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From the 10/15/2021 release of VAERS data:

Found 800,916 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 388 out of 8,010

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VAERS ID: 1729995 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Cold sweat, Cyanosis
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: cold sweat; lips turned purple; left upper back pain; This regulatory authority case was reported by a pharmacist and describes the occurrence of COLD SWEAT (cold sweat), CYANOSIS (lips turned purple) and BACK PAIN (left upper back pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021 at 4:30 AM, the patient experienced COLD SWEAT (cold sweat) (seriousness criterion life threatening), CYANOSIS (lips turned purple) (seriousness criterion life threatening) and BACK PAIN (left upper back pain) (seriousness criterion life threatening). At the time of the report, COLD SWEAT (cold sweat), CYANOSIS (lips turned purple) and BACK PAIN (left upper back pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. The patient had visited the emergency room (ER) on 26-AUG-2021. No treatment information was reported Company comment: This case concerns a female patient with no previous relevant medical history, who experienced the unexpected events of coled sweat, cyanosis, and back pain. The events occurred 7 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender''s Comments: This case concerns a female patient with no previous relevant medical history, who experienced the unexpected events of coled sweat, cyanosis, and back pain. The events occurred 7 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1730682 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939900 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Cough, Decreased appetite, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: cough; Loss of appetite; Muscle pain; Joint pain; Body malaise/ Body weakness; This regulatory authority case was reported by an other health care professional and describes the occurrence of COUGH (cough), DECREASED APPETITE (Loss of appetite), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and ASTHENIA (Body malaise/ Body weakness) in a 60-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 939900) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced ASTHENIA (Body malaise/ Body weakness) (seriousness criterion medically significant). On 27-Aug-2021 at 9:00 AM, the patient experienced COUGH (cough) (seriousness criterion medically significant), DECREASED APPETITE (Loss of appetite) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). At the time of the report, COUGH (cough), DECREASED APPETITE (Loss of appetite), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had not resolved and ASTHENIA (Body malaise/ Body weakness) outcome was unknown. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This case concerns a 60-year-old, male patient with no relevant medical history, who experienced the unexpected events of Cough, Decreased appetite, Asthenia and the expected events of Arthralgia, Myalgia. The events occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The events Arthralgia, Myalgia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. The events are assessed as serious by the Regulatory Authority; however, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the events are not considered serious.; Sender''s Comments: This case concerns a 60-year-old, male patient with no relevant medical history, who experienced the unexpected events of Cough, Decreased appetite, Asthenia and the expected events of Arthralgia, Myalgia. The events occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The events Arthralgia, Myalgia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. The events are assessed as serious by the Regulatory Authority; however, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the events are not considered serious.


VAERS ID: 1730875 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003604 / 2 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, C-reactive protein, COVID-19 immunisation, Chills, Interchange of vaccine products, Muscle spasms, Presyncope
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: C-reactive protein; Result Unstructured Data: increased.
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00047864) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), in a 19-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003604) for Vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Vaccination: Comirnaty. On 26-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PRESYNCOPE (seriousness criterion hospitalization), ABDOMINAL PAIN (seriousness criterion hospitalization), MUSCLE SPASMS (Ble gitt 2 dose Moderna p? innleggelsesdagen (f?rste dose pfeizer). (seriousness criterion hospitalization) and CHILLS (Ble gitt 2 dose Moderna p? innleggelsesdagen (f?rste dose pfeizer). (seriousness criterion hospitalization). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) (seriousness criterion hospitalization) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and ABDOMINAL PAIN. had resolved, PRESYNCOPE (CHILLS (Ble gitt 2 dose Moderna p? innleggelsesdagen (f?rste dose pfizer). was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2021, C-reactive protein: increased (High) increased. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. concomitant medications were not reported. The patient was given a 2nd dose of Moderna on the admission date (first dose Pfizer). Yesterday evening, the patient had sudden and migrating abdominal pain (later resolved spontaneously after a bowel movement; pain-free since then), and developed tremor/kra. Treatment medications were not reported. Company Comment: .his case concerns a 19-year-old, male subject, who experienced the unexpected events of PRESYNCOPE, ABDOMINAL PAIN, MUSCLE SPASMS and CHILLS. Additionally, revaccination with different COVID-19 vaccine was reported as a serious event by Regulatory Authority. The events occurred on the same day after the dose of Spikevax Vaccine. The rechallenge was not applicable because he received Pfizer vaccine as first dose of COVID immunization. The events was considered related to the study drug per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation received on 20-SEP-2021 and does not contain any new information.; Sender''s Comments: .his case concerns a 19-year-old, male subject, who experienced the unexpected events of PRESYNCOPE, ABDOMINAL PAIN, MUSCLE SPASMS and CHILLS. Additionally, revaccination with different COVID-19 vaccine was reported as a serious event by Regulatory Authority. The events occurred on the same day after the dose of Spikevax Vaccine. The rechallenge was not applicable because he received Pfizer vaccine as first dose of COVID immunization. The events was considered related to the study drug per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1730887 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-26
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CRESTOR; ATACAND; PANTOC; SINTROM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial occlusion; Thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTMODERNATX, INC.MOD20213

Write-up: urinar sangue com espuma e co?gulos ap?s vacina covid - Moderna; This case was received via regulatory authority(Reference number: PT-INFARMED-B202108-3746) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT in a 47-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The patient''s past medical history included Arterial occlusion and Thrombosis. Previously administered products included for an unreported indication: Xarelto in 2019 and Xarelto in 2021. Past adverse reactions to the above products included Fatigue with Xarelto; and Thrombosis with Xarelto. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), CANDESARTAN CILEXETIL (ATACAND), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOC) and ACENOCOUMAROL (SINTROM) for an unknown indication. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced HAEMORRHAGE URINARY TRACT (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE URINARY TRACT outcome was unknown. It was reported that the patient experienced blood in his urine with foam and clots after receiving the COVID-19 vaccine - Moderna. It was further reported that the patient has been undergoing autoimmune studies since 2018. Treatment information was not provided. Company Comment : This case concerns a 47-year-old male patient with a history of Arterial occlusion and thrombosis, under treatment with acenocumarol, who experienced the serious unexpected event Haemorrhage urinary tract. The event occurred approximately one month after the first dose and 2 days after the second and most recent dose of mRNA-1273 Moderna vaccine. No causality assessment was provided by the reporter. Use of concomitant medication Acenocumarol could be a potentially confounder/cos-suspect. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation document received on 20-Sep-2021; concomitant product details, relevant medical history and narrative updated.; Sender''s Comments: This case concerns a 47-year-old male patient with a history of Arterial occlusion and thrombosis, under treatment with acenocumarol, who experienced the serious unexpected event Haemorrhage urinary tract. The event occurred approximately one month after the first dose and 2 days after the second and most recent dose of mRNA-1273 Moderna vaccine. No causality assessment was provided by the reporter. Use of concomitant medication Acenocumarol could be a potentially confounder/cos-suspect. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.


VAERS ID: 1732467 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8236 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Iridocyclitis
SMQs:, Ocular infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101193370

Write-up: Iridocyclitis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, Regulatory Authority number DE-PEI-202100185496. A twenty-eight-year-old female patient received BNT162B2 (COMIRNATY; Lot number: FE8236) via an unspecified route of administration on 22Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of Comirnaty on 12Jul2021 for COVID-19 immunisation. The patient experienced iridocyclitis on 26Aug2021. Event was considered serious, medically significant. Outcome of the event was not recovered. Relatedness of drug to reaction/event was considered D. Unclassifiable. No follow-up attempts possible. No further information expected.


VAERS ID: 1732644 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-08-26
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002546 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angiocardiogram, Chest pain, Computerised tomogram, Echocardiogram, Electrocardiogram, Magnetic resonance imaging heart, Myocardial infarction, Troponin
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: MIRENA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Arteriogram coronary; Result Unstructured Data: On RDP a sharpening of vessel indicate dissection; Test Date: 2021; Test Name: Arteriogram coronary; Result Unstructured Data: smooth surfaces on RCA distal branch; Test Date: 20210831; Test Name: CT scan; Result Unstructured Data: vascular changes could not be excluded (heart CT); Test Date: 2021; Test Name: Echocardiography; Result Unstructured Data: pumping function normal; Test Date: 2021; Test Name: EKG; Result Unstructured Data: infero-lateral changes that has now normalised; Test Date: 20210831; Test Name: Cardiac MRI; Result Unstructured Data: Ejection fraction intact; Test Date: 20210831; Test Name: Cardiac MRI; Result Unstructured Data: area with oedema + transmural charging of contrast; Test Date: 2021; Test Name: Troponin; Result Unstructured Data: up to 300 unit not specified
CDC Split Type: DKMODERNATX, INC.MOD20213

Write-up: Myocardial infarction; chest pain with slight radiation to the neck; This case was received via European Medicines Agency (Reference number: DK-DKMA-ADR 25898950) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) and CHEST PAIN (chest pain with slight radiation to the neck) in a 39-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3002546 and 3004730) for COVID-19 vaccination. Concomitant products included LEVONORGESTREL (MIRENA) from 01-Jan-2015 to an unknown date for Contraception. On 29-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criteria hospitalization, medically significant and life threatening) and CHEST PAIN (chest pain with slight radiation to the neck) (seriousness criteria hospitalization and life threatening). On 02-Sep-2021, MYOCARDIAL INFARCTION (Myocardial infarction) had resolved with sequelae. At the time of the report, CHEST PAIN (chest pain with slight radiation to the neck) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Angiocardiogram: abnormal (abnormal) On RDP a sharpening of vessel indicate dissection and abnormal (abnormal) smooth surfaces on RCA distal branch. In 2021, Echocardiogram: normal (normal) pumping function normal. In 2021, Electrocardiogram: normal (normal) infero-lateral changes that has now normalised. In 2021, Troponin: abnormal (abnormal) up to 300 unit not specified. On 31-Aug-2021, Computerised tomogram: abnormal (abnormal) vascular changes could not be excluded (heart CT). On 31-Aug-2021, Magnetic resonance imaging heart: abnormal (abnormal) Ejection fraction intact and abnormal (abnormal) area with oedema + transmural charging of contrast. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication listed. No treatment information provided. Company Comment: This case concerns a 39-year-old female patient, with no relevant medical history of who experienced the unexpected events of myocardial infarction and chest pain. The events occurred 28 days after the first dose of mRNA-1273. The rechallenge was not unknown as details of second dose was not disclosed. Causality for the reported events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Myocardial infarction considered an important medical event.; Sender''s Comments: This case concerns a 39-year-old female patient, with no relevant medical history of who experienced the unexpected events of myocardial infarction and chest pain. The events occurred 28 days after the first dose of mRNA-1273. The rechallenge was not unknown as details of second dose was not disclosed. Causality for the reported events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Myocardial infarction considered an important medical event.


VAERS ID: 1732670 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-26
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214010 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Echocardiogram, Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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: Medical History/Concurrent Conditions: Recreational drug use (Occasional consumption of ecstasy); Smoker (10 Cigarettes a day)
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: Blood test; Result Unstructured Data: RBC 5.59 x10^6/?l, hemoglobin * 17.9 g/dl, hematocrit * 53.6%, mean corpuscular volume 95.9 fl, mean corpuscular hb 32.0 pg, Mean corpuscular hb concentration 33.4 g/dl, leukocytes 8.80x10^3/?l, Neutrophils 74.5%, absolute neutrophils 6.55 x10^3/?l, lymphocytes 18.7%, Absolute lymphocytes 1.65 x10^3/?l, Platelets 171 x10^3/?l, inr 0.95, glucose 86mg/dl, creatinine * 0.89 mg/dl, urea 18 mg/dl, sodium * 135 mmol/l, potassium pending. - Hs troponin i curve: 1) 5141, 2) 9347, 3) 6832.1; Test Date: 20210826; Test Name: Echocardiography; Result Unstructured Data: Visually preserved LVEF 60% without cavity dilation or hypertrophy. No segmental contraction alterations observed. Normal diastolic function. RV size and function normal. Tricuspid aortic valve functioning normally. AV valves functioning normally. No pericardial effusion observed. Ascending aorta and arch normal. IVC not dilated.; Test Date: 20210827; Test Name: Echocardiography; Result Unstructured Data: Visually preserved LVEF 60% without cavity dilation or hypertrophy. No segmental contraction alterations observed. Normal diastolic function. RV size and function normal. Tricuspid aortic valve functioning normally. AV valves functioning normally. No pericardial effusion observed. Ascending aorta and arch normal. IVC not dilated.
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: ES-AEMPS-987223) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of MYOCARDITIS in a 26-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 214013 and 214010) for COVID-19 vaccination. The patient''s past medical history included Recreational drug use (Occasional consumption of ecstasy) and Smoker (10 Cigarettes a day). On 26-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, MYOCARDITIS was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2021, Echocardiogram: normal (normal) Visually preserved LVEF 60% without cavity dilation or hypertrophy. No segmental contraction alterations observed. Normal diastolic function. RV size and function normal. Tricuspid aortic valve functioning normally. AV valves functioning normally. No pericardial effusion observed. Ascending aorta and arch normal. IVC not dilated.. On 27-Aug-2021, Blood test: abnormal (abnormal) RBC 5.59 x10^6/?l, hemoglobin * 17.9 g/dl, hematocrit * 53.6%, mean corpuscular volume 95.9 fl, mean corpuscular hb 32.0 pg, Mean corpuscular hb concentration 33.4 g/dl, leukocytes 8.80x10^3/?l, Neutrophils 74.5%, absolute neutrophils 6.55 x10^3/?l, lymphocytes 18.7%, Absolute lymphocytes 1.65 x10^3/?l, Platelets 171 x10^3/?l, inr 0.95, glucose 86mg/dl, creatinine * 0.89 mg/dl, urea 18 mg/dl, sodium * 135 mmol/l, potassium pending. - Hs troponin i curve: 1) 5141, 2) 9347, 3) 6832.1. On 27-Aug-2021, Echocardiogram: normal (normal) Visually preserved LVEF 60% without cavity dilation or hypertrophy. No segmental contraction alterations observed. Normal diastolic function. RV size and function normal. Tricuspid aortic valve functioning normally. AV valves functioning normally. No pericardial effusion observed. Ascending aorta and arch normal. IVC not dilated.. mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. It was reported that the patient had perimyocarditis likely due to Moderna vaccine adverse effect. Treatment medication use information was not provided by reporter. Company comment: This case concerns a 26-year-old, male patient with previous relevant medical history of recreational drug use, who experienced the expected event of Myocarditis. The event occurred three days after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The medical history of recreational drug use remains a confounder. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation received on 22 Sep 2021 updated lab data and medical history comments; Sender''s Comments: This case concerns a 26-year-old, male patient with previous relevant medical history of recreational drug use, who experienced the expected event of Myocarditis. The event occurred three days after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The medical history of recreational drug use remains a confounder. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1732725 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-26
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30044233 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
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: Allergy to insect sting
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Myocardite; This case was received via regulatory authority (Reference number: FR-AFSSAPS-BS20211690) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocardite) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3004738 and 30044233) for COVID-19 vaccination. The patient''s past medical history included Epilepsy in 2000. Concurrent medical conditions included Allergy to insect sting since 2019. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced MYOCARDITIS (Myocardite) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocardite) was resolving. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medications were not reported. The treatment information was not provided. Company Comment : This case concerns a 33 year old male patient with medical history of epilepsy who experienced the expected event of myocarditis. The event myocarditis occurred approximately 3 days after the second dose of the Moderna COVID-19 vaccine. The rechallenge was unknown .The event is considered related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Translation document received on 21-Sep-2021 included no new information.; Sender''s Comments: This case concerns a 33 year old male patient with medical history of epilepsy who experienced the expected event of myocarditis. The event myocarditis occurred approximately 3 days after the second dose of the Moderna COVID-19 vaccine. The rechallenge was unknown .The event is considered related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report


VAERS ID: 1732785 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-26
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214018 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Deep vein thrombosis, Inappropriate schedule of product administration
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Medication errors (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: FRMODERNATX, INC.MOD20213

Write-up: time interval between two doses was 14 days; Thrombosis of leg deep venous; This case was received via (Reference number: FR-AFSSAPS-PB20216077) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEEP VEIN THROMBOSIS (Thrombosis of leg deep venous) in a 47-year-old male patient who received mRNA-1273 (batch nos. 214018 and 214018) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021, after starting mRNA-1273, the patient experienced DEEP VEIN THROMBOSIS (Thrombosis of leg deep venous) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (time interval between two doses was 14 days). At the time of the report, DEEP VEIN THROMBOSIS (Thrombosis of leg deep venous) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (time interval between two doses was 14 days) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided. Company Comment This case concerns a 47-year-old male patient with no relevant medical history who experienced serious unexpected event of Deep vein thrombosis. The event occurred approximately two days after the second dose. The rechallenge was not applicable since the event occurred following the second dose. Very limited information regarding clinical course of this event has been provided at this time. No informtation regarding concomitant medications was provided. The benefit-risk relationship is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation document received on 21-Sep-2021. Dose 1 details added.; Sender''s Comments: This case concerns a 47-year-old male patient with no relevant medical history who experienced serious unexpected event of Deep vein thrombosis. The event occurred approximately two days after the second dose. The rechallenge was not applicable since the event occurred following the second dose. Very limited information regarding clinical course of this event has been provided at this time. No informtation regarding concomitant medications was provided. The benefit-risk relationship is not affected by this report.


