chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Gait inability, Hypoaesthesia, Loss of consciousness
Clinical narrative: LOSS OF CONSCIOUSNESS/PASSED OUT; DIZZY; COULD NOT WALK; SPINAL SURGERY IMMEDIATELY AFTER THE INCIDENT; LIMPRING ON RIGHT LEG, BEFORE AND AFTER THE SURGERY; RIGHT ARM NUMBED BEFORE AND AFTER THE SURGERY; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included: neck pain for 10-15 years, and concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination on right arm. The batch number was not reported and has been requested. Concomitant medications included Stelera (ustekinumab).  In JUL-2021, the patient experienced loss of consciousness, dizzy, could not walk, spinal surgery immediately after the incident, limpring on right leg, before and after the surgery, and right arm numbed before and after the surgery. On an unspecified date, the patient visited emergency room for these events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, loss of consciousness, could not walk, spinal surgery immediately after the incident, right arm numbed before and after the surgery and limpring on right leg, before and after the surgery was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220200405-covid-19 vaccine ad26.cov2.s- Loss of consciousness.This event is considered unassessable. The event 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
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Spinal operation
Clinical narrative: LOSS OF CONSCIOUSNESS/PASSED OUT; DIZZY; COULD NOT WALK; SPINAL SURGERY IMMEDIATELY AFTER THE INCIDENT; LIMPRING ON RIGHT LEG, BEFORE AND AFTER THE SURGERY; RIGHT ARM NUMBED BEFORE AND AFTER THE SURGERY; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included: neck pain for 10-15 years, and concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination on right arm. The batch number was not reported and has been requested. Concomitant medications included Stelera (ustekinumab).  In JUL-2021, the patient experienced loss of consciousness, dizzy, could not walk, spinal surgery immediately after the incident, limpring on right leg, before and after the surgery, and right arm numbed before and after the surgery. On an unspecified date, the patient visited emergency room for these events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, loss of consciousness, could not walk, spinal surgery immediately after the incident, right arm numbed before and after the surgery and limpring on right leg, before and after the surgery was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220200405-covid-19 vaccine ad26.cov2.s- Loss of consciousness.This event is considered unassessable. The event 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
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Thrombosis
Clinical narrative: CLOTS; CARDIOVASCULAR SIDE EFFECTS; This solicited report received from a physician via JS2021-31955: COVID 19 Booster Exploration concerned an adult female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no illness and 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: Unknown) dose was not reported, 01 total, administered on unspecified date (therapy start date and therapy end date were not provided) for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the physician stated that the patient had clots and transient cardiovascular side effects. Physician refused to provide diagnostic data. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the clots and cardiovascular side effects was not reported. The reporter provided no causality assessment.  The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and clots, and cardiovascular side effects as related. Company causality between covid-19 vaccine ad26.cov2.s, and clots, and cardiovascular side effects was not related.   This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0 20220201193-COVID-19 VACCINE AD26.COV2.S- clots, cardiovascular side effects. This event(s) is considered not related. 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).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination complication
Clinical narrative: all the side effects listed on the website; she had full blown body rash from neck to her feet for a week; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (all the side effects listed on the website) and RASH (she had full blown body rash from neck to her feet for a week) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-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 VACCINATION COMPLICATION (all the side effects listed on the website) and RASH (she had full blown body rash from neck to her feet for a week). At the time of the report, VACCINATION COMPLICATION (all the side effects listed on the website) and RASH (she had full blown body rash from neck to her feet for a week) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.   This case was linked to MOD-2022-472021 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: they administered 7 doses of an expired vial to 7 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they administered 7 doses of an expired vial to 7 patients) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (they administered 7 doses of an expired vial to 7 patients). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (they administered 7 doses of an expired vial to 7 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   HCP stated they administered 7 doses of an expired vial of Moderna COVID-19 Vaccine to 7 patients on 19Jan2022. Caller mentioned no adverse events were observed in any of the patients. HCP stated no treatment was given and patients were not under any concomitant or regular medication.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Malaise
Clinical narrative: feels sick; Does not feel good; complains of a headache.; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feels sick), FEELING ABNORMAL (Does not feel good) and HEADACHE (complains of a headache.) 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 01-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feels sick), FEELING ABNORMAL (Does not feel good) and HEADACHE (complains of a headache.). At the time of the report, MALAISE (feels sick), FEELING ABNORMAL (Does not feel good) and HEADACHE (complains of a headache.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 028A21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022 at 12:26 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022 at 12:26 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date). On 24-Jan-2022 at 12:26 PM, EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) to be not related.    No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.  No Adverse events were reported.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced. On 18-Nov-2021, had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication details reported.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported. The vaccine was stored in the freezer and one to two vials were taken out and placed in the fridge each day as needed.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. The pharmacist called about the administration of expired Moderna vaccine that were given as event or problem booster shot to patient around 490 to 500 people on the date last 20-Oct-2021 to 29-Nov-2021. The Lot Number of vaccines are as follows: 006C21A (10-Oct-2021) 026B21A (17-Sep-2021) 031 B21A (22-Sep-2021). It was reported that the vaccines was stored in freezer, they take out one to two vials and place in fridge each day as needed. No treatment given on the patients.
