chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Nasopharyngitis
Clinical narrative: FLU; COLD; This spontaneous report received from a patient concerned a 3 decade old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: Crohn's disease (Moderate to severe adult Crohn's disease). On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose and start therapy date were not reported, administered 1 in total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 3 decade old. On an unspecified date, the patient experienced flu, and cold (Dose number in series 1). On an unspecified date, patient received non-company suspect vaccine included: tozinameran (Pfizer biotech covid-19 vaccine) (Dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose and start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with tozinameran (Pfizer biotech covid-19 vaccine) (Dose number in series 2) On an unspecified date, the patient received non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult Crohn's disease. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tozinameran, and adalimumab was not reported. The outcome of the flu and cold was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a parent via a company representative concerned a 55 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number and expiry date were not reported) ) 1 total, dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient additionally received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number and expiry date were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination which was an off label use, and inappropriate schedule of vaccine administered (dose number in series 2).  The batch number was not reported and has been requested. No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to .
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: NAUSEOUS / FELT LIKE THROW UP FOR 3 DAYS; VOMITING; DIARRHEA; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced nauseous / felt like throw up for 3 days, vomiting, and diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient was recovering from nauseous / felt like throw up for 3 days, vomiting, and diarrhea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED THE JANSSEN COVID 19 VACCINE TO PATIENTS MORE THAN 6 HOURS AFTER THE FIRST VIAL PUNCTURE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced administered the Janssen COVID 19 vaccine to subjects more than 6 hours after the first vial puncture, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered the Janssen COVID 19 vaccine to patients more than 6 hours after the first vial puncture and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to .
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERING THE JANSSEN COVID 19 VACCINE TO PATIENTS MORE THAN 6 HOURS AFTER THE FIRST VIAL PUNCTURE (VIALS STORED IN THE FRIDGE AFTER PUNCTURE) (OUT OF SPECIFICATION PRODUCT USE); INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced administering the Janssen covid 19 vaccine to subjects more than 6 hours after the first vial puncture (vials stored in the fridge after puncture) (out of specification product use), and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and administering the Janssen covid 19 vaccine to patients more than 6 hours after the first vial puncture (vials stored in the fridge after puncture) (out of specification product use) was not reported. This report was non-serious. This case, from the same reporter is linked to 20220527916, 20220528196, 20220528223 and 20220528115.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE FOR MORE THAN 6 HOURS AFTER THE FIRST VIAL PUNCTURE (VIALS STORED IN THE FRIDGE AFTER PUNCTURE) (OUT OF SPECIFICATION PRODUCT USE); INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced administration of vaccine for more than 6 hours after the first vial puncture (vials stored in the fridge after puncture) (out of specification product use), and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and administration of vaccine for more than 6 hours after the first vial puncture (vials stored in the fridge after puncture) (out of specification product use) was not reported. This report was non-serious. This case, from the same reporter is linked to 20220527916, 20220528115, 20220528178 and 20220528223.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE FOR MORE THAN 6 HOURS AFTER THE FIRST VIAL PUNCTURE (VIALS STORED IN THE FRIDGE AFTER PUNCTURE) (OUT OF SPECIFICATION PRODUCT USE); INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1855835 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced administration of vaccine for more than 6 hours after the first vial puncture (vials stored in the fridge after puncture) (out of specification product use), and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine for more than 6 hours after the first vial puncture (vials stored in the fridge after puncture) (out of specification product use) and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220527916, 20220528196, 20220528178 and 20220528115.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer (on behalf of her son) concerned a male (works on a ship) of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (first shot) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, vaccinated on left arm, administered on an unspecified date in AUG-2021 for prophylactic vaccination.  The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date in FEB-2022, the patient developed covid-19 infection, while on board of the ship. He experienced fever for 3 days with runny nose (suspected covid-19 infection and suspected clinical vaccination failure).  Laboratory data included: Body temperature (NR: not provided) 140 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on 2022, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20220528254-COVID-19 VACCINE Ad26.COV2.S-suspected   clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Chromaturia, Feeling cold, Gastrooesophageal reflux disease, Headache
