chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines administered at our pharmacies that were stored in an unapproved freezer; vaccines administered at our pharmacies that were stored in an unapproved freezer; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vaccines administered at our pharmacies that were stored in an unapproved freezer) and EXPIRED PRODUCT ADMINISTERED (vaccines administered at our pharmacies that were stored in an unapproved freezer) 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 24-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines administered at our pharmacies that were stored in an unapproved freezer). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines administered at our pharmacies that were stored in an unapproved freezer). At the time of the report, PRODUCT STORAGE ERROR (vaccines administered at our pharmacies that were stored in an unapproved freezer) and EXPIRED PRODUCT ADMINISTERED (vaccines administered at our pharmacies that were stored in an unapproved freezer) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reporter had a group of 13 pharmacies and have administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. Approved date or the vaccine is 01Nov and BUD is 01Dec. No treatment information was provided.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 3 incidents in clinic where 3 minors were given Moderna Covid-19 vaccine booster doses (0.25mL).; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 incidents in clinic where 3 minors were given Moderna Covid-19 vaccine booster doses (0.25mL).) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer (2nd dose) and Pfizer (1st dose). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 incidents in clinic where 3 minors were given Moderna Covid-19 vaccine booster doses (0.25mL).). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 incidents in clinic where 3 minors were given Moderna Covid-19 vaccine booster doses (0.25mL).) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Tremor
Clinical narrative: Tremors after first primary shot/Tremors never went away after first shot; Nervous system was affected after first primary shot; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremors after first primary shot/Tremors never went away after first shot) and NERVOUS SYSTEM DISORDER (Nervous system was affected after first primary shot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0391-2A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included PIROXICAM (PAXIL [PIROXICAM]) and ATORVASTATIN for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced TREMOR (Tremors after first primary shot/Tremors never went away after first shot) and NERVOUS SYSTEM DISORDER (Nervous system was affected after first primary shot). The patient was treated with PRIMIDONE for Tremor, at an unspecified dose and frequency. At the time of the report, TREMOR (Tremors after first primary shot/Tremors never went away after first shot) had not resolved and NERVOUS SYSTEM DISORDER (Nervous system was affected after first primary shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient stated that the Tremors never went away.HCP prescribed primidone for tremors but that did not help to patient.   This case was linked to MOD-2022-572262, MOD-2022-572224, MOD-2022-572261 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Malaise, Myalgia, Pain
Clinical narrative: Moderna was bad and the  Moderna gave him bad aches for two days; whole body aches; tired; not feeling good; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Moderna was bad and the  Moderna gave him bad aches for two days), MYALGIA (whole body aches), FATIGUE (tired) and MALAISE (not feeling good) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for COVID-19 vaccination.    No Medical History information was reported.   On 18-May-2022, the patient received fourth dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, received first dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced FATIGUE (tired) and MALAISE (not feeling good). On 19-May-2022, the patient experienced MYALGIA (whole body aches). On an unknown date, the patient experienced PAIN (Moderna was bad and the  Moderna gave him bad aches for two days). At the time of the report, PAIN (Moderna was bad and the  Moderna gave him bad aches for two days) had resolved, MYALGIA (whole body aches) and FATIGUE (tired) had not resolved and MALAISE (not feeling good) outcome was unknown.            No concomitant medications were reported. It was reported that he had his 2nd booster dose and he had body aches and was tired.  He took Pfizer vaccine when it was first coming out and he never felt anything with the first two vaccines.  The only side effect he was having was whole body aches and he was tired. Patient started feeling his body aching on 19-May-2022, it was more intense. Patient did not want it to go into the second day. It was reported that patient's first booster was Moderna vaccine. All along he was saying, the Moderna was bad and the Moderna gave him bad aches for two days but was getting the same with the Pfizer vaccine. It was also reported that it may be because he took the vaccines months ago and they were in his system, because the first two he had nothing. No treatment medications were reported by the reporter.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: Moderna was bad and the  Moderna gave him bad aches for two days; whole body aches; tired; not feeling good; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Moderna was bad and the  Moderna gave him bad aches for two days), MYALGIA (whole body aches), FATIGUE (tired) and MALAISE (not feeling good) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for COVID-19 vaccination.    No Medical History information was reported.   