chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 09-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 09-Apr-2022) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milligram. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 09-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 09-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022.   The pharmacist reported that vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022. The vial had not undergone any temperature excursions. The pharmacist does not have any other information on the patients at that time and would call Moderna when additional information was known. The health care professional further stated to provide missed information and mentioned that 155 patients were vaccinated with expired doses from 02-Apr-2022 to 19-Apr-2022.  No treatment medications were reported.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refrigerator on 04-Apr-2022, vaccine administered on 12-Apr-2022) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination. No Medical History information was reported. On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refrigerator on 04-Apr-2022, vaccine administered on 12-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refrigerator on 04-Apr-2022, vaccine administered on 12-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment medication was provided. The vials were initially stored in refrigerator on 04-Apr-2022. The vial has not undergone temperature excursion. It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, However the vaccine expired on 01-Apr-2022.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 04-Apr-2022 and administrated on 18-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 04-Apr-2022 and administrated on 18-Apr-2022) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 04-Apr-2022 and administrated on 18-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 04-Apr-2022 and administrated on 18-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 04 Apr 2022, expired on 01 Apr 2022 and administered on 16 Apr 2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 04 Apr 2022, expired on 01 Apr 2022 and administered on 16 Apr 2022) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 04 Apr 2022, expired on 01 Apr 2022 and administered on 16 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 04 Apr 2022, expired on 01 Apr 2022 and administered on 16 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that the vial was stored in the refrigerator on 04-APR-2022. The vial did not undergo any temperature excursion. The pharmacist thought that the vaccine expire on Jun 2022, however it expired on 01 Apr 2022.   No treatment medications information was reported.   This case was linked to MOD-2022-551714 (Patient Link).
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 05-Apr-2022; Vaccine was expired on 01-Apr-2022 administered on 05-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 05-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 05-Apr-2022) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 05-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 05-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 05-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported   This case was linked to MOD-2022-551714 (Patient Link).
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 11-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 11-Apr-2022) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 11-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 11-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Apr-2022.  The pharmacist reported that vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022. The vial had not undergone any temperature excursions. The pharmacist does not have any other information on the patients at that time and would call Moderna when additional information was known. The health care professional further stated to provide missed information and mentioned that 155 patients were vaccinated with expired doses from 02-Apr-2022 to 19-Apr-2022. No treatment medications were reported.
Age: 84.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022) in an 84-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vial was initially refrigerated on 4 Apr 2022 and no temperature excursion happened.  No treatment medication was reported by reporter.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 19-Apr-2022; Expired vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 19-Apr-2022) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 19-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 19-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, However the vaccine expired on 01-Apr-2022. The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo temperature excursion.  No treatment medication was provided.
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The pharmacist thought that the vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022.  No adverse events were reported.  The vial did not undergo any temperature excursions.   No treatment medications were provided.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, when the vaccine received to pharmacy on 23-Feb-2022, the pharmacy staff member looked up the expiration date and came up with expiry date of June 2022. However, the correct expiry date for lot was 01-Apr-2022.  The vial was initially stored in refrigerator on 04-Apr-2022 and the vial did not undergo any temperature excursions.  No treatment information was reported
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 11-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 11-Apr-2022) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 11-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 11-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The pharmacist thought that the vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022.  No adverse events were reported.  The vial did not undergo any temperature excursions.   No treatment medications were provided.
