chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired Pediarix administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 6th September 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment: The reporter reported that, a patient inadvertently received an expired dose of Pediarix at the time of reporting. The reporter was not asked but no further information was provided regarding patient or product. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a patient inadvertently received an expired dose of Pediarix at the time of reporting, which led to expired vaccine used.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired Pediarix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 6th September 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's comment: Health Center Manager stated that an expired dose of Pediarix was administered to a patient today (on the day of reporting). The reporter consented to follow-up via postal. Additional Supportive Information:  The patient received a dose of Pediarix which was already expired on 5th September 2022, which led to expired vaccine used. This case has been linked with case US2022128918, reported by the same reporter.; Sender's Comments:  US-GSK-US2022128918:Same reporter
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva587a, expiry date 31st August 2022) for prophylaxis.   On 6th September 2022, the patient received Menveo. On 6th September 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's comment: The medical assistant reported that a dose of Menveo was given to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Menveo dose, which was already expired on 31st August 2022, which led to expired vaccine used.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: ALMOST DIED; This spontaneous report received from a patient via a company representative concerned a 46 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 admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 46 years old. No concomitant medications were reported. On an unspecified date, the patient experienced almost died. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost died was not reported. This report was non-serious.  Version created to amend previously reported information on 01-MAY-2021. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient reports red bumps on hand  and body, body aches, fever, joint pain which has not improved.  Went to primary doctor and Urgent care.  Will call Pfizer to report side effects
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site swelling, Pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient reports red bumps on hand  and body, body aches, fever, joint pain which has not improved.  Went to primary doctor and Urgent care.  Will call Pfizer to report side effects
Age: 34.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: Headache and fever on and off for 5 days consecutive starting 4 days after vaccination. Soreness in arm at application area had been persistent from time of vaccination to present which is 34 days after administered.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Dizziness, Flushing, Hyperhidrosis, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: mild numbness on face-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: facial numbness on left side (side of vaccination).
Age: 80.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Pruritus
Clinical narrative: Patient states that her hands and bottoms of her feet are itching
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Thyroid disorder, Thyroid mass
Clinical narrative: Pain in thyroid started about 2 hours after getting the new booster on 9/8/2022. It is still sore 2 days after. I also had thyroid pain 1 week after 1st dose of Moderna vaccine on 4/10/2021 and what felt like athyroid nodule. It seemed to get worse after 2nd dose and got better after 6 months without vaccination (lump gotmsmaller and stopped being sore). I reported the symptoms last year but was not sure it was connected to the vaccine. Due to extenuating circumstances, I did not see a doctor and might not see a doctor for several weeks or months from now.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Vasculitic ulcer, Vasculitis
Clinical narrative: Vasculitis and ulcers after that
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient incorrectly given the COVID-19 (Moderna pediatric age 6 to 11 NDC: 80777-275-05) instead of the COVID-19 Moderna updated booster 18+.
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Presyncope
Clinical narrative: vasovagal reaction
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: gave pediatric dose instead
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: RED RAISED INJECTION SITE AREA
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PFIZER MONOVALENT WAS GIVEN AS BOOSTER DOSE FOR PATIENT ON AUG 31, 2022.  FDA APPROVED PFIZER BIVALENT AS BOOSTER DOSE ON AUG 31, 2022 AND WE ARE UNWARE OF THE CHANGES.  PATIENT DIDN'T REPORT ANY SIDE EFFECTS. WE ARE REQUIRED BY PHARMACY TO REPORT THIS ERROR TO VAERS AND KEEP RECORD FOR 3 YEARS
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: gave pediatric dose instead of this
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Bone disorder, Pruritus, Rash, Sensitive skin
Clinical narrative: Small bumps on forehead under the skin. Bumps on  eyebrow bones   Eyebrow bones becoming more pronounced at corners  and sensitive to the touch  , also itchy . Also, before this  (1st booster) shot , I experienced  itchy face and eyes for about 3 or 4 weeks up until the shot .
