chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    No relevant concomitant medications were reported. It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment medication reported.   This case was for the 36th patient out of 77 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion).    Concomitant product use was not provided by the reporter.  On an unknown date, the patient received Moderna bivalent booster dose that had undergone a temperature excursion. The dose was administered before it was known if the vaccine was ok.  Treatment information was not provided.  This case contains information for 37th of 77 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and PRODUCT STORAGE ERROR (Product storage error).    It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. This case is for 39th patient out of 77 patients reported. No concomitant medication information provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    This case contains information for the 38th patient out of 77 patients described by the reporter. No concomitant medication information provided. It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:case
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram, Cough, Ear discomfort
Clinical narrative: Sweats, cough, fever, chest pain after 10 days, the pain travelled from my chest to the neck, to the left head by the left ear, with feeling of pressure behind the ear.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperhidrosis, Laboratory test, Neck pain, Pain, Pyrexia
Clinical narrative: Sweats, cough, fever, chest pain after 10 days, the pain travelled from my chest to the neck, to the left head by the left ear, with feeling of pressure behind the ear.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody positive, Condition aggravated, Hidradenitis, Psoriasis, Skin disorder
Clinical narrative: Worsen of  psoriasis about a month after 2nd shot.  Had major skin issues at the end of July.  These skin issues continue to progress.  Numerous dermatology appointments and diagnosed with hidradenditis suppertiva of face.  In Aug  21, newly diagnosed with Psoriatic Arthritis and was in a major flare.  Referred and have been treated with her since 11/29/21.
Age: 67.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Chills, Condition aggravated, Headache, Nausea, Pain
Clinical narrative: Fever 103.5, headache, all over body aches, chills, nausea
Age: 67.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Pyrexia
Clinical narrative: Fever 103.5, headache, all over body aches, chills, nausea
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Herpes zoster, Loss of personal independence in daily activities, Pain
Clinical narrative: Pain; Burning; Exhaustion, tired; can't rest; lost all of Christmas this year; Have shingles, had the vaccination / Suspected vaccination failure; Still have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In November 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain, burning sensation, exhaustion, restlessness and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, burning sensation, exhaustion, restlessness and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, burning sensation, exhaustion, restlessness and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK receipt date: 9 JAN 2023 Reporters comment: This case was reported by a patient via interactive digital media. The patient reported that had shingles which started 2 months ago from reporting. The patient had the vaccination, but it hit like a ton of bricks. The patient never experienced pain like this and the burning and the exhaustion. The patient could not rest and was tired. The patient lost all of Christmas this year and it was not over yet. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Restlessness, Vaccination failure
Clinical narrative: Pain; Burning; Exhaustion, tired; can't rest; lost all of Christmas this year; Have shingles, had the vaccination / Suspected vaccination failure; Still have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In November 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain, burning sensation, exhaustion, restlessness and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, burning sensation, exhaustion, restlessness and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, burning sensation, exhaustion, restlessness and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK receipt date: 9 JAN 2023 Reporters comment: This case was reported by a patient via interactive digital media. The patient reported that had shingles which started 2 months ago from reporting. The patient had the vaccination, but it hit like a ton of bricks. The patient never experienced pain like this and the burning and the exhaustion. The patient could not rest and was tired. The patient lost all of Christmas this year and it was not over yet. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got the latest strain of COVID/still battling symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got the latest strain of COVID/still battling symptoms) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced COVID-19 (got the latest strain of COVID/still battling symptoms). At the time of the report, COVID-19 (got the latest strain of COVID/still battling symptoms) was resolving.            No concomitant medications were reported. It was reported two weeks ago patient and wife received the latest strain of COVID.  Both were boosted in October. But that booster did not save them and two weeks later patients were still battling symptoms, which was gradually diminishing with time and were not well yet. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696394.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696394:Wife case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medication was provided by reporter.  It was reported as 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    This case is for 34th patient out of 77 patients reported.  No concomitant medication information was provided.  It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:case