On 18-May-2022, the patient received fourth dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, received first dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced FATIGUE (tired) and MALAISE (not feeling good). On 19-May-2022, the patient experienced MYALGIA (whole body aches). On an unknown date, the patient experienced PAIN (Moderna was bad and the  Moderna gave him bad aches for two days). At the time of the report, PAIN (Moderna was bad and the  Moderna gave him bad aches for two days) had resolved, MYALGIA (whole body aches) and FATIGUE (tired) had not resolved and MALAISE (not feeling good) outcome was unknown.            No concomitant medications were reported. It was reported that he had his 2nd booster dose and he had body aches and was tired.  He took Pfizer vaccine when it was first coming out and he never felt anything with the first two vaccines.  The only side effect he was having was whole body aches and he was tired. Patient started feeling his body aching on 19-May-2022, it was more intense. Patient did not want it to go into the second day. It was reported that patient's first booster was Moderna vaccine. All along he was saying, the Moderna was bad and the Moderna gave him bad aches for two days but was getting the same with the Pfizer vaccine. It was also reported that it may be because he took the vaccines months ago and they were in his system, because the first two he had nothing. No treatment medications were reported by the reporter.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Malaise, Myalgia, Pain
Clinical narrative: he has been having body aches/bad aches; tired; not feeling good; 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 64-year-old male patient received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (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, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), administration date: 2022, for COVID-19 Immunization, reaction(s): bad aches. The following information was reported: PAIN (non-serious) with onset 19May2022, outcome unknown, described as "he has been having body aches/bad aches; MALAISE (non-serious) with onset 19May2022, outcome unknown, described as not feeling good; FATIGUE (non-serious) with onset 19May2022, outcome unknown, described as tired.  Additional information: Reporter was a 64-year-old male consumer/patient who was calling about side effects from the Pfizer COVID-19 2nd booster dose. Reporter stated he had Moderna as his 1st COVID-19 booster. Reporter stated he had his 2nd booster dose yesterday and this morning he had been suffered from body aches and was tired. Reporter states that he didn't feel any side effects with his first 2 Pfizer COVID-19 vaccines, but he did now after the 2nd booster. Reporter enquired can he took Tylenol and there was something which he took that help him to recover from side effects. Reporter calling that had booster yesterday, his fourth vaccination, second booster. The first times he took Pfizer vaccine when it was first coming out and he never felt anything with the first two vaccines. Today he started feeling his body aching, it's more intense now. There has to be something he can do like drink water, orange juice, take vitamins, and go walking around. He didn't want it to go into the second day. All along he was saying the Moderna was bad and the Moderna gave him bad aches for two days, but now he is getting the same with the Pfizer vaccine. Maybe it was because he took the vaccines months ago and they were in his system because the first two he had nothing. The information on the batch/lot number for BNT162b2 had been requested and it had been submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: he has been having body aches/bad aches; tired; not feeling good; 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 64-year-old male patient received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (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, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), administration date: 2022, for COVID-19 Immunization, reaction(s): bad aches. The following information was reported: PAIN (non-serious) with onset 19May2022, outcome unknown, described as "he has been having body aches/bad aches; MALAISE (non-serious) with onset 19May2022, outcome unknown, described as not feeling good; FATIGUE (non-serious) with onset 19May2022, outcome unknown, described as tired.  Additional information: Reporter was a 64-year-old male consumer/patient who was calling about side effects from the Pfizer COVID-19 2nd booster dose. Reporter stated he had Moderna as his 1st COVID-19 booster. Reporter stated he had his 2nd booster dose yesterday and this morning he had been suffered from body aches and was tired. Reporter states that he didn't feel any side effects with his first 2 Pfizer COVID-19 vaccines, but he did now after the 2nd booster. Reporter enquired can he took Tylenol and there was something which he took that help him to recover from side effects. Reporter calling that had booster yesterday, his fourth vaccination, second booster. The first times he took Pfizer vaccine when it was first coming out and he never felt anything with the first two vaccines. Today he started feeling his body aching, it's more intense now. There has to be something he can do like drink water, orange juice, take vitamins, and go walking around. He didn't want it to go into the second day. All along he was saying the Moderna was bad and the Moderna gave him bad aches for two days, but now he is getting the same with the Pfizer vaccine. Maybe it was because he took the vaccines months ago and they were in his system because the first two he had nothing. The information on the batch/lot number for BNT162b2 had been requested and it had been submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Tremor
