chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: FATIGUE; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue, fever, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, fever, headache and nausea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Type 1 diabetes mellitus, Vaccination failure
Clinical narrative: TYPE-1 DIABETES; COVID; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 23 year old male of unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced type-1 diabetes, covid, and suspected clinical vaccination failure. On an unspecified date, patient had J&J shot and died from complications of covid and type 1 diabetes. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of type-1 diabetes on an unspecified date, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000200111.; Sender's Comments: V0:  20211104184-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. 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  20211104184-Covid-19 vaccine ad26.cov2.s- Type 1 diabetes, Covid. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COVID; TYPE 1 DIABETES
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Death
Clinical narrative: THE PATIENT DIED (THE PATIENT SURVIVED 2 WEEKS IN ICU BEFORE SHE PAST 2); This spontaneous report received from a patient via a company representative via social media concerned a 3 decade old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: stage 4 colon cancer, and kidney stone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry : unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died (the patient survived 2 weeks in icu before she past 2 ) and was hospitalized in ICU (date unspecified). Laboratory data (dates unspecified) included: CT scan (NR: not provided) kidney stone, clear. On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211104964-Covid-19 vaccine ad26.cov2.s - The patient died (the patient survived 2 weeks in icu before she past 2 ). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19, UNK
Symptoms: Allergy to vaccine, Thrombosis
Clinical narrative: Thrombosis leg; Allergy to vaccine; This spontaneous report received from a patient concerned an adult female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, 1 total, start therapy date was 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: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: unknown) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in left leg (thrombosis leg) and allergy to vaccination shot with humira (adalimumab)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported for event blood clot in left leg (thrombosis leg) and not applicable for event allergy to vaccination shot. The patient recovered from allergy to vaccine, and had not recovered from thrombosis leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211105084-covid-19 vaccine ad26.cov2.s-thrombosis leg. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Confusional state, Dizziness, Pain
Clinical narrative: DIZZINESS; CONFUSION; CHILLS; FEVER, HIGH TEMPERATURE; BODY ACHES; This spontaneous report received from a patient concerned a male 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 (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 01-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-NOV-2021, the patient experienced body aches. On 02-NOV-2021, the patient experienced dizziness. On 02-NOV-2021, the patient experienced confusion. On 02-NOV-2021, the patient experienced chills. On 02-NOV-2021, the patient experienced fever, high temperature. Laboratory data included: Body temperature (NR: not provided) High (Fever). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, high temperature, body aches, dizziness, confusion, and chills. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: DIZZINESS; CONFUSION; CHILLS; FEVER, HIGH TEMPERATURE; BODY ACHES; This spontaneous report received from a patient concerned a male 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 (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 01-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-NOV-2021, the patient experienced body aches. On 02-NOV-2021, the patient experienced dizziness. On 02-NOV-2021, the patient experienced confusion. On 02-NOV-2021, the patient experienced chills. On 02-NOV-2021, the patient experienced fever, high temperature. Laboratory data included: Body temperature (NR: not provided) High (Fever). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, high temperature, body aches, dizziness, confusion, and chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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, and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 02-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hangover, Pyrexia
Clinical narrative: MILD HANGOVER LIKE SYMPTOMS; SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned an adult male. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced mild hangover like symptoms, and slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild hangover like symptoms, and slight fever. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Faeces hard, Polymenorrhoea, Vaginal discharge, Vaginal haemorrhage
Clinical narrative: WHITE CLOTS COMING OUT AFTER GOING TO THE BATHROOM (FROM VAGINA) AND ONE CLOT WAS HALF AN INCH IN DIAMETER AND  A LOT OF OTHER SCATTERED SMALLER ONES SITTING IN THE BOWL.; CRAMPING IN THE STOMACH SIMILAR TO FIRST DAY OF PERIOD; SPOTTING (IN THE UNDERWEAR) 10 DAYS AFTER GETTING THE VACCINE.; STRANGE BOWEL MOVEMENTS WITH HARD TEXTURE AND CLUMPY FOR ABOUT 2 WEEKS; PERIOD CAME 1 WEEK EARLIER THAN IT SHOULD HAVE; This spontaneous report received from a patient concerned a 50 year old female. 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, intramuscular, and batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced period came 1 week earlier than it should have. On 15-OCT-2021, the patient experienced strange bowel movements with hard texture and clumpy for about 2 weeks. On 18-OCT-2021, the patient experienced spotting (in the underwear) 10 days after getting the vaccine. On 01-NOV-2021, the patient experienced cramping in the stomach similar to first day of period. On 02-NOV-2021, the patient experienced white clots coming out after going to the bathroom (from vagina) and one clot was half an inch in diameter and a lot of other scattered smaller ones sitting in the bowl. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from period came 1 week earlier than it should have, and spotting (in the underwear) 10 days after getting the vaccine. on 20-OCT-2021, had not recovered from cramping in the stomach similar to first day of period, and strange bowel movements with hard texture and clumpy for about 2 weeks, and the outcome of white clots coming out after going to the bathroom (from vagina) and one clot was half an inch in diameter and a lot of other scattered smaller ones sitting in the bowl. was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: WEAKNESS IN LEGS (WOBBLY LEGS); This spontaneous report received from a consumer via a company representative concerned a female 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced weakness in legs (wobbly legs). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of weakness in legs (wobbly legs) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211107853.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: UNDERAGE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 15 year old female. 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: 1822811, and expiry: UNKNOWN) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-OCT-2021, the patient experienced underage administration. On 29-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and underage administration was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Night sweats, Pyrexia
Clinical narrative: WOKE UP THROUGHOUT THE NIGHT MULTIPLE TIMES WITH NIGHT SWEATS; WOKE UP WITH CHILLS; 101.4 FAHRENHEIT FEVER; This spontaneous report received from a patient concerned a 35 year old male. 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: 1822811, and expiry: UNKNOWN) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-OCT-2021, the patient woke up with chills. On 29-OCT-2021, the patient experienced 101.4 fahrenheit fever. Laboratory data included: Body temperature (NR: not provided) 101.4 F. On 30-OCT-2021, the patient experienced woke up throughout the night multiple times with night sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from woke up with chills, and 101.4 fahrenheit fever, and had not recovered from woke up throughout the night multiple times with night sweats. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Muscular weakness
Clinical narrative: COULD NOT STAND UP FROM A KNEELING POSITION WITHOUT A DEVICE PATIENT CAN LEAN ON TO STAND UP; LEGS WERE WEAK; This spontaneous report received from a patient via a company representative concerned a male 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced could not stand up from a kneeling position without a device patient can lean on to stand up. On APR-2021, the patient experienced legs were weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the legs were weak and could not stand up from a kneeling position without a device patient can lean on to stand up was not reported. This report was non-serious. This case, from the same reporter is linked to 20211107590.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia
Clinical narrative: SORE BICEP BELOW INJECTION SITE (LITTLE PAIN BELOW THE BICEP); SORE AT INJECTION SITE; This spontaneous report received from a patient concerned an 80 year old male. 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the patient experienced sore at injection site. On 19-MAR-2021, the patient experienced sore bicep below injection site (little pain below the bicep). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore at injection site and sore bicep below injection site (little pain below the bicep) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS/RINGING IN BOTH EARS FOR 3 MONTHS; This spontaneous report received from a patient concerned a male 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 (suspension for injection, route of admin not reported, batch number: unknown and expiry: Unknown) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-AUG-2021, the patient experienced tinnitus/ringing in both ears for 3 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus/ringing in both ears for 3 months. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: gave the vaccine past the 12 hour mark,26.5 hours at room temp; 26.5 hours at room temp; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave the vaccine past the 12 hour mark,26.5 hours at room temp) and PRODUCT STORAGE ERROR (26.5 hours at room temp) 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 EXPIRED PRODUCT ADMINISTERED (gave the vaccine past the 12 hour mark,26.5 hours at room temp) and PRODUCT STORAGE ERROR (26.5 hours at room temp). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave the vaccine past the 12 hour mark,26.5 hours at room temp) and PRODUCT STORAGE ERROR (26.5 hours at room temp) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-365212, MOD-2021-365214 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received contains Reporter details included Email address and Fax number.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Vaccination complication
Clinical narrative: Second dose taken before day 25 after the first dose; sore arm (in the right arm).; felt "blah"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm (in the right arm).), VACCINATION COMPLICATION (felt "blah") and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken before day 25 after the first dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot in October 2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included CREST syndrome. Concomitant products included PANTOPRAZOLE for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm (in the right arm).) and VACCINATION COMPLICATION (felt "blah"). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken before day 25 after the first dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm (in the right arm).) and VACCINATION COMPLICATION (felt "blah") outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken before day 25 after the first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient also mentioned that she has an autoimmune disorder called CREST, and got the flu shot the first week of October   This case was linked to MOD-2021-363419 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Feeding disorder, Feeling abnormal, Headache, Heart rate decreased