VAERS ID: 1732789 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCEL5 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Chest pain, Electrocardiogram, Electrocardiogram repolarisation abnormality, Troponin
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Conduction defects (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Congenital iris anomaly; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Angiogram; Result Unstructured Data: Test Result:normal; Test Date: 20210826; Test Name: electrocardiogram; Result Unstructured Data: Test Result:early repolarization V3V4; Test Date: 20210826; Test Name: troponin; Test Result: Negative
CDC Split Type: FRPFIZER INC202101228480

Write-up: febrile chest pain; early repolarization V3V4 on the electrocardiogram; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. -WEB FR-AFSSAPS-PC20213502. A 33-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: SCEL5), intramuscular, administered in Arm Left on 16Aug2021 (at age of 33 years old) as single dose for COVID-19 immunisation. Medical history: congenital absence of iris (Aniridia) and mutation of the PAX6 gene, Obesity. No History of COVID-19. The patient''s concomitant medications were not reported. On 26Aug2021: febrile chest pain. Going to the emergency room: early repolarization V3V4 on the electrocardiogram. Normal angiogram and troponin negative. Both events were Life-threatening. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1732940 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature abnormal, Cough, Dyspnoea, Fatigue, Headache
SMQs:, Anaphylactic reaction (broad), 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: SERTRALINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Body temperature; Result Unstructured Data: Test Result:abnormal
CDC Split Type: GBPFIZER INC202101196459

Write-up: Body temperature abnormal; Coughing; Short of breath; Fatigue; Headache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109120807148940-ZVV2I, Safety Report Unique Identifier GB-MHRA-ADR 25928914. A 27-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: UNKNOWN) via an unspecified route of administration on 19Aug2021 as dose 2, single for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. The patient did not undergo a COVID-19 test. Concomitant medication included sertraline. On an unknown date in 2021, the patient experienced coughing, short of breath, fatigue and headache; on 26Aug2021, the patient experienced body temperature abnormal; all the events were reported as serious for being medically significant. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events coughing, short of breath, fatigue, and headache was not resolved while that of the event body temperature abnormal was resolved on an unknown date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1732967 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Electrocardiogram, Pericarditis, SARS-CoV-2 test
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: blood test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210826; Test Name: ECG; Result Unstructured Data: Test Result:unknown results; Test Date: 20210826; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196368

Write-up: Pericarditis; chest pain; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109121612201020-VOFQQ with Safety Report Unique Identifier of GB-MHRA-ADR 25929191. A 19-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE8087) via an unspecified route of administration on 25Aug2021, as a single dose for COVID-19 immunisation. Patient had no relevant medical history (none) to suggest another link and was not on any concomitant medications (none). The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. On 26Aug2021, 1 day after vaccination, the patient experienced chest pain and pericarditis; both the events were reported as serious for being medically significant. Events resulted in emergency room visit and therapeutic measure was taken. The clinical course was reported as follows: Morning after the jab, the patient had pretty bad chest pain and he called 111. The patient eventually ended up being sent to accident and emergency (A&E). The patient underwent electrocardiogram (ECG) and blood tests on 26Aug2021 with unknown results; and the doctor suspected that the patient had pericarditis but could not confirm it. The patient was then sent home and advised to take ibuprofen for chest pain and pericarditis. It was reported that the patient had delayed hospital appointment a week later due to communication issues between departments, at which point the patient was recovering. Disagreement between consultant and nurse practitioner meant that the patient was not diagnosed with anything and was not given any drugs. On 26Aug2021, the patient underwent COVID-19 virus test and the result was negative. The patient had not tested positive for COVID-19, since having the vaccine. The clinical outcome of the event chest pain was resolved on an unknown date in 2021 while that of pericarditis was recovered on 06Sep2021, after the duration of 11 days. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1733106 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Maternal exposure during breast feeding, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neonatal exposures via breast milk (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPO-PROVERA
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Maternal exposure during breast feeding; Vaginal bleeding; This case was received via RA (Reference number: RA-ADR 25951383) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. Concurrent medical conditions included Breast feeding. Concomitant products included MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) from April 2021 to an unknown date for Contraception. On 21-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding) had not resolved and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Patient was given first dose in an unknown date in July 2021 with no side effects. As per general practitioner the adverse event was caused by Depo and that it could cause irregular bleeding. Second dose given in July with no side effects until second dose of Moderna vaccine. Five days after the second dose the patient began experiencing vaginal bleeding and this has continued to date. Company Comment: This case concerns a 35-year-old, female patient with no relevant medical history, who experienced the unexpected events of vaginal haemorrhage and maternal exposure during breast feeding. The event vaginal haemorrhage occurred 5 days after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. Concomitant medications (MEDROXYPROGESTERONE ACETATE) could be potentially confounders for vaginal haemorrhage. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. This case was linked to MOD-2021-325123 (Parent-Child Link). See case MOD-2021-325123 for details regarding the child case.; Sender''s Comments: This case concerns a 35-year-old, female patient with no relevant medical history, who experienced the unexpected events of vaginal haemorrhage and maternal exposure during breast feeding. The event vaginal haemorrhage occurred 5 days after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. Concomitant medications (MEDROXYPROGESTERONE ACETATE) could be potentially confounders for vaginal haemorrhage. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1733354 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-26
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF7481 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Gait disturbance, Headache, Migraine
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101193438

Write-up: OTHER, HEADACHE; WALKING DISORDER; migrainous-like; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-780963. A 12-year-old male patient received BNT162B2 (COMIRNATY), via intramuscular, administered in deltoid left on 13Aug2021 at 16:39 (Lot Number: FF7481; Expiration Date: 30Nov2021) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced other, headache and walking disorder on 26Aug2021. Specialized tests and and examinations, the neurological examination in particular excludes any organic illness and classifies the episode as migrainous-like. The patient was hospitalized for the events from 26Aug2021 to 30Aug2021. The outcome of the events was recovered on 30Aug2021. Reporter''s comment: Injection site: LEFT DELTOID Sender''s comment: 06Sep2021 Local RA Manager: Request that the documentation attached in database be sent. Awaiting.; Reporter''s Comments: Injection site: LEFT DELTOID


VAERS ID: 1733359 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: Myopericarditis; This case was received via regulatory Agency (Reference number: IT-MINISAL02-781519) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myopericarditis) in a 20-year-old male patient who received mRNA-1273 (Spikevax) for SARS-CoV-2 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced MYOCARDITIS (Myopericarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myopericarditis) was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. Batch number of the suspect product was unknown. No treatment information was provided. Company comment: This case concerns a 20-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis, however, the temporal relationship was unknown, having in mind that that the date of vaccination was not provided and it was also not provided whether the patient received the first or the second dose of Spikevax. The outcome of the event was reported as resolving at the time of the report. The rechallenge was unknown, having in mind that it is unknown which dose of the vaccine the patient actually received. The benefit-risk relationship of Spikevax is not affected by this report. Event Myocarditis was automatically upgraded as serious as per IME list and was also assessed as serious during medical reviewtaking into consideration very limited information provided and based on medical judgement and nature of the reported event.; Sender''s Comments: This case concerns a 20-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis, however, the temporal relationship was unknown, having in mind that that the date of vaccination was not provided and it was also not provided whether the patient received the first or the second dose of Spikevax. The outcome of the event was reported as resolving at the time of the report. The rechallenge was unknown, having in mind that it is unknown which dose of the vaccine the patient actually received. The benefit-risk relationship of Spikevax is not affected by this report. Event Myocarditis was automatically upgraded as serious as per IME list and was also assessed as serious during medical reviewtaking into consideration very limited information provided and based on medical judgement and nature of the reported event.


VAERS ID: 1733611 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Hemiplegia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101205011

Write-up: Facial paralysis; Hemiplegia; Paraesthesia; This is a spontaneous report from a contactable other health care professional from the regulatory authority report number is AEFI-A-012756. A 32-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Aug2021 15:20, the patient experienced facial paralysis, hemiplegia, paraesthesia with outcome of not recovered. Seriousness criteria of the events was reported as medically significant. The clinical course was reported as follows: Progressive heaviness and altered sensation in the left arm, spreading up to the left face. As evening progressed, left arm/leg weakness and facial droop. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1736083 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea exertional
SMQs:, Pulmonary hypertension (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: DEJNJFOC20210944962

Write-up: DYSPNOEA EXERTIONAL; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, DE-PEI-CADR2021174157) on 23-SEP-2021 concerned a 45 year old male. The patient''s weight was 85 kilograms, and height was 188 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, administered on 19-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 26-AUG-2021, the patient experienced dyspnoea exertional. On an unspecified date, the patient was hospitalized. Number of days of hospitalization was not reported. It was unknown if patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dyspnoea exertional. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1736087 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Dyspnoea, Myocarditis, Oedema
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210944750

Write-up: DYSPNOEA; EDEMA; CARDIAC INSUFFICIENCY; MYOCARDITIS; This spontaneous report received from a consumer via Regulatory Authority (EVHUMAN Vaccines, DE-PEI-CADR2021175742) on 23-SEP-2021 concerned a 43 year old male. The patient''s weight was 105 kilograms, and height was 180 centimeters. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 23-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 26-AUG-2021, the patient experienced myocarditis and cardiac insufficiency. On an unspecified date, he experienced dyspnoea and edema. On an unspecified date, the patient was hospitalized. Number of days of hospitalization was not reported. It was unknown if patient was discharged. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dyspnoea, myocarditis, edema, and cardiac insufficiency. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1736323 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 100031184 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypotension, Influenza like illness, Loss of consciousness, Malaise, SARS-CoV-2 test, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: 20210826; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Consciousness loss; Feeling sick; Influenza like illness; Arterial hypotension; Emesis; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-ST20213366) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Consciousness loss) and MALAISE (Feeling sick) in a 49-year-old female patient who received mRNA-1273 (batch no. 100031184) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Intramuscular) .5 milliliter. On 26-Aug-2021, the patient experienced LOSS OF CONSCIOUSNESS (Consciousness loss) (seriousness criterion medically significant), MALAISE (Feeling sick) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Influenza like illness), HYPOTENSION (Arterial hypotension) and VOMITING (Emesis). At the time of the report, LOSS OF CONSCIOUSNESS (Consciousness loss), MALAISE (Feeling sick), HYPOTENSION (Arterial hypotension) and VOMITING (Emesis) had resolved and INFLUENZA LIKE ILLNESS (Influenza like illness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Intramuscular) was unknown. No concomitant and treatment information was provided. Company Comment: This case concerns a 49-year-old, female patient with no relevant medical history, who experienced the unexpected events of loss of consciousness and malaise. The events occurred on the same day after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation document recieved on 23 Sep 2021 contains no new information.; Sender''s Comments: This case concerns a 49-year-old, female patient with no relevant medical history, who experienced the unexpected events of loss of consciousness and malaise. The events occurred on the same day after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1736434 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210826; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive Iu international unit (s)
CDC Split Type: PTJNJFOC20210945676

Write-up: Vaccination failure; This spontaneous report received from a health care professional via a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202109-539) on 23-SEP-2021 concerned a 41 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C18-05, expiry: UNKNOWN) 0.5 ml, 1 total, drug start period 48 days, administered on 09-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 26-AUG-2021, the patient experienced vaccination failure. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive Iu (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination failure on 04-SEP-2021. This report was serious (Other Medically Important Condition).


VAERS ID: 1737741 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 INC202101194110

Write-up: Thrombosis; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority WEB, regulatory authority number DE-PEI-202100184712. A 57-years-old male patient received bnt162b2 (COMIRNATY, Strength 0.3 ml), dose 2 via an unspecified route of administration on 19Aug2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Historical Vaccine included 1st dose of bnt162b2 (COMIRNATY, Strength 0.3 ml), on 14Jul2021 for COVID-19 vaccination. The patient''s concomitant medications were not reported. The patient experienced thrombosis (medically significant) on 26Aug2021 with outcome of not recovered. Causality assessment: Source of assessment: PEI, Result of Assessment D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1737830 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-26
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: DEMODERNATX, INC.MOD20213

Write-up: Thrombosis leg; This case was received via Regulatory Authority (Reference number: DE-PEI-202100185672) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of THROMBOSIS (Thrombosis leg) in a 37-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced THROMBOSIS (Thrombosis leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Thrombosis leg) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant product was not provided. Treatment medication was not reported. Initials: D-Dimer test positive on 31-Aug Deep vein thrombosis supported by Doppler ultrasound on 01-Sep Company Comment:This case concerns a 42-year-old, female patient with no relevant medical history, who experienced the unexpected event of Thrombosis. The event Thrombosis. occurred the 22 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation received on 23-sep-2021. senders comment added; Sender''s Comments: This case concerns a 42-year-old, female patient with no relevant medical history, who experienced the unexpected event of Thrombosis. The event Thrombosis. occurred the 22 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1737832 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E026A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Blood creatine phosphokinase, Bradycardia, C-reactive protein, Electrocardiogram, Troponin
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CK; Result Unstructured Data: Test Result:normal; Test Name: CRP; Result Unstructured Data: Test Result:normal; Test Name: EKG; Result Unstructured Data: Test Result:Bradycardia and cardiac pain; Test Name: troponin; Result Unstructured Data: Test Result:normal
CDC Split Type: DEPFIZER INC202101194271

Write-up: Cardiac pain; Bradycardia; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100185688. A 31-years-old patient of an unspecified gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on 25Aug2021 (Lot Number: 1E026A) as dose number unknown, single (at age of 31-years-old) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Aug2021, the patient experienced Bradycardia, Cardiac pain. Outcome of the events was not recovered. This report was reported as non-serious. Sender Comment: Bradycardia and cardiac pain, Supported by EKG. Myocarditis was excluded because CK, CRP and troponin were normal. Result of assessment (all events: source: regulatory authority) indeterminate. No follow-up activities possible. No further information expected.


VAERS ID: 1737954 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-26
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E021A / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Varicose vein
Preexisting Conditions: Medical History/Concurrent Conditions: Mite allergy; Nickel sensitivity
Allergies:
Diagnostic Lab Data: Test Name: USG; Result Unstructured Data: Test Result:received the diagnosis (Thrombosis leg)
CDC Split Type: DEPFIZER INC202101195436

Write-up: Thrombosis in left lower leg; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021175652. Safety Report Unique Identifier: DE-PEI-202100185227. A 34-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, strength: 0.3 ml), via intramuscular on 02Aug2021 (Lot Number: 1E021A) as a single dose for covid-19 immunization. Medical history included ongoing varicose vein, allergy nickel, allergy dust mites. The patient previously took the first dose of bnt162b2 (COMIRNATY, strength: 0.3 ml) on 17Jun2021 for COVID-19 immunization. The patient''s concomitant medications were not reported. On 26Aug2021 the patient experienced Thrombosis leg. The patient was hospitalization due to this event. The patient had varicose veins in left lower leg, which will have favored thrombosis formation. Immediately after vaccination he had no significant reactions. Then three weeks later pain and swelling in left leg. After a few days in which the pain became stronger then went to the family doctor and from there to the emergency room for ultrasound, where he received the diagnosis, Thrombosis leg. The outcome of the event was not recovered. The causality assessment per Thrombosis leg for Comirnaty/Thrombosis leg provided as D (Unclassifiable). No follow-up attempts possible. No further information expected.


VAERS ID: 1738174 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-26
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Eye infection, Headache, Herpes zoster
SMQs:, Ocular infections (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101194038

Write-up: Headache unilateral/left side headache; Eye infection; Herpes zoster/blistering shingles rash; This is a spontaneous report from a contactable physician downloaded from the WEB with regulatory authority report number FI-FIMEA-20214349. A 56-year-old female patient received BNT162b2 (COMIRNATY, solution for injection, lot number/expiry date unknown), via an unspecified route of administration, administered in left upper arm on 18Aug2021 as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced headache unilateral/left side headache that started on 26Aug2021 (also reported as already a couple of days), after vaccination. The patient also had eye symptoms and went to the doctor at that time who suspected eye infection on 26Aug2021 and started putting in drops (Fucithalmic). Also, on 26Aug2021 (also reported as 27Aug2021) the patient experienced herpes zoster/a typical blistering shingles rash developed on the left face around the eye in an area about the size of the palm of the hand. The outcome of the events was not recovered. The case is reported as serious due to medically significant. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738180 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Pyrexia; Myocarditis; This case was received via regulatory authority (Reference number: FI-FIMEA-20214392) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of PYREXIA (Pyrexia) and MYOCARDITIS (Myocarditis) in a 16-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced PYREXIA (Pyrexia) (seriousness criterion hospitalization) and MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, PYREXIA (Pyrexia) and MYOCARDITIS (Myocarditis) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment information mentioned. Company Comment : This case concerns a 16-year-old, female patient with no relevant medical history, who experienced the unexpected events of pyrexia and myocarditis. The events occurred approximately 1 day after the first dose of mRNA-1273. The rechallenge was unknown, as the events happened after the first dose and not resolved. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 in not affected by this report.; Sender''s Comments: This case concerns a 16-year-old, female patient with no relevant medical history, who experienced the unexpected events of pyrexia and myocarditis. The events occurred approximately 1 day after the first dose of mRNA-1273. The rechallenge was unknown, as the events happened after the first dose and not resolved. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 1738427 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-26
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test normal, Chest pain, Echocardiogram, Palpitations, Pericarditis, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Aortic incompetence; Solitary kidney
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac septal defect repair; Deformity of spine; Heart disease congenital; Hernia inguinal; Premature baby
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: Blood panel; Result Unstructured Data: Test Result:normal; Test Date: 20210828; Test Name: Cardiac Ultrasound; Result Unstructured Data: Test Result:suggestive of pericarditis
CDC Split Type: FRPFIZER INC202101194713

Write-up: Pericarditis; Thoracic pain aggravation; Tachycardia; Palpitations; thoracic pain; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-MP20217156. A 14-years-old male patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 03Aug2021 (Batch/Lot Number: FE8244) as single dose for covid-19 immunisation. Medical history included inguinal hernia from an unknown date and not ongoing , premature baby, aortic valve incompetence from Dec2020 and ongoing, ongoing solitary kidney, heart disease congenital, cardiac septal defect repair from Jan2017 and not ongoing, deformity spinal. The concomitant medications were not reported. The patient experienced pericarditis on 26Aug2021 which considered as serious per hospitalization, thoracic pain on 26Aug2021, thoracic pain aggravation, tachycardia and palpitations on 28Aug2021. Clinical course as follow: On 26Aug2021: onset of pericarditis. From 26Aug2021, onset of thoracic pains, at 3 weeks from their first dose of the bnt162b2 vaccine. 28Aug2021: the patient consulted their general practitioner who prescribed a blood panel (normal), corticosteroid treatment with solupred and antibiotic treatment with Rovamycine (1 tablet taken). He consulted at the Emergency Room for an aggravation of the thoracic pain with a feeling of tachycardia and palpitations. Cardiologist opinion: cardiac ultrasound suggestive of pericarditis. Put on Aspegic and then hopsitalised on the paediatrics ward. The patient underwent lab tests and procedures which included blood test was normal and cardiac ultrasound suggestive of pericarditis on 28Aug2021. The outcome of the events was recovering. No follow-up attempt are possible. No expected further information.