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angina pectoris, Myocardial ischaemia
Clinical narrative: Angina ischemia of lower heart. Cardiac angioplasty planned
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    This case is for 16th patient out of 77 patients reported.  No concomitant medication information was provided.  It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medication information provided. It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment information provided.  This case is for 26th patient out of 77 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  This case is for 28th patient out of 77 patients reported.  No concomitant medication information provided.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122: case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    This case was for 29th patient out of 77 patients reported.  No concomitant medication information provided.  It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bone marrow transplant, Unevaluable event
Clinical narrative: Nurse that administered the COVID vaccine on 12/06/2022 and 01/09/2023 was informed by patient that his physician requested him to be revaccinated with all vaccine due to being a Bone Marrow Transplant (BMT) patient.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Nausea, Paraesthesia
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: patient experienced tingling and nausea with headaches after the vaccine. Patient was told to lie down for a few minutes trhen had patient sit up and given water. After about 20 minutes patient was able to stand an walk around on her own. She expressed that she still felt some tingling still. Will call later to follow up. Will also have 1 more follow up call tomorrow
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain, Laboratory test, X-ray limb
Clinical narrative: Site: Bruising at Injection Site-Medium, Additional Details: pt  had pain in left shoulder beginning the day of the injection. she went ot the general practicitoner after 30 days. she got a rx for predisone & pain pill. on 1/12/23  went to ortho. xrays & tests showed the injection went through the deltoid muscle into the bursa. she is now on panin meds & got a cortisone injection
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: after injection pt complained of redness and swelling at and around injection site .advised to call md or visit urgent care
Age: 21.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Dizziness, Hypotension
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Shakiness-Mild, Additional Details: Pt came back 30 min after vaccination given at 7pm. Was shopping in store, but felt very faint. Had patient lay down with legs propped up. Took blood pressure was low 106/68 and pulse rate was 158. Decided at that point to call Emergency medical due to time of day and wait time at urgent care. Both Fire and EMS came. Patient was stable blood pressure had rebounded all other vitals were good, EMS transported to facility of choice for evaluation.
Age: 21.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Blood pressure measurement, Body temperature, Dizziness, Electrocardiogram, Fall
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Shakiness-Mild, Additional Details: Pt came back 30 min after vaccination given at 7pm. Was shopping in store, but felt very faint. Had patient lay down with legs propped up. Took blood pressure was low 106/68 and pulse rate was 158. Decided at that point to call Emergency medical due to time of day and wait time at urgent care. Both Fire and EMS came. Patient was stable blood pressure had rebounded all other vitals were good, EMS transported to facility of choice for evaluation.
Age: 21.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Heart rate, Heart rate increased, Hypotension, Investigation, Lymphadenopathy
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Shakiness-Mild, Additional Details: Pt came back 30 min after vaccination given at 7pm. Was shopping in store, but felt very faint. Had patient lay down with legs propped up. Took blood pressure was low 106/68 and pulse rate was 158. Decided at that point to call Emergency medical due to time of day and wait time at urgent care. Both Fire and EMS came. Patient was stable blood pressure had rebounded all other vitals were good, EMS transported to facility of choice for evaluation.
Age: 21.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Presyncope, Pyrexia
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Shakiness-Mild, Additional Details: Pt came back 30 min after vaccination given at 7pm. Was shopping in store, but felt very faint. Had patient lay down with legs propped up. Took blood pressure was low 106/68 and pulse rate was 158. Decided at that point to call Emergency medical due to time of day and wait time at urgent care. Both Fire and EMS came. Patient was stable blood pressure had rebounded all other vitals were good, EMS transported to facility of choice for evaluation.
Age: 21.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Blood pressure measurement, Chills, Diarrhoea, Dizziness, Electrocardiogram
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Shakiness-Mild, Additional Details: Pt came back 30 min after vaccination given at 7pm. Was shopping in store, but felt very faint. Had patient lay down with legs propped up. Took blood pressure was low 106/68 and pulse rate was 158. Decided at that point to call Emergency medical due to time of day and wait time at urgent care. Both Fire and EMS came. Patient was stable blood pressure had rebounded all other vitals were good, EMS transported to facility of choice for evaluation.