Clinical narrative: couldn't eat any food; really bad headache; temperature of 100.8 F; arm was a little bit sore; started to feel bad; really sick; could hardly move; eyes hurt and felt really bad; hearbeat was very slow; couldn't even call 911, couldn't get up of the bed to open the door and let her dog in; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started to feel bad), MALAISE (really sick), HYPOKINESIA (could hardly move), EYE PAIN (eyes hurt and felt really bad) and HEART RATE DECREASED (hearbeat was very slow) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A, 002A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included CREST syndrome. Previously administered products included for Product used for unknown indication: Flu shot in October 2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concomitant products included PANTOPRAZOLE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced FEELING ABNORMAL (started to feel bad), MALAISE (really sick), HYPOKINESIA (could hardly move), EYE PAIN (eyes hurt and felt really bad), HEART RATE DECREASED (hearbeat was very slow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't even call 911, couldn't get up of the bed to open the door and let her dog in), HEADACHE (really bad headache), PYREXIA (temperature of 100.8 F) and MYALGIA (arm was a little bit sore). On 23-Oct-2021, the patient experienced FEEDING DISORDER (couldn't eat any food). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (started to feel bad), MALAISE (really sick), HYPOKINESIA (could hardly move), EYE PAIN (eyes hurt and felt really bad), HEART RATE DECREASED (hearbeat was very slow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't even call 911, couldn't get up of the bed to open the door and let her dog in), FEEDING DISORDER (couldn't eat any food), HEADACHE (really bad headache), PYREXIA (temperature of 100.8 F) and MYALGIA (arm was a little bit sore) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-363406 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Loss of personal independence in daily activities, Malaise, Myalgia, Pyrexia
Clinical narrative: couldn't eat any food; really bad headache; temperature of 100.8 F; arm was a little bit sore; started to feel bad; really sick; could hardly move; eyes hurt and felt really bad; hearbeat was very slow; couldn't even call 911, couldn't get up of the bed to open the door and let her dog in; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started to feel bad), MALAISE (really sick), HYPOKINESIA (could hardly move), EYE PAIN (eyes hurt and felt really bad) and HEART RATE DECREASED (hearbeat was very slow) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A, 002A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included CREST syndrome. Previously administered products included for Product used for unknown indication: Flu shot in October 2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concomitant products included PANTOPRAZOLE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced FEELING ABNORMAL (started to feel bad), MALAISE (really sick), HYPOKINESIA (could hardly move), EYE PAIN (eyes hurt and felt really bad), HEART RATE DECREASED (hearbeat was very slow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't even call 911, couldn't get up of the bed to open the door and let her dog in), HEADACHE (really bad headache), PYREXIA (temperature of 100.8 F) and MYALGIA (arm was a little bit sore). On 23-Oct-2021, the patient experienced FEEDING DISORDER (couldn't eat any food). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (started to feel bad), MALAISE (really sick), HYPOKINESIA (could hardly move), EYE PAIN (eyes hurt and felt really bad), HEART RATE DECREASED (hearbeat was very slow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't even call 911, couldn't get up of the bed to open the door and let her dog in), FEEDING DISORDER (couldn't eat any food), HEADACHE (really bad headache), PYREXIA (temperature of 100.8 F) and MYALGIA (arm was a little bit sore) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-363406 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: noticed a change after the first dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (noticed a change after the first dose of the Moderna COVID-19 vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy since 1995. Concomitant products included LEVETIRACETAM (KEPRA) for Seizure.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION COMPLICATION (noticed a change after the first dose of the Moderna COVID-19 vaccine). At the time of the report, VACCINATION COMPLICATION (noticed a change after the first dose of the Moderna COVID-19 vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-363263 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow up received on 27-OCT-2021,contains patient demographic details, medical history and concomitant medication.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Pericarditis, Pleural effusion
Clinical narrative: atrial fibrillation; Pericarditis; pleural effusion; This spontaneous case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) and PERICARDITIS (Pericarditis) in a 60-year-old patient of an unknown gender 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 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 ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant) and PLEURAL EFFUSION (pleural effusion). At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), PERICARDITIS (Pericarditis) and PLEURAL EFFUSION (pleural effusion) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported.  Patient had no cardiac history.  Company comment: A physician reported a 60-year-old patient (sex not specified) with no cardiac history, who experienced the Expected event of Pericarditis; and Unexpected events of Atrial Fibrillation and Pleural Effusion. The events occurred at unknown interval after a dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after a dose. Limited information provided precludes a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   This case was linked to MOD-2021-363486 (Patient Link).; Sender's Comments: A physician reported a 60-year-old patient (sex not specified) with no cardiac history, who experienced the Expected event of Pericarditis; and Unexpected events of Atrial Fibrillation and Pleural Effusion . The events occurred at unknown interval after a dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after a dose. Limited information provided precludes a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 28-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Date of refrigeration of vaccine was 07-May-2021.   