chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a history of shingles and took acyclovir for the month prior to Shingrix vaccination). Previously administered products included acyclovir and Zostavax vaccination. Concurrent medical conditions included parkinson's disease.   In AUG-2023, the patient received the 1st dose of Shingrix. On an unknown date, 6 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles rash). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-NOV-2023 The patient reported she received he first dose of Shingrix and six days after she developed a shingles rash on her left upper back and shoulder. The patient reported rash has not resolved. The patient had history of shingles and she took acyclovir for the month prior to shingrix vaccination. The patient was rash free at the time of Shingrix vaccination. The patient had a follow up appointment with her doctor. The reporter did not consented to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error, Underdose
Clinical narrative: she administered just the liquid conjugate portion of Menveo to a patient; she administered just the liquid conjugate portion of Menveo to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a adult male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA983A, expiry date 30-SEP-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: she administered just the liquid conjugate portion of Menveo to a patient) and inappropriate dose of vaccine administered (Verbatim: she administered just the liquid conjugate portion of Menveo to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-NOV-2023 Registered Nurse reported she administered just the liquid conjugate portion of Menveo to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up to healthcare professional email.
Age: 13.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Product storage error
Clinical narrative: Clinical Resource Nurse states Fluarix and Boostrix were exposed to minus 2.04 C and administered to a patient.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 13-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 5KT7B, expiry date 30-JUN-2024) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 54CP2, expiry date 11-JAN-2026) for prophylaxis.   On 31-OCT-2023, the patient received Fluarix Quadrivalent 2023-2024 season and Boostrix. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Clinical Resource Nurse states Fluarix and Boostrix were exposed to minus 2.04 C and administered to a patient.). The outcome of the incorrect storage of drug 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: 15-NOV-2023 Clinical Resource Nurse stated Fluarix and Boostrix were exposed to minus 2.04 degree C and administered to a patient, which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Age: 12.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Product storage error
Clinical narrative: Fluarix and Boostrix were exposed to -2.04 C and was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 12-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 5KT7B, expiry date 30-JUN-2024) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 54CP2, expiry date 11-JAN-2026) for prophylaxis.   On 31-OCT-2023, the patient received Fluarix Quadrivalent 2023-2024 season and Boostrix. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Fluarix and Boostrix were exposed to -2.04 C and was administered to a patient). The outcome of the incorrect storage of drug 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: 15-NOV-2023 The vaccine administration facility was the same as primary reporter The Clinical Resource Nurse stated Fluarix and Boostrix were exposed to -2.04 C and was administered to a patient, which led to incorrect storage of drug. The reporter consented to follow up via postal.
Sex: U
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: Possible wrong reconstitution; dose was probably reconstituted about a week ago with the incorrect or extra component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In NOV-2023, the patient received Arexvy. In NOV-2023, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: Possible wrong reconstitution) and inappropriate dose of vaccine administered (Verbatim: dose was probably reconstituted about a week ago with the incorrect or extra component). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 15-NOV-2023 The reporter called into request information about the possibility of receiving a replacement of the diluent for Arexvy as a dose was probably reconstitute about a week ago from reporting day with the incorrect or extra component. Reporter did not have any information about the possible event. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Reporter reported that the Arexvy dose was reconstituted with incorrect or extra component, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Possible wrong reconstitution; dose was probably reconstituted about a week ago with the incorrect or extra component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2023, the patient received Shingrix. In NOV-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Possible wrong reconstitution) and inappropriate dose of vaccine administered (Verbatim: dose was probably reconstituted about a week ago with the incorrect or extra component). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 15-NOV-2023 The reporter called into request information about the possibility of receiving a replacement of the diluent for Shingrix as a dose was probably reconstitute about a week ago from reporting day with the incorrect or extra component. Reporter did not have any information about the possible event. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Reporter reported that the Shingrix dose was reconstituted with incorrect or extra component, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received after two weeks; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 09-NOV-2023, the patient received the 2nd dose of Shingrix. On 09-NOV-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose received after two weeks). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 13-NOV-2023 The consumer stated that she received her 1st dose of Shingrix about 2 weeks ago, and her 2nd dose on 09 November 2023. The patient questioned that what happens if 2nd dose is received too early. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccinations schedule. (Drug dose administration interval too short) minus 4 days.