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: gave pediatric moderna instead
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: gave pediatric moderna instead
Sex: U
Vaccine: COVID19
Symptoms: Acquired immunodeficiency syndrome
Clinical narrative: AIDS; This spontaneous report received from a patient via social media concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that "Your vaccine gave me aids" (coded as Acquired immunodeficiency syndrome (AIDS)). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of AIDS was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 14-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1:Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event. 20220126763 -Covid-19 vaccine ad26.cov2.s-AIDS. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative concerned 4 patients of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, and batch number: unknown expiry: unknown) dose, start therapy date were not reported dose number in series was 1, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that, "4 people died after vaccination" (dose number in was series 1). On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).  Version created to amend previously reported information on 15-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V2: Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event. 20220127913 -covid-19 vaccine ad26.cov2.s- 4 people died after vaccination. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via social media via a company representative concerned a patient of an unspecified age, sex, 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 (dose number in series: 1), (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter reported that "I have a friend who was young, took the Johnson shot and died two weeks later." On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220127876.  Version created to amend previously reported information on 15-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1-Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event.  20220128561-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Died. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a social media through company representative concerned a patient of unspecified age, sex, 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, route of admin were not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered at the end of NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient felt pretty sick and on 14-JAN-2022, the patient was tested positive for corona virus disease (Covid-19) which was confirmed clinical vaccination failure and had confirmed covid-19 infection. It was also reported that the patient was fully vaccinated for 6 weeks and 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000211987. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Version created to amend previously reported information on 25-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V2:Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event  20220128576-COVID-19 VACCINE AD26.COV2.S: Confirmed Clinical Vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media through a company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. The patient reported as "Know this 1st hand, three of us had COVID19 positive, sick for 10 plus days, despite Pfizer, Moderna and JNJ vaccines". Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000212246. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. a manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220130852.  Version created to amend previously reported information on 31-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V2: Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event.  20220130649-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: CAUGHT COVID; This spontaneous report received from a patient via Social media via a company representative concerned a patient of unspecified age, sex, unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported expiry: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. It was unknown if the patient had any adverse events with covid-19 vaccine ad26. cov2. s (dose number series1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient caught covid. The patient stated that "Took J and J shot and booster and still caught Covid, All I can say is just be careful" (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of caught covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000212957. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria because there is no report of symptoms or statement indicating the vaccine did not work) based on the PQC evaluation/investigation performed.  Version created to amend previously reported information on 19-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Death
Clinical narrative: DEATH; ILLNESS PROGRESSED FASTER; This spontaneous report received from a consumer via social media via a company representative concerned a male of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 1 total administered, for prophylactic vaccination (dose number in series:1). The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. The reporter stated that "I am pretty sure this vaccine made my brother's illness progress faster than it should've and now he is no longer here". On an unspecified date, the patient's illness progressed faster than it should had (condition aggravated) and was no longer there (death). On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of illness progressed faster was not reported. This report was serious (Death).  Version created to amend previously reported information on 19-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: This version updates: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. The prior causality assessment remains unaltered with this added information. 20220140120-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Epistaxis, Hypertension
Clinical narrative: HIGH BLOOD PRESSURE; BLOODY  NOSE; This spontaneous report received from a patient via social media via a company representative concerned a 23 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never gotten a bloody nose without an injury, and no history of blood pressure was never that high. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on an unspecified date on SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date after vaccination, the patient experienced high blood pressure, and bloody nose. On an unspecified date at NOV-2021, Laboratory data included: Blood pressure (NR: not provided) 220/113 mmHg (millimetre(s) of mercury). As per reporter it was reported that "patient reported that "I am a 23y/o male and I received your Covid vaccine back in September 2021, ever since I was vaccinated my blood pressure has been through the roof. I get bloody noses about once a week. Before the shot I had never gotten a bloody nose without an injury Also my blood pressure was never that high. In November I measured it at 220/113." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure, and bloody nose. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 22-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event   20220144642-COVID-19 VACCINE AD26.COV2.S-high blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Cardiac arrest, Myocardial infarction
