chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Body temperature decreased, Chills
Clinical narrative: shivers; temp has gone down to the 20s; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shivers in a 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 shivers (Verbatim: shivers) and body temperature decreased (Verbatim: temp has gone down to the 20s). The outcome of the shivers and body temperature decreased were not reported.   It was unknown if the reporter considered the shivers and body temperature decreased to be related to Arexvy.     It was unknown if the company considered the shivers and body temperature decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient had shiver and the temperature had gone down to the 20s.
Sex: U
Vaccine: RSV
Symptoms: Influenza, Nasopharyngitis, Rhinorrhoea, Sneezing
Clinical narrative: sneezing; running nose; cold flu symptoms; cold flu symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sneezing in a 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 sneezing (Verbatim: sneezing), runny nose (Verbatim: running nose), flu symptoms (Verbatim: cold flu symptoms) and cold symptoms (Verbatim: cold flu symptoms). The outcome of the sneezing, runny nose, flu symptoms and cold symptoms were not reported.   It was unknown if the reporter considered the sneezing, runny nose, flu symptoms and cold symptoms to be related to Arexvy.     It was unknown if the company considered the sneezing, runny nose, flu symptoms and cold symptoms to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-Mar-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient wanted to know was it possible that he/she get sneezing, running nose and cold flu symptoms after the vaccine. That was how patient felt.
Sex: U
Vaccine: RSV
Symptoms: Illness, Pain
Clinical narrative: Sick; quite a bit of pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 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 sickness (Verbatim: Sick) and pain (Verbatim: quite a bit of pain). The outcome of the sickness and pain were not reported.   It was unknown if the reporter considered the sickness and pain to be related to Arexvy.     It was unknown if the company considered the sickness and pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-Mar-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient needs more information as he/she had the vaccine 3 full days ago and he/she had been sick and in quite a bit of pain. The patient wanted to know if his/her symptoms were illegible text.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: Covid multiple times; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of covid-19 in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced covid-19 (Verbatim: Covid multiple times). The outcome of the covid-19 was not reported.   It was unknown if the reporter considered the covid-19 to be related to Shingles vaccine.     It was unknown if the company considered the covid-19 to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-MAR-2024 This case was reported via interactive digital media. The reporter stated that every single person he/she knew who got the shot got Covid multiple times after.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Arthritis
Clinical narrative: joint pain; arthritis; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a 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 joint pain (Verbatim: joint pain) and arthritis (Verbatim: arthritis). The outcome of the joint pain and arthritis were not reported.   It was unknown if the reporter considered the joint pain and arthritis to be related to Arexvy.     It was unknown if the company considered the joint pain and arthritis to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024 This case was received from the patient via (Open field AE monitoring) interactive digital media. The patient had joint pain and arthritis, but he/she felt that the vaccine triggered.
Sex: U
Vaccine: RSV
Symptoms: Cough, Fatigue, Oropharyngeal pain
Clinical narrative: Sore throat; Cough; feel exhausted; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sore throat in a 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 sore throat (Verbatim: Sore throat), cough (Verbatim: Cough) and exhaustion (Verbatim: feel exhausted). The outcome of the sore throat, cough and exhaustion were not reported.   It was unknown if the reporter considered the sore throat, cough and exhaustion to be related to Arexvy.     It was unknown if the company considered the sore throat, cough and exhaustion to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-Mar-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient experienced sore throat, cough and felt exhausted.
Sex: U
Vaccine: RSV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: my arm was also sore; baseball size reddened area around my injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a 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 injection site erythema (Verbatim: baseball size reddened area around my injection site) and pain in arm (Verbatim: my arm was also sore). The outcome of the injection site erythema was resolved (duration 5 days) and the outcome of the pain in arm was not reported.   It was unknown if the reporter considered the injection site erythema and pain in arm to be related to Arexvy.     It was unknown if the company considered the injection site erythema and pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-Mar-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient had a baseball size reddened area around his/her injection site for 5 days and arm was also sore. He/she never had a reaction to any vaccines.