Sex: U
Vaccine: RSV
Symptoms: Off label use, Product prescribing issue
Clinical narrative: Doctor would like for a 58 year old patient to receive Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of off label use in unapproved age group in a 58-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced off label use in unapproved age group (Verbatim: Doctor would like for a 58 year old patient to receive Arexvy). The outcome of the off label use in unapproved age group was unknown.   Additional Information: GSK Receipt date: 15-NOV-2023 The pharmacist called to inquire if any information available as registered pharmacist mentioned that they had a 58 year old cancer patient and the Doctor would like for this patient to receive Arexvy which led to off label use in unapproved age group. The registered pharmacist confirmed that the patient had not been administered but they have a standing order of the vaccine for the patient and asked for guidance. The reporter did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Injection site discolouration, Injection site erythema, Injection site necrosis, Injection site pain, Injection site swelling
Clinical narrative: necrotic tissue/Necrotic tissue at the injection site/Surgery to remove necrotic tissue; with a bump in the middle at the injection site; Red circle/Changing color; developed a a red circle hot to the touch; burning; This serious case was reported by a consumer via call center representative and described the occurrence of necrosis in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 27-SEP-2023, the patient received Arexvy (intramuscular, left arm). On 28-SEP-2023, 1 days after receiving Arexvy, the patient experienced necrosis (Verbatim: necrotic tissue/Necrotic tissue at the injection site/Surgery to remove necrotic tissue) (serious criteria GSK medically significant and clinically significant/intervention required), injection site swelling (Verbatim: with a bump in the middle at the injection site) (serious criteria clinically significant/intervention required), erythema (Verbatim: Red circle) (serious criteria clinically significant/intervention required), feeling hot (Verbatim: developed a a red circle hot to the touch) (serious criteria clinically significant/intervention required) and burning sensation (Verbatim: Changing color and burning) (serious criteria clinically significant/intervention required). The patient was treated with doxycycline. The outcome of the necrosis, injection site swelling, erythema, feeling hot and burning sensation were unknown.   It was unknown if the reporter considered the necrosis, injection site swelling, erythema, feeling hot and burning sensation to be related to Arexvy.     It was unknown if the company considered the necrosis, injection site swelling, erythema, feeling hot and burning sensation to be related to Arexvy.   Additional Information: GSK Receipt Date:16-NOV-2023 The reporter was the patient who stated that she received Arexvy and the next morning she developed a red circle hot to the touch with a bump in the middle at the injection site. The reporter applied cold compresses then the red circle started changing color and burning in the following days. According to the patient she visited her primary doctor who prescribed Doxycycline and referred her to a wound doctor who did a surgery on her arm to remove some necrotic tissue on 03-NOV-2023. The patient still had 4 stiches that supposed to get removed tomorrow. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth, Soft tissue necrosis, Surgery, Suture insertion
Clinical narrative: necrotic tissue/Necrotic tissue at the injection site/Surgery to remove necrotic tissue; with a bump in the middle at the injection site; Red circle/Changing color; developed a a red circle hot to the touch; burning; This serious case was reported by a consumer via call center representative and described the occurrence of necrosis in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 27-SEP-2023, the patient received Arexvy (intramuscular, left arm). On 28-SEP-2023, 1 days after receiving Arexvy, the patient experienced necrosis (Verbatim: necrotic tissue/Necrotic tissue at the injection site/Surgery to remove necrotic tissue) (serious criteria GSK medically significant and clinically significant/intervention required), injection site swelling (Verbatim: with a bump in the middle at the injection site) (serious criteria clinically significant/intervention required), erythema (Verbatim: Red circle) (serious criteria clinically significant/intervention required), feeling hot (Verbatim: developed a a red circle hot to the touch) (serious criteria clinically significant/intervention required) and burning sensation (Verbatim: Changing color and burning) (serious criteria clinically significant/intervention required). The patient was treated with doxycycline. The outcome of the necrosis, injection site swelling, erythema, feeling hot and burning sensation were unknown.   It was unknown if the reporter considered the necrosis, injection site swelling, erythema, feeling hot and burning sensation to be related to Arexvy.     It was unknown if the company considered the necrosis, injection site swelling, erythema, feeling hot and burning sensation to be related to Arexvy.   Additional Information: GSK Receipt Date:16-NOV-2023 The reporter was the patient who stated that she received Arexvy and the next morning she developed a red circle hot to the touch with a bump in the middle at the injection site. The reporter applied cold compresses then the red circle started changing color and burning in the following days. According to the patient she visited her primary doctor who prescribed Doxycycline and referred her to a wound doctor who did a surgery on her arm to remove some necrotic tissue on 03-NOV-2023. The patient still had 4 stiches that supposed to get removed tomorrow. The reporter consented to follow up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (pfizer) concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, obesity, and unspecified drug allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, expiry date and batch number were not reported) dose was not reported, 1 total administered on 18-MAR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.   