chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 68-year-old female patient who received HBV (Engerix B adult) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   On 23rd September 2022, the patient received Engerix B adult. On 23rd September 2022, unknown after receiving Engerix B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 29-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of adult Engerix- B, which led to expired vaccine used.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 30-SEP-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Drug Not Reported). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number: unknown, and expiry: unknown) dose was not reported, 1 total, administered on 02-APR-2021 to left arm for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.  On SEP-2022, the patient experienced confirmed clinical vaccination failure (dose number in series 1). The patient additionally received non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered on 01-NOV-2021 to left arm for an unspecified indication.  On SEP-2022, the patient experienced Fatigue, coughing, sneezing, fever returned lost taste, smell, and confirmed covid-19 infection. On 01-NOV-2021, the patient experienced revaccination with different covid-19 vaccine (dose number in series 2).  The patient received unspecified medication from pfizer from 08-SEP-2022 to 13-SEP-2022 for treatment of COVID-19. Treatment was stop on 13-SEP-2022. On 16-SEP-2022, Laboratory data included: COVID-19 virus test Negative. On 19-SEP-2022, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000253685. Sender's Comments: V0:20220959719-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: DIAGNOSED WITHIN A FEW WEEKS OF VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced diagnosed within a few weeks of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diagnosed within a few weeks of vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Aunt developed Heart arrhythmia after Moderna; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Aunt developed Heart arrhythmia after Moderna) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Aunt developed Heart arrhythmia after Moderna) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Aunt developed Heart arrhythmia after Moderna) outcome was unknown.            No Concomitant and Treatment Drug was provided by reporter.  Company comment: This Spontaneous case concerns a female patient of unknown age, with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of Arrhythmia. The event occurred on an unknown date after the a dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5). No information about dose number or vaccination schedule was provided. No diagnostic or laboratory findings or information about clinical course of event was provided. The benefit-risk relationship of  Spikevax Bivalent .222 (Original/Omicron BA.4/5) is not affected by this report.; Sender's Comments: This Spontaneous case concerns a female patient of unknown age, with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of Arrhythmia. The event occurred on an unknown date after the a dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5). No information about dose number or vaccination schedule was provided. No diagnostic or laboratory findings or information about clinical course of event was provided. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) is not affected by this report.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hypotension, Migraine, Myalgia
Clinical narrative: low blood pressure; body parts are aching; throwing up; dizziness; migraines; can't breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (can't breath), HYPOTENSION (low blood pressure), DIZZINESS (dizziness), MIGRAINE (migraines) and MYALGIA (body parts are aching) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DYSPNOEA (can't breath), DIZZINESS (dizziness), MIGRAINE (migraines) and VOMITING (throwing up). On 18-Mar-2021, the patient experienced HYPOTENSION (low blood pressure) and MYALGIA (body parts are aching). On 14-Mar-2021, VOMITING (throwing up) had resolved. At the time of the report, DYSPNOEA (can't breath), HYPOTENSION (low blood pressure), DIZZINESS (dizziness), MIGRAINE (migraines) and MYALGIA (body parts are aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Treatments of the events included Aleve(naproxen) and some pain medications.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 19-Mar-2021: Upon internal review on 27-Sep-2022, Non-significant correction was performed to update case level seriousness.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: low blood pressure; body parts are aching; throwing up; dizziness; migraines; can't breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (can't breath), HYPOTENSION (low blood pressure), DIZZINESS (dizziness), MIGRAINE (migraines) and MYALGIA (body parts are aching) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DYSPNOEA (can't breath), DIZZINESS (dizziness), MIGRAINE (migraines) and VOMITING (throwing up). On 18-Mar-2021, the patient experienced HYPOTENSION (low blood pressure) and MYALGIA (body parts are aching). On 14-Mar-2021, VOMITING (throwing up) had resolved. At the time of the report, DYSPNOEA (can't breath), HYPOTENSION (low blood pressure), DIZZINESS (dizziness), MIGRAINE (migraines) and MYALGIA (body parts are aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Treatments of the events included Aleve(naproxen) and some pain medications.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 19-Mar-2021: Upon internal review on 27-Sep-2022, Non-significant correction was performed to update case level seriousness.