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was given to the patient.  The vaccines was stored in freezer, take out one to two vials and place in fridge each day as needed.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine ) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 32030BD) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine ). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant use were reported No Treatment were reported It was reported that the vaccine was stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) had resolved.        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.   Expired Vaccine was given as booster shot to 500 people.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: LPN administered Pfizer COVID-19 pediatric dose of 0.2 ml IM out of orange Pfizer vial for ages 5-11 year old patients. Patient's mother was immediately notified via telephone on the same day once it was discovered that patient received a lower dose than what was required. No reported adverse reactions of vaccine verbalized by patient's mother.
Sex: M
Vaccine: VARZOS
Symptoms: Transient ischaemic attack
Clinical narrative: mini stroke; This case was reported by a consumer via interactive digital media and described the occurrence of ministroke in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced ministroke (serious criteria GSK medically significant). On an unknown date, the outcome of the ministroke was unknown.   The reporter considered the ministroke to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's spouse. The age at vaccination was not reported. The reporter stated his/her husband had a mini stroke from the vaccine. The follow-up would not be possible as no contact details were available.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Syncope
Clinical narrative: Fainting episode; severe diarrhea; This case was reported by a consumer via call center representative and described the occurrence of fainting in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant) and diarrhea. On an unknown date, the outcome of the fainting and diarrhea were recovered/resolved.   It was unknown if the reporter considered the fainting and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix approximately 2 months prior to the reporting date at the age of 73 years. The patient reported experiencing severe diarrhea and a fainting episode approximately 12 hours after receiving Shingrix.  Severe diarrhea and fainting episode occurred simultaneously.  Severe diarrhea and fainting episode lasted approximately 10 minutes. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: both doses of SHINGRIX 1 month apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 19th November 2021, the patient received the 2nd dose of Shingrix. On 19th November 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: Pharmacist reported that the patient received both doses of Shingrix 1 month apart, which led to shortening of vaccination schedule. Pharmacist would like to know if they need a 3rd dose. Pharmacist was unsure if the patient was immunodeficient or immunosuppressed. Spoke from content. No further information reported. The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Muscular weakness
Clinical narrative: A LOT LESS MOBILITY; CAN'T LIFT ARM UP; This spontaneous report received from a patient via a company representative 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, 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 number. No concomitant medications were reported.  On an unspecified date, the patient experienced a lot less mobility, and can't lift arm up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a lot less mobility and can't lift arm up was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LITTLE SORENESS IN ARM; This spontaneous report received from a patient via social media via a company representative concerned a 76 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, and batch number were not reported) dose was not reported, administered on MAR-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 MAR-2021, the patient experienced little soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little soreness in arm on MAR-2021. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Axillary pain, Blood cholesterol, Blood pressure measurement, Erythema
Clinical narrative: SORENESS UNDERNEATH ARMPIT; SOME BODY ACHES; LETHARGIC FEELING; REDNESS UNDERNEATH ARMPIT; STOMACH UPSET; SORE ARM; HEADACHE; SORENESS AT SITE OF INJECTION; REDNESS AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, gastro esophageal reflux disease, high cholesterol, penicillin allergy, and sulfa allergy. The patient was previously treated with hydrochlorothiazide, and sulfamethoxazole/trimethoprim.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, expiry: UNKNOWN) dose was not reported, administered on 01-FEB-2022 for prophylactic vaccination. No concomitant medications were reported.  On 01-FEB-2022, the patient experienced soreness at site of injection, and redness at site of injection. On 02-FEB-2022, the patient experienced soreness underneath armpit, some body aches, lethargic feeling, redness underneath armpit, stomach upset, sore arm, and headache. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high, and Cholesterol (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some body aches, lethargic feeling, stomach upset, and headache on FEB-2022, and had not recovered from soreness underneath armpit, soreness at site of injection, sore arm, redness at site of injection, and redness underneath armpit. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Lethargy, Pain