The patient additionally received non-company suspect vaccine Moderna (elasomeran) (Dose number in series 2) (form of admin, route of admin, expiry date and batch number were not reported) dose was not reported, administered on 17-NOV-2021 at left arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with non-company suspect vaccine Moderna (elasomeran) (Dose number in series 2) The patient additionally received non-company suspect vaccine Moderna (elasomeran) (Dose number in series 3) (form of admin, route of admin, expiry date and batch number were not reported) dose was not reported, administered on 21-JUL-2022 at right arm for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). Concomitant medications included vitamins.  On unspecified date in 2023, the patient experienced covid-19 infection (confirmed covid-19 infection) (Dose number in series 3) which led to confirmed clinical vaccination failure (Dose number in series 1) and received treatment drug paxlovid from 04-NOV-2023 to 8-NOV-2023 for covid-19. After taking paxlovid for five days, patient tested negative 2 days in a row (09-NOV-2023 and 10-NOV-2023) and then now patient was testing positive and having mild cold symptoms (11-NOV-2023). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (Dose number in series 2), and elasomeran (Dose number in series 3) was not applicable. The patient was recovering 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).; Sender's Comments: V0: 20231161671-confirmed clinical vaccination failure . The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (COVID-19) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.     Concurrent medical conditions included Rheumatoid arthritis, Sjogren's syndrome, Long QT and Drug allergy (Several drugs). Concomitant products included CARVEDILOL, OMEPRAZOLE, ATORVASTATIN, BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), ASCORBIC ACID (VITAMIN C ACID), FERROUS SULFATE and NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 19-Oct-2023 at 11:30 AM, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In 2023, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 01-Nov-2023 to 06-Nov-2023 for COVID-19 treatment, at an unspecified dose and frequency. In November 2023, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, SARS-CoV-2 test: (Negative) After complete resolution of symptoms, (Negative) 48 hours apart first test and Positive.         It was reported that the patient had  recurrence of nasal congestion and malaise 12 days after original symptom onset, accompanied by positive home Covid test.
Sex: U
Vaccine: COVID19
Symptoms: Device breakage, No adverse event
Clinical narrative: when the nurse was removing the grey cap twisting clockwise, it broke and they can't use the syringe with the vaccine in it; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE BREAKAGE (when the nurse was removing the grey cap twisting clockwise, it broke and they can't use the syringe with the vaccine in it) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032712) for COVID-19 prophylaxis.    Suspect product included Pre-filled Syringe injection (batch no. 3032712) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE BREAKAGE (when the nurse was removing the grey cap twisting clockwise, it broke and they can't use the syringe with the vaccine in it) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE BREAKAGE (when the nurse was removing the grey cap twisting clockwise, it broke and they can't use the syringe with the vaccine in it) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE BREAKAGE (when the nurse was removing the grey cap twisting clockwise, it broke and they can't use the syringe with the vaccine in it).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE BREAKAGE (when the nurse was removing the grey cap twisting clockwise, it broke and they can't use the syringe with the vaccine in it).    No concomitant or treatment medications were provided.  The pharmacist reported that they had one of their PFS of Spikevax the cap broke off of it before they could even get it off, like when the nurse was removing the grey cap twisting clockwise, it was broken and they could not use the syringe with the vaccine in it.  On 02-Nov-2023, shipment of the vaccine was received.  It was reported that the issue was not related to difficulty drawing the vaccine into the syringe, the syringe was not missing and it was not leaking. Did not notice any liquid, or staining in the carton/blister pack, PFS was not broken when received it, until tried to twist the cap it broke and there was no any issues noticed with the carton/packaging. Vaccines were put in the fridge at least 1 hour before administering, temperature was freezer set at -21°C and temperature was refrigerator set at 4.5°C. Currently the PFS was in a ziploc bag in the fridge.  The Device problem code for Spikevax syringe include FDA code 2588, RA code A0203 which include Defective Device.  The device was malfunctioned, and the malfunction type was CIRM.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032230) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (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-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  There was a total of 97 doses consisting of 9 half boxes of vaccines in the vial.  Treatment information was not provided.  Company comment: This regulatory authority case concerns a patient of unknown age and gender with no medical history information reported, who experienced the unexpected serious event of death. The event of death occurred on unknown date. Temporal association with a dose of SPIKEVAX 2023-2024 PFS is unclear. The cause of death was not reported. It is unknown if an autopsy was performed. No further information about the event was provided. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2023-750249, US-MODERNATX, INC.-MOD-2023-750490, US-MODERNATX, INC.-MOD-2023-750486, US-MODERNATX, INC.-MOD-2023-750488 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750249:Same Reporter US-MODERNATX, INC.-MOD-2023-750490:Same Reporter US-MODERNATX, INC.-MOD-2023-750486:Same Reporter US-MODERNATX, INC.-MOD-2023-750488:Same Reporter; Reported Cause(s) of Death: Death
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness
Clinical narrative: Passed out; Fell; This spontaneous case was reported by a pharmacist and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032230) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and FALL (Fell). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) and FALL (Fell) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not reported.  Company comment: This spontaneous case concerns a male patient of unknown age, with no medical history information reported, who experienced the unexpected serious (medically significant) event of loss of consciousness (passed out) and non serious event of fall. The events occurred on unknown date. Temporal association with a dose of SPIKEVAX 2023-2024 PFS is unclear. No further information about the events was provided. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-750249, US-MODERNATX, INC.-MOD-2023-750488, US-MODERNATX, INC.-MOD-2023-750490, US-MODERNATX, INC.-MOD-2023-750485 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750249:Same Reporter US-MODERNATX, INC.-MOD-2023-750488:Same Reporter US-MODERNATX, INC.-MOD-2023-750490:Same Reporter US-MODERNATX, INC.-MOD-2023-750485:Same Reporter
Sex: F
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness
Clinical narrative: Passed out; Fell; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032230) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and FALL (Fell). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) and FALL (Fell) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.  Company comment: This spontaneous case concerns a female patient of unknown age, with no medical history information reported, who experienced the unexpected serious (medically significant) event of loss of consciousness (passed out) and non serious event of fall. The events occurred on unknown date. Temporal association with a dose of SPIKEVAX 2023-2024 PFS is unclear. No further information about the events was provided. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-750490, US-MODERNATX, INC.-MOD-2023-750486, US-MODERNATX, INC.-MOD-2023-750249, US-MODERNATX, INC.-MOD-2023-750485 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750490:Same Reporter US-MODERNATX, INC.-MOD-2023-750486:Same Reporter US-MODERNATX, INC.-MOD-2023-750249:Same Reporter US-MODERNATX, INC.-MOD-2023-750485:Same Reporter
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: had an emergency; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (had an emergency) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 17-Nov-2023, the patient experienced IMMUNISATION REACTION (had an emergency). At the time of the report, IMMUNISATION REACTION (had an emergency) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant and treatment medications were not reported.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Fatigue
Clinical narrative: some fluctuation in blood pressure; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (some fluctuation in blood pressure) and FATIGUE (tiredness) in a 78-year-old female patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2023, the patient received dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced BLOOD PRESSURE FLUCTUATION (some fluctuation in blood pressure) and FATIGUE (tiredness). At the time of the report, BLOOD PRESSURE FLUCTUATION (some fluctuation in blood pressure) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: some fluctuation.         Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bell's palsy; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (bell's palsy) in a 22-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient was never diagnosed with or tested positive for COVID-19. The patient had no acute illnesses at the time of vaccination and up to one month before. The patient had no chronic or long-standing health conditions.  Concurrent medical conditions included Penicillin allergy.    On 09-Jan-2023 at 1:00 PM, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In February 2023, the patient experienced BELL'S PALSY (bell's palsy) (seriousness criterion medically significant). On 20-Jul-2023, BELL'S PALSY (bell's palsy) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered BELL'S PALSY (bell's palsy) to have an unknown relationship.    No concomitant medications were reported.  The event caused the patient to seek physician's office/urgent care visit.  The other potential cause was wisdom teeth removal 3 days post vaccine.  The patient did not experience a similar event in the past.  No treatment medications were reported.  Company Comment This spontaneous case concerns a 22-year-old female patient with medical history of penicillin allergy who experienced the seriousness criterion medically significant expected AESI of Bell´s palsy the following month after 1st. dose of SPIKEVAX NOS vaccine. Concomitant medication details nor Treatment details were reported On 20-Jul-2023, Bell's palsy had resolved.  The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.   This case was linked to MOD-2023-746659.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dyspnoea, Headache, Malaise
Clinical narrative: She is out of breath when she goes for her regular walk; She has no energy; I just don't feel good; She has constant headache; She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F); This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), HEADACHE (She has constant headache) and PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F)) in a 72-year-old female 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 DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), HEADACHE (She has constant headache) and PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F)). The patient was treated with PARACETAMOL (TYLENOL) for Low grade fever, at a dose of 2 dosage form. At the time of the report, DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), HEADACHE (She has constant headache) and PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2023, Body temperature: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F)..     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient states that after all the other Moderna shots, she had similar side effects but with previous shots the side effects lasted only 4 days. After the shot on 06NOV2023, the side effects did not go away. It has been 15 days now. When she takes 2 Tylenol the fever goes away, but it comes back the next day. No Concomitant medications were reported.   