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022; Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 08 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 08 Apr 2022) and PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 08 Apr 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 08 Apr 2022) and PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided Treatment medication was not provided by the reporter  It was reported that they thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022 Date the vial was initially stored in refrigerator was 04 Apr 2022. Vial had not undergone any temperature excursion.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022; Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 09 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 09 Apr 2022) and PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 09 Apr 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 09 Apr 2022) and PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that they thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022 Date the vial was initially stored in refrigerator was 04 Apr 2022. Vial had not undergone any temperature excursion.  Treatment medication was not provided by the reporter.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: I had a pneumonia shot (unspecified pneumonia shot)/I had no reaction with that other than the muscle on that arm, I got the shot and it (left arm) swelled for a couple of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), on 17Apr2022 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm. The patient's relevant medical history included: "AFib" (unspecified if ongoing), notes: Comments: AFib. The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "I had a pneumonia shot (unspecified pneumonia shot)/I had no reaction with that other than the muscle on that arm, I got the shot and it (left arm) swelled for a couple of days". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous Information: Updated suspect product coding.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Renal failure
Clinical narrative: renal failure; hard to catch my breath/SOB; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The following information was reported: RENAL FAILURE (medically significant), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "hard to catch my breath/SOB". Clinical course: The patient did not have Dyspnea, Tachypnea, COVID-pneumonia, Respiratory failure, Acute Respiratory Distress Syndrome, Cardiovascular, Heart failure, Cardiogenic shock, Arrhythmia, Myocarditis, Vomiting , Abdominal pain, Jaundice, Acute liver failure, Vascular, Deep vein thrombosis, Pulmonary embolism, Limb ischemia, Vasculitis, Renal, Acute kidney injury, Neurological, Altered consciousness: No, Convulsions/seizures Encephalopathy, Meningitis, Cerebrovascular accident, Hematological Thrombocytopenia, Disseminated intravascular coagulation, Dermatological, Chilblain, Erythema multiforme: No OTHER (e.g. multisystem inflammatory syndrome [MIS]: No and it was unknown the patient had Hypoxemia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Electric shock sensation, Feeling abnormal, Immunisation reaction, Insomnia
Clinical narrative: stated that she is half dead; stated that the symptoms that she is feeling are terrible; stated that she is not sleeping; stated that she is not eating; stated that her body is electrified; stated that there is something in the chemical that is not agreeing to her; had a very bad reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "stated that she is half dead"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "stated that the symptoms that she is feeling are terrible"; INSOMNIA (non-serious), outcome "unknown", described as "stated that she is not sleeping"; EATING DISORDER (non-serious), outcome "unknown", described as "stated that she is not eating"; ELECTRIC SHOCK SENSATION (non-serious), outcome "unknown", described as "stated that her body is electrified"; PRODUCT FORMULATION ISSUE (non-serious), outcome "unknown", described as "stated that there is something in the chemical that is not agreeing to her"; VACCINATION COMPLICATION (non-serious), outcome "unknown", described as "had a very bad reaction". Reason for no lot number of Pfizer Covid vaccine: Complainant hung up abruptly/transfer incomplete.  Clinical course: Warm transfer from agent (name Withheld) Pfizer (name withheld), no CEP provided has a caller who had a very bad reaction to the Pfizer Covid vaccine. Stated that she is half dead. Wanted to speak with someone who knows what they are doing. Stated that she is recording the call. Stated that they were racially profiling and discriminating her. Stated that Pfizer called her. Stated that she is a joke to them. Stated that the nurse (Name withheld) hung up. Stated that the symptoms that she is feeling are terrible, is not sleeping, is not eating and her is body electrified. Stated that there is something in the chemical that is not agreeing to her. Stated that she is pissed off at Pfizer that called at 8:00am for a survey. Stated that they are not offering people anything. Caller rambling on. Unable to speak due to caller rambling on. Unable to clarify details. Caller started to use profanity. Caller told agent  to be quiet so that she can tell how bad the situation is.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Near death experience, Product formulation issue
