chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dyspnoea, Feeling abnormal, Nausea
Clinical narrative: Feeling lousy; Increased shortness of breath; Feeling nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling lousy), DYSPNOEA (Increased shortness of breath) and NAUSEA (Feeling nausea) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TADALAFIL and RIVAROXABAN (XARELTO) for an unknown indication.   On 01-Oct-2021, the patient started TREPROSTINIL SODIUM (TYVASO) (unknown route) 18 microgram four times per day. On 06-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling lousy) and DYSPNOEA (Increased shortness of breath). an unknown date, the patient experienced NAUSEA (Feeling nausea). At the time of the report, FEELING ABNORMAL (Feeling lousy), DYSPNOEA (Increased shortness of breath) and NAUSEA (Feeling nausea) outcome was unknown.            no treatment medications were reported.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 12 hours of vial puncture/Dose administered after being more than 24 hours at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture/Dose administered after being more than 24 hours at room temperature) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture/Dose administered after being more than 24 hours at room temperature). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture/Dose administered after being more than 24 hours at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.  The vial was exposed to room temperature range (8 degrees Celsius to 25 degrees Celsius/46 degree Fahrenheit to 77 degree Fahrenheit) for around 30 hours. On 12-Oct-2021 at 8 A.M, the vials were taken out of the fridge to room temperature. The vial did not undergo any temperature excursion.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Have so much side effects in vaccine/tore up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Have so much side effects in vaccine/tore up) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Have so much side effects in vaccine/tore up). At the time of the report, VACCINATION COMPLICATION (Have so much side effects in vaccine/tore up) outcome was unknown.      No concomitant medications reported.  No treatment medications reported.  It was reported that, patient had to stay home for 4 days that's 2 weeks.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04713211A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medication was provided. No treatment  was provided.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Vicodin Allergy) and Drug allergy (Lexapro Allergy).   On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) to be not related.    No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ultram), Drug allergy (Codeine) and Drug allergy (Bactrim).    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 10-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter.  Patient received vaccination in deltoid.  No known food allergies reported.  No Treatment Information was provided by the reporter.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Paracetamol.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period). On 27-Aug-2021, PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) to be not related.    No concomitant medication was reported.  Allergies to food medications and other products.  Patient received the injection in deltoid.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyond 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period) to be not related.    The patient received the vaccine at deltoid.  No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 23-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008021A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information provided. No treatment medication information provided.   This case was linked to MOD-2021-313106 (Patient Link).; Sender's Comments: This case concerns a 29 year old female with no reported history who experienced the non-serious, unlisted event of Expired product administered on the day of the first dose of mRNA-1273. Re-challenge is not applicable. Benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine given beyond 30 days of refrigeration period; Vaccine given beyond 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyond 30 days of refrigeration period) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Cefdinir).   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyond 30 days of refrigeration period). On 23-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyond 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details not provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-313106 (Patient Link).
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) to be not related.    No treatment and concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 03-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided. Anatomical location for the suspect administration were deltoid.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy, Food allergy (Plum), Drug allergy (Sulpha allergy) and Food allergy (Pepper allergy).    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 21-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient other medical history includes allergy.  No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0471321A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (CODANE), Drug allergy (DANES DEMEROL) and Tetanus.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided   This case was linked to MOD-2021-313106 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008CZIA) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided . No treatment medication was provided .   This case was linked to MOD-2021-313106 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Naproxen) and Drug allergy (Ibuprofen).    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period). On 22-Aug-2021, PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) to be not related.    No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   This case was linked to MOD-2021-313106 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008021A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Reglan).    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 22-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported,   This case was linked to MOD-2021-313106 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided by the reporter. No treatment information provided.   This case was linked to MOD-2021-313106 (Patient Link).