This case was linked to MOD-2023-750464 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She is out of breath when she goes for her regular walk; She has no energy; I just don't feel good; She has constant headache; She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F); This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), HEADACHE (She has constant headache) and PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F)) in a 72-year-old female 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 DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), HEADACHE (She has constant headache) and PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F)). The patient was treated with PARACETAMOL (TYLENOL) for Low grade fever, at a dose of 2 dosage form. At the time of the report, DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), HEADACHE (She has constant headache) and PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2023, Body temperature: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F)..     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient states that after all the other Moderna shots, she had similar side effects but with previous shots the side effects lasted only 4 days. After the shot on 06NOV2023, the side effects did not go away. It has been 15 days now. When she takes 2 Tylenol the fever goes away, but it comes back the next day. No Concomitant medications were reported.   This case was linked to MOD-2023-750464 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Body temperature, Dyspnoea, Headache, Malaise
Clinical narrative: She is out of breath when she goes for her regular walk; She has no energy; I just don't feel good; She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),; She has constant headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache) in a 72-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.     No Medical History information was reported.   On an unknown date, the patient received third 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 fourth 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 an unknown date, the patient experienced DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 2 dosage form. At the time of the report, DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.9 F to 99.9 F  normal temperature was 97.8 F.     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.   The patient stated that after all the other Moderna shots, she had similar side effects but with previous shots the side effects lasted only 4 days.   No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750464 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750464:Case for Shot 3 and Shot 4: First Moderna Booster dose
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: She is out of breath when she goes for her regular walk; She has no energy; I just don't feel good; She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),; She has constant headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache) in a 72-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.     No Medical History information was reported.   On an unknown date, the patient received third 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 fourth 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 an unknown date, the patient experienced DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 2 dosage form. At the time of the report, DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.9 F to 99.9 F  normal temperature was 97.8 F.     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.   The patient stated that after all the other Moderna shots, she had similar side effects but with previous shots the side effects lasted only 4 days.   No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750464 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750464:Case for Shot 3 and Shot 4: First Moderna Booster dose
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (Pneumonia) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Company comment:  This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of pneumonia after the administration of the second dose of mRNA-1273 vaccine. Latency could not be assessed due to lack of information on vaccination date and onset date of event. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-749833 (E2B Linked Report). This case was linked to MOD-2023-749833 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749833:Same reporter, different product
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: cough; runny nose; sore throat; chills; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Pneumonia (in the fall). Previously administered products included for Product used for unknown indication: Pfizer vaccine in January 2023. Past adverse reactions to the above products included No adverse event with Pfizer vaccine. Concurrent medical conditions included Blood pressure high and Hypercholesterolaemia.    On 13-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced COUGH (cough), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In November 2023, OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, COUGH (cough), RHINORRHOEA (runny nose) and CHILLS (chills) had not resolved.            Patient had Pfizer vaccine last January as she could not get it in the fall because she had pneumonia.  Concomitant medication included unspecified medication for blood pressure and cholesterol.  It was reported that patient was not sure if it was her third or fourth dose.  It was reported that patient had Spikevax vaccine on Monday afternoon. On the same night, patient started with cough, Sore throat, Chills. Symptoms were ongoing at the time of reporting. Patient still had coughing but did not had sore throat anymore, but she had a runny nose and a cough at the time of reporting.  Patient was treated with Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2023-750647 (E2B Linked Report). This case was linked to MOD-2023-750647 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750647:Same patient, different product