chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER OVER 100 DEGREE; EXHAUSTION; 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 24-MAR-2021 for prophylactic vaccination. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. No concomitant medications were reported. On 2021, Laboratory data included: Body temperature (NR: not provided) over 100 degree. On an unspecified date, the subject experienced body aches, fever over 100 degree, and exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever over 100 degree, exhaustion and body aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210449130.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a pharmacist concerned a 60 year old of unspecified 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: 1808978, expiry: 14-JUN-2021) dose was not reported,  frequency once total, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced suspected immunological vaccine failure.  The test done was SARS COV2an (IGg spike) - Semi Quant. Laboratory data (dates unspecified) included: SARS-CoV-2 antibody test negative (NR: not provided) Negative antibody. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210449920-COVID-19 VACCINE AD26.COV2.S-Suspected Immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: SENSATION OF TICKLING PINS AND NEEDLES ON BOTH ARM TO HANDS; This spontaneous report received from a patient via a company representative concerned a 40 decade old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known medical history. 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-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced sensation of tickling pins and needles on both arm to hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensation of tickling pins and needles on both arm to hands on APR-2021. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Muscle spasms, Pain in extremity, Pyrexia
Clinical narrative: NECK LOCKED UP; ARM DEAD; PAIN ABOVE ELBOW; HIGH FEVER; SHEETS COMPLETELY SOAKED; This spontaneous report received from a consumer concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and 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, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced sheets completely soaked. On APR-2021, the subject experienced high fever. Treatment medications included: diazepam, and lidocaine. On 15-APR-2021, the subject experienced neck locked up. On 15-APR-2021, the subject experienced arm dead. On 15-APR-2021, the subject experienced pain above elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever on APR-2021, was recovering from neck locked up, had not recovered from arm dead, and pain above elbow, and the outcome of sheets completely soaked was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SLIGHT SORENESS ON VERY SPOT AT INJECTION SITE; 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: UNKNWON) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced slight soreness on very spot at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight soreness on very spot at injection site was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain
Clinical narrative: SORENESS; FATIGUE; This spontaneous report received from a patient concerned a 22 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, intramuscular, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for Crohn's disease. 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 soreness, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from fatigue, and soreness. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Palpitations, Paraesthesia, Restless legs syndrome, Sensory disturbance
Clinical narrative: ANXIETY; HEART RACING; STRANGE FEELING IN LEGS; RESTLESS LEG SYNDROME; NUMBNESS AND TINGLING IN LEFT ARM; This spontaneous report received from a patient concerned a 63 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: 206A21A and 205A221A expiry: 01-JUN-2023) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced strange feeling in legs. On 07-APR-2021, the subject experienced restless leg syndrome. On 07-APR-2021, the subject experienced numbness and tingling in left arm. On 13-APR-2021, the subject experienced anxiety. On 13-APR-2021, the subject experienced heart racing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from strange feeling in legs, restless leg syndrome, numbness and tingling in left arm, anxiety, and heart racing. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Pain
Clinical narrative: SHORT OF BREATH; FATIGUE; HEADACHE; GENERALISED ACHING; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: ibuprofen. On 11-APR-2021, the subject experienced generalised aching. On 24-APR-2021, the subject experienced short of breath. On 24-APR-2021, the subject experienced fatigue. On 24-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalised aching on 12-APR-2021, and had not recovered from fatigue, headache, and short of breath. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORENESS ON INJECTION SITE ARM; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis in hip, and smoker. 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 not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced soreness on injection site arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness on injection site arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; 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 not reported, batch number: Unknown) dose was not reported, administered on 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 2021, the subject experienced fever. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and headache on 2021. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE PAIN (ARM SORE AND ACHY); This spontaneous report received from a consumer concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe polyarticular juvenile idiopathic arthritis, and moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe polyarticular juvenile idiopathic arthritis, and moderate to severe rheumatoid arthritis. 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 injection site pain (arm sore and Achy). The action taken with covid-19 vaccine ad26.cov2.s, and adalimumab was not applicable. The patient was recovering from injection site pain (arm sore and Achy). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH FROM ELBOWS TO WRISTS ON BOTH ARMS; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced rash from elbows to wrists on both arms. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash from elbows to wrists on both arms on 12-APR-2021. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nodule, Pain, Pruritus
Clinical narrative: BUMPS; ACHE; ITCHING; RASH; HIVES; SORE MUSCLES; TIRED; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. Concomitant medications included lorazepam for diabetes, and metformin for diabetes. On APR-2021, the subject experienced bumps. On APR-2021, the subject experienced ache. On APR-2021, the subject experienced itching. On APR-2021, the subject experienced rash. On APR-2021, the subject experienced hives. On APR-2021, the subject experienced sore muscles. On APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching, rash, hives, ache, sore muscles, tired, and bumps. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: BUMPS; ACHE; ITCHING; RASH; HIVES; SORE MUSCLES; TIRED; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. Concomitant medications included lorazepam for diabetes, and metformin for diabetes. On APR-2021, the subject experienced bumps. On APR-2021, the subject experienced ache. On APR-2021, the subject experienced itching. On APR-2021, the subject experienced rash. On APR-2021, the subject experienced hives. On APR-2021, the subject experienced sore muscles. On APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching, rash, hives, ache, sore muscles, tired, and bumps. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Mobility decreased, Pain, Pain in extremity
Clinical narrative: HIGHER LEVEL OF PAIN (EXTREME PAIN) IN THE SHOULDER AND IN UPPER ARM; LACK OF MOBILITY IN THE SHOULDER AND THE UPPER ARM OF THE INJECTED SITE; FROZEN SHOULDER; HIGHER LEVEL OF PAIN (EXTREME PAIN)  AT THE LOCATION OF INJECTION; SORE ARM; LITTLE FATIGUE; 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 immune thrombocytopenic purpura, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced sore arm. On 01-APR-2021, the subject experienced little fatigue. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) in the shoulder and in upper arm. On 24-APR-2021, the subject experienced lack of mobility in the shoulder and the upper arm of the injected site. On 24-APR-2021, the subject experienced frozen shoulder. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) at the location of injection. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) Platelet count before the vaccination was 40. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fatigue on 03-APR-2021, and had not recovered from sore arm, higher level of pain (extreme pain) at the location of injection, lack of mobility in the shoulder and the upper arm of the injected site, higher level of pain (extreme pain) in the shoulder and in upper arm, and frozen shoulder. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Periarthritis, Platelet count
Clinical narrative: HIGHER LEVEL OF PAIN (EXTREME PAIN) IN THE SHOULDER AND IN UPPER ARM; LACK OF MOBILITY IN THE SHOULDER AND THE UPPER ARM OF THE INJECTED SITE; FROZEN SHOULDER; HIGHER LEVEL OF PAIN (EXTREME PAIN)  AT THE LOCATION OF INJECTION; SORE ARM; LITTLE FATIGUE; 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 immune thrombocytopenic purpura, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced sore arm. On 01-APR-2021, the subject experienced little fatigue. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) in the shoulder and in upper arm. On 24-APR-2021, the subject experienced lack of mobility in the shoulder and the upper arm of the injected site. On 24-APR-2021, the subject experienced frozen shoulder. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) at the location of injection. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) Platelet count before the vaccination was 40. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fatigue on 03-APR-2021, and had not recovered from sore arm, higher level of pain (extreme pain) at the location of injection, lack of mobility in the shoulder and the upper arm of the injected site, higher level of pain (extreme pain) in the shoulder and in upper arm, and frozen shoulder. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain
Clinical narrative: SHOULDER PAIN; INJECTION SITE PAIN; This spontaneous report received from a patient via a company representative concerned an adult 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 ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. 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 shoulder pain, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the injection site pain and shoulder pain was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Migraine, Pain assessment, Pain in extremity
