chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Brain fog, Cardiac disorder, Deafness unilateral, Device difficult to use
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 7 out of 68.  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected event of Death which occurred on an unknown date and onset latency with an unspecified dose number of mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time, the cause of death was not reported, and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (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 7 of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Injection site bruising, Injection site pain, Insomnia, Intervertebral disc degeneration
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 7 out of 68.  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected event of Death which occurred on an unknown date and onset latency with an unspecified dose number of mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time, the cause of death was not reported, and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (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 7 of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Lyme disease, Magnetic resonance imaging neck, Mastocytosis, Mental disorder, Pain
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 7 out of 68.  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected event of Death which occurred on an unknown date and onset latency with an unspecified dose number of mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time, the cause of death was not reported, and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (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 7 of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Rash, Raynaud's phenomenon, SARS-CoV-2 test, Sjogren's syndrome, Sleep apnoea syndrome
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 7 out of 68.  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected event of Death which occurred on an unknown date and onset latency with an unspecified dose number of mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time, the cause of death was not reported, and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (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 7 of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Stomatitis, Temperature intolerance, Tinnitus, Tremor, Undifferentiated connective tissue disease
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 7 out of 68.  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected event of Death which occurred on an unknown date and onset latency with an unspecified dose number of mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time, the cause of death was not reported, and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (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 7 of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vocal cord paralysis, Weight decreased
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 7 out of 68.  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected event of Death which occurred on an unknown date and onset latency with an unspecified dose number of mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time, the cause of death was not reported, and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (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 7 of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19, 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 7 out of 68.  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected event of Death which occurred on an unknown date and onset latency with an unspecified dose number of mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time, the cause of death was not reported, and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (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 7 of 68; Reported Cause(s) of Death: Unknown cause of death
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Cough, Gait disturbance, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Immediate joint pain swelling.   Extreme pain.  Difficulty walking.   Numbness in lower extremities- lumber puncture to rule out GBS.   Treated for serum sickness.   Have been on prednisone for 6 months.  Unable to taper off.   Recently diagnosed with RA due to flu vaccine.  Started methotrexate- had to stop due to nausea and vomiting.    Starting on Leflunomide
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Joint swelling, Laboratory test, Lumbar puncture, Pain, Rheumatoid arthritis
Clinical narrative: Immediate joint pain swelling.   Extreme pain.  Difficulty walking.   Numbness in lower extremities- lumber puncture to rule out GBS.   Treated for serum sickness.   Have been on prednisone for 6 months.  Unable to taper off.   Recently diagnosed with RA due to flu vaccine.  Started methotrexate- had to stop due to nausea and vomiting.    Starting on Leflunomide
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Rheumatoid factor, Serum sickness
Clinical narrative: Immediate joint pain swelling.   Extreme pain.  Difficulty walking.   Numbness in lower extremities- lumber puncture to rule out GBS.   Treated for serum sickness.   Have been on prednisone for 6 months.  Unable to taper off.   Recently diagnosed with RA due to flu vaccine.  Started methotrexate- had to stop due to nausea and vomiting.    Starting on Leflunomide
Age: 78.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Laboratory test, Pulmonary embolism, Thrombectomy
Clinical narrative: Bilateral pulmonary embolism. Hospitalization with thrombectomy. Following this there is a significant improvement but still not to baseline as of 04/17/2024.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient reported tingling sensation on legs and face at first shortly after 1st shingle +shot was given. Then tingling traveled to other parts of the body and has had this issue since 2/2024. Patient claims she has paresthesia and only affects left side of her face now.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: Patient reported tingling sensation on legs and face at first shortly after 1st shingle +shot was given. Then tingling traveled to other parts of the body and has had this issue since 2/2024. Patient claims she has paresthesia and only affects left side of her face now.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Temperature excursion. Dose administered to patient was considered "not supported" after temperature excursion evaluation; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 24-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliters, lot #W018824, expiration date: 14-JUN-2024, administered for prophylaxis (strength and route of administration were not provided) that underwent a temperature excursion from minus 10 degrees Celsius up to 8 degrees Celsius (minus 6 degrees Celsius) for more than 999 hours. The dose administered was considered as "not supported" after temperature excursion evaluation. It was noted that the were no previous temperature excursions. No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Dose administered to patient was considered "not supported" after temperature excursion evaluation; Dose administered to patient was considered "not supported" after temperature excursion evaluation.; Dose administered to patient was considered "not supported" after temperature excursion evaluation.; This spontaneous information was received from an office manager concerning a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, and concomitant therapies were not provided.  On 27-DEC-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #W018824, expiration date: 14-JUN-2024, administered for prophylaxis (strength, frequency, route of administration and anatomical location were not provided) that underwent a temperature excursion of -10 degrees Celsius up to 8 degrees Celsius (-6 degrees Celsius) for more than 999 hours. There was no previous excursion.    On 28-FEB-2024, the patient was vaccinated with another varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X000999, expiration date: 09-JAN-2025, administered for prophylaxis (strength, frequency, route of administration and anatomical location were not provided) that underwent a temperature excursion of -10 degrees Celsius up to 8 degrees Celsius (-6 degrees Celsius) for more than 999 hours. There was no previous excursion.  On an unknown date, the administered dose was considered not supported after temperature excursion evaluation (unevaluable event).
