chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Heart rate increased, Myalgia, Nasal congestion
Clinical narrative: HIGH HEART RATE; CONGESTION; BODY SHAKES; VOMITING; FEVER OF 102 F; MUSCLE ACHES; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, 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, intramuscular, batch number: 043a21a, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at 17:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 01-APR-2021 01:00, the subject experienced high heart rate. On 01-APR-2021 01:00, the subject experienced congestion. On 01-APR-2021 01:00, the subject experienced body shakes. On 01-APR-2021 01:00, the subject experienced vomiting. On 01-APR-2021 01:00, the subject experienced fever of 102 f. On 01-APR-2021 01:00, the subject experienced muscle aches. On 01-APR-2021 01:00, the subject experienced nausea. On 01-APR-2021 01:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 102 f, high heart rate, muscle aches, nausea, vomiting, headache, congestion, and body shakes. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tremor, Vomiting
Clinical narrative: HIGH HEART RATE; CONGESTION; BODY SHAKES; VOMITING; FEVER OF 102 F; MUSCLE ACHES; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, 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, intramuscular, batch number: 043a21a, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at 17:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 01-APR-2021 01:00, the subject experienced high heart rate. On 01-APR-2021 01:00, the subject experienced congestion. On 01-APR-2021 01:00, the subject experienced body shakes. On 01-APR-2021 01:00, the subject experienced vomiting. On 01-APR-2021 01:00, the subject experienced fever of 102 f. On 01-APR-2021 01:00, the subject experienced muscle aches. On 01-APR-2021 01:00, the subject experienced nausea. On 01-APR-2021 01:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 102 f, high heart rate, muscle aches, nausea, vomiting, headache, congestion, and body shakes. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: SLIGHT FATIGUE; MUSCLE ACHES; 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 31-MAR-2021 for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case.  No concomitant medications were reported. On 31-MAR-2021, the subject experienced slight fatigue. On 31-MAR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight fatigue, and muscle aches on 01-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: BROKE OUT IN HIVES; This spontaneous report received from a parent 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 01-APR-2021 on left arm 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 01-APR-2021, the subject experienced broke out in hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from broke out in hives on 01-APR-2021. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: FEVER; MUSCLE PAIN; FATIGUE; This spontaneous report received from a patient concerned a 60 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced muscle pain. On MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 38.2 C. On 26-MAR-2021, Laboratory data included: COVID-19 PCR test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, muscle pain and fatigue was not reported. This report was non-serious.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: ACHENESS; TIREDNESS; This spontaneous report received from a patient. 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, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the patient experienced acheness. On 12-MAR-2021, the patient experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acheness, and tiredness on 2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Heart rate, Heart rate increased, Insomnia
Clinical narrative: LOWER BACK HURTING; AWAKE SINCE MID-NIGHT; RAPID HEARTBEAT; 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,  and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 30-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced rapid heartbeat. Laboratory data included: Heart rate (NR: not provided) rapid. On 01-APR-2021, the subject experienced lower back hurting. On 01-APR-2021, the subject experienced awake since mid-night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid heartbeat, and lower back hurting, and the outcome of awake since mid-night was not reported. This report was non-serious.; Sender's Comments: V0 : Medical assessment comment not required as per standard operating procedure as case was assessed as non-serious
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: ACHINESS FOR A WEEK ON AND OFF; TIREDNESS FOR A WEEK ON AND OFF; This spontaneous report received from a consumer concerned an 84 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced achiness for a week on and off. On 11-MAR-2021, the subject experienced tiredness for a week on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness for a week on and off, and tiredness for a week on and off on 18-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210403886.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Malaise
