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From the 11/19/2021 release of VAERS data:

Found 894,019 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 463 out of 8,941

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VAERS ID: 1838589 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7898 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heart rate, Heart rate increased, Lymphadenopathy, Malaise, Nausea, Palpitations
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210929; Test Name: heartbeats; Result Unstructured Data: Test Result:168-173; Comments: 168-173 per minute
CDC Split Type: SEPFIZER INC202101398805

Write-up: Heart rate increased/168-173 heartbeats per minute; General malaise; Nausea; very high heart rate with mild exertion (about 20 beats increase from previous heart rate with the same effort); Swollen lymph nodes; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-089376. Other case identifying number(s): SE-VISMA-1634078615039. A 31-years-old male patient received BNT162B2 (COMIRNATY) at the age of 31-years, dose 1 via an unspecified route of administration on 27Sep2021 (batch/lot number: FG7898) as dose 1, single for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient experienced heart rate increased on 29Sep2021 with outcome of not recovered, swollen lymph nodes on 27Sep2021 with outcome of recovered on 01Oct2021, general malaise on 28Sep2021 with outcome of recovered on 04Oct2021, nausea on 28Sep2021 with outcome of recovered, very high heart rate with mild exertion (about 20 beats increase from previous heart rate with the same effort) on 28Sep2021 with outcome of not recovered. It was described that two days after the first dose on 29Sep2021 was given he went out on an easy jogging and had around 168-173 heartbeats per minute. After 25 minutes, he interrupted his jogging and did not run for over a week. His heart rate rose and was extremely high with milder exertion this had continued since his vaccination. He felt that his level of performance had decreased extremely much for no apparent reason after the first dose. This report assessed as serious, disability. No follow-up attempts are possible. No further information expected.


VAERS ID: 1841027 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-19
Onset:2021-09-27
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: HIV test, Hepatitis C virus test, Laboratory test, Thrombocytopenic purpura, Ultrasound scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: HCV test; Test Result: Negative ; Test Name: HIV test; Test Result: Negative ; Test Name: laboratory test; Result Unstructured Data: Test Result:supported the diagnosis; Test Name: sonography; Result Unstructured Data: Test Result:supported the diagnosis
CDC Split Type: DEPFIZER INC202101461789

Write-up: Thrombocytopenia purpura; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB DE-PEI-202100212223. An 82-year-old male patient received bnt162b2 (COMIRNATY Batch/Lot Number: Unknown) intramuscular on 19Sep2021 (at 82-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Sep2021 the patient experienced Thrombocytopenia purpura. Symptoms: epistaxis, hematoma. The patient''s outcome was: not recovered/not resolved for Thrombocytopenia purpura. This report is serious - hospitalization, life threatening. Result of assessment for event /regulatory authority / B. Indeterminate. Lab data included laboratory and sonography supported the diagnosis, Hepatitis C virus and HIV negative. No follow-up attempts are possible, information on batch number cannot be obtained.


VAERS ID: 1841328 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-27
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4206 / 2 - / OT

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

Life Threatening? 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: Non-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101414352

Write-up: Phlebitis; very localized thrombosis of the free great saphenous vein; Thrombosis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority.-WEB, regulatory authority number FR-AFSSAPS-BX20219260. A 46-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF4206), via intramuscularly route of administration on 08Sep2021 as dose 2, single for covid-19 immunisation. Medical history included non-smoker. The patient concomitant medications were not reported. Patient had No obesity, no current Treatment, good health habits, walking every day for one hour, no family history of venous thromboembolism, no recent immobilization. The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FA7812), via intramuscular route of administration, administered in left arm on 16Aug2021 as dose 1 single for COVID-19 immunisation. The patient experienced thrombosis on 27Sep2021, on an unspecified date she had phlebitis, On 27Sep2021 very localized thrombosis of the free great saphenous vein opposite the patella and right popliteal fossa, freedom of the great saphenous veins, free vena cava. The event thrombosis was assessed as (medically significant). Treatment received with injection innohep 10 000 IU for the events on 29Sep2021. Outcome of the events thrombosis, superficial vein thrombosis was recovering and event phlebitis was unknown. Imputation made without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable procedures of compensation. No follow-up attempts possible. No further information expected.


VAERS ID: 1841860 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-09-27
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN; HYDROCHLOORTHIAZIDE; ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Menopause (No menstrual period for 13 months)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101405159

Write-up: Blood loss after menopause; postmenopausal bleeding; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB NL-LRB-00691931. A 52-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 04Jul2021 (Lot Number: FE1573) as dose 2, single for COVID-19 immunisation. Medical history included menopause (No menstrual period for 13 months) from an unknown date. Concomitant medications included metformin 500 mg tablet, hydrochloorthiazide 12.5 mg tablet and atorvastatin 10 mg tablet taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (COMIRNATY) on 30May2021 as 1st dose, 0.3mL for COVID-19 immunisation. On 27Sep2021, the patient experienced blood loss after menopause; reported as postmenopausal bleeding following administration of COVID-19 vaccine Pfizer injection solution for COVID-19 immunisation. The outcome of the events was not recovered. Reporter''s Comments : BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 30May2021 Blood loss after menopause Additional information ADR: No menstrual period for 13 months now. Now blood loss again 2.5 months after 2nd vaccination. COVID-19 Previous COVID-19 infection: No Other diagnostic procedures: no No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 30May2021 Blood loss after menopause Additional information ADR: No menstrual period for 13 months now. Now blood loss again 2.5 months after 2th vaccination. COVID-19 Previous COVID-19 infection: No Other diagnostic procedures: no


VAERS ID: 1842403 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-09-27
   Days after vaccination:132
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (broad)

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

Write-up: Pronounced thoracic herpes zoster; This regulatory authority case was reported by a physician and describes the occurrence of HERPES ZOSTER (Pronounced thoracic herpes zoster) in a 55-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 18-May-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 100 microgram. On 18-Jun-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 100 microgram. On 27-Sep-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced HERPES ZOSTER (Pronounced thoracic herpes zoster) (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER (Pronounced thoracic herpes zoster) had not resolved. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered HERPES ZOSTER (Pronounced thoracic herpes zoster) to be possibly related. No concomitant medications were reported. Treatment information was not provided. Company Comment : This case concerns a 55-year-old, female patient, with no known medical history, who experienced the serious, unexpected event of herpes zoster. The events occurred 3 months after second dose of Moderna vaccine. The rechallenge is not applicable as there is no information regarding a third dose. The events were considered related to the product per the reporter''s assessment. The long onset latency of 3 months remain as a confounder to the events. The benefit-risk relationship of Moderna vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, event is considered non-serious. Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Received on 29-OCT-21 includes event verbatim updated.; Reporter''s Comments: The case is serious and unlabelled. Due to temporal relationship and the known safety profile of the vaccine, the causality is assessed as possible. Sender''s Comments: This case concerns a 55-year-old, female patient, with no known medical history, who experienced the serious, unexpected event of herpes zoster. The events occurred 3 months after second dose of Moderna vaccine. The rechallenge is not applicable as there is no information regarding a third dose. The events were considered related to the product per the reporter''s assessment. The long onset latency of 3 months remain as a confounder to the events. The benefit-risk relationship of Moderna vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, event is considered non-serious.


VAERS ID: 1843939 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211109177

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-052980] concerned a 54 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: XD974 expiry: UNKNOWN) dose was not reported, 1 total first dose administered on 19-AUG-2021 for an unspecified indication. No concomitant medications were reported. On 27-SEP-2021, the patient experienced sars-cov-2 infection and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. 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 a product quality complaint, and reference number requested.


VAERS ID: 1843942 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211109164

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053019] concerned a 51 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: XD955 expiry: unknown) dose was not reported, 1 total, administered on 20-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 27-SEP-2021, the patient experienced vaccination failure and sars-cov-2 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. 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 case was associated with product quality complaint.


VAERS ID: 1843946 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211109348

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053120] 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 06-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 27-SEP-2021, the patient had sars-cov-2 infection, and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. 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 report is associated with product quality complaints.


VAERS ID: 1844095 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Infection, 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: Hyperlipoproteinemia; Pollinosis
Preexisting Conditions: Medical History/Concurrent Conditions: Burn (femoral, bilateral, II grade); Forearm fracture (left, with dislocation); Lipoma (extirpation)
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: CZJNJFOC20211107875

Write-up: BREAKTHROUGH INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, CZ-CZSUKL-21011355] concerned a 43 year old adult male. The patient''s weight was 73 kilograms, and height was 170 centimeters. The patient''s past medical history included: burn (femoral, bilateral, II grade), lipoma(extirpation), and left forearm fracture with dislocation, and concurrent conditions included: pollinosis, and hyperlipoproteinemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955 expiry: Unknown) 1 dosage forms, 1 in total, administered on 27-APR-2021 for covid-19 vaccination. The drug last period was 5 months. No concomitant medications were reported. On 27-SEP-2021, the patient experienced COVID-19 breakthrough infection which indicated vaccination failure (confirmed clinical vaccination failure). Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough infection on 11-OCT-2021, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition) This report was associated with a product quality complaint.


VAERS ID: 1844370 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute lymphocytic leukaemia, Chills, Inappropriate schedule of product administration, Insomnia, Lumbar puncture, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (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: lumbar fluid; Result Unstructured Data: Test Result:lumbar fluid with antibodies
CDC Split Type: DEPFIZER INC202101415240

Write-up: acute lymphoblastic leukemia; Fever; chills; insomnia; 1st dose in July, 2nd dose at the end of September 2021; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 25Oct2021, this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from a contactable other healthcare professional (HCP) based on information received by Pfizer from Biontech [manufacturer control number: 91835, license party for Comirnaty]. A male patient of unspecified age received the second dose of BNT162b2 (COMIRNATY; solution for injection; Lot Number: Unknown) via an unspecified route of administration on 27Sep2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY; solution for injection; Lot Number: Unknown) via an unspecified route of administration in Jul2021 as a single dose for COVID-19 immunization and experienced facial paresis and lumbar fluid with antibodies. On an unspecified date, the patient experienced acute lymphoblastic leukemia, on 27Sep2021, the patient experienced 1st dose in July, 2nd dose at the end of September 2021 and on 29Sep2021, the patient experienced fever, chills and insomnia. The reporter (patient''s friend) reported that the patient had been diagnosed with acute lymphoblastic leukemia in the meanwhile. Therapeutic measures were taken due to the events fever and chills and included Ibuprofen and Paracetamol. The clinical outcomes of the events acute lymphoblastic leukemia and 1st dose in July, 2nd dose at the end of September 2021 were unknown while the clinical outcomes of the events fever, chills and insomnia were not recovered/not resolved. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on limited information in the case a possible causal association between the reported events Acute lymphocytic leukaemia and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-202101357828 Same patient, different doses of Vaccine


VAERS ID: 1844836 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Diabetes.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101426572

Write-up: Swollen lymph nodes; off label use; booster; Interchange of vaccine products; swelling; pain in armpit area; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110212224213520-CSC8I, Safety Report Unique Identifier GB-MHRA-ADR 26106566. A 47-year-old non-pregnant female patient received the third dose of bnt162b2 (COMIRNATY, solution for injection, lot number: FF8222), via an unspecified route of administration, on 27Sep2021 (at the age of 47-year-old), as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included diabetes mellitus and previously took sukkarto (recently diagnosed with Diabetes type 2 and taking prescribed Sukkarto). Patient not had symptoms associated with COVID-19. Patient was not pregnant at the time of vaccination. Patient was not breastfeeding. Patient was not enrolled in clinical trial. Patient last menstrual period date was 15Sep2021. The patient''s concomitant medications were not reported. The patient''s historical vaccine included the first and second dose of COVID-19 Vaccine (MANUFACTURER UNKNOWN) via an unspecified route on an unspecified date for Covid-19 immunization. The patient had off label use, booster and interchange of vaccine products on 27Sep2021. The patient experienced swelling, pain in armpit area on an unspecified date in 2021, swollen lymph nodes on 29Sep2021 (2 days after the third dose). Clinical information included 2 days after the booster patient had pain in armpit area, swollen very painful lymph node, swelling in whole of armpit. This was on the same side as the injection site. Injection site itself was fine. Patient went to local minor injuries to get checked. The doctor confirmed it was a swollen lymph node. Patient''s report did not relate to possible inflammation of the heart (myocarditis or pericarditis). Seriousness criteria for the events swelling, pain in armpit area and swollen lymph nodes were reported as medically significant. The patient underwent lab test which included COVID-19 virus test was negative (no- negative COVID-19 test). Since the vaccination, the patient not had tested positive for covid-19. Outcome of the event swollen lymph nodes was recovered on 06Oct2021 and outcome of the events swelling, pain in armpit area was unknown. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1845004 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Hyporeflexia, Nasal congestion, Rhinitis allergic, Sputum retention
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (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: ALLEGRA; NEXIUM HP; BIOFERMIN R
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rhinitis allergic
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101429833

Write-up: Dyspnoea; Rhinitis allergic; Nasal congestion; Decreased pharyngeal reflex; Cough; Sputum expectoration difficult; This is a spontaneous report from a contactable Physician received via Pfizer colleague. A 45-year-old female patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FH0151, Expiration date 31Dec2021) intramuscular in the right arm on 27Sep2021 (at the age of 45-year-old ) as 0.3 ML single for COVID-19 immunization. The patient received ALLEGRA TABLET, NEXIUM and BIOFERMIN within 2 weeks of vaccination. Medical history included rhinitis allergic. On 27Sep2021 the patient received BNT162B2. On 27Sep2021(45 minutes after the vaccination), the patient experienced rhinitis allergic and Dyspnoea. The clinical course was reported as follows: 45 minutes after the vaccination, the patient experienced nasal congestion, decreased pharyngeal reflex, cough, dyspnea and sputum expectoration difficult. Symptoms gradually change. Therefore, the patient took Allegra tablet 1 tablet and her symptoms improved. After that, the patient took Allegra tablet, and on the same day, symptoms improved and recovered on the next day. Regarding severeness, the physician said that severeness might be severe. The outcome of the events was recovered on 28Sep2021 with treatment including Allegra tablet . The reporting physician stated that the events were probably related to the BNT162B2. No follow up attempts are possible. No further information is expected. ; Sender''s Comments: As there is limited information in the case provided, the causal association between the event Dyspnoea, Rhinitis allergic, Nasal Congestion, Hyporeflexia, Cough, and Sputum retention and the suspect drug cannot be excluded. The case will be reassessed once new information is available.