Sex: U
Vaccine: RSV
Symptoms: Swelling
Clinical narrative: swelled up; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling in a 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 swelling (Verbatim: swelled up). The outcome of the swelling was not reported.   It was unknown if the reporter considered the swelling to be related to Arexvy.     It was unknown if the company considered the swelling to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-Mar-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. It was reported that, site was (illegible text) and swelled up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Vaccine left painful reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles about 40 years ago) and rash (rash along the hip bone).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Vaccine left painful reaction). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-Mar-2024 This case was reported by the patient via interactive digital media. The patient stated that he/she had one shingle vaccine a couple of years ago. The patient stated that vaccine left painful reaction.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: developed mild shingles in February 2024/ Suspected vaccination failure; Shingles; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (On an unknown date, received the vaccine).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In FEB-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: developed mild shingles in February 2024/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved.   The reporter considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix.   The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 05-MAR-2024 The reporter reported that the patient received both doses of Shingrix in the year of 2021 at the pharmacy and later developed mild shingles in February 2024. Reporter did not feel that this was an adverse event for Shingrix. Reporter medical opinion was no for the reported product defect caused the adverse event. Health care provider prescribed patients valtrex and the condition resolved within days. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding laboratory details were unknown at a time of reporting. This case had been linked with the case US2024029072, reported by same reporter.; Sender's Comments:  US-GSK-US2024029072:different patient
Sex: U
Vaccine: HEP, HEPA, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Maladministration of vaccines after exposure to freezing temperatures; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in a specified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Boostrix, Havrix, Engerix B and Menveo. On an unknown date, an unknown time after receiving Boostrix, Havrix, Engerix B and Menveo, the patient experienced incorrect product storage (Verbatim: Maladministration of vaccines after exposure to freezing temperatures). The outcome of the incorrect product storage was unknown.   Additional Information: GSK Receipt Date: 29-FEB-2024 The worker reported that the following temperature excursion for Boostrix, Havrix, Engerix-B and Menveo two vials presentation.  On December 14th, 2023, lowest temperature minus 0.8 degree Celsius, time out of range was 77 hours 54 minutes. No prior excursions. The reporter reported that after December 14th, 2023, the two patients received some of these vaccines which led to incorrect storage of drug. The reporter consented to follow up and requested to contact, manager phone number for further details.; Sender's Comments:  US-GSK-US2024027030:Different patient
Age: 22.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix vaccine was stored outside of recommended storage conditions, exposed to minus 0.8 degree celsius; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 22-year-old male patient who received HAV (Havrix) for prophylaxis.   On 04-JAN-2024, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Havrix vaccine was stored outside of recommended storage conditions, exposed to minus 0.8 degree celsius). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 05-MAR-2024. Front desk worker reported that Havrix vaccine was stored outside of recommended storage conditions, exposed to minus 0.8 degree C, which led to incorrect storage of drug.  After this temperature excursion vaccine was administered to a patient. The reporter consented to follow up via email agreed.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chemotherapy, Herpes zoster, Lymphoma, Vaccination failure