Age: 74.0
Sex: M
Vaccine: HPV9
Symptoms: Off label use
Clinical narrative: Cutaneous Squamous Cell Carcinoma treated with Gardasil 9; Literature Report.  This literature marketed report was received from the authors in a published literature article, entitled as stated above, concerning a 74-year-old male patient. No known past medical history. Concomitant medications, previous drug reactions, or allergies were not mentioned.   On unknown dates, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered intramuscularly (IM) at week 0, week 9, week 28 and one final booster on week 63. Also, on unknown dates intralesional (IL) injections were administered at weeks 3, 7, and 23, and one final IL at the time of the booster shot (week 63) as treatment of Cutaneous Squamous Cell Carcinoma (Off label use) (strength, lot # and expiration date were not reported).   A copy of the published article is attached as further documentation of the patient's experience.
Age: 1.08
Sex: F
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Product storage error; This spontaneous report was received from medical assistant (MA) (also reported as office coordinator), concerning a 13-month-old female.The facility was a public clinic.   The patient's medical history and concurrent conditions were not reported. Concomitant medications included  colecalciferol (VITAMIN D). It was reported that her mom was diabetic.   On 05-JAN-2024, the patient was vaccinated by MA with an improperly dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, unk, (lot #W028536, has been verified to be valid, expiration date: 12-MAY-2025), administered in the left thigh for prophylaxis (strength and route was not provided). On that same day, she received hepatitis a vaccine inact (HEP A IN VAC) (dose, frequency, route, anatomical location, lot number and expiration date were not reported) as prophylaxis. No adverse event reported.  This is one of the several cases created from the same source.
Age: 1.17
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Product storage error; This spontaneous report was received from medical assistant (MA) (also reported as office coordinator), concerning a 14-month-old female. The facility was a public clinic.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 11-JAN-2024, the patient was vaccinated by MA with an improperly dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, unk, (lot #W028536, has been verified to be valid, expiration date: 12-MAY-2025), administered intramuscularly in the left vastus lateralis (LVL) for prophylaxis (strength was not provided). On that same day, she received hepatitis a vaccine inact (HEP A IN VAC) (dose, frequency, route, anatomical location, lot number and expiration date were not reported) as prophylaxis. No adverse event reported.   This is one of the several cases created from the same source.
Age: 1.58
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Product storage error; This spontaneous report was received from medical assistant (MA) (also reported as office coordinator), concerning a 19-month-old male. The facility was a public clinic.   The patient's concurrent and concomitant medication were not reported. His medical conditions included hyperbilirubinaemia.  On 15-JAN-2024, the patient was vaccinated by MA with an improperly dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, unk, (lot #W028536, has been verified to be valid, expiration date: 12-MAY-2025), administered in the left thigh for prophylaxis (strength was not provided). On that same day, he received fluenza vaccine (FLU VACCINE VII) (dose, frequency, route, anatomical location, lot number and expiration date were not reported) as prophylaxis. No adverse event reported.   This is one of the several cases created from the same source.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; HCP reporting that she was not aware that patient received first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in 2019.  HCP administered what she thought was 1st dose in February 2024 and 2nd dose today, 4/16/2024.; This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date in 2019. The patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, abd expiration date were not reported) for prophylaxis. On an unknown date in February 2024, the patient was vaccinated with her second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis by a healthcare professional while the reporter considered it was the patient's first dose (inappropriate schedule of product administration). On 16-APR-2024, the patient was vaccinated with her third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis by a healthcare professional while the reporter considered it was the patient's second dose. The reporter considered that there was a language barrier with the patient since she was Hispanic and she did not speak English. No adverse effects reported.    Lot# is being requested and will be submitted if received.
