chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache
Clinical narrative: SORENESS FROM STOMACH DOWN AND BACK; HEADACHE; 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: high blood pressure, and stroke, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 07-MAR-2022) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced soreness from stomach down and back. On 04-OCT-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of soreness from stomach down and back was not reported. This report was non-serious.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Therapeutic response unexpected
Clinical narrative: DID NOT USE NEBULIZER AS OFTEN; This spontaneous report received from a patient concerned an 81 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, prostate cancer, penicillin's allergy, alcohol user, and non smoker. The patient was previously treated with salbutamol for asthma.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 23-AUG-2021) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included budesonide/formoterol fumarate.  On an unspecified date, the patient experienced did not use nebulizer as often. Laboratory data (dates unspecified) included: Lab test (NR: not provided) 0.02. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of did not use nebulizer as often was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211009653, 20211006668, 20211006798 and 20211006371.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned 3 patients. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patients 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. This case, from the same reporter is linked to 20211006371, 20211006668, 20211006798 and 20211009632.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ISSUES PARTLY BECAUSE OF THE VACCINE; 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced issues partly because of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of issues partly because of the vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: SEVERE REACTION TO THE VACCINE; This spontaneous report received from a parent 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, 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 severe reaction to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction to the vaccine was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Formication, Hypertension, Muscle spasms, Pain, Vaccination site discomfort
Clinical narrative: felt like something was crawling on her arm and she kept brushing it off; felt like she had blood pressure cuff on that arm compressed and release, hard tight, like something gripping in arm, pressure point/they hit a nerve; hypertension; Lot of agony; muscle spasm; pain at injection arm; This spontaneous case was reported by a consumer and describes the occurrence of FORMICATION (felt like something was crawling on her arm and she kept brushing it off), VACCINATION SITE DISCOMFORT (felt like she had blood pressure cuff on that arm compressed and release, hard tight, like something gripping in arm, pressure point/they hit a nerve), HYPERTENSION (hypertension), PAIN (Lot of agony) and MUSCLE SPASMS (muscle spasm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: flu short in November 2020.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-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 FORMICATION (felt like something was crawling on her arm and she kept brushing it off), VACCINATION SITE DISCOMFORT (felt like she had blood pressure cuff on that arm compressed and release, hard tight, like something gripping in arm, pressure point/they hit a nerve), HYPERTENSION (hypertension), PAIN (Lot of agony), MUSCLE SPASMS (muscle spasm) and VACCINATION SITE PAIN (pain at injection arm). At the time of the report, FORMICATION (felt like something was crawling on her arm and she kept brushing it off), VACCINATION SITE DISCOMFORT (felt like she had blood pressure cuff on that arm compressed and release, hard tight, like something gripping in arm, pressure point/they hit a nerve), HYPERTENSION (hypertension), PAIN (Lot of agony), MUSCLE SPASMS (muscle spasm) and VACCINATION SITE PAIN (pain at injection arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. Treatment to the events given as cortisone cream.   This case was linked to MOD-2021-276731 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Non significant information On 28-Sep-2021: Significant follow-up appended Event added and patient initials updated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: felt like something was crawling on her arm and she kept brushing it off; felt like she had blood pressure cuff on that arm compressed and release, hard tight, like something gripping in arm, pressure point/they hit a nerve; hypertension; Lot of agony; muscle spasm; pain at injection arm; This spontaneous case was reported by a consumer and describes the occurrence of FORMICATION (felt like something was crawling on her arm and she kept brushing it off), VACCINATION SITE DISCOMFORT (felt like she had blood pressure cuff on that arm compressed and release, hard tight, like something gripping in arm, pressure point/they hit a nerve), HYPERTENSION (hypertension), PAIN (Lot of agony) and MUSCLE SPASMS (muscle spasm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: flu short in November 2020.