chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Pain, Pyrexia
Clinical narrative: BODYACHES; COUGHING; CHILLS; SLIGHT FEVER; MILD HEADACHE; 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: 1082068, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced bodyaches. On 23-MAR-2021, the subject experienced coughing. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced slight fever. On 23-MAR-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slight fever, bodyaches, chills, coughing, and mild headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Musculoskeletal stiffness, Pruritus
Clinical narrative: STIFF NECK; ITCHY; RED DOTS ON SHOULDER OF INJECTION SITE ARM; INJECTION SITE PAIN; EXHAUSTION; HEADACHE; 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced stiff neck. On MAR-2021, the subject experienced itchy. On MAR-2021, the subject experienced red dots on shoulder of injection site arm. On MAR-2021, the subject experienced injection site pain. On MAR-2021, the subject experienced exhaustion. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stiff neck, injection site pain, red dots on shoulder of injection site arm, itchy, exhaustion and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: STIFF NECK; ITCHY; RED DOTS ON SHOULDER OF INJECTION SITE ARM; INJECTION SITE PAIN; EXHAUSTION; HEADACHE; 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced stiff neck. On MAR-2021, the subject experienced itchy. On MAR-2021, the subject experienced red dots on shoulder of injection site arm. On MAR-2021, the subject experienced injection site pain. On MAR-2021, the subject experienced exhaustion. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stiff neck, injection site pain, red dots on shoulder of injection site arm, itchy, exhaustion and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: VERY SICK; This spontaneous report received from a vaccine facility concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid. 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 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.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: MUSCLE ACHE; HEADACHE; TIREDNESS; 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 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced muscle ache. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle ache, headache and tiredness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Rash
Clinical narrative: PERSISTENT RASH/LITTLE BUMPS ON BOTH LEGS; CHILLS; FEVER; BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 175 pounds, and height was 57 inches. The patient's concurrent conditions included ceclor allergy, occasional alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no diagnostic data available. The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination at left arm. No concomitant medications were reported.  On 12-MAR-2021, the subject experienced body aches. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced persistent rash/little bumps on both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 15-MAR-2021, and chills, and fever on 13-MAR-2021, and had not recovered from persistent rash/little bumps on both legs. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: DIZZINESS; SLEEPINESS; BRUISE ON ARM AT SITE OF INJECTION; PAIN IN ARM; FEVER; 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 concurrent conditions included diabetes, and legally blind, and other pre-existing medical conditions included she has diabetes and wanted to know if her sugar level would go up because she is on insulin. she wanted to know how long side effects would last because she needs to go to work tomorrow.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 on right arm. Concomitant medications included insulin for diabetes. On 24-MAR-2021, the subject experienced dizziness. On 24-MAR-2021, the subject experienced sleepiness. On 24-MAR-2021, the subject experienced bruise on arm at site of injection. On 24-MAR-2021, the subject experienced pain in arm. On 24-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, dizziness, sleepiness, pain in arm, and bruise on arm at site of injection. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. This report was non-serious.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Confusional state
Clinical narrative: CONFUSION; AMNESIA; This spontaneous report received from a consumer concerned an 83 year old female. The patient's height, and weight were not reported. The patient's past medical history included previous heart attack, and concurrent conditions included diabetes, high blood pressure, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient do not have any known drug allergies nor drug abuse or illicit drug usage. 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 19-MAR-2021 15:19 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021 03:00, the subject experienced confusion. On 20-MAR-2021 03:00, the subject experienced amnesia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confusion, and amnesia on 20-MAR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Headache
Clinical narrative: FEELS BODY HURTS; DIZZINESS; WEAKNESS; HURTS HANDS ESPECIALLY; CHILLS; HEADACHE; FEVER 102 C; This spontaneous report received from a patient concerned a 51 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 allergies. 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 23-MAR-2021, 10:30 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102 C. On 23-MAR-2021 17:30, the subject experienced chills. On 23-MAR-2021 17:30, the subject experienced dizziness. On 23-MAR-2021 17:30, the subject experienced weakness. On 23-MAR-2021 17:30, the subject experienced headache. On 23-MAR-2021 17:30, the subject experienced fever 102c. On 23-MAR-2021 17:30, the subject experienced feels body hurts. On 23-MAR-2021 17:30, the subject experienced hurts hands especially. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, dizziness, weakness, headache, fever 102c, feels body hurts, and hurts hands especially. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: FEELS BODY HURTS; DIZZINESS; WEAKNESS; HURTS HANDS ESPECIALLY; CHILLS; HEADACHE; FEVER 102 C; This spontaneous report received from a patient concerned a 51 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 allergies. 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 23-MAR-2021, 10:30 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102 C. On 23-MAR-2021 17:30, the subject experienced chills. On 23-MAR-2021 17:30, the subject experienced dizziness. On 23-MAR-2021 17:30, the subject experienced weakness. On 23-MAR-2021 17:30, the subject experienced headache. On 23-MAR-2021 17:30, the subject experienced fever 102c. On 23-MAR-2021 17:30, the subject experienced feels body hurts. On 23-MAR-2021 17:30, the subject experienced hurts hands especially. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, dizziness, weakness, headache, fever 102c, feels body hurts, and hurts hands especially. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Injection site pain