Clinical narrative: stated that she is half dead; stated that the symptoms that she is feeling are terrible; stated that she is not sleeping; stated that she is not eating; stated that her body is electrified; stated that there is something in the chemical that is not agreeing to her; had a very bad reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "stated that she is half dead"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "stated that the symptoms that she is feeling are terrible"; INSOMNIA (non-serious), outcome "unknown", described as "stated that she is not sleeping"; EATING DISORDER (non-serious), outcome "unknown", described as "stated that she is not eating"; ELECTRIC SHOCK SENSATION (non-serious), outcome "unknown", described as "stated that her body is electrified"; PRODUCT FORMULATION ISSUE (non-serious), outcome "unknown", described as "stated that there is something in the chemical that is not agreeing to her"; VACCINATION COMPLICATION (non-serious), outcome "unknown", described as "had a very bad reaction". Reason for no lot number of Pfizer Covid vaccine: Complainant hung up abruptly/transfer incomplete.  Clinical course: Warm transfer from agent (name Withheld) Pfizer (name withheld), no CEP provided has a caller who had a very bad reaction to the Pfizer Covid vaccine. Stated that she is half dead. Wanted to speak with someone who knows what they are doing. Stated that she is recording the call. Stated that they were racially profiling and discriminating her. Stated that Pfizer called her. Stated that she is a joke to them. Stated that the nurse (Name withheld) hung up. Stated that the symptoms that she is feeling are terrible, is not sleeping, is not eating and her is body electrified. Stated that there is something in the chemical that is not agreeing to her. Stated that she is pissed off at Pfizer that called at 8:00am for a survey. Stated that they are not offering people anything. Caller rambling on. Unable to speak due to caller rambling on. Unable to clarify details. Caller started to use profanity. Caller told agent  to be quiet so that she can tell how bad the situation is.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Palpitations
Clinical narrative: About 3 wks after 2nd dose felt extreme increas in frequency, duration and intensity of arrhythmias; Heart thumping  kept me awake; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "osteoporosis/osteopenia" (unspecified if ongoing); "infrequent SVT" (unspecified if ongoing); "Mild PVCs PACs" (unspecified if ongoing); "known allergies; Contrast dye, sulfa" (unspecified if ongoing); "known allergies; Contrast dye, sulfa" (unspecified if ongoing). Concomitant medication(s) included: ACEBUTOLOL; ALENDRONATE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 04Mar2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9267, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 11Feb2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: ARRHYTHMIA (medically significant), outcome "recovering", described as "About 3 wks after 2nd dose felt extreme increas in frequency, duration and intensity of arrhythmias"; PALPITATIONS (non-serious), outcome "recovering", described as "Heart thumping kept me awake". The events "about 3 wks after 2nd dose felt extreme increas in frequency, duration and intensity of arrhythmias" and "heart thumping kept me awake" required physician office visit. Therapeutic measures were not taken as a result of arrhythmia, palpitations. Clinical information: There was no other vaccine in four weeks. Other medications in two weeks was Acebutolol, Alendronate. I've had mild PVCs, PACs and 3 occasions of SVT in the past 30 yrs. so on Acebutolol. About 3 wks. after 2nd dose felt extreme increase in frequency, duration and intensity of arrhythmias. Heart thumping kept me awake. Abated some by 6 mos when I got 3rd. 15 days later it all started again. Abating some now but still more frequent and intense than before shots. There was no covid prior vaccination. There was no covid tested post vaccination. Known allergies was Contrast dye, sulfa. Other medical history included Mild PVCs PACs, infrequent SVT, osteoporosis/osteopenia.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient experienced:COVID; patient experienced:COVID/ Double pneumonia; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): LRN3451164.  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "relapsing-remitting MS" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; VITAMIN D [VITAMIN D NOS]. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03Feb2022, outcome "recovered", described as "patient experienced:COVID"; COVID-19 (medically significant) with onset 03Feb2022, outcome "recovered", described as "patient experienced:COVID/ Double pneumonia". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Feb2022) Positive, notes: patient experienced: COVID.  Clinical Course: On 24Mar, patient started therapy with COVID-19 vaccine for relapsing-remitting MS. On 03Feb2022, it was reported that patient experienced: COVID, Double pneumonia  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, drug ineffective and the administration of the vaccine cannot be excluded.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Retested with a home antigen test and came up positive for Covid. Retested again an hour later to make sure and came up positive; Retested with a home antigen test and came up positive for Covid. Retested again an hour later to make sure and came up positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: other medical history: High blood pressure; "Cholesterol" (unspecified if ongoing), notes: other medical history: cholesterol. Other medication in 2 weeks concomitant medication(s) included: LOSARTAN. The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Known allergies: None. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Apr2022 at 15:00, outcome "unknown", COVID-19 (medically significant) with onset 25Apr2022 at 15:00, outcome "recovering" and all described as "Retested with a home antigen test and came up positive for Covid. Retested again an hour later to make sure and came up positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Apr2022) Negative; (22Apr2022) Negative; (25Apr2022) Positive, notes: retested with a home antigen test and came up positive for Covid. Therapeutic measures were not taken as a result of drug ineffective, covid-19. It was reported that, on Thursday 21Apr felt much better and took home antigen test which showed negative for Covid. Retested on Friday again showed negative. On Monday 25Apr developed a scratchy throat and cough late in the day retested with a home antigen test and came up positive for Covid. Retested again an hour later to make sure and came up positive. Anti viral details: product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 15Apr2022, Treatment stop date: 20Apr2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Deep vein thrombosis
Clinical narrative: deep vein thrombosis in leg; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4369015-00.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Manufacturer: Pfizer Biontech Covid-19 Vaccine, Route of Administration: Intramuscular), administration date: 09Feb2021, when the patient was 65-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 1, SINGLE, Manufacturer: Pfizer Biontech Covid-19 Vaccine, Route of Administration: Intramuscular), administration date: 19Jan2021, when the patient was 65-year-old, for Covid-19 Immunization. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "deep vein thrombosis in leg". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of deep vein thrombosis. The patient was treated with Xarelto. Patient was on was on blood thinner. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of DEEP VEIN THROMBOSIS IN LEG with HUMIRA(ADALIMUMAB) was a reasonable possibility.  The reporter's assessment of the causal relationship of "deep vein thrombosis in leg" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event DEEP VEIN THROMBOSIS and the suspect drug BNT162B2.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Eye swelling, Fatigue, Lethargy, Ocular hyperaemia
Clinical narrative: feel tired; lethargic; left eye is puffy underneath/his left eye is real puffy underneath; eye is red and irritated; eye is red and irritated; arm is still sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "feel tired"; LETHARGY (non-serious), outcome "unknown", described as "lethargic"; EYE SWELLING (non-serious), outcome "unknown", described as "left eye is puffy underneath/his left eye is real puffy underneath"; OCULAR HYPERAEMIA (non-serious), EYE IRRITATION (non-serious), outcome "unknown" and all described as "eye is red and irritated"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm is still sore".  Additional information: He reported receiving the 2nd booster on Monday, he had no problems with previous s shots. Caller said that he was trying to figure out what was going on. Caller stated that he has been looking over the sheet they gave him. Caller said he felt tired, lethargic, his left eye was real puffy underneath and also red and irritated, and his arm was still sore. Asked if these were side effects or what? He did not feel sick. Caller was unsure whether he received the purple or grey capped COVID vaccine. This report was non-serious.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: feel tired; lethargic; left eye is puffy underneath/his left eye is real puffy underneath; eye is red and irritated; eye is red and irritated; arm is still sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "feel tired"; LETHARGY (non-serious), outcome "unknown", described as "lethargic"; EYE SWELLING (non-serious), outcome "unknown", described as "left eye is puffy underneath/his left eye is real puffy underneath"; OCULAR HYPERAEMIA (non-serious), EYE IRRITATION (non-serious), outcome "unknown" and all described as "eye is red and irritated"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm is still sore".  Additional information: He reported receiving the 2nd booster on Monday, he had no problems with previous s shots. Caller said that he was trying to figure out what was going on. Caller stated that he has been looking over the sheet they gave him. Caller said he felt tired, lethargic, his left eye was real puffy underneath and also red and irritated, and his arm was still sore. Asked if these were side effects or what? He did not feel sick. Caller was unsure whether he received the purple or grey capped COVID vaccine. This report was non-serious.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: fever; did not feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "and did not give correctly"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "and did not give correctly".  The following information was reported: MALAISE (non-serious) with onset Nov2021, outcome "unknown", described as "did not feel well"; PYREXIA (non-serious) with onset Nov2021, outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.