Clinical narrative: who had two doses of Shingrix two years ago currently he has shingles and wants a booster third dose of Shingrix/suspected vaccination failure; who was diagnosed with lymphoma and finished his chemotherapy recently; who had two doses of Shingrix two years ago currently he has shingles and wants a booster third dose of Shingrix; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: who had two doses of Shingrix two years ago currently he has shingles and wants a booster third dose of Shingrix/suspected vaccination failure) (serious criteria GSK medically significant), lymphoma (Verbatim: who was diagnosed with lymphoma and finished his chemotherapy recently) (serious criteria GSK medically significant) and shingles (Verbatim: who had two doses of Shingrix two years ago currently he has shingles and wants a booster third dose of Shingrix). The outcome of the vaccination failure was unknown and the outcome of the lymphoma was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure, lymphoma and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, lymphoma and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 05-MAR-2024 The reporter was a medical assistant. The reporter wanted to know if a patient who had two doses of Shingrix two years ago, who was diagnosed with lymphoma and finished his chemotherapy recently but currently he had shingles and wanted a booster third dose of Shingrix.  The reporter did not have lot number or expiration date because he was vaccinated two years ago. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Adverse event, COVID-19 immunisation, Feeling abnormal, Magnetic resonance imaging, Vertigo
Clinical narrative: REACTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; VERTIGO; FELT AWFUL; This spontaneous report received from a health care professional concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced reaction (mapped to Adverse event NOS) (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of reaction was not reported. On an unspecified date, the patient received additional non-company suspect vaccine included: davesomeran/elasomeran (Dose number in series 2) ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported, and dose, frequency, and therapy dates were not reported for covid-19 prophylaxis. On 15-JAN-2023, the patient received covid-19 vaccine ad26.cov2.s (Dose number in series 3) ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported, and dose, frequency, and therapy dates were not reported for covid-19 prophylaxis. On an unspecified date in JAN-2023, following vaccination withcovid-19 vaccine ad26.cov2.s (Dose number in series 3) , the patient experienced vertigo and felt awful and revaccination with different covid-19 vaccine.(Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo on MAR-2023, recovered with sequelae from i felt awful on MAR-2023. This report was non-serious.  Version created to amend previously reported information on 02-FEB-2024. Upon review the following information was amended: Amendment Multiple (Amendment event: additional event of revaccination with different covid-19 vaccine and related fields updated. Amendment Product: product type and product coding for covid vaccine and moderna vaccine have been updated. )
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; REBOUND COVID POSITIVE TEST; This spontaneous report received from a consumer via another company (Pfizer Inc.) and concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A) dose was not reported (dose number series 1), administered on 02-APR-2021 11:00 to Left Arm for covid-19 prophylaxis.  Non-company suspect vaccine included: elasomeran (intramuscular, batch number: 032F21A, batch number: AS7143C, form of admin was not reported) dose was not reported, administered on 05-NOV-2021 12:00 dose number series 2), and dose was not reported, administered on 14-SEP-2022 18:00 (dose number series 4) for prophylactic vaccination ; and tozinameran (intramuscular, batch number: FF8841, batch number: HG 4671, form of admin was not reported) dose was not reported, administered on 31-MAR-2022 11:00 (dose number series 3), and dose was not reported, administered on 08-OCT-2023 10:00 (dose number series 5) for prophylactic vaccination.  Concomitant medications included nirmatrelvir/ritonavir for covid-19, and prednisone.  On 19-FEB-2024, the patient experienced rebound covid positive test (dose number in series 1). The patient had positive test five days after completion of Paxlovid and four days after negative test.  On an unspecified date, the patient experienced revaccination with different covid-19 vaccine. (dose number in series 1).. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable. The patient was recovering from rebound covid positive test, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This spontaneous report received from a consumer via J&J managed social media site concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced sick(Dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: menstrual cycle was delayed; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUATION DELAYED (menstrual cycle was delayed) 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, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUATION DELAYED (menstrual cycle was delayed). At the time of the report, MENSTRUATION DELAYED (menstrual cycle was delayed) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that patient received 4 doses of moderna vaccine and occurred her menstrual cycle delayed each time.  Treatment information was not reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Movement disorder