Clinical narrative: LIGHTHEADED; NOT FEELING GOOD; TIRED; This spontaneous report received from a patient concerned a 77 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced lightheaded, not feeling good, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from not feeling good, tired, and lightheaded. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER (100.5); HEADACHE; 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, and batch number were not reported) dose was not reported, administered on 03-MAR-2021 10:30 a.m. for prophylactic vaccination. Batch number was not reported has been requested. No concomitant medications were reported. On 01-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100.5 F. On 01-APR-2021 05:00:00 a.m., the subject experienced chills. On 01-APR-2021 05:00:00 a.m., the subject experienced fever (100.5). On 01-APR-2021 05:00:00 a.m., the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever (100.5) and headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: SICK; FEELING UNWELL; This spontaneous report received from a consumer via a company representative concerned a 20 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 sick, and feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick and feeling unwell was not reported. This report was non-serious. This case, involving the twin/triplet is linked to 20210403156.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Swelling
Clinical narrative: SKIN SLIGHTLY TENDER TO TOUCH; SWELLING IN THE LEFT ARMPIT AROUND LYMPH NODE AREA; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included gallbladder removal, and ovary removal, and concurrent conditions included allergy to dust mites, consumes alcohol- couple of glasses of wine per week, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse/ illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 around 13:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced swelling in the left armpit around lymph node area. On an unspecified date, the subject experienced skin slightly tender to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in the left armpit around lymph node area, and the outcome of skin slightly tender to touch was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Medication error, Multiple use of single-use product
Clinical narrative: MEDICATION ERROR; PUNTURED VIAL USED AFTER 6 HOURS; This spontaneous report received from a health care professional concerned a 50-year-old female. The patient's height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On 01-APR-2021, the patient experienced medication error. On 01-APR-2021, the patient experienced punctured vial used after 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from medication error, and punctured vial used after 6 hours. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: BODY ACHES; SORE ARM; 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) dose was not reported, administered on 12-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 body aches. On MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Chills, Feeling cold
Clinical narrative: FEELING COLD; CHILLS; FEELING A SPLATTER OF LIQUID ON HER SKIN DURING ADMINISTRATION; .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 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced feeling cold. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced feeling a splatter of liquid on her skin during administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling cold, and chills on 01-APR-2021, and the outcome of feeling a splatter of liquid on her skin during administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210403868.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling of body temperature change, Influenza like illness, Pyrexia
Clinical narrative: FLU-LIKE SYMPTOMS; JOINT PAIN; HOT AND COLD SENSATIONS IN BODY; REAL HIGH FEVER/FEVER; 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: 041S21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination at left deltoid. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced flu-like symptoms. On 31-MAR-2021, the subject experienced joint pain. On 31-MAR-2021, the subject experienced real high fever. On 31-MAR-2021, the subject experienced hot and cold sensations in body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu-like symptoms, joint pain, real high fever, and hot and cold sensations in body. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: FATIGUE; HEADACHES; 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) 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 fatigue. On MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headaches on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210400162.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Neck pain, Pyrexia
Clinical narrative: PRESSURE AT THE EARS; NECK PAIN; DIZZINESS; 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 past medical history included pork allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced fever. On an unspecified date, the subject experienced pressure at the ears, neck pain, and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of pressure at the ears, neck pain and dizziness was not reported. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Fatigue, Injection site pain, Pain
