chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Influenza like illness, Nausea
Clinical narrative: DIARRHEA; FLU-LIKE SYMPTOMS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced diarrhea, and flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and the outcome of nausea, diarrhea and flu-like symptoms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERING EXPIRED SOLUTION TO 2 PATIENTS.; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 an unspecified date, the subject experienced administering expired solution to 2 subjects.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administering expired solution to 2 patients. was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination.  No concomitant medications were reported. On an unspecified date, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PARTIAL DOSE ADMINISTRED; This spontaneous report received from a pharmacist . The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no history 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 subject experienced partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Tremor
Clinical narrative: SHORTNESS OF BREATH (WORSE IN THE MORNING); TREMBLING HANDS INTERMITTENTLY; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-MAR-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 shortness of breath (worse in the morning), and trembling hands intermittently. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath (worse in the morning) and trembling hands intermittently was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARMS ARE SORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On 09-MAY-2021, the subject experienced arms are sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arms are sore was not reported. This report was non-serious. This case, involving the same patient is linked to 20210517216.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC BENEFIT /NO MORE TREMORS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included tremors. The patient was previously treated with primidone for tremors. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unexpected therapeutic benefit /no more tremors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unexpected therapeutic benefit /no more tremors. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 410 pounds, and height was not reported. The patient's past medical history included meneires disease, and other pre-existing medical conditions included the patient's family has cancer, atrial fibrillation (mother), and glaucoma (mother).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206H21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 09:20 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Dysmenorrhoea, Fatigue
Clinical narrative: BODY ACHES; MENSTRUAL CRAMPS; DIARRHEA; CHILLS; FEVER; HEADACHE; TIREDNESS; This spontaneous report received from a parent concerned a 46 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: Unknown) .5 ml, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced menstrual cramps. On 02-APR-2021, the subject experienced diarrhea. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, menstrual cramps, diarrhea, chills, fever, headache, and tiredness on APR-2021. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; MENSTRUAL CRAMPS; DIARRHEA; CHILLS; FEVER; HEADACHE; TIREDNESS; This spontaneous report received from a parent concerned a 46 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: Unknown) .5 ml, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced menstrual cramps. On 02-APR-2021, the subject experienced diarrhea. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, menstrual cramps, diarrhea, chills, fever, headache, and tiredness on APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: MILD NEGATIVE EFFECTS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced mild negative effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild negative effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS AT THE INJECTION SITE; TENDERNESS AT THE INJECTION SITE; SWELLING AT THE INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced redness at the injection site. On 30-APR-2021, the subject experienced tenderness at the injection site. On 30-APR-2021, the subject experienced swelling at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness at the injection site, swelling at the injection site, and tenderness at the injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Inappropriate schedule of product administration, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: EXPOSURE TO COVID-19; OFF MEDICATION AFTER BEING EXPOSED TO COVID; NEEDLE STABBING/PRICKLE STABBING FEELING; VACCINATION SITE PAIN; SWELLING OF LEGS; PAINFUL R ARM; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included there was no reported medical history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 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. Concomitant medications included upadacitinib for rheumatoid arthritis.  On 01-APR-2021, the subject experienced painful r arm. On 30-APR-2021, the subject experienced swelling of legs. On an unspecified date, the subject experienced exposure to covid-19, off medication after being exposed to covid, needle stabbing/prickle stabbing feeling, and vaccination site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful r arm, and swelling of legs, and the outcome of vaccination site pain, exposure to covid-19, needle stabbing/prickle stabbing feeling and off medication after being exposed to covid was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: EXPOSURE TO COVID-19; OFF MEDICATION AFTER BEING EXPOSED TO COVID; NEEDLE STABBING/PRICKLE STABBING FEELING; VACCINATION SITE PAIN; SWELLING OF LEGS; PAINFUL R ARM; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included there was no reported medical history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 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. Concomitant medications included upadacitinib for rheumatoid arthritis.  On 01-APR-2021, the subject experienced painful r arm. On 30-APR-2021, the subject experienced swelling of legs. On an unspecified date, the subject experienced exposure to covid-19, off medication after being exposed to covid, needle stabbing/prickle stabbing feeling, and vaccination site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful r arm, and swelling of legs, and the outcome of vaccination site pain, exposure to covid-19, needle stabbing/prickle stabbing feeling and off medication after being exposed to covid was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Contusion