Clinical narrative: Tremors continued with the same intensity after subsequent shots; First dose on 20JAN2021 and 2nd shot on 07FEB2021; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremors continued with the same intensity after subsequent shots) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 20JAN2021 and 2nd shot on 07FEB2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032120A and 0391-2A) for COVID-19 vaccination.     Family history included Parkinson's disease (Father had Parkinson's disease) since an unknown date. Concomitant products included PIROXICAM (PAXIL [PIROXICAM]) and ATORVASTATIN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced TREMOR (Tremors continued with the same intensity after subsequent shots) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 20JAN2021 and 2nd shot on 07FEB2021). The patient was treated with PRIMIDONE for Prevention, at an unspecified dose and frequency. At the time of the report, TREMOR (Tremors continued with the same intensity after subsequent shots) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 20JAN2021 and 2nd shot on 07FEB2021) outcome was unknown.            After the very first primary shot, patient started having tremors, and her nervous System was affected. She stated that the tremors never went away. It continued with the same intensity after subsequent shots.  Recently she was diagnosed with Parkinson's Disease, but not started on any medications.  Primidone did not help for tremors.   This case was linked to MOD-2022-572262, MOD-2022-572193, MOD-2022-572261 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Parkinson's disease
Clinical narrative: Tremors continued with the same intensity after subsequent shots; First dose on 20JAN2021 and 2nd shot on 07FEB2021; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremors continued with the same intensity after subsequent shots) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 20JAN2021 and 2nd shot on 07FEB2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032120A and 0391-2A) for COVID-19 vaccination.     Family history included Parkinson's disease (Father had Parkinson's disease) since an unknown date. Concomitant products included PIROXICAM (PAXIL [PIROXICAM]) and ATORVASTATIN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced TREMOR (Tremors continued with the same intensity after subsequent shots) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 20JAN2021 and 2nd shot on 07FEB2021). The patient was treated with PRIMIDONE for Prevention, at an unspecified dose and frequency. At the time of the report, TREMOR (Tremors continued with the same intensity after subsequent shots) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 20JAN2021 and 2nd shot on 07FEB2021) outcome was unknown.            After the very first primary shot, patient started having tremors, and her nervous System was affected. She stated that the tremors never went away. It continued with the same intensity after subsequent shots.  Recently she was diagnosed with Parkinson's Disease, but not started on any medications.  Primidone did not help for tremors.   This case was linked to MOD-2022-572262, MOD-2022-572193, MOD-2022-572261 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Tremors continued with the same intensity after subsequent shots; First dose on 20JAN2021 and 2nd shot on 07FEB2021; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremors continued with the same intensity after subsequent shots) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 20JAN2021 and 2nd shot on 07FEB2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032120A and 0391-2A) for COVID-19 vaccination.     Family history included Parkinson's disease (Father had Parkinson's disease) since an unknown date. Concomitant products included PIROXICAM (PAXIL [PIROXICAM]) and ATORVASTATIN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced TREMOR (Tremors continued with the same intensity after subsequent shots) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 20JAN2021 and 2nd shot on 07FEB2021). The patient was treated with PRIMIDONE for Prevention, at an unspecified dose and frequency. At the time of the report, TREMOR (Tremors continued with the same intensity after subsequent shots) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 20JAN2021 and 2nd shot on 07FEB2021) outcome was unknown.            After the very first primary shot, patient started having tremors, and her nervous System was affected. She stated that the tremors never went away. It continued with the same intensity after subsequent shots.  Recently she was diagnosed with Parkinson's Disease, but not started on any medications.  Primidone did not help for tremors.   This case was linked to MOD-2022-572262, MOD-2022-572193, MOD-2022-572261 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Tremor
Clinical narrative: Tremors continued with the same intensity after subsequent shots; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremors continued with the same intensity after subsequent shots) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03910-2A, 032120A and 0391-2A) for COVID-19 vaccination.     Family history included Parkinson's disease (her Father had Parkinson's disease). Concomitant products included PIROXICAM (PAXIL [PIROXICAM]) and ATORVASTATIN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (Tremors continued with the same intensity after subsequent shots). The patient was treated with PRIMIDONE for Tremor, at an unspecified dose and frequency. At the time of the report, TREMOR (Tremors continued with the same intensity after subsequent shots) had not resolved.     Treatment medication primidone was prescribed for tremors but it did not help.   This case was linked to MOD-2022-572262, MOD-2022-572193, MOD-2022-572224 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Parkinson's disease