VAERS ID: 1845636 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-27
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214005 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute coronary syndrome, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

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

Write-up: Acute coronary syndrome; Infarct myocardial; This case was received via Agency Regulatory Authority (Reference number: FR-AFSSAPS-NC20214939) on 28-Oct-2021 and was forwarded to Moderna on 28-Oct-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ACUTE CORONARY SYNDROME (Acute coronary syndrome) and MYOCARDIAL INFARCTION (Infarct myocardial) in a 48-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214005) for COVID-19 vaccination. No Medical History information was reported. On 11-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form once a day. On 27-Sep-2021, the patient experienced ACUTE CORONARY SYNDROME (Acute coronary syndrome) (seriousness criteria hospitalization and medically significant) and MYOCARDIAL INFARCTION (Infarct myocardial) (seriousness criteria hospitalization and medically significant). At the time of the report, ACUTE CORONARY SYNDROME (Acute coronary syndrome) and MYOCARDIAL INFARCTION (Infarct myocardial) had resolved with sequelae. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. Company Comment: This case concerns a 48-year-old, male patient with no relevant medical history, who experienced the unexpected serious AESI events of myocardial infarction and acute coronary syndrome. The events occurred 16 days after the first dose of mRNA-1273 Moderna vaccine. The rechallenge was unknown as per RA reporting. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Translation Received on 01-Nov-2021. Contains No new information; Sender''s Comments: This case concerns a 48-year-old, male patient with no relevant medical history, who experienced the unexpected serious AESI events of myocardial infarction and acute coronary syndrome. The events occurred 16 days after the first dose of mRNA-1273 Moderna vaccine. The rechallenge was unknown as per RA reporting. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.


VAERS ID: 1845857 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211110941

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053233] concerned a 32 year old male patient of an 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, 01 total (first dose), administered on 27-AUG-2021 for an unspecified indication. No concomitant medications were reported. On 27-SEP-2021, Laboratory data included: COVID-19 (corona virus) PCR (polymerase chain reaction) test was positive. The patient experienced severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and had 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:90000200779.


VAERS ID: 1845859 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211110733

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053248] concerned a 30 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: UNKNOWN) dose was not reported,1 total, (first dose) administered on 17-JUL-2021 for an unknown indication. No concomitant medications were reported. On 27-SEP-202, the patient underwent COVID-19 PCR (polymerase chain reaction) test (NR: not provided) and result found to be positive which indicates patient had SARS-CoV-2 infection (severe acute respiratory syndrome coronavirus 2 infection) hence vaccination failure. 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 a product quality complaint.


VAERS ID: 1846161 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Investigation, Thrombophlebitis, Ultrasound Doppler, Vaccination site discomfort, Vaccination site pain
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: exams; Result Unstructured Data: Test Result:unknown result; Test Name: lower limb Doppler; Result Unstructured Data: Test Result:unknown result
CDC Split Type: BRPFIZER INC202101418167

Write-up: thrombophlebitis/feet started to swell and hurt a little/swelling or such pain in legs/still feel pain and had bruises on feet; right arm, the same where they applied the vaccine, become heavy and painful; right arm, the same where they applied the vaccine, become heavy and painful; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Right on 27Sep2021 (at the age of 36-year-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced thrombophlebitis/feet started to swell and hurt a little/swelling or such pain in legs/still feel pain and had bruises on feet (medically significant) on 27Sep2021; right arm, the same where they applied the vaccine, become heavy and painful on 27Sep2021. She had an adverse reaction to vaccine. It was given on 27Sep2021, at the family clinic, in the morning. At the time of application she felt right arm, the same where they applied the vaccine, become heavy and painful. At the end of the day, her feet started to swell and hurt a little. The next day, when she woke up, she couldn''t put feet on the ground because of so much pain. She took many pain medications, analgesics, but none were really just palliatives, as the pain continued to get more and more intense and the swelling only increased, she had all the photos, footage and exams. On 05Oct2021 she returned to the same Family Clinic unit, as she had no health insurance and needed medical advice to improve. On the day she was seen by Doctor, who even reported her problem to the Agency, at the time the doctor prescribed Venaflon, diosmin + hesperidin 450 + 50mg and also instructed her to look for an angiologist, since that day her feet they were too swollen and had very severe pain in feet. At the time, the diagnosis was thrombophlebitis, but she also informed, that she never had swelling or such pain in legs. In the days that followed, in addition to taking the medication described above, she also used dipyrone 1 gram, two or three times at the same time to support the pain. She searched in the region where she live and found a physician, she did an appointment and on October 14th she was attended by her. On this occasion, the physician did an anamnesis, examined her and prescribed a lower limb Doppler for her to do it. The request was for arterial and venous Doppler, which with the pink guide cost 600 reais for the right and left legs. The doctor also changed the medication and prescribed Daflom 1000, children''s AAS, one tablet a day, in addition to Deocil SOS, if necessary, she also prescribed Fletop or another gel ointment, so far more than 200 reais in medicines , and there are still three more Predisin vials, she remember that the ones are still visible until today, October 21st. On her return, the physician already holding the exams, took her away from work activities for another 20 days, because she still feel pain and she had bruises on feet. After the medication prescribed by her, she really had a significant improvement, but she cannot work and she was working for lack of options. The outcome of the event thrombophlebitis was recovering, others was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1847262 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-09-27
   Days after vaccination:256
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Diarrhoea, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: 20210927; Test Name: PCR COVID-19 test; Test Result: Positive.
CDC Split Type: FRPFIZER INC202101422817

Write-up: Vaccination failure; COVID-19; diarrhea; This is a spontaneous report from a contactable consumer from the Regulatory Authority. The regulatory authority report number FR-AFSSAPS-AN20214051. A 90-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 04Feb2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE, dose 1 intramuscular on 14Jan2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced vaccination failure occurring 7 months after complete vaccination regimen with covid 19 Comirnaty vaccine. Occurrence of symptomatic COVID-19 infection with diarrhea was reported. The outcome of the events was not recovered. The lot number for BNT162B2 was not provided and will be requested during follow-up. Linked Report(s): FR-AFSSAPS-AN20214050; FR-AFSSAPS-AN20213944; FR-AFSSAPS-AN20213945; FR-AFSSAPS-AN20213943; FR-AFSSAPS-AN20213946; FR-AFSSAPS-AN20213933; FR-PFIZER INC-202101437127; FR-PFIZER INC-202101437287 same cluster of reports; FR-PFIZER INC-202101437438 same cluster of reports; FR-PFIZER INC-202101422822.


VAERS ID: 1847904 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUPRENORPHINE; DAVITAMON; ROPINIROL [ROPINIROLE]; HYDROXOCOBALAMIN; HYDROXOCOBALAMIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20211109753

Write-up: COLD CHILLS; FEELING UNWELL; FATIGUE; MUSCLE PAIN; TEMPERATURE 34.9; NAUSEA; This spontaneous report received from a consumer via a Regulatory Authority [NL-LRB-00696457] concerned a 53 year old female of unspecified race and ethnicity.. The patient''s weight was 75 kilograms, and height was 160 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, batch number: 21C11-02 expiry: UNKNOWN)0.5 ml, 1 dosage forms, 1 total administered on 01-SEP-2021 for covid-19 immunisation. The drug start period was 24 hours. Concomitant medications included buprenorphine transdermal patch, 1 patch per week, therapy started in 2015, hydroxocobalamin suspension for injection 500microgram per milliliter, 40mg every 12 hours, 2 per day, hydroxocobalamin suspension for injection 500microgram per milliliter, 1 dosage forms, once every 8 weeks, Davitamon(retinol palmitate), 1 dosage form, every 8 hours, thrice per day, therapy started in 2013 and ropinirole coated tablet 0.25mg 1 - 1mg plus 2 - 0.25 mg, so together 1.50 mg per day before going to sleep(therapy started in 2019 and ended on 07-Aug-2021), Paracetamol/caffeine/ascorbic effervescent tablet 500/50/100mg (6- 500mg). On 27-SEP-2021, the patient experienced nausea. On an unspecified date, the patient experienced cold chills, feeling unwell, fatigue, muscle pain, and temperature 34.9. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold chills, feeling unwell, fatigue, nausea, muscle pain, and temperature 34.9. This report was serious (Other Medically Important Condition).


VAERS ID: 1850324 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-09-27
   Days after vaccination:117
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result: posititve; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101436500

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-051067. A 37-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 02Jun2021 (Batch/Lot Number: FC2473) as DOSE 2, SINGLE, dose 1 intramuscular on 28Apr2021 (Batch/Lot Number: EY3014) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Sep2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient''s outcome was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test positive (Variant PCR-based B.1.617.2, Sequenced variant, n501y-positive: No) on 27Sep2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1850741 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-09-27
   Days after vaccination:97
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101436719

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number is AT-BASGAGES-2021-051196. A 49-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FA4598) on 18May2021 and second dose on 22Jun2021 (Batch/Lot Number: FD0168) both via intramuscular as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced vaccination failure and SARS-CoV-2 infection. It was reported that the patient underwent lab tests and procedures which included COVID-19 PCR test: positive, variant PCR-based: B.1.617.2, sequenced variant: n.a. and N501Y-positive: no on 27Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1851535 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211113278

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, AT-BASGAGES-2021-052851] concerned a 35 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: XD975 expiry: UNKNOWN) dose was not reported, 1 total, administered on 21-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 27-SEP-2021, the patient experienced vaccination failure and sars-cov-2 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. 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).


VAERS ID: 1851541 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211109369

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, AT-BASGAGES-2021-052985] concerned a 30 year old female of an 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 time 1 total, administered on 05-JUL-2021 for an unspecified indication. No concomitant medications were reported at the time of reporting. On 27-SEP-2021,the patient underwent Covid-19 polymerase chain reaction (PCR) test and diagnosed with Positive covid-19 infection. On same date she experienced severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection and had 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: 90000200679.


VAERS ID: 1851543 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211113329

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, AT-BASGAGES-2021-053146] concerned a 57 year old male of an 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: 21C18-03 expiry: UNKNOWN) dose was not reported, 1 total administered on 25-AUG-2021 for an unspecified indication. No concomitant medications were reported. On 27-SEP-2021, the patient experienced sars-cov-2 infection and had vaccination failure Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. 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: 1852073 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-09-27
   Days after vaccination:235
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test, Vaccination failure
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, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Angina pectoris; Atrophy; Bladder neurogenic; Cystostomy; Hypertension; Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: SARS-CoV-2 PCR test; Test Result: Positive.
CDC Split Type: EEPFIZER INC202101436212

Write-up: COVID-19; Vaccination failure; This is a spontaneous report from a contactable physician from the Regulatory Authority. The Regulatory Authority number EE-SAM-53662110049. A 72-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 04Feb2021 (Batch/Lot Number: EL8723; Expiration Date: 31May2021) as DOSE 2, 0.3 ML SINGLE, dose 1 intramuscular on 14Jan2021 (Batch/Lot Number: EL1491; Expiration Date: 30Apr2021) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included ongoing parkinson''s disease, ongoing cystostomy, ongoing neurogenic bladder, ongoing atrophy, ongoing angina pectoris, ongoing hypertension. The patient''s concomitant medications were not reported. The patient was vaccinated with the first and second dose of Comirnaty vaccine on 14Jan and 04Feb2021 respectively. On 27Sep2021, the patient developed COVID pneumonia. SARS-CoV-2 PCR test was positive on 28Sep. The course of the disease was severe, the patient was hospitalized from 30Sep to 14Oct. Treatment included Remdesivir, oxygen therapy, and antibiotic therapy. The patient was discharged from hospital on 14Oct2021 and he went to the nursing clinic. The condition is improving. The patient has concomitant hypertension, Parkinsons disease, multisystem atrophy, neurogenic bladder, angina pectoris + stenting, and he has been placed epicystostomy. Therapeutic measures were taken as a result of the events. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 28Sep2021. The outcome of events was recovering. 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 EL1491, and EL8723. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root causes were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.