Clinical narrative: MUSCLE ACHES ALL OVER; INCREASE IN URINE/PEEING A LOT; THROWING UP ACID, LIKE REFLUX/ HAD LIKE ACID COMING UP THAT SHE HAD TO SPIT OUT; URINE WAS DARK; CHILLS; FELT COLD; TINGLING IN WRIST, ANKLES AND HANDS; HEADACHE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's past medical history included: anemia (she had been diagnosed with anemia in the past), and concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2022 for prophylactic vaccination. Age at time of vaccination 32 years old. No concomitant medications were reported. On 13-MAY-2022, the patient experienced increase in urine/peeing a lot, throwing up acid, like reflux/ had like acid coming up that she had to spit out, urine was dark, chills, felt cold, tingling in wrist, ankles and hands, and headache. On 14-MAY-2022, the patient experienced muscle aches all over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-MAY-2022, had not recovered from tingling in wrist, ankles and hands, and muscle aches all over, and the outcome of chills, felt cold, increase in urine/peeing a lot, throwing up acid, like reflux/ had like acid coming up that she had to spit out and urine was dark was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia, Urine output increased
Clinical narrative: MUSCLE ACHES ALL OVER; INCREASE IN URINE/PEEING A LOT; THROWING UP ACID, LIKE REFLUX/ HAD LIKE ACID COMING UP THAT SHE HAD TO SPIT OUT; URINE WAS DARK; CHILLS; FELT COLD; TINGLING IN WRIST, ANKLES AND HANDS; HEADACHE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's past medical history included: anemia (she had been diagnosed with anemia in the past), and concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2022 for prophylactic vaccination. Age at time of vaccination 32 years old. No concomitant medications were reported. On 13-MAY-2022, the patient experienced increase in urine/peeing a lot, throwing up acid, like reflux/ had like acid coming up that she had to spit out, urine was dark, chills, felt cold, tingling in wrist, ankles and hands, and headache. On 14-MAY-2022, the patient experienced muscle aches all over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-MAY-2022, had not recovered from tingling in wrist, ankles and hands, and muscle aches all over, and the outcome of chills, felt cold, increase in urine/peeing a lot, throwing up acid, like reflux/ had like acid coming up that she had to spit out and urine was dark was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via other manufacturer (Pfizer) concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination.  The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient died of a blood clot from the Johnson and Johnson vaccine. It was reported as reporter's pharmacist had a patient whose husband died of a blood clot from the Johnson and Johnson vaccine.  It was unknown if an autopsy performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220530466-Covid-19 vaccine ad26.cov2.s-blood clot . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lethargy, Malaise
Clinical narrative: This spontaneous report received from a patient concerned an 84 year old female. The patient's height, and weight were not reported. The patient's past medical history included: blood clot in right leg (approximately 8 months, on blood thinners, but now stopped), and concurrent conditions included: type 2 diabetes, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not had any drug abuse or illicit drug usage. The patient did not had any known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 28-FEB-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid.  On 01-APR-2021, the patient experienced lethargic, general feeling of unwell, and numbness in both legs/feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, numbness in both legs/feet, and general feeling of unwell. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred Vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred Vision) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurred Vision). At the time of the report, VISION BLURRED (Blurred Vision) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medication were given by the reporter. No Treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Upon internal review on 17-May-2022, significant correction was performed. The reporter country was updated from unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (vision problems/blurred vision - it occurs temporarily lasts for a few seconds and then goes back to normal) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (vision problems/blurred vision - it occurs temporarily lasts for a few seconds and then goes back to normal). At the time of the report, VISION BLURRED (vision problems/blurred vision - it occurs temporarily lasts for a few seconds and then goes back to normal) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment medications were not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Upon internal review on 17-May-2022, significant correction was performed. The reporter country was updated.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Feeling abnormal, Headache