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: itchy hives on neck; itchy hives; This case was reported by a consumer and described the occurrence of hives in a 53-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date and experienced sore arm, refer case US2021AMR215015).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced hives and pruritus. On an unknown date, the outcome of the hives and pruritus were recovering/resolving.   It was unknown if the reporter considered the hives and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. Patient received second dose of shingles vaccine a few days ago about 2.5 months after the first dose and experienced more significant issues like extremely itchy hives on neck. The patient could not wait for them to go away.  The hoped that it's not a recurring issue. It started going away yesterday, and was even better on the day of reporting. The patient never had hives before and had not been exposed to any strange environmental situations.  The patient did not wore cologne or put any chemicals on his/her body.  The patient reported that it seemed like it's going to be completely fine in another couple of days; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR215015:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: awful, very hard on the body; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and felt awful. The patient also stated that be careful of these shots, they were very hard on the body. The follow-up would not possible as no contact details were available. This is one of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR215057:same patient diferent dose US-GLAXOSMITHKLINE-US2021AMR215055:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Vaccine positive rechallenge
Clinical narrative: awful, very hard on the body; This case was reported by a consumer and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (feels awful- refer caseUS2021AMR215043, US2021AMR215057).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.   Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and felt awful. The patient also stated that be careful of these shots, they were very hard on the body. The follow-up would not possible as no contact details were available. This is one of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR215057:same patient diferent dose US-GLAXOSMITHKLINE-US2021AMR215043:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got shingles vaccine 5 yrs ago and never got a second shot; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 5 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient never get  2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: cannot remember if they received vaccine; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 4 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient could not remember if received shingrix vaccine 4 years ago and the provider did not have any record. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked Would it be safe to repeat the two dose series.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Rash pruritic, Rash vesicular
Clinical narrative: Herpes Zoster like rash; raised itchy; itchy rash; This case was reported by a nurse via call center representative and described the occurrence of vesicular rash in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 4N2AB, expiry date 10th February 2023) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix. On 13th August 2021, less than a week after receiving Shingrix, the patient experienced vesicular rash, raised rash and itchy rash. On 18th October 2021, the outcome of the vesicular rash, raised rash and itchy rash were recovered/resolved.   It was unknown if the reporter considered the vesicular rash, raised rash and itchy rash to be related to Shingrix.  Additional details were reported as follows; This case was reported by the nurse. The age at vaccination was not reported.  The adverse event was reported via afterhours voicemail box, exact date of Shingrix vaccination was unknown, reporter just stated "2 months ago" on the recording. The nurse stated that the patient experienced raised itchy bumps, approximately 6 bumps near injection site, herpes zoster like rash 4-5 days following Shingrix vaccine 2 months ago, no systemic effects, fever or illness. No additional details were available. The reporter consented for follow-up. This case linked with US2021215524, US2021215511, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215524:same reporter US-GLAXOSMITHKLINE-US2021215511:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Herpes Zoster like rash; raised itchy; itchy rash; This case was reported by a nurse via call center representative and described the occurrence of vesicular rash in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 4N2AB, expiry date 10th February 2023) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix. On 13th August 2021, less than a week after receiving Shingrix, the patient experienced vesicular rash, raised rash and itchy rash. On 18th October 2021, the outcome of the vesicular rash, raised rash and itchy rash were recovered/resolved.   It was unknown if the reporter considered the vesicular rash, raised rash and itchy rash to be related to Shingrix.  Additional details were reported as follows; This case was reported by the nurse. The age at vaccination was not reported.  The adverse event was reported via afterhours voicemail box, exact date of Shingrix vaccination was unknown, reporter just stated "2 months ago" on the recording. The nurse stated that the patient experienced raised itchy bumps, approximately 6 bumps near injection site, herpes zoster like rash 4-5 days following Shingrix vaccine 2 months ago, no systemic effects, fever or illness. No additional details were available. The reporter consented for follow-up. This case linked with US2021215524, US2021215511, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215524:same reporter US-GLAXOSMITHKLINE-US2021215511:same reporter