VAERS ID: 1738459 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-08-26
   Days after vaccination:206
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Arrhythmia (due to atrial fibrillation); Coronary bypass; Pacemaker insertion
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Positive.
CDC Split Type: FRPFIZER INC202101194632

Write-up: Vaccination failure; oxygen-related Sars-Cov2 pneumonia; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number FR-AFSSAPS-NT20213567. A 91-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection), via an intramuscular on an unspecified date in Feb2021 (Lot Number: unknown) as single dose and patient received second dose of bnt162b2 (COMIRNATY, solution for injection), via an intramuscular on an unspecified date in Feb2021 (Lot Number: unknown) as single dose for COVID-19 immunization. Patient had no known allergies. The patient relevant medical history includes coronary bypass pacemaker, AFib (atrial fibrillation), and complete arrhythmia (due to atrial fibrillation). The patient concomitant medications were not reported. It was reported that patient was hospitalization for oxygen-related Sars-Cov2 pneumonia on 26Aug2021. The patient vaccinated against COVID-19 by a complete regimen with COMIRNATY. The patient had SARS-CoV-2 test on an unspecified date with positive result. The outcome of the event was unknown. No Follow-up attempts are possible. No information is expected further.


VAERS ID: 1738537 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-08-26
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC6997 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Feeling hot, Oedema peripheral, Pain in extremity, Skin discolouration, Telangiectasia, Ultrasound Doppler
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Diabetes mellitus; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Doppler ultrasound; Result Unstructured Data: Test Result:returned to normal; Comments: The doctor noted the remote persistence of telangiectasia on the anterior internal surface of both legs
CDC Split Type: FRPFIZER INC202101194748

Write-up: Edema of lower extremities; purplish skin color; pain and a feeling of heat in the lower limbs; pain and a feeling of heat in the lower limbs; telangiectasia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FR-AFSSAPS-PC20213359. A 57-year-old female patient received BNT162B2 (COMIRNATY) at the age of 57-years-old, intramuscular, administered in Arm Left on 26May2021 (Batch/Lot Number: FC6997) as dose 2, 0.3 ml, single for COVID-19 immunization. Medical history included arterial hypertension, diabetes and obesity. The patient''s concomitant medications were not reported. The patient is considered to be at risk for a severe form of COVID-19 disease due to her medical history. No history of COVID-19 and no test performed. On 26Aug2021, during a medical consultation, confirmation of the presence of edema in both lower limbs associated with a purplish skin color, pain and a feeling of heat in the lower limbs. Faced with these symptoms, the female patient underwent a venous Doppler ultrasound of the lower limbs which returned to normal. The doctor noted the remote persistence of telangiectasia on the anterior internal surface of both legs. Corticosteroid therapy ineffective. In total, confirmation of the presence of edema of the lower limbs, on day 93 after dose 2. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738909 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Dizziness, Myalgia, Nausea, Palpitations, Peripheral swelling, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101217781

Write-up: muscular pain; arm was burning; Heart pounding; Feverish; Dizzy; Large arm swelling; Muscular pains; Nauseous; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109151934550560-N7RIM. Safety Report Unique Identifier GB-MHRA-ADR 25947979. A 34-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: FE3380 and Expiry date was not reported), dose 2, via an unspecified route of administration on an unspecified date in 2021 as dose 2, single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history in-cluded suspected covid-19 from 20Apr2020 to an unknown date, unsure when symptoms stopped. The patient concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had not a COVID-19 test. Pa-tient was not currently breastfeeding. The patient previously received BNT162B2 (Lot Number and Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single dose for COVID-19 immunisation. She has never been tested for COVID. However, her sister tested positive at the start of lockdown in April when her whole family was sick, so assume we all had it. However, she cannot confirm since she never has been tested. Her brother was a nurse, so she asked for his professional advice to deal with these side effects. She had been intuitively yet safely alternating between Paracetamol for fevers and Ibuprofen for the muscular pain and swelling of the arm. The arm was burning more than the first dose but didn''t swell as big in size as the first. On an unspecified date, the patient experienced muscular pain, arm was burning, on 26Aug2021 patient experienced nauseous, muscular pains, on 27Aug2021 patient experienced large arm swelling, dizzy, on 28Aug2021 patient experienced heart pounding, feverish. Therapeutic measures were taken as a result of muscular pain, feverish, muscular pains, large arm swelling. Outcome of the event arm was burning was unknown, muscular pain (unknown start date) was recovering, large arm swelling was recovered on 29Aug2021, nauseous was recovered on 30Aug2021, dizzy was recovered on 31Aug2021, heart pounding was recovered 03Sep2021, feverish and muscular pains (onset date: 26Aug2021) was recovered on 04Sep2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1739187 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Electrocardiogram, Heart rate, Myocarditis, Troponin
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Diffuse accentuation of the lung pattern. Cardiac; Comments: Diffuse accentuation of the lung pattern. Cardiac silhouette to the limit; Test Date: 20210830; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Name: heart rate; Result Unstructured Data: Test Result:65 bpm; Test Date: 20210830; Test Name: Troponin; Result Unstructured Data: Test Result:3.9 ng/dL
CDC Split Type: ITPFIZER INC202101194428

Write-up: myopericarditis; This is a spontaneous report from a contactable physician downloaded from the REGULATORY AUTHORITY-WEB IT-MINISAL02-780572. A 31-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), dose 2 intramuscular on 23Aug2021 14:00 (Lot Number: FG7387; Expiration Date: 30Nov2021) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient previously took first dose of comirnaty (batch number: FF7481, expiry date: 30Nov2021) on 01Aug2021 13:00 for covid-19 immunisation. The patient experienced myopericarditis on 26Aug2021. The patient was hospitalized due to the events. The patient received treatment for the event myopericarditis. Therapeutic measures were Pantorc 20 mg 2 tablets per day, Triatec 2.5 mg 1 tablet per day, Brufen 600 mg 1 tablet every 3 days. Diffuse accentuation of the lung pattern. The patient underwent lab tests and procedures which included chest x-ray: diffuse accentuation of the lung pattern. Cardiac silhouette to the limit on 30Aug2021, electrocardiogram: results unknown on 30Aug2021, heart rate: 65 bpm on an unspecified date, troponin: 3.9 ng/dl on 30Aug2021. The outcome of the myopericarditis was recovering. Sender comment: On 06Sep2021 the reporter was contacted to request: expiry date of the batch of the suspected vaccine and to specify whether it is the first or second dose (in case of the suspected adverse reaction occurring after the second dose, it''s required to also specify the date of administration, the batch, and the expiry date of the batch of the first dose); medical history, evolution of symptoms, therapies carried out, results of hematochemical and instrumental tests carried out, and update of the outcome. The sheet will be updated on 07Sep2021. No follow-up attempts are possible. No further information is expected. Information about batch number has been obtained.


VAERS ID: 1739219 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Panic attack, Stridor, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101194203

Write-up: Stridor; Feeling of constriction in the throat; Dry cough; Panic attack; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-780872. A 48-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FG4686; Expiration Date: 30Nov2021) via intramuscular route of administration, administered in Arm Left on 26Aug2021 (at the age of 48-year-old) as Dose 1,Single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously took influenza vaccine from which she experienced non-serious adverse reaction and regressed at home. On 26Aug2021, the patient experienced stridor, constriction in the throat, dry cough and had panic attack. Therapeutic measures were taken in the form of (urbason 40 mg, flebocortid 500 mg, trimeton 10 mg. Transfer to emergency room for observation, administration of delorazepam and hydration. On 26Aug2021, the outcome of events was recovered.


VAERS ID: 1739463 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-08-26
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: JPMODERNATX, INC.MOD20213

Write-up: Coronavirus infection; This case was received via Regulatory Authority (Reference number: 2021TJP088633) on 10-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case was reported by a physician via the medical representative. Coronavirus infection was assessed as serious by the RA. On 20-Jul-2021, the patient received the 1st dose of this vaccination. On 26-Aug-2021, corona infection confirmed. The outcome of coronavirus infection was reported as unknown. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns an unknown age male patient with no medical history reported, who experienced the unexpected serious event of COVID 19 infection, within 1 month 6 days after the first dose of mRNA-1273 vaccine. Limited information regarding the events have been provided at this time. Rechallenge is unknown. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1739479 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204B21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event, Diarrhoea, Headache, Myalgia, Nausea, Paralysis, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRJNJFOC20210947138

Write-up: ACUTE PARALYSIS; OTHER EVENTS; NAUSEA; VOMITING; DIARRHEA; MUSCLE PAIN; HEADACHE; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 5 decade old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 204B21A expiry: 11-DEC-2021) dose was not reported,1 total administered to deltoid on 26-AUG-2021 for an unspecified indication. No concomitant medications were reported. On 26-AUG-2021, the patient experienced acute paralysis, other events, nausea, vomiting, diarrhea, muscle pain, headache. No treatment was given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute paralysis, nausea, vomiting, diarrhea, muscle pain, headache and other events was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210947138-covid-19 vaccine ad26.cov2.s-acute paralysis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1739520 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-26
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Electrocardiogram, Pericarditis, SARS-CoV-2 test, Ultrasound scan
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Egg allergy (Allergic to: Chicken protein)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (disease symptoms: none)
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown results; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:unknown results; Test Name: sars-cov-2 test; Test Result: Positive ; Test Name: echography; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC202101194152

Write-up: Pericarditis; This is a spontaneous report from a contactable consumer downloaded from the WEB. The regulatory authority number is NL-LRB-00677208. A 37-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 29Jul2021 (Batch/Lot Number: FE4728) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history included ongoing egg allergy (allergic to chicken protein), and Covid-19 on an unknown date and unknown if ongoing (disease symptoms: none). The patient''s concomitant medications were not reported. The patient received the first dose of COMIRNATY on 18Jun2021 for Covid-19 immunisation ( possible adverse reactions not reported). The patient experienced pericarditis on 26Aug2021. The patient was hospitalized on an unknown date for the event. The patient was treated with a non specified pain killer and a non specified anti-inflammatory drug. The patient underwent lab tests and procedures on an unknow n date, which included unknown results for blood test, electrocardiogram and echography; and was sars-cov-2-test positive. The patient was recovering from pericarditis 8 days after onset. No follow-up attempts possible. No further information expected. Information about batch/lot number already obtained.


VAERS ID: 1739703 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Convulsion in childhood
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (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: PTPFIZER INC202101195601

Write-up: Convulsion in childhood; This is a Spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. This is a report received from Regulatory authority report number PT-INFARMED-T202108-3734 with Safety Report Unique Identifier PT-INFARMED-T202108-3734. A 12-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 26Aug2021 (Batch/Lot Number: FE4728) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for covid-19 immunisation at the age of 12-year-old. The patient medical history and concomitant medications were not reported. No information was provided on the occurrence of infection with the SARS-CoV-2 virus. The patient experienced convulsion in childhood on 26Aug2021 with outcome of unknown. The patient received 2 doses COMIRNATY (0.3 ml each) intramuscular with a recommended interval of 3 weeks between doses. The case was reported as serious (hospitalization). There is no information about the maintenance or suspension of the vaccine schedule. There is no suspicion of drug interactions. Specific treatment of the reaction described as Self-limited was carried out. There is no information about the most current evolution of the condition. Evolution of ADR: unknown. The reporters assessment of the causal relationship of the event (Convulsion in childhood) with the suspect product was: Relatedness of drug to reaction(s)/event(s): 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: 1739704 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005696 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Diarrhoea, Dizziness, Headache, Malaise, Nausea, Pain of skin, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (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: ANETTE
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTMODERNATX, INC.MOD20213

Write-up: Diarrhea; Malaise; Dizziness; Weakness; Headache; Fever; Nausea; Skin pain; This case was received via regulatory authority (Reference number: PT-INFARMED-T202108-3779) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DIARRHOEA (Diarrhea), MALAISE (Malaise), DIZZINESS (Dizziness), ASTHENIA (Weakness), HEADACHE (Headache), PYREXIA (Fever) and NAUSEA (Nausea) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005696) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included ETHINYLESTRADIOL, ETONOGESTREL (ANETTE) for an unknown indication. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 26-Aug-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant), MALAISE (Malaise) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and PAIN OF SKIN (Skin pain). At the time of the report, DIARRHOEA (Diarrhea), MALAISE (Malaise), DIZZINESS (Dizziness), ASTHENIA (Weakness), HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and PAIN OF SKIN (Skin pain) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Patient experienced headache, myalgia, diarrhea, nausea, weakness, fever of 38?C and skin pain (sic) that was treated with BUR and brufen. The patient became unfit for work and so a CIT was carried out. Company Comment - This case concerns a 24-year-old female patient with no relevant medical history who experienced serious unexpected events of diarrhea, malaise, dizziness, asthenia, headache, pyrexia and nausea. The events occurred 1 day after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translated document was received on 20-Sep-2021; updated with senders comment.; Reporter''s Comments: Concomitant medication- Anette - vaginal ring Did a medication occur?- No Other information- 24h after receiving the 2nd dose of the Moderna Vaccine on Aug 25, 2021, the patient started to experience headache, myalgia, diarrhea, nausea, weakness, fever of 38?C and "skin pain" (sic) that was treated with BUR and brufen. The patient became unfit for work and so a CIT was carried out; Sender''s Comments: This case concerns a 24-year-old female patient with no relevant medical history who experienced serious unexpected events of diarrhea, malaise, dizziness, asthenia, headache, pyrexia and nausea. The events occurred 1 day after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1739717 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005696 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Fatigue, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: This case was received via Regulatory Agency (Reference number: PT-INFARMED-V202109-873) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS, DYSPNOEA , PYREXIA and FATIGUE in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005696) for COVID-19 immunisation. No Medical History information was reported. On 26-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 26-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced PYREXIA (seriousness criterion disability). On 27-Aug-2021, the patient experienced DIZZINESS (seriousness criterion disability), DYSPNOEA (seriousness criterion disability) and FATIGUE (seriousness criterion disability). On 30-Aug-2021, DIZZINESS, DYSPNOEA, PYREXIA and FATIGUE had resolved. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. company comment: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected events of pyrexia, dizziness, dyspnoea and fatigue. The event of Pyrexia occurred on the same day after the second dose of Spikevax, while the remaining events occurred during the following day after vaccine administration. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent disability.; Sender''s Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected events of pyrexia, dizziness, dyspnoea and fatigue. The event of Pyrexia occurred on the same day after the second dose of Spikevax, while the remaining events occurred during the following day after vaccine administration. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent disability.


VAERS ID: 1740466 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-26
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4421 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Induration, Joint swelling, Musculoskeletal stiffness, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202101199341

Write-up: Swelling left leg from groin to toes; Hardness of the left limb (affecting movement); Swelling beyond nearest joint; Induration; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received BNT162B2 (COMIRNATY) dose 1 administration on 18Aug2021 at patient age of 48-year-old (Batch/Lot Number: FG4421) for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced swelling left leg from groin to toes, hardness of the left limb, swelling beyond nearest joint and induration on 26Aug2021. The patient was hospitalized on an unspecified date. The outcome of the events was unknown.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Peripheral Swelling, Joint Swelling, Musculoskeletal stiffness, induration) and the administration of the vaccine 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: 1742560 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-26
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast mass, SARS-CoV-2 test
SMQs:, 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: 20210912; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217830

Write-up: Breast lump; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109151715531580-K2EL4. Senders (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25946807. A 43-year-old patient of an unspecified gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, (Lot Number: FF3319), via an unspecified route of administration on 28Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patients concomitant medications were not reported. The patient had experienced breast lump on 26Aug2021. The event seriousness was assessed as medically significant. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The patient underwent lab tests and procedures which included COVID-19 virus test (SARS-CoV-2 test): negative on 12Sep2021 No - Negative COVID-19 test. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1743211 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-26
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise, Pyrexia, Seizure
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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Generalized tonic convulsion; Malaise; Pyrexia; This case was received via Pharmaceutical Company(Reference number: JP-TAKEDA-2021TJP094382) on 15-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the Regulatory Authority by a (physician/pharmacist etc.), was received via the Regulatory Authority(Ref, v21126490). On 29-Jul-2021, the patient received the 1st dose of this vaccine. On 26-Aug-2021, the patient received the 2nd dose of this vaccine. After the vaccination, the patient had strong malaise for 2 days with pyrexia of 39s degrees Celsius. The symptoms subsided with oral administration of acetaminophen 200 mg 2 tablets twice. On 10-Sep-2021, the patient experienced generalized tonic convulsion and was urgently transported to the hospital. The convulsion abruptly subsided in a few minutes. The patient had no history of epilepsy nor febrile convulsions in childhood, so this was the first convulsion. Thereafter, recovery of the symptoms was confirmed. The outcome of malaise, pyrexia, and generalized tonic convulsion was reported as recovered. Follow-up investigation will be made. Company Comment: If idiopathic epilepsy can be ruled out by further evaluation and examination, the causality with the vaccination would be strongly suspected. There is a possibility of suspected idiopathic epilepsy as another factor. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: .; Sender''s Comments: This case concerns a 20-year-old, male patient with no relevant medical history, who experienced the serious unexpected event of Seizure. The event occurred approximately 15 days after the second dose of Spikevax. The rechallenge was not applicable since no events were reported after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1743226 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005239 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Peripheral nerve disorder; This case was received via regulatory authority (Reference number: 2021TJP095856) on 17-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the agency by a physician, was received via the agency (Ref,v21126999). Peripheral nerve disorder was assessed as serious by the regulatory authority. On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 26-Aug-2021, at 17:09, the patient received the 1st dose of the vaccine to the outside of the left upper arm. At 17:16, peripheral nerve disorder developed. The patient noticed numbness in the left palm and in the 4th and 5th fingers. There were no other abnormal physical findings. At 17:22, the patient had abnormal perception on the inner side of the left upper arm. There were no other abnormal physical findings. At 17:50, although the symptom remained, no tendency of deterioration was seen, and thus the patient returned home. The outcome of peripheral nerve disorder was reported as ongoing and unchanged. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship; Reporter''s Comments: The possibility of joint defect after the vaccination cannot be ruled out. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 32-year-old female patient with no relevant medical history, who experienced the unexpected, serious event of neuropathy peripheral. The events occurred on the same day after first dose of Spikevax. The rechallenge is unknown. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1743353 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4721 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Burns second degree, Limb discomfort, Peripheral swelling, Rash erythematous, Vaccination site oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to animals (hair of some animals)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101209542