VAERS ID: 1852364 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood calcium, Blood pressure increased, Blood pressure measurement, Blood sodium, Body temperature, C-reactive protein, Cardiovascular examination, Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram, Fibrin D dimer, Haemoglobin, Heart rate, Investigation, Mean cell volume, Musculoskeletal chest pain, Oxygen saturation, Physical examination, Platelet count, Pulmonary physical examination, Respiratory disorder, Troponin, Troponin increased, White blood cell count, X-ray limb
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210930; Test Name: Calcium; Result Unstructured Data: Test Result:2.45 mmol/L; Test Date: 20210930; Test Name: Blood pressure; Result Unstructured Data: Test Result:147/72 mmHg; Test Date: 20210930; Test Name: Sodium; Result Unstructured Data: Test Result:140 mmol/L; Test Date: 20210930; Test Name: Temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210930; Test Name: Cardiology; Result Unstructured Data: Test Result:Regular heart sounds; Comments: without murmur, left thoracic pain, non-radiating, increased by palpation and movement, not increased by bending forward. Soft and painless calves, palpable peripheral pulses on all 4 limbs.; Test Date: 20210930; Test Name: Chest radiography; Result Unstructured Data: Test Result:Normal cardiomedulla silhouette; Comments: absence of progressive pleuroparenchymal lesion. Normal cardiomedulla silhouette.; Test Date: 20210930; Test Name: C-reactive protein; Result Unstructured Data: Test Result:6.6 mg/l; Test Date: 20210930; Test Name: Trans-thoracic echocardiography; Result Unstructured Data: Test Result:no effusion; Comments: no effusion, no abnormality demonstrated.; Test Date: 20210930; Test Name: Electrocardiography; Result Unstructured Data: Test Result:Regular sinus rhythm; Comments: normal axis, no atrioventricular block, normal QRS complexes, early repolarisation.; Test Date: 20210930; Test Name: D-dimers; Result Unstructured Data: Test Result:440 mg/l; Test Date: 20210930; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.2 g/dl; Test Date: 20210930; Test Name: Heart rate; Result Unstructured Data: Test Result:72; Comments: bpm; Test Date: 20210930; Test Name: Blood heparin control; Result Unstructured Data: Test Result:28.6 ng/L; Test Date: 20210930; Test Name: Mean corpuscular volume; Result Unstructured Data: Test Result:81 fL; Test Date: 20210930; Test Name: Oxygen saturation; Test Result: 100 %; Test Date: 20210930; Test Name: Abdomen; Result Unstructured Data: Test Result:soft, yielding, painless; Comments: no intestinal peristalsis problems, no urinary symptoms.; Test Date: 20210930; Test Name: Platelets; Result Unstructured Data: Test Result:223 g/l; Test Date: 20210930; Test Name: Pneumology; Result Unstructured Data: Test Result:Vesicular murmur; Comments: +/+, no sino-atrial block (sinus disfunction), eupneic in ambient air; Test Name: Troponin; Result Unstructured Data: Test Result:Increased ng/L; Comments: increase of troponin confirmed by 2 samples; Test Date: 20210930; Test Name: Troponin; Result Unstructured Data: Test Result:21.1 ng/L; Test Date: 20210930; Test Name: White blood cells; Result Unstructured Data: Test Result:10.41 g/l; Test Date: 20210930; Test Name: Radiography of the left shoulder; Result Unstructured Data: Test Result:normal radiological assessment
CDC Split Type: FRPFIZER INC202101437690

Write-up: Troponin increased; respiratory discomfort; Blood pressure 147/72 mmHg; Precordial pain; Chest wall pain; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RS20213541. A 16-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 24Sep2021 (Lot Number: FG4686) as dose 1, single for COVID-19 immunisation. Medical history included asthma. The patient''s concomitant medications were not reported. The patient experienced chest wall pain (medically significant) on 27Sep2021, troponin increased (medically significant) on 30Sep2021. 3 days after the injection, precordial pain with increase of troponin confirmed by 2 samples. Ongoing medical care at hospital. Taken care of in the Emergency Room on 30Sep2021 for chest pain, persistent, not relieved by paracetamol and feeling of respiratory discomfort. The male patient complained of oppressive left chest pain for 2-3 days, with onset upon awakening, persistent, increasing progressively and increased by movement. Afebrile Not relieved by paracetamol. No recent infectious syndrome. Clinical examination included Blood pressure 147/72 mmHg; Heart rate 72 bpm; saturation 100% in ambient air; Temperature 36.6 C. Cardiology: Regular heart sounds without murmur, left thoracic pain, non-radiating, increased by palpation and movement, not increased by bending forward. Soft and painless calves, palpable peripheral pulses on all 4 limbs. Electrocardiography: Regular sinus rhythm, normal axis, no atrioventricular block, normal QRS complexes, early repolarisation. Pneumology: Vesicular murmur +/+, no sino-atrial block (sinus disfunction), eupneic in ambient air. Abdomen: soft, yielding, painless, no intestinal peristalsis problems, no urinary symptoms. Blood test findings: Hemoglobin 14.2 g/dL; mean corpuscular volume 81 fL; platelets 223 G/L; White blood cells 10.41 G/L; Sodium 140 mmol/L; Calcium 2.45 mmol/L; troponins 21.1 ng/L; blood heparin control 28.6 ng/L; C-reactive protein 6.6 mg/L; D-dimers 440 mg/L. Elevation of troponins on physical effort the day before. Trans-thoracic echocardiography: no effusion, no abnormality demonstrated. Chest radiography: absence of progressive pleuroparenchymal lesion. Normal cardiomedulla silhouette. Radiography of the left shoulder: normal radiological assessment. Conclusion of the visit to the emergency room: left parietal chest pain. Blood test assessment and Electrocardiography normal. Stable troponin elevation, explained by the physical effort the day before, trans-thoracic echocardiography normal. Discharged with pain management medication. Therapeutic measures were taken as a result of chest wall pain. The outcome of events Chest wall pain and Troponin increased was not recovered, of other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1852765 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-09-27
   Days after vaccination:244
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, COVID-19, Fatigue, Oropharyngeal pain, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: 202106; Test Name: RDB-IgG antibodies to Sars-Cov-2 spike protein; Result Unstructured Data: Test Result:230; Comments: U/L; Test Date: 20210927; Test Name: SARS-CoV-2 RT-PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101438048

Write-up: DRUG INEFFECTIVE; COVID-19 INFECTION; MARKED FATIGUE; BACK PAIN; SORE THROAT; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB IT-MINISAL02-800578. A 53-years-old female patient received bnt162b2 (COMIRNATY) via intramuscular, the first dose on 05Jan2021 (Batch/Lot number was not reported) and the second dose on 26Jan2021 at 10:00 (Batch/Lot Number: EJ6136; Expiration Date: 30Apr2021), both as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced covid-19 infection on 27Sep2021, drug ineffective on 27Sep2021, marked fatigue on 27Sep2021, back pain on 27Sep2021, sore throat on 27Sep2021. The events were reported as serious due to medically significant. The patient underwent lab tests and procedures which included RDB-IgG antibodies to Sars-Cov-2 spike protein: 230 u/l on Jun2021; SARS-CoV-2 RT-PCR test: positive on 27Sep2021. The outcome of the events was recovered on 09Oct2021. Subsequently, the product quality complaint group from division reported Investigational Report which concludes: 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 EJ6136. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Reporter''s comments: SECOND DOSE. DELTOID INTRAMUSCULAR ADMINISTRATION. TIME OF ADMINISTRATION 10:00 AM Jun2021: RDB-IgG SARS-Cov-2 spike protein antibodies 230 U/L.; Reporter''s Comments: SECOND DOSE. DELTOID INTRAMUSCULAR ADMINISTRATION. TIME OF ADMINISTRATION 10:00 AM Jun2021: RDB-IgG SARS-Cov-2 spike protein antibodies 230 U/L.


VAERS ID: 1852774 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Blood creatinine, Blood creatinine decreased, Body temperature, Chest pain, Cholelithiasis, Diarrhoea, Lipase, Lipase decreased, Nausea, Pain, Pyrexia, Ultrasound abdomen
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211006; Test Name: Blood creatinine; Result Unstructured Data: Test Result:0.54 mg/ml; Test Name: fever; Result Unstructured Data: Test Result:38.2 Centigrade; Test Date: 20211006; Test Name: Lipase; Result Unstructured Data: Test Result:103 IU/l; Test Name: abdominal ultrasound; Result Unstructured Data: Test Result:gallbladder was found to be free of gallstones; Test Date: 20211006; Test Name: abdominal ultrasound; Result Unstructured Data: Test Result:gallstones in the gallbladder; Comments: maximum size of 3mm
CDC Split Type: ITPFIZER INC202101438324

Write-up: gallstones in the gallbladder; strong pain; Blood creatinine 0.54 mg/mL; Lipase 103 iU/L; Diarrhea; Abdominal cramps; Weakness; Pyrexia / fever max 38.2 ?; Pain chest; Nausea; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-800771. A 13-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 27Sep2021 (Batch/Lot Number: FF2382) at the age of 13-years-old, as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pyrexia, abdominal cramps, weakness, nausea, pain chest and diarrhea. It was reported from the afternoon of 27Sep2021 to 01Oct2021 the patient showed weakness, fever max 38.2 centigrade, chest pain, nausea. From the evening of 01Oct2021 diarrhea and abdominal cramps. Events were serious (Other medically important condition). On Monday 04Oct2021, she was visited by the pediatrician, who prescribed anti-diarrheics and milk enzymes. On 06Oct2021, due to strong pain, access to the emergency room, where she was carried out blood count and abdominal ultrasound, which showed gallstones in the gallbladder of a maximum size of 3mm, ursodeoxycholic acid (URSOBIL) tablets were prescribed, light diet, paracetamol in case of pain. It was deemed useful to consult the Gastroenterologist. During the time spent in the emergency room, i.e. more than 4 hours, the reaction was assessed as serious. The reporter indicated that after accessing the emergency room, the patient was privately examined by a gastroenterologist, who prescribed hematochemical tests and a search for occult blood in the faeces; as soon as they have the results they will return to see the doctor. The ultrasound examination of the abdomen was also repeated, and the gallbladder was found to be free of gallstones. To date the patient continued to have serious abdominal cramps. The patient underwent lab tests and procedures which included blood creatinine: 0.54 mg/ml on 06Oct2021 (normal range: 0.7-0.81 mg/ml), body temperature: 38.2 centigrade, lipase: 103 IU/l on 06Oct2021 (normal range: 145- 211 IU/l). Therapeutic measures were taken as a result of weakness, pyrexia, Abdominal cramps, nausea, chest pain, diarrhoea, cholelithiasis, strong pain, blood creatinine decreased, lipase decreased. The outcome of events "weakness, Pyrexia, Abdominal cramps, nausea, chest pain, diarrhoea" was not recovered; of event "cholelithiasis" was recovered; of other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1853465 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-09-27
   Days after vaccination:178
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001177 / 1 - / OT

Administered by: Unknown       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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: Vaccination failure; SARS-CoV-2 infection; This case was received via Regulatory Authority (Reference number: AT-BASGAGES-2021-052141) on 01-Nov-2021 and was forwarded to Moderna on 01-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) in a 24-year-old female patient who received mRNA-1273 (batch nos. 3001938 and 3001177) for COVID-19 vaccination. No Medical History information was reported. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant) and COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant). At the time of the report, VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. The action taken with mRNA-1273 in response to the event was not applicable. Company Comment: This case concerns a 24-year-old female patient with no relevant medical history who experienced serious unexpected event of COVID-19 (adverse event of special interest). The event occurred approximately five months after the second dose of Moderna COVID-19 vaccine. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. Vaccination failure was coded as an additional event as per RA and was retained as such having in mind that the patient developed COVID-19 after vaccination with both doses of vaccine. Re-challenge was not applicable as the event happened after the second dose. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable, while the causality for the event of Vaccination failure is assessed as possible. The benefit risk relationship of Moderna COVID-19 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Translation Received on 2-Nov-2021 contains translated dosage text; Sender''s Comments: This case concerns a 24-year-old female patient with no relevant medical history who experienced serious unexpected event of COVID-19 (adverse event of special interest). The event occurred approximately five months after the second dose of Moderna COVID-19 vaccine. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. Vaccination failure was coded as an additional event as per RA and was retained as such having in mind that the patient developed COVID-19 after vaccination with both doses of vaccine. Re-challenge was not applicable as the event happened after the second dose. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable, while the causality for the event of Vaccination failure is assessed as possible. The benefit risk relationship of Moderna COVID-19 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1855034 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-09-27
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101455609

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB AT-BASGAGES-2021-052021. A 38-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 20Jul2021 (Batch/Lot Number: FE6208) as DOSE 2, SINGLE, dose 1 intramuscular on 24Jun2021 (Batch/Lot Number: FD0168) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced sars-cov-2 infection and vaccination failure on 27Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive (variant PCR-based: B.1.617.2, sequenced variant: n501y-positive: No) on 27Sep2021. The outcome was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1855053 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211114732

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-052820] concerned a 73 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, frequency 1 total, administered on 10-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 27-SEP-2021, the patient experienced sars-cov-2 infection and had vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. 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.


VAERS ID: 1855074 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211117107

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053259] concerned a 33 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: XD975 and expiry: unknown) dose was not reported, frequency time 1 total, administered on 28-MAY-2021 for product use for unknown indication. No concomitant medications were reported. On 27-SEP-2021, the patient''s laboratory data included COVID-19 PCR (polymerase chain reaction) test (NR: not provided) Positive and experienced vaccination failure and had 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: 1855192 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Erectile dysfunction
SMQs:, Sexual dysfunction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101452857

Write-up: Erectile dysfunction; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. The Regulatory Authority report number is 647719. A 37-year-old male patient received BNT162B2 (COMIRNATY) (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced erectile dysfunction. Clinical outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1855424 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Infection, 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: Diabetes mellitus gestational; Dysplasia (gallbladder); Myopia; Pollinosis
Preexisting Conditions: Medical History/Concurrent Conditions: Ovarian cyst ruptured (surgery); Sclerotherapy (varices); Comments: avulsion of the right anterior cruciate ligament (ACL) due to injury and surgery performed on an unspecified date in MAR-2013.
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: CZJNJFOC20211109288

Write-up: BREAKTHROUGH INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, CZ-CZSUKL-21011356] concerned a 41-year-old female. The patient''s weight was 50 kilograms, and height was 160 centimeters. The patient''s past medical history included: ovarian cyst ruptured, and sclerotherapy, and concurrent conditions included: myopia, pollinosis, diabetes mellitus gestational, and dysplasia, and other pre-existing medical conditions included: avulsion of the right anterior cruciate ligament (ACL) due to injury and surgery performed on an unspecified date in MAR-2013. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955 expiry: unknown) 1 dosage forms, 1 total, administered on 26-APR-2021 for covid-19 vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient reported breakthrough infection. On the same date, COVID-19 PCR test (Polymerase chain reaction) result was positive and reported suspected clinical vaccination failure. The last dose latency was 05 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough infection on 11-OCT-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report is associated with product quality complaint.


