chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Erythema, Feeling abnormal, Herpes zoster, Hypoaesthesia
Clinical narrative: Funny feeling; heart palpitations; The place patient got the shot was all red; Started scratching the place patient got the shot; little bit of a fever; whole arm was red; Sometimes patient had the shingles in the left eye and the numbness is on that side; affected whole left side of the face, felt a little numb; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (whole arm was red), HERPES ZOSTER (Sometimes patient had the shingles in the left eye and the numbness is on that side), HYPOAESTHESIA (affected whole left side of the face, felt a little numb), FEELING ABNORMAL (Funny feeling) and PALPITATIONS (heart palpitations) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced ERYTHEMA (whole arm was red), HERPES ZOSTER (Sometimes patient had the shingles in the left eye and the numbness is on that side), HYPOAESTHESIA (affected whole left side of the face, felt a little numb), VACCINATION SITE ERYTHEMA (The place patient got the shot was all red), VACCINATION SITE PRURITUS (Started scratching the place patient got the shot) and PYREXIA (little bit of a fever). October 2021, the patient experienced PALPITATIONS (heart palpitations). On 28-Oct-2021, the patient experienced FEELING ABNORMAL (Funny feeling). In October 2021, PALPITATIONS (heart palpitations) had resolved. At the time of the report, ERYTHEMA (whole arm was red), VACCINATION SITE ERYTHEMA (The place patient got the shot was all red) and VACCINATION SITE PRURITUS (Started scratching the place patient got the shot) had not resolved and HERPES ZOSTER (Sometimes patient had the shingles in the left eye and the numbness is on that side), HYPOAESTHESIA (affected whole left side of the face, felt a little numb), FEELING ABNORMAL (Funny feeling) and PYREXIA (little bit of a fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.    Patient experienced palpitations started at 3 in the afternoon, and by 6 pm it slow down and went away. Patient went to the emergency room. After the vaccination, patient was for an hour and it was all calm.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Funny feeling; heart palpitations; The place patient got the shot was all red; Started scratching the place patient got the shot; little bit of a fever; whole arm was red; Sometimes patient had the shingles in the left eye and the numbness is on that side; affected whole left side of the face, felt a little numb; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (whole arm was red), HERPES ZOSTER (Sometimes patient had the shingles in the left eye and the numbness is on that side), HYPOAESTHESIA (affected whole left side of the face, felt a little numb), FEELING ABNORMAL (Funny feeling) and PALPITATIONS (heart palpitations) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced ERYTHEMA (whole arm was red), HERPES ZOSTER (Sometimes patient had the shingles in the left eye and the numbness is on that side), HYPOAESTHESIA (affected whole left side of the face, felt a little numb), VACCINATION SITE ERYTHEMA (The place patient got the shot was all red), VACCINATION SITE PRURITUS (Started scratching the place patient got the shot) and PYREXIA (little bit of a fever). October 2021, the patient experienced PALPITATIONS (heart palpitations). On 28-Oct-2021, the patient experienced FEELING ABNORMAL (Funny feeling). In October 2021, PALPITATIONS (heart palpitations) had resolved. At the time of the report, ERYTHEMA (whole arm was red), VACCINATION SITE ERYTHEMA (The place patient got the shot was all red) and VACCINATION SITE PRURITUS (Started scratching the place patient got the shot) had not resolved and HERPES ZOSTER (Sometimes patient had the shingles in the left eye and the numbness is on that side), HYPOAESTHESIA (affected whole left side of the face, felt a little numb), FEELING ABNORMAL (Funny feeling) and PYREXIA (little bit of a fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.    Patient experienced palpitations started at 3 in the afternoon, and by 6 pm it slow down and went away. Patient went to the emergency room. After the vaccination, patient was for an hour and it was all calm.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT TO THE VACCINE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse event to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event to the vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Mass, Ocular hyperaemia, Periorbital swelling
Clinical narrative: LEFT EYE SWOLLEN; PUFFINESS IN LEFT EYE; RIGHT EYE WAS REDDIDSH BUT NOT SWOLLEN/REDNESSS IN LEFT EYE; BAGGY LUMP IN LEFT EYE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Generally healthy, saw physician for checkup in 2020 routine. Patient had no drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: UNKNOWN) dose was not reported, administered on 01-NOV-2021 07:20 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced left eye swollen. On 02-NOV-2021, the patient experienced puffiness in left eye. On 02-NOV-2021, the patient experienced right eye was reddidsh but not swollen/rednesss in left eye. On 02-NOV-2021, the patient experienced baggy lump in left eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left eye swollen, puffiness in left eye, and right eye was reddidsh but not swollen/rednesss in left eye, and the outcome of baggy lump in left eye was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: MYOCARDITIS; PERICARDITIS; .This spontaneous report received from a consumer via a company representative concerned a 33 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) 1 total, 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, it was reported that the patient developed myocarditis, and pericarditis. However, the doctor told that there was no correlation between the vaccine and these conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myocarditis and pericarditis was not reported. The reporter causality of the event myocarditis, and pericarditis was not related to covid-19 vaccine ad26.cov2.s and company causality was not related to covid-19 vaccine ad26.cov2.s. This report was serious (Other Medically Important Condition) This case, from the same reporter is linked to 20211110332.    .; Sender's Comments: V0- 20211109933- covid-19 vaccine ad26.cov2.s Myocarditis, Pericarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: BODY ACHES; SHIVERING UNDER A BLANKET AT ROOM TEMPERATURE 75; FEVER; VOMITING; 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 and lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced body aches, shivering under a blanket at room temperature 75, fever, and vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, shivering under a blanket at room temperature 75, fever, and vomiting. This report was non-serious. This case, from the same reporter is linked to 20211109933.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Sinusitis, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SINUS INFECTION; This spontaneous report received from a patient concerned a 53 year old male with unspecified ethnicity. The patient's weight was 260 pounds, and height was 71 inches. The patient's concurrent conditions included: diabetic, non-smoker, and alcohol use 1 or 2 drinks a week, and other pre-existing medical conditions included: The patient has no known allergies. The patient has no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) 1 total, dose was not reported, administered on 16-JUL-2021 for prophylactic vaccination. Concomitant medications included empagliflozin for diabetes, metformin for diabetes, and metformin hydrochloride/pioglitazone hydrochloride for diabetes.  On OCT-2021, the patient experienced confirmed covid-19 infection. On OCT-2021, the patient experienced sinus infection. On an unspecified date, the patient experienced confirmed clinical vaccination failure. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, confirmed clinical vaccination failure and sinus infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority.; Sender's Comments: V0 20211110640-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Euphoric mood, Fatigue
Clinical narrative: FELT EUPHORIC; KIND OF TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, non-smoker, hypertension, generalized anxiety, penicillin allergy, and mushrooms allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient was part of a study for RSV vaccine and was vaccinated in late august 2021. The patient experienced drug allergy when treated with nitrofurantoin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 23-AUG-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination.  Concomitant medications included sertraline for generalized anxiety, and amlodipine for hypertension.  On 10-MAR-2021, the patient experienced felt euphoric. On 10-MAR-2021, the patient experienced kind of tired. On 20-APR-2021, Laboratory data included: Antibody test (NR: not provided) Positive IgG. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt euphoric, and kind of tired on 11-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: SORE ARM; SEVERE FATIGUE/FATIGUE; HEADACHE; This spontaneous report received from a consumer concerned an elderly male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm, severe fatigue/fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe fatigue/fatigue, and headache, and the outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20211110204.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Fatigue, Feeling hot, Headache, Paraesthesia
Clinical narrative: HAIR FALLING OFF DRASTICALLY/THINNING HAIR; FEELING WARM; TINGLING IN LEGS; FELT VERY TIRED/ FELT TIRED TO EXERCISE; HEADACHE LIKE PRESSURE IN THE HEAD; .This spontaneous report received from a patient concerned a 36 year old female. The patient's weight was 140 pounds, and height was 64 inches. The patient's concurrent conditions included: social alcohol drinker, non-smoker, and hair loss, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse/illicit drug use. The patient had no medical conditions and was not taking any medication except for the hair vitamins and local hair treatment. The patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced feeling warm. On 06-APR-2021, the patient experienced tingling in legs. On 06-APR-2021, the patient experienced felt very tired/ felt tired to exercise. On 06-APR-2021, the patient experienced headache like pressure in the head. Treatment medications included: paracetamol. On MAY-2021, the patient experienced hair falling off drastically/thinning hair. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling warm, tingling in legs, and headache like pressure in the head on 06-APR-2021, and felt very tired/ felt tired to exercise on 13-APR-2021, and had not recovered from hair falling off drastically/thinning hair. This report was non-serious. This case, from the same reporter is linked to 20211112231.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 36 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: GOT PFIZER COVID VACCINE THEN FOUND OUT ALREADY RECEIVED THE JANSSEN COVID VACCINE; This spontaneous report received from a pharmacist concerned a 71 year old male. The patient's weight was 78.93 kilograms, and height was 173 centimeters. The patient's concurrent conditions included: schizophrenia, and hypertension. 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. Per procedure, no follow-up will be requested for this case.   Concomitant medications included amlodipine for hypertension, lisinopril for hypertension, bnt 162 for prophylactic vaccination, and haloperidol. On 27-OCT-2021, the patient experienced got pfizer covid vaccine then found out already received the janssen covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got pfizer covid vaccine then found out already received the janssen covid vaccine was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Dizziness, Head discomfort, Headache