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-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 FORMICATION (felt like something was crawling on her arm and she kept brushing it off), VACCINATION SITE DISCOMFORT (felt like she had blood pressure cuff on that arm compressed and release, hard tight, like something gripping in arm, pressure point/they hit a nerve), HYPERTENSION (hypertension), PAIN (Lot of agony), MUSCLE SPASMS (muscle spasm) and VACCINATION SITE PAIN (pain at injection arm). At the time of the report, FORMICATION (felt like something was crawling on her arm and she kept brushing it off), VACCINATION SITE DISCOMFORT (felt like she had blood pressure cuff on that arm compressed and release, hard tight, like something gripping in arm, pressure point/they hit a nerve), HYPERTENSION (hypertension), PAIN (Lot of agony), MUSCLE SPASMS (muscle spasm) and VACCINATION SITE PAIN (pain at injection arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. Treatment to the events given as cortisone cream.   This case was linked to MOD-2021-276731 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Non significant information On 28-Sep-2021: Significant follow-up appended Event added and patient initials updated.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: he had the same problems; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (he had the same problems) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (he had the same problems). At the time of the report, DISCOMFORT (he had the same problems) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No treatment medication was provided.  No concomitant medication was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Bone pain, Chills
Clinical narrative: My back's hurting; Bones and everything was hurting; Hurting all over / aching all over, Bones and everything was hurting; Joint pain,; Fever of 100.9°F,101 fever; Chills; Headache; Nauseated; felt like going to vomit, only could drink tea; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (My back's hurting), BONE PAIN (Bones and everything was hurting), PAIN (Hurting all over / aching all over,Bones and everything was hurting), ARTHRALGIA (Joint pain,) and PYREXIA (Fever of 100.9°F,101 fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 025L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lumpectomy on 07-Apr-2021, Radiation therapy (First 3 weeks in May 2021.) in May 2021 and Mammogram on 27-Jan-2021. Concurrent medical conditions included Breast cancer since 15-Mar-2021.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced BACK PAIN (My back's hurting), PAIN (Hurting all over / aching all over,Bones and everything was hurting), ARTHRALGIA (Joint pain,), PYREXIA (Fever of 100.9°F,101 fever), CHILLS (Chills) and HEADACHE (Headache). 02-Sep-2021, the patient experienced BONE PAIN (Bones and everything was hurting), NAUSEA (Nauseated) and NAUSEA (felt like going to vomit, only could drink tea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of q6h. At the time of the report, BACK PAIN (My back's hurting), BONE PAIN (Bones and everything was hurting), PAIN (Hurting all over / aching all over,Bones and everything was hurting), ARTHRALGIA (Joint pain,), PYREXIA (Fever of 100.9°F,101 fever), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nauseated) and NAUSEA (felt like going to vomit, only could drink tea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, Body temperature: 101 (High) fever of 101.         No concomitant medication was reported. The patient reported she would take ibuprofen when the 6 hrs is up.  Patient thought patient was going to die.   This case was linked to MOD-2021-305899, MOD-2021-305824 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Significant follow up received  Event added.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: My back's hurting; Bones and everything was hurting; Hurting all over / aching all over, Bones and everything was hurting; Joint pain,; Fever of 100.9°F,101 fever; Chills; Headache; Nauseated; felt like going to vomit, only could drink tea; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (My back's hurting), BONE PAIN (Bones and everything was hurting), PAIN (Hurting all over / aching all over,Bones and everything was hurting), ARTHRALGIA (Joint pain,) and PYREXIA (Fever of 100.9°F,101 fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 025L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lumpectomy on 07-Apr-2021, Radiation therapy (First 3 weeks in May 2021.) in May 2021 and Mammogram on 27-Jan-2021. Concurrent medical conditions included Breast cancer since 15-Mar-2021.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced BACK PAIN (My back's hurting), PAIN (Hurting all over / aching all over,Bones and everything was hurting), ARTHRALGIA (Joint pain,), PYREXIA (Fever of 100.9°F,101 fever), CHILLS (Chills) and HEADACHE (Headache). 