Clinical narrative: FEELING WORSE; FEVER; FATIGUE; PAIN AT INJECTION SITE; SHIVERING; SORE ALL OVER; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight was 72 kilograms, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 31-MAR-2021 at 13:30 on left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced sore all over. On 01-APR-2021, the subject experienced shivering. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021, the subject experienced pain at injection site. On 01-APR-2021 07:00, the subject experienced feeling worse. On 01-APR-2021 07:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling worse, and the outcome of fever, shivering, fatigue, pain at injection site and sore all over was not reported. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEELING WORSE; FEVER; FATIGUE; PAIN AT INJECTION SITE; SHIVERING; SORE ALL OVER; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight was 72 kilograms, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 31-MAR-2021 at 13:30 on left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced sore all over. On 01-APR-2021, the subject experienced shivering. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021, the subject experienced pain at injection site. On 01-APR-2021 07:00, the subject experienced feeling worse. On 01-APR-2021 07:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling worse, and the outcome of fever, shivering, fatigue, pain at injection site and sore all over was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 in the morning for prophylactic vaccination. The batch No. was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: FEELING SICK; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 68.2 kilograms, and height was not reported. The patient's concurrent conditions included secondary pulmonary hypertension. The patient received macitentan (tablet, oral, batch number: ZM021B0101 expiry: 30-NOV-2023) 10 mg, every 1 day, frequency, and therapy dates were not reported for secondary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin were 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 number. Concomitant medications included tadalafil, and treprostinil diolamin. On an unspecified date, the subject experienced feeling sick, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of the fever and feeling sick was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Tremor
Clinical narrative: UNCONTROLLABLE SHAKING; SORE ARM; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included headache.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 13:05 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included acetylsalicylic acid/caffeine/paracetamol/salicylamide for headache. On 01-APR-2021, around 23:00 the subject experienced uncontrollable shaking. On 01-APR-2021, the subject experienced sore arm. On 01-APR-2021, around 23:00 the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, chills and uncontrollable shaking was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: SPOTS ON THE SKIN OF BOTH ARMS; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's past medical history included total hip replacement surgery, and concurrent conditions included back pain, alcohol use- couple of beers after work, non smoker, and chew tobacco, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 18:50 on left arm for prophylactic vaccination. Concomitant medications included baclofen for pain relief, and muscle relaxation, gabapentin, ibuprofen, and tramadol.  On 2021, the subject experienced spots on the skin of both arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from spots on the skin of both arms. This report was non-serious
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Headache, Nausea
Clinical narrative: VOMITING; CHILLS; HORRIBLE HEADACHE; NAUSEA; TEMPERATURE 98.9 F; 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 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 01-APR-2021, the subject experienced vomiting. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced horrible headache. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced temperature 98.9 f. Laboratory data included: Body temperature (NR: not provided) 98.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, horrible headache, chills, temperature 98.9 f, and vomiting. 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: Vomiting
Clinical narrative: VOMITING; CHILLS; HORRIBLE HEADACHE; NAUSEA; TEMPERATURE 98.9 F; 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 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 01-APR-2021, the subject experienced vomiting. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced horrible headache. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced temperature 98.9 f. Laboratory data included: Body temperature (NR: not provided) 98.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, horrible headache, chills, temperature 98.9 f, and vomiting. 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: Body temperature, Headache, Pyrexia
Clinical narrative: HEADACHE; FEVER 38.9 CELSIUS; This spontaneous report received from a patient concerned a female of an 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 right deltoid on 31-MAR-2021c, 17:10 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 01-APR-2021, Laboratory data included: Body temperature (NR: not provided) 38.9 degree celsius. On 01-APR-2021 08:00, the subject experienced headache. On 01-APR-2021 08:00, the subject experienced fever 38.9 celsius. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and fever 38.9 celsius. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Feeling hot, Insomnia