Clinical narrative: FLU LIKE SYMPTOMS; PAIN AT SITE OF INJECTION; FATIGUE; 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 and expiry: unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch no was not reported ,The company is unable to performed follow up to request batch /Lot numbers. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced flu like symptoms. On 24-MAR-2021, the subject experienced pain at site of injection. On 24-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at site of injection, fatigue, and flu like symptoms. 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: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: NAUSEA; This spontaneous report received from a health care professional 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) once a total 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 nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHE; NAUSEA; TIRED; FEVER; HEADACHE; 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, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, nausea, tired, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from body ache, nausea, tired, fever, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nerve injury
Clinical narrative: NERVE DAMAGE (HAND WENT NUMB WITH ALL FINGERS TWITCHING) 48 HOURS AFTER VACCINATION; 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 concurrent conditions included carpal tunnel.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry date: UNKNOWN) dose was not reported, administered on MAR-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 MAR-2021, the subject experienced nerve damage (hand went numb with all fingers twitching) 48 hours after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nerve damage (hand went numb with all fingers twitching) 48 hours after vaccination was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included headache, and concurrent conditions included allergy, and other pre-existing medical conditions included none. The patient's height, and weight were not reported. The patient's concurrent conditions included headache, and other pre-existing medical conditions included none.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry date: unknown) dose was not reported, administered on 23-MAR-2021 around 16:30 or 17:00 to left arm 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 slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slight headache. This report was non-serious.    s.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Headache, Muscle spasms
Clinical narrative: This spontaneous report received from a patient concerned a 76 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: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced cramps. On 08-MAR-2021, the subject experienced aches. On 08-MAR-2021, the subject experienced dizzy. On 08-MAR-2021, the subject experienced sore arm. On 08-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced stomach cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramps, aches, dizzy, and headache on 09-MAR-2021, and sore arm on 12-MAR-2021, and had not recovered from diarrhea, and stomach cramps. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: This spontaneous report received from a patient concerned a 76 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: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced cramps. On 08-MAR-2021, the subject experienced aches. On 08-MAR-2021, the subject experienced dizzy. On 08-MAR-2021, the subject experienced sore arm. On 08-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced stomach cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramps, aches, dizzy, and headache on 09-MAR-2021, and sore arm on 12-MAR-2021, and had not recovered from diarrhea, and stomach cramps. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Off label use
Clinical narrative: DRUG ADMINISTERED VIA INAPPROPRIATE ROUTE; OFF LABEL USE; This spontaneous report received from a health care professional 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, intravenous, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced drug administered via inappropriate route, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administered via inappropriate route and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Tremor
Clinical narrative: FEVER; CHILLS; FATIGUE; SHAKING; This spontaneous report received from a consumer 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 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced shaking. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient had not recovered from fever, chills, fatigue, and shaking. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: LITTLE SORE ARM; LIGHT NAUSEA FOR A COUPLE OF DAYS; 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, expiry: 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 little sore arm, and light nausea for a couple of days but still ate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little sore arm and light nausea for a couple of days but still ate was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Headache, Injection site pain, Musculoskeletal stiffness
