chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: accidentally administered 1 dose of Kinrix to a 7 year old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On 28-MAR-2024, the patient received the 1st dose of Kinrix. On 28-MAR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: accidentally administered 1 dose of Kinrix to a 7 year old patient). The outcome of the inappropriate age at vaccine administration 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: 09-APR-2024 The medical assistant explained that they accidentally administered 1 dose of Kinrix to a 7 year old patient, which led to inappropriate age at vaccine administration. The reporter also reported that patient's 5 year old sibling was administered with the same vaccine, but it was clarified with the caller that no adverse event needed to be reported for that patient since in the prescribing information of Kinrix, the vaccine was indicated for children aged 4 through 6 years. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 was not reported, administered on 11-SEP-2021 for covid-19 prophylaxis. 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 21-DEC-2021, the patient experienced covid (Dose number in series: 1). Patient was diagnosed with Covid on 21-DEC-2021. No further information was reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: COVID-19. 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 16th out of 68 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Reporter's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the fatal event of Death, which occurred on an unknown date related to an unspecified dose of mRNA-1273 vaccine. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 16 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment medication was reported. This case is reported for patient 3 out of 68 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Reporter's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the fatal event of Death, which occurred on an unknown date related to an unspecified dose of mRNA-1273 vaccine. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 3 of 68; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.  Company Comment This spontaneous case concerns an unknown age and gender patient, with no medical history reported, who experienced the unexpected, medically significant and death seriousness criteria event of death unknown days after a dose of mRNA-1273 vaccine. Concomitant medication nor Treatment details were reported. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 17 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 18th out of 68 patients.  Company Comment This spontaneous case concerns an unknown age and gender patient, with no medical history reported, who experienced the unexpected, medically significant and death seriousness criteria event of death unknown days after a dose of mRNA-1273 vaccine. Concomitant medication nor Treatment details were reported. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Master Case; Reported Cause(s) of Death: Patient had died
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter.  It was reported that, a 52-year-old female reported 68 people died with that lot number (012L20A). So, she dodged a bullet. No other details were provided. Dosage text for suspect product was reported as unknown. The treatment medication was not reported by reporter. This case contains information for patient 12 out of 68 described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Reporter's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the fatal event of Death, which occurred on an unknown date related to an unspecified dose of mRNA-1273 vaccine. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 12 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. An autopsy was not performed.            Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 6th out of 68 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Reporter's Comments: Company comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history information reported, who experienced the unexpected serious (death and medically significant) event of death. The event occurred on an unknown date after a dose of mRNA-1273. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 6 of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment medication was reported. This case is reported for patient 4 out of 68 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Reporter's Comments: Company comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history information reported, who experienced the unexpected serious (death and medically significant) event of death. The event occurred on an unknown date after a dose of mRNA-1273. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 4 of 68; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. It was reported that, a 52-year-old female reported 68 people die with that lot number (012L20A). "So, she dodged a bullet. No other details were provided. The treatment medication was not reported by reporter. This case contains information about 8th patient out of 68 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Reporter's Comments: Company comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history information reported, who experienced the unexpected serious (death and medically significant) event of death. The event occurred on an unknown date after a dose of mRNA-1273. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 8 of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 9th out of 68 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Reporter's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the fatal event of Death, which occurred on an unknown date related to an unspecified dose of mRNA-1273 vaccine. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 9 of 68; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter.  Dosage text for suspect product was reported as unknown. The treatment medication was not reported by reporter. This case contains information for patient 5 out of 68 described by the reporter.  Company comment: This spontaneous case was reported by a consumer and describes the occurrence of DEATH (reported as 68 people died) in a patient of an unknown age and gender who received mRNA-1273 vaccine for COVID-19 prophylaxis. Neither vaccination date nor the date of death has been reported, hence latency could not be assessed. No further information is available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Master case; Reported Cause(s) of Death: 68 people died
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment medication was reported. This case is reported for patient 28 out of 68  Company comment-This is a fatal spontaneous case concerning a patient of unknown age and gender with no medical history reported who experienced the serious (medically significant and death) unexpected event of death. A dose of mRNA-1273 vaccine (unknown dose) was administered. Onset date of the event and vaccination date was not provided hence latency cannot be assessed. It was reported that 68 people died with the same lot number. It is unknown if autopsy was performed. No further details on cause of death were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 28 out of 68; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter.  Dosage text for suspect product was reported as unknown.  Company comment-This is a fatal spontaneous case concerning a patient of unknown age and gender with no medical history reported who experienced the serious (medically significant and death) unexpected event of death. A dose of mRNA-1273 vaccine (unknown dose) was administered. Onset date of the event and vaccination date were not provided hence latency cannot be assessed. It was reported that 68 people died with the same lot number. It is unknown if autopsy was performed. No further details on cause of death were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The treatment medication was not reported by reporter. This case contains information for patient 30 out of 68 described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 30 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Medical assistant requesting information on MMRII that was administered today, 4/12/2024 but expired on 4/6/2024. She confirmed the dose has not undergone any temperature excursions. No additional AE, no PQC. No additional information.; This spontaneous report was received from medical assistance, concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 12-APR-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 (unit not provided), (lot #W022943, has been verified to be valid expiration date: 06-APR-2024, albumin status: recombinant human albumin), administered for prophylaxis (strength, and route of administration were not provided). The reporter confirmed that dose had not undergone any temperature excursions. No adverse events reported.