Clinical narrative: Very weak and dazed again; Headache; Muscle pain in legs; Joint pain in legs; I felt itching at the injection site; The site was also somewhat red at first; Tired; Weak/very weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak/very weak), FEELING ABNORMAL (Very weak and dazed again), VACCINATION SITE PRURITUS (I felt itching at the injection site), VACCINATION SITE ERYTHEMA (The site was also somewhat red at first) and HEADACHE (Headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.   On 26-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced ASTHENIA (Weak/very weak) and FATIGUE (Tired). On 28-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (I felt itching at the injection site) and VACCINATION SITE ERYTHEMA (The site was also somewhat red at first). On 30-Jul-2021, the patient experienced FEELING ABNORMAL (Very weak and dazed again), HEADACHE (Headache), MYALGIA (Muscle pain in legs) and ARTHRALGIA (Joint pain in legs). At the time of the report, ASTHENIA (Weak/very weak), FEELING ABNORMAL (Very weak and dazed again), VACCINATION SITE PRURITUS (I felt itching at the injection site), VACCINATION SITE ERYTHEMA (The site was also somewhat red at first), HEADACHE (Headache), MYALGIA (Muscle pain in legs), FATIGUE (Tired) and ARTHRALGIA (Joint pain in legs) outcome was unknown.  No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Upon internal review on 17-May-2022, significant correction was performed. The reporter country was updated.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Very weak and dazed again; Headache; Muscle pain in legs; Joint pain in legs; I felt itching at the injection site; The site was also somewhat red at first; Tired; Weak/very weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak/very weak), FEELING ABNORMAL (Very weak and dazed again), VACCINATION SITE PRURITUS (I felt itching at the injection site), VACCINATION SITE ERYTHEMA (The site was also somewhat red at first) and HEADACHE (Headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.   On 26-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced ASTHENIA (Weak/very weak) and FATIGUE (Tired). On 28-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (I felt itching at the injection site) and VACCINATION SITE ERYTHEMA (The site was also somewhat red at first). On 30-Jul-2021, the patient experienced FEELING ABNORMAL (Very weak and dazed again), HEADACHE (Headache), MYALGIA (Muscle pain in legs) and ARTHRALGIA (Joint pain in legs). At the time of the report, ASTHENIA (Weak/very weak), FEELING ABNORMAL (Very weak and dazed again), VACCINATION SITE PRURITUS (I felt itching at the injection site), VACCINATION SITE ERYTHEMA (The site was also somewhat red at first), HEADACHE (Headache), MYALGIA (Muscle pain in legs), FATIGUE (Tired) and ARTHRALGIA (Joint pain in legs) outcome was unknown.  No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Upon internal review on 17-May-2022, significant correction was performed. The reporter country was updated.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Insomnia
Clinical narrative: I can no longer sleep on my left side; no longer sleep on my left side; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (I can no longer sleep on my left side) and DISCOMFORT (no longer sleep on my left side) 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 INSOMNIA (I can no longer sleep on my left side) and DISCOMFORT (no longer sleep on my left side). At the time of the report, INSOMNIA (I can no longer sleep on my left side) and DISCOMFORT (no longer sleep on my left side) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication were reported. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2021: Upon internal review on 17-May-2022, significant correction was performed. The reporter country was updated from unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 06-Apr-2022 and administered on 09-May-2022; They administer a Moderna COVID-19 vaccine after the 30 day by use date to 4 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They administer a Moderna COVID-19 vaccine after the 30 day by use date to 4 patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 06-Apr-2022 and administered on 09-May-2022) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001m21a) for COVID-19 vaccination.     No allergic history to food and other products were available.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (They administer a Moderna COVID-19 vaccine after the 30 day by use date to 4 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 06-Apr-2022 and administered on 09-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They administer a Moderna COVID-19 vaccine after the 30 day by use date to 4 patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 06-Apr-2022 and administered on 09-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The dose number was reported as 4 doses at 1 vial for four patients.  No concomitant medication information was not reported.  Dose was administered after 30-day Use By Date or after manufacturer date of expiry.  Vial did not undergo any temperature excursion.  It was unknown whether patient had COVID-19 test or diagnosis and also similar event in the past.  No treatment medications were provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 06-Apr-2022 and administered to patient on 09-May-2022 post 30day usage duration; The vial was initially stored in the refrigerator on 06-Apr-2022 and administered to patient on 09-May-2022 post 30day usage duration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 06-Apr-2022 and administered to patient on 09-May-2022 post 30day usage duration) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Apr-2022 and administered to patient on 09-May-2022 post 30day usage duration) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001m21a) for COVID-19 vaccination.     Patient had no Acute and Chronic illness at the time of vaccination.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 06-Apr-2022 and administered to patient on 09-May-2022 post 30day usage duration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Apr-2022 and administered to patient on 09-May-2022 post 30day usage duration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 06-Apr-2022 and administered to patient on 09-May-2022 post 30day usage duration) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Apr-2022 and administered to patient on 09-May-2022 post 30day usage duration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided by reporter. No treatment information was provided by reporter Date the vial was initially stored in the refrigerator: 06Apr2022. The vial didn't undergo any temperature excursions.