chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: SORE ARM; RASH ON LEFT ARM AT ADMINISTRATION SITE (LEFT DELTOID)/3 OR 4 RASHES UNDER OR CLOSER TO THE ARMPIT (ABOUT 1-2 CENTIMETERS)/THE OTHER ONE BY INNER ELBOW/LIKE A MOSQUITO BITE THAT WELTS; HEADACHE; NAUSEA; BURNING; ITCHING; This spontaneous report received from a patient 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, intramuscular, batch number: 203a21a, expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced burning. On JUN-2021, the subject experienced itching. On 05-JUN-2021, the subject experienced sore arm. On 05-JUN-2021, the subject experienced rash on left arm at administration site (left deltoid) /3 or 4 rashes under or closer to the armpit (about 1-2 centimeters) /the other one by inner elbow/like a mosquito bite that welts. On 05-JUN-2021, the subject experienced headache. On 05-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on left arm at administration site (left deltoid)/3 or 4 rashes under or closer to the armpit (about 1-2 centimeters)/the other one by inner elbow/like a mosquito bite that welts, itching, burning, headache, sore arm and nausea was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache
Clinical narrative: This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, non-smoker, and sulfa allergy, and other pre-existing medical conditions included the patient had no relevant medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced headache. On 26-MAY-2021, the subject experienced bruising all over body (left arm and the left thigh). Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and had not recovered from bruising all over body (left arm and the left thigh). This report was non-serious.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 14 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, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the subject experienced product administered to patient of inappropriate age. On 04-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE ADMINISTERED FROM THE OVERNIGHT REFRIGERATED PUNCTURED VIAL; This spontaneous report received from a health care professional concerned a 71 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021, the subject experienced vaccine administered from the overnight refrigerated punctured vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered from the overnight refrigerated punctured vial was not reported. This report was non-serious. This case, from the same reporter is linked to 20210613154.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Rash, Swelling face
Clinical narrative: DIDN'T SLEEP MUCH LAST NIGHT; LITTLE RED DOTS ALL OVER BODY; SWOLLEN FACE; This spontaneous report received from a patient concerned an 84 year old female. The patient's weight was 201 pounds, and height was 68 inches. The patient's past medical history included could not sleep, and hospitalized, and concurrent conditions included asthma (asthmatic), hypothyroidism, senile, slow metabolism, arthritis, non-smoker, non alcoholic, heavily incontinent, unable to drive, and highly allergic. The patient experienced drug allergy when treated with oxycodone hydrochloride/paracetamol, and acetylsalicylic acid/caffeine/homatropine terephthalate/oxycodone hydrochloride/oxycodone terephthalate/phenacetin. 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 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levothyroxine for hypothyroidism. On JUN-2021, the subject experienced swollen face. On JUN-2021, the subject experienced little red dots all over body. On 04-JUN-2021, the subject experienced didn't sleep much last night. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen face, and little red dots all over body on JUN-2021, and the outcome of didn't sleep much last night was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: A LOSS OF MY TASTEBUDS, MOSTLY SWEET AND SALT; This spontaneous report received from a patient 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: Unk) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced a loss of my tastebuds, mostly sweet and salt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from a loss of my tastebuds, mostly sweet and salt. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: FACE SWELLING; RASH ON FACE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hypochondria. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced face swelling, and rash on face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the face swelling and rash on face was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: PAIN; NOT FEELING WELL; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced pain. On 2021, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling well and pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache
Clinical narrative: EYE PAIN; SEVERE HEADACHE; 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, and batch number were not reported) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-JUN-2021, the subject experienced eye pain. On 06-JUN-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, and eye pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Eye movement disorder, Fatigue, Headache, Hypoacusis, Hypoaesthesia
Clinical narrative: RIGHT ARM NUMBNESS; NECK PAIN; SLIGHT HEARING LOSS; HEADACHE; NAUSEA; TIREDNESS; EAR FLUTTERING; TINNITUS; EYE LID TWITCHING; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 190 pounds, and height was 178 centimeters. The patient's concurrent conditions included seasonal allergy, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no pertinent medical history and did not had drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Concomitant medications included for drug used for unknown indication.  On 24-MAR-2021, the subject experienced ear fluttering. On 24-MAR-2021, the subject experienced tinnitus. On 24-MAR-2021, the subject experienced eye lid twitching. On 24-MAR-2021, the subject experienced slight hearing loss. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced tiredness. On 31-MAR-2021, the subject experienced right arm numbness. On 31-MAR-2021, the subject experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, tiredness, ear fluttering, eye lid twitching, right arm numbness, neck pain, and slight hearing loss, and the outcome of tinnitus was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Inner ear disorder, Nausea, Neck pain, Tinnitus