Write-up: Arm: burn blisters; Swollen and heavy arm; Reddish and black zone; Swollen and heavy arm; Swollen and heavy arm; This is a spontaneous report from a contactable consumer or other non hcp (patient) downloaded from the regulatory authority-WEB, regulatory authority number PT-INFARMED-T202108-3855. A 23-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FE4721), intramuscular on 26Aug2021 (at the age of 23-years-old) as dose number unknown, 0.3ml single for covid-19 immunisation. The patient''s medical history and concomitant medications was not reported. The patient previously experienced known allergies to hair of some animals. There is no information on clinical history. Previous known infection with the SARS-CoV-2 virus is unknown. The adverse reaction (ADR) arose after inoculation of the vaccine (with no known temporal relationship), with unknown duration. According to the reporter, the reaction was not reported to the health professional. Compliance with the 2-dose schedule was unknown. There was no suspected interaction between medications. Denies previous reactions to other drugs, or allergies identified. The patient experienced swollen and heavy arm, burn blisters, reddish and black zone on 26Aug2021. The patient received treatment for all the events. The outcome of all the events was unknown. The reporter''s assessment of the causal relationship of the (event) with the suspect product was: This part was not received in the source document. Since no determination has been received, the case was managed based on the company causality assessment. Reporter''s comment: Concomitant Medication -I do not use other medications, just took paracetamol. Occurred Medication Error? -Prefer not to state anything. Other information -The only allergy that is to my knowledge is the hair of some animals. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1743359 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-26
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / 2 - / 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: 20210826; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Positive (IU) in international units
CDC Split Type: PTPFIZER INC202101229723

Write-up: Covid 19; COVID-19; This is a Spontaneous report from a contactable physician downloaded from the regulatory authority. This is a report received RA Regulatory authority report number PT-INFARMED-T202108-3945 with Safety Report Unique Identifier PT-INFARMED-T202108-3945. A 22-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number FG4442), via intramuscular route of administration, administered anatomical location not reported, on 07Aug2021 as dose 2, 0.3 ml single for COVID-19 immunization. The patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number FE1573), via intramuscular route of administration, administered anatomical location not reported, on 10Jul2021 as dose 1, 0.3 ml single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 26Aug2021, patient experienced vaccination failure and COVID-19. On 26Aug2021, patient underwent lab tests and procedures which included SARS-COV-2 test: positive (IU) in international units. The outcome of the event was recovering. The reporter''s assessment of the causal relationship of the event (COVID-19 and vaccination failure) with the suspect product was: Relatedness of drug to reaction(s)/event(s): Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: probable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1743363 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210826; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20210944557

Write-up: Vaccination failure; This spontaneous report received from a health care professional via a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202109-534) on 23-SEP-2021 and concerned a 22 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-04 expiry: unknown) 0.5 ml, 1 total administered on 09-AUG-2021 for covid-19 immunisation. The drug start period 17 days. No concomitant medications were reported. On 26-AUG-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. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Other info-no answer


VAERS ID: 1746067 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-08-26
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004672 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Myopericarditis; This case was received via regulatory authority (Reference number: ES-AEMPS-994215) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of MYOCARDITIS (Myopericarditis) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3005703 and 3004672) for COVID-19 vaccination. No Medical History information was reported. On 24-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced MYOCARDITIS (Myopericarditis) (seriousness criteria hospitalization and medically significant). On 29-Aug-2021, MYOCARDITIS (Myopericarditis) had resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 24-Jul-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment This case concerns a 18-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event occurred approximately 6 days after the second dose of Spikevax. The rechallenge was not applicable, as the event happened after the second dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation uploaded on 27-SEP-2021 in which event verbatim and dose information was translated.; Sender''s Comments: This case concerns a 18-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event occurred approximately 6 days after the second dose of Spikevax. The rechallenge was not applicable, as the event happened after the second dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1746107 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Deafness unilateral, Pyrexia, Sudden hearing loss
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hearing impairment (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Sudden deafness; Hearing loss unilateral; Pyrexia; This case was received via Regulatory Agency (Reference number: FI-FIMEA-20214656) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SUDDEN HEARING LOSS (Sudden deafness), DEAFNESS UNILATERAL (Hearing loss unilateral) and PYREXIA (Pyrexia) in a 44-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced SUDDEN HEARING LOSS (Sudden deafness) (seriousness criteria hospitalization and medically significant), DEAFNESS UNILATERAL (Hearing loss unilateral) (seriousness criteria hospitalization and medically significant) and PYREXIA (Pyrexia) (seriousness criterion hospitalization). At the time of the report, SUDDEN HEARING LOSS (Sudden deafness), DEAFNESS UNILATERAL (Hearing loss unilateral) and PYREXIA (Pyrexia) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant product was not provided by the reporter. Treatment information was not provided. Company comment: This case concerns a 44 year-old female patient with no reported medical history who experienced the unexpected events of sudden hearing loss, unilateral deafness, and pyrexia. The events occurred approximately 2 days after the first dose of mRNA-1273 (Spikevax). The rechallenge was not applicable as only the first dose was administered. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report.; Sender''s Comments: This case concerns a 44 year-old female patient with no reported medical history who experienced the unexpected events of sudden hearing loss, unilateral deafness, and pyrexia. The events occurred approximately 2 days after the first dose of mRNA-1273 (Spikevax). The rechallenge was not applicable as only the first dose was administered. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report.


VAERS ID: 1746701 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Condition aggravated, Dysmenorrhoea, Electrocardiogram, Heart rate, Heart rate increased, Heavy menstrual bleeding, Menstruation irregular, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Fertility disorders (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heavy periods
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:unknown result; Test Date: 20210826; Test Name: heart rate; Result Unstructured Data: Test Result:BPM 130; Comments: increased heart rate; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225392

Write-up: painful period; period 2 weeks earlier than her expected period; Heavy periods, periods were usually heavy and not painful but this one was even heavier; Heavy periods, periods were usually heavy and not painful but this one was even heavier; Chest pain; Vomiting; Heart rate, increased heart rate (BPM 130); This is a spontaneous report from a contactable consumer. this is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161202574300-HC6DB, safety report unique identifier is GB-MHRA-ADR 25952221. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Aug2021 (at the age of 26-years old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included suspected covid-19 from 27Aug2021 to 29Aug2021. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation.The patient''s concomitant medications were not reported. The patient experienced heavy periods (heavy menstrual bleeding) (medically significant) on 29Aug2021 with outcome of recovered on 01Sep2021, chest pain (chest pain) (medically significant) on 27Aug2021 with outcome of recovered on 29Aug2021, heart rate (heart rate) (medically significant) on 26Aug2021 with outcome of recovered with sequelae on an unspecified date, vomiting (vomiting) (medically significant) on 27Aug2021 with outcome of recovered on 28Aug2021, painful period (dysmenorrhoea) (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included electrocardiogram: unknown results on Unknown Results , heart rate: bpm 130 on BPM 130 , sars-cov-2 test: negative on No - Negative COVID-19 test. Therapeutic measures were taken as a result of vomiting (vomiting). Additional Information: Patient is not pregnant,Patient is not currently breastfeeding I had a heavy, painful period 2 weeks earlier than my expected period. My periods are usually heavy and not painful but this one was even heavier and very painful. I also had severe chest pain roughly 10 hours after having the vaccine and increased heart rate (BPM 130), I had to call 111 who called me an ambulance. I also had excessive vomiting and had 3 anti-sickness jabs from the paramedic and GP. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Suspect Reactions Please provide details of any relevant investigations or tests conducted: "ECG " No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746856 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-08-26
   Days after vaccination:81
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dehydration, Kidney infection, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: nausea; high temperature; chills; Vomiting; Kidney infection; Dehydration; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25967318) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (Kidney infection), DEHYDRATION (Dehydration), NAUSEA (nausea), PYREXIA (high temperature), CHILLS (chills), VOMITING (Vomiting) and PYREXIA (Fever) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization). On 28-Aug-2021, the patient experienced KIDNEY INFECTION (Kidney infection) (seriousness criteria hospitalization and medically significant), DEHYDRATION (Dehydration) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). On an unknown date, the patient experienced NAUSEA (nausea) (seriousness criterion hospitalization), PYREXIA (high temperature) (seriousness criterion hospitalization) and CHILLS (chills) (seriousness criterion hospitalization). On 31-Aug-2021, DEHYDRATION (Dehydration), VOMITING (Vomiting) and PYREXIA (Fever) had resolved. At the time of the report, KIDNEY INFECTION (Kidney infection) was resolving and NAUSEA (nausea), PYREXIA (high temperature) and CHILLS (chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Two days after vaccination patient had fever, chills, high temperature, nausea and loss of appetite for a couple of days and dehydration. Patient was not felt well with those symptoms and also vomited. Admitted to hospital for four days with right pyelonephritis. They tested patient''s blood urine, chest x-ray and ultrasound but results weren''t provided. No concomitant medications reported No treatment medications provided Company comment:This case concerns a 30-year-old female subject with no relevant medical history, who experienced unexpected serious events of Kidney infection, Dehydration, nausea, pyrexia, chills and vomiting. The events started approximately 12 hours after the administration of the second dose of Moderna COVID-19 vaccine. The rechallenge is not applicable as no additional dosing will be given. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 30-year-old female subject with no relevant medical history, who experienced unexpected serious events of Kidney infection, Dehydration, nausea, pyrexia, chills and vomiting. The events started approximately 12 hours after the administration of the second dose of Moderna COVID-19 vaccine. The rechallenge is not applicable as no additional dosing will be given. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1746873 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: FOLIC ACID.
Current Illness: Arthritis; Collagen disorder (I have a condition called Ehlers Danlos Syndrome, which is a low amount of collagen in the body.); Depression; Fibromyalgia.
Preexisting Conditions: Medical History/Concurrent Conditions: Heart murmur; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Maternal exposure during pregnancy; High temperature; Miscarriage; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25972265) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 31-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. The patient''s past medical history included Heart murmur and Pregnancy (Patient no longer pregnant at the time of reporting.) on 14-Aug-2021. Concurrent medical conditions included Fibromyalgia, Depression, Arthritis and Collagen disorder (I have a condition called Ehlers Danlos Syndrome, which is a low amount of collagen in the body.). Concomitant products included FOLIC ACID for Folic acid supplementation. On 19-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 26-Aug-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and PYREXIA (High temperature). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and PYREXIA (High temperature) was resolving and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient was pregnant on the 14th August 2021, approximately 6 weeks pregnant. She was getting darker positive tests each day the 20th she did another pregnancy test, which was a lighter positive, and then the next day 21st August the pregnancy test she did was completely negative, no 2nd line at all. She did a urine sample for her GP to send to the hospital, which came back negative on the 27th August, which was also the day she started to lose her baby. She miscarried over the weekend which was also her son''s birthday and during the following week.. 2 previous successful pregnancies. Patient was exposed to the medicine in first-trimester 1 12 weeks. No treatment medication were provided. This case concerns a 31-year-old male patient with reported medical history OF Fibromyalgia, Depression, Arthritis and Ehlers Danlos Syndrome who experienced abortion spontaneous 8 days after maternal exposure during pregnancy and pyrexia Unspecified days after second dose of Spikevax. The reporter did not provide causality assessment. Patient experienced AEs after second dose and no information about the first dose is available rechallenge is not applicable as no additional dosing will be given. The benefit-risk relationship of Spikevax in not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2021: Follow up received on 26th September 2021 included: medical history Ehlers-Danlos syndrome.; Sender''s Comments: This case concerns a 31-year-old male patient with reported medical history OF Fibromyalgia, Depression, Arthritis and Ehlers Danlos Syndrome who experienced abortion spontaneous 8 days after maternal exposure during pregnancy and pyrexia Unspecified days after second dose of Spikevax. The reporter did not provide causality assessment. Patient experienced AEs after second dose and no information about the first dose is available rechallenge is not applicable as no additional dosing will be given. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1747026 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049283017 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental overdose, Erythema, Maternal exposure during pregnancy
SMQs:, Anaphylactic reaction (broad), Drug abuse and dependence (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypersensitivity (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Maternal exposure during pregnancy; accidental overdose; This case was received via regulatory authority (Reference number: IT-MINISAL02-785232) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ERYTHEMA in a 12-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049283017) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 milliliter. Last menstrual period and estimated date of delivery were not provided. On 26-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and ACCIDENTAL OVERDOSE (accidental overdose). On 09-Sep-2021, the patient experienced ERYTHEMA (seriousness criterion disability). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 26-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and ACCIDENTAL OVERDOSE (accidental overdose) had resolved. At the time of the report, ERYTHEMA had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant and treatment medications were not provided. This case concerns a 12-year-old, female subject with no relevant history reported, who experienced the unexpected events of vaccine exposure during pregnancy and ERYTHEMA. The patient received the first dose of vaccine at 28 weeks of gestation and erythema occurred fourteen days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation received on 24-sep-21 and contains no new information.; Sender''s Comments: This case concerns a 12-year-old, female subject with no relevant history reported, who experienced the unexpected events of vaccine exposure during pregnancy and ERYTHEMA. The patient received the first dose of vaccine at 28 weeks of gestation and erythema occurred fourteen days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1747318 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004224 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, COVID-19 immunisation, Chest pain, Echocardiogram, Fatigue, Fibrin D dimer, Headache, Hypotension, Leukopenia, Nausea, Neutrophil count, Platelet count, Taste disorder, Thrombocytopenia, Transaminases, White blood cell count
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVAXIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Echocardiography; Result Unstructured Data: No signs of pericarditis, pericardial fluid or flap pathology; Test Date: 202108; Test Name: Fibrin D dimer; Result Unstructured Data: Slightly elevated; Test Date: 202108; Test Name: Neutrophil count; Result Unstructured Data: Test result 0.8 10*9/L; Test Date: 202108; Test Name: Thrombocyte count; Result Unstructured Data: Lowest measured value: 119 x 10*9/L; Test Date: 20210908; Test Name: Thrombocyte count; Result Unstructured Data: 10*9/L (billion per litre); Test Date: 20210908; Test Name: Transaminase NOS; Result Unstructured Data: Persistently slightly increased; Test Date: 202108; Test Name: Leucocyte count; Result Unstructured Data: Lowest measured value: 1.7 x 10*9/L; Test Date: 20210908; Test Name: Leucocyte count; Result Unstructured Data: Normal
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: IMPAIRED TASTE; TIREDNESS; CHEST PAIN; THROMBOCYTOPENIA; LEUCOPENIA; HYPOTENSION; NAUSEA; HEADACHE; BACK PAIN; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This case was received via Regulatory Agency (Reference number: NO-NOMAADVRE-E2B_00050581) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of TASTE DISORDER (IMPAIRED TASTE), FATIGUE (TIREDNESS), CHEST PAIN (CHEST PAIN), THROMBOCYTOPENIA (THROMBOCYTOPENIA), LEUKOPENIA (LEUCOPENIA), HYPOTENSION (HYPOTENSION), NAUSEA (NAUSEA), HEADACHE (HEADACHE) and BACK PAIN (BACK PAIN) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004224) for Vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Vaccination: Comirnaty since an unknown date. Past adverse reactions to the above products included No adverse event with Comirnaty. Concomitant products included LEVOTHYROXINE SODIUM (LEVAXIN) for Hypothyreosis. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced TASTE DISORDER (IMPAIRED TASTE) (seriousness criterion hospitalization), FATIGUE (TIREDNESS) (seriousness criterion hospitalization), CHEST PAIN (CHEST PAIN) (seriousness criterion hospitalization), THROMBOCYTOPENIA (THROMBOCYTOPENIA) (seriousness criteria hospitalization and medically significant), LEUKOPENIA (LEUCOPENIA) (seriousness criteria hospitalization and medically significant), HYPOTENSION (HYPOTENSION) (seriousness criterion hospitalization), NAUSEA (NAUSEA) (seriousness criterion hospitalization), HEADACHE (HEADACHE) (seriousness criterion hospitalization) and BACK PAIN (BACK PAIN) (seriousness criterion hospitalization). On an unknown date, the patient experienced COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE). On 07-Sep-2021, TASTE DISORDER (IMPAIRED TASTE), FATIGUE (TIREDNESS), CHEST PAIN (CHEST PAIN), THROMBOCYTOPENIA (THROMBOCYTOPENIA), LEUKOPENIA (LEUCOPENIA), HYPOTENSION (HYPOTENSION), NAUSEA (NAUSEA), HEADACHE (HEADACHE) and BACK PAIN (BACK PAIN) was resolving. At the time of the report, COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Echocardiogram: normal (normal) No signs of pericarditis, pericardial fluid or flap pathology. In August 2021, Fibrin D dimer: slightly elevated (High) Slightly elevated. In August 2021, Neutrophil count: 0.8 billion per litre (Low) Test result 0.8 10*9/L. In August 2021, Platelet count: 119 x 10*9/l (Low) Lowest measured value: 119 x 10*9/L. In August 2021, White blood cell count: 1.7 x 10*9/l (Low) Lowest measured value: 1.7 x 10*9/L. On 08-Sep-2021, Platelet count: 483 billion per litre (High) 10*9/L (billion per litre). On 08-Sep-2021, Transaminases: persistently slightly increased (High) Persistently slightly increased. On 08-Sep-2021, White blood cell count: normal (normal) Normal. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered TASTE DISORDER (IMPAIRED TASTE), FATIGUE (TIREDNESS), CHEST PAIN (CHEST PAIN), THROMBOCYTOPENIA (THROMBOCYTOPENIA), LEUKOPENIA (LEUCOPENIA), HYPOTENSION (HYPOTENSION), NAUSEA (NAUSEA), HEADACHE (HEADACHE) and BACK PAIN (BACK PAIN) to be possibly related. No further causality assessment was provided for COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE). On unknown date Aug 2021 Computerised tomogram thorax was performed result No findings Concomitant medications was not provided by the reporter Treatment information was not provided Company Comment; This case concerns a 44-year-old female patient with medical history of vaccination with Comirnaty COVID-19 vaccine, who experienced the unexpected, serious events of taste disorder, fatigue, chest pain, thrombocytopenia, leukopenia, hypotension, nausea, headache and back pain. Revaccination with different COVID-19 vaccine was also reported. The events occurred approximately 1 day after first dose of Spikevax. The rechallenge was unknown. The benefit-risk relationship of Spikevax is not affected by this report. Coding, seriousness, and dates of events were captured as per Regulatory Authority assessment provided in Source Document. Translation is expected.; Sender''s Comments: This case concerns a 44-year-old female patient with medical history of vaccination with Comirnaty COVID-19 vaccine, who experienced the unexpected, serious events of taste disorder, fatigue, chest pain, thrombocytopenia, leukopenia, hypotension, nausea, headache and back pain. Revaccination with different COVID-19 vaccine was also reported. The events occurred approximately 1 day after first dose of Spikevax. The rechallenge was unknown. The benefit-risk relationship of Spikevax is not affected by this report. Coding, seriousness, and dates of events were captured as per Regulatory Authority assessment provided in Source Document. Translation is expected.