Clinical narrative: PRESSURE IN HEAD; DIZZINESS; MUSCLE WEAKNESS (JUST FEELING EXHAUSTED WHEN HE STANDS); POUNDING HEADACHE; TEMPERATURE (100.6 F); This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's past medical history included: migraines, and heart murmur, and concurrent conditions included: shellfish allergy, iodine allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 03-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-NOV-2021, the patient experienced pressure in head, dizziness, muscle weakness (just feeling exhausted when he stands), pounding headache, and temperature (100.6 f). Laboratory data included: Body temperature (NR: not provided) 100.6 F. On 04-NOV-2021, Laboratory data included: Body temperature (NR: not provided) 99.9 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pounding headache, pressure in head, dizziness, temperature (100.6 f), and muscle weakness (just feeling exhausted when he stands). This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: PRESSURE IN HEAD; DIZZINESS; MUSCLE WEAKNESS (JUST FEELING EXHAUSTED WHEN HE STANDS); POUNDING HEADACHE; TEMPERATURE (100.6 F); This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's past medical history included: migraines, and heart murmur, and concurrent conditions included: shellfish allergy, iodine allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 03-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-NOV-2021, the patient experienced pressure in head, dizziness, muscle weakness (just feeling exhausted when he stands), pounding headache, and temperature (100.6 f). Laboratory data included: Body temperature (NR: not provided) 100.6 F. On 04-NOV-2021, Laboratory data included: Body temperature (NR: not provided) 99.9 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pounding headache, pressure in head, dizziness, temperature (100.6 f), and muscle weakness (just feeling exhausted when he stands). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SEVERELY SICK THAT COULD NOT GO UP AND DOWN THE STAIRS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 severely sick that could not go up and down the stairs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severely sick that could not go up and down the stairs was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF VACCINE WHICH REMAINED PUNCTURED IN THE FRIDGE FOR LONGER THAN 6 HOURS; This spontaneous report received from a health care professional 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: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 03-NOV-2021 10:32 for prophylactic vaccination. No concomitant medications were reported. On 03-NOV-2021, the patient experienced administration of vaccine which remained punctured in the fridge for longer than 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine which remained punctured in the fridge for longer than 6 hours was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF THE JANSSEN COVID-19 VACCINE AFTER IT HAD BEEN PUNCTURED AND LEFT AT ROOM TEMPERATURE FOR 4 HOURS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: 09-APR-2022) dose was not reported, administered on 03-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-NOV-2021, the patient experienced administration of the janssen covid-19 vaccine after it had been punctured and left at room temperature for 4 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of the janssen covid-19 vaccine after it had been punctured and left at room temperature for 4 hours was not reported. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Heart rate, Heart rate increased
Clinical narrative: CHEST TIGHTNESS; PERSISTENT HEADACHE; ELEVATED HEART RATE OF 90-100 BEATS PER MINUTE AT REST; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies, no drug abuse nor illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1822811 expiry: 20-MAR-2022) dose was not reported, administered on 27-OCT-2021 08:30 for prophylactic vaccination. No concomitant medications were reported. On 27-OCT-2021, the patient experienced elevated heart rate of 90-100 beats per minute at rest. Laboratory data included: Heart rate (NR: 50 - 60) elevated at 90-100 beats per minute. On 28-OCT-2021, treatment medications included: ibuprofen. On 29-OCT-2021, the patient experienced chest tightness. On 29-OCT-2021, the patient experienced persistent headache. Additional treatment medications (dates unspecified) included: pseudoephedrine, naproxen sodium, and acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated heart rate of 90-100 beats per minute at rest on 28-OCT-2021, and had not recovered from chest tightness, and persistent headache. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Depression, Diarrhoea, Eczema, Fatigue