Clinical narrative: RIGHT ARM NUMBNESS; NECK PAIN; SLIGHT HEARING LOSS; HEADACHE; NAUSEA; TIREDNESS; EAR FLUTTERING; TINNITUS; EYE LID TWITCHING; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 190 pounds, and height was 178 centimeters. The patient's concurrent conditions included seasonal allergy, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no pertinent medical history and did not had drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Concomitant medications included for drug used for unknown indication.  On 24-MAR-2021, the subject experienced ear fluttering. On 24-MAR-2021, the subject experienced tinnitus. On 24-MAR-2021, the subject experienced eye lid twitching. On 24-MAR-2021, the subject experienced slight hearing loss. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced tiredness. On 31-MAR-2021, the subject experienced right arm numbness. On 31-MAR-2021, the subject experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, tiredness, ear fluttering, eye lid twitching, right arm numbness, neck pain, and slight hearing loss, and the outcome of tinnitus was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Blood pressure measurement, Cardiovascular evaluation, Dehydration
Clinical narrative: PASSED OUT; LIGHT HEADED; DEHYDRATED; FELT WEAK; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included controlled high blood pressure, controlled high cholesterol, stroke like symptoms in MAR-20219, however he was not diagnosed as having stroke because all tests were negative but he still had the symptoms, and alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: UNKNOWN) 1 total, dose was not reported, administered on left arm on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021 after vaccination, the patient felt weak but it was not significant. On 05-JUN-2021, the patient felt weak while doing daily activities. The patient had not felt anything and had breakfast. He got in the sun and got dehydrated as not had water for three hours during the day. Later, he got water. The patient had taken one drink of alcohol, sat down and got light headed then passed out for less than a minute. It was reported that, upon contacting emergency services advised patient to visit emergency room to check him as a precaution but the patient denied. It was reported that, the patient's heart, blood pressure, and blood glucose were normal. The patient was fine at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 05-JUN-2021, and light headed, dehydrated, and felt weak on JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210613161-covid-19 vaccine ad26.cov2.s-passed out. 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).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: PASSED OUT; LIGHT HEADED; DEHYDRATED; FELT WEAK; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included controlled high blood pressure, controlled high cholesterol, stroke like symptoms in MAR-20219, however he was not diagnosed as having stroke because all tests were negative but he still had the symptoms, and alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: UNKNOWN) 1 total, dose was not reported, administered on left arm on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021 after vaccination, the patient felt weak but it was not significant. On 05-JUN-2021, the patient felt weak while doing daily activities. The patient had not felt anything and had breakfast. He got in the sun and got dehydrated as not had water for three hours during the day. Later, he got water. The patient had taken one drink of alcohol, sat down and got light headed then passed out for less than a minute. It was reported that, upon contacting emergency services advised patient to visit emergency room to check him as a precaution but the patient denied. It was reported that, the patient's heart, blood pressure, and blood glucose were normal. The patient was fine at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 05-JUN-2021, and light headed, dehydrated, and felt weak on JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210613161-covid-19 vaccine ad26.cov2.s-passed out. 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: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Hypersomnia
Clinical narrative: IN AND OUT OF A WEIRD FEVER DREAM WITHOUT THE FEVER AND DISTRESSING DREAMS; SLEPT WILDLY; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 subject experienced in and out of a weird fever dream without the fever and distressing dreams, and slept wildly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the in and out of a weird fever dream without the fever and distressing dreams and slept wildly was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: SHIVERS; FEVER; HEADACHE IN NIGHT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported 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 subject experienced shivers, fever, and headache in night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shivers, fever, and headache in night. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Therapeutic response unexpected
Clinical narrative: WARTS ON LEFT MIDDLE FINGER STARTED SHRINKING NOW ALMOST COMPLETELY GONE; SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included two warts on left middle finger for a long time. 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 subject experienced warts on left middle finger started shrinking now almost completely gone, and side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the warts on left middle finger started shrinking now almost completely gone and side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FEELS LIKE A FLU; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) 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 subject experienced feels like a flu. The action taken with covid-19 vaccine was not applicable. The patient recovered from feels like a flu. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pyrexia