Clinical narrative: SORENESS UNDERNEATH ARMPIT; SOME BODY ACHES; LETHARGIC FEELING; REDNESS UNDERNEATH ARMPIT; STOMACH UPSET; SORE ARM; HEADACHE; SORENESS AT SITE OF INJECTION; REDNESS AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, gastro esophageal reflux disease, high cholesterol, penicillin allergy, and sulfa allergy. The patient was previously treated with hydrochlorothiazide, and sulfamethoxazole/trimethoprim.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, expiry: UNKNOWN) dose was not reported, administered on 01-FEB-2022 for prophylactic vaccination. No concomitant medications were reported.  On 01-FEB-2022, the patient experienced soreness at site of injection, and redness at site of injection. On 02-FEB-2022, the patient experienced soreness underneath armpit, some body aches, lethargic feeling, redness underneath armpit, stomach upset, sore arm, and headache. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high, and Cholesterol (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some body aches, lethargic feeling, stomach upset, and headache on FEB-2022, and had not recovered from soreness underneath armpit, soreness at site of injection, sore arm, redness at site of injection, and redness underneath armpit. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORENESS UNDERNEATH ARMPIT; SOME BODY ACHES; LETHARGIC FEELING; REDNESS UNDERNEATH ARMPIT; STOMACH UPSET; SORE ARM; HEADACHE; SORENESS AT SITE OF INJECTION; REDNESS AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, gastro esophageal reflux disease, high cholesterol, penicillin allergy, and sulfa allergy. The patient was previously treated with hydrochlorothiazide, and sulfamethoxazole/trimethoprim.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, expiry: UNKNOWN) dose was not reported, administered on 01-FEB-2022 for prophylactic vaccination. No concomitant medications were reported.  On 01-FEB-2022, the patient experienced soreness at site of injection, and redness at site of injection. On 02-FEB-2022, the patient experienced soreness underneath armpit, some body aches, lethargic feeling, redness underneath armpit, stomach upset, sore arm, and headache. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high, and Cholesterol (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some body aches, lethargic feeling, stomach upset, and headache on FEB-2022, and had not recovered from soreness underneath armpit, soreness at site of injection, sore arm, redness at site of injection, and redness underneath armpit. This report was non-serious.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Muscle disorder, Seizure
Clinical narrative: bad seizure/it was horrible; fell on the floor; all muscles gone; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (bad seizure/it was horrible) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 146A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Drug allergy (cortisone type steroids).   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced SEIZURE (bad seizure/it was horrible) (seriousness criterion medically significant), FALL (fell on the floor) and MUSCLE DISORDER (all muscles gone). At the time of the report, SEIZURE (bad seizure/it was horrible), FALL (fell on the floor) and MUSCLE DISORDER (all muscles gone) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided.  Company Comment: This spontaneous case concerns an 89-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious AESI of seizure and the unexpected, non-serious events of fall and muscle disorder. The events occurred 1 day after administration of the booster dose of the Moderna mRNA-1273 vaccine. The report stated that the patient had a seizure which was described as 'horrible'. She also fell on the floor and 'all muscles gone'. Treatment information was not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.   This case was linked to MOD-2022-467243 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Follow-up contains no new information.; Sender's Comments: This spontaneous case concerns an 89-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious AESI of seizure and the unexpected, non-serious events of fall and muscle disorder. The events occurred 1 day after administration of the booster dose of the Moderna mRNA-1273 vaccine. The report stated that the patient had a seizure which was described as 'horrible'. She also fell on the floor and 'all muscles gone'. Treatment information was not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Respiratory failure