VAERS ID: 1855733 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Chest pain, Dyspnoea, Fatigue, Heart rate increased, Pain, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Tendinopathies and ligament disorders (broad), Dehydration (broad)

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

Write-up: Arrhythmia; Chest pain; Pain in hand; Heart rate increased; Shortness of breath; Referred pain; Fatigue; This case was received via Regulatory Agency (Reference number: FI-FIMEA-20215953) on 01-Nov-2021 and was forwarded to Moderna on 01-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a 15-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant medical history was provided by the reporter. Concomitant products included METHYLPHENIDATE HYDROCHLORIDE (MEDIKINET) for ADHD. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Pain in hand), HEART RATE INCREASED (Heart rate increased), DYSPNOEA (Shortness of breath), PAIN (Referred pain) and FATIGUE (Fatigue). At the time of the report, ARRHYTHMIA (Arrhythmia), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Pain in hand), HEART RATE INCREASED (Heart rate increased), DYSPNOEA (Shortness of breath), PAIN (Referred pain) and FATIGUE (Fatigue) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No Treatment medication was reported. Company comment: This case concerns a 15-year-old male patient with no relevant medical history, who experienced the serious unexpected event of Arrhythmia (AESI), non-serious unexpected events of chest pain, pain in extremity, heart rate increased, dyspnoea, pain, non-serious expected event of fatigue. The events occurred the day after the first dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 15-year-old male patient with no relevant medical history, who experienced the serious unexpected event of Arrhythmia (AESI), non-serious unexpected events of chest pain, pain in extremity, heart rate increased, dyspnoea, pain, non-serious expected event of fatigue. The events occurred the day after the first dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1855994 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Blood test, Immunisation, Lumbar puncture, Magnetic resonance imaging, Mobility decreased, Off label use, Paraesthesia, Urinary retention
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Demyelination (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELVANSE ADULT; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Attention deficit hyperactivity disorder; Gastrooesophageal reflux disease
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: lumbar punch; Result Unstructured Data: Test Result:Unknown results; Test Name: MRI scan head and spine; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101450081

Write-up: urinary retention; reduced mobility/power in lower limbs; pins and needles from waist down; Acute disseminated encephalomyelitis; Off label use; booster; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110251736583880-O8KBA. Safety Report Unique Identifier: GB-MHRA-ADR 26118716. A 35-year-old male patient received 3rd dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 27Sep2021 (Batch/Lot number was not reported) as DOSE 3, (BOOSTER), SINGLE for COVID-19 immunisation. The patient''s medical history included attention deficit hyperactivity disorder (ADHD) and gastrooesophageal reflux disease (GERD). Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient previously received BNT162B2, dose 1 and dose 2 on unspecified dates, both for COVID-19 immunization. Concomitant medications included lisdexamfetamine mesilate (ELVANSE ADULT) taken for attention deficit hyperactivity disorder (ADHD); and omeprazole taken for gastrooesophageal reflux disease (GERD). The patient experienced urinary retention, reduced mobility/power in lower limbs and pins and needles from waist down on an unspecified date with outcome of unknown, acute disseminated encephalomyelitis on 15Oct2021 with outcome of recovering, off label use and booster on 27Sep2021 with outcome of unknown. Patient was admitted to neurology specialist as inpatient and was administered with high dose IV steroid treatment. The patient underwent lab tests and procedures which included blood test: unknown results, MRI scan head and spine: unknown results, and lumbar punch: unknown results, all on unspecified dates. The case was reported serious due to hospitalization and medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The report does not relate to possible blood clots or low platelet counts; and report does not relate to possible myocarditis or pericarditis. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1856071 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Basal cell carcinoma, Haemorrhage, Immunisation, Off label use, Tumour haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related conditions (narrow), Skin malignant tumours (narrow), Non-haematological malignant tumours (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: APIXABAN; ATORVASTATIN; BISOPROLOL; FUROSEMIDE; LANSOPRAZOLE; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart rate abnormal; Open heart surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101457286

Write-up: bleeding; Basial Cell Carcinoma; Tumor bleeding; off label use; booster; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110261408026420-FAFAM. Safety Report Unique Identifier GB-MHRA-ADR 26123606. An 81-year-old male patient received BNT162B2 (COMIRNATY), dose 3 via an unspecified route of administration on 27Sep2021 (Lot Number: FF8222) as dose 3 (booster), single for COVID-19 immunization. Medical history included heart rate abnormal, Open heart surgery. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test. Concomitant medications included apixaban; atorvastatin taken for Open heart surgery; bisoprolol taken for heart rate abnormal; furosemide; lansoprazole; and tamsulosin. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, as dose 1 and dose 2 on unspecified date for COVID-19 immunization. The patient experienced bleeding (medically significant) on an unspecified date, tumor bleeding (medically significant) on 30Sep2021. Case narrative: Patient bleed hemorrhage from Basial Cell Carcinoma after vaccine and blood pooled in pajama top. Patient''s daughter was a nurse so need to go to hospital as he stopped bleeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The reporter did not relate reaction to possible inflammation of the heart (myocarditis or pericarditis). The outcome of event "bleeding, Basal cell carcinoma" was unknown, of "tumor bleeding" was recovered on 01Oct2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1856328 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Febrile convulsion, Immunisation
SMQs:, Convulsions (narrow), Guillain-Barre syndrome (broad), 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? 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: ITPFIZER INC202101445586

Write-up: COMIRNATY as dose 3 (booster), single; FEBRILE CONVULSIONS; ASTHENIA; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 28Oct2021, this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from a contactable other healthcare professional downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number IT-MINISAL02-802477. A 52-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in deltoid left on 27Sep2021 15:59 (Batch/Lot Number: FG6273; Expiration Date: 30Nov2021) at the age of 52 years old as dose 3 (booster), single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first and second dose of COVID-19 Vaccine (MANUFACTURER UNKNOWN). On 27Sep2021, the patient experienced febrile convulsions and asthenia. Events were considered medically significant. Outcome of events were recovered on 13Oct2021. Reporter Comment: Inoculation site: DELTOID LEFT. Other information: USER EMAIL IS ATTACHED WITH THE ALERT. Sender Comment: 25Oct2021 Regional Center of Pharmacovigilance: this report card is updated from NON-SERIOUS to SERIOUS as the suspected adverse reaction described represents a clinically relevant event on the IME list. Regional Center of Pharmacovigilance: follow-up information is requested from the reporter regarding the medical documentation of the case. Awaiting reply. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Inoculation site: DELTOID LEFT. Other information: USER EMAIL IS ATTACHED WITH THE ALERT.


VAERS ID: 1857321 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-09-27
   Days after vaccination:110
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 - / -

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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101461979

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-051467. A 59-year-old male patient received second dose of bnt162b2 (Solution for injection, Lot Number: FD1921 and Expiry date was not reported), via an unspecified route of administration on 09Jun2021 as dose 2, single and first dose of bnt162b2 (Solution for injection, Lot Number: EY3014 and Expiry date was not reported) via an intramuscular route of administration on 05May2021 as dose 1, single for COVID-19 immunization. The patient relevant medical history, concurrent conditions, and concomitant medications were not reported. On 27Sep2021, the patient experienced vaccination failure and sars-cov-2 infection. The patient underwent lab tests and procedures which included sars-cov-2 test: positive, Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No. The outcome of events was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1858564 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-09-27
   Days after vaccination:71
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 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: 20210927; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2. Variant Sequenced: n501y positive: No
CDC Split Type: ATPFIZER INC202101455298

Write-up: Vaccination failure; SARS-CoV-2 infection/positive SARS-CoV-2 test, Variant PCR-based: B.1.617.2. Variant Sequenced: n501y positive: No; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-051566. A 36-year-old male patient received bnt162b2 on 18Jul2021 (Lot Number: FF0680) as dose 2 single and on 15Jun2021 (Lot Number: FD1921) as dose 1, single both intramuscular for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced SARS-CoV-2 infection and Vaccination failure. On 27Sep2021, the patient had a positive SARS-CoV-2 test, Variant PCR-based: B.1.617.2. Variant Sequenced: n501y positive: No. The outcome of the events was unknown. This case was reported as serious. No follow-up attempts possible. No further information expected.


VAERS ID: 1858575 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211116916

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-051903] concerned a 39 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: 21C18-03 expiry: unknown) dose was not reported, 1 total administered on 25-AUG-2021 for an unspecified indication. No concomitant medications were reported. On 27-SEP-2021, the patient had vaccination failure and severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection. Laboratory data included: COVID-19 polymerase chain reaction (PCR) test (NR: not provided) which was positive. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and polymerase chain reaction (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: 1858673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-09-27
   Days after vaccination:90
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101462104

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052122. A 38-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection) intramuscular on 29Jun2021 (Lot Number: FD6840) as dose 2, single for COVID-19 immunization and bnt162b2 (COMIRNATY, Solution for injection) intramuscular on 28May2021 (Lot Number: FC0681) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced vaccination failure and SARS-CoV-2 infection (COVID-19) (medically significant). The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 27Sep2021; Variant PCR-based: B.1.617.2, Variant Sequenced, n501y-positive: No. The outcome of the event SARS-CoV-2 infection was unknown. No follow-up attempts were possible. No further information was expected. ; Sender''s Comments: Linked Report(s) : AT-BASGAGES-2021-052122 BASGAGES


VAERS ID: 1858694 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-09-27
   Days after vaccination:209
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP 2166 / 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101462151

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB AT-BASGAGES-2021-052524. A 85-years-old female patient received bnt162b2 (COMIRNATY, formulation: Solution for injection, lot number: EP 2166), intramuscular administration on 02Mar2021 as dose 2, single, dose 1 bnt162b2 (COMIRNATY, formulation: Solution for injection, lot number: EJ6134), intramuscular administration on 11Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced sars-cov-2 infection and vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Sep2021 Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1858699 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211119884

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053186] concerned a 45 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: 21C18-03 expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-AUG-2021 for product use for an unknown indication. No concomitant medications were reported. On 27-SEP-2021, COVID-19 PCR (Polymerase Chain Reaction) test was performed with positive result which indicated sars-cov-2 (severe acute respiratory syndrome coronavirus 2) infection and 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).


VAERS ID: 1858700 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211119895

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053190] concerned a 23 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 03-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 27-SEP-2021, the patient experienced vaccination failure and sars-cov-2 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. 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: 1858702 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211119799

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053210] concerned a 20 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 08-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 27-SEP-2021, the patient experienced sars-cov-2 infection and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. 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, and reference number requested.


VAERS ID: 1858703 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211119599

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053284] concerned a 48 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 28-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 27-SEP-2021, the patient experienced sars-cov-2 infection and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. 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, and reference requested.


VAERS ID: 1858705 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211119801

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053320] concerned a 20 year old male patient. 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, 01 total (first dose), administered on 19-AUG-2021 for an unspecified indication. No concomitant medications were reported. On 27-SEP-2021, Laboratory data included: COVID-19 (corona virus disease) PCR (polymerase chain reaction) test was Positive. The patient experienced severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and had 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: 1858735 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Disturbance in attention, Fatigue, Headache, Intracranial pressure increased, Lethargy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101452960

Write-up: Intracranial pressure increased; Disturbance in attention; Fatigue; Headache; Lethargy; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 647866. A 25-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced intracranial pressure increased, disturbance in attention, fatigue, headache and lethargy on 27Sep2021. 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: 1858826 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood glucose, Blood glucose decreased, Hypotension, Loss of consciousness, Malaise, Nausea
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), Termination of pregnancy and risk of abortion (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: blood glucose; Result Unstructured Data: Test Result:decreased
CDC Split Type: AUPFIZER INC202101453001

Write-up: Abortion spontaneous; Loss of consciousness; Blood glucose decreased; Hypotension; Malaise; Nausea; This is a spontaneous report from a contactable other health professional received from the Regulatory Authority. The regulatory authority report number is 648045. A 39-year-old female patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on 27Sep2021 (lot number not reported), at age 39 years old, as dose number unknown, single, for COVID-19 immunisation. The patient was pregnant at the time of vaccination. Relevant medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced abortion spontaneous, loss of consciousness, blood glucose decreased, hypotension, malaise and nausea. 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: 1859084 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-10
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: DEJNJFOC20211120092

Write-up: VACCINATION FAILURE; COVID-19; This spontaneous report received from a consumer via a Regulatory Authority [regulatory authority, DE-PEI-202100218041] concerned a 55 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, route of administration not reported, batch number: BXE395 expiry: Unknown) 1 dosage forms, 1 total, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced vaccination failure and Covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and Covid-19 was not reported. This report was serious (Other Medically Important Condition). This case is associated with a product quality Complaint.


VAERS ID: 1859404 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation reaction, Myalgia, Pyrexia, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101462604

Write-up: Nettle rash; Reactogenicity event; fever; myalgia; headaches; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RN20213184. A 12-year-old female patient received the first dose of BNT162b2 (COMIRNATY, Batch/Lot Number: FG7387) intramuscular, administered in Arm Left on 25Sep2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. Relevant medical history of allergies was unknown. There was no COVID-10 medical history and no COVID-19 test. On 27Sep2021 the patient experienced nettle rash, reactogenicity event, fever, myalgia and headaches. Clinical course was described as follows. Within 48 hours of vaccination: reactogenicity event with fever, myalgia and headaches, urticaria spread all over the body. Medical care in the Emergency Room for urticaria and treatment with corticosteroids. In summary, onset of urticaria in a 12-year-old girl within 48 hours of dose 1 of Comirnaty. Nettle rash was serious as medically significant, other events were non-serious. The events resolved on an unspecified date. No follow-up attempts are possible. No further information expected.


VAERS ID: 1859708 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG 4442 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pyrexia, Rash morbilliform
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Thrombophilia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Test Result:39.5 degrees Celsius
CDC Split Type: GRPFIZER INC202101463198

Write-up: Measles-like rash; Fever; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number GR-GREOF-202109010. A 44-year-old female patient received the second dose of bnt162b2 (COMIRNATY, solution for injection, Lot number: FG 4442), via intramuscular route of administration, on 27Sep2021 (at the age of 44-year-old), as DOSE 2, 0.3 ML SINGLE for covid-19 immunization. Medical history included ongoing thrombophilia. The patient''s concomitant medications were not reported. The patient''s historical vaccine included the first dose of COVID-19 vaccine (MANUFACTURER UNKNOWN, Batch/Lot Number was unknown) via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced measles-like rash on 27Sep2021, fever on an unspecified date in 2021. A few hours later patient presented with measles-like rash. Patient had an image of initial toxic rash on the limbs and the torso. Patient also presented with fever of 39.5 degrees Celsius. The seriousness criteria of the event measles-like rash were reported as medically significant. The patient underwent lab tests and procedures which included body temperature: 39.5 degrees celsius on unknown date in 2021. Outcome of the event measles-like rash was recovering and outcome of the event fever was recovered on unknown date in 2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1860651 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211119827

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053191] concerned a 27 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: XE393 and expiry: Unknown) dose was not reported, 1 total, administered on 09-AUG-2021 for unknown indication. No concomitant medications were reported. On 27-SEP-2021, Covid-19 polymerase chain reaction (PCR) test result was positive. On the same day, the patient experienced severe acute respiratory syndrome (SARS-CoV-2) infection and had vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe acute respiratory syndrome (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.


VAERS ID: 1860653 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211120260

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053302] concerned a 54 year old male of an 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: XE423, and expiry: unknown) dose was not reported, 1 total was administered on 24-AUG-2021 for an unknown indication. No concomitant medications were reported. On 27-SEP-2021,the patient experienced severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection. On the same day, COVID-19 polymerase chain reaction (PCR) test was performed which was positive and the patient had 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: 90000201523.


