date: 31May2021. Past drug history included: Loceryl, start date: 20Mar2019, for Nail fungal infection NOS, notes: Name of Drug as Reported: LOCERYL , Start Date: 20Mar2021, Indication (MedDRA code): Nail fungal infection NOS; Praluent, start date: 2017, reaction(s): "Headache", notes: Name of Drug as Reported: PRALUENT, Reaction (MedDRA code): Headache. Vaccination history included: Comirnaty (Dose 1), administration date: 13Jan2021, for COVID-19 immunisation; Comirnaty (Dose 2), administration date: 06Feb2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; ANGINA PECTORIS (hospitalization, medically significant) with onset 22Nov2021, outcome "not recovered", described as "Angina pectoris"; PARAESTHESIA (hospitalization) with onset 22Nov2021, outcome "not recovered", described as "Tingling"; MUSCLE SPASMS (hospitalization) with onset 22Nov2021, outcome "not recovered", described as "Muscle cramps"; HEADACHE (hospitalization) with onset 22Nov2021, outcome "not recovered", described as "Headache". The events "booster", "angina pectoris", "tingling", "muscle cramps" and "headache" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: hypokalaemia: (Nov2021) slight low potassium, notes: Slight low potassium. Clinical course: The ADRs were by the reporter reported as resulting in hospitalisation. The patient was at the emergency department on the 25Nov2021. No treatment or medical procedure due to the ADRs were reported. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DK-SA-2017SA196935


VAERS ID: 2029486 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-11-18
   Days after vaccination:167
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Ophthalmic herpes zoster
SMQs:, Ocular infections (narrow), Opportunistic infections (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? No
Previous Vaccinations:
Other Medications: PROLIA; UVEDOSE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101879883

Write-up: fatigue; Herpes zoster ophthalmic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory authority. A 61 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 04Jun2021 (Lot number: FD0785, expiration date unknown) as dose 2, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: PROLIA; UVEDOSE. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: OPHTHALMIC HERPES ZOSTER (medically significant) with onset 18Nov2021, outcome "recovered" (12Dec2021), described as "Herpes zoster ophthalmic"; FATIGUE (non-serious) with onset 21Nov2021, outcome "unknown", described as "fatigue". The event "herpes zoster ophthalmic" was evaluated at the emergency room visit. Clinical course: ophthalmological shingles 18Nov2021 and 19Nov2021 first tingling in the right eye and forehead 20Nov2021 and 21Nov2021 severe fatigue, first redness in the eye and forehead then the eyelid began to gain volume. Patient also went to Emergency room consultation on 23Nov2021. Diagnosis of ophthalmologic shingles and prescription of drugs. Appointment with the doctor on 24Nov2021. Improvement after 3 days (no possibility of looking with eye because the eyelid has covered over) and the situation improved to be rectified in week 49. Third vaccination on 08Dec2021 with COMIRNATY (Booster 1) with no reaction reported. The third vaccination of comirnaty (R1) was conducted on 08Dec2021. Therapeutic measures were taken as a result of ophthalmic herpes zoster. Additional information: delay between the vaccination and the long term effect and not very compatible with the role of the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029496 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7911 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Chest pain, Electrocardiogram, Fibrin D dimer, Interchange of vaccine products, Off label use, Troponin
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: C-reactive protein; Test Result: Negative ; Test Date: 2021; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:regular rhythm, strong beat,; Comments: normal, normoaxed. No conduction or repolarisation problems; Test Date: 2021; Test Name: D-Dimers; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: troponins; Test Result: Negative
CDC Split Type: FRPFIZER INC202101873228

Write-up: Chest pain; Initially vaccinated with Moderna COVID-19 Vaccine and then with Comirnaty; Initially vaccinated with Moderna COVID-19 Vaccine and then with Comirnaty; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: FR-AFSSAPS-TO20219792 (AFSSAPS). A 19 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 18Nov2021 (Lot number: FG7911) as dose 2 (initial pfizer dose), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 1, Batch/lot number: 214028 , Route of Administration: Intramuscular in left arm), administration date: 14Oct2021, for COVID-19 vaccination, reaction(s): "chest pain". The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 18Nov2021, outcome "unknown" and all described as "Initially vaccinated with Moderna COVID-19 Vaccine and then with Comirnaty"; CHEST PAIN (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Chest pain". The patient underwent the following laboratory tests and procedures: c-reactive protein: (2021) negative; electrocardiogram: (2021) regular rhythm, strong beat,, notes: normal, normoaxed. No conduction or repolarisation problems; fibrin d dimer: (2021) normal; troponin: (2021) negative. Clinical course: On 21Oct2021, the patient visited to the emergency department for chest pain for 7 days. The pain was pin-like, intermittent, with no particular triggering factor. The pain was not relieved with anteflexion and is not punctuated by breathing. No fever, no dyspnoea. In summary: chest pain without evidence to suggest an acute cardiopulmonary cause. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029860 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101885566