Clinical narrative: Tremors continued with the same intensity after subsequent shots; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremors continued with the same intensity after subsequent shots) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03910-2A, 032120A and 0391-2A) for COVID-19 vaccination.     Family history included Parkinson's disease (her Father had Parkinson's disease). Concomitant products included PIROXICAM (PAXIL [PIROXICAM]) and ATORVASTATIN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (Tremors continued with the same intensity after subsequent shots). The patient was treated with PRIMIDONE for Tremor, at an unspecified dose and frequency. At the time of the report, TREMOR (Tremors continued with the same intensity after subsequent shots) had not resolved.     Treatment medication primidone was prescribed for tremors but it did not help.   This case was linked to MOD-2022-572262, MOD-2022-572193, MOD-2022-572224 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Tremors continued with the same intensity after subsequent shots; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremors continued with the same intensity after subsequent shots) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03910-2A, 032120A and 0391-2A) for COVID-19 vaccination.     Family history included Parkinson's disease (her Father had Parkinson's disease). Concomitant products included PIROXICAM (PAXIL [PIROXICAM]) and ATORVASTATIN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (Tremors continued with the same intensity after subsequent shots). The patient was treated with PRIMIDONE for Tremor, at an unspecified dose and frequency. At the time of the report, TREMOR (Tremors continued with the same intensity after subsequent shots) had not resolved.     Treatment medication primidone was prescribed for tremors but it did not help.   This case was linked to MOD-2022-572262, MOD-2022-572193, MOD-2022-572224 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1 patient was administered expired vaccine on 07-Apr-2022, CDC expiration was 02-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 07-Apr-2022, CDC expiration was 02-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 07-Apr-2022, CDC expiration was 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 07-Apr-2022, CDC expiration was 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Treatment of COVID-19 on 10-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Treatment of COVID-19 on 10-May-2022) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002m21a, 076c31a, 029l20A and 037k20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Motrim).   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Treatment of COVID-19 on 10-May-2022). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 15-May-2022 for COVID-19 vaccination, at an unspecified dose and frequency. At the time of the report, COVID-19 (Treatment of COVID-19 on 10-May-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 indication provided for Paxlovid was Treatment of COVID-19.  company comment: This spontaneous case concerns a 59-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 which occurred unspecified days after and after the fourth dose mRNA-1273 vaccine. Patient was administered with NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID-19 for 5 days. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 59-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 which occurred unspecified days after and after the fourth dose mRNA-1273 vaccine. Patient was administered with NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID-19 for 5 days. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine expired on 03-May-2022 and vaccine administered on 04-MAY-2022; Moderna COVID-19 vaccine that expired on 3MAY2022 was administered to 3 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that expired on 3MAY2022 was administered to 3 patients) and PRODUCT STORAGE ERROR (The vaccine expired on 03-May-2022 and vaccine administered on 04-MAY-2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 038K20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that expired on 3MAY2022 was administered to 3 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired on 03-May-2022 and vaccine administered on 04-MAY-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that expired on 3MAY2022 was administered to 3 patients) and PRODUCT STORAGE ERROR (The vaccine expired on 03-May-2022 and vaccine administered on 04-MAY-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. The vial was initially stored in the refrigerator :21-Apr-2022. The vial didn't undergone any temperature excursion. No treatment medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1 patient was administered expired vaccine on 08-Apr-2022, CDC expiration was 02-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 08-Apr-2022, CDC expiration was 02-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 08-Apr-2022, CDC expiration was 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 08-Apr-2022, CDC expiration was 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Reporter stated that they have reviewed historical storage records and can verify they were properly stored the entire duration of time on site. The vaccines were removed from the freezer on the day of each respective immunization. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1 patient was administered expired vaccine on 11-Apr-2022, expiration was 02-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 11-Apr-2022, expiration was 02-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 11-Apr-2022, expiration was 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 11-Apr-2022, expiration was 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1 patient was administered expired vaccine on 13-Apr-2022, expiration was 02-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 13-Apr-2022, expiration was 02-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 13-Apr-2022, expiration was 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 13-Apr-2022, expiration was 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   One of COVID providers gave doses of Moderna COVID-19 vaccine after expiration of 4/2/22. They were properly stored the entire duration of time on site. The vaccines were removed from the freezer on the day of each respective immunization. No concomitant medication were given. No treatment information were given.