02-Sep-2021, the patient experienced BONE PAIN (Bones and everything was hurting), NAUSEA (Nauseated) and NAUSEA (felt like going to vomit, only could drink tea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of q6h. At the time of the report, BACK PAIN (My back's hurting), BONE PAIN (Bones and everything was hurting), PAIN (Hurting all over / aching all over,Bones and everything was hurting), ARTHRALGIA (Joint pain,), PYREXIA (Fever of 100.9°F,101 fever), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nauseated) and NAUSEA (felt like going to vomit, only could drink tea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, Body temperature: 101 (High) fever of 101.         No concomitant medication was reported. The patient reported she would take ibuprofen when the 6 hrs is up.  Patient thought patient was going to die.   This case was linked to MOD-2021-305899, MOD-2021-305824 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Significant follow up received  Event added.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Maternal exposure during breast feeding, Product dose omission issue
Clinical narrative: never went for the second dose; Had a cough; Gave birth 2 months ago / breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (never went for the second dose), COUGH (Had a cough) and MATERNAL EXPOSURE DURING BREAST FEEDING (Gave birth 2 months ago / breastfeeding) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never went for the second dose), COUGH (Had a cough) and MATERNAL EXPOSURE DURING BREAST FEEDING (Gave birth 2 months ago / breastfeeding). At the time of the report, PRODUCT DOSE OMISSION ISSUE (never went for the second dose) had resolved and COUGH (Had a cough) and MATERNAL EXPOSURE DURING BREAST FEEDING (Gave birth 2 months ago / breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.  This is a case of product omission issue for this 25-year-old, female patient with no known medical history, who experienced the unexpected events of maternal exposure during breastfeeding and cough. It is unknown when events occurred after first dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-326863 (Parent-Child Link).   See case MOD-2021-326863 for details regarding the child case.; Sender's Comments: This is a case of product omission issue for this 25-year-old, female patient with no known medical history, who experienced the unexpected events of maternal exposure during breastfeeding and cough. It is unknown when events occurred after first dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose administered from a vial that was more than 30 days on the fridge; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered from a vial that was more than 30 days on the fridge) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Aug-2021 at 2:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021 at 3:26 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered from a vial that was more than 30 days on the fridge). On 20-Sep-2021, PRODUCT STORAGE ERROR (Dose administered from a vial that was more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.   This case was linked to MOD-2021-326226, MOD-2021-326432 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow-up was  received on 23-SEP-2021 and contains initials, race, ethinicity and vaccination facility details added.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered  from a vial that was more than 30 days on the fridge; vial that spent more than 30 days on the fridge; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered  from a vial that was more than 30 days on the fridge) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered  from a vial that was more than 30 days on the fridge). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered  from a vial that was more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Facility administered by error a dose from a vial that spent more than 30 days on the fridge(since 19Aug2021). No concomitant medication information were provided. No treatment medications were reported.   This case was linked to MOD-2021-326226, MOD-2021-326432 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow-up received contains- Patient demographic- ethnicity, contains vaccination facility information, Updated dose number.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Loss of personal independence in daily activities, Myalgia, Nausea, Vaccination complication