VAERS ID: 1862231 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RAMIPRIL
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101462863

Write-up: bilateral pneumonia; persistent weakness; Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number EE-SAM-55122110125. A 93-year-old female patient received BNT162B2 (COMIRNATY solution for injection), first dose on an unspecified date (lot number: EM0477, expiration date: 30Apr2021) at dose 1, 0.3 ml single, then second dose on 22Feb2021 (lot number reported as EJ7690, pending clarification) at dose 2, 0.3 ml single; both via intramuscular at an unspecified age for COVID-19 immunisation. Medical history included ongoing hypertension. Concomitant medication included Ramipril for hypertension. On 27Sep2021, the patient experienced vaccination failure and COVID-19. On 06Oct2021, the patient experienced bilateral pneumonia and on Oct2021, the patient experienced persistent weakness. It was reported that the patient was mostly in bed and was a nursing home patient. Therapeutic measures such as dexamethasone and supplemental oxygen were taken as a result of the events. Due to the events the patient was hospitalized for 6 days from 06Oct2021 to 12Oct2021. The patient underwent SARS-CoV-2 PCR test on 27Sep2021 with positive result. Outcome of the event weakness was not recovered, and for other events was recovered on 12Oct2021. The causal relation of BNT162B2 to the events was reported as possible. On 28Oct2021, investigation results for BNT162B2 (COMIRNATY; lot number: EM0477, expiration date 30Apr2021) concluded that: The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EM0477. 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. The site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Sender''s Comment: Serious vaccine ineffectiveness report. The causal relationship is considered possible. The lot number for dose 2 of the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1862233 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-09-27
   Days after vaccination:137
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, SARS-CoV-2 test, Vaccination failure
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart valve operation
Allergies:
Diagnostic Lab Data: Test Date: 20211001; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101462869

Write-up: vaccination failure; COVID-19; COVID pneumonia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number EE-SAM-552321101216. A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 01Apr2021 (Batch/Lot Number: ER9480; Expiration Date: 31Jul2021) as DOSE 1, 0.3 ML SINGLE, dose 2 intramuscular on 13May2021 (Batch/Lot Number: EW6126; Expiration Date: 31Jul2021) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. The patient has a medical history of heart valve surgery. The patient''s concomitant medications were not reported. The patient experienced vaccination failure after vaccination with COVID-19 mRNA vaccine. On 27Sep2021, the patient developed COVID pneumonia. SARS-CoV-2 PCR test was positive on 01Oct2021. The course of the disease was severe and the patient was hospitalized on 04Oct2021. Treatment included remdesivir, oxygen therapy, antibiotic therapy. The patient recovered and was discharged home on 15Oct2021. The outcome of the events was recovered on 15Oct2021. Based on investigational results on 28Oct2021, from product quality complaint team regarding consumer''s complaint about Comirnaty (Injectable, lot: ER9480, expiration date: 31Jul2021) and (Injectable, lot: EW6126, expiration date: 31Jul2021). Investigational report conclusion was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5845624 and 5973683. The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ER9480 and lot EW6126. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Sender Comment: Serious vaccine ineffectiveness report. The causal relationship is considered possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1862239 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-09-27
   Days after vaccination:230
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test, Vaccination failure
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Mental retardation; Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211004; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101462932

Write-up: Vaccination failure; COVID-19/ COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from a Regulatory Authority, regulatory authority number EE-SAM-553221101225. A 43-year-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscular on 09Feb2021 (Batch/Lot Number: EL8723, expiration date: 31May2021) as DOSE 2, 0.3 ML SINGLE, and the first dose of BNT162B2 intramuscular on 19Jan2021 (Batch/Lot Number: EL1491, expiration date: 30Apr2021) as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing mental retardation, and ongoing obesity. The patient''s concomitant medications were not reported. On 27Sep2021, the patient experienced vaccination failure (hospitalization, medically significant) and developed COVID-19/ COVID-19 pneumonia (hospitalization, medically significant). The course of the disease was severe, the patient was hospitalized on 09Oct2021. The patient underwent lab tests and procedures which included SARS-CoV PCR-2 test: positive on 04Oct2021. Treatment included oxygen therapy. The patient recovered and was discharged home on 19Oct2021. The outcome of the events was recovered on 19Oct2021. The product quality complaint team provided investigation results regarding consumer''s complaint about: Comirnaty (Solution for injection) lot: EL1491, expiration date: 30Apr2021. Investigational report conclusion from (site name) division was: 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 EL1491. 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. (Site name) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. A Regulatory Authority process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Comirnaty (Solution for injection) lot: EL8723, expiration date: 31MAY2021. Investigational report conclusion from (site name) division was: 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 EL8723. 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. (Site name) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. A Regulatory Authority process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Sender Comment: Serious vaccine ineffectiveness report. The causal relationship is considered possible. No follow-up attempts are possible. No further information expected.


VAERS ID: 1862707 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-09-27
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Myocarditis, Pericarditis, Pyrexia, SARS-CoV-2 test, Troponin
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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? 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: 20211012; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test; Test Name: Troponin; Result Unstructured Data: 102
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Chest pain; Shortness of breath; Fatigue/unusual tiredness; Fever; Myocarditis; Pericarditis; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26144627) on 03-Nov-2021 and was forwarded to Moderna on 03-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), FATIGUE (Fatigue/unusual tiredness), PYREXIA (Fever), MYOCARDITIS (Myocarditis) and PERICARDITIS (Pericarditis) in a 24-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003607) for COVID-19 immunisation. No Medical History information was reported. On 28-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion hospitalization) and PERICARDITIS (Pericarditis) (seriousness criterion hospitalization). On an unknown date, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion hospitalization) and PYREXIA (Fever) (seriousness criterion hospitalization). At the time of the report, CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), FATIGUE (Fatigue/unusual tiredness) and PYREXIA (Fever) outcome was unknown and MYOCARDITIS (Myocarditis) and PERICARDITIS (Pericarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Oct-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. On an unknown date, Troponin: 102 (High) 102. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient stayed in the hospital for 4 days. Concomitant medication was not reported. He was treated with Colcichine, ibruprofen, codeine and paracetamol. Laboratory data included Chest, X-ray and ECG and result was unknown. Company Comment: This case concerns a 24 year-old male patient with no reported medical history who experienced the unexpected serious adverse events of special interest of myocarditis and pericarditis, and also the serious events of pyrexia and fatigue. The event occurred approximately 60 days after the first dose of Moderna COVID-19 Vaccine. The rechallenge was unknown as only the first dose was administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow-up received included no new information.; Sender''s Comments: This case concerns a 24 year-old male patient with no reported medical history who experienced the unexpected serious adverse events of special interest of myocarditis and pericarditis, and also the serious events of pyrexia and fatigue. The event occurred approximately 60 days after the first dose of Moderna COVID-19 Vaccine. The rechallenge was unknown as only the first dose was administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1862857 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Migraine
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Stomach ache, migraine; Stomach ache, migraine; This case was received via the Regulatory Authority (Reference number: IT-MINISAL02-802569) on 02-Nov-2021 and was forwarded to Moderna on 02-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache, migraine) and MIGRAINE (Stomach ache, migraine) in a 53-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 vaccination. The patient''s past medical history included Dermatitis atopic. Concurrent medical conditions included Food allergy. On 25-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 27-Sep-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache, migraine) (seriousness criterion medically significant) and MIGRAINE (Stomach ache, migraine) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache, migraine) and MIGRAINE (Stomach ache, migraine) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant medication use was unknown. Treatment information was unknown. Company comment: This case concerns a 53-year-old male patient with a relevant medical history of Food allergy (NOS), who experienced the serious unexpected events of Abdominal pain upper and Migraine. The events occurred 2 days after the patient received the dose of Moderna COVID-19 vaccine. (Dose sequence not provided). The medical history of food allergy is a confounder for abdominal pain. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report. Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Document received on 05-Nov-2021 and contain event verbatim; Sender''s Comments: This case concerns a 53-year-old male patient with a relevant medical history of Food allergy (NOS), who experienced the serious unexpected events of Abdominal pain upper and Migraine. The events occurred 2 days after the patient received the dose of Moderna COVID-19 vaccine. (Dose sequence not provided). The medical history of food allergy is a confounder for abdominal pain. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1863228 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-09-27
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003658 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
SMQs:, 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: 20210920; Test Name: Body temperature; Result Unstructured Data: 37.0-37.2 Cel; Test Date: 20210921; Test Name: Body temperature; Result Unstructured Data: Normal Cel; Test Date: 20210927; Test Name: PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Novel coronavirus infection; This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP116383) on 03-Nov-2021 and was forwarded to Moderna on 09-Nov-2021. This case, initially reported by a nurse, was received via Moderna''s adverse reaction reporting site (TASK0022359). Novel coronavirus infection was assessed as serious. On 29-Jul-2021, at 09:30, the patient received the 1st dose of this vaccine. There was no adverse event. On 26-Aug-2021, at 09:30, the patient received the 2nd dose of this vaccine. There was no adverse event. On 20-Sep-2021, nasal discharge, malaise, and low-grade fever of 37.0-37.2 degrees Celsius developed. On 21-Sep-2021, nasal discharge persisted. Body temperature was normal. On 27-Sep-2021, the patient underwent the PCR test for personal activities. The patient was found to be positive and confirmed to be infected with novel coronavirus infection. No symptoms were noted when the patient was found to be positive. On an unknown date, novel coronavirus infection resolved. The outcome of novel coronavirus infection was reported as resolved. 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 event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 21 year-old female patient with no reported medical history, who experienced the unexpected serious AESI of COVID-19. The event occurred 1 month 2 days after the second dose of mRNA-1273 vaccine. Symptoms developed prior to positive PCR test, and Medically significant seriousness criteria was maintained for consistency with partner report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1863258 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-27
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1435 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Angiogram
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: coronary angiography; Result Unstructured Data: Test Result:non-STEMI
CDC Split Type: SIPFIZER INC202101465004

Write-up: NSTEMI; This is a spontaneous report from a contactable physician downloaded from the regulatory authority SI-JAZMP-NCPHV-2021SI0979_0979. Additional case identifier: JAZMP-300017171. An 89-year-old female patient received the first dose of bnt162b2 (COMIRNATY, solution for injection) intramuscular on 09Sep2021 (Batch/Lot Number: FC1435; Expiration Date: 31Oct2021) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant therapy were not reported. On 27Sep2021, the patient experienced chest pain, NSTEMI (lasted 3 days). A good 14 days after vaccination (as reported), the patient experienced chest pain. On 27Sep2021, the patient was examined in the emergency, a new left-handed block. The patient was referred to the hospital, where they confirmed NSTEMI and performed coronary angiography (on Sep2021). The event resulted in an emergency room visit. The patient was hospitalized due to the event. The patient''s condition improved (recovering at the time of report). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1863261 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4721 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Coagulation test, Contusion, Dyspnoea, Nausea, Platelet count, Tension headache
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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: DEPAKINE CHRONO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache
Allergies:
Diagnostic Lab Data: Test Date: 20211003; Test Name: Coagulogram; Result Unstructured Data: Test Result:within normal limits; Test Date: 20211003; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:within normal limits
CDC Split Type: SIPFIZER INC202101465010

Write-up: Nausea; bruising on the legs; Tension headache; shortness of breath immediately after vaccination; This is a spontaneous report from a contactable physician downloaded from the regulatory authority SI-JAZMP-NCPHV-2021SI0983_0983. A 15-year-old female patient received first dose of bnt162b2 (COMIRNATY, Lot Number: FE4721; Expiration Date: 31Oct2021), intramuscular on 27Sep2021 as single for covid-19 immunisation. Medical history included headache from an unknown date and unknown if ongoing. Concomitant medication included valproate sodium, valproic acid (DEPAKINE CHRONO). On 27Sep2021, the patient experienced shortness of breath immediately after vaccination. Later the patient experienced headache (headache as many times before, according to the description of the tension character), nausea and bruising on the legs. The patient was hospitalised, on 03Oct 2021 platelet count and coagulogram were within normal limits. The patient recovered from tension headache on 02Oct2021, while recovered from shortness of breath, bruising on the legs and nausea on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1863268 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101424654

Write-up: This is a spontaneous report from a non-contactable healthcare professional (regulatory authority number: -TFDA-TVS-1100008227) based on information received by Pfizer from BioNtech SE (manufacturer control number: -Fosun-2021FOS003872), license party for bnt162b2 (COMIRNATY). A 15-year-old female patient started to receive a dose of Tozinameran (COMIRNATY) (batch number was not specified), via unknown route of administration on 24-Sep-2021 at dose number unknown, single for COVID-19 immunisation. No Medical history was reported. Concomitant medications and past product were not reported. The patient experienced skin itchy, skin rash (non-injection site) and urticaria on 27-Sep-2021. At 12:30 of 27-Sep-2021, after receiving the BNT vaccine, the patient experienced diffused itchy skin rash over her face, trunk, and four limbs an hour after injection. No short of breath, no swollen mucosa were noted. Under suspect of urticaria, the doctor prescribed diphenhydramine injection initially. The doctor kept following her clinical manifestation closely. Skin itchy, skin rash (non-injection site) and urticaria met the seriousness criterion of other medically important condition. At the time of the report, the outcome of the events were unknown. The primary reporter and BioNTech SE assessed the causal relationship between bnt162b2 and events as possible. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.Follow-up (29Oct2021): New information based on query response received (regulatory authority number: -TFDA-TVS-1100008227) based on information received by Pfizer from BioNtech SE (manufacturer control number: -Fosun-2021FOS003872), license party for bnt162b2 (COMIRNATY) included: the start date of vaccine should be 24-Sep-2021. Additional changes done such as event details (onset time of all events updated as 27Sep2021 at 12:30) and minor update in narrative. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1864081 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005288 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Neuropathy peripheral, Vaccination site pain
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fruit allergy (Kiwifruit allergy); Hypertension (Hypertension)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.5 degree Celsius
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Peripheral neuropathy; Vaccination site pain; This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP115906) on 02-Nov-2021 and was forwarded to Moderna on 08-Nov-2021. This case, reported by a physician, was received by Takeda Pharmaceutical Company Limited via Moderna''s adverse reaction reporting site (TASK0022349), and reported to the Pharmaceuticals and Medical Devices Agency (PMDA)by a physician, was received via the PMDA (Ref, v21130506). Peripheral neuropathy was assessed as serious by the MAH. The patient was on medication with Telmisartan, Amlodipine Besilate due to hypertension. On 27-Sep-2021, at 10:19, the patient received the 1st dose of the vaccine. No nerve pain nor numbness at the time of vaccination. The patient had vaccination site pain at night, which persisted for several days. No redness, swelling, nor pruritus was noted. Around 10-Oct-2021, peripheral neuropathy developed. The patient had dull pain from the left shoulder to the ulnar side of left forearm. On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 25-Oct-2021, no motor paralysis, hypesthesia, blood circulation disorder, or skin abnormalities were observed in the left upper limb in the examination before the second vaccination. It was judged that there was no problem with vaccination. At 10:35, the 2nd dose of the vaccine was administered in the left deltoid region. On 01-Nov-2021, the symptoms were confirmed to have disappeared by telephone medical care. The outcome of vaccination site pain and peripheral neuropathy was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: As other contributing factors, the event was suspected to be caused by overuse due to Judo experience. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 47-year-old, male with medical history of hypertension, who experienced the serious unexpected events of neuropathy peripheral and vaccination site pain. The event vaccination site pain occurred the same day after the administration of the first dose of Moderna COVID-19 Vaccine. The event neuropathy peripheral occurred on an unknown date after the administration of a dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as per TAKEDA. The medical history of hypertension remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. The onset dates of the event Neuropathy peripheral captured per SD from TAKEDA in structured field (1-NOV-2021) differ from what is described on the narrative field (10-Oct-2021) of the same SD.