Clinical narrative: Could barely drink and ate nothing; Couldn't move for 3 days; Severe severe what headache wver / Bedridden from the head pain; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (Could barely drink and ate nothing), MOVEMENT DISORDER (Couldn't move for 3 days) and HEADACHE (Severe severe what headache wver / Bedridden from the head pain) in a 51-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Mar-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 07-Mar-2024, the patient experienced DECREASED APPETITE (Could barely drink and ate nothing), MOVEMENT DISORDER (Couldn't move for 3 days) and HEADACHE (Severe severe what headache wver / Bedridden from the head pain). At the time of the report, DECREASED APPETITE (Could barely drink and ate nothing) and HEADACHE (Severe severe what headache wver / Bedridden from the head pain) was resolving and MOVEMENT DISORDER (Couldn't move for 3 days) had resolved.            Concomitant medication use information was not provided by reporter.  Reporter causality was not reported. It was unknown if the patient experienced any additional symptoms/events.   Treatment medication use information was not provided by reporter.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Loss of personal independence in daily activities, Malaise, Meningism
Clinical narrative: Reports malaise after vaccination 8 to 10 hours later; meningism; Mild chills; Patient reports not being able to "hit a ball" while playing tennis the day after the vaccine was received, however symptoms resolved within 24 hours.; Patient reports that he feels crummy.; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Reports malaise after vaccination 8 to 10 hours later), MENINGISM (meningism), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Patient reports not being able to "hit a ball" while playing tennis the day after the vaccine was received, however symptoms resolved within 24 hours.), FEELING ABNORMAL (Patient reports that he feels crummy.) and CHILLS (Mild chills) in a 72-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030368) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In September 2023, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Patient reports not being able to "hit a ball" while playing tennis the day after the vaccine was received, however symptoms resolved within 24 hours.) and FEELING ABNORMAL (Patient reports that he feels crummy.). On 23-Sep-2023, the patient experienced MALAISE (Reports malaise after vaccination 8 to 10 hours later), MENINGISM (meningism) and CHILLS (Mild chills). In September 2023, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Patient reports not being able to "hit a ball" while playing tennis the day after the vaccine was received, however symptoms resolved within 24 hours.) and FEELING ABNORMAL (Patient reports that he feels crummy.) had resolved. On 24-Sep-2023, MALAISE (Reports malaise after vaccination 8 to 10 hours later), MENINGISM (meningism) and CHILLS (Mild chills) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Headache, Nausea, Pain
Clinical narrative: Terrible body aches; can't get out of bed; nausea; head aches; temp 101.3; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Terrible body aches), BEDRIDDEN (can't get out of bed), NAUSEA (nausea), HEADACHE (head aches) and PYREXIA (temp 101.3) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 10-Mar-2024, the patient experienced PAIN (Terrible body aches), BEDRIDDEN (can't get out of bed), NAUSEA (nausea), HEADACHE (head aches) and PYREXIA (temp 101.3). At the time of the report, PAIN (Terrible body aches), BEDRIDDEN (can't get out of bed), NAUSEA (nausea) and HEADACHE (head aches) had not resolved and PYREXIA (temp 101.3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: temp 101.3.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Terrible body aches; can't get out of bed; nausea; head aches; temp 101.3; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Terrible body aches), BEDRIDDEN (can't get out of bed), NAUSEA (nausea), HEADACHE (head aches) and PYREXIA (temp 101.3) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 10-Mar-2024, the patient experienced PAIN (Terrible body aches), BEDRIDDEN (can't get out of bed), NAUSEA (nausea), HEADACHE (head aches) and PYREXIA (temp 101.3). At the time of the report, PAIN (Terrible body aches), BEDRIDDEN (can't get out of bed), NAUSEA (nausea) and HEADACHE (head aches) had not resolved and PYREXIA (temp 101.3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: temp 101.3.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient had covid the 1 MAR 2024 with positive covid test; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient had covid the 1 MAR 2024 with positive covid test) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) on 23-Mar-2021, Moderna COVID-19 Vaccine (Dose 2) on 20-Apr-2021, Moderna COVID-19 Vaccine (Dose 3) on 09-Nov-2021 and Moderna COVID-19 Vaccine (Dose 4) on 24-Jun-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Controlled hypertension (controlled high blood pressure). Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 25-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 01-Mar-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (Patient had covid the 1 MAR 2024 with positive covid test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient had covid the 1 MAR 2024 with positive covid test) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2024, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient reported having no allergies.   This case was linked to US-MODERNATX, INC.-MOD-2024-762963 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-762963:Same Reporter other patient