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: They administer a Moderna COVID-19 vaccine after the 30 day by use date to 4 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They administer a Moderna COVID-19 vaccine after the 30 day by use date to 4 patients) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001m21a) for COVID-19 vaccination.     Allergies (medications, food and other products) were unknown. It was unknown if the patient ever had COVID + test or diagnosis. Medical Hx: Hx relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination was not provided. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine were unknown.     On 09-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They administer a Moderna COVID-19 vaccine after the 30 day by use date to 4 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They administer a Moderna COVID-19 vaccine after the 30 day by use date to 4 patients) 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 the HCP wanted to know what to do with the 4 patients that they administered a Moderna COVID-19 vaccine after the 30 day by use date, by mistake.  Date the vial was initially stored in the refrigerator was reported as 06-Apr-2022. The vial did not undergo any temperature excursions. No treatment medications were provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive on 28-Apr and started taking paxlovid on 29-Apr. The symptoms lessened within 48 hours of taking the medicine and patient tested negative on 06-May; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient tested positive on 28-Apr and started taking paxlovid on 29-Apr. The symptoms lessened within 48 hours of taking the medicine and patient tested negative on 06-May) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Patient had an allergic reaction to an unknown historical drug.     On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced COVID-19 (Patient tested positive on 28-Apr and started taking paxlovid on 29-Apr. The symptoms lessened within 48 hours of taking the medicine and patient tested negative on 06-May). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 29-Apr-2022 to 04-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 06-May-2022, COVID-19 (Patient tested positive on 28-Apr and started taking paxlovid on 29-Apr. The symptoms lessened within 48 hours of taking the medicine and patient tested negative on 06-May) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 06-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 09-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication information was provided.  Company comment- This spontaneous case concerns a 32-year-old male patient with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 (with a positive SARS-CoV-2 test) that occurred 4 months and 6 days after vaccination with a third dose of mRNA-1273. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 32-year-old male patient with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 (with a positive SARS-CoV-2 test) that occurred 4 months and 6 days after vaccination with a third dose of mRNA-1273. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Joint pain after the second booster, but not as severe/shoulders/they got better/pain in the left knee; It affected his feet, hands and shoulders, they got better; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain after the second booster, but not as severe/shoulders/they got better/pain in the left knee) and PAIN IN EXTREMITY (It affected his feet, hands and shoulders, they got better) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084521A, 011F21A, 012A21A and 039K20A) for COVID-19 vaccination.     No other vaccines received by the patient within one month or prior to Moderna COVID-19 vaccine. Patient has never tested positive or diagnosed with COVID-19.  Previously administered products included for Drug use for unknown indication: Medrol dose-pak in November 2021. Past adverse reactions to the above products included No adverse event with Medrol dose-pak. Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Sulfa drugs), Allergy to antibiotic (Cipro) and Osteoarthritis (Many years ago).   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-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 ARTHRALGIA (Joint pain after the second booster, but not as severe/shoulders/they got better/pain in the left knee) and PAIN IN EXTREMITY (It affected his feet, hands and shoulders, they got better). The patient was treated with TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) for Joint pain, at a dose of on the joints a day or two after the shot. At the time of the report, ARTHRALGIA (Joint pain after the second booster, but not as severe/shoulders/they got better/pain in the left knee) had not resolved and PAIN IN EXTREMITY (It affected his feet, hands and shoulders, they got better) was resolving.            No concomitant medication information provided. patient's left knee pain was still ongoing on 12 May 2022. Patient did not experience any similar events in the past. Patient doesn't use  Aspercreme all the time   This case was linked to MOD-2022-566600 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid returned 6 days after treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid returned 6 days after treatment) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    In January 2022, 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 returned 6 days after treatment). At the time of the report, COVID-19 (Covid returned 6 days after treatment) had resolved. Not Provided          No concomitant medication was reported.  