VAERS ID: 1864615 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-09-27
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8813 / 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101491023

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician from Austria downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-052557.This is first of two reports. A 40-year-old male patient received second dose of BNT162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF8813), via an Intramuscular route of administration on 27Jul2021, as DOSE 2, SINGLE and first dose of BNT162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FD0168), via an Intramuscular route of administration on 15Jun2021 as DOSE 1, SINGLE both via intramuscular route, for COVID-19 immunisation. The patient had no medical history and concurrent conditions. No concomitant medication was reported. On 27Sep2021, the patient experienced SARS-COV-2 infection (COVID-19). The patient underwent lab tests and procedures which included SARS-COV-2 test was positive on 27Sep2021 (variant PCR-based: B.1.617.2, sequenced variant: n501y-positive: No). The outcome of event was unknown at the time of this report. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101511896 LOE/At risk


VAERS ID: 1865902 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-09-27
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1440 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101501123

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable consumer. This is the first of 2 reports. The first report is received from downloaded hcp downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100214427. This is the first of two reports. A 41-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection) (Lot number: FC1440), dose 2 intramuscular on 01Jul2021 as dose 2, single, dose 1 (Lot Number: EX7823) intramuscular on 20May2021 as dose 1, single for COVID-19 immunization. The patient medical history and patient''s concomitant medications were not reported. On 27Sep2021, patient experienced vaccination failure, covid-19. The outcome was unknown. Sender''s comment: Initials: PRIVACY Symptoms: Loss of smell and taste, general weakness, shortness of breath. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101525739 same patient, same vaccine, inappropriate schedule


VAERS ID: 1866146 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-09-27
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214013 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Suppressed lactation
SMQs:, Functional lactation disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Euthyrox
Current Illness:
Preexisting Conditions: Comments: The medical history was not provided by the reporter
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Low milk supply in nursing mother; This case was received via Regulatory Authority (Reference number: ES-AEMPS-1018027) on 05-Nov-2021 and was forwarded to Moderna on 05-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SUPPRESSED LACTATION (Low milk supply in nursing mother) in a 38-year-old female patient who received mRNA-1273 (batch nos. 3006276 and 214013) for COVID-19 vaccination. The medical history was not provided by the reporter. Concomitant products included LEVOTHYROXINE SODIUM from 01-Apr-2021 to an unknown date for an unknown indication. On 26-Aug-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced SUPPRESSED LACTATION (Low milk supply in nursing mother) (seriousness criterion medically significant). On 30-Sep-2021, SUPPRESSED LACTATION (Low milk supply in nursing mother) was resolving. Treatment information was not provided. Company comment:This case of maternal exposure during breastfeeding concerns a 38-year-old female patient, with no reported relevant medical history, who experienced the unexpected non-serious event of SUPPRESSED LACTATION. The event occurred on the same day of the administration of the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Translation received on 08-Nov-2021. Event verbatim and dosage text were updated.; Sender''s Comments: This case of maternal exposure during breastfeeding concerns a 38-year-old female patient, with no reported relevant medical history, who experienced the unexpected non-serious event of SUPPRESSED LACTATION. The event occurred on the same day of the administration of the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1866551 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG9019 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Asthenia, Bedridden, Body temperature, Feeling hot, Flushing, Headache, Hypoaesthesia, Influenza like illness, Oropharyngeal pain, Rash papular, SARS-CoV-2 test, Sinus congestion, Sneezing
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to animal ((cats and horses)); Asthma (Had asthma when younger); Factor VII deficiency ((mild)); Hernia repair (At 4 years old); Seasonal allergy (grass, tree and flower pollen); Seizures (Had seizures during one day, aged 2 years (no sign of epilepsy when tested aged 2 and a half).); Tonsillectomy (At 3 yrs old)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Test Result:Normal; Comments: Normal; Test Date: 20211001; Test Name: COVID-19 antigen test; Test Result: Negative ; Comments: Negative
CDC Split Type: IEPFIZER INC202101494563

Write-up: DEAD ARM; FEELING WEAK; SICK STOMACH; FACE FEELS REALLY HOT WHEN THIS HAPPENS/CHECKED TEMPERATURE AND IT IS NORMAL WHEN THIS HAPPENS; HEADACHE; FLU LIKE SYMPTOMS; VERY BLOCKED SINUSES FOR A WEEK, POSSIBLY THE WORST BLOCKED SINUSES THAT HE''S EVER HAD, AND HE GETS THAT A LOT WITH ALLERGIES; SORE THROAT; HAD TO STAY IN BED; GETS A FLUSHED FACE NOW, EVERY COUPLE OF DAYS/ RED FLUSHING OF THE FACE; CHEEKS ARE BRIGHT RED, WITH LITTLE BUMPS IN THE RED AREAS; SNEEZING; This is a spontaneous report from a contactable consumer. This is a report downloaded from the regulatory authority, report number IE-HPRA-2021-085678. Safety Report Unique Identifier IE-HPRA-2021-085678. A 12-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for Injection), via an unspecified route of administration on 26Sep2021 (Lot Number: FG9019) as dose 1, single for COVID-19 immunisation. Medical history included tonsillectomy (at 3-year-old), asthma (had asthma when younger), factor VII deficiency (mild), seasonal allergy (grass, tree, and flower pollen), seizure (had seizures for one day, aged 2 years (no sign of epilepsy when tested aged 2 and a half), allergy to animal (cats and horses), and hernia repair (at 4 years old). Patient Never had COVID-19. The patient''s concomitant medications were reported as none. On 27Sep2021, the patient experienced dead arm, feeling weak, sick stomach, face feels really hot when this happens/checked temperature and it is normal when this happens, headache, flu like symptoms, very blocked sinuses for a week, possibly the worst blocked sinuses that he''s ever had, and he gets that a lot with allergies, sore throat, had to stay in bed, gets a flushed face now, every couple of days/ red flushing of the face, cheeks are bright red, with little bumps in the red areas, and sneezing. The patient underwent lab tests and procedures which included body temperature: normal in 2021, and SARS-COV-2 test: negative on 01Oct2021. It was reported that 24 hours after vaccination with the first dose of Comirnaty, on 27Sep2021, the patient experienced very blocked sinuses, persisting for a week. The reporter stated that this was possibly the worst blocked sinuses that the patient had ever experienced, noting that he gets that a lot with his allergies. The patient experienced a sick stomach for 4 days, felt weak for 5 days and had to stay in bed, a headache for 2 days, a sore throat for 2 days, a dead arm for 2 days and sneezing for a few days. The reported outlined that, since having the first vaccine, the patient had been experiencing a flushed face, every couple of days. The reporter described the patient''s cheeks as bright red, with little bumps in the red areas. According to the reporter his face felt really hot when this happens, however they have checked his temperature and it was normal. Patient received second dose of bnt162b2 (COMIRNATY, Solution for Injection), via an unspecified route of administration on 17Oct2021 (Batch/Lot Number: Unknown) as dose 2 single for COVID-19 immunisation. The patient was treated with Nurofen, Calpol and his usual antihistamines (unspecified) for the events. Outcome for events face feels really hot when this happens/checked temperature and it is normal when this happens, gets a flushed face now, every couple of days/red flushing of the face, and cheeks are bright red, with little bumps in the red areas were not resolved and other events were resolved in 2021. No follow-up attempts are possible, No further information is expected.


VAERS ID: 1866717 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-09-27
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2021-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Suddenly had a menstrual period; I have not a period eight years due to the menopause; This case was received via Agency Regulatory Authority (Reference number: NL-LRB-00696286) on 29-Oct-2021 and was forwarded to Moderna on 29-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Suddenly had a menstrual period; I have not a period eight years due to the menopause) in a 54-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003186) for COVID-19 vaccination. No Medical History information was reported. On 24-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 ml. On 28-Jun-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 ml. On 27-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Suddenly had a menstrual period; I have not a period eight years due to the menopause) (seriousness criterion medically significant). On 03-Oct-2021, POSTMENOPAUSAL HAEMORRHAGE (Suddenly had a menstrual period; I have not a period eight years due to the menopause) had resolved. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case concerns a 54 year old female with no reported medical history, who experienced non-serious , unexpected event of Post-menopausal bleeding which occurred 92 days after vaccinaton with the 2nd dose of mRNA-1273 (Moderna Covid 19 Vaccine) . The re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 (Moderna Covid 19 Vaccine ) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Batch lot number of suspected product as updated. On 29-Oct-2021: Translation document received on 31 Oct 2021 included translated version of Past drug history section, Events section and Drug information section.; Sender''s Comments: This case concerns a 54 year old female with no reported medical history, who experienced non-serious , unexpected event of Post-menopausal bleeding which occurred 92 days after vaccinaton with the 2nd dose of mRNA-1273 (Moderna Covid 19 Vaccine) . The re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 (Moderna Covid 19 Vaccine ) is not affected by this report.


VAERS ID: 1868890 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Pyrexia; Fainting; This case was received via Regulatory authority (Reference number: FI-FIMEA-20216046) on 05-Nov-2021 and was forwarded to Moderna on 05-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Pyrexia) and SYNCOPE (Fainting) in a 14-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced PYREXIA (Pyrexia) (seriousness criterion medically significant) and SYNCOPE (Fainting) (seriousness criterion medically significant). At the time of the report, PYREXIA (Pyrexia) and SYNCOPE (Fainting) had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not provided. Company Comment: This case concerns a 14 year old male patient with no relevant medical history, who experienced the unexpected events of pyrexia and syncope. The events occurred on 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.; Sender''s Comments: This case concerns a 14 year old male patient with no relevant medical history, who experienced the unexpected events of pyrexia and syncope. The events occurred on 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: 1868948 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-09-27
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cold sweat, Nausea, Palpitations, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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: SEMODERNATX, INC.MOD20213

Write-up: Fainting; Palpitations; Felt nauseous; Cold sweats; This case was received via the RA (Reference number: SE-MPA-2021-091353) on 05-Nov-2021 and was forwarded to Moderna on 05-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting), PALPITATIONS (Palpitations), NAUSEA (Felt nauseous) and COLD SWEAT (Cold sweats) in a 38-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3005238 and 3004493) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NAUSEA (Felt nauseous) (seriousness criterion disability) and COLD SWEAT (Cold sweats) (seriousness criterion disability). On 27-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced SYNCOPE (Fainting) (seriousness criteria disability and medically significant) and PALPITATIONS (Palpitations) (seriousness criterion disability). At the time of the report, SYNCOPE (Fainting) and PALPITATIONS (Palpitations) had not resolved and NAUSEA (Felt nauseous) and COLD SWEAT (Cold sweats) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment: This is a regulatory case concerning a 38 year-old female patient with no relevant medical history reported, who experienced the serious unexpected events of SYNCOPE, PALPITATIONS, NAUSEA and COLD SWEAT approximately one week after receiving the second dose of mRNA-1273. Time interval between doses was more than 35 days as per Source document information. 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 05-Nov-2021: Translation received on 08-Nov-2021 included events verbatim were updated.; Sender''s Comments: This is a regulatory case concerning a 38 year-old female patient with no relevant medical history reported, who experienced the serious unexpected events of SYNCOPE, PALPITATIONS, NAUSEA and COLD SWEAT approximately one week after receiving the second dose of mRNA-1273. Time interval between doses was more than 35 days as per Source document information. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory authority reporting.


VAERS ID: 1869704 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-09-27
   Days after vaccination:82
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101490870

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-051822. A 21-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 07Jul2021 (Batch/Lot Number: FD0168) as dose 2, single and intramuscular on 02Jun2021 (Batch/Lot Number: FC0681) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 27Sep2021, the aptient experienced vaccination failure and SARS-CoV-2 infection. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive (Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No) on 27Sep2021. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1870267 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-09-27
   Days after vaccination:117
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101490509

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from a Regulatory Authority, regulatory authority number AT-BASGAGES-2021-051856. A 29-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EY7015) via intramuscular on 10May2021 as dose 1, single for covid-19 immunisation and second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: FC2473), dose 2 via intramuscular on 02Jun2021 as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced sars-cov-2 infection and vaccination failure. The report was assessed as serious by health authority. The patient underwent lab tests and procedures which included sars-cov-2 test resulted positive on 27Sep2021, variant PCR-based: B.1.617.2, variant sequenced: n501y-positive: no. The outcome of both the events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1870310 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-09-27
   Days after vaccination:102
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101490084

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority report number is AT-BASGAGES-2021-052211. A 50-year-old female patient received BNT162B2 (COMIRNATY), via intramuscular route on 17Jun2021 (Lot Number: FD0168, Expiration date: Not reported) as dose 2, single and on 11May2021 (Lot Number: EY7015, Expiration date: Not reported) as dose 1, single for COVID-19 immunization. There was no relevant medical history and no concomitant medications reported. On 27Sep2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and vaccination failure. On 27Sep2021, the patient''s COVID test was done with variant polymerase chain reaction (PCR) based reported as B.1.617 not differentiated; sequenced variant was reported with no n501y-positive. This report was considered to be serious. The outcome of these events was unknown at the time of report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1870326 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-09-27
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101490344

Write-up: vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052237. This is the first of two cases. A 64-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: FD1921, Expiry date was not reported) intramuscular on 06Jun2021 as dose 2, single, first dose of intramuscular on 25Apr2021 (Batch/Lot Number: EX0893, Expiry date was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced SARS-CoV-2 infection, vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Sep2021 Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: no. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101511211 The same patient, different events, second dose.