Clinical narrative: ALL THE OTHER FLU LIKE SYMPTOMS; FEVER; HEADACHE; 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 subject experienced all the other flu like symptoms, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache and all the other flu like symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: IMPROVEMENT IN ARTHRITIS  SYMPTOMS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included severely arthritic. 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 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced improvement in arthritis symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of improvement in arthritis symptoms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Headache, Pain
Clinical narrative: BODY ACHE; DIZZINESS; TEMPERATURE; LIGHT HEADACHE; 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) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced body ache, dizziness, temperature, and light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature, light headache, body ache and dizziness was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia, Pyrexia
Clinical narrative: CHILLS; LOW ENERGY; MUSCLE ACHES; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included stomach issues, nerve pain, high blood pressure, diabetes pain, non smoker, and non alcohol user, and other pre-existing medical conditions included patient have unspecified allergy. patient did not had any 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: 0U1A21A, expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. Concomitant medications included lisinopril for blood pressure, gabapentin for nerve pain, hydrocodone for pain, menthol/methyl salicylate for pain, pantoprazole for stomach issue, ascorbic acid, ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, potassium, sucralfate, and zinc.  On 07-JUN-2021, the subject experienced chills. On 07-JUN-2021, the subject experienced low energy. On 07-JUN-2021, the subject experienced muscle aches. On 07-JUN-2021, the subject experienced low grade fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, low energy, muscle aches, and low grade fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; HEADACHEY; 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 subject experienced chills, and headachey. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headachey and chills was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: TASTE HAS CHANGED; FEELING SICK; CHILLS; FEVER; NAUSEA; EXHAUSTION; This spontaneous report received from a patient concerned a 70-year-old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no other medical history reported. The patient experienced drug allergy when treated with codeine, and levofloxacin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the subject experienced taste has changed. On 18-MAY-2021, the subject experienced feeling sick. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced fever. On 18-MAY-2021, the subject experienced nausea. On 18-MAY-2021, the subject experienced exhaustion. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and nausea on MAY-2021, was recovering from chills, and had not recovered from exhaustion, taste has changed, and feeling sick. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: TASTE HAS CHANGED; FEELING SICK; CHILLS; FEVER; NAUSEA; EXHAUSTION; This spontaneous report received from a patient concerned a 70-year-old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no other medical history reported. The patient experienced drug allergy when treated with codeine, and levofloxacin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the subject experienced taste has changed. On 18-MAY-2021, the subject experienced feeling sick. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced fever. On 18-MAY-2021, the subject experienced nausea. On 18-MAY-2021, the subject experienced exhaustion. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and nausea on MAY-2021, was recovering from chills, and had not recovered from exhaustion, taste has changed, and feeling sick. This report was non-serious.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, COVID-19 pneumonia, Condition aggravated, Fatigue, Pyrexia
Clinical narrative: Heart Rhythm problems increase infrequency after vaccination; Heart Rhythm problems increase infrequency after vaccination; Fever (Low grade); Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Heart Rhythm problems increase infrequency after vaccination) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 pneumonia (treated with ramdesivir during which he was coughing up blood.) in November 2020. Concurrent medical conditions included Dysrhythmias (heart rhythm problem which he has had for 6 years).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PYREXIA (Fever (Low grade)) and FATIGUE (Tiredness). On 22-Feb-2021, the patient experienced ARRHYTHMIA (Heart Rhythm problems increase infrequency after vaccination) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Heart Rhythm problems increase infrequency after vaccination). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Feb-2021, PYREXIA (Fever (Low grade)) had resolved. At the time of the report, ARRHYTHMIA (Heart Rhythm problems increase infrequency after vaccination), CONDITION AGGRAVATED (Heart Rhythm problems increase infrequency after vaccination) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19 pneumonia: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that his heart rhythm problem which he has had for 6 years has gotten worse after vaccination. He used to have about 1 episode every month, it increased to about 1 episode every week after infection with COVID-19 and how now increase to about 1 episode every 2 to 3 days after the first dose of the Moderna vaccine.   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. No concomitant information was reported.; 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Headache