Write-up: pain; not being able to use arm at all between 0 to 60 seconds; Muscle spasm; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112301041118460-1DVPR (RA). Other Case identifier(s): GB-MHRA-ADR 26414977 (RA). A 55 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 18Nov2021 (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 last menstrual period date: 01Jan2012. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; PAIN (medically significant), outcome "not recovered", described as "pain"; MUSCLE SPASMS (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Muscle spasm"; HYPOKINESIA (medically significant), outcome "unknown", described as "not being able to use arm at all between 0 to 60 seconds". The events "pain", "muscle spasm" and "not being able to use arm at all between 0 to 60 seconds" were evaluated at the physician office visit. Since been given the booster she regularly got muscle spasms in the middle of top left arm muscles where booster was administered this especially occurs with sudden movements which results in not being able to use arm at all between 0 to 60 seconds. She had been using VOLTAREN gel to relief the pain. Patient has not tested positive for COVID-19 since having the vaccine. pending GP appointment after speaking to GP on phone. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of pain, muscle spasms, hypokinesia. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030294 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Chest discomfort, Inflammation, Pruritus, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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: COVID-19 VACCINE ASTRAZENECA
Current Illness: Polio (Patient had polio in his right side nose and patient was waiting for operation)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Asthma; Tight chest; Inflammation; Itching; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424577) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (Itching), CHEST DISCOMFORT (Tight chest), INFLAMMATION (Inflammation) and ASTHMA (Asthma) in a 47-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concurrent medical conditions included Polio (Patient had polio in his right side nose and patient was waiting for operation). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from an unknown date to 05-Jun-2021 for COVID-19 vaccination. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced PRURITUS (Itching) (seriousness criterion medically significant) and INFLAMMATION (Inflammation) (seriousness criterion medically significant). On 04-Dec-2021, the patient experienced CHEST DISCOMFORT (Tight chest) (seriousness criterion medically significant). On 16-Dec-2021, the patient experienced ASTHMA (Asthma) (seriousness criterion medically significant). At the time of the report, PRURITUS (Itching), CHEST DISCOMFORT (Tight chest), INFLAMMATION (Inflammation) and ASTHMA (Asthma) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient did not had symptoms associated with COVID-19 Immediately after the booster patient became sick for two days. After the high fever and the shivering stopped, patient had blocked nose and a lot of coughing with yellowish mucous. The general physician (GP) gave him antibiotics and after 10 days of no improvement the GP gave him another set of antibiotics and x-ray. Patient finished the antibiotics and the x-ray came clean. With no improvement and increasing difficulty to breathed the GP gave him blue inhaler. More than six weeks after the booster patient still not back to himself and suffered from multiple issues that effected his day to day life. Adverse reaction did not occur as a result of an exposure during pregnancy Company comment: This regulatory case concerns a 47-year-old male patient, with no relevant medical history, who experienced the serious unexpected events of PRURITUS, CHEST DISCOMFORT, INFLAMMATION and ASTHMA. The events PRURITUS and INFLAMMATION occurred after two days of the third dose of mRNA-1273. The event DISCOMFORT occurred after eight-teen days of the third dose of the mRNA-1273 vaccine. The event ASTHMA occurred after thirty days of the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable as no information about further dosing has been disclosed. A SARS-CoV-2 test: negative was performed on an unknown date. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.; Sender''s Comments: This regulatory case concerns a 47-year-old male patient, with no relevant medical history, who experienced the serious unexpected events of PRURITUS, CHEST DISCOMFORT, INFLAMMATION and ASTHMA. The events PRURITUS and INFLAMMATION occurred after two days of the third dose of mRNA-1273. The event DISCOMFORT occurred after eight-teen days of the third dose of the mRNA-1273 vaccine. The event ASTHMA occurred after thirty days of the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable as no information about further dosing has been disclosed. A SARS-CoV-2 test: negative was performed on an unknown date. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.


VAERS ID: 2030600 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6270 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Paraesthesia
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mitral valve prolapse; Penicillin allergy (allergy to penicillin)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202200006754

Write-up: Paraesthesia; fainting lasted one hour with transport to the emergency room within 24 hours after administration of Pfizer vaccine (17Nov2021); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: IT-MINISAL02-825743. A 54 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 17Nov2021 (Lot number: FG6270) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing), notes: Mitral valve prolapse; "penicillin allergy" (unspecified if ongoing), notes: allergy to penicillin. The patient''s concomitant medications were not reported. The following information was reported: PARAESTHESIA (hospitalization) with onset 18Nov2021, outcome "recovering", described as "Paraesthesia"; LOSS OF CONSCIOUSNESS (hospitalization) with onset 18Nov2021, outcome "recovering", described as "fainting lasted one hour with transport to the emergency room within 24 hours after administration of Pfizer vaccine (17Nov2021)". The events "paraesthesia" and "fainting lasted one hour with transport to the emergency room within 24 hours after administration of pfizer vaccine (17nov2021)" were evaluated at the emergency room visit. Clinical course: on 27Dec2021 attending physician specified: SYMPTOM Fainting; 18Nov2021 manifested paresthesia right upper limb and right lower limb which persist to date (27Dec2021). On 27Dec2021 it was prescribed Computed axial tomography. Actions taken: transport to emergency room, no hospitalization, same day discharge; Impact on quality of life (5/10). Sender''s comments: symptoms appeared on the day of administration. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2034022 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101876310

Write-up: PALPITATE; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party(Biotech) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100014360. Other Case identifier(s): TW-Fosun-2021FOS007169. This is a spontaneous report received from a non-contactable HCP received via RA. The regulatory authority report number is TW-TFDA-TVS-1100014360. A 18-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: unknown) on 18Nov2021 via unknown route at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history was not reported. Concomitant medications and past product were not reported. The patient experienced palpitate on 18Nov2021. On 18Nov2021, the patient received 1st dose of vaccine, after the BNT vaccination, she began to palpitate. On 24Nov2021, because the symptoms did not improve, the patient went to the hospital for emergency treatment, used normal saline (N/S) 500ml, Diphenhydramine 30mg 1ml, Herbesser Inj. 50mg, Neutral and Fucole Paran 500mg, Buclizine 25mg Oral Pharma, oral pharmaceutical treatment. 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 15Dec2021. The event palpitate was considered as serious (Medically Significant). Causality Assessment: Drug: bnt162b2 Palpitation Per Reporter = Possible Per Company (BioNTech SE)= Possible Follow-up closed, no further information is possible. Bnt162b2(COMIRNATY) is under agreement with BIONTECH SE.


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