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 2nd out of 68 patients.  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected event of Death which occurred on an unknown date and onset latency with an unspecified dose number of mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time, the cause of death was not reported, and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (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 2 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 13 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:Patient 13 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. 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 14th patient 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:Patient 14 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 15th 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: 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.   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 16 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: Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected event of Death which occurred on an unknown date and onset latency with an unspecified dose number of mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time, the cause of death was not reported, and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. US-MODERNATX, INC.-MOD-2024-761576:Patient 16 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: DTAP, MEN
Symptoms: Anxiety, Tic
Clinical narrative: motor tic; anxiety; Initial information received on 10-Apr-2024 regarding an unsolicited valid Social Media non-serious case received from Non-Healthcare Professional.  This case involves a male patient (unknown age) who had motor tic and anxiety after receiving Diphtheria, Tetanus And Acellular Pertussis Vaccine and Meningococcal Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of Diphtheria, Tetanus And Acellular Pertussis Vaccine and Meningococcal Vaccine produced by unknown manufacturer (dose, lot number, strength, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  Information regarding batch number will be requested in this case.  On an unknown date the patient had motor tic (tic) and anxiety (latency: unknown) following the administration of Diphtheria, Tetanus And Acellular Pertussis Vaccine and Meningococcal Vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Cough, Erythema, Injection site erythema, Injection site induration
Clinical narrative: 4/17: 2-3 inch  area of redness at site, erythema, raised  induration of circle, 99.5 fever, body aches, myalgia, dry cough intermittently, body weakness.  4/18 worsening redness and raised induration of injection site 99.3 fever  in early morning, weakness, body aches, fever at site
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Pain
Clinical narrative: 4/17: 2-3 inch  area of redness at site, erythema, raised  induration of circle, 99.5 fever, body aches, myalgia, dry cough intermittently, body weakness.  4/18 worsening redness and raised induration of injection site 99.3 fever  in early morning, weakness, body aches, fever at site
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Facial pain, Feeling hot, Skin burning sensation
Clinical narrative: Flu Shot taken 17th of April 2024, morning of 18 April 2024, it feels like my face is on fire, and nothing seems to help. It's like a heat flash, but it doesn't show, and it hurts
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporting temperature excursion. Dose administered to patient was considered "not supported" after temperature excursion evaluation. No additional AE, no PQC. No additional information.   Date of administration: 9/13/2023        ?    Names o; This spontaneous report was received from office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml, lot #W018824, expiration date: 14-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). On unkonwn date, this vaccine underwent temperature excursion in -10 degree Celsius to 8 degree Celsius (average of -6 degree Celsius) for les than 999 hours with no previous excursion (Product storage error). No additional adverse event was reported.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired dose of Bexsero was given to a patient today, 10 days after the expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number J52PN, expiry date 31-MAR-2024) for prophylaxis.   On 10-APR-2024, the patient received Bexsero. On 10-APR-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: expired dose of Bexsero was given to a patient today, 10 days after the expiration 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: 10-APR-2024 The nurse reported that an expired dose of Bexsero was given to a patient 10 days after the expiration date, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up, mailing address provided in the case.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: Reported Symptoms:   10000081:ABDOMINAL PAIN;  10028813:NAUSEA;  10047700: VOMITING;     Narrative:   Other Relevant HX:  Other: ABDOMINAL PAIN; NAUSEA
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood thyroid stimulating hormone decreased, Depression, Dizziness, Echocardiogram
Clinical narrative: I received COVID Vaccine Booster in Sept 2021. Within a couple of weeks, I began fainting and having chest palpitations. This required a cardiology consult, holter monitor, and cardiac ultrasound. I was cleared by cardiology but continued with symptoms of palpitations, lightheadedness, and fainting. I had seen a couple of doctors throughout the end of 2021 to 2024, with no answers. In 2024 the palpitations continued but I began having serious depression and anxiety, continued palpitations and then tremors and incontinence. In February 2024, I had a neurology consult for my symptoms. This lead to an MRI, EEG, and labwork. It was discovered I had developed Hyperthyroidism and was referred to Endocrinology. In April 2024 Endo did a thorough workup including labs and a Neck US and I was diagnosed with Graves disease. I went from working out 6 days a week to not being allowed to exercise. The amount of stress- mentally, emotionally, financially, is burdensome. I KNOW this is directly related to the vaccine and it's a shame this was forced upon healthcare providers.