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 63-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 24Nov2023 at 19:00 as dose 1 (toppac), single (Lot number: HG4675) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Patient had no other medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: GH9702, Location of injection: Arm Left, Time: 07:00 PM), administration date: 10Nov2022, when the patient was 62-year-old, for COVID-19 immunization; moderna (Dose 4 , Batch/Lot No: fj9943, Location of injection: Arm Left, Time: 01:00 PM), administration date: 08May2022, when the patient was 61-year-old, for COVID-19 immunization; moderna (Dose 3, Batch/Lot No: 939903, Location of injection: Arm Left, Time: 07:00 PM), administration date: 23Nov2021, when the patient was 61-year-old, for COVID-19 immunization; moderna (Dose 2, Batch/Lot No: 002A21A, Location of injection: Arm Left, Time: 12:00 PM), administration date: 27Feb2021, when the patient was 60-year-old, for COVID-19 immunization; moderna (Dose 1, Batch/Lot No: 011L20A, Location of injection: Arm Left, Time: 01:00 AM), administration date: 22Jan2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Mar2024) Negative, notes: Symptoms completely gone. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid (lot number=HL3796) from 29Feb2024 to 05Mar2024 for COVID-19 Treatment.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19; COVID 19; vaccine brand=Pfizer /BioNTech, vaccine dose number=3; vaccine brand other=Moderna, vaccine dose number=4; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 at 12:00 as dose 3 (booster), single (Lot number: EL1283) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Jan2022 at 12:00 as dose 2, single (Lot number: 025-LZ1B), in left arm and on 26Apr2023 at 12:00 as dose 5 (booster), single), in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 06Sep2022 at 12:00 as dose 4 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "lupus" (unspecified if ongoing); "mctd" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Feb2021 at 12:00, outcome "unknown", described as "vaccine brand=Pfizer /BioNTech, vaccine dose number=3; vaccine brand other=Moderna, vaccine dose number=4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 Included Paxlovid from 02Mar2024 to 07Mar2024.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Lot number: Gh9703) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Nov2021 as dose 2, single (Lot number: 071f211a), in left arm, on 07Apr2023 as dose 3 (booster), single (Lot number: 066k21a), in left arm and on 14Oct2023 as dose 5 (booster), single (Lot number: Au3832b), in left arm for covid-19 immunisation; COVID-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 08Mar2021 as dose 1, single (Lot number: 1802072), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Seasonal allergies" (unspecified if ongoing); "PVCs" (unspecified if ongoing); "High familial cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 06Mar2024 to 09Mar2024. This case was reported as non-Serious.
Sex: M
Vaccine: COVID19
Symptoms: Atrial enlargement, Atrial fibrillation, Echocardiogram, Electrocardiogram, Heart rate
Clinical narrative: AFib; had an enlarge atrium; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 70-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: Apr2021, for covid-19 immunization. The following information was reported: ATRIAL FIBRILLATION (hospitalization, medically significant) with onset 21Oct2021, outcome "unknown", described as "AFib"; ATRIAL ENLARGEMENT (hospitalization) with onset 21Oct2021, outcome "unknown", described as "had an enlarge atrium". The patient underwent the following laboratory tests and procedures: Echocardiogram: Unknown Results, notes: shocked his heart, nothing happened, 20 minutes later he was given with Caller stated that his heart rhythm went back to normal almost instantly; Electrocardiogram: passed, notes: 5 EKG's in a row were conducted and he passed; Heart rate: 150 beats per minute. Therapeutic measures were taken as a result of atrial fibrillation.  Clinical course: HCP contact information was not available. PQC was not present. Caller mentioned that he received both doses of Pfizer COVID vaccine in Apr2021, on 21Oct2021, he was hospitalized due to AFib and the withheld came up with an article regarding the increase of patients coming due to AFib and there was a connection to the vaccine and AFib. Caller added that his cardiologist told him that he had an enlarge atrium. Caller stated that he was healthy his whole life and he was 70 years old and the only time he was in the hospital was because it was AFib.