Clinical narrative: HEADACHE; MIGRAINE AND FELT LIKE BACK OF HEAD WAS GOING TO EXPLODE; FELT LIKE CRAP; FELT LIKE HAD BEEN HIT BY TRUCK; LEFT CALF PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid disorder, addison diseases, leiden factor v, and steroids. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced migraine and felt like back of head was going to explode. On APR-2021, the subject experienced felt like crap. On APR-2021, the subject experienced felt like had been hit by truck. On APR-2021, the subject experienced left calf pain. Laboratory data included: Pain scale (NR: not provided) 5 and 10. Treatment medications included: acetylsalicylic acid, eugenol/menthol/methyl salicylate, and rizatriptan. On 07-APR-2021, the subject experienced headache. Additional treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine and felt like back of head was going to explode, felt like crap, felt like had been hit by truck, left calf pain, and headache on APR-2021. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: HEADACHE; MIGRAINE AND FELT LIKE BACK OF HEAD WAS GOING TO EXPLODE; FELT LIKE CRAP; FELT LIKE HAD BEEN HIT BY TRUCK; LEFT CALF PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid disorder, addison diseases, leiden factor v, and steroids. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced migraine and felt like back of head was going to explode. On APR-2021, the subject experienced felt like crap. On APR-2021, the subject experienced felt like had been hit by truck. On APR-2021, the subject experienced left calf pain. Laboratory data included: Pain scale (NR: not provided) 5 and 10. Treatment medications included: acetylsalicylic acid, eugenol/menthol/methyl salicylate, and rizatriptan. On 07-APR-2021, the subject experienced headache. Additional treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine and felt like back of head was going to explode, felt like crap, felt like had been hit by truck, left calf pain, and headache on APR-2021. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Neurological symptom
Clinical narrative: FATIGUE; OUTER NERVE SENSATION; WARM AND COLDNESS OF ELBOW AND 2 FINGERS; This spontaneous report received from a patient concerned a 38 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, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 24-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 24-APR-2021 15:30, the subject experienced outer nerve sensation. On 24-APR-2021 15:30, the subject experienced warm and coldness of elbow and 2 fingers. On 25-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and outer nerve sensation, and the outcome of warm and coldness of elbow and 2 fingers was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Injection site papule, Vaccination site erythema
Clinical narrative: INJECTION SITE PAPULE; SHOULDER PAIN; VACCINATION SITE ERYTHEMA; PAINFUL JOINTS; This spontaneous report received from a patient concerned a 37 year old female. The patient's past medical history included rheumatoid arthritis flare up, Crohn's aggravated, and allergic cough, and concurrent conditions included social smoker, non alcoholic, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (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 unspecified Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1132647 expiry: UNKNOWN) dose was not reported, 1 time every 2 weeks, from SEP-2019 for Crohn's disease, and rheumatoid arthritis. No concomitant medications were reported. On MAR-2021, the subject experienced painful joints. On 30-MAR-2021, the subject experienced injection site papule. On 30-MAR-2021, the subject experienced shoulder pain. On 30-MAR-2021, the subject experienced vaccination site erythema. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from injection site papule, and vaccination site erythema on 01-APR-2021, and shoulder pain on APR-2021, and had not recovered from painful joints. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Decreased appetite, Dizziness, Fatigue
Clinical narrative: RED PIN POINT DOTS ON STOMACH; LATE/ABNORMAL PERIOD; LIGHT PERIOD WHICH WAS USUALLY HEAVY; FELT HORMONAL ANXIETY, PIT IN STOMACH; NAUSEA; FELT DRAINED AND TIRED; TREMENDOUS HEAD PRESSURE; LIFTING DIZZINESS; ATE BUT DID NOT FEEL LIKE EATING; LEG PAIN; FELT OUT OF CONTROL; This spontaneous report received from a patient concerned a 43 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: 041A71A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced felt out of control. Laboratory data included: Blood test (NR: not provided) complete blood count, vitamins and thyroid : Normal. On 13-APR-2021, the subject experienced leg pain. On 16-APR-2021, the subject experienced lifting dizziness. On 16-APR-2021, the subject experienced ate but did not feel like eating. On 16-APR-2021, the subject experienced tremendous head pressure. On 16-APR-2021, the subject experienced felt drained and tired. On 17-APR-2021, the subject experienced felt hormonal anxiety, pit in stomach. On 17-APR-2021, the subject experienced nausea. On 19-APR-2021, the subject experienced late/abnormal period. On 19-APR-2021, the subject experienced light period which was usually heavy. On 21-APR-2021, the subject experienced red pin point dots on stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt drained and tired, lifting dizziness, nausea, ate but did not feel like eating, felt hormonal anxiety, pit in stomach, tremendous head pressure, leg pain, and red pin point dots on stomach, and the outcome of light period which was usually heavy, late/abnormal period and felt out of control was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Head discomfort, Hypomenorrhoea, Menstruation delayed, Nausea