Clinical narrative: Back Pain; Stomach Ache; Head Ache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Pain) and ABDOMINAL PAIN UPPER (Stomach Ache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced BACK PAIN (Back Pain) (seriousness criterion hospitalization), ABDOMINAL PAIN UPPER (Stomach Ache) (seriousness criterion hospitalization) and HEADACHE (Head Ache). At the time of the report, BACK PAIN (Back Pain), ABDOMINAL PAIN UPPER (Stomach Ache) and HEADACHE (Head Ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  Patient was hospitalized after receiving the Moderna COVID-19 vaccine.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. However, the Company believes the hospitalization in Unlikely related to the product as it occurred over two (2) months after vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up received on 04-JUN2021 was added the new event which was serious.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. However, the Company believes the hospitalization in Unlikely related to the product as it occurred over two (2) months after vaccination.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Vaccination site pain, Vaccination site swelling
Clinical narrative: Superficial blood clot; it was bigger after the first dose; Very painful to touch/arm was in pain; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Superficial blood clot) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Superficial blood clot) (seriousness criterion medically significant), VACCINATION SITE SWELLING (it was bigger after the first dose) and VACCINATION SITE PAIN (Very painful to touch/arm was in pain). At the time of the report, THROMBOSIS (Superficial blood clot), VACCINATION SITE SWELLING (it was bigger after the first dose) and VACCINATION SITE PAIN (Very painful to touch/arm was in pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. Treatment information was not provided.  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.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced THROMBOSIS (blood clots) (seriousness criteria hospitalization and medically significant). At the time of the report, THROMBOSIS (blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information included blood thinners.  This a case of a male patient of unknown age who had blood clots and was hospitalized after receiving a dose of Moderna COVID Vaccine. Very limited information has been provided at this time.; Sender's Comments: This a case of a male patient of unknown age who had blood clots and was hospitalized after receiving a dose of Moderna COVID Vaccine. Very limited information has been provided at this time.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Ill-defined disorder, Product dose omission issue
Clinical narrative: Went into the hospital/he went in for other problems not because of the injection; Product dose omission; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILL-DEFINED DISORDER (Went into the hospital/he went in for other problems not because of the injection) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included AMLODIPINE, ACETYLSALICYLIC ACID (ASPRIN), PREDNISONE and METOPROLOL for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILL-DEFINED DISORDER (Went into the hospital/he went in for other problems not because of the injection) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Product dose omission). The patient was hospitalized from 25-Mar-2021 to 20-May-2021 due to ILL-DEFINED DISORDER. At the time of the report, ILL-DEFINED DISORDER (Went into the hospital/he went in for other problems not because of the injection) and PRODUCT DOSE OMISSION ISSUE (Product dose omission) outcome was unknown.            Treatment information was not reported.  On 25-Mar-2021 he was admitted into the hospital and was there for 8 days and was out for 4 days and then he went back in and stayed in in the hospital for 20 days and went back in back in two days later and stayed for 16 days then was released on 20-May-2021 and had been home since. Patient's wife stated that was why he was received his second dose so late, because he had been in the hospital. She denied patient had any adverse reaction from the Moderna Covid-19 injection.  Company comment: Based on current available information and the lack of temporal association between product use and the start date of the event a causal relationship is unlikely.   This case was linked to MOD-2021-187082 (Patient Link).; Sender's Comments: Based on current available information and the lack of temporal association between product use and the start date of the event a causal relationship is unlikely.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Breakout of a rash on the arm where she was given the injection; Rash started with itching; This is a spontaneous report from two contactable consumers one of (patient) via Medical information team. A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: PFR, EN5318, Expiration date was not reported), via an unspecified route of administration in right arm on 28Jan2021 as single dose for covid-19 immunisation. Medical history included she had a severe allergic reaction to sulfa. The patient concomitant medication was not reported. Prior Vaccinations (within 4 weeks) patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient reports on the first dose, she had a breakout of a rash on the arm where she was given the injection. Patient answers as the rash started with itching on 28Jan2021 and then she started getting scabs and lesions, within 24 to 48 hours, after the first vaccine. Patient states she still has a little bit of the rash left on her forearm, but it is very minimal. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: loss of smell and taste; loss of smell and taste; This is a spontaneous report from a contactable consumer (Patient). A female patient of unspecified age (as reported 34; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Feb2021 as 1st dose, single for Covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient reported loss of smell and taste after the first dose of the pfizer covid 19 vaccine on 05Feb2021. Patient wanted to know if there were reports of this side effect after the first dose. Case reported as non-serious. The outcome of events was unknown.   Information about lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Diarrhoea, Erythema, Fatigue