Sex: F
Vaccine: COVID19
Symptoms: Economic problem, Electrocardiogram ambulatory, Electroencephalogram, Emotional distress, Exercise tolerance decreased
Clinical narrative: I received COVID Vaccine Booster in Sept 2021. Within a couple of weeks, I began fainting and having chest palpitations. This required a cardiology consult, holter monitor, and cardiac ultrasound. I was cleared by cardiology but continued with symptoms of palpitations, lightheadedness, and fainting. I had seen a couple of doctors throughout the end of 2021 to 2024, with no answers. In 2024 the palpitations continued but I began having serious depression and anxiety, continued palpitations and then tremors and incontinence. In February 2024, I had a neurology consult for my symptoms. This lead to an MRI, EEG, and labwork. It was discovered I had developed Hyperthyroidism and was referred to Endocrinology. In April 2024 Endo did a thorough workup including labs and a Neck US and I was diagnosed with Graves disease. I went from working out 6 days a week to not being allowed to exercise. The amount of stress- mentally, emotionally, financially, is burdensome. I KNOW this is directly related to the vaccine and it's a shame this was forced upon healthcare providers.
Sex: F
Vaccine: COVID19
Symptoms: Graves' disease, Hyperthyroidism, Incontinence, Laboratory test, Magnetic resonance imaging
Clinical narrative: I received COVID Vaccine Booster in Sept 2021. Within a couple of weeks, I began fainting and having chest palpitations. This required a cardiology consult, holter monitor, and cardiac ultrasound. I was cleared by cardiology but continued with symptoms of palpitations, lightheadedness, and fainting. I had seen a couple of doctors throughout the end of 2021 to 2024, with no answers. In 2024 the palpitations continued but I began having serious depression and anxiety, continued palpitations and then tremors and incontinence. In February 2024, I had a neurology consult for my symptoms. This lead to an MRI, EEG, and labwork. It was discovered I had developed Hyperthyroidism and was referred to Endocrinology. In April 2024 Endo did a thorough workup including labs and a Neck US and I was diagnosed with Graves disease. I went from working out 6 days a week to not being allowed to exercise. The amount of stress- mentally, emotionally, financially, is burdensome. I KNOW this is directly related to the vaccine and it's a shame this was forced upon healthcare providers.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Stress, Syncope, Thyroxine free increased, Tremor
Clinical narrative: I received COVID Vaccine Booster in Sept 2021. Within a couple of weeks, I began fainting and having chest palpitations. This required a cardiology consult, holter monitor, and cardiac ultrasound. I was cleared by cardiology but continued with symptoms of palpitations, lightheadedness, and fainting. I had seen a couple of doctors throughout the end of 2021 to 2024, with no answers. In 2024 the palpitations continued but I began having serious depression and anxiety, continued palpitations and then tremors and incontinence. In February 2024, I had a neurology consult for my symptoms. This lead to an MRI, EEG, and labwork. It was discovered I had developed Hyperthyroidism and was referred to Endocrinology. In April 2024 Endo did a thorough workup including labs and a Neck US and I was diagnosed with Graves disease. I went from working out 6 days a week to not being allowed to exercise. The amount of stress- mentally, emotionally, financially, is burdensome. I KNOW this is directly related to the vaccine and it's a shame this was forced upon healthcare providers.
Sex: F
Vaccine: COVID19
Symptoms: Tri-iodothyronine increased, Ultrasound neck
Clinical narrative: I received COVID Vaccine Booster in Sept 2021. Within a couple of weeks, I began fainting and having chest palpitations. This required a cardiology consult, holter monitor, and cardiac ultrasound. I was cleared by cardiology but continued with symptoms of palpitations, lightheadedness, and fainting. I had seen a couple of doctors throughout the end of 2021 to 2024, with no answers. In 2024 the palpitations continued but I began having serious depression and anxiety, continued palpitations and then tremors and incontinence. In February 2024, I had a neurology consult for my symptoms. This lead to an MRI, EEG, and labwork. It was discovered I had developed Hyperthyroidism and was referred to Endocrinology. In April 2024 Endo did a thorough workup including labs and a Neck US and I was diagnosed with Graves disease. I went from working out 6 days a week to not being allowed to exercise. The amount of stress- mentally, emotionally, financially, is burdensome. I KNOW this is directly related to the vaccine and it's a shame this was forced upon healthcare providers.