This case was linked to MOD-2021-363789 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered dose past 12-hour mark; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose past 12-hour mark) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Oct-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose past 12-hour mark). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered dose past 12-hour mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-365212, MOD-2021-365214 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Added reporter email address.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: They found several blood clots in the lungs; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (They found several blood clots in the lungs) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M200) for COVID-19 vaccination.     Concurrent medical conditions included Deaf (deaf at baseline). Concomitant products included ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]), TIMOLOL, BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN) and IPRATROPIUM BROMIDE (IPRATROPIUM [IPRATROPIUM BROMIDE]) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced THROMBOSIS (They found several blood clots in the lungs) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (They found several blood clots in the lungs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication- Lisinopril HCTZ 10-12.5mg, vitamins treatment :blood thinner  Company comment: This case concerns a 63-year-old male patient with no relevant medical history, who experienced the unexpected events Thrombosis. The event occurred approximately 3 months after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) with serious outcome. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 63-year-old male patient with no relevant medical history, who experienced the unexpected events Thrombosis. The event occurred approximately 3 months after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) with serious outcome. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) 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 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-364470 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Chest attention; Chest pain; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest pain) in a 21-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.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant) and CHEST DISCOMFORT (Chest attention). At the time of the report, CHEST PAIN (Chest pain) and CHEST DISCOMFORT (Chest attention) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information was provided.  Reporter mentioned that patient had two dose of vaccine in April and May. The patient experiencing chest pain and chest attention.  Company Comment - This case concerns a 21-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of chest pain and chest discomfort. The date of onset was not reported, neither vaccination date. The events occurred after the second dose of Spikevax. The rechallenge was not applicable as the outcome of the events is unknown. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 21-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of chest pain and chest discomfort. The date of onset was not reported, neither vaccination date. The events occurred after the second dose of Spikevax. The rechallenge was not applicable as the outcome of the events is unknown. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue
Clinical narrative: Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 024M20A and 058E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, LISINOPRIL, METFORMIN and METOPROLOL SUCCINATE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, Body temperature: 99.6 (High) temperature of the forehead was 93.9 and body temperature was 99.6 (taken under the tongue).         No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: several patients received vaccine from expired lot number with expiry of October 9 2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (several patients received vaccine from expired lot number with expiry of October 9 2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) 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 EXPIRED PRODUCT ADMINISTERED (several patients received vaccine from expired lot number with expiry of October 9 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (several patients received vaccine from expired lot number with expiry of October 9 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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. Dose administered after 30-day Use By Date or after manufacturer date of expiry.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 11-Aug-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Optic neuritis
Clinical narrative: Optic neuritis; This spontaneous case was reported by a consumer and describes the occurrence of OPTIC NEURITIS (Optic neuritis) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OPTIC NEURITIS (Optic neuritis) (seriousness criterion medically significant). At the time of the report, OPTIC NEURITIS (Optic neuritis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment information was mentioned.  Company Comment : This case concerns a 20-year-old, female patient with no relevant medical history, who experienced the unexpected event of optic neuritis. The event optic neuritis occurred 3 weeks after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 20-year-old, female patient with no relevant medical history, who experienced the unexpected event of optic neuritis. The event optic neuritis occurred 3 weeks after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Booster dose. In October 2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.       No Concomitant medication details were provided. No Treatment medication details were provided.  Caller did mention one or two other AE, but agent unable to capture. Caller declined to report /disclose additional AE information.   Reporter did not allow further contact