Clinical narrative: REALLY COLD, COULDN'T GET WARM; STIFF FOR SEVERAL HOURS; FELT ODD; MUSCLES ACHED; A BIT OF A HEADACHE; SORE WHERE THE INJECTION WAS; 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 23-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers . No concomitant medications were reported. On MAR-2021, the subject experienced really cold, couldn't get warm. On MAR-2021, the subject experienced stiff for several hours. On MAR-2021, the subject experienced felt odd. On MAR-2021, the subject experienced muscles ached. On MAR-2021, the subject experienced a bit of a headache. On MAR-2021, the subject experienced sore where the injection was. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from really cold, couldn't get warm, stiff for several hours, muscles ached, a bit of a headache, sore where the injection was, and felt odd. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: REALLY COLD, COULDN'T GET WARM; STIFF FOR SEVERAL HOURS; FELT ODD; MUSCLES ACHED; A BIT OF A HEADACHE; SORE WHERE THE INJECTION WAS; 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 23-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers . No concomitant medications were reported. On MAR-2021, the subject experienced really cold, couldn't get warm. On MAR-2021, the subject experienced stiff for several hours. On MAR-2021, the subject experienced felt odd. On MAR-2021, the subject experienced muscles ached. On MAR-2021, the subject experienced a bit of a headache. On MAR-2021, the subject experienced sore where the injection was. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from really cold, couldn't get warm, stiff for several hours, muscles ached, a bit of a headache, sore where the injection was, and felt odd. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Rash
Clinical narrative: NOT FEELING HERSELF; RASH; TIRED; 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 has had anaphylactic shock before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered to left arm on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced rash, not feeling herself, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, rash and not feeling herself was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: SORENESS; NAUSEA; INTENSE HEADACHE; This spontaneous report received from a consumer 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 20-MAR-2021 14:30 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 nausea, intense headache, and soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, intense headache and soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nonspecific reaction
Clinical narrative: SIDE EFFECTS HAD BEEN HORRIBLE; 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 and expiry: 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 side effects have been horrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects have been horrible was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold
Clinical narrative: FEELING COLD; MILD FATIGUE; 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) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced feeling cold. On 09-MAR-2021, the subject experienced mild fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild fatigue and feeling cold was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Chills, Diarrhoea, Pyrexia
Clinical narrative: ABDOMINAL PAIN; DIARRHEA; SEVERE CHILLS; FEVER; This spontaneous report received from a patient concerned a 63 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, intramuscular, batch number:1805020 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. On 20-MAR-2021, the subject experienced abdominal pain. On 20-MAR-2021, the subject experienced diarrhea. On 20-MAR-2021, the subject experienced severe chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 21-MAR-2021, and had not recovered from severe chills, diarrhea, and abdominal pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Dizziness, Feeling hot, Headache, Nausea
Clinical narrative: HEADACHE; INCREASED BLOOD SUGAR; SHAKINESS; LIGHTHEADEDNESS AND DIZZINESS; SORE ARM; FEELING WARM; NAUSEA; This spontaneous report received from a patient concerned a not Hispanic/Latino Asian female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no history of any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered in left arm on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-MAR-2021, the subject experienced increased blood sugar. On 23-MAR-2021, the subject experienced shakiness. On 23-MAR-2021, the subject experienced lightheadedness and dizziness. On 23-MAR-2021, the subject experienced sore arm. On 23-MAR-2021, the subject experienced feeling warm. On 23-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol (Tylenol). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shakiness, lightheadedness and dizziness, sore arm, feeling warm, increased blood sugar, nausea, and headache. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: HEADACHE; INCREASED BLOOD SUGAR; SHAKINESS; LIGHTHEADEDNESS AND DIZZINESS; SORE ARM; FEELING WARM; NAUSEA; This spontaneous report received from a patient concerned a not Hispanic/Latino Asian female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no history of any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered in left arm on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-MAR-2021, the subject experienced increased blood sugar. On 23-MAR-2021, the subject experienced shakiness. On 23-MAR-2021, the subject experienced lightheadedness and dizziness. On 23-MAR-2021, the subject experienced sore arm. On 23-MAR-2021, the subject experienced feeling warm. On 23-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol (Tylenol). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shakiness, lightheadedness and dizziness, sore arm, feeling warm, increased blood sugar, nausea, and headache. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: TROUBLE BREATHING; DIZZINESS; 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced trouble breathing. On 24-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from trouble breathing, and dizziness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Electric shock sensation, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: HEADACHE; ARM SORENESS; FELT ELECTRIFYING; FELT THE MEDICINE GOING INTO THE  MUSCLE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included fiber myalgia in arms. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180525, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 14:40 for prophylactic vaccination on left arm. No concomitant medications were reported. On 19-MAR-2021, the subject experienced felt electrifying. On 19-MAR-2021, the subject experienced felt the medicine going into the muscle. On 21-MAR-2021, the subject experienced arm soreness. On 24-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt electrifying, and felt the medicine going into the muscle on 19-MAR-2021, and had not recovered from headache, and arm soreness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Fatigue, Pain, Pain in extremity