VAERS ID: 1870379 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-09-27
   Days after vaccination:100
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 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: 20210927; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: not reported n501y-positive: No
CDC Split Type: ATPFIZER INC202101500849

Write-up: Vaccination failure/Variant PCR-based: B.1.617.2; SARS-CoV-2 infection/Variant PCR-based: B.1.617.2; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-052351. A 62-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular on 15May2021 (Batch/Lot Number: EY7015) as dose 1, single, and intramuscular on 19Jun2021 (Batch/Lot Number: FD1921) as dose 2, single, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 27Sep2021, 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; Variant Sequenced: not reported; n501y-positive: No) on 27Sep2021. The outcome of the events was unknown. The report was reported as serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1870386 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-09-27
   Days after vaccination:96
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: variant PCR-based: B.1.617.2 variant sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101490541

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from a Regulatory Authority, regulatory authority number AT-BASGAGES-2021-052532. A 66-years-old female patient received BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: FD4555) via intramuscular route on 23Jun2021 as DOSE 2, SINGLE and received first dose via intramuscular route on 26May2021 (Batch/Lot Number: FC0681) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure and sars-cov-2 infection on 27Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Sep2021 variant PCR-based: B.1.617.2 variant sequenced: n501y-positive: No. The clinical outcome of the event was unknown. No follow-up attempts are possible. No further information was expected.


VAERS ID: 1870400 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-09-27
   Days after vaccination:129
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No
CDC Split Type: ATPFIZER INC202101489941

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-052560.A 65-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FA4598), dose 2 intramuscular on 21May2021 as dose 2, single for COVID-19 immunization.The patient medical history and concomitant medications were not reported.The patient had received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EX0893), intramuscular on 28Apr2021 as dose 1, single for COVID-19 immunization On 27Sep2021, the patient experienced sars-cov-2 infection, vaccination failure (all medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Sep2021 Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No. The outcome of events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1870409 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-09-27
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2, Sequenced variant:, n501y-positive: No
CDC Split Type: ATPFIZER INC202101490691

Write-up: Vaccination failure; SARS-CoV-2 infection/COVID-19 PCR test positive (Variant PCR-based: B.1.617.2, Sequenced variant: n501y-positive: No); This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-052562. A 38-year-old female patient received bnt162b2 (COMIRNATY), on 28Jun2021 (Batch/Lot Number: FD6840) as DOSE 1, SINGLE then on 26Jul2021 (Batch/Lot Number: FE6208) as DOSE 2, SINGLE both given intramuscularly for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had vaccination failure as the patient had SARS-COV-2 infection on 27Sep2021. The patient had positive COVID-19 PCR test (Variant PCR-based: B.1.617.2, Sequenced variant: n501y-positive: No) on that same day of 27Sep2021. Outcome of the events were unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1870483 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-09-27
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Sequenced variant: n501y-positive: Unknown.
CDC Split Type: ATPFIZER INC202101490126

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052613. A 39-years-old female patient received second dose BNT162B2 (COMIRNATY, formulation: Solution for injection, Lot Number: FD0168) via intramuscular route on 20Jul2021 as dose 2, single; and first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Lot Number: FD0168), via intramuscular route on 21Jun2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Sep2021 patient experienced vaccination failure, and sars-cov-2 infection. On 27Sep2021, the patient underwent lab tests and procedures which included sars-cov-2 test: positive, Variant PCR-based: Sequenced variant: n501y-positive was Unknown. The outcome of events was unknown. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1870498 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-09-27
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2; n501y-positive: No
CDC Split Type: ATPFIZER INC202101490794

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-052644. A 58-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 27Jul2021 (lot number: FF0680; expiry date: unknown) as dose 2, single, intramuscular on 22Jun2021 (lot number: FD4555; expiry date: unknown) as dose 1, single for Covid-19 immunisation.The patient''s medical history and concomitant medications were not reported. On 27Sep2021, 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; n501y-positive: No) on 27Sep2021. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1870536 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211128801

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053369] concerned a 29 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 07-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 27-SEP-2021, the patient had laboratory test: COVID-19 polymerase chain reaction (PCR) test which showed positive result and had the 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 case is associated with a product quality complaint.


VAERS ID: 1870537 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211129235

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053383] concerned a 30 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C17-05 expiry: UNKNOWN) dose was not reported, 1 total administered on 10-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 27-SEP-2021, the patient experienced sars-cov-2 infection and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. 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 was associated with a product quality complaint and reference number was requested.


VAERS ID: 1870538 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211128743

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053403] concerned a 21 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: XD974 expiry: UNKNOWN) dose was not reported, 1 total administered on 18-JUN-2021 for an unspecified indication. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On 27-SEP-2021, the patient experienced vaccination failure and sars-cov-2 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. 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 a product quality complaint, and reference requested.


VAERS ID: 1870606 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-17
Onset:2021-09-27
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dysphonia, Laryngitis, Oropharyngeal pain, SARS-CoV-2 antibody test, Vocal cord dysfunction
SMQs:, Anaphylactic reaction (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LAMOTRIGINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy
Allergies:
Diagnostic Lab Data: Test Date: 20211102; Test Name: COVID-19 Test; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: CAPFIZER INC202101520511

Write-up: Sounds like laryngitis; Vocal cord dysfunction; I can barely talk anymore; coughing; My throat is getting more sore over time; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 17Sep2021 (Batch/Lot Number: Unknown) at the age of 43-year-old as single dose for COVID-19 immunization. Medical history included epilepsy. Known allergy was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient didn''t received other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included lamotrigine for epilepsy. On 27Sep2021, the patient experienced adverse events. The patient stated:"Sounds like laryngitis or Vocal cord dysfunction of some kind. I can barely talk anymore. When drinking fluids sometimes goes down wind pipe causing coughing as I try to cough the fluids back up (like my gag reflex isn''t working sometimes) My throat is getting more sore over time. My voice is also getting worse over time. I have never had issues like this. It started after first vaccination and got significantly worse shortly after the second.". The patient receive the second dose of BNT162B2 via an unspecified route of administration on the left arm on 15Oct2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient performed COVID test (Nasal Swab) on 02Nov2021 and result was negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was received, just some steroid to try to reduce any swelling. The outcome of events was not recovered. The lot number for BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1870771 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-09-27
   Days after vaccination:107
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3095 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, COVID-19, Headache, Rhinitis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Guillain-Barre syndrome (broad), Arthritis (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: DEPFIZER INC202101491087

Write-up: Rhinitis; general weakness; headache; joint pain; Vaccination failure; COVID-19; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB with regulatory authority report number DE-PEI-202100212262. A 42-year-old male patient received dose 1 of bnt162b2 (Batch/Lot Number: EX3510) intramuscular on 02May2021 as a single dose and dose 2 of BNT162B2 (Batch/Lot Number: FC3095) intramuscular on 12Jun2021as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced vaccination failure and COVID-19. The events were reported as serious. On unspecified dates the patient experienced rhinitis, general weakness, headache, and joint pain. The outcomes of vaccination failure, COVID-19, rhinitis, general weakness, headache, and joint pain were unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1870775 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-09-27
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRWW2 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cough, Drug ineffective, Headache, Nasopharyngitis, Pyrexia, Suspected COVID-19
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), 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:
CDC Split Type: DEPFIZER INC202101491009

Write-up: SUSPECTED COVID-19; Drug Ineffective; Fever; cough; cold; general weakness; headache; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority, regulatory authority number DE-PEI-202100212340. A 50-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 20Aug2021 (Batch/Lot Number: SCRWW2) as dose 2, single, dose 1 intramuscular on 16Jul2021 (Batch/Lot Number: FD7958) 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 experienced suspected suspected covid-19 (medically significant) on 27Sep2021 with outcome of unknown, drug ineffective (medically significant) on 2021 with outcome of unknown, fever (non-serious) on 2021 with outcome of unknown, cough (non-serious) on 2021 with outcome of unknown , cold (non-serious) on 2021 with outcome of unknown , general weakness (non-serious) on 2021 with outcome of unknown , headache (non-serious) on 2021 with outcome of unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1870797 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-09-27
   Days after vaccination:90
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101490414

Write-up: Vaccination failure; COVID-19 / Symptoms: cough, sore throat, bronchial pain; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from a Regulatory Authority, regulatory authority number DE-PEI-202100213113. A 48-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 29Jun2021 (Lot Number: FD7958) as single, and dose 1 intramuscular on 18May2021 (Lot number was not reported) as single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure (drug ineffective) and COVID-19 / symptoms: cough, sore throat, bronchial pain (suspected COVID-19) on 27Sep2021 with outcome of unknown. No follow-up attempts are possible; information on the lot number of 1st dose cannot be obtained. No further information is expected.


VAERS ID: 1870834 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-09-27
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-11-15
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, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis, Troponin
SMQs:, Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: creatine phosphokinase; Result Unstructured Data: Test Result:increased; Test Name: ECG; Result Unstructured Data: Test Result:unknown result; Test Name: Cardio MRI; Result Unstructured Data: Test Result:Urgent suspicion of Myocarditis; Comments: Urgent suspicion of Myocarditis in the basal to central anterolateral and inferolateral wall of the left ventricle. Quantitatively limited left ventricular systolic function.; Test Name: troponin; Result Unstructured Data: Test Result:increased
CDC Split Type: DEPFIZER INC202101490056

Write-up: Myocarditis; Angina pectoris; This is a spontaneous report from a non-contactable other health professional (HCP) downloaded from the Agency-WEB DE-PEI-202100214334 received via regulatory authority. A 29-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: 1E026A), via an unspecified route of administration on 04Aug2021 (at the age of 29-years-old) as dose number unknown, 0.3ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced myocarditis and angina pectoris on 27Sep2021. The patient underwent lab tests and procedures which included blood creatine phosphokinase: increased, electrocardiogram: unknown result, magnetic resonance imaging heart: urgent suspicion of myocarditis (Urgent suspicion of Myocarditis in the basal to central anterolateral and inferolateral wall of the left ventricle. Quantitatively limited left ventricular systolic function) and troponin: increased, all on an unspecified date. This report is serious - hospitalization. The outcome of the event was recovered on an unspecified date. Causal relationship between the adverse events and the administration of COMIRNATY was assessed as "Unclassifiable". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1871172 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0161 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Drug ineffective, Inappropriate schedule of product administration, Polymerase chain reaction positive, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Medication errors (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211021; Test Name: body temperature; Result Unstructured Data: Test Result:38; Test Date: 202110; Test Name: polymerase chain reaction test; Test Result: Positive ; Test Date: 202110; Test Name: Covid 19 antigen test; Test Result: Positive
CDC Split Type: FIPFIZER INC202101490086

Write-up: Drug ineffective; COVID-19; 1st dose 5Jul2021, 2nd dose 27Sep2021; This is a spontaneous report from a contactable nurse, downloaded from the regulatory authority-WEB, company number FI-FIMEA-20216044. A 32-year-old male patient received BNT162b2 (COMIRNATY), dose 1 intramuscularly on 05Jul2021 (Batch/Lot Number: FE2296) as 0.3 ml single dose, dose 2 intramuscularly on 27Sep2021 (Batch/Lot Number: FH0161) as 0.3 ml single dose for COVID-19 immunisation. There was no medical history. The patient''s concomitant medications were not reported. The patient experienced "vaccination failure" (drug ineffective), COVID-19 on 21Oct2021, medically significant. The patient was travelling in 14Oct - 20Oct2021. An antigen test taken at the border, which was positive. A polymerase chain reaction test also taken at the border, which was positive. On 21Oct2021, at home, onset of fever up to 38. Also loss of olfactory sense, headache, sore throat and rhinitis. No underlying diseases. He had taken two vaccine doses. The outcome of events was reported as recovering. Follow-up attempt are not possible. No expected further information.