Clinical narrative: VOMITING; FEELS HOT; FEVER; DIARRHEA; COULDNT SLEEP; CHILLS; MUSCLE ACHES; NAUSEA; This spontaneous report received from a consumer concerned a 61 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: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021  to left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced could not sleep. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced muscle aches. On 31-MAR-2021, the subject experienced nausea. On APR-2021, Laboratory data included: Body temperature (NR: not provided) under 100. On 01-APR-2021, the subject experienced vomiting. On 01-APR-2021, the subject experienced feels hot. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting, and nausea, had not recovered from muscle aches, chills, feels hot, and fever, and the outcome of diarrhea and could not sleep was not reported. This report was non-serious.  Version created to amend previously reported information on 01-Apr-2021. Upon review the following information was amended: Event ranking updated and reporter type changed to consumer/ non health care professional from contact.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: VOMITING; FEELS HOT; FEVER; DIARRHEA; COULDNT SLEEP; CHILLS; MUSCLE ACHES; NAUSEA; This spontaneous report received from a consumer concerned a 61 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: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021  to left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced could not sleep. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced muscle aches. On 31-MAR-2021, the subject experienced nausea. On APR-2021, Laboratory data included: Body temperature (NR: not provided) under 100. On 01-APR-2021, the subject experienced vomiting. On 01-APR-2021, the subject experienced feels hot. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting, and nausea, had not recovered from muscle aches, chills, feels hot, and fever, and the outcome of diarrhea and could not sleep was not reported. This report was non-serious.  Version created to amend previously reported information on 01-Apr-2021. Upon review the following information was amended: Event ranking updated and reporter type changed to consumer/ non health care professional from contact.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Chills, Fatigue, Feeling abnormal
Clinical narrative: FELT SHE IS GOING TO DIE; GAGGED ALL OVER HERSELF; VOMITING; COULDN'T WALK/TRIED TO DRAG HERSELF TO BATHROOM; CHILLS; FEVER; FEELING WEAK AND CAN'T DO ANYTHING; TIRED; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis, lupus, non alcohol user and non smoker and other pre-existing medical conditions included no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A-HR, expiry: UNKNOWN) dose was not reported, 1 total administered on 30-MAR-2021 at 09:15 on right arm for prophylactic vaccination. The concomitant medications included immuno-suppressant medications. On 30-MAR-2021, the patient started experiencing chills which kept getting worse and got fever then started with vomiting and could not walk. The patient Gagged all over herself.  The patient felt like she was going die and can't do anything so she called an ambulance. She was hospitalized on 30-Mar-2021 for all night. At hospital patient treated with medication for vomiting and was put on IV and blood test was performed. On 31-Mar-2021, At 13:00 , the patient was discharged from hospital but patient still experience weak, tired and can't do anything. The patient was hospitalized for 1 day. Hospital stated note for visit was Adverse Drug Reaction and instructed for follow up with treating physician in 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt she is going to die, and vomiting, couldn't walk/tried to drag herself to bathroom, chills, and fever on 31-MAR-2021, had not recovered from feeling weak and can't do anything, and tired, and the outcome of gagged all over herself was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0: 20210404324-covid-19 vaccine ad26.cov2.s -Vomiting, couldn't walk and tried to drag herself to the bathroom, gagged all over herself, felt like she is going to die. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210404324-covid-19 vaccine ad26.cov2.s -Fever, chills. These events are labeled per Agency and are therefore considered potentially related.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Pyrexia, Retching, Vomiting
Clinical narrative: FELT SHE IS GOING TO DIE; GAGGED ALL OVER HERSELF; VOMITING; COULDN'T WALK/TRIED TO DRAG HERSELF TO BATHROOM; CHILLS; FEVER; FEELING WEAK AND CAN'T DO ANYTHING; TIRED; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis, lupus, non alcohol user and non smoker and other pre-existing medical conditions included no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A-HR, expiry: UNKNOWN) dose was not reported, 1 total administered on 30-MAR-2021 at 09:15 on right arm for prophylactic vaccination. The concomitant medications included immuno-suppressant medications. On 30-MAR-2021, the patient started experiencing chills which kept getting worse and got fever then started with vomiting and could not walk. The patient Gagged all over herself.  The patient felt like she was going die and can't do anything so she called an ambulance. She was hospitalized on 30-Mar-2021 for all night. At hospital patient treated with medication for vomiting and was put on IV and blood test was performed. On 31-Mar-2021, At 13:00 , the patient was discharged from hospital but patient still experience weak, tired and can't do anything. The patient was hospitalized for 1 day. Hospital stated note for visit was Adverse Drug Reaction and instructed for follow up with treating physician in 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt she is going to die, and vomiting, couldn't walk/tried to drag herself to bathroom, chills, and fever on 31-MAR-2021, had not recovered from feeling weak and can't do anything, and tired, and the outcome of gagged all over herself was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0: 20210404324-covid-19 vaccine ad26.cov2.s -Vomiting, couldn't walk and tried to drag herself to the bathroom, gagged all over herself, felt like she is going to die. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210404324-covid-19 vaccine ad26.cov2.s -Fever, chills. These events are labeled per Agency and are therefore considered potentially related.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; DIARRHEA; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with naproxen sodium, and acetylsalicylic acid. 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 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced diarrhea. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced fever. Treatment medications included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and fever, and the outcome of body aches, headache and diarrhea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dyspnoea, Nausea, Pyrexia