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 05-May-2022 to 09-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2022, SARS-CoV-2 test: positive (Positive) Testing positive for COVID 19 (10 days after finishing treatment).         No concomitant medication were reported.  It was reported that Batch/LOT number of suspect drug was misplaced or mismatched.  Company comment: This spontaneous case concerns a 43-year-old female patient who experienced the unexpected non-serious AESI, Covid-19, on an unspecified date after receiving the 3rd dose of mRNA-1273 vaccine. The patient was started on Paxlovid (Nirmatrelvir + Ritonavir) for Covid-19 and 10 days after finishing the course he was tested positive for SARS-CoV-2. Details of previous doses was not provided. Details of medical history, symptoms, clinical course, diagnostic reports, and further treatment was not provided. The outcome of the event was unknown. Recent Covid-19 infection could be a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 43-year-old female patient who experienced the unexpected non-serious AESI, Covid-19, on an unspecified date after receiving the 3rd dose of mRNA-1273 vaccine. The patient was started on Paxlovid (Nirmatrelvir + Ritonavir) for Covid-19 and 10 days after finishing the course he was tested positive for SARS-CoV-2. Details of previous doses was not provided. Details of medical history, symptoms, clinical course, diagnostic reports, and further treatment was not provided. The outcome of the event was unknown. Recent Covid-19 infection could be a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: rebound Covid 8 days post Rx wit Paxlovid, Ag+; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (rebound Covid 8 days post Rx wit Paxlovid, Ag+) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Lymphoma, Polymyalgia rheumatica and Penicillin allergy.   On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 15-May-2022, the patient experienced COVID-19 (rebound Covid 8 days post Rx wit Paxlovid, Ag+). At the time of the report, COVID-19 (rebound Covid 8 days post Rx wit Paxlovid, Ag+) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2022, SARS-CoV-2 test: ag+ (Positive) Ag+.         The concomitant medication was not provided. The patient had rebound Covid 8 days post treatment with Paxlovid, Ag positive.  Company comment: This spontaneous case concerns  a patient of unspecified age and gender with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) and unexpected, which occurred 1 month 7 days after receiving the fourth dose of mRNA-1273 vaccine. The event COVID-19 (rebound Covid 8 days post Rx wit Paxlovid, Ag+). SARS-CoV-2 test was positive as on 15-May-2022. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) and unexpected, which occurred 1 month 7 days after receiving the fourth dose of mRNA-1273 vaccine. The event COVID-19 (rebound Covid 8 days post Rx wit Paxlovid, Ag+). SARS-CoV-2 test was positive as on 15-May-2022. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid rebound after finishing Paxlovid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid rebound after finishing Paxlovid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Obesity, Depression and Penicillin allergy. Concomitant products included NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 15-May-2022 for COVID-19 treatment, SERTRALINE, VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid rebound after finishing Paxlovid). At the time of the report, COVID-19 (Covid rebound after finishing Paxlovid) outcome was unknown. Not Provided          It was reported that patient had not find vaccine card at that moment.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 unspecified days after the third dose mRNA-1273 vaccine. It was reported that patient had Covid rebound after finishing Paxlovid treatment regimen. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 unspecified days after the third dose mRNA-1273 vaccine. It was reported that patient had Covid rebound after finishing Paxlovid treatment regimen. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: dose administered after excursion; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered after excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered after excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered after excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported Treatment information was not reported  On 24-May-2022 Case became invalid because multiple patient case.
Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pollakiuria, Vaccination site pain, Weight, Weight decreased
Clinical narrative: Weight loss; Occasionally goes to the bathroom frequently; Fatigue; Sore arm due to COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Weight loss), POLLAKIURIA (Occasionally goes to the bathroom frequently), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore arm due to COVID vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included COVID-19 in November 2020.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre filled pen, citrate free. In 2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore arm due to COVID vaccine). On an unknown date, the patient experienced WEIGHT DECREASED (Weight loss) and POLLAKIURIA (Occasionally goes to the bathroom frequently). At the time of the report, WEIGHT DECREASED (Weight loss), POLLAKIURIA (Occasionally goes to the bathroom frequently), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore arm due to COVID vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: lost 6 pounds lost 6 pounds.         Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.