Clinical narrative: RED PIN POINT DOTS ON STOMACH; LATE/ABNORMAL PERIOD; LIGHT PERIOD WHICH WAS USUALLY HEAVY; FELT HORMONAL ANXIETY, PIT IN STOMACH; NAUSEA; FELT DRAINED AND TIRED; TREMENDOUS HEAD PRESSURE; LIFTING DIZZINESS; ATE BUT DID NOT FEEL LIKE EATING; LEG PAIN; FELT OUT OF CONTROL; This spontaneous report received from a patient concerned a 43 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: 041A71A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced felt out of control. Laboratory data included: Blood test (NR: not provided) complete blood count, vitamins and thyroid : Normal. On 13-APR-2021, the subject experienced leg pain. On 16-APR-2021, the subject experienced lifting dizziness. On 16-APR-2021, the subject experienced ate but did not feel like eating. On 16-APR-2021, the subject experienced tremendous head pressure. On 16-APR-2021, the subject experienced felt drained and tired. On 17-APR-2021, the subject experienced felt hormonal anxiety, pit in stomach. On 17-APR-2021, the subject experienced nausea. On 19-APR-2021, the subject experienced late/abnormal period. On 19-APR-2021, the subject experienced light period which was usually heavy. On 21-APR-2021, the subject experienced red pin point dots on stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt drained and tired, lifting dizziness, nausea, ate but did not feel like eating, felt hormonal anxiety, pit in stomach, tremendous head pressure, leg pain, and red pin point dots on stomach, and the outcome of light period which was usually heavy, late/abnormal period and felt out of control was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Petechiae
Clinical narrative: RED PIN POINT DOTS ON STOMACH; LATE/ABNORMAL PERIOD; LIGHT PERIOD WHICH WAS USUALLY HEAVY; FELT HORMONAL ANXIETY, PIT IN STOMACH; NAUSEA; FELT DRAINED AND TIRED; TREMENDOUS HEAD PRESSURE; LIFTING DIZZINESS; ATE BUT DID NOT FEEL LIKE EATING; LEG PAIN; FELT OUT OF CONTROL; This spontaneous report received from a patient concerned a 43 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: 041A71A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced felt out of control. Laboratory data included: Blood test (NR: not provided) complete blood count, vitamins and thyroid : Normal. On 13-APR-2021, the subject experienced leg pain. On 16-APR-2021, the subject experienced lifting dizziness. On 16-APR-2021, the subject experienced ate but did not feel like eating. On 16-APR-2021, the subject experienced tremendous head pressure. On 16-APR-2021, the subject experienced felt drained and tired. On 17-APR-2021, the subject experienced felt hormonal anxiety, pit in stomach. On 17-APR-2021, the subject experienced nausea. On 19-APR-2021, the subject experienced late/abnormal period. On 19-APR-2021, the subject experienced light period which was usually heavy. On 21-APR-2021, the subject experienced red pin point dots on stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt drained and tired, lifting dizziness, nausea, ate but did not feel like eating, felt hormonal anxiety, pit in stomach, tremendous head pressure, leg pain, and red pin point dots on stomach, and the outcome of light period which was usually heavy, late/abnormal period and felt out of control was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: BLOW-OUT DIARRHEA; TIRED; SWELLING AT SITE OF INJECTION; REDNESS AT SITE OF INJECTION; This spontaneous report received from a consumer concerned an 18 year old male. The patient's height, and weight were not reported. The patient's past medical history included encephalitis, and concurrent conditions included autism. The patient was previously treated with Hib vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced blow-out diarrhea. On APR-2021, the subject experienced tired. On APR-2021, the subject experienced swelling at site of injection. On APR-2021, the subject experienced redness at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blow-out diarrhea, tired, swelling at site of injection, and redness at site of injection. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Pyrexia, Vaccination complication
Clinical narrative: HEADACHE; FEVER; COVID VACCINE REACTION; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 160 pounds, and height was 190.5 centimeters. The patient's concurrent conditions included sterilization, anxiety, depression, rheumatoid arthritis, sulfa allergy manifested by hives, and iodine allergy manifested by hives. The patient was previously treated with iodine, and sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine; and experienced drug allergy when treated with diphenhydramine hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 15 days, from 2018 for rheumatoid arthritis. Concomitant medications included clonazepam for anxiety, bupropion hydrochloride for depression, fluoxetine hydrochloride for depression, and metoprolol succinate for high blood pressure. On APR-2021, the subject experienced covid vaccine reaction.  On 08-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid vaccine reaction on APR-2021, and fever, and headache on 13-APR-2021. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Migraine, Pyrexia