VAERS ID: 1747366 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3430 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia
SMQs:, Arrhythmia related investigations, signs and symptoms (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 INC202101219778

Write-up: Bradycardia; This is a spontaneous report from a contactable healthcare professional received from the Regulatory Authority(Regulatory Authority report number: PH-PHFDA-300104805). A 25-year-old male patient received BNT162B2 (COMIRNATY, Lot Number: FE3430; Expiration date was not reported), intramuscular on 26Aug2021 as dose number unknown, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 26Aug2021 (10:57), the patient had bradycardia. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1747417 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004493 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
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: ELIQUIS
Current Illness: Asthma; Hypothyreosis; Pulmonary embolism
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: This case was received via a regulatory authority (Reference number: SE-MPA-2021-079989) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004493) for COVID-19 vaccination. The patient''s past medical history included COVID-19 in March 2021. Concurrent medical conditions included Pulmonary embolism since March 2021, Hypothyreosis and Asthma. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 24-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by reporter. No treatment medications provided by the reporter. Company comment: This case concerns a 23-year-old, male patient with no relevant medical history, who experienced the expected event of myocarditis. The event myocarditis occurred 2 days after the unknown dose of mRNA-1273 vaccine administration. The rechallenge was not applicable since the only information about this unknown dose number was disclosed. No product report assessment was given from the reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translated Document received on 27-SEP-2021 contains NNI.; Sender''s Comments: This case concerns a 23-year-old, male patient with no relevant medical history, who experienced the expected event of myocarditis. The event myocarditis occurred 2 days after the unknown dose of mRNA-1273 vaccine administration. The rechallenge was not applicable since the only information about this unknown dose number was disclosed. No product report assessment was given from the reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1749197 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-08-26
   Days after vaccination:121
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Nasopharyngitis, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210831; Test Name: Coronavirus SARS-CoV-2 PCR; Test Result: Positive
CDC Split Type: DEPFIZER INC202101207917

Write-up: Vaccination failure; COVID-19; cough; Sore throat; Cold; Fever; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100187437. A 55-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 27Apr2021 (Batch/Lot Number: EX3510) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: ER9480) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient became ill on 26Aug2021 with cough, sore throat, cold and fever. In the smear taken on 31Aug2021 Coronavirus SARS-CoV-2 PCR positive. The outcome of the events was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31Aug2021. Relatedness: COVID-19 - Comirnaty both doses/ Regulatory Authority/ B. Indeterminate Sender''s comments: Initials PRIVACY Patient became ill on 26Aug2021 with cough, sore throat, cold and fever. In the smear taken on 31Aug2021 Coronavirus SARS-CoV-2 PCR positive. No follow-up attempts possible. No further information expected.


VAERS ID: 1749295 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-08-26
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003602 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Amniorrhexis, Blood test, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Ultrasound abdomen, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: Blood test; Result Unstructured Data: Blood count: Hb 13.3 g/dl, leukos 9900 (N 66%), Plt 226000 - Coagulation: normal - Biochemistry: normal CRP: 1.5 - Urine sed.: ketones 15, RBC 250, rest normal; Test Date: 20210904; Test Name: Ultrasound abdomen; Result Unstructured Data: single fetus, LF+, MF+, Reduced AF, normal placental insertion.
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Drug exposure during pregnancy; Inappropriate schedule of vaccine administered; This case was initially received via the RA (Reference number: ES-AEMPS-994777) on 17-Sep-2021. The most recent information was received on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority prospective pregnancy case was reported by a physician and describes the occurrence of VAGINAL HAEMORRHAGE, AMNIORRHEXIS and MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3005695 and 3003602) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 26-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 04-Sep-2021, the patient experienced VAGINAL HAEMORRHAGE (seriousness criterion hospitalization prolonged), AMNIORRHEXIS (seriousness criterion hospitalization prolonged) and MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) (seriousness criterion hospitalization prolonged). On 26-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, VAGINAL HAEMORRHAGE, AMNIORRHEXIS and MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, Blood test: normal Blood count: Hb 13.3 g/dl, leukos 9900 (N 66%), Plt 226000 - Coagulation: normal - Biochemistry: normal CRP: 1.5 - Urine sed.: ketones 15, RBC 250, rest normal. On 04-Sep-2021, Ultrasound abdomen: normal single fetus, LF+, MF+, Reduced AF, normal placental insertion.. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No Treatment medications were reported. No Concomitant medications were reported. Company Comment: This case concerns a 42-year-old, female patient with no relevant medical history, who experienced the unexpected events of Vaginal haemorrhage and Amniorrhexis. Vaccine exposure during pregnancy and Inappropriate schedule of vaccine administered were considered as additional events. Last menstrual period and estimated date of delivery were not provided. The events occurred approximately 9 days after the second dose of Spikevax. The rechallenge was not applicable since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation received on 23-sep-2021 of initial document and lab test result and dosage text were updated. On 23-Sep-2021: Significant follow up received and added event, updated onset latency and onset from last dose; Sender''s Comments: This case concerns a 42-year-old, female patient with no relevant medical history, who experienced the unexpected events of Vaginal haemorrhage and Amniorrhexis. Vaccine exposure during pregnancy and Inappropriate schedule of vaccine administered were considered as additional events. Last menstrual period and estimated date of delivery were not provided. The events occurred approximately 9 days after the second dose of Spikevax. The rechallenge was not applicable since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1750709 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-26
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acoustic neuroma; Herniated disc; Prolapsed disc NOS
Allergies:
Diagnostic Lab Data: Test Name: Magnetic Resonance Imaging; Result Unstructured Data: Test Result:facial paralysis confirmed
CDC Split Type: FRPFIZER INC202101228994

Write-up: Facial palsy; This is a spontaneous report from a contactable consumer or other non-health care professional downloaded from the regulatory authority -WEB, regulatory authority number FR-AFSSAPS-DJ20213611. A 31-year-old female patient received BNT162B2 (COMIRNATY; solution for injection, Lot Number: unknown) via intramuscularly, on unspecified date of Jul2021 as a dose 1, single and second dose of BNT162B2 (COMIRNATY; solution for injection, Lot Number: unknown) via intramuscularly, in right arm on 19Aug2021 as a dose 2, single for COVID-19 immunization. The patient''s medical history included acoustic neuroma, prolapsed disc and disc herniation. The concomitant medication of the patient was not reported. On 26Aug2021 the patient experienced facial palsy. One week after the injection of the first dose, she had already presented with facial paralysis on the left side which quickly resolved. The paralysis that appeared after the second dose was more pronounced, stronger and was still present at the time of the report on 10Sep2021. The patient had emergency room visit. The patient underwent lab tests and procedures which included magnetic resonance imaging: facial paralysis confirmed on unknown date. Outcome of the reported event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1750761 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214005 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Facial paralysis, Hemiparesis, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (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: Obesity
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Hemiparesis (left); ; This case was received via Regulatory Authority (Reference number: AFSSAPS-NY20214204) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of HEMIPARESIS (Hemiparesis (left)) and FACIAL PARALYSIS (Facioplegia) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214005) for COVID-19 vaccination. The patient''s past medical history included COVID-19. Concurrent medical conditions included Obesity. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced HEMIPARESIS (Hemiparesis (left)) (seriousness criterion medically significant) and FACIAL PARALYSIS (seriousness criterion medically significant). At the time of the report, HEMIPARESIS (Hemiparesis (left)) and FACIAL PARALYSIS was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medications were provided. This case concerns a 42 year old female patient with no relevant medical history, who experienced the unexpected event of hemiparesis and the expected event of facial paralysis. The events occurred the same day after the first dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable as this is the first dose. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.; Reporter''s Comments: COVID-19. .; Sender''s Comments: This case concerns a 42 year old female patient with no relevant medical history, who experienced the unexpected event of hemiparesis and the expected event of facial paralysis. The events occurred the same day after the first dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable as this is the first dose. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1750966 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dysmenorrhoea, Hyperhidrosis, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226720

Write-up: lightheadedness; sweating; Painful periods; This is a spontaneous report from a contactable consumer (Patient). This is a report received from the Regulatory Authority(UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109170914146850-KCJ0A. Safety Report Unique Identifier GB-MHRA-ADR 25957749. A 25-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was FF3319) via an unspecified route of administration on 24Aug2021 as DOSE 1, SINGLE for COVID-19 immunization. Patient is not currently breastfeeding. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced light-headedness on an unspecified date, sweating on an unspecified date, painful periods on 26Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (No-Negative COVID-19 test). The outcome of Event for painful periods was recovered on 28Aug2021 and for others was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1751046 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Pain of skin, SARS-CoV-2 test
SMQs:, Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226983

Write-up: Skin pain; Headache; Joint ache; Tiredness; This is a spontaneous report from a contactable consumer received from a Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109171743185470-JQPC9, Safety Report Unique Identifier GB-MHRA-ADR 25960499. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF3319) via an unspecified route of administration, on 26Aug2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced headache on 26Aug2021 with outcome of not recovered, joint ache on 26Aug2021 with outcome of not recovered, tiredness on 26Aug2021 with outcome of not recovered, skin pain on 27Aug2021 with outcome of recovered on 31Aug2021. The patient has been tested for COVID-19 on an unspecified date and resulted negative. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1751169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Hypomenorrhoea, Intermenstrual bleeding, Myalgia, Suspected COVID-19
SMQs:, Rhabdomyolysis/myopathy (broad), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Eosinophilic pneumonia (broad), Fertility disorders (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101226515

Write-up: Drug ineffective; Light periods; Suspected COVID-19; Spotting menstrual; Muscle ache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109181633559740-LKB6Q. Safety Report Unique Identifier is GB-MHRA-ADR 25964934. A 21-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: Not known) via unspecified route of administration on 25Aug2021 as Dose 2 Single for COVID-19 immunization. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: Not known) on an unknown date via an unspecified route of administration as Dose 1 single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient has not tested positive for COVID-19 since having the vaccine and not had a COVID-19 test. The patient was not enrolled in clinical trial. The patient was not currently breastfeeding. On 26Aug2021 (1 day after vaccination), the patient experienced muscle ache. On 16Sep2021 (22 days after vaccination), the patient experienced spotting menstrual. On 17Sep2021 (23 days after vaccination), the patient experienced light periods and suspected COVID-19. All events were medically significant. The outcome of event muscle ache was resolved on 26Aug2021 while the outcome of the events spotting menstrual and light periods was resolving and suspected COVID-19 was not resolved. No follow-up attempts are possible


VAERS ID: 1751577 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-08-26
   Days after vaccination:219
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH E1484 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210428; Test Name: COVID-19 antibody test; Result Unstructured Data: Test Result:2594,3 IU/ml; Test Date: 20210825; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Test done on 25Aug2021, positive result on 26Aug2021.
CDC Split Type: PTPFIZER INC202101250492

Write-up: Vaccine failure associated with the use of Comirnaty; COVID-19; This is a spontaneous report from a contactable pharmacist downloaded from the WEB. This is a report received from INFARMED Regulatory authority report number PT-INFARMED-F202109-1589 [Worldwide unique case identification number] with Safety Report Unique Identifier PT-INFARMED-F202109-1589. A 30-years-old male patient received bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot Number: EJ6797, expiry date was unknown) via intramuscular route of administration on 29Dec2020 as dose1, 0.3ml single for COVID-19 immunisation, and received second dose(Lot Number: E1484, expiry date was unknown) via intramuscular route of administration on 19Jan2021 as dose2, 0.3ml single for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. There was no suspicion of drug interactions. No previous reactions to other drugs or identified allergies are known. There was no reference to the taking of concomitant medications and/or reference to the concomitant consumption of other types of products. There was no history of comorbidities. Hospital pharmacist reported that patient presented with COVID SARS-CoV-2 (asymptomatic) vaccine failure associated with the use of Comirnaty/mRNA vaccine against the COVID-19 (with modified nucleoside), 30 ug/0.3 mL, concentrate for injectable dispersion (1st dose lot number: EJ6797; 2nd dose lot number: EL1484), in 2nd dose of 2, for active immunization against COVID -19, with a dosage of 2 intramuscular doses (0.3 ml each) with an interval of at least 21 days between each dose. There is no relevant clinical history. Information on previous infection with the SARS-CoV-2 virus was unknown. Vaccine failure was identified around 218 days after the dose 2 of the vaccine, with an approximate duration of 10 days. According to information provided by the institution occupational medicine, the individual is currently asymptomatic. The patient underwent lab tests and procedures which included COVID-19 antibody test: 2594,3 IU/ml on 28Apr2021, COVID-19 PCR test: positive on 25Aug2021 Test done on 25Aug2021, positive result on 26Aug2021. The need for specific treatment of SARS-CoV-2 infection is unknown. Outcome of the events was resolved on 04sep2021. The reporter assessment of the causal relationship of the Vaccination failure and COVID-19 with the suspect product was: Relatedness of drug to reaction(s)/event(s) Vaccinacion failure and covid-19: Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: definitive. No follow-up attempts are possible. No further information expected.


VAERS ID: 1751591 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-26
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202101237390

Write-up: Vaccine against COVID-19 - Vaccine failure - User with a complete vaccine schedule for $g2 weeks had COVID-19; COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number PT-INFARMED-T202109-117. A 27-years-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: FF0680), via intramuscular on 14Jul2021 as dose 1, 0.3 ML single and received the second dose of BNT162B2 (COMIRNATY, solution for injection; Lot Number: FE4728), via intramuscular on 11Aug2021 as dose 2, 0.3 single for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 26Aug2021, the patient experienced vaccine against covid-19 - vaccine failure, user with a complete vaccine schedule for $g2 weeks had covid-19. Onset of symptoms was associated with SARS-CoV-2 infection on the day of the test. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Aug2021 Positive Iu international unit(s). The outcome of the events were unknown. The reporter assessment of the causal relationship of the vaccination failure and COVID-19 with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Reporter Comment: Other information-Symptoms starting on 26Aug2021 Test carried out on 26Aug2021 No follow-up attempts are possible. No further information expected.; Reporter''s Comments: Other information-Symptoms starting on 26Aug2021 Test carried out on 26Aug2021


VAERS ID: 1751593 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-08-26
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Positive (IU) in international units
CDC Split Type: PTPFIZER INC202101236970

Write-up: Vaccine against COVID-19 - Vaccine failure - User with a complete vaccine schedule for $g2 weeks had COVID-19; COVID-19; This is a Spontaneous report from a contactable physician downloaded from the WEB. This report received from INFARMED Regulatory authority report number PT-INFARMED-T202109-142 with Safety Report Unique Identifier PT-INFARMED-T202109-142. A 47-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FA4632) via an intramuscular route of administration on an 14Jun2021 as Dose 1, 0.3 ml, Single and received second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FE1573) via intramuscular route of administration on an 12Jul2021 as Dose 2, 0.3 ml, Single for COVID-19 immunization. The patient''s medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced vaccine against COVID-19 - vaccine failure - user with a complete vaccine schedule for 2 weeks had COVID-19 and had COVID-19 on 26Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Aug2021 Positive (IU) in international units. The patient had adverse event after dose 2. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information: Other information: symptoms starting on 26Aug2021. Test performed on 27Aug2021.


VAERS ID: 1752891 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diagnostic procedure, Pain in extremity, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: Diagnostic procedure; Test Result: Negative; Result Unstructured Data: (for blood clot) It was not a blood clot.
CDC Split Type: DKMODERNATX, INC.MOD20213

Write-up: Sensory disturbance in the same side as the 2nd vaccinaiton. This time given in the thigh; Pain in the leg, s? I can only walk with great pain following the second vaccination; Severe "cold trips" where the body shakes following the second vaccination; Sensory disturbance in the same side as the 1st vaccinaiton, especially in the face; This case was received via Regulatory Authority (Reference number: DK-DKMA-ADR 25898706) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SENSORY DISTURBANCE (Sensory disturbance in the same side as the 2nd vaccinaiton. This time given in the thigh), PAIN IN EXTREMITY (Pain in the leg, s? I can only walk with great pain following the second vaccination), CHILLS (Severe "cold trips" where the body shakes following the second vaccination) and SENSORY DISTURBANCE (Sensory disturbance in the same side as the 1st vaccinaiton, especially in the face) in a 36-year-old male patient who received mRNA-1273 (batch nos. 3004954 and 3004730) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced SENSORY DISTURBANCE (Sensory disturbance in the same side as the 1st vaccinaiton, especially in the face) (seriousness criterion hospitalization). On 05-Sep-2021, after starting mRNA-1273, the patient experienced SENSORY DISTURBANCE (Sensory disturbance in the same side as the 2nd vaccinaiton. This time given in the thigh) (seriousness criterion hospitalization). In September 2021, the patient experienced PAIN IN EXTREMITY (Pain in the leg, s? I can only walk with great pain following the second vaccination) (seriousness criterion hospitalization) and CHILLS (Severe "cold trips" where the body shakes following the second vaccination) (seriousness criterion hospitalization). At the time of the report, SENSORY DISTURBANCE (Sensory disturbance in the same side as the 2nd vaccinaiton. This time given in the thigh), PAIN IN EXTREMITY (Pain in the leg, s? I can only walk with great pain following the second vaccination) and CHILLS (Severe "cold trips" where the body shakes following the second vaccination) had not resolved and SENSORY DISTURBANCE (Sensory disturbance in the same side as the 1st vaccinaiton, especially in the face) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Diagnostic procedure: negative (Negative) (for blood clot) It was not a blood clot.. mRNA-1273 (Unknown) dosing remained unchanged. No concomitant medication was reported. Treatment medication was not provided by the reporter. Company Comment: This case concerns a 36 year old male patient, with no medical history reported who experienced the unexpected event of sensory disturbance after the first dose of mRNA-12 and sensory disturbance, chills and pain in extremity after second dose of mRNA-1273. The events occurred the same day after receiving mRNA-1273. Regarding the event sensory disturbance rechallenge is positive and for the events chills and pain in extremity rechallenge is not applicable The benefit-risk relationship is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow-up received with no new information; Sender''s Comments: This case concerns a 36 year old male patient, with no medical history reported who experienced the unexpected event of sensory disturbance after the first dose of mRNA-12 and sensory disturbance, chills and pain in extremity after second dose of mRNA-1273. The events occurred the same day after receiving mRNA-1273. Regarding the event sensory disturbance rechallenge is positive and for the events chills and pain in extremity rechallenge is not applicable The benefit-risk relationship is not affected by this report.