Clinical narrative: Depression; Diarrhea; Eczema flair up last was 30+ years ago; Increased joint problems; Fatigue continues today; Headache; Fever (102F); This spontaneous case was reported by a nurse and describes the occurrence of DEPRESSION (Depression), DIARRHOEA (Diarrhea), ECZEMA (Eczema flair up last was 30+ years ago), MUSCULOSKELETAL DISCOMFORT (Increased joint problems) and FATIGUE (Fatigue continues today) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema (eczema flair up last was 30+ years ago). Concurrent medical conditions included Asthma.    On 23-Feb-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 DEPRESSION (Depression), DIARRHOEA (Diarrhea), ECZEMA (Eczema flair up last was 30+ years ago), MUSCULOSKELETAL DISCOMFORT (Increased joint problems), FATIGUE (Fatigue continues today), HEADACHE (Headache) and PYREXIA (Fever (102F)). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, DEPRESSION (Depression), DIARRHOEA (Diarrhea), ECZEMA (Eczema flair up last was 30+ years ago), MUSCULOSKELETAL DISCOMFORT (Increased joint problems), HEADACHE (Headache) and PYREXIA (Fever (102F)) outcome was unknown and FATIGUE (Fatigue continues today) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever (102F).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.   This case was linked to MOD-2021-270806 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received includes additional events (Significant follow-up).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal discomfort, Pyrexia
Clinical narrative: Depression; Diarrhea; Eczema flair up last was 30+ years ago; Increased joint problems; Fatigue continues today; Headache; Fever (102F); This spontaneous case was reported by a nurse and describes the occurrence of DEPRESSION (Depression), DIARRHOEA (Diarrhea), ECZEMA (Eczema flair up last was 30+ years ago), MUSCULOSKELETAL DISCOMFORT (Increased joint problems) and FATIGUE (Fatigue continues today) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema (eczema flair up last was 30+ years ago). Concurrent medical conditions included Asthma.    On 23-Feb-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 DEPRESSION (Depression), DIARRHOEA (Diarrhea), ECZEMA (Eczema flair up last was 30+ years ago), MUSCULOSKELETAL DISCOMFORT (Increased joint problems), FATIGUE (Fatigue continues today), HEADACHE (Headache) and PYREXIA (Fever (102F)). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, DEPRESSION (Depression), DIARRHOEA (Diarrhea), ECZEMA (Eczema flair up last was 30+ years ago), MUSCULOSKELETAL DISCOMFORT (Increased joint problems), HEADACHE (Headache) and PYREXIA (Fever (102F)) outcome was unknown and FATIGUE (Fatigue continues today) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever (102F).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.   This case was linked to MOD-2021-270806 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received includes additional events (Significant follow-up).
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, SARS-CoV-2 antibody test, Wrong technique in product usage process
Clinical narrative: vaccine thawed inappropriately/ vial was shaken; He actually got full dose instead of a booster dose on 22Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccine thawed inappropriately/ vial was shaken) and ACCIDENTAL OVERDOSE (He actually got full dose instead of a booster dose on 22Oct2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccine thawed inappropriately/ vial was shaken) and ACCIDENTAL OVERDOSE (He actually got full dose instead of a booster dose on 22Oct2021). On 22-Oct-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccine thawed inappropriately/ vial was shaken) and ACCIDENTAL OVERDOSE (He actually got full dose instead of a booster dose on 22Oct2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, SARS-CoV-2 antibody test: 10.22 (High) it shows that he is positive for antibodies..         Concomitant medications were not provided. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Significant Follow-up - Reporter updating for antibody test results. And that he received full dose instead of booster dose.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Feeling abnormal, Pain in extremity
Clinical narrative: Dizziness; Stabbing pain in both their feet/ It was both her feet, very sharp, and very constant; Very very bad for at least 12 hours; The sore arm extended in the back of her neck, so it became one huge pain in the back to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (Stabbing pain in both their feet/ It was both her feet, very sharp, and very constant), FEELING ABNORMAL (Very very bad for at least 12 hours) and ARTHRALGIA (The sore arm extended in the back of her neck, so it became one huge pain in the back to shoulder) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy (for years).    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (Stabbing pain in both their feet/ It was both her feet, very sharp, and very constant), FEELING ABNORMAL (Very very bad for at least 12 hours) and ARTHRALGIA (The sore arm extended in the back of her neck, so it became one huge pain in the back to shoulder). The patient was treated with GABAPENTIN on 23-Oct-2021 for Pain, at a dose of 3 gabapentin at night and GABAPENTIN on 24-Oct-2021 for Pain, at a dose of 2 gabapentin at morning. At the time of the report, DIZZINESS (Dizziness) and PAIN IN EXTREMITY (Stabbing pain in both their feet/ It was both her feet, very sharp, and very constant) had not resolved, FEELING ABNORMAL (Very very bad for at least 12 hours) outcome was unknown and ARTHRALGIA (The sore arm extended in the back of her neck, so it became one huge pain in the back to shoulder) was resolving.            No Concomitant product use was reported.  It was also reported that the patient suffered from neuropathy and these symptoms rarely occurred. The patient took 3 gabapentin on 23-Oct-2021 night and 2 on 24-Oct-2021 morning to alleviate the pain. The sore arm extended in the back of her neck, so it became one huge pain in the back to her shoulder. It's a lot better now 26Oct2021.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Reporter added /Event updated