Clinical narrative: MIGRAINE; FEVER; This spontaneous report received from a patient via a company representative concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, frequency was not reported, from 10-JAN-2021 for psoriasis.  No concomitant medications were reported.  On APR-2021, the subject experienced migraine. On APR-2021, the subject experienced fever.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient was recovering from migraine, and the outcome of fever was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: REDNESS AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned an 18 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: Unknown) dose was not reported, administered on 08-APR-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 APR-2021, the subject experienced redness at injection site. Treatment medications included: diphenhydramine hydrochloride. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from redness at injection site. This report was non-serious. This parent/child case is linked to 20210450484.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: MILD STOMACH ACHE; 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: Unk) dose was not reported, administered on 08-APR-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 08-APR-2021, the subject experienced mild stomach ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild stomach ache on 08-APR-2021. This report was non-serious. This case, from the same reporter is linked to
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FEEL CRAPPY; 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 APR-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 APR-2021, the subject experienced feel crappy. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feel crappy was not reported. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule
Clinical narrative: BUMP ON LEFT DELTOID AREA WHERE RECEIVED THE VACCINE; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight was 270 pounds, and height was 64.8 inches. The patient's past medical history included anemia, and concurrent conditions included non smoker, alcohol user, and penicillin allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced bump on left deltoid area where received the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bump on left deltoid area where received the vaccine. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Chills, Hot flush, Pain in extremity, Tinnitus
Clinical narrative: TINNITUS; HOT FLASHES; SEVERE CHILLS; SORE ARM; 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced tinnitus. On 08-APR-2021, the subject experienced hot flashes. On 08-APR-2021, the subject experienced severe chills. On 22-APR-2021, Laboratory data included: Hearing test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus, and the outcome of sore arm, severe chills and hot flashes was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Blood test
Clinical narrative: LOW BLOOD SUGAR; This spontaneous report received from a patient concerned a 62 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, 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. No concomitant medications were reported. On an unspecified date, the subject experienced low blood sugar. Laboratory data (dates unspecified) included: Blood test (NR: not provided) low blood sugar reading was 86. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low blood sugar. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Nausea
Clinical narrative: BACK PAIN; NAUSEATED; This spontaneous report received from a consumer 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, and batch number were not reported) 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 back pain, and nauseated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nauseated and back pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210409436.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICKNESS FOR UNDER 48 HOURS; 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, 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 sickness for under 48 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sickness for under 48 hours was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: VERY SICK; This spontaneous report (social media) received from a health care professional via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included possible idiopathic thrombocytopenic purpura, and possible cyclic thrombocytopenia. The patient received covid-19 vaccine ad26.cov2.s (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. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included allergies. 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 unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: ACHES; CHILLS; MILD FEVER; This spontaneous report received from a consumer 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, expiry: unknown) dose was not reported, administered on 08-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 aches, chills, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, chills, and mild fever. This report was non-serious. This case, from the same reporter is linked to 20210448596.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe chronic plaque psoriasis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm. This report was non-serious.