Clinical narrative: CARDIAC ARRESTS; COLLAPSE IN THE MIDDLE OF A GAME  DUE TO A HEART ATTACK; ADVERSE REACTIONS; This spontaneous report received from a consumer via company representative via social media concerned 140 patients of an unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total,  for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  As per the reporter, "318 athlete cardiac arrests and 178 deaths in 2021 after coronavirus disease (COVID) shot". "It was definitely not normal for the patients to suffer from cardiac arrests or to die while playing their sport. All of these heart issues and deaths come shortly after they got a (COVID) vaccine". On an unspecified date, the patients (athletes / soccer players and other stars) had adverse reactions after their first COVID vaccinations, collapsed in the middle of a game due to a heart attack.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cardiac arrests, collapse in the middle of a game due to a heart attack, and adverse reactions was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220153841, 20220156651, 20220156495 and 20220156967.  Version created to amend previously reported information on 21-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events.  20220146936 -COVID-19 VACCINE AD26.COV2.S-Cardiac arrests, collapse in the middle of a game due to a heart attack . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age and sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, after 2 months of vaccination the patient got covid (suspected covid-19 infection and suspected clinical vaccination failure). As per reporter it was reported that "I got your vaccine, and two months later, I got Covid. Do you have one that works, Asking for a friend, as I don't trust anything you folks say anymore" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000213899. The suspected product quality complaint has been confirmed to be voided (does not meet PQC criteria) based on the PQC evaluation/investigation performed.  Version created to amend previously reported information on 25-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This updated information does not change the causality of the previously reported events. 20220150529- covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: BAD SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced bad side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad side effects was not reported. This report was non-serious.  Version created to amend previously reported information on 27-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients of unspecified race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified dated in 2021, 178 patients died (cause unknown) after Covid shot. It was unspecified if an autopsy was performed. The reporter stated that, 318 people had cardiac arrests and 178 people had deaths in 2021, after COVID Shot. It was stated that It was definitely not normal for young athletes to suffer from cardiac arrests or to die while playing their sport, but this year it was happened All of these heart issues and deaths came shortly after they got a COVID vaccine. While it was possible this could happen to people who did not get a COVID vaccine, the sheer numbers clearly point to the only obvious cause. So in response to their pronouncement, here was a non-exhaustive and continuously growing list of young athletes who had major medical issues in 2021 after receiving one or more COVID vaccines. Initially, many of these were not reported. We know that many people were told not to tell anyone about their adverse reactions and collapse in the middle of a game due to a heart attack. Sidelined Athletes with Illness. Their immune systems are likely to have been compromised by something. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220146936, 20220156495, 20220156651 and 20210842132.  Version created to amend previously reported information on 21-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1- Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event.  : 20220153841-COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Illness, Immune system disorder
Clinical narrative: ILLNESS; IMMUNE SYSTEMS ARE LIKELY TO HAVE BEEN COMPROMISED BY SOMETHING; This spontaneous report received from a patient via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced illness, and immune systems are likely to have been compromised by something. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the illness and immune systems are likely to have been compromised by something was not reported. This report was non-serious. This case, from the same reporter is linked to 20220146936 and 20220153841.  Version created to amend previously reported information on 21-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media via a company representative concerned two patients of unspecified demographics. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the reporter stated that "Before or after the vaccine was available. No control until the vaccine was available. And no one wants to put out any numbers on deaths or serious side effects of the Vaccinated Ones. I personally know of 2 who died of the vaccine and another Lady right now that is going downhill fast within a day or two of getting it. She was a very healthy woman and, a daily walker" On an unspecified date, the patients died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220200910.  Version created to amend previously reported information on 31-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events. 20220200358-COVID-19 VACCINE AD26.COV2.S-Death.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients (7 people out of 14 million) of an unspecified age, sex, race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose not reported, 01 total, in 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients experienced blood clots. Reporter stated that "When 7 people out of over 14 million developed blood clots after receiving the J&J vaccine last year (2021), it was widely reported on by all media outlets and vaccine administration was halted until the risk could be thoroughly evaluated." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 29-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1- Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event.  20220200454-Covid-19 vaccine ad26.CoV-2.s-Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEAD; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated "Then go get all 50 of the boosters. A friends of mine's son dropped dead from it."  On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220207151.  Version created to amend previously reported information on 02-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events.  V0: 20220207255- COVID-19 VACCINE AD26.COV2.S- Dead. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a social media via a company representative concerned a 58 year old male of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and controlled high blood pressure. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on JUL-2021 for prophylactic vaccination. On JUL-2021, following vaccination with first dose of covid-19 vaccine ad26.cov2.s, the patient had sore arm (Dose number in series 1). The patient recovered from sore arm in JUL-2021. The patient received additional covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of administration, and batch number were not reported) dose was not reported, 1 total administered on 22-JAN-2022 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  On 22-JAN-2022, following vaccination with covid-19 vaccine ad26.cov2.s, the patient had sore arm (Dose number in Series 2). Concomitant medications included ascorbic acid, and vitamin B complex. It was reported that "I received the J & J in July 2021. No side effects other than a sore arm a few hours. Had the booster Jan 22. Same thing. Haven't tested positive ever for COVID. I don't wear mask unless required. I wash my hands and use common sense. I take vitamins c, B complex. Male nonsmoker 58 years old. High blood pressure under control with daily meds 10 years now". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 22-JAN-2022. This report was non-serious. This case, involving the same patient is linked to 20220210398.  Version created to amend previously reported information on 03-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: SORE SPOT; This spontaneous report received from a consumer via a company representative via social media concerned a 9 decade 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, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, dose number in series 1, 01 total administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced sore spot (dose number in series 1). It was further reported that the patient had no breakthrough covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore spot was not reported. The patient received Moderna booster (MRNA 1273) (form of administration and route of administration was not reported, batch number: unknown, expiry: unknown) dose was not reported, dose number in series 2, start therapy date were not reported for prophylactic vaccination. No adverse events were reported following administration of Moderna vaccine (dose number in series 2). This report was non-serious. This case, from the same reporter is linked to 20220213343.  Version created to amend previously reported information on 04-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).