VAERS ID: 1753074 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-08-26
   Days after vaccination:188
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Variant PCR-based: B.1.617.2; Result Unstructured Data: Test Result:possitive; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n.a. n501y-positive: No.
CDC Split Type: ATPFIZER INC202101238945

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number AT-BASGAGES-2021-044541. A 44-years-old female patient received second dose of BNT162B2 (COMIRANTY; Solution for injection, Batch/Lot Number: EP2163, expiration date: unknown), via intramuscular on 19Feb2021 as dose 2, single and dose 1 intramuscular on 20Jan2021 (Batch/Lot Number: EL1491, expiration date: unknown) as dose 1, single for COVID-19 immunization. The patient''s medical history and concurrent conditions included: no relevant medical history reported. No concomitant medication was reported. On 26Aug2021, the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive (Variant PCR-based: B.1.617.2 Sequenced variant: n.a. n501y-positive: No). The outcome of the events was unknown. No follow-up attempts were possible, no information was expected.


VAERS ID: 1754818 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic dilatation, Blood creatinine, C-reactive protein, Cardiac monitoring, Echocardiogram, Fibrin D dimer, Haemoglobin, Haemoglobin decreased, Investigation, Myocarditis, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Pericardial effusion, Platelet count, Pyrexia, SARS-CoV-2 test, Troponin, White blood cell count
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210829; Test Name: Creatinine; Result Unstructured Data: Test Result:40 umol/l; Test Date: 2021; Test Name: Cardiac oscilloscope across 48H; Result Unstructured Data: Test Result:no rhythm disturbance; Test Date: 20210829; Test Name: C-reactive protein; Result Unstructured Data: Test Result:4.8 mg/l; Test Date: 20210901; Test Name: C-reactive protein; Result Unstructured Data: Test Result:0.6 mg/l; Test Date: 20210829; Test Name: cardiac ultrasound; Result Unstructured Data: Test Result:minimal pericardial effusion at the bottom; Comments: dilated aortic root, normal kinetics, ventricular and valvular functions; Test Date: 20210901; Test Name: cardiac ultrasound; Result Unstructured Data: Test Result:no pericardial effusion; Test Date: 20210829; Test Name: D-dimers; Result Unstructured Data: Test Result:less than 270 ng/ml; Test Date: 2021; Test Name: Haemoglobin; Result Unstructured Data: Test Result:13.1 g/dl; Test Date: 20210829; Test Name: Clinical examination; Result Unstructured Data: Test Result:apyretic, regular heart sound, no audible murmur,; Comments: no rubbing. No pain on chest palpation. Eupneic.; Test Date: 2021; Test Name: neutrophils; Result Unstructured Data: Test Result:1.71 g/l; Test Date: 2021; Test Name: NT-proB-type Natriuretic Peptide; Result Unstructured Data: Test Result:111 pg/mL; Test Date: 2021; Test Name: platelets; Result Unstructured Data: Test Result:207 g/l; Test Date: 20210512; Test Name: COVID-19 test; Result Unstructured Data: Test Result:No COVID-19 (negative); Test Date: 20210829; Test Name: troponin; Result Unstructured Data: Test Result:2915 ng/L; Test Date: 20210830; Test Name: troponin; Result Unstructured Data: Test Result:638 ng/L; Test Date: 20210901; Test Name: troponin; Result Unstructured Data: Test Result:50 ng/L; Test Date: 2021; Test Name: white blood cells; Result Unstructured Data: Test Result:4.5 g/l
CDC Split Type: FRPFIZER INC202101229435

Write-up: Myopericarditis; slight pericardial effusion; dilated aortic root; Fever; Haemoglobin 13.1 g/dL; This is a spontaneous report from a contactable pharmacist downloaded from the RA. The regulatory authority report number is FR-AFSSAPS-BX20218363. A 12-year-old male patient received BNT162B2 (COMIRNATY, lot number and expiration date were unknown), intramuscular on 25Aug2021 at dose 2, single for COVID-19 immunisation. Medical history included asthma. He has no history of COVID as evidenced by a test performed on 12May2021 which was negative. The patient''s concomitant medications were not reported. Family history included her mother having a history of viral pericarditis. The patient previously received BNT162B2 (COMIRNATY, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at dose 1, single for COVID-19 immunisation. There was no information on the tolerance of the first dose. On 27Aug2021, the patient experienced myopericarditis associated with a slight pericardial effusion which required hospitalization from 29Aug2021. The course of events was as follows: Fever spiked on 26Aug2021, 1 day after vaccination, then during the night from 27Aug2021 to 28Aug221, day 2 to day 3 after vaccination, progressive chest pain occurred, these were resolved with paracetamol. There was a recurrence of pain during the night from 28Aug2021 to 29Aug2021, day 3 to day 4 after vaccination, with resistance to paracetamol. The patient was then hospitalized on 29Aug2021. On 29Aug2021, clinical examination included being apyretic, with regular heart sound, no audible murmur, no rubbing. No pain on chest palpation. Eupneic. Blood tests on 29Aug2021 included creatinine: 40 umol/L, C-reactive protein: 4.8 mg/L, D-dimers: less than 270 ng/mL, and troponin: 2915 ng/L. Cardiac ultrasound on 29Aug2021: minimal pericardial effusion at the bottom, dilated aortic root, normal kinetics, ventricular and valvular functions. On 30Aug2021, troponin was 638 ng/L. On 01Sep2021, C-reactive protein: 0.6 mg/L, control cardiac ultrasound: no pericardial effusion, and troponin: 50 ng/L. On an unspecified date in 2021, cardiac oscilloscope across 48H: no rhythm disturbance, haemoglobin: 13.1 g/dL, neutrophils: 1.71 g/L, NT-proB-type natriuretic peptide (NTBNP): 111 pg/mL, platelets: 207 g/L, and white blood cells: 4.5 g/L. There was a lack of information on aetiological assessment, especially regarding infections. Magnetic resonance imaging was prescribed after discharge. Therapeutic measures were taken as a result of "myopericarditis", "slight pericardial effusion", and "fever" and included treatment with aspirin, paracetamol, and lansoprazole. The outcome of the event "myopericarditis" was recovering; recovered on 01Sep2021 for "slight pericardial effusion"; recovered on Aug2021 for "fever"; and unknown for all other events. Note: Accountability without prejudice to further investigations that could be carried out as part of legal or amicable compensation procedures. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1755146 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-26
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Menstrual flooding; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25981330) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Menstrual flooding) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Menstrual flooding) (seriousness criterion medically significant). At the time of the report, HEAVY MENSTRUAL BLEEDING (Menstrual flooding) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that patient experienced significant increase in blood loss during monthly menstrual cycle. No concomitant medication information was reported. No treatment information was reported. Company Comment: This case concerns a 44-year-old, female patient with no relevant medical history, who experienced the unexpected event of Heavy menstrual bleeding. The event occurred approximately 14 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity; Sender''s Comments: This case concerns a 44-year-old, female patient with no relevant medical history, who experienced the unexpected event of Heavy menstrual bleeding. The event occurred approximately 14 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1755364 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005244 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Disorientation, Head discomfort, Ocular discomfort
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: This case was received via Regulatory Agency (Reference number: IT-MINISAL02-787072) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT, OCULAR DISCOMFORT and DISORIENTATION in a 38-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005244) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 26-Aug-2021, the patient experienced HEAD DISCOMFORT (seriousness criterion medically significant), OCULAR DISCOMFORT (seriousness criterion medically significant) and DISORIENTATION (seriousness criterion medically significant). At the time of the report, HEAD DISCOMFORT, OCULAR DISCOMFORT and DISORIENTATION was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medication were reported. No treatment information was provided by the reporter. After vaccination Patient were experienced with sense of significant disorientation even for simple actions. Feeling of a heavy head, in particular on the left, and was suffered with irritation in the left eye. Company comment: This case concerns a 38-year-old female subject, with no relevant medical history, who experienced the unexpected serious events of HEAD DISCOMFORT, OCULAR DISCOMFORT and DISORIENTATION. The events occurred approximately 4 days after the administration of a dose of Spikevax vaccine. The rechallenge is not applicable since it cannot be assessed (there is no information about which dose gave the adverse events). The benefit-risk relationship of Spikevax vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Additional information received on 28-SEP-2021 that contains updated Narrative.; Sender''s Comments: This case concerns a 38-year-old female subject, with no relevant medical history, who experienced the unexpected serious events of HEAD DISCOMFORT, OCULAR DISCOMFORT and DISORIENTATION. The events occurred approximately 4 days after the administration of a dose of Spikevax vaccine. The rechallenge is not applicable since it cannot be assessed (there is no information about which dose gave the adverse events). The benefit-risk relationship of Spikevax vaccine is not affected by this report.


VAERS ID: 1755513 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-08-26
   Days after vaccination:117
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Aspartate aminotransferase, Basophil count, Blood creatinine, Blood lactate dehydrogenase, Blood potassium, Blood sodium, C-reactive protein, Diplopia, Dizziness, Dysarthria, Echocardiogram, Electrocardiogram, Eosinophil count, Gamma-glutamyltransferase, Glomerular filtration rate, Haematocrit, Haemoglobin, Headache, Heart rate, International normalised ratio, Lymphocyte count, Magnetic resonance imaging, Monocyte count, Nausea, Neutrophil count, Platelet count, Thalamic infarction, White blood cell count
SMQs:, Acute pancreatitis (broad), 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), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Ocular motility disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: APTT; Test Result: 26 s; Test Date: 202108; Test Name: ALAT (SGPT); Result Unstructured Data: Test Result:33 IU/l; Test Date: 202108; Test Name: ASAT (SGOT); Result Unstructured Data: Test Result:28 IU/l; Test Date: 202108; Test Name: Basophil granulocytes; Result Unstructured Data: Test Result:0.06 x10 9/l; Test Date: 202108; Test Name: Creatinine; Result Unstructured Data: Test Result:64 umol/l; Test Date: 202108; Test Name: LDH; Result Unstructured Data: Test Result:159 IU/l; Test Date: 202108; Test Name: Potassium; Result Unstructured Data: Test Result:4.5 mmol/L; Test Date: 202108; Test Name: Sodium; Result Unstructured Data: Test Result:137 mmol/L; Test Date: 202108; Test Name: CRP 2 mg/l; Result Unstructured Data: Test Result:2 mg/l; Test Date: 202108; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:no signs of cardiac source for embolism; Test Date: 202108; Test Name: echo cor; Result Unstructured Data: Test Result:Good LV and RV function; Test Date: 202108; Test Name: ECG; Result Unstructured Data: Test Result:HR 66bpm, intermediate axis; Test Date: 202108; Test Name: Eosinophil granulocytes; Result Unstructured Data: Test Result:0.09 x10 9/l; Test Date: 202108; Test Name: Gamma-GT; Result Unstructured Data: Test Result:28 IU/l; Test Date: 202108; Test Name: estimated glomerular filtration rate; Result Unstructured Data: Test Result:1.73 m2 $g90 ml/min; Test Date: 202108; Test Name: Hematocrit; Result Unstructured Data: Test Result:0.43; Comments: l/l; Test Date: 202108; Test Name: Hemoglobin; Result Unstructured Data: Test Result:8.9 mmol/L; Test Date: 202108; Test Name: HR; Result Unstructured Data: Test Result:66; Comments: bpm; Test Date: 202108; Test Name: PT Oral anticoagulation INR; Result Unstructured Data: Test Result:0.9; Test Date: 202108; Test Name: Lymphocytes; Result Unstructured Data: Test Result:1.6 x10 9/l; Test Date: 20210827; Test Name: MRI brain; Result Unstructured Data: Test Result:Known recent infarction in the left thalamus; Test Date: 202108; Test Name: Monocytes; Result Unstructured Data: Test Result:0.6 x10 9/l; Test Date: 202108; Test Name: Neutrophil granulocytes; Result Unstructured Data: Test Result:9 x10 9/l; Test Date: 202108; Test Name: thrombocytes 319 x10^9/l; Result Unstructured Data: Test Result:319 x10 9/l; Test Date: 202108; Test Name: Leukocytes (WBC) 11.4 x10^9/l; Result Unstructured Data: Test Result:11.4 x10 9/l
CDC Split Type: NLPFIZER INC202101229069

Write-up: Headache; Nausea; Dizziness; Dysarthria; Double vision; Thalamus infarction right; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00680270. A 37-year-old female patient received second dose of bnt162b2 (COMIRNATY, lot number not reported), via an unspecified route of administration on 11Aug2021 as single dose for covid-19 immunisation; levonorgestrel, ethinyl estradiol (MANUFACTURER UNKNOWN), via an unspecified route of administration from May2021 to 26Aug2021 at 1 DF, 1x/day for contraception. The patient''s medical history and concomitant medications were not reported. The patient did not have a previous COVID-19 infection. The patient previously received first dose of BNT162b2 (COMIRNATY, lot number not reported) for covid-19 immunisation. The patient experienced thalamus infarction right, headache, nausea, dizziness, dysarthria and double vision on 26Aug2021. All the events were reported as serious due to hospitalization. The patient was treated with clopidogrel, acetylsalicylic acid and simvastatin. Thalamus infarct on the right side was described as cerebrovascular accident requiring urgent admission, medical treatment and secondary prophylaxis. Hospitalization information: Young stroke. Monitoring op brain-care unit. Secondary prophylaxis initiated. Additional information regarding adverse drug reaction included headache, symptoms of nausea, symptoms of dizziness, dysarthria and double vision. Developed 7:30 am 26Aug2021. Admission to the brain care unit via the emergency department was necessary. Discharged on 06Sep2021 to start clinical rehabilitation with mild sequelae (dysarthria). Lab: thrombocyte count 319, APTT 25 sec, INR 0.9. MRI: recent thalamic infarction left. In addition, two areas in mesencephalon with diffusion restriction. No signs of vasculitis. Cardiac ultrasound: no signs of cardiac source for embolism. Cardiac contrast: no signs of atrial septal defect/patent foramen ovale or ventricular septal defect. Other diagnostic procedures: Blood lab results: Hemoglobin 8.9 mmol/l, Hematocrit 0.43 l/l, White blood cells 11.4 x10^9/l, Platelets 319 x10^9/L, Basophil granulocytes 0.06 x10^9/L, Eosinophil granulocytes 0.09 x10^9/l, Neutrophil granulocytes 9.0 x10^9/l, Monocytes 0.6 x10^9/L, Lymphocytes 1.6 x10^9/L, Activated partial thromboplastin time 26 sec, Prothrombin time oral anticoagulation 0.9 international normalized ratio, Sodium 137 mmol/l, Potassium 4.5 mmol/l, Creatinine 64 umol/l, estimated glomerular filtration rate/1.73 m2 $g90 ml/min, Gamma-GT 28 U/l, ASAT (SGOT) 28 U/l, ALAT (SGPT) 33 U/l, LDH 159 U/l, CRP 2 mg/l. Conclusion from Magnetic resonance imaging of the brain (27Aug2021 3:35 pm): Patient had a recent infarct in the thalamus on the left side. Two areas with restricted diffusion in the area of the mesencephalon, on the left side in the peduncle and in the left posterior region. Elsewhere, normal distribution of signal intensities. The M1-segment on the left side, as well as the right distal vertebral artery look a bit thin. No indications of vasculitis. Cardiac ultrasound to rule out a cardiac source of embolism: Good left and right ventricular function, minor tricuspid valve insufficiency. No indications of a cardiac source of embolism. Cardiac ultrasound + right contrast: No indications of an atrial septal defect / patent foramen ovale with right contrast. No indications of a ventricular septal defect with color Doppler. Electrocardiogram: sinus rhythm 66 beats per minute, intermediate axis, normal conduction times, normal R-wave progression, sinus tachycardia within normal limits. MRI brain: Known recent infarction in the left thalamus. Also at the location of the mesencephalon two areas with diffusion restriction, left in the peduncle and left posterior. Elsewhere normal distribution of signal intensities. Somewhat graceful aspect of the M1 segment on the left as well as of the distal vertebral artery on the right. No evidence of vasculitis. ECG: HR 66bpm, intermediate axis, normal conduction times, normal R progression, ST-T within the norm. Echo cor: Good LV and RV function, low tricusp idal valve insufficiency. No evidence of cardiac embolism source. Echo cor + right contrast: no evidence of ASD (atrial septal defect) / PFO (patent foramen ovale) with right contrast no evidence of VSD (ventricular septal defect) with color Doppler. The action taken in response to the events for levonorgestrel, ethinyl estradiol was permanently withdrawn on 26Aug2021. The patient was recovering from thalamus infarction right, while outcome of the remaining events was unknown. Pfizer is Marketing Authorization Holder of Levonorgestrel, Ethinyl Estradiol in the reporter''s country. This may be a duplicate report in situations where another Marketing Authorization Holder of Levonorgestrel, Ethinyl Estradiol has submitted the same report to the regulatory authorities. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1755565 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-26
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatinine, Blood creatinine increased, COVID-19 pneumonia, Cough
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Blood creatinine; Test Result: Inconclusive ; Result Unstructured Data: Elevated
CDC Split Type: PHMODERNATX, INC.MOD20213