Clinical narrative: Extreme fatigue; malaise / Unwell feeling; congestion; cough; headaches; nausea; diarrhea; chest rash; thumb and side of hand became red and itched; thumb and side of hand became red and itched; hand spasm; 99.2 fever once; This is a spontaneous report from a contactable other HCP (patient). A 71-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN5318) via an unspecified route of administration in right arm on 03Feb2021 at 11:00 AM as 1st dose, single dose for COVID-19 immunization. Medical history included hypothyroidism, allergic to Penicillin, Sulfa drugs, dust, hay fever. Concomitant medications were not reported. Patient was not pregnant. Patient did not receive any other vaccine in four weeks. Patient took other medication in two weeks. Patient was not diagnosed COVID prior vaccination. On 04Feb2021 at 10:00 AM, patient experienced Extreme fatigue, malaise, unwell feeling, congestion, cough, headaches, nausea, diarrhea, chest rash, thumb and side of hand became red and itched, hand spasm, 99.2 fever once. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. Patient had not been COVID tested post vaccination. The outcome of the events was not recovered.   Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Muscle spasms, Nasal congestion, Nausea
Clinical narrative: Extreme fatigue; malaise / Unwell feeling; congestion; cough; headaches; nausea; diarrhea; chest rash; thumb and side of hand became red and itched; thumb and side of hand became red and itched; hand spasm; 99.2 fever once; This is a spontaneous report from a contactable other HCP (patient). A 71-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN5318) via an unspecified route of administration in right arm on 03Feb2021 at 11:00 AM as 1st dose, single dose for COVID-19 immunization. Medical history included hypothyroidism, allergic to Penicillin, Sulfa drugs, dust, hay fever. Concomitant medications were not reported. Patient was not pregnant. Patient did not receive any other vaccine in four weeks. Patient took other medication in two weeks. Patient was not diagnosed COVID prior vaccination. On 04Feb2021 at 10:00 AM, patient experienced Extreme fatigue, malaise, unwell feeling, congestion, cough, headaches, nausea, diarrhea, chest rash, thumb and side of hand became red and itched, hand spasm, 99.2 fever once. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. Patient had not been COVID tested post vaccination. The outcome of the events was not recovered.   Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Extreme fatigue; malaise / Unwell feeling; congestion; cough; headaches; nausea; diarrhea; chest rash; thumb and side of hand became red and itched; thumb and side of hand became red and itched; hand spasm; 99.2 fever once; This is a spontaneous report from a contactable other HCP (patient). A 71-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN5318) via an unspecified route of administration in right arm on 03Feb2021 at 11:00 AM as 1st dose, single dose for COVID-19 immunization. Medical history included hypothyroidism, allergic to Penicillin, Sulfa drugs, dust, hay fever. Concomitant medications were not reported. Patient was not pregnant. Patient did not receive any other vaccine in four weeks. Patient took other medication in two weeks. Patient was not diagnosed COVID prior vaccination. On 04Feb2021 at 10:00 AM, patient experienced Extreme fatigue, malaise, unwell feeling, congestion, cough, headaches, nausea, diarrhea, chest rash, thumb and side of hand became red and itched, hand spasm, 99.2 fever once. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. Patient had not been COVID tested post vaccination. The outcome of the events was not recovered.   Follow-up attempts completed. No further information expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Rash erythematous
Clinical narrative: Aching muscles; headache; Light red rash on both facial cheeks; This is a Spontaneous report from a Contactable Consumer (Patient). An 89-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810, Expiration date was not reported), via unknown route in the Arm left on 11Feb2021 at 13:30 (at the age of 89-year-old non-pregnant) as UNKNOWN, SINGLE DOSE, for COVID-19 immunization. The patient medical history included rheumatoid arthritis (Diagnosed one year ago), high blood pressure, historical vaccination included shingrix (Lot_number: NDC58160-082311, in left arm). Past drug included hyzaar for hives in mouth. Allergic to methotrexate, Sulpha, hyzaar. The patient's concomitant medications included amlodipine besilate, benazepril hydrochloride (LOTREL [AMLODIPINE BESILATE; BENAZEPRIL HYDROCHLORIDE]); Omeprazole ; levothyroxine sodium (THYROXIN) daily for unspecified indications, Prednisone 10 mg per daily for unspecified indications. On 13Feb2021, the patient experienced light red rash on both facial cheeks. Did not itch nor painful, it had brighter red center almost looked like an insect bite. On an unspecified date the patient experienced aching muscles and headache. The patient did not receive any treatment for the event, 'light red rash on both facial cheeks'. All the events were non-serious. The outcome of the event light red rash on both facial cheeks was not recovered. The outcome of the events aching muscles and head-ache was unknown.