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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.            No concomitant medications were reported.  No treatment medications were reported.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious  (death and medically significant) event of Death (reported as Died) on an unknown date after receiving an unspecified dose of mRNA-1273 vaccine.  Onset latency could not be determined as dates of vaccination and fatal event were not provided. Cause of death and autopsy result were undisclosed. No further 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-2022-651049 (Linked Report).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious  (death and medically significant) event of Death (reported as Died) on an unknown date after receiving an unspecified dose of mRNA-1273 vaccine.  Onset latency could not be determined as dates of vaccination and fatal event were not provided. Cause of death and autopsy result were undisclosed. No further information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-651049:same reporter; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Hepatitis C
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of HEPATITIS C (Hep C) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2022, the patient experienced HEPATITIS C (Hep C) (seriousness criterion medically significant). The patient was treated with SOFOSBUVIR, VELPATASVIR (EPCLUSA) ongoing since an unknown date for Hepatitis C, at an unspecified dose and frequency. At the time of the report, HEPATITIS C (Hep C) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Company comment: This spontaneous case report concerns a patient of an unknown age and gender with no medical history provided, who experienced serious (medically significant) unexpected event of Hepatitis C. According to the currently provided information, it is unclear whether the event occurred after the patient had received the third dose of the mRNA-1273 vaccine or Hepatitis C occurred prior to vaccination with mRNA-1273 vaccine. At the time of the reporting, the patient was treated with Epclusa for Hepatitis C infection and no additional details were available for medical assessment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case report concerns a patient of an unknown age and gender with no medical history provided, who experienced serious (medically significant) unexpected event of Hepatitis C. According to the currently provided information, it is unclear whether the event occurred after the patient had received the third dose of the mRNA-1273 vaccine or Hepatitis C occurred prior to vaccination with mRNA-1273 vaccine. At the time of the reporting, the patient was treated with Epclusa for Hepatitis C infection and no additional details were available for medical assessment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: He suffered a pretty significant seizure; This spontaneous case was reported by an other health care professional and describes the occurrence of SEIZURE (He suffered a pretty significant seizure) in a 45-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2022 at 10:10 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Sep-2022 at 12:00 PM, the patient experienced SEIZURE (He suffered a pretty significant seizure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 24-Sep-2022 to 27-Sep-2022 due to SEIZURE. At the time of the report, SEIZURE (He suffered a pretty significant seizure) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information were reported. No treatment information were reported.  Reporter had to call 911 as the patient (reporter's husband) suffered a pretty significant seizure.  Patient never had seizures before.  Patient had received first, second, as well as 1 booster dose, all Moderna Covid-19 vaccines (Monovalent).  Company comment:  This spontaneous case report concerns a 45-year-old male patient with no medical history provided, who experienced serious (due to hospitalization and medically significance) unexpected event of Seizure. Reportedly, one day after the patient had received the mRNA-1273 vaccine.222 (as fourth dose), he developed significant seizure and was admitted to hospital for four days. No additional details regarding laboratory investigations, diagnostic procedures and treatment medications were provided. The patient was discharged from hospital, however, the outcome of the event remained unknown at the time of this report. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This spontaneous case report concerns a 45-year-old male patient with no medical history provided, who experienced serious (due to hospitalization and medically significance) unexpected event of Seizure. Reportedly, one day after the patient had received the mRNA-1273 vaccine.222 (as fourth dose), he developed significant seizure and was admitted to hospital for four days. No additional details regarding laboratory investigations, diagnostic procedures and treatment medications were provided. The patient was discharged from hospital, however, the outcome of the event remained unknown at the time of this report. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis microscopic