Write-up: Critical covid pneumonia; Cough; Elevated creatinine; This regulatory authority case was reported by a pharmacist and describes the occurrence of COVID-19 PNEUMONIA (Critical covid pneumonia), COUGH (Cough) and BLOOD CREATININE INCREASED (Elevated creatinine) in a 64-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced COVID-19 PNEUMONIA (Critical covid pneumonia) (seriousness criteria hospitalization and medically significant), COUGH (Cough) (seriousness criterion hospitalization) and BLOOD CREATININE INCREASED (Elevated creatinine) (seriousness criterion hospitalization). At the time of the report, COVID-19 PNEUMONIA (Critical covid pneumonia), COUGH (Cough) and BLOOD CREATININE INCREASED (Elevated creatinine) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2021, Blood creatinine: elevated (Inconclusive) Elevated. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was not provided by the reporter. No treatment information was provided by the reporter. This case concerns a 64 year-old, male patient with no relevant medical history, who experienced the serious unexpected events of COVID-19 pneumonia, cough and Blood creatinine increased. The event occurred approximately 15 days after the Moderna COVID-19 vaccine. The rechallenge was unknown since dose number was not provided. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Regulatory reference: PH-PHFDA-300106582; Sender''s Comments: This case concerns a 64 year-old, male patient with no relevant medical history, who experienced the serious unexpected events of COVID-19 pneumonia, cough and Blood creatinine increased. The event occurred approximately 15 days after the Moderna COVID-19 vaccine. The rechallenge was unknown since dose number was not provided. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1757701 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005696 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Loss of consciousness, Respiratory distress
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: This case was received via regulatory authority (Reference number: PT-INFARMED-T202109-455) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RESPIRATORY DISTRESS, LOSS OF CONSCIOUSNESS and DIZZINESS in a 43-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005696) for COVID-19 immunisation. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 26-Aug-2021, the patient experienced RESPIRATORY DISTRESS (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (seriousness criterion medically significant) and DIZZINESS (seriousness criterion medically significant). On 26-Aug-2021, RESPIRATORY DISTRESS, LOSS OF CONSCIOUSNESS and DIZZINESS had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant and treatment medications not reported. Severe dizziness, difficulty breathing and loss of consciousness with a fall Company Comment: This case concerns a 43 year-old, male subject, with no relevant medical history, who experienced the unexpected events of Respiratory distress, Loss of consciousness, and Dizziness. The events occurred after an unknown lapse of time with an unknown dose of Spikevax. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation document received on 29-SEP-2021, dosage text translated and events verbatim translated.; Sender''s Comments: This case concerns a 43 year-old, male subject, with no relevant medical history, who experienced the unexpected events of Respiratory distress, Loss of consciousness, and Dizziness. The events occurred after an unknown lapse of time with an unknown dose of Spikevax. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1757976 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRM8 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Atrial fibrillation, Cardiovascular disorder, Chest discomfort, Electrocardiogram, Presyncope, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:unknown results
CDC Split Type: DEPFIZER INC202101230489

Write-up: Arrhythmia; Atrial fibrillation; Circulatory weakness immediately 5-10 min; Tachycardia; Pressure chest; vasovagal reaction; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB. Regulatory authority report number is DE-PEI-202100190384. A 24-year-old patient of an unspecified gender received BNT162B2 (COMIRNATY, Lot Number: SCRM8 (as reported)), via an unspecified route of administration on 26Aug2021 (at 24-year-old) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Aug2021 the patient experienced arrhythmia, atrial fibrillation, circulatory weakness immediately 5-10 min, tachycardia, pressure chest. The patient underwent lab tests and procedures which included: ECG (electrocardiogram): unknown results on an unspecified date. The outcome of the events was recovered on unknown date. Sender''s comment: ECG, monitoring PRIVACY Clinic. Differential diagnosis: vasovagal reaction Causality assessment: Relatedness of COMIRNATY to event Acute circulatory failure was reported as unclassifiable by Regulatory Authority. Relatedness of COMIRNATY to events: Tachycardia, Pressure chest, Arrhythmia, Atrial fibrillation was reported as indeterminate by regulatory authority.


VAERS ID: 1758024 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214005 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Headache, Presyncope, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Vagal reaction; Asthenia; Fever; Headache; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-BR20213351) on 27-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of PRESYNCOPE (Vagal reaction), ASTHENIA (Asthenia), PYREXIA (Fever) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (batch no. 214005) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PRESYNCOPE (Vagal reaction) (seriousness criterion medically significant), ASTHENIA (Asthenia) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PRESYNCOPE (Vagal reaction), ASTHENIA (Asthenia), PYREXIA (Fever) and HEADACHE (Headache) was resolving. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided. Company Comment: This case concerns a 40-year-old, female patient with no relevant medical history, who experienced the serious unexpected events of Presyncope, Asthenia, Pyrexia and Headache. The events occurred approximately 2 days after the first dose of Spikevax. The rechallenge was unknown since no information about the second dose was disclosed. The events Pyrexia and Headache are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Translation received on 29-SEP-2021, included no new information.; Sender''s Comments: This case concerns a 40-year-old, female patient with no relevant medical history, who experienced the serious unexpected events of Presyncope, Asthenia, Pyrexia and Headache. The events occurred approximately 2 days after the first dose of Spikevax. The rechallenge was unknown since no information about the second dose was disclosed. The events Pyrexia and Headache are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1758322 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-08-26
   Days after vaccination:168
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / 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: 20210827; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202101228954

Write-up: SARS-CoV-2 PCR test: Positive/diagnosis of SARS-CoV-2 infection; SARS-CoV-2 PCR test: Positive/diagnosis of SARS-CoV-2 infection; This is a spontaneous report from a contactable Physician, downloaded from the Regulatory Authority-WEB. This is a report received from INFARMED Regulatory authority report number and Safety Report Unique Identifier [PT-INFARMED-T202109-166]. A 94-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: ER7812; Expiration Date: 30Jun2021), via parenteral route on 11Mar2021 as dose 2, 0.3 ml single, and received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: EP9598; Expiration Date: 30Jun2021), via parenteral route on 18Feb2021 as dose 1, 0.3 ml single for COVID-19 immunisation. A cumulative dose of 0.6 ml. The patient medical history and concomitant medications were not reported. Patient had no known allergies. It was unknown whether there was a history of infection with the SARS-CoV-2 virus prior to vaccination. On 26Aug2021, about 5 months after the 2nd dose of the suspected drug patient was hospitalized for prostration and hypotension. The patient''s hosp was prolonged as a result of this event. The patient underwent lab tests and procedures which included SARS-CoV-2 test (PCR test): Positive (Positive Iu international unit(s)) on 27Aug2021. Treatment given during hosp was unknown. According to the notifier, the reported condition was clinically relevant and the respective causal link was possible. There was no suspicion of drug interaction or medication error. The outcome of the event was unknown. Upon information received on 21Sep2021, from product quality complaint team regarding complaint about BNT162B2 (COMIRNATY, Batch/Lot Number: ER7812; Expiration Date: 30Jun2021 and Batch/Lot Number: EP9598; expiration date: 30Jun2021). "For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the 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. Conclusion from Site division (Reference PR ID 5793871 and Reference PR ID 5736784) included: The com-plaint 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 ER7812 and EP9598. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regu-latory notification was required. The reported defect could not be confirmed. No root cause or CA-PA were identified as the complaint was not confirmed." Reporter Comment: Other information-Symptoms starting on 26Aug2021 Admitted to Hospital PRIVACY on 26Aug2021, they reported prostration and hypotension; Test performed on 27Aug2021 LAB: PRIVACY The reporter''s assessment of the causal relationship of the [vaccination failure, covid-19] with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts needed. No further information expected.; Reporter''s Comments: Other information-Symptoms starting on 26Aug2021 Admitted to Hospital PRIVACY on 26Aug2021, they reported prostration and hypotension; Test performed on 27Aug2021 LAB: PRIVACY


VAERS ID: 1759935 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE478 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Eyelid oedema, Musculoskeletal chest pain, Tinnitus
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hearing impairment (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101228609

Write-up: This is a spontaneous report from a contactable consumer, regulatory authority number ES-AEMPS-999444. The consumer reported for 2 patients (mother and daughter). This is the 2nd of 2 reports report (daughter). A non-pregnant 12-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number FE478, Expiration date was not reported) intramuscularly, administered in the left arm on 24Aug2021, as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was unknown if patient has had COVID-19. The patient experienced tinnitus on 26Aug2021, edema eyelid on 01Sep2021, and costal pain on 08Sep2021. It was also reported that the patient was scheduled for 2nd dose on 14Sep2021. The reporter was asking if vaccination can happen without risk of having sequelae that has left him/her. The reporter stated that he/she knew that there were more people with whom these were happening, even some children, after the 1st vaccine, but stated that we need the certainty that we will not be left with a sequela for life was needed. Patient received antihistamine eye drops as a result of edema eyelid. Events were assessed as serious (medically significant). The outcome of tinnitus was recovered on 30Aug2021, edema eyelid recovered on 03Sep2021, and costal pain recovered on 10Sep2021. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : ES-PFIZER INC-202101135085 Same reporter/drug, similar event, different patient.;ES-AEMPS-987411 AEMPS


VAERS ID: 1759977 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCDN1 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Angiocardiogram, Cardiac ventriculogram, Echocardiogram, Electrocardiogram, Heart rate, Pericarditis, Troponin
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (narrow), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Ex-tobacco user ($g 10 pack-years); Hypercholesterolemia
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Coronarography; Result Unstructured Data: Test Result:Normal; Test Date: 20210826; Test Name: Ventriculography; Result Unstructured Data: Test Result:Left ventricular ejection fraction = 55%.; Test Date: 20210826; Test Name: Trans-thoracic echocardiography; Result Unstructured Data: Test Result:Left ventricular ejection fraction is 55%; Comments: left ventricle not dilated, not hypertrophied. Normal left ventricular (LV) kinetics. Non-dilated ascending aorta. Minimal mitral insufficiency. No aortic insufficiency. Normal left ventricular filling pressures (LVFP). Normal, non-dilated right ventricle. No tricuspid valve regurgitation. Dry pericarditis. Thin and compliant inferior vena cava.; Test Date: 20210826; Test Name: Electrocardiography; Result Unstructured Data: Test Result:sinus rhythm, heart rate 65 bpm, no conduction dis; Comments: sinus rhythm, heart rate 65 bpm, no conduction disorders (CDs), no repolarisation disorders; Test Date: 20210826; Test Name: heart rate; Result Unstructured Data: Test Result:65; Comments: bpm; Test Date: 20210826; Test Name: Troponin; Result Unstructured Data: Test Result:280; Test Date: 20210826; Test Name: Troponin; Result Unstructured Data: Test Result:876
CDC Split Type: FRPFIZER INC202101239640

Write-up: Non ST segment elevation acute coronary syndrome; Dry pericarditis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FR-AFSSAPS-NC20214267. A 50-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 24Aug2021 (Lot Number: SCDN1) as single dose for COVID-19 immunization. Medical history included Hypercholesterolemia, appendicectomy, Tobacco abstinence ($g 10 pack-years). The patient''s concomitant medications were not reported. The patient experienced non ST segment elevation acute coronary syndrome on 26Aug2021. The patient was hospitalized for the event from 26Aug2021 to 30Aug2021. The event required Emergency Room Visit. On 24Aug2021: vaccination against COVID-19 with the Comirnaty vaccine: dose 2 of batch SCDN1 in the left arm. Clinical signs and chronology of events: on 26Aug2021: emergency room visit for chest tightness without radiation of pain, resolved spontaneously within 4 hours. Haemodynamically stable patient. No sign of cardiac insufficiency. Hospitalisation in ICU (intensive care unit) from 26Aug2021 to 30Aug2021. Blood test / additional tests / aetiological tests: on 26Aug2021. Troponin: 280 then 876, Electrocardiography: sinus rhythm, heart rate 65 bpm, no conduction disorders (CDs), no repolarisation disorders, Trans-thoracic echocardiography: Left ventricular ejection fraction is 55%, left ventricle not dilated, not hypertrophied. Normal left ventricular (LV) kinetics. Non-dilated ascending aorta. Minimal mitral insufficiency. No aortic insufficiency. Normal left ventricular filling pressures (LVFP). Normal, non-dilated right ventricle. No tricuspid valve regurgitation. Dry pericarditis. Thin and compliant inferior vena cava. Coronarography: normal. Ventriculography: Left ventricular ejection fraction = 55%. Summary of therapeutic management: Hospitalisation, Aspegic (administered intravenously). Cardiac Magnetic Resonance Imaging to be scheduled. Treatment prescribed upon discharge: atorvastatin 40mg, aspirin 75 mg, pantoprazole 40 mg. Outcome: pain resolved spontaneously. Conclusion: Non-ST-elevation acute coronary syndrome (NSTE-ACS) at Day 2 post-vaccination (second dose vaccination of COMIRNATY). Therapeutic measures were taken as a result of the event. The outcome of the event was recovered on an unspecified date. Note from pharmacovigilance: "Accountability score(s) established without prejudice to the elements of investigation that could be carried out as part of legal or amicable compensation procedures." Official Bulletin of the Ministry of Health No. 84/50, 24Jan1985. Published in Therapie 2011; 66(6): 517-525) No follow-up attempts are possible. No further information expected.


VAERS ID: 1760704 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004234 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate, Loss of consciousness, Malaise, Oxygen saturation, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? 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: 20210813; Test Name: Pulse; Result Unstructured Data: 63 beats per minute; Test Date: 20210813; Test Name: oxygen saturation; Result Unstructured Data: 98%; Test Date: 20210826; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Consciousness loss; Feeling sick; This case was received via regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Consciousness loss) in a 39-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004234) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced LOSS OF CONSCIOUSNESS (Consciousness loss) (seriousness criterion medically significant) and MALAISE (Feeling sick). At the time of the report, LOSS OF CONSCIOUSNESS (Consciousness loss) and MALAISE (Feeling sick) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, Heart rate: normal (normal) 63 beats per minute. On 13-Aug-2021, Oxygen saturation: normal (normal) 98%. On 26-Aug-2021, SARS-CoV-2 test: negative (Negative) negative. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication were provided. No treatment medication were provided. Patient had correct vital signs before injection and a negative Trod. Company comment This case concerns a 39-year-old male with a serious unexpected event of loss of consciousness and non-serious malaise. Event onset the same day as mRNA-1273. Events reported as resolved. Rechallenge not available. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Translation document received on 3-Sep-2021 contains information.Added Lab Data.; Sender''s Comments: This case concerns a 39-year-old male with a serious unexpected event of loss of consciousness and non-serious malaise. Event onset the same day as mRNA-1273. Events reported as resolved. Rechallenge not available. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1761077 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211005125

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046495) on 04-OCT-2021 and concerned a 19 year old female. The patient''s height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-JUN-2021 for product use for unknown indication. No concomitant medications were reported. On 26-AUG-2021, the patient experienced vaccination failure and SARS-COV-2 (severe acute respiratory syndrome coronavirus 2) infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and SARS-COV-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1761083 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211005066

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician by Regulatory Authority(EVHUMAN Vaccines, AT-BASGAGES-2021-046547) on 04-OCT-2021 concerned a 50 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C16-04 expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 26-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1761100 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-26
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101242570

Write-up: Pericarditis; This is a spontaneous report from a contactable healthcare professional via the regulatory authority. The regulatory authority report number is 622819. A 30-year-old male patient received BNT162B2 (COMIRNATY) solution for injection intramuscular, first dose on 27Jul2021 with unknown lot, and second dose on 17Aug2021 with unknown lot, as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 26Aug2021, the patient experienced pericarditis. The outcome of the event pericarditis was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1761141 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Ear discomfort, Headache, Hypoaesthesia, Non-cardiac chest pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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 INC202101244006

Write-up: Arrhythmia; Ear discomfort; Headache; Hypoaesthesia; Non-cardiac chest pain; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 626096. A 38-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 26Aug2021, the patient experienced arrhythmia, ear discomfort, headache, hypoaesthesia and non-cardiac chest pain. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1761156 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101244436

Write-up: Bell''s palsy; Ear pain; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 627203. A 48-years-old female patient received bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 26Aug2021, the patient experienced bell''s palsy (medically significant), ear pain. Clinical outcome of the events was reported as not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1763172 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101256748

Write-up: Shortness of breath; Fatigue; Sore arm; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number IE-HPRA-2021-083930. A 16-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 26Aug2021 (at the age of 16-years) (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Aug2021, the patient experienced sore arm, persisting for 3 days, and on 28Aug2021 fatigue persisting for 1 day and on 31Aug2021 shortness of breath, persisting for 3 day. The patient was treated with an asthma inhaler (unspecified) for shortness of breath. The outcome of the events shortness of breath was recovered on 03Sep2021, sore arm and fatigue was recovered on 29Aug2021. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained.