Clinical narrative: BRUISING ALL OVER; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, 1 time every 2 weeks, from 16-APR-2021 for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On APR-2021, the subject experienced bruising all over. The action taken with covid-19 vaccine was not applicable. The outcome of bruising all over was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: MISERABLE LOUD RINGING IN EARS (TINNITUS); This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-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 MAR-2021, the subject experienced miserable loud ringing in ears (tinnitus). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of miserable loud ringing in ears (tinnitus) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the Patient  experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210519940.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POOR QUALITY VACCINE ADMINISTERED; VACCINE THAT HAD BEEN SITTING IN THE FRIDGE FOR MORE THAN 6 HOURS; This spontaneous report received from a health care professional concerned a 50 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced poor quality vaccine administered. On 11-MAY-2021, the subject experienced vaccine that had been sitting in the fridge for more than 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality vaccine administered and vaccine that had been sitting in the fridge for more than 6 hours was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Pyrexia
Clinical narrative: LEFT SIDE OF FACE RED; TEMPERATURE OF ALMOST 100; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 left side of face red, and temperature of almost 100. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Almost 100 degree C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left side of face red and temperature of almost 100 was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Ear pain, Fatigue, Headache, Hyperhidrosis
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included epilepsy, and asthmatic, and concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced sweating. On 08-MAY-2021, the subject experienced weakness. On 08-MAY-2021, the subject experienced fever. On 08-MAY-2021, the subject experienced tiredness. On 08-MAY-2021, the subject experienced headache. On 09-MAY-2021, the subject experienced body aches. On 10-MAY-2021, the subject experienced throat inflammation. On 10-MAY-2021, the subject experienced pain in ear. On 10-MAY-2021, the subject experienced fluids in ear. On 10-MAY-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine was not applicable. The patient recovered from sweating, and fever on 09-MAY-2021, and had not recovered from headache, weakness, tiredness, body aches, pain in arm, throat inflammation, pain in ear, and fluids in ear. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Middle ear effusion, Pain, Pain in extremity, Pharyngitis, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included epilepsy, and asthmatic, and concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced sweating. On 08-MAY-2021, the subject experienced weakness. On 08-MAY-2021, the subject experienced fever. On 08-MAY-2021, the subject experienced tiredness. On 08-MAY-2021, the subject experienced headache. On 09-MAY-2021, the subject experienced body aches. On 10-MAY-2021, the subject experienced throat inflammation. On 10-MAY-2021, the subject experienced pain in ear. On 10-MAY-2021, the subject experienced fluids in ear. On 10-MAY-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine was not applicable. The patient recovered from sweating, and fever on 09-MAY-2021, and had not recovered from headache, weakness, tiredness, body aches, pain in arm, throat inflammation, pain in ear, and fluids in ear. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: ABSOLUTELY MISERABLE EXPERIENCE FOR 24 TO 36 HOURS; 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. The patient's past medical history included already had corona. 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 07-MAY-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 MAY-2021, the subject experienced absolutely miserable experience for 24 to 36 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from absolutely miserable experience for 24 to 36 hours on MAY-2021. This report was non-serious.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Visual impairment
Clinical narrative: CHANGES IN VISION; HEADACHE; This spontaneous report received from a patient concerned an 80 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced changes in vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of changes in vision was not reported. This report was non-serious. This case, from the same reporter is linked to 20210521409.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain in extremity, Pyrexia, Ultrasound scan
Clinical narrative: LEG PAIN; FATIGUE; FEVER; DIZZY; This spontaneous report received from a parent concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced dizzy. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced leg pain. On 16-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Not had clots. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, fatigue, and fever on 08-APR-2021, and leg pain. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Burning sensation, Injection site pain
Clinical narrative: UNDER ARM PAIN; UNDERARM BURNING LITTLE BIT; SHOULDER SORENESS IN INJECTION ARM; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced under arm pain, underarm burning little bit, shoulder soreness in injection arm, and injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site soreness, shoulder soreness in injection arm, under arm pain and underarm burning little bit was not reported. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Erythema, Flushing, Pain in extremity