Clinical narrative: Lymphocytic colitis; This literature-non-study case was reported in a literature article and describes the occurrence of COLITIS MICROSCOPIC (Lymphocytic colitis) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.         No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLITIS MICROSCOPIC (Lymphocytic colitis) (seriousness criterion medically significant). At the time of the report, COLITIS MICROSCOPIC (Lymphocytic colitis) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered COLITIS MICROSCOPIC (Lymphocytic colitis) to be related.    No concomitant and treatment medications were reported.  Lymphocytic colitis occurred in a healthy middle-aged man post 1st and 2nd dose of Moderna SARS-CoV-2 mRNA vaccination. This revealed an unexpected complication of a mRNA vaccine that presented as worsening diarrhea after vaccination in a dose dependent pattern.  Author stated caregivers should be aware of lymphocytic colitis as a possible complication of the Moderna vaccine and monitor those patients closely for symptom resolution.  Company comment:  This  literature-non-study case report concerns a 71-year-old male patient, with no relevant medical history, who experienced serious (medically significant) unexpected event of Colitis microscopic which occurred after the patient had received the first dose of the mRNA-1273 vaccine, as well as after he received the second dose of the mRNA-1273 vaccine, therefore rechallenge is considered positive. Reportedly, the patient developed worsening diarrhoea. At the time of this report, the outcome of the event remained unknown and no additional details regarding clinical course of the event, as well as treatment information were available. The patient's age is considered as a risk factor for the reported event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This  literature-non-study case report concerns a 71-year-old male patient, with no relevant medical history, who experienced serious (medically significant) unexpected event of Colitis microscopic which occurred after the patient had received the first dose of the mRNA-1273 vaccine, as well as after he received the second dose of the mRNA-1273 vaccine, therefore rechallenge is considered positive. Reportedly, the patient developed worsening diarrhoea. At the time of this report, the outcome of the event remained unknown and no additional details regarding clinical course of the event, as well as treatment information were available. The patient's age is considered as a risk factor for the reported event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No adverse event; I gave somebody 2 shots of Moderna Covid-19 Vaccine, Bivalent yesterday.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (I gave somebody 2 shots of Moderna Covid-19 Vaccine, Bivalent yesterday.) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2022, the patient experienced ACCIDENTAL OVERDOSE (I gave somebody 2 shots of Moderna Covid-19 Vaccine, Bivalent yesterday.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (I gave somebody 2 shots of Moderna Covid-19 Vaccine, Bivalent yesterday.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (I gave somebody 2 shots of Moderna Covid-19 Vaccine, Bivalent yesterday.).    No concomitant information provided It was reported that hcp gave somebody 2 shots of Moderna Covid-19 Vaccine, Bivalent yesterday. Hcp gave them a dose in his left arm, then in their right arm. No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Severe dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Severe dizziness) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Severe dizziness). At the time of the report, DIZZINESS (Severe dizziness) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant drug was reported. No treatment drug was reported. Caller said that they had a friend whose niece had severe dizziness after getting the Covid-19 shot and stayed in bed for one week.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: bivalent Covid-19 vaccine that leaked out while Pharmacist was administering a dose of the Moderna bivalent Covid-19 vaccine; About 80% of the dose was administered the other 20% leaked down the patient's arm; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (bivalent Covid-19 vaccine that leaked out while Pharmacist was administering a dose of the Moderna bivalent Covid-19 vaccine), UNDERDOSE (About 80% of the dose was administered the other 20% leaked down the patient's arm) and NO ADVERSE EVENT (no adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (bivalent Covid-19 vaccine that leaked out while Pharmacist was administering a dose of the Moderna bivalent Covid-19 vaccine), UNDERDOSE (About 80% of the dose was administered the other 20% leaked down the patient's arm) and NO ADVERSE EVENT (no adverse event). At the time of the report, DEVICE CONNECTION ISSUE (bivalent Covid-19 vaccine that leaked out while Pharmacist was administering a dose of the Moderna bivalent Covid-19 vaccine), UNDERDOSE (About 80% of the dose was administered the other 20% leaked down the patient's arm) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for DEVICE CONNECTION ISSUE (bivalent Covid-19 vaccine that leaked out while Pharmacist was administering a dose of the Moderna bivalent Covid-19 vaccine) and UNDERDOSE (About 80% of the dose was administered the other 20% leaked down the patient's arm).    No concomitant medications were reported.  It was reported as first four Moderna Covid-19 vaccines two primary series and two booster doses were not known. Reporter did not feel that the Moderna Covid-19 vaccine itself contributed to this incident. Reporter not aware of any other adverse reactions.  No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Giant cell arteritis