VAERS ID: 1871343 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood pressure measurement, Blood urea, Body temperature, C-reactive protein, Electrocardiogram, Heart rate, Investigation, Laboratory test, Myocarditis, N-terminal prohormone brain natriuretic peptide, Neurological examination, SARS-CoV-2 test, Troponin
SMQs:, 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Febrile convulsion
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: creatinine; Result Unstructured Data: Test Result:43 umol/l; Test Date: 20210927; Test Name: blood pressure; Result Unstructured Data: Test Result:117/56 mmHg; Test Date: 20210927; Test Name: Urea; Result Unstructured Data: Test Result:4.6 mmol/L; Test Date: 20210927; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: afebrile; Test Date: 20210927; Test Name: C-reactive protein; Result Unstructured Data: Test Result:33.5 mg/l; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:records a regular sinus rhythm. Absence of ST; Comments: segment elevation (by discharge electrocardiogram); Test Date: 20210927; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Regular sinus rhythms; Comments: with initial ST segment elevation in V4-V6.; Test Date: 20210927; Test Name: heart rate; Result Unstructured Data: Test Result:73; Comments: beats/minute; Test Date: 20210927; Test Name: clinical examination; Result Unstructured Data: Test Result:found regular heart sounds, without a perceived; Comments: murmur. No signs of right or left cardiac insufficiency. Peripheral pulses well detected.; Test Date: 20210927; Test Name: Digestive examination; Result Unstructured Data: Test Result:Painful abdomen throughout. Non-mucous-bloody; Comments: watery diarrhoea for 2 days. Bowel noises. No organomegaly.; Test Date: 20210927; Test Name: lab test; Result Unstructured Data: Test Result:found balanced electrolytes,; Comments: preserved renal function with creatinine at 43 ?mol/l, urea at 4.6 mmol/l, troponin at 710 ng/l, C-reactive protein at 33.5 mg/l, N-terminal pro brain natriuretic peptide at 143 pg/ml; Test Date: 20210927; Test Name: Neurological examination; Result Unstructured Data: Test Result:No meningeal syndrome; Test Date: 20210927; Test Name: N-terminal pro brain natriuretic peptide; Result Unstructured Data: Test Result:143 pg/mL; Test Date: 20210927; Test Name: Test SARS-CoV-2; Test Result: Negative ; Test Date: 20210927; Test Name: Troponin; Result Unstructured Data: Test Result:710 ng/L
CDC Split Type: FRPFIZER INC202101490187

Write-up: Acute myocarditis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number is FR-AFSSAPS-TO20218664. A 12-year-old male patient received bnt162b2 (COMIRNATY), dose 2, intramuscularly on 24Sep2021 (batch/lot number: unknown) as single dose for COVID-19 immunization. Medical history included febrile convulsion from 2010. Concomitant medications were not reported. Historical vaccine included first dose of COVID-19 (manufacture unknown) on an unspecified date for COVID-19 immunization. The patient experienced acute myocarditis (serious with seriousness criteria of hospitalization) on 27Sep2021 with outcome of recovering. The patient consulted on 27Sep2021 with the paediatric emergency department for oppressive chest pain in the context of fever and diarrhoea. He was haemodynamically stable with a heart rate of 73 beats/minute, a blood pressure of 117/56 mmHg. He was afebrile at 36?4. He seems to be in pain. The clinical examination found regular heart sounds, without a perceived murmur. No signs of right or left cardiac insufficiency. Peripheral pulses well detected. Neurological examination: No meningeal syndrome. Digestive examination: Painful abdomen throughout. Non-mucous-bloody watery diarrhoea for 2 days. Bowel noises. No organomegaly. The lab test performed found balanced electrolytes, preserved renal function with creatinine at 43 ?mol/l, urea at 4.6 mmol/l, troponin at 710 ng/l, C-reactive protein at 33.5 mg/l, N-terminal pro brain natriuretic peptide at 143 pg/ml. Electrocardiogram: Regular sinus rhythms with initial ST segment elevation in V4-V6. The discharge electrocardiogram records a regular sinus rhythm. Absence of ST segment elevation. In Summary on 07Oct2021: Follow-up of post-vaccination messenger ribonucleic acid with preserved left ventricular ejection fraction myocarditis. Normal echocardiogram and electrocardiogram on this day. Continuation of cardio-protective treatment with bisoprolol and ramipril. The anti-inflammatory drug was also continued until 10Oct2021. SARS-CoV-2 test on 27Sep2021 was negative. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1871865 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Chest pain, Cough, Dizziness, Dyspnoea, Forced expiratory flow, Forced expiratory flow decreased, Inappropriate schedule of product administration, Oxygen saturation, Oxygen saturation decreased, Respiratory distress, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Ehlers-Danlos syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylactic reaction
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: expiratory force; Result Unstructured Data: Test Result:difficulties; Comments: difficulties with expiratory force. She was tired and weak.; Test Date: 20210928; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: SEPFIZER INC202101495043

Write-up: Respiratory distress; Difficulty coughing; Desaturation; Chest pain; Forced expiration/difficulties with expiratory force; dyspnoea; dizziness; tachycardia; severe anaphylactic reaction; first dose on 09Aug2021/second dose on 27Sep2021; This is a spontaneous report from a contactable physician downloaded from the regulatory authority -WEB, regulatory authority number SE-MPA-2021-090925. A 26-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 27Sep2021 (Lot Number: FF2832), at the age of 26-year-old, as single dose for covid-19 immunisation. Medical history included EDS (Ehlers-Danlos syndrom) and ongoing, anaphylactic reaction from an unspecified date and unknow if it was ongoing. The patient''s concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (COMIRNATY, lot# FF0680) on 09Aug2021 for covid-19 immunization. Reported suspect adverse events were decreased oxygen saturation, respiratory distress, chest pain, difficulties with coughing and forced expiratory flow, which all commenced a day after the second vaccination on 28Sep2021 and report assessed as serious, hospitalisation. The female recovered from the chest pain six days after debut. It is described that vaccination induced a severe anaphylactic reaction and she was treated at the location on 27Sep2021. The next day on 28Sep2021 she had chest pain, dyspnoea, dizziness, desaturation and tachycardia. The female was hospitalised, for one week (in 2021), due to a suspect pulmonary embolism. Further investigations did not generate any clear results. According to the report she has not recovered from the desaturation. It is also described that she has a sense that she is not able to cough, difficulties to build up pressure and difficulties with expiratory force. She was tired and weak. No further details were provided. The outcome of the events decreased oxygen saturation, respiratory distress, difficulties with coughing and forced expiratory flow was not recovered; of the event chest pain was recovered on 04Oct2021; of the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1872411 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-09-27
   Days after vaccination:234
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

Administered by: Unknown       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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: SARS-CoV-2 infection; Vaccination failure; This case was received via regulatory authority (Reference number: AT-BASGAGES-2021-053054) on 08-Nov-2021 and was forwarded to Moderna on 08-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 (SARS-CoV-2 infection) and VACCINATION FAILURE (Vaccination failure) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 300042721 and 300042698) for COVID-19 vaccination. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant). At the time of the report, COVID-19 (SARS-CoV-2 infection) and VACCINATION FAILURE (Vaccination failure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. The action taken with the drug in response to the events was not applicable. Company comment: This case concerns a 44-year-old female patient with no relevant medical history who experienced serious unexpected event of special interest of COVID-19. The event occurred approximately six months and a 22days after the second dose of Moderna COVID-19 vaccine. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. Vaccination failure was coded as an additional event as per RA, and was retained as such, having in mind that the patient developed COVID-19 after vaccination with both doses of vaccine. Re-challenge was not applicable as the event happened after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Event seriousness was captured as per Regulatory Authority reporting.. Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Translation received on 09-NOV-2021. Dosage text was updated.; Sender''s Comments: This case concerns a 44-year-old female patient with no relevant medical history who experienced serious unexpected event of special interest of COVID-19. The event occurred approximately six months and a 22days after the second dose of Moderna COVID-19 vaccine. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. Vaccination failure was coded as an additional event as per RA, and was retained as such, having in mind that the patient developed COVID-19 after vaccination with both doses of vaccine. Re-challenge was not applicable as the event happened after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Event seriousness was captured as per Regulatory Authority reporting.


VAERS ID: 1872482 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006273 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREDNISOLON [PREDNISOLONE]; NPLATE
Current Illness: Idiopathic thrombocytopenic purpura
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: DIP IN PLATELET PARTICLE CONCENTRATION AFTER COVID-19 VACCINE, SEVERE THROMBOCYTOPENIA; This case was received via regulatory authority (Reference number: SE-MPA-2021-090637) on 08-Nov-2021 and was forwarded to Moderna on 08-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of THROMBOCYTOPENIA (DIP IN PLATELET PARTICLE CONCENTRATION AFTER COVID-19 VACCINE, SEVERE THROMBOCYTOPENIA) in a 49-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3006273) for COVID-19 vaccination. Concurrent medical conditions included Idiopathic thrombocytopenic purpura. Concomitant products included PREDNISOLON [PREDNISOLONE] and ROMIPLOSTIM (NPLATE) for an unknown indication. On 24-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) at an unspecified dose. On 27-Sep-2021, the patient experienced THROMBOCYTOPENIA (DIP IN PLATELET PARTICLE CONCENTRATION AFTER COVID-19 VACCINE, SEVERE THROMBOCYTOPENIA) (seriousness criterion medically significant). At the time of the report, THROMBOCYTOPENIA (DIP IN PLATELET PARTICLE CONCENTRATION AFTER COVID-19 VACCINE, SEVERE THROMBOCYTOPENIA) was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No treatment medications were reported. Company comment: This case concerns a 49-year-old female patient, with medical history of Idiopathic thrombocytopenic purpura, who experienced the serious unexpected event of THROMBOCYTOPENIA (AESI). The event occurred 4 days after the second dose mRNA-1273 vaccine. Re-challenge was not applicable. Patient?s medical history of Idiopathic thrombocytopenic purpura, remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Translation received on 09-Nov-21 included, translation of Event verbatim received .; Sender''s Comments: This case concerns a 49-year-old female patient, with medical history of Idiopathic thrombocytopenic purpura, who experienced the serious unexpected event of THROMBOCYTOPENIA (AESI). The event occurred 4 days after the second dose mRNA-1273 vaccine. Re-challenge was not applicable. Patient?s medical history of Idiopathic thrombocytopenic purpura, remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1872489 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-09-27
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004670 / 2 - / OT

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

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

Write-up: DEEP VEIN THROMBOSIS, LEFT ARM; PULMONARY EMBOLISM; This case was received via regulatory authority (Reference number: SE-MPA-2021-091528) on 08-Nov-2021 and was forwarded to Moderna on 08-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEEP VEIN THROMBOSIS (DEEP VEIN THROMBOSIS, LEFT ARM) and PULMONARY THROMBOSIS (PULMONARY EMBOLISM) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004670) for COVID-19 vaccination. No Medical History information was reported. On 04-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced DEEP VEIN THROMBOSIS (DEEP VEIN THROMBOSIS, LEFT ARM) (seriousness criterion medically significant) and PULMONARY THROMBOSIS (PULMONARY EMBOLISM) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (DEEP VEIN THROMBOSIS, LEFT ARM) and PULMONARY THROMBOSIS (PULMONARY EMBOLISM) was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were provided. Company Comment: This case concerns a 36-year-old male patient with no medical history, who experienced the serious unexpected (AESI) of Deep vein thrombosis and Pulmonary thrombosis. The events occurred 1 months and 23 days after the second dose of mRNA- 1273 vaccine. The rechallenge is not applicable since the events were reported after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report. Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Translation document received on 09-Nov-2021, included Dosage text updated and event verbatim translated.; Sender''s Comments: This case concerns a 36-year-old male patient with no medical history, who experienced the serious unexpected (AESI) of Deep vein thrombosis and Pulmonary thrombosis. The events occurred 1 months and 23 days after the second dose of mRNA- 1273 vaccine. The rechallenge is not applicable since the events were reported after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1873989 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-09-27
   Days after vaccination:165
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 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: 20210927; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101508342

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number AT-BASGAGES-2021-052969. A 80-years-old male patient received second dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number EW4815 and Expiration Date was not reported) via intramuscular, on 15Apr2021, as dose 2, single for COVID-19 immunization and first dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number ET1831 and Expiration Date was not reported) via intramuscular, on 25Mar2021, as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 27Sep2021 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 Variant Sequenced: n501y-positive: No) on 27Sep2021. Outcome of the events was unknown. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1873994 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-09-27
   Days after vaccination:223
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508374

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number AT-BASGAGES-2021-052976. An 83-year-old male patient received two doses of BNT162b2 (COMIRNATY), dose 2 on 16Feb2021 (Lot Number: EJ6790) and dose 1 on 26Jan2021 (Lot Number: EJ6134), both intramuscular as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection/vaccination failure on 27Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive (Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No) on 27Sep2021. No follow-up attempts are needed. No further information expected.


VAERS ID: 1873996 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-09-27
   Days after vaccination:132
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002188 / 1 - / OT

Administered by: Unknown       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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: Vaccination failure; SARS-CoV-2 infection; This case was received via European Medicines Agency (Reference number: AT-BASGAGES-2021-052981) on 08-Nov-2021 and was forwarded to Moderna on 08-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) in a 49-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 214001 and 3002188) for COVID-19 vaccination. No Medical History information was reported. On 18-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant) and COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant). At the time of the report, VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided. Company comment: This case concerns a 49-year-old, female patient, with no reported medical history, who experienced the serious, unexpected and AESI event of COVID 19. Vaccination failure was also reported. The event occurred approximately 3 months after second dose of Moderna COVID 19 Vaccine. Doses were administered in an inappropriate schedule, as they were given in a 42-day interval. The rechallenge is not applicable considering the nature of the event and that no additional dose is expected. The benefit-risk relation of Moderna COVID 19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 49-year-old, female patient, with no reported medical history, who experienced the serious, unexpected and AESI event of COVID 19. Vaccination failure was also reported. The event occurred approximately 3 months after second dose of Moderna COVID 19 Vaccine. Doses were administered in an inappropriate schedule, as they were given in a 42-day interval. The rechallenge is not applicable considering the nature of the event and that no additional dose is expected. The benefit-risk relation of Moderna COVID 19 vaccine is not affected by this report.


VAERS ID: 1874002 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-09-27
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: not provided n501y-positive: No.
CDC Split Type: ATPFIZER INC202101508407

Write-up: vaccination failure/variant PCR-based was B.1.617.2, sequenced variant was not provided and n501y-positive was no; SARS-CoV-2 infection, other/variant PCR-based was B.1.617.2, sequenced variant was not provided and n501y-positive was no; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB with regulatory authority number AT-BASGAGES-2021-052992. A 33-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 12Aug2021 (Lot Number: FE7051) as dose 2, single, dose 1 intramuscular on 01Jul2021 (Lot Number: FD6840) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced vaccination failure and sars-cov-2 infection, other. The patient underwent lab tests and procedures which included sars-cov-2 test was positive with variant PCR-based was B.1.617.2, sequenced variant was not provided and n501y-positive was no on 27Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1874030 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-09-27
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 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: 20210927; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210927; Test Name: Variant PCR-based: B.1.617.2; Result Unstructured Data: Test Result:N501Y negative; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: N501Y-positive: No
CDC Split Type: ATPFIZER INC202101508688

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is AT-BASGAGES-2021-053065. A 72-year-old female patient received BNT162B2 (COMIRNATY, solution for injection) (also reported as Tozinameran), via intramuscular on 30May2021 (Lot Number: FC2473) as dose 2, single; and via intramuscular on 18Apr2021 (Lot Number: EW4815) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 27Sep2021, the patient experienced vaccination failure and SARS-CoV-2 infection. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 27Sep2021 and SARS-CoV-2 test: N501Y negative on 27Sep2021 (Variant PCR-based: B.1.617.2). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


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