The patient previously received a COVID-19 Vaccine.  The COVID-19 treatment started on 4-Apr-2022 and stopped on 9-May-2022 but treatment drug was unknown and COVID returned 6 days after treatment.  Company Comment:  This is a spontaneous case concerning a 68-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of a dose of mRNA-1273 as third dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the diagnostic procedures were provided. Patient was given with unknown COVID-19 treatment, however patient reported that COVID-19 returned 6 days after treatment. Patient reported that the event COVID-19 had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 68-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of a dose of mRNA-1273 as third dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the diagnostic procedures were provided. Patient was given with unknown COVID-19 treatment, however patient reported that COVID-19 returned 6 days after treatment. Patient reported that the event COVID-19 had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: Developed blood clots after the second dose/got blood clots after the second shot; Stroke; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed blood clots after the second dose/got blood clots after the second shot) and CEREBROVASCULAR ACCIDENT (Stroke) in a 7-decade-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Developed blood clots after the second dose/got blood clots after the second shot) (seriousness criterion medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Developed blood clots after the second dose/got blood clots after the second shot) and CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            No concomitant products were reported.  Reporter and 8 other women all age 60 and above presented with blood clot post their second dose.  Women's in their 60s who got blood clots after the second shot of Moderna and resulted in a stroke as well.  No treatment information was reported by the reporter.  Company Comment: This is a spontaneous case concerning  a  7-decade-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Thrombosis, Cerebrovascular accident. The events occurred on an unknown day after the second dose of mRNA-1273 COVID 19 Vaccine which was received on an unknown date. The events outcome were reported as unknown at time of report. No treatment information was reported by the reporter. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to MOD-2022-566820, MOD-2022-566808, MOD-2022-566718, MOD-2022-566814, MOD-2022-566821, MOD-2022-566839, MOD-2022-566828.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2022: Follow up received with added reporter information, verbatim for event thrombosis and new event stroke.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  7-decade-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Thrombosis, Cerebrovascular accident. The events occurred on an unknown day after the second dose of mRNA-1273 COVID 19 Vaccine which was received on an unknown date. The events outcome were reported as unknown at time of report. No treatment information was reported by the reporter. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was out of the fridge for 24 hours post puncture; Dose administered more than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (vial was out of the fridge for 24 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was out of the fridge for 24 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (vial was out of the fridge for 24 hours post puncture) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided.  On 22-Apr-2022, the vial was initially stored in the refrigerator. On 28-Apr-2022 at 7:30 AM, the vial was first punctured. The vial was stored at room temperature post puncture and exposed to room temperature range of 8 to 25 degree Celsius = 46-to-77-degree Fahrenheit for 27-28 Hours. Later on, 29-Apr-2022 at 10:30-11:00 AM, the vaccine was administered.  It was reported that, the vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Illness, SARS-CoV-2 test, Therapeutic response unexpected, Weight
Clinical narrative: he got a little ill; no longer detect diabetes or hypertension. A1C levels went from 11 to 5.3.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he got a little ill) and THERAPEUTIC RESPONSE UNEXPECTED (no longer detect diabetes or hypertension. A1C levels went from 11 to 5.3.) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included Hypertension, Diabetes and Hip replacement. Concurrent medical conditions included Allergy (Maxvibe), Drug allergy (ACE inhibitors), Drug allergy (Motrin/NSAIDS) and Drug allergy (Tramadol). Concomitant products included COLECALCIFEROL (VITAMINE D) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ILLNESS (he got a little ill) and THERAPEUTIC RESPONSE UNEXPECTED (no longer detect diabetes or hypertension. A1C levels went from 11 to 5.3.). At the time of the report, ILLNESS (he got a little ill) and THERAPEUTIC RESPONSE UNEXPECTED (no longer detect diabetes or hypertension. A1C levels went from 11 to 5.3.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Weight: 405lbs to 298lbs (Low) 405lbs to 298lbs.         Patient Height was reported as 5'11. Concomitant medication included heavy doses of diabetes and hypertension medications (unspecified). It was reported that after the second shot patient got a little ill,  Covid test was negative. 4-5 months after they did blood work. All blood work came back normal. They could no longer detect diabetes or hypertension. Now does not have hypertension or diabetes anymore. patient  A1C levels went from 11 to 5.3. weight went from 405lbs to 298lbs. Patient took heavy doses of diabetes and hypertension medications.  The vaccine improved baseline health issues.