Clinical narrative: loss of vision in eye transiently; diagnosed with giant cell arteritis; This spontaneous case was reported by a physician and describes the occurrence of BLINDNESS TRANSIENT (loss of vision in eye transiently) and GIANT CELL ARTERITIS (diagnosed with giant cell arteritis) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS TRANSIENT (loss of vision in eye transiently) (seriousness criterion medically significant) and GIANT CELL ARTERITIS (diagnosed with giant cell arteritis) (seriousness criterion medically significant). At the time of the report, BLINDNESS TRANSIENT (loss of vision in eye transiently) and GIANT CELL ARTERITIS (diagnosed with giant cell arteritis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Giant Cell Arteritis being treated by steroids.  Patient who received their Moderna booster dose in November of last year had experienced exacerbated symptoms which included : scalp burning, jaw pain, developed loss of vison in eye transiently and was then diagnosed with Giant Cell Arteritis being treated by steroids.  Company comment: This Spontaneous case concerns a 68-year-old, female patient with no medical history information reported, who experienced the unexpected serious (medically significant) events of Giant cell arteritis and transient vision loss. The events occurred on an unknown date after a dose of mRNA-1273. No information about dose number of vaccination schedule was provided. As reported, the patient experienced exacerbated symptoms which included scalp burning, jaw pain, loss of vison in eye transiently and was then diagnosed with Giant Cell Arteritis and was being treated by steroids. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This Spontaneous case concerns a 68-year-old, female patient with no medical history information reported, who experienced the unexpected serious (medically significant) events of Giant cell arteritis and transient vision loss. The events occurred on an unknown date after a dose of mRNA-1273. No information about dose number of vaccination schedule was provided. As reported, the patient experienced exacerbated symptoms which included scalp burning, jaw pain, loss of vison in eye transiently and was then diagnosed with Giant Cell Arteritis and was being treated by steroids. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Dizziness, SARS-CoV-2 test
Clinical narrative: a lot of dizziness; some weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (a lot of dizziness) and ASTHENIA (some weakness) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 1 Lot number: EI0142) on 12-Jan-2021, Pfizer (Dose Number: 2 Lot number: E13249) on 02-Feb-2021, Pfizer (Dose Number: 1st booster Lot number: FF2587) on 19-Nov-2021, Pfizer (Lot number: FM9992 Dose Number: 2nd booster) on 20-May-2022 and flu shot on 14-Sep-2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer, Pfizer and flu shot. Concurrent medical conditions included Blood pressure high, Anxiety, Stress, Allergy to antibiotic and Latex allergy.   On 29-Sep-2022 at 9:00 AM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced DIZZINESS (a lot of dizziness) and ASTHENIA (some weakness). At the time of the report, DIZZINESS (a lot of dizziness) and ASTHENIA (some weakness) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: (Positive) positive.   No concomitant information provided. It was told to the patient that she tested positive a month ago, but she did not believe it. The patient had a severe reaction to the newest Moderna shot. She lives in a senior center. She states that people from the pharmacy came to her senior home to administer the shots. She got the shot an hour to an hour and a half later, she got the severe reaction. She was feeling better. Adverse reactions did not cause patient to seek medical care. No treatment information provided.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Tested Positive for COVID 19/Suddenly sick and positive; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and COVID-19 (Tested Positive for COVID 19/Suddenly sick and positive) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Concurrent medical conditions included Non-smoker (never smoked).    On 23-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Sep-2022, the patient experienced PAIN IN EXTREMITY (Sore arm). On 27-Sep-2022, the patient experienced COVID-19 (Tested Positive for COVID 19/Suddenly sick and positive). On 25-Sep-2022, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, COVID-19 (Tested Positive for COVID 19/Suddenly sick and positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2022, SARS-CoV-2 test: (Positive) home test came up positive.. On an unknown date, SARS-CoV-2 test: (Negative) PCR test or home test if patient felt a little sick or thought she was exposed, results were always negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 23-Sep-2022 Friday, the patient received Moderna bivalent vaccine, and she had the usual side effects during Saturday into Sunday of fever, headache, fatigue, and sore arm which passed by Sunday afternoon. On 26-Sep-2022 Monday, she started sneezing and blowing her nose. On 27-Sep-2022 Tuesday, she felt like she was getting a cold. So, did a home test and it came up positive. She further stated that, she and her husband both still wear masks in every store they enter and only time not masked was an occasional dinner out and with their senior bowling league if none had signs of illness. She wore masks all last winter season bowling and not entering any restaurants and only take out once in a while. She never got COVID that whole time. She would either get a polymerase chain reaction (PCR) test or home test if she felt a little sick or thought she was exposed, and results were always negative. She had not lost her taste or smell. Her symptoms were runny nose, scratchy dry cough, similar to a cold with no fever. She was a retired nurse and was very careful with wiping the handles of shopping carts and hand washing frequently and mask wearing. She was aware that there was not supposed to be any live virus in a vaccine but did not understand why she was suddenly sick and positive.   