Age: 17.0
Sex: M
Vaccine: MEN, MENB
Symptoms: Dizziness, Fatigue, Hot flush
Clinical narrative: fatigue; hot flush/ hot flashes; dizziness; This non-serious case was reported by a non-health professional via other manufacturer and described the occurrence of fatigue in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   On an unknown date, the patient received Bexsero and Menquadfi (unknown arm). On an unknown date, 1 hr after receiving Bexsero, the patient experienced fatigue (Verbatim: fatigue), hot flush (Verbatim: hot flush/ hot flashes) and dizziness (Verbatim: dizziness). The outcome of the fatigue, hot flush and dizziness were unknown.   It was unknown if the reporter considered the fatigue, hot flush and dizziness to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fatigue, hot flush and dizziness to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 08-APR-2024 The reporter reported that the patient had received Meningococcal Vaccine B RFHBP/ NADA/NHBA OMV (Bexsero) and Meningococcal A-C-Y-W135 (T CONJ) Vaccine (Menquadli) both for prophylactic vaccination and 1 hour later experienced fatigue, hot flashes and dizziness. The patient's past medical history, medical treatments, vaccinations and family history were not provided. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was unknown for all the events. It was unknown if the reporter considered the fatigue, hot flush and dizziness to be related to Menquadfi.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Headache, Immediate post-injection reaction
Clinical narrative: headache; metal taste in my mouth that taste very gross/immediately had a metal taste in my mouth; metal taste in my mouth that taste very gross/It is like when you have IV contrast; This non-serious case was reported by a nurse via call center representative and described the occurrence of headache in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-APR-2024 12:35, the patient received the 1st dose of Shingrix (left arm). On 08-APR-2024, immediately after receiving Shingrix, the patient experienced headache (Verbatim: headache), taste metallic (Verbatim: metal taste in my mouth that taste very gross/immediately had a metal taste in my mouth) and taste disturbance (Verbatim: metal taste in my mouth that taste very gross/It is like when you have IV contrast). The outcome of the headache and taste disturbance were not reported and the outcome of the taste metallic was not resolved.   It was unknown if the reporter considered the headache, taste metallic and taste disturbance to be related to Shingrix.     It was unknown if the company considered the headache, taste metallic and taste disturbance to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-APR-2024 The nurse reported that she just had a vaccine Shingrix vaccine and immediately got a metal taste in mouth. The reported that the tastes very gross.  The right after injection, she had a headache and then the metal taste. The reported that it was like when you have intravenous contrast. The reported that patient still had metallic taste in mouth. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 11 out of 68.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the Fatal serious (medically significant) unexpected, event of death, which occurred associated to the first mRNA-1273 vaccine, dose number not provided. The cause of death was not reported. It is unknown if an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 11 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 21st out of 68 patients.  Company comment:  This spontaneous case was reported by a consumer and describes the occurrence of DEATH in a patient of an unknown age and gender who received mRNA-1273 vaccine for COVID-19 prophylaxis. Neither vaccination date nor the date of death has been reported, hence latency could not be assessed. No further information is available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Master case; Reported Cause(s) of Death: Patient had died
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment medication was reported. This case is reported for patient 22 out of 68 patient. Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (due to medically significant), Fatal, unexpected, event of Death, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273 vaccine. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. No further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Master case; Reported Cause(s) of Death: Death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   This case contains information for patient 23 out of 68.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the serious (due to medically significant and Fatal) unexpected event of Death. The event occurred on an unknown date after a dose of mRNA-1273 vaccine. Reason, date for death, whether an autopsy was performed or not, dates for vaccination and dose numbers, circumstances leading to death, supportive diagnostic procedures, treatment, medical history and concomitant medications, that would contribute the assessment of the events, were not provided. The outcome of the event was reported as fatal. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 23 of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter. No other details were provided. The treatment medication was not reported by reporter. This case contains information about 24th patient out of 68 patients.  Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (due to medically significant), Fatal, unexpected, event of Death, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273 vaccine. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. No further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Master case; Reported Cause(s) of Death: 68 people died