VAERS ID: 1763771 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Subcutaneous abscess
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: Comments: Patient went to the emergency room several times for pain in the right foot where he was medicated several times and was discharged. He was admitted to the emergency room 17 days after the vaccination, and was hospitalized for a history of swelling and pain of the right foot on the day after the vaccination for SARS CoV2 (Janssen). He was presented with inflammatory signs of the lateral and infero medial region of the right foot, with no port of entry to the skin, namely wounds, insect bites. Patient had no interdigital lesions. The next day he was admitted for surgical drainage of a plantar suprafacial abscess. The patient during hospitalization showed improvement of pain complaints, hemodynamically stable and apyretic, right foot had edema, good peripheral perfusion and improvement of inflammatory parameters. Currently he was hospitalized and during the time of hospitalization he had been presenting DH / stable and apyretic, improvement of mobility and pain complaints maintains foot edema, more evident in the lateral region of the foot, small incision in the lateral region with outflow of hematic liquid. 12 days after drainage he returned to the operating room for exploration of the wound and surgical drainage was performed with discharge of hematic fluid and clots.
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20211002121

Write-up: SKIN & SUBCUTANEOUS TISSUE ABSCESS; This spontaneous report received from a pharmacist via regulatory authority (EVHUMAN Vaccines, PT-INFARMED-V202109-2869) on 01-OCT-2021 concerned a 23 year old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient was hospitalized for a history of swelling and pain of the right foot on the day after the vaccination for SARS CoV2 (Janssen). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) 0.5 ml, 1 total, administered on 25-AUG-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 26-AUG-2021, the patient experienced skin & subcutaneous tissue abscess (suprafacial plantar abscess). Patient went to the emergency room several times for pain in the right foot where he was medicated several times and was discharged. On 11-SEP-2021, 17 days post vaccination, he was admitted to the emergency room. He was presented with inflammatory signs of the lateral and inferior medial region of the right foot, with no port of entry to the skin, namely wounds, insect bites. There were interdigital lesions. On 12-SEP-2021, he was admitted for surgical drainage of a plantar suprafacial abscess. The patient during hospitalization showed improvement of pain complaints, hemodynamically stable and apyretic, right foot keeps edema, good peripheral perfusion and improvement of inflammatory parameters. Currently he remained hospitalized and during the time of hospitalization he had been presented DH/stable and apyretic, improvement of mobility and pain complaints maintains foot edema, more evident in the lateral region of the foot, small incision in the lateral region with outflow of hematic liquid. On 24-Sep-2021, 12 days after drainage, he was returned to the operating room for exploration of the wound and surgical drainage was performed with discharge of hematic fluid and clots. Number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skin & subcutaneous tissue abscess. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1764454 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211007748

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046756) on 05-OCT-2021 and concerned a 25 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 (suspension for injection, intramuscular, batch number: XD985 expiry: UNKNOWN) dose was not reported,1 total administered on 08-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 26-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.


VAERS ID: 1764455 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211007738

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046771) on 05-OCT-2021 and concerned a 28 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-03 expiry: UNKNOWN) dose was not reported, one total, administered on 23-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 26-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1766430 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-26
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101263088

Write-up: Spontaneous abortion detected in the emergency room; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number IT-MINISAL02-788986. A 32-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FG4686), via intramuscular route of administration, administered in Arm Left on 18Aug2021 15:35 dose 1, 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Aug2021 patient experienced spontaneous abortion detected in the emergency room (abortion spontaneous). The mother was 6 Weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1769413 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Asthenia, SARS-CoV-2 test, Ultrasound scan
SMQs:, Guillain-Barre syndrome (broad), Termination of pregnancy and risk of abortion (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: Medical History/Concurrent Conditions: Cesarean section (2 pregnancies 1 childbirth)
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210910; Test Name: ultrasound; Result Unstructured Data: Test Result:Non-progressive mono-embryonic intrauterine pregna; Comments: non-progressive mono-embryonic intrauterine pregnancy; Test Date: 20210917; Test Name: ultrasound; Result Unstructured Data: Test Result:Intrauterine pregnancy stopped at about 5 weeks +; Comments: Intrauterine pregnancy stopped at about 5 weeks + 4 days. either around 26Aug2021
CDC Split Type: FRPFIZER INC202101262320

Write-up: intense asthenia; Miscarriage; This is a spontaneous report received from a contactable consumer or other non-HCP downloaded from the Regulatory Agency (RA)-WEB. The regulatory authority report number is FR-AFSSAPS-LY202111266. This consumer reported different events for both doses of Comirnaty for the same patient. This is the first of two reports. A 36-year-old (pregnant) female patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FG6273) via an intramuscular route of administration on 26Aug2021 as a dose 2, single for (at the age of 36 year) COVID-19 immunisation. The patient was pregnant at the time of vaccination. The patient medical history include G2 P1 (2 pregnancies 1 childbirth) 1 cesarean section. The patient had no history of Covid. Last menstruation was on 18Jul2021. Concomitant medications were not reported. Historical vaccine include the first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: unknown) via an unspecified route of administration on 27Jul2021 as dose 1, single for COVID-19 immunisation and patient was on first trimester of pregnancy during the first dose. On 28Aug2021, 48 hours post second vaccination, the patient experienced intense asthenia for 72 hours. The patient was pregnant with 4 weeks during the second dose of the COVID 19 vaccine. On 28Aug2021, she was 5 weeks pregnant, undergone Miscarriage on 26Aug2021. Due date for delivery provided was on 24Apr2022. Treatment medication included drug management with (mifepristone) MIFEGYNE and (misoprostol) MISOONE for the event. The patient underwent lab tests and procedures which included follow-up ultrasound: non-progressive mono-embryonic intrauterine pregnancy on 10Sep2021, on 17Sep2021, control ultrasound: Intrauterine pregnancy stopped at about 5 weeks plus 4 days. either around 26Aug2021 and SARS-CoV-2 test negative on 25Aug2021. Outcome of the event asthenia was recovered on an unspecified date in 2021 while for miscarriage was unknown. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101269768 same patient, same drug, different AE


VAERS ID: 1772421 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Herpes zoster, Pain, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FORXIGA; METFORMIN
Current Illness: Abscess (all over the body at regular intervals (localization was switching)); Drug allergy; House dust allergy; Nickel sensitivity
Preexisting Conditions: Medical History/Concurrent Conditions: Shingles (had very often and also after 1st dose of Shingrix); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101273507

Write-up: Vaccination failure; Shingles; got shingles again; Strong pain (acute or persisting) during or after the rash; This is a spontaneous report from a non-contactable physician and consumer downloaded from a regulatory authority-WEB, company number DE-GLAXOSMITHKLINE-DE2021EME182583. A 52-year-old female patient received bnt162b2 (COVID-19 Vaccine - Manufacturer Unknown), via an unspecified route of administration on 23Aug2021 (batch/lot number unknown) as dose 2, single for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), intramuscular in left upper arm on 13Mar2021 (also reported as "12Mar2021") (batch/lot number 9SB5F), as dose 2, single, and intramuscular in left upper arm on 12Jan2021 (batch/lot number 339FK), as dose 1, single for prophylaxis; pantoprazole, via an unspecified route of administration from an unspecified date (batch/lot number unknown) to an unspecified date, at 40 mg, 1x/day for an unspecified indication; and acetylsalicylic acid (ASS), via an unspecified route of administration from an unspecified date (batch/lot number unknown) to an unspecified date, at 100 mg, 1x/day for an unspecified indication. Medical history included shingles for which the patient had very often and also after 1st dose of Shingrix, ongoing drug allergy, ongoing abscess, ongoing house dust allergy, ongoing nickel sensitivity and type 2 diabetes mellitus. For many years, the patient had herpes zoster several times, additionally she had abscesses all over the body at regular intervals (localization was switching). Concomitant medications included dapagliflozin propanediol monohydrate (FORXIGA) and metformin, both taken for type 2 diabetes mellitus. The patient previously took caffeine, paracetamol, propyphenazone (NOVALGIN) and experienced allergy. On 26Aug2021, 167 days after receiving Shingrix and 226 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was vaccinated with both doses of Shingrix. The patient got her 2nd corona vaccination (most likely a mRNA vaccine, physician unsure). 3 days after corona vaccination, the patient got shingles again. Less than 9 months after 1st and 2nd dose of Shingrix (2021), the patient experienced strong pain (acute or persisting) during or after the rash. The patient had therapy with Zostex for 7 days and Valoron N retard 50/4 mg. It was unknown if all the adverse event had subsided. The patient was not admitted to the hospital. The diagnosis of herpes zoster was confirmed as classical herpes zoster (half sided limited to up to three adjacent dermatomes). The exact localization of the affected dermatomes was not known. There were no complications or there was no systemic organ involvement. Laboratory values were not determined. The action taken in response to the events for pantoprazole and acetylsalicylic acid was unknown. The outcome of the events was unknown. The reporter considered the vaccination failure and shingles to be possibly related to 1st dose and 2nd dose of Shingrix and it was unknown for pain. It was unknown if the reporter considered shingles and pain to be related to Acetylsalicylacid 100, Pantoprazol and mRNA COVID-19 vaccine. Causal relationship between the events pain, vaccination failure, shingles and the administration of both doses of Shingrix were assessed as reasonable possibility by health care professional using EU Method of Assessment. The lot number for BNT162b2, was not provided and will be requested during follow-up. Follow-up (29Sep2021): This is a follow-up spontaneous report from a non-contactable physician based on information received by Pfizer from Takeda (manufacturer control number DE-TAKEDA-2021TEU008346) through EudraVigilance (DE-GLAXOSMITHKLINE-DE2021EME182583), license party for pantoprazole. Other reference number DE-GLAXOSMITHKLINE-DECH2021EME064746. This spontaneous case was reported by a physician and received from EudraVigilance (DE-GLAXOSMITHKLINE-DE2021EME182583) on 29-Sep-2021. Linked reference number: DE-GLAXOSMITHKLINE-DE2021182079. This case concerned a 52-year-old adult female patient. The relevant medical history included drug allergy, abscess, house dust allergy, nickel sensitivity and shingles. The concomitant medications included Forxiga and metformin. On an unknown date, the patient started treatment with Pantoprazol tablet (pantoprazole) 40 milligram daily and ASS 100 tablet (acetylsalicylic acid) 1 tablet in a day, both via unknown route due to unknown indication. On 12-Jan-2021, the patient started treatment with Shingrix solution for injection (varicella zoster vaccine rgE (CHO), batch no. 339FK) at unknown dose and frequency via intramuscular route, for prophylaxis. On 13-Mar-2021, the patient started treatment with Shingrix solution for injection (varicella zoster vaccine rgE (CHO), batch no. 9SB5F) at unknown dose and frequency via intramuscular route, for prophylaxis. On 23-Aug-2021, the patient started treatment with COVID-19 vaccine mRNA (brand name unspecified) at unknown dose and frequency via unknown route, for prophylaxis. On 26-Aug-2021, the patient experienced vaccination failure and shingles. On an unknown date, the patient experienced strong pain (acute or persisting) during or after the rash (LLT: Pain). At the time of this report, the action taken with suspects Pantoprazol, ASS 100 and outcome of all events was unknown. The event vaccination failure was assessed as serious due to the criterion of medical significance. The events pain and shingles were assessed as non-serious. No additional information was provided. Company Comment: The company assessed the reported serious event of Vaccination failure as unlikely related to Pantoprazole. There is no compelling evidence to implicate suspect drug with the event. Reporter comment: The reporter''s causality assessment was not reported. Takeda comment: Company Comment: The company assessed the reported serious event of Vaccination failure as unlikely related to Pantoprazole. There is no compelling evidence to implicate suspect drug with the event. The causality of the events shingles, vaccination failure, and pain were assessed by Takeda as related (as reported) to pantoprazole, and acetylsalicylic acid; while there was no reported causality from the reporter.; Reporter''s Comments: The reporter''s causality assessment was not reported.; Sender''s Comments: Based on the current available information , Vaccination failure is considered related to Shingrix and unrelated to the antoprazole or mRNA COVID-19 vaccine. The case will be reassessed if additional information becomes 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.


VAERS ID: 1772943 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram ST segment depression
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (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: THYROHORMONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRJNJFOC20211012868

Write-up: CHEST PAIN; ST SEGMENT DEPRESSION; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, GR-GREOF-20217398) on 07-OCT-2021 and concerned a 61 year old female. The patient''s weight was 65 kilograms, and height was 165 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 19-AUG-2021 for product used for unknown indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included levothyroxine sodium for hashimoto''s thyroiditis. On 26-AUG-2021, the patient experienced chest pain, st segment depression and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain and st segment depression was not reported. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1772965 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3716 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Maternal exposure during pregnancy, Musculoskeletal stiffness, Pain in extremity, Paraesthesia, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101272973

Write-up: SWOLLEN FINGERS; FINGERS ARE SORE AND STIFF ALL DAY EVERY DAY SINCE; PINS AND NEEDLES IN HANDS AND FEET / PINS AND NEEDLES COMES AND GOES THROUGHOUT THE DAY; PREGNANT / 3RD TRIMESTER; SORE FINGERS / FINGERS ARE SORE AND STIFF ALL DAY EVERY DAY SINCE; VERY ANXIOUS FOR ME AND MY BABY; This is a spontaneous report from a contactable consumer or other non-health care professional downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number IE-HPRA-2021-083589. Safety Report Unique Identifier IE-HPRA-2021-083589. This consumer reported information for both mother and foetus. This is a maternal report. A 36-year-old pregnant female patient received BNT162B2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: FG3716) via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 26Aug2021 the patient experienced pregnant 3rd trimester, sore fingers/fingers are sore and stiff all day every day since, very anxious for me and my baby, swollen fingers, fingers are sore and stiff all day every day since and pins and needles in hands and feet/pins and needles comes and goes throughout the day. The event were assessed as serious (disability) by the health authority. Patient reports it has been constant since Thursday 26Aug2021, her fingers are sore and stiff all day every day since and pins and needles come and goes throughout the day. Patient is aware her symptoms can be a pregnancy symptom. Patient has never had this issue before in this pregnancy or her last. The mother reported she became pregnant while taking BNT162B2. The mother was 3 Trimester pregnant at the onset of the event. The outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1773023 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Chest pain, Dyspnoea, Heart rate irregular, Hypoaesthesia, Investigation, Palpitations, Paraesthesia, Tachycardia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Dehydration (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma; Anaphylactic shock (Various episodes); Drug allergy (Allergy to many drugs, penicillin, pain relievers/nibs painkillers)
Allergies:
Diagnostic Lab Data: Test Name: breath palpitations; Result Unstructured Data: Test Result:134 beats per minute; Test Date: 20210914; Test Name: cardiological examination; Result Unstructured Data: Test Result:Results unknown; Test Name: possible exam; Result Unstructured Data: Test Result:Results unknown
CDC Split Type: ITPFIZER INC202101272545

Write-up: Cardiopalmus cardiocirculatory decompensation heart pains shortness of breath palpitations at 134 beats per minute numbness in limbs; Cardiopalmus cardiocirculatory decompensation heart pains shortness of breath palpitations at 134 beats per minute numbness in limbs; Cardiopalmus cardiocirculatory decompensation heart pains shortness of breath palpitations at 134 beats per minute numbness in limbs; Cardiopalmus cardiocirculatory decompensation heart pains shortness of breath palpitations at 134 beats per minute numbness in limbs; Cardiopalmus cardiocirculatory decompensation heart pains shortness of breath palpitations at 134 beats per minute numbness in limbs; Cardiopalmus cardiocirculatory decompensation heart pains shortness of breath palpitations at 134 beats per minute numbness in limbs; Cardiopalmus cardiocirculatory decompensation heart pains shortness of breath palpitations at 134 beats per minute numbness in limbs/tingling in her left arm and left leg; This is a spontaneous report from a contactable consumer or other non-health care professional downloaded from the Regulatory Agency (RA)-WEB [IT-MINISAL02-789588]. A 29-years-old female pregnant patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular, administered in Deltoid Left (left shoulder) on 25Aug2021 at 18:22 (Lot Number: FF2834; Expiration Date: 30Nov2021) as DOSE 1, 0.3 ML SINGLE (booster dose number (1)) for COVID-19 immunisation. Medical history included allergic asthma, allergy to almost all drugs (Allergy to many drugs, penicillin, pain relievers/nibs painkillers), anaphylactic shock (Various episodes). Concomitant medications were not reported. On 26Aug2021, the patient experienced Cardiopalmus cardiocirculatory decompensation heart pains shortness of breath palpitations at 134 beats per minute numbness in limbs, she has experienced tingling in her left arm and left leg. There was Impact on quality of life (10/10) (unspecified). The patient underwent Hospitalization. On 23Sep2021 the reporter transmitted the report of the emergency room of 14Sep2021 and cardiological examination of 14Sep2021, which were attached. She also reported that the reaction has not yet resolved and that in addition to chest pains, she has experienced tingling in her left arm and left leg. The patient underwent lab test and procedure which included cardiological examination: Results unknown on 14Sep2021, breath palpitations: 134 beats per minute on an unspecified date, possible exam: results unknown on an unspecified date. The outcome of other events was not recovered. Reporter''s comment: Allergy to almost all drugs, nibs painkillers allergic asthma various anaphylactic shock episodes.


VAERS ID: 1776205 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211016426

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via a Regulatory authority (regulatory authority, AT-BASGAGES-2021-047060) on 08-OCT-2021 and concerned a 39 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C17-05 expiry: unknown) dose was not reported, 1 total administered on 09-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 26-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.


VAERS ID: 1776206 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211015327

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (AT-BASGAGES-2021-047063) on 08-OCT-2021 concerned a 62 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 (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) dose was not reported,1 total, administered on 04-JUL-2021 for product used for unknown indication. No concomitant medications were reported. On 26-AUG-2021, the patient had sars-cov-2 infection(severe acute respiratory syndrome coronavirus 2 infection) which indicates vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1776207 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211016478

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician by a Regulatory Authority (AT-BASGAGES-2021-047064) on 08-OCT-2021 and concerned a 22 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 expiry: UNKNOWN) dose was not reported, frequency 1 total administered on 09-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 26-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.


VAERS ID: 1776208 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211015501

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (AT-BASGAGES-2021-047122) on 08-OCT-2021 and concerned a 41 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 (suspension for injection, intramuscular, batch number: XE393 expiry: unknown) dose was not reported, frequency time 1 total was administered on 17-JUL-2021 for drug used for an unknown indication. No concomitant medications were reported. On 26-AUG-2021, the patient experienced vaccination failure and severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and SARS-COV-2 infection was not reported. This report was serious (Other Medically Important Condition). The case was associated with product quality complaint (PQC).


VAERS ID: 1776210 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211016505

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician by via a Regulatory authority (AT-BASGAGES-2021-047132) on 08-OCT-2021 and concerned a 39 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) dose was not reported, 1 total administered on 16-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 26-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1778603 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211013669

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046814) on 07-OCT-2021 and concerned a 41 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393, Expiry: Unknown) dose was not reported, 1 total administered on 28-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 26-AUG-2021, the patient experienced severe acute respiratory syndrome coronavirus 2( sars-cov-2) infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000196849.


VAERS ID: 1778604 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: ATJNJFOC20211015307

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-047054) on 08-OCT-2021 concerned a 58 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 (suspension for injection, intramuscular, batch number: XD985 expiry: UNKNOWN) dose was not reported,1 total, administered on 30-JUN-2021 for product used for unknown indication. No concomitant medications were reported. On 26-AUG-2021, the patient had sars-cov-2 infection(severe acute respiratory syndrome coronavirus 2 infection) which indicates vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


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