Clinical narrative: SEVERE SHORTNESS OF BREATH; DRYNESS OF MOUTH; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart surgery back in 2011, and stent placement in 2012, and concurrent conditions included cipro allergy. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, vaccination on left arm administered on 31-MAR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ticagrelor for heart surgery. On 01-APR-2021, the subject experienced severe shortness of breath. On 01-APR-2021, the subject experienced dryness of mouth. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe shortness of breath, and the outcome of dryness of mouth, nausea and fever 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: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Rash
Clinical narrative: RIGHT HAND RASH; FATIGUE; RIGHT LEG INFLAMMATION; 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced right leg inflammation. On MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced right hand rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right hand rash, and the outcome of right leg inflammation and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Decreased appetite, Insomnia, Nausea
Clinical narrative: ABDOMINAL PAIN,ABDOMINAL CRAMPS,SORE BELLY; NAUSEA; LOSS OF APPETITE; CANNOT SLEEP; CHILLS; This spontaneous report received from a parent 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 31-MAR-2021 at 14:30  left arm for prophylactic vaccination.The batch number was not reported and has been requested No concomitant medications were reported. On 2021, treatment medications included: paracetamol. On 31-MAR-2021, the subject experienced loss of appetite. On 31-MAR-2021, the subject experienced cannot sleep. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021 18:30, the subject experienced abdominal pain, abdominal cramps, sore belly. On 31-MAR-2021 18:30, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cannot sleep on 01-APR-2021, and chills on 2021, was recovering from abdominal pain,abdominal cramps,sore belly, and loss of appetite, and had not recovered from nausea. 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Nervousness, Paraesthesia
Clinical narrative: SWELLING IN ARM; SWELLING OF FACE; TINGLING OF BODY; THROAT STARTED TO CONSTRICT; LEGS ARE ITCHY; SHAKY FEELING ALL OVER; RASH ON TORSO; CHILLS; KILLER HEADACHE; LITTLE BIT OF NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination, vaccinated at the left arm at 12:00 PM. No concomitant medications were reported. On 01-APR-2021, the subject experienced swelling in arm. On 01-APR-2021, the subject experienced swelling of face. On 01-APR-2021, the subject experienced tingling on face. On 01-APR-2021, the subject experienced tingling of body. On 01-APR-2021, the subject experienced throat started to constrict. On 01-APR-2021, the subject experienced legs are itchy. On 01-APR-2021, the subject experienced shaky feeling all over. On 01-APR-2021, the subject experienced rash on torso. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced killer headache. On 01-APR-2021, the subject experienced little bit of nausea. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling of face, tingling on face, tingling of body, throat started to constrict, chills, shaky feeling all over, and little bit of nausea, and had not recovered from swelling in arm, rash on torso, legs are itchy, and killer headache. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash, Swelling face, Throat tightness
Clinical narrative: SWELLING IN ARM; SWELLING OF FACE; TINGLING OF BODY; THROAT STARTED TO CONSTRICT; LEGS ARE ITCHY; SHAKY FEELING ALL OVER; RASH ON TORSO; CHILLS; KILLER HEADACHE; LITTLE BIT OF NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination, vaccinated at the left arm at 12:00 PM. No concomitant medications were reported. On 01-APR-2021, the subject experienced swelling in arm. On 01-APR-2021, the subject experienced swelling of face. On 01-APR-2021, the subject experienced tingling on face. On 01-APR-2021, the subject experienced tingling of body. On 01-APR-2021, the subject experienced throat started to constrict. On 01-APR-2021, the subject experienced legs are itchy. On 01-APR-2021, the subject experienced shaky feeling all over. On 01-APR-2021, the subject experienced rash on torso. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced killer headache. On 01-APR-2021, the subject experienced little bit of nausea. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling of face, tingling on face, tingling of body, throat started to constrict, chills, shaky feeling all over, and little bit of nausea, and had not recovered from swelling in arm, rash on torso, legs are itchy, and killer headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; 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 01-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021 22:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.