Clinical narrative: respiratory failure; COVID-19 pneumonia; This literature-non-study case was reported in a literature article and describes the occurrence of RESPIRATORY FAILURE (respiratory failure) and COVID-19 PNEUMONIA (COVID-19 pneumonia) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       The patient's past medical history included Liver transplant.    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, the patient experienced RESPIRATORY FAILURE (respiratory failure) (seriousness criteria death and medically significant) and COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criterion medically significant). The patient died on an unknown date. The reported cause of death was Respiratory failure. It is unknown if an autopsy was performed. At the time of death, COVID-19 PNEUMONIA (COVID-19 pneumonia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RESPIRATORY FAILURE (respiratory failure) and COVID-19 PNEUMONIA (COVID-19 pneumonia) to be related.    No concomitant and Treatment medications were reported. This is a literature case concerning an 82-year-old male patient with medical history of liver transplant, who experienced the serious unexpected ADR of COVID-19 pneumonia and serious unexpected fatal event of respiratory failure. The events occurred 10 days after the second dose of the mRNA-1273 vaccine. Causality for the event of COVID-19 pneumonia was not applicable to the product administration and assessed as related for respiratory failure event. The rechallenge was not applicable due to the events outcome. Very limited information available on the medical history, disease course and treatment at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.   This case was linked to MOD-2022-469625 (Patient Link).; Sender's Comments: This is a literature case concerning an 82-year-old male patient with medical history of liver transplant, who experienced the serious unexpected ADR of COVID-19 pneumonia and serious unexpected fatal event of respiratory failure. The events occurred 10 days after the second dose of the mRNA-1273 vaccine. Causality for the event of COVID-19 pneumonia was not applicable to the product administration and assessed as related for respiratory failure event. The rechallenge was not applicable due to the events outcome. Very limited information available on the medical history, disease course and treatment at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.; Reported Cause(s) of Death: respiratory failure
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to 7 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported.  No adverse events were observed in any of the patients. Date the vial was initially stored in the refrigerator on 19-Jan-2022. The vial undergone no temperature excursions.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: received a double dose accidentally; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (received a double dose accidentally) 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) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (received a double dose accidentally). At the time of the report, ACCIDENTAL OVERDOSE (received a double dose accidentally) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided. Reporter enquired what if she received a double dose accidentally.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received half dose booster instead of 3rd full shot for immunocompromised; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Received half dose booster instead of 3rd full shot for immunocompromised) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Severely).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received half dose booster instead of 3rd full shot for immunocompromised). At the time of the report, ACCIDENTAL UNDERDOSE (Received half dose booster instead of 3rd full shot for immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided.. No treatment medication details was provided.   Reporter did not allow further contact
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 040B21A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to bactrim), AFib, Diabetes and Drug allergy (oxybutynin allergy). Concomitant products included APIXABAN for AFib, METFORMIN for Diabetes, FLUOXETINE, HYDROCORTISONE and OMEPRAZOLE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022 at 12:45 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022 at 12:45 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date). On 24-Jan-2022 at 12:45 PM, EXPIRED PRODUCT ADMINISTERED (receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) to be not related.    The patient did not experience a similar event in the past. There were no other potential causes reported. The patient did not experience any associated adverse events. It was reported that, per Moderna, the vaccine will maintain the necessary effectiveness against COVID-19. The patient did not seek medical care for the event.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatments were reported.
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people) in a 23-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.   No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided The vaccines were stored in freezer , they take out one to two vials and placed in fridge each day as needed.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medication was given to the patient.  The vaccines were stored in freezer and took out one to two vials and placed in freezer each day as needed.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Expired Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  Treatment details were not given.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) had resolved.        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.   Expired Vaccine was given as booster shot to 500 people.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired vaccine in a 64-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 031B21A) for COVID-19 immunization. No medical history reported. On Nov 11, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 11, 2021, patient administered expired vaccine). On Nov 11, 2021, administered expired vaccine resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.