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a Nurse.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 at 13:00 as dose 1, single (Lot number: EK5730), in left arm, on 08Jan2021 at 10:00 as dose 2, single (Lot number: EL3248), in right arm and on 29Sep2021 at 10:00 as dose 3 (booster), single (Lot number: FD0809) at the age of 72 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Apr2022 at 13:00 as dose 4 (booster), single (Lot number: 070H21A), in right arm and on 18Sep2023 at 12:15 as dose 6 (booster), single (Lot number: 80777-0102-96), in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 09Sep2022 at 13:00 as dose 5 (booster), single (Lot number: AS71436), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing), notes: Hypothyroid; "Anemia" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medication(s) included: SYNTHROID, start date: 01Oct2020. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Apr2022 at 13:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2024) Negative, notes: Day 10 negative test; (Mar2024) Positive, notes: Day 12 sick all over again and test positive again. Therapeutic measure which included Paxlovid was administered from  26Feb2024 to 02Mar2024.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 as dose 4 (booster), single (Lot number: GJ6665) at the age of 43 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2023 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single), as dose 4 (booster), single) and as dose 5 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "type II diabetes" (unspecified if ongoing); "Known Allergies: Sulfa" (unspecified if ongoing); "Known Allergies: Shellfish" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "Interstitial Cystitis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known Allergies: Cipro". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment was Paxlovid from 01Mar2024 to 06Mar2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Candida infection
Clinical narrative: thrush; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: diagnosed 5 years ago when he was 65. It will be six years he was diagnosed in July; "COPD" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL taken for heart rate; LOSARTAN HCTZ; MONTELUKAST. Vaccination history included: Influenza vaccine, when the patient was 65 years old, for immunisation; Bnt162b2 (dose number unknown), for Covid-19 immunisation, reaction(s): "thrush". The following information was reported: CANDIDA INFECTION (non-serious), outcome "unknown", described as "thrush". Therapeutic measures were taken as a result of candida infection. Additional information: This patient is reporting about Pfizer Covid vaccine, has had all the doses. Every 3 months after getting the vaccines he has thrush. He has had thrush 8 times now. The doctor has given him some medicine.  Caller states he has one vocal cord and that is why he sounds funny. Caller clarified that he had one vocal cord prior to getting Pfizer Covid vaccines. All his Covid vaccines were manufactured by Pfizer. He hasn't missed a shot. He has got them from the beginning and the last one he got was in Sep2023. The thrush didn't start until after getting the Covid vaccines. Caller clarified any of the times he gets Covid shot within 6 months he has had thrush twice, every time.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400061506 same patient/drug, different dose/AE;US-PFIZER INC-202400061745 same patient/drug, different dose/AE;US-PFIZER INC-202400061506 same patient/drug, different dose/AE;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Candida infection
Clinical narrative: thrush; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An elderly male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: diagnosed 5 years before this report when he was 65. It will be six years he was diagnosed in July; "COPD" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation; ATENOLOL taken for heart rate; LOSARTAN HCTZ; MONTELUKAST. The following information was reported: CANDIDA INFECTION (non-serious), outcome "unknown", described as "thrush". Therapeutic measures were taken as a result of candida infection.  Additional information: This patient is reporting about Pfizer Covid vaccine, has had all the doses. Every 3 months after getting the vaccines he has thrush. He has had thrush 8 times now. The doctor has given him some medicine.  Caller states he has one vocal cord and that is why he sounds funny. Caller clarified that he had one vocal cord prior to getting Pfizer Covid vaccines. All his Covid vaccines were manufactured by Pfizer. He hasn't missed a shot. He has got them from the beginning and the last one he got was in Sep2023. The thrush didn't start until after getting the Covid vaccines. Caller clarified any of the times he gets Covid shot within 6 months he has had thrush twice, every time.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400061744 same patient/drug, different dose/AE;US-PFIZER INC-202400061506 same patient/drug, different dose/AE;