Sex: M
Vaccine: HEP
Symptoms: Apnoea, Laboratory test normal, Oxygen saturation decreased
Clinical narrative: Patient was taking all feed by mouth on 11/21/23 am and received both nirsevimab and hepatitis B vaccine on 11/21 at 13:48 and 16:41 respectively in anticipation for discharge the next day. however patient had two desaturation events on 11/22/23 and an apenic episode on 11/26/23. infection workup was negative.
Age: 67.0
Sex: M
Vaccine: HEP
Symptoms: Product label confusion, Wrong product administered
Clinical narrative: Patient was given a dialysis formulation Hepatitis B vaccination for his 3rd Hepatitis dose instead of Hepatitis B Vaccine (High Dose - Recombivax HB)-One/Booster". Investigation of this error showed Vial with vaccine does state "dialysis formulation", but in small print under other information, which is not extremely noticeable and was missed by nurse giving injection.
Sex: U
Vaccine: HEP
Symptoms: Gastrointestinal tube insertion, Product administration error
Clinical narrative: Patient was taking all feed by mouth since 11/30/2023. Nirsevimab was administered on 12/2/23 @01:18 along with hepatitis B vaccine in anticipation for discharge. However, patient required NG feeding starting on 12/2/23 ~14:00 till 12/7/23.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: The patient did not have any adverse effects due to the immunization
Age: 7.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient. Clinic was notified. Manufacturer was contacted. Manufacturer notified presence of data to support stability of vaccine past expiration date.
Age: 1.5
Sex: F
Vaccine: HIBV, PNC20
Symptoms: Body temperature increased, Injection site nodule, Injection site swelling, Irritability
Clinical narrative: Mom states child's left leg was swollen, and had a knot, low grade temp of 101.0 cranky at daycare.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in extremity, Rash
Clinical narrative: arm pain for a week, rash under right breast, severe nerve pain
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Wrong product administered
Clinical narrative: Kinrix was ordered and Pediarix was drawn up and given.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient is a 11 yo male who should have received the Tdap but received the DTaP that was ordered.  Contacted clinic was informed DTaP given to a person age 11 yo or older to count this dose as a routine Tdap dose.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction occurred.  This was a medication error for MMR.  This patient had a positive titer already and did not need a vaccine post delivery.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Covid vial used for vaccination was beyond expiration date.  Error discovered when charting after client had left post vaccination waiting area. Client contacted at home and denied all symptoms and reported feeling "good". Client plans on receiving repeat dose when she returns for 2nd Hep B vaccination
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Provider ordered  Covid-19 Pfizer Fall 2023-2024 12+ vaccine for this patient.  Was administered by RN along with other age appropriate vaccines BUT when documenting, it was alerted that patient in fact was not quite 12 years old yet.  Only 11 years and 9 months.  Patient with no untoward effect but was reported to Agency and pharmacy on 4/4/24.  Internal reporting was done as required.  Provider also noticed of the event.  On 4/16/24 Agency returned contact and stated that while there may not have been any harm to patient, this should be filed.  No Adverse effect.  Process identified that medication should not be administered without double checking. Provider ordered incorrectly and RN trusted the order and administered FIRST. Had she documented she would have received a hard stop not allowing her to proceed with administration. Provider was noticed on 4/16/24 to contact patient and advise of the error.  Agency and pharmacy advised that no further vaccination was required as patient is in fact covered by the vaccine given.
Age: 62.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: CMA gave only Diluent, did not mix with powder
Age: 54.0
Sex: M
Vaccine: PNC20
Symptoms: Fatigue, Headache
Clinical narrative: Headaches and fatigue several hours following PCV20 administration. Headaches symptoms improved with tylenol 500mg Q4H. Overall, reports feeling 80% better 3-4 days following administration in terms of fatigue and headache.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, and redness a the injection site
Age: 0.42
Sex: F
Vaccine: RV5
Symptoms: Barium double contrast, Infant irritability, Infantile vomiting, Metabolic function test, Ultrasound abdomen
Clinical narrative: Parents reported vomiting , irritability and decreased urine output starting 4/14/2024
Age: 0.42
Sex: F
Vaccine: RV5
Symptoms: Urine output decreased
Clinical narrative: Parents reported vomiting , irritability and decreased urine output starting 4/14/2024
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Medical Assistant administered Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) with no diluent and gave the full dose in vial which contains 3 doses.  Pfizer-BioNTech COVID-19 Vaccine was administered with no diluent, resulting in higher than authorized dose.