Clinical narrative: METALLIC TASTE IN MOUTH; FACE WAS RED; FLUSHING ON FACE; RIGHT LEG PAIN DESCRIBED AS DULL ACHE; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included gout. The patient could not take statins because they cause muscle pain but not an allergic reaction.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAY-2021, the subject experienced metallic taste in mouth. On 10-MAY-2021, the subject experienced face was red. On 10-MAY-2021, the subject experienced flushing on face. On 10-MAY-2021, the subject experienced right leg pain described as dull ache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from face was red, and flushing on face on 10-MAY-2021, and was recovering from metallic taste in mouth, and right leg pain described as dull ache. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: GOT THE VACCINE AFTER IT HAD BEEN EXPIRED FOR 2 HOURS; This spontaneous report received from a health care professional concerned an 18 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced got the vaccine after it had been expired for 2 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got the vaccine after it had been expired for 2 hours was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pruritus, Rash macular
Clinical narrative: TIRED; ITCHINING ON ARM AND WAISTLINE; RED PATCHES ABOUT THE SIZE OF A GRAPEFRUIT BETWEEN ELBOW AND SHOULDER ON BOTH ARMS AND THREE RED PATCHES ABOUT THE SIZE OF QUARTER; HEADACHE; EXTREME BODY ACHES; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, kidney stone, gall bladder problem, non-smoker, and no alcohol use, and other pre-existing medical conditions included the patient had no immune disorder, no 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 and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced itching on arm and waistline. On 11-MAY-2021, the subject experienced red patches about the size of a grapefruit between elbow and shoulder on both arms and three red patches about the size of quarter. On an unspecified date, the subject experienced extreme body aches, headache, and tired. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme body aches, and headache, had not recovered from red patches about the size of a grapefruit between elbow and shoulder on both arms and three red patches about the size of quarter, and itching on arm and waistline, and the outcome of tired was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chest discomfort, Cough, Dyspnoea exertional
Clinical narrative: DOWN IN BED/BED-RIDDEN; TIGHTNESS IN CHEST; WINDED TO WALK; COUGH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-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 MAY-2021, the subject experienced tightness in chest. On MAY-2021, the subject experienced winded to walk. On MAY-2021, the subject experienced cough. On 07-MAY-2021, the subject experienced down in bed/bed-ridden. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from winded to walk, and the outcome of tightness in chest, cough and down in bed/bed-ridden was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electric shock sensation, Motion sickness, Presyncope, Vertigo
Clinical narrative: FEELING OF BRAIN WAS ROTATING OR SPINNING; LIGHT HEADED; FELLING OF GOING TO FAINT; MOTION SICKNESS; BRAIN JOLTS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 17-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 subject experienced feeling of brain was rotating or spinning, light headed, felling of going to faint, motion sickness, and brain jolts. The action taken with covid-19 vaccine  was not applicable. The patient recovered from light headed, and felling of going to faint, had not recovered from motion sickness, and the outcome of feeling of brain was rotating or spinning and brain jolts was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC BENEFIT/BP WENT DOWN, NO NECK  AND LEG PAIN, NO ERECTION PROBLEM, NO FREQUENT URINATION; BLOOD PRESSURE WENT DOWN TO 120/79; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included leg pain, neck pain, erection problem, and frequent urination, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included patient took medicine for frequent urination or bathroom use. 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 10-MAY-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 MAY-2021, the subject experienced unexpected therapeutic benefit/bp went down, no neck and leg pain, no erection problem, no frequent urination. On MAY-2021, the subject experienced blood pressure went down to 120/79. Laboratory data included: Blood pressure (NR: not provided) 120/79 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unexpected therapeutic benefit/bp went down, no neck and leg pain, no erection problem, no frequent urination and blood pressure went down to 120/79 was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: NECK PAIN; "VERY BAD PAIN" ON THE SAME SHOULDER IN WHICH ARM SHE "GOT THE SHOT"; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 11-APR-2021, the subject experienced neck pain. On 11-APR-2021, the subject experienced "very bad pain" on the same shoulder in which arm she "got the shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from "very bad pain" on the same shoulder in which arm she "got the shot", and neck pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour
Clinical narrative: OUT OF SORTS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 01-MAY-2021, the subject experienced out of sorts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of sorts was not reported. This report was non-serious. This case, from the same reporter is linked to 20210520625 and 20210520722.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Head discomfort, Influenza like illness, Myalgia