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient received by error a third dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 7GM34, expiry date 10th February 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in February 2021) and Shingrix (received 2nd dose in May 2021).   On 10th October 2021, the patient received the 3rd dose of Shingrix. On 10th October 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received by error a Shingrix third dose, which led to extra dose administered. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted lyophilized powder with normal saline and administered; reconstituted lyophilized powder with normal saline and administered; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number K7K23, expiry date 3rd February 2023) for prophylaxis.   On 16th October 2021, the patient received the 1st dose of Shingrix. On 16th October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The pharmacy reconstituted Shingrix lyophilized powder with normal saline and inadvertently administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Illness, Incomplete course of vaccination
Clinical narrative: Shingles after dose 1; Sick after first dose; 2nd dose has not been administered yet; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, sickness and incomplete course of vaccination. On an unknown date, the outcome of the shingles, sickness and incomplete course of vaccination were unknown.   The reporter considered the shingles and sickness to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that the patient received dose of Shinngrix vaccine and felt sick (unknown cause) and experienced shingles.  The patient did not receive the 2nd dose till the time of reporting, which led to incomplete course of vaccination. It was unknown what symptoms the patient experienced. The reporter did not have additional information during the call. The reporter did not what kind of sick the patient was or what symptoms the patient had. The reporter consented to follow-up via postal mail. The reporter not believed that the Shingrix caused the patient's symptoms.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000197749.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Illness, Pyrexia
Clinical narrative: Felt bad; Temperature has been 101.6°F; Sick; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad), ILLNESS (Sick) and PYREXIA (Temperature has been 101.6°F) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A, 032B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Dialysis. Concurrent medical conditions included Immune system disorder.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced FEELING ABNORMAL (Felt bad) and PYREXIA (Temperature has been 101.6°F). In October 2021, the patient experienced ILLNESS (Sick). At the time of the report, FEELING ABNORMAL (Felt bad), ILLNESS (Sick) and PYREXIA (Temperature has been 101.6°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2021, Body temperature: 101.6°f (High) since 6am.         No concomitant medication information was mentioned by reporter  Patient take around 40 medications for several heath conditions, including immune diseases.  Treatment medication was not reported.  Patient states they were recently in the hospital to have their bladder removed (10Sep2021), and had an infection with a bacteria from taking a lot of antibiotics.  Company Comment: This case concerns a 63-year-old female patient with no relevant medical history, who experienced the serious unexpected event of bladder disorder. The event occurred 176 days after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-356595 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Depression, Gait inability, Impaired work ability
Clinical narrative: Anxiety; Depression; Patient was unable to work because of the symptoms; Horrible fever; Chills; Neuropathy; Pins and needles/paresthesia; Not being able to walk; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020f21a and 052e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), PARAESTHESIA (Pins and needles/paresthesia), GAIT INABILITY (Not being able to walk), PYREXIA (Horrible fever) and CHILLS (Chills). On an unknown date, the patient experienced ANXIETY (Anxiety), DEPRESSION (Depression) and IMPAIRED WORK ABILITY (Patient was unable to work because of the symptoms). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), ANXIETY (Anxiety), DEPRESSION (Depression), PARAESTHESIA (Pins and needles/paresthesia), GAIT INABILITY (Not being able to walk), IMPAIRED WORK ABILITY (Patient was unable to work because of the symptoms), PYREXIA (Horrible fever) and CHILLS (Chills) had not resolved.            Concomitant product not reported  Treatment medications also included unspecified depression and anxiety medications  Noted discrepancy in Date of Birth (19-AUG-1997) and Age at time of onset of reaction/event - 34  Company comment: This case concerns a  24-year-old, female patient with no relevant medical history, who experienced the unexpected events of Neuropathy peripheral, Paraesthesia, Gait Inability and the expected events Pyrexia and Chills approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The events Anxiety, Depression and Impaired wor ability occurred on an unknown date. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a  24-year-old, female patient with no relevant medical history, who experienced the unexpected events of Neuropathy peripheral, Paraesthesia, Gait Inability and the expected events Pyrexia and Chills approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The events Anxiety, Depression and Impaired wor ability occurred on an unknown date. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.