Clinical narrative: STRANGE SIDE EFFECTS; ACHEY; SORE ARM; TIRED; This spontaneous report received from a patient concerned a 68 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 expiry date: UNKNOWN) dose was not reported, administered on 17-MAR-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 MAR-2021, the subject experienced strange side effects. On MAR-2021, the subject experienced achey. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, achey, strange side effects and tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: SORE THROAT; HEADACHE; MUSCLE ACHE IN THIGH AND OTHER; FATIGUE; 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 concurrent conditions included non insulin dependent diabetes. The patient was previously treated with metformin for non insulin dependent diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021to right arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced muscle ache in thigh and other. On 20-MAR-2021, the subject experienced fatigue. On 24-MAR-2021, the subject experienced sore throat. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from sore throat, muscle ache in thigh and other, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Insomnia, Myalgia
Clinical narrative: NO SLEEP; CHILLS; MUSCLES ACHES; HEADACHES; SWEATING; 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 concurrent conditions included non-smoker, and other pre-existing medical conditions included patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced muscles aches. On 23-MAR-2021, the subject experienced headaches. On 23-MAR-2021, the subject experienced sweating. On an unspecified date, the subject experienced no sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and muscles aches on 23-MAR-2021, had not recovered from headaches, and sweating, and the outcome of no sleep was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: LACRIMATION; MUSCLE CRAMPS; JOINT ACHES; CHILLS; FEVER; HEADACHE; TIREDNESS AND  FATIGUE; 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: Unknown) dose was not reported, administered on 23-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced joint aches. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced fever. On 23-MAR-2021, the subject experienced headache. On 23-MAR-2021, the subject experienced tiredness and fatigue. On 24-MAR-2021, the subject experienced lacrimation. On 24-MAR-2021, the subject experienced muscle cramps. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.6 F, 100.6 F. Treatment medications (dates unspecified) included: magnesium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps, and headache on 24-MAR-2021, was recovering from fever, and chills, and had not recovered from joint aches, tiredness and fatigue, and lacrimation. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Muscle spasms, Pyrexia
Clinical narrative: LACRIMATION; MUSCLE CRAMPS; JOINT ACHES; CHILLS; FEVER; HEADACHE; TIREDNESS AND  FATIGUE; 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: Unknown) dose was not reported, administered on 23-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced joint aches. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced fever. On 23-MAR-2021, the subject experienced headache. On 23-MAR-2021, the subject experienced tiredness and fatigue. On 24-MAR-2021, the subject experienced lacrimation. On 24-MAR-2021, the subject experienced muscle cramps. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.6 F, 100.6 F. Treatment medications (dates unspecified) included: magnesium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps, and headache on 24-MAR-2021, was recovering from fever, and chills, and had not recovered from joint aches, tiredness and fatigue, and lacrimation. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES (GETTING WORSE); 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 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 23-MAR-2021, the subject experienced hives (getting worse). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives (getting worse). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Influenza like illness, Pyrexia
Clinical narrative: FEVER; FLU LIKE SYMPTOMS; CHILLS; DIARRHEA; HEADACHE; 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 concurrent conditions included arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1806609, expiry date: unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination at left deltoid. Concomitant medications included paracetamol for arthritis. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced flu like symptoms. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, chills, and diarrhea on MAR-2021, and was recovering from fever, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM FOR A DAY OR TWO; This spontaneous report received from a patient concerned a 71 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) dose was not reported, administered on MAR-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 MAR-2021, the subject experienced sore arm for a day or two. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm for a day or two on MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: TINGLING; NUMBNESS; 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, 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 tingling, and numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling and numbness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Headache, Insomnia
Clinical narrative: FEELING ACHY; SINUSES WERE CLOG; TIRED FROM NOT SLEEPING; COULDN'T GET WARM; NO SIDE EFFECTS; SHIVERING; HEADACHE; NAUSEOUS; FEVER; TIRED; 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: 1805028 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced feeling achy, sinuses were clog, tired from not sleeping, couldn't get warm, shivering, headache, nauseous, fever,  tired and 48 hours after vaccination had no side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling achy, shivering, tired, couldn't get warm, fever, nauseous, sinuses were clog, headache, tired from not sleeping and no side effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, No adverse event, Pain, Pyrexia, Sinus congestion
Clinical narrative: FEELING ACHY; SINUSES WERE CLOG; TIRED FROM NOT SLEEPING; COULDN'T GET WARM; NO SIDE EFFECTS; SHIVERING; HEADACHE; NAUSEOUS; FEVER; TIRED; 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: 1805028 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced feeling achy, sinuses were clog, tired from not sleeping, couldn't get warm, shivering, headache, nauseous, fever,  tired and 48 hours after vaccination had no side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling achy, shivering, tired, couldn't get warm, fever, nauseous, sinuses were clog, headache, tired from not sleeping and no side effects was not reported. This report was non-serious.