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received dose from expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 029A21A and 042L20A) for COVID-19 vaccination.     Previously administered products included for Congestive heart failure: Bisoprolol (5 mg orally) on 23-Mar-2021; for an unreported indication: FLUZONE [INFLUENZA VACCINE] (Sanofi vaccine, Batch no:UJ704AA and intramuscularly on right deltoid) on 30-Sep-2021. Concurrent medical conditions included Asthma on 20-Mar-2018, COPD on 20-Mar-2018, Coronary artery disease on 08-Feb-2015, Heart failure on 08-Jul-2018, Obesity on 08-Apr-2015 and Peripheral vascular disease on 12-Apr-2021. Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) from 19-Nov-2015 to an unknown date for Depression, ATORVASTATIN CALCIUM (LIPITOR) from 07-Sep-2019 to an unknown date for High cholesterol, LISINOPRIL from 25-Apr-2015 to an unknown date for Hypertension, DABIGATRAN ETEXILATE MESILATE (PRADAXA) from 08-Feb-1018 to an unknown date for Stent placement.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry) to be not related.    Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Significant follow up received on 29-Oct-21 :- reporter HCP details, relevant history, concomitant medications and narrative updated.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient/expired dose administered to patient; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient/expired dose administered to patient) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient/expired dose administered to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient/expired dose administered to patient) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  No treatment information was reported.  There are no adverse events reported for the patient.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow-up received includes significant information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided. It has been reported that there  were no adverse event for patient.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received contains significant Information added in I narrative.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site erythema, Vaccination site pain
Clinical narrative: soreness at injection side; lately incredible red site at injection site; headache; Severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection side), VACCINATION SITE ERYTHEMA (lately incredible red site at injection site), HEADACHE (headache) and NAUSEA (Severe nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Asthma, Allergy to antibiotic (sulfa) and Allergy to antibiotic (cephalosporins).    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 VACCINATION SITE PAIN (soreness at injection side), VACCINATION SITE ERYTHEMA (lately incredible red site at injection site), HEADACHE (headache) and NAUSEA (Severe nausea). At the time of the report, VACCINATION SITE PAIN (soreness at injection side), VACCINATION SITE ERYTHEMA (lately incredible red site at injection site), HEADACHE (headache) and NAUSEA (Severe nausea) outcome was unknown.            No concomitant medication was provided by patient. No treatment information was provided by patient.   This case was linked to MOD-2021-365089 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Non-Significant follow up appended-Contact info updated
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided. Upon follow-up it was confirmed that no adverse events to report for that patient.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received on 02-Nov 2021 included updated query response.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Inappropriate schedule of product administration, Loss of consciousness
Clinical narrative: He pass out; Dizzy; Chills; Inappropiriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (He pass out) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 044A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, METOPROLOL and LOSARTAN for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropiriate schedule of vaccine administered). On 27-Oct-2021, the patient experienced CHILLS (Chills). On 27-Oct-2021 at 10:00 AM, the patient experienced LOSS OF CONSCIOUSNESS (He pass out) (seriousness criterion medically significant) and DIZZINESS (Dizzy). The patient was treated with PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency. On 26-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropiriate schedule of vaccine administered) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (He pass out), DIZZINESS (Dizzy) and CHILLS (Chills) outcome was unknown.            Company comment: This case concerns a  80-year-old, male patient with no relevant medical history, who experienced the unexpected event of Loss of Consciousness. The event occurred approximately 1 day after the third dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a  80-year-old, male patient with no relevant medical history, who experienced the unexpected event of Loss of Consciousness. The event occurred approximately 1 day after the third dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Myalgia, Pyrexia
Clinical narrative: Coughing dry; Chills; Low grade fever; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing dry), CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (myalgia) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (myalgia). On 27-Oct-2021, the patient experienced COUGH (coughing dry). At the time of the report, COUGH (coughing dry), CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (myalgia) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-002894, MOD-2021-365406 (Patient Link).