Clinical narrative: pericarditist; dizziness; block head; muscle pain/ body aches; soreness in the injected arm; fever; tiredness; flu like; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERICARDITIS (pericarditist) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis since 1999, Blood pressure high since 2000 and Food allergy (lobster, crab). Concomitant products included AMLODIPINE and QUINAPRIL for Blood pressure high, METHOTREXATE for RA, IBUPROFEN for Rheumatoid arthritis, FOLIC ACID for an unknown indication.   On 26-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2002, the patient experienced INFLUENZA LIKE ILLNESS (flu like). On 24-Feb-2021, the patient experienced DIZZINESS (dizziness), MYALGIA (muscle pain/ body aches) and VACCINATION SITE PAIN (soreness in the injected arm). 24-Feb-2021, the patient experienced HEAD DISCOMFORT (block head), PYREXIA (fever) and FATIGUE (tiredness). On 10-Apr-2021, the patient experienced PERICARDITIS (pericarditist) (seriousness criterion hospitalization). The patient was hospitalized from 10-Apr-2021 to 11-Apr-2021 due to PERICARDITIS. On 25-Feb-2021, INFLUENZA LIKE ILLNESS (flu like), DIZZINESS (dizziness), HEAD DISCOMFORT (block head), MYALGIA (muscle pain/ body aches), VACCINATION SITE PAIN (soreness in the injected arm), PYREXIA (fever) and FATIGUE (tiredness) had resolved. At the time of the report, PERICARDITIS (pericarditist) had resolved.            The patient did not seek medical attention for the events that occurred on 24 Feb 2021.   On 10 Apr 2021, the patient was hospitalized overnight with "pericarditist from unknown source".  Treatment information for this event was not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot e excluded.   This case was linked to MOD-2021-026045 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Case upgraded per hospitalization for event of pericarditis.  Patient completed the vaccine adverse event reporting form.  Multiple fields updated.; 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 e excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis, Pyrexia, Vaccination site pain
Clinical narrative: pericarditist; dizziness; block head; muscle pain/ body aches; soreness in the injected arm; fever; tiredness; flu like; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERICARDITIS (pericarditist) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis since 1999, Blood pressure high since 2000 and Food allergy (lobster, crab). Concomitant products included AMLODIPINE and QUINAPRIL for Blood pressure high, METHOTREXATE for RA, IBUPROFEN for Rheumatoid arthritis, FOLIC ACID for an unknown indication.   On 26-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2002, the patient experienced INFLUENZA LIKE ILLNESS (flu like). On 24-Feb-2021, the patient experienced DIZZINESS (dizziness), MYALGIA (muscle pain/ body aches) and VACCINATION SITE PAIN (soreness in the injected arm). 24-Feb-2021, the patient experienced HEAD DISCOMFORT (block head), PYREXIA (fever) and FATIGUE (tiredness). On 10-Apr-2021, the patient experienced PERICARDITIS (pericarditist) (seriousness criterion hospitalization). The patient was hospitalized from 10-Apr-2021 to 11-Apr-2021 due to PERICARDITIS. On 25-Feb-2021, INFLUENZA LIKE ILLNESS (flu like), DIZZINESS (dizziness), HEAD DISCOMFORT (block head), MYALGIA (muscle pain/ body aches), VACCINATION SITE PAIN (soreness in the injected arm), PYREXIA (fever) and FATIGUE (tiredness) had resolved. At the time of the report, PERICARDITIS (pericarditist) had resolved.            The patient did not seek medical attention for the events that occurred on 24 Feb 2021.   On 10 Apr 2021, the patient was hospitalized overnight with "pericarditist from unknown source".  Treatment information for this event was not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot e excluded.   This case was linked to MOD-2021-026045 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Case upgraded per hospitalization for event of pericarditis.  Patient completed the vaccine adverse event reporting form.  Multiple fields updated.; 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 e excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Heart disease, unspecified since 1994. Concomitant products included RIVAROXABAN (XARELTO), VALSARTAN, SOTALOL and ROSUVASTATIN for an unknown indication.    On 26-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HERPES ZOSTER (shingles) (seriousness criterion hospitalization). The patient was hospitalized from 03-Feb-2021 to 04-Feb-2021 due to HERPES ZOSTER. On 01-Apr-2021, HERPES ZOSTER (shingles) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment also included Acyclovir. The patient described the adverse event as "a rash with blisters, very itchy and painful". The patient received their second dose of mRNA-1273 (Moderna COVID-19 Vaccine; batch no. unknown) (Intramuscular) 1 dosage form on 04-Mar-2021 at 1:00 PM, and no adverse events were reported at the time of the report.  Company Comment : This case concerns a 78-year-old male with a serious unexpected event of herpes zoster. Latency 8 days after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Case upgraded via VAERs form received which listed hospitalization for event; Patient race, history, Suspect drug dosage details, concomitant drugs details; Sender's Comments: This case concerns a 78-year-old male hospitalized with a serious unexpected event of herpes zoster. Latency 8 days after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Influenza, Lower respiratory tract infection, Pain in extremity
Clinical narrative: Chest cold; Flu; Hard welt that burned at the injection site; Sore arm; Diarrhea; Exhausted; welt at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (Chest cold) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Sjogren's.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (Chest cold) (seriousness criterion medically significant), INFLUENZA (Flu), VACCINATION SITE PAIN (Hard welt that burned at the injection site), PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), FATIGUE (Exhausted) and INJECTION SITE URTICARIA (welt at the injection site). At the time of the report, LOWER RESPIRATORY TRACT INFECTION (Chest cold) outcome was unknown and INFLUENZA (Flu), VACCINATION SITE PAIN (Hard welt that burned at the injection site), PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), FATIGUE (Exhausted) and INJECTION SITE URTICARIA (welt at the injection site) had not resolved.            Treatment included Gluten free diet. Concomitant medications were not provided.   This case was linked to MOD-2021-099463 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional info-2 On 03-May-2021: Initial additional - NNI; Sender's Comments: Limited information regarding the events has been provided at this time. A causal relationship cannot be excluded. Further information has been requested.