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 25th out of 68 patients.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the serious (due to medically significant and Fatal) unexpected event of Death. The event occurred on an unknown date after a dose of mRNA-1273 vaccine. Reason, date for death, whether an autopsy was performed or not, dates for vaccination and dose numbers, circumstances leading to death, supportive diagnostic procedures, treatment, medical history and concomitant medications, that would contribute the assessment of the case, were not provided. The outcome of the event was reported as fatal. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 25 of 68; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter.  Dosage text for suspect product was reported as unknown. As date of death was reported as 01-Jan-1990 which was a discrepancy, and no dates were reported in the narrative, so date of death was captured as unknown. The treatment medication was not reported by reporter. This case contains information for patient 26 out of 68 described by the reporter.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the Fatal serious (medically significant) unexpected, event of death, which occurred associated to the first mRNA-1273 vaccine, dose number not provided. The cause of death was not reported. It is unknown if an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 26 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 27th out of 68 patients.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the fatal serious (medically significant) unexpected, event of death, which occurred associated to the first mRNA-1273 vaccine, dose number not provided. The cause of death was not reported. It is unknown if an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 27 out of 68; Reported Cause(s) of Death: Unknown cause of death
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 infection; COVID-19 infection; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 60-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Lot number: HG4677) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Nickel" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing); "Known allergies: ragweed" (unspecified if ongoing). Concomitant medication(s) included: ANTIHISTAMINE ALLERGY RELIEF; NISOLDIPINE taken for hypertension; LISINOPRIL taken for hypertension; FLUOXETINE taken for depression. Vaccination history included: BNT162b2 (DOSE 5(BOOSTER), SINGLE , lot number:GJ2524), administration date: 09Sep2022, when the patient was 58-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 4(BOOSTER), SINGLE, Lot number: EW0167), administration date: 04Nov2021, when the patient was 57-year-old, for Covid-19 Immunization; moderna (DOSE 3 (BOOSTER), SINGLE, lot number:033K212A,), administration date: 06Apr2021, when the patient was 57-year-old, for Covid-19 Immunization; moderna (DOSE 2, SINGLE, Lot number: 011A21A,), administration date: 28Feb2021, when the patient was 57-year-old, for Covid-19 Immunization; moderna (DOSE 1, SINGLE, Lot number: 010M20A,), administration date: 29Jan2021, when the patient was 57-year-old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "unknown" and all described as "COVID-19 infection". Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course:  Paxlovid was taken as treatment for COVID-19 from 06Apr2024 to 10Apr2024  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 10Apr2024 to 12Apr2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Major depressive disorder" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: coconut" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 05Apr2024 to 10Apr2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Jaw disorder, Pain in jaw
Clinical narrative: jaw issues; extreme pain when trying to chew anything; This is a spontaneous report and received from Consumer or other non HCPs.  A 77-year-old patient received BNT162b2 (BNT162B2), on 27Jan2021 at 10:00 as dose 1,single (Lot number: EL3247) at the age of 77 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "fibromyalgia" (unspecified if ongoing); "aneurysm" (unspecified if ongoing); "platinum coil in head" (unspecified if ongoing). There were no concomitant medications. The following information was reported: JAW DISORDER (non-serious), outcome "not recovered", described as "jaw issues"; PAIN IN JAW (non-serious), outcome "not recovered", described as "extreme pain when trying to chew anything".  Additional information: The patient never had any jaw issues before taking the first shot. Then the patient started having extreme pain when trying to chew anything. It lasted for the whole year with the patient still experiencing it when chewing raw fruits, vegetables or chew meats. When the patient went for the third shot, the patient told the pharmacist about the jaw problems and the patient was told that the patient was the second to tell the pharmacist this.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400040641 same patient/suspect vaccine; different dose/event;US-PFIZER INC-PV202400040642 same patient/suspect vaccine; different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: her immune system is down; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient (unknown if pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "her immune system is down".  Additional information: Her immune system was down for these Pfizer shots.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.