Age: 21.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Heart rate, Heart rate increased, Hypotension, Lymphadenopathy, Pain
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Shakiness-Mild, Additional Details: Pt came back 30 min after vaccination given at 7pm. Was shopping in store, but felt very faint. Had patient lay down with legs propped up. Took blood pressure was low 106/68 and pulse rate was 158. Decided at that point to call Emergency medical due to time of day and wait time at urgent care. Both Fire and EMS came. Patient was stable blood pressure had rebounded all other vitals were good, EMS transported to facility of choice for evaluation.
Age: 21.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19
Symptoms: Pyrexia
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Shakiness-Mild, Additional Details: Pt came back 30 min after vaccination given at 7pm. Was shopping in store, but felt very faint. Had patient lay down with legs propped up. Took blood pressure was low 106/68 and pulse rate was 158. Decided at that point to call Emergency medical due to time of day and wait time at urgent care. Both Fire and EMS came. Patient was stable blood pressure had rebounded all other vitals were good, EMS transported to facility of choice for evaluation.
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, VARZOS
Symptoms: Flushing, Somnolence, Vomiting
Clinical narrative: flushing, vomiting and sleepiness
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient presented for routine follow up visit with her PCP.  Patient was now age 65 and doctor ordered a Prevnar 13 vaccination for patient.  Nurse administered a PPSV 23 vaccine instead.  Patient had a previous dose of PPSV 23 on 09/14/2018.  No adverse reactions noted.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Gastritis, Gastrooesophageal reflux disease, Oesophagitis, Oesophagogastroduodenoscopy abnormal
Clinical narrative: Have had acid reflux for a long time, it has gotten worse so I got an EGD, at this time gastritis and esophagitis was discovered (I have had previous EGDs that were clear), based on my follow up questionnaire for the vaccine I was encouraged to report, probably NOT vaccine related but still an event I suppose
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: fever, body aches, swelling at sight of injection
Age: 43.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Had  MPOX vaccine on 1/5/2023 . Presents with FEVER AND RIGHT GROIN CELLULITIS.
Age: 69.0
Sex: M
Vaccine: COVID19-2, FLUN4
Symptoms: COVID-19, Cough, Headache, Lethargy, Oropharyngeal pain
Clinical narrative: My wife started having a slight headache, head congestion, sore throat and coughing. A few days later I started having the same symptoms three days later. I did a at home COVID-19 test and, I was positive. I did a telehealth visit and was given Paxlovid. All my symptoms went away I think the worse was a fever and a slight cough. The treatment did help. I am still having some congestion and lethargic.
Age: 69.0
Sex: M
Vaccine: COVID19-2, FLUN4
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: My wife started having a slight headache, head congestion, sore throat and coughing. A few days later I started having the same symptoms three days later. I did a at home COVID-19 test and, I was positive. I did a telehealth visit and was given Paxlovid. All my symptoms went away I think the worse was a fever and a slight cough. The treatment did help. I am still having some congestion and lethargic.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure diastolic increased, Dizziness
Clinical narrative: About seven months after receiving the third dose of Pfizer, I experienced spells of feeling dizzy. I went to the doctor when the dizzy spells became more frequent. After checking my blood pressure, he noticed that the diastolic number was very high. I have been on HCTZ since September 2022. The medication has been helping and my blood pressure is back to normal now.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Flushing, Hypertension, Lacrimation increased, Malaise
Clinical narrative: I received my vaccine and within minutes I felt unwell. My whole face flushed and hives, throat was itchy and felt bigger, runny nose, eyes watering and lightheadedness. I had an extremely high blood pressure, and I was unable to use my EPIPEN. The hospital and pharmacy were close to each other. I went to the emergency room for observation for the whole day. I had symptoms for over a month after that. My allergist said I should have used the EPIPEN anyway.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, Throat irritation, Urticaria
Clinical narrative: I received my vaccine and within minutes I felt unwell. My whole face flushed and hives, throat was itchy and felt bigger, runny nose, eyes watering and lightheadedness. I had an extremely high blood pressure, and I was unable to use my EPIPEN. The hospital and pharmacy were close to each other. I went to the emergency room for observation for the whole day. I had symptoms for over a month after that. My allergist said I should have used the EPIPEN anyway.
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient inadvertently received the Pfizer 5-11 yr old bivalent booster dose instead of the Pfizer >12 years old bivalent booster dose as recommended. No adverse reactions reported.