Clinical narrative: Can barely walk; Delayed reaction to my first dose; Severe vertigo; cannot drive a motor vehicle; Nausea; Pain and soreness in my right arm; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Can barely walk), VACCINATION COMPLICATION (Delayed reaction to my first dose), VERTIGO (Severe vertigo), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot drive a motor vehicle) and NAUSEA (Nausea) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced MYALGIA (Pain and soreness in my right arm). On 19-Sep-2021, the patient experienced GAIT DISTURBANCE (Can barely walk), VACCINATION COMPLICATION (Delayed reaction to my first dose), VERTIGO (Severe vertigo), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot drive a motor vehicle) and NAUSEA (Nausea). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency; MECLIZINE [MECLOZINE] at an unspecified dose and frequency and DIAZEPAM (VALIUM) at an unspecified dose and frequency. On 12-Sep-2021, MYALGIA (Pain and soreness in my right arm) had resolved. At the time of the report, GAIT DISTURBANCE (Can barely walk), VACCINATION COMPLICATION (Delayed reaction to my first dose), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot drive a motor vehicle) and NAUSEA (Nausea) outcome was unknown and VERTIGO (Severe vertigo) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Laboratory data included CT scan of head, MRI of head, Bloodwork, COVID test, and a neurological exam  with inconclusive results. Patient had appointment with an ENT specialist and an audiologist and had a hearing exam with inconclusive result.  No relevant concomitant medications were reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Can barely walk; Delayed reaction to my first dose; Severe vertigo; cannot drive a motor vehicle; Nausea; Pain and soreness in my right arm; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Can barely walk), VACCINATION COMPLICATION (Delayed reaction to my first dose), VERTIGO (Severe vertigo), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot drive a motor vehicle) and NAUSEA (Nausea) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced MYALGIA (Pain and soreness in my right arm). On 19-Sep-2021, the patient experienced GAIT DISTURBANCE (Can barely walk), VACCINATION COMPLICATION (Delayed reaction to my first dose), VERTIGO (Severe vertigo), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot drive a motor vehicle) and NAUSEA (Nausea). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency; MECLIZINE [MECLOZINE] at an unspecified dose and frequency and DIAZEPAM (VALIUM) at an unspecified dose and frequency. On 12-Sep-2021, MYALGIA (Pain and soreness in my right arm) had resolved. At the time of the report, GAIT DISTURBANCE (Can barely walk), VACCINATION COMPLICATION (Delayed reaction to my first dose), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot drive a motor vehicle) and NAUSEA (Nausea) outcome was unknown and VERTIGO (Severe vertigo) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Laboratory data included CT scan of head, MRI of head, Bloodwork, COVID test, and a neurological exam  with inconclusive results. Patient had appointment with an ENT specialist and an audiologist and had a hearing exam with inconclusive result.  No relevant concomitant medications were reported.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received dose from expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from expired vial) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine, Hypertension, Bipolar disorder and GERD.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from expired vial). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported No treatment medicines were reported   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Significant follow up appended- Patient demographics, past medical history, suspected dose information, and vaccine facility information updated
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after allowed time after first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after allowed time after first vial puncture) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 4:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after allowed time after first vial puncture). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after allowed time after first vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up information received and contains No new information On 29-Sep-2021: Followup document received on 29-SEP-2021,Patient demographics, concomitant medicines were reported and the event were added
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vertigo
Clinical narrative: arm pain; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and VERTIGO (vertigo) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included METOPROLOL, CALCIUM ACETATE, VITAMIN D3 and MAGNESIUM for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-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 PAIN IN EXTREMITY (arm pain) and VERTIGO (vertigo). At the time of the report, PAIN IN EXTREMITY (arm pain) and VERTIGO (vertigo) had resolved.            Patient had an Epley Maneuver which resolved the vertigo.   This case was linked to MOD-2021-330839 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow-up received on 29-SEP-2021 contains Patient demographics and lot number for both doses added.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscle fatigue, Muscle spasms