She stated that, she was relatively healthy, never smoker or diabetic.   No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Had Moderna vaccines for the last three vaccines and was only sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Had Moderna vaccines for the last three vaccines and was only sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Had Moderna vaccines for the last three vaccines and was only sick). At the time of the report, ILLNESS (Had Moderna vaccines for the last three vaccines and was only sick) had resolved.            Concomitant medication list was not provided. It was reported that the patient got Pfizer Covid-19 booster on Friday and she had been very sick since then. Its the fourth day since getting it. Last night, she had trouble breathing. Tested herself with an at home Covid test and she was negative, but she was sick. The patient had lung pain, coughing, and extreme exhaustion, muscle pain, and jaw pain in particular. Treatment information was not provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Therapeutic response unexpected
Clinical narrative: No adverse event; Oral Herpes improved for a period of 6 months after each Moderna shot.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Oral Herpes improved for a period of 6 months after each Moderna shot.) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084L21A, 004F21A, 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Oral herpes.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Oral Herpes improved for a period of 6 months after each Moderna shot.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Oral Herpes improved for a period of 6 months after each Moderna shot.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant information was reported.  It was reported that patient was trying to get Bivalent Moderna COVID-19 booster vaccine.  No treatment information was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Pediatric Moderna administered to adult patient instead of Moderna bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric Moderna administered to adult patient instead of Moderna bivalent) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Sep-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric Moderna administered to adult patient instead of Moderna bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric Moderna administered to adult patient instead of Moderna bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric Moderna administered to adult patient instead of Moderna bivalent).    Concomitant medication information was not provided by the reporter.  The patient received 1st booster dose, after having the primary series.   The patient has not reported any adverse reactions to this dose at this time.  Treatment information was not provided by the reporter.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN (sore) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (sore). At the time of the report, PAIN (sore) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654236, US-MODERNATX, INC.-MOD-2022-654320, US-MODERNATX, INC.-MOD-2022-654324 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654236:MOD22-025207 (Wife's case) US-MODERNATX, INC.-MOD-2022-654320:Wife's case US-MODERNATX, INC.-MOD-2022-654324:Wife's case
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; Received 2nd primary Monovalent  dose 9 months after The  first dose/Received the 2 primary doses too far apart; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd primary Monovalent  dose 9 months after The  first dose/Received the 2 primary doses too far apart) and NO ADVERSE EVENT (No Adverse Event) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd primary Monovalent  dose 9 months after The  first dose/Received the 2 primary doses too far apart). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd primary Monovalent  dose 9 months after The  first dose/Received the 2 primary doses too far apart) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd primary Monovalent  dose 9 months after The  first dose/Received the 2 primary doses too far apart).    No concomitant medications were reported.  No treatment information was provided.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Age: 0.42
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse event; Patient received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose; 5 months old patient administered Moderna Covid 19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 months old patient administered Moderna Covid 19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 5-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 months old patient administered Moderna Covid 19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 months old patient administered Moderna Covid 19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 months old patient administered Moderna Covid 19 vaccine).    No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654129, US-MODERNATX, INC.-MOD-2022-654135, US-MODERNATX, INC.-MOD-2022-654136 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654129:same reporter US-MODERNATX, INC.-MOD-2022-654135:same reporter US-MODERNATX, INC.-MOD-2022-654136:same reporter