Clinical narrative: Muscle Cramps/symptoms much, much worse; Muscle Fatigue/symptoms much, much worse; joint ache/symptoms much, much worse; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle Cramps/symptoms much, much worse), MUSCLE FATIGUE (Muscle Fatigue/symptoms much, much worse) and ARTHRALGIA (joint ache/symptoms much, much worse) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030821A and 019821A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-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 MUSCLE SPASMS (Muscle Cramps/symptoms much, much worse), MUSCLE FATIGUE (Muscle Fatigue/symptoms much, much worse) and ARTHRALGIA (joint ache/symptoms much, much worse). At the time of the report, MUSCLE SPASMS (Muscle Cramps/symptoms much, much worse), MUSCLE FATIGUE (Muscle Fatigue/symptoms much, much worse) and ARTHRALGIA (joint ache/symptoms much, much worse) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-327992 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow-up received and contains No New Information.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Felt malaise for a day after his first two shots; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt malaise for a day after his first two shots) and VACCINATION SITE PAIN (Sore arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K7CA and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-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 15-Jan-2021, the patient experienced MALAISE (Felt malaise for a day after his first two shots) and VACCINATION SITE PAIN (Sore arm). At the time of the report, MALAISE (Felt malaise for a day after his first two shots) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  The patient reported that post receiving their second dose of vaccine the patient only had a sore arm and felt malaise for a day. The patient's weight information provided as 171 with no units.   This case was linked to MOD-2021-331183, MOD-2021-331295, MOD-2021-331192 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Eczema, Inappropriate schedule of product administration, Influenza, Joint swelling
Clinical narrative: Arm pain; Joiint swelling; Eczema worsened; Severe flu symptoms; Fever; Itching/burning at vaccination site; Itching/burning at vaccination site; Burning; Itching; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PRURITUS (Itching), JOINT SWELLING (Joiint swelling), BURNING SENSATION (Burning) and ECZEMA (Eczema worsened) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Influenza vaccine (Flu shot (thimerosal ingredient), In the past, localized reaction to thimerosal ingredient and but no longer a problem since it's no longer an ingredient). Concurrent medical conditions included Hypersensitivity, Sulfonamide allergy (Sulfa drugs- Reaction reported includes hives.), Fruit allergy (Allergy to apples.primarily, throat itching and swelling.), Fruit allergy (Allergy to Peaches-primarily, throat itching and swelling.), Seasonal allergy, Eczema (Worsened after Moderna vaccine) and Hay fever. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and TRIAMCINOLONE ACETONIDE (NASACORT) for Allergy, MULTIVITAMIN [VITAMINS NOS] and FISH OIL for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In August 2021, the patient experienced PRURITUS (Itching), BURNING SENSATION (Burning), VACCINATION SITE PRURITUS (Itching/burning at vaccination site) and VACCINATION SITE PAIN (Itching/burning at vaccination site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), JOINT SWELLING (Joiint swelling), ECZEMA (Eczema worsened), INFLUENZA (Severe flu symptoms) and PYREXIA (Fever). On 24-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm pain), INFLUENZA (Severe flu symptoms) and PYREXIA (Fever) had resolved, PRURITUS (Itching), JOINT SWELLING (Joiint swelling), BURNING SENSATION (Burning), VACCINATION SITE PRURITUS (Itching/burning at vaccination site) and VACCINATION SITE PAIN (Itching/burning at vaccination site) had not resolved and ECZEMA (Eczema worsened) outcome was unknown.            Patient took injection on the right side. It is reported that patient continued to take Zyrtec but no other treatment information was provided.   This case was linked to MOD-2021-194570 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Pyrexia, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Arm pain; Joiint swelling; Eczema worsened; Severe flu symptoms; Fever; Itching/burning at vaccination site; Itching/burning at vaccination site; Burning; Itching; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PRURITUS (Itching), JOINT SWELLING (Joiint swelling), BURNING SENSATION (Burning) and ECZEMA (Eczema worsened) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Influenza vaccine (Flu shot (thimerosal ingredient), In the past, localized reaction to thimerosal ingredient and but no longer a problem since it's no longer an ingredient). Concurrent medical conditions included Hypersensitivity, Sulfonamide allergy (Sulfa drugs- Reaction reported includes hives.), Fruit allergy (Allergy to apples.primarily, throat itching and swelling.), Fruit allergy (Allergy to Peaches-primarily, throat itching and swelling.), Seasonal allergy, Eczema (Worsened after Moderna vaccine) and Hay fever. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and TRIAMCINOLONE ACETONIDE (NASACORT) for Allergy, MULTIVITAMIN [VITAMINS NOS] and FISH OIL for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In August 2021, the patient experienced PRURITUS (Itching), BURNING SENSATION (Burning), VACCINATION SITE PRURITUS (Itching/burning at vaccination site) and VACCINATION SITE PAIN (Itching/burning at vaccination site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), JOINT SWELLING (Joiint swelling), ECZEMA (Eczema worsened), INFLUENZA (Severe flu symptoms) and PYREXIA (Fever). On 24-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm pain), INFLUENZA (Severe flu symptoms) and PYREXIA (Fever) had resolved, PRURITUS (Itching), JOINT SWELLING (Joiint swelling), BURNING SENSATION (Burning), VACCINATION SITE PRURITUS (Itching/burning at vaccination site) and VACCINATION SITE PAIN (Itching/burning at vaccination site) had not resolved and ECZEMA (Eczema worsened) outcome was unknown.            Patient took injection on the right side. It is reported that patient continued to take Zyrtec but no other treatment information was provided.   This case was linked to MOD-2021-194570 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Nausea, Night sweats, Vaccination site pain
Clinical narrative: Dry cough; Night sweats; soreness at the injection site; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), NIGHT SWEATS (Night sweats), VACCINATION SITE PAIN (soreness at the injection site), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A., 018B21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seizure and Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol, LEVETIRACETAM (KEPRA) and LAMOTRIGINE (LAMICTAL) for Seizure.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced COUGH (Dry cough), NIGHT SWEATS (Night sweats), VACCINATION SITE PAIN (soreness at the injection site), FATIGUE (Fatigue) and NAUSEA (Nausea). On 22-Sep-2021, NIGHT SWEATS (Night sweats) had resolved. On 23-Sep-2021, NAUSEA (Nausea) had resolved. At the time of the report, COUGH (Dry cough), VACCINATION SITE PAIN (soreness at the injection site) and FATIGUE (Fatigue) had not resolved.            Treatment drug was not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: left arm swelled up at the injection site; left arm red at the injection site; Left arm slightly painful upon pressure at injection site / size had expanded and it was sore; Reaction to that vaccine, Covid Arm; left arm hard at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Reaction to that vaccine, Covid Arm), VACCINATION SITE INDURATION (left arm hard at the injection site), VACCINATION SITE SWELLING (left arm swelled up at the injection site), VACCINATION SITE ERYTHEMA (left arm red at the injection site) and VACCINATION SITE PAIN (Left arm slightly painful upon pressure at injection site / size had expanded and it was sore) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #032M20A and 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Factor V Leiden mutation, Asthma and Allergy to antibiotic (Allergy to erythromycin.). Concomitant products included SALBUTAMOL (VENTOLIN [SALBUTAMOL]), MONTELUKAST and NATTOKINASE for an unknown indication.   On 09-Mar-2021 at 10:46 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE REACTION (Reaction to that vaccine, Covid Arm). March 2021, the patient experienced VACCINATION SITE INDURATION (left arm hard at the injection site), VACCINATION SITE ERYTHEMA (left arm red at the injection site) and VACCINATION SITE PAIN (Left arm slightly painful upon pressure at injection site / size had expanded and it was sore). On 19-Mar-2021, the patient experienced VACCINATION SITE SWELLING (left arm swelled up at the injection site). On 29-Mar-2021, VACCINATION SITE SWELLING (left arm swelled up at the injection site) had resolved. At the time of the report, VACCINATION SITE REACTION (Reaction to that vaccine, Covid Arm), VACCINATION SITE INDURATION (left arm hard at the injection site), VACCINATION SITE ERYTHEMA (left arm red at the injection site) and VACCINATION SITE PAIN (Left arm slightly painful upon pressure at injection site / size had expanded and it was sore) outcome was unknown. Not Provided          Patient went to an Urgent care and the emergency room, but no treatment information mentioned. It was also reported that patient had no reactions to second shot. Patient was on Pyconogel 200 mg two times a day, indication - blood thinner  Nattokinase - indication - blood thinner.   Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2021: Updated patient date of birth On 03-Oct-2021: updated patient demographics, past medical history, vaccine details, concomitant medications, events.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7 patients were given a dose of the Moderna vaccine 26 hours after first puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients were given a dose of the Moderna vaccine 26 hours after first puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients were given a dose of the Moderna vaccine 26 hours after first puncture). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (7 patients were given a dose of the Moderna vaccine 26 hours after first puncture) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.