chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hot flush, Pyrexia, Skin burning sensation
Clinical narrative: CHILLS; FEVER; BURNING SKIN; HOT FLASHES/FEELING HOT; FATIGUE; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight was 77.1 kilograms, and height was 175.26 centimeters. The patient's concurrent conditions included seasonal allergy, alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient was previously treated with diphtheria vaccine toxoid/pertussis vaccine acellular/ toxoid for prophylactic vaccination; and experienced reactions to vaccines when treated with diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid, and tetanus vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609 expiry: 09-JUN-2021) dose was not reported, administered on 19-MAR-2021 14:00 in the right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced hot flashes/feeling hot. On MAR-2021, the subject experienced fatigue. On 19-MAR-2021, the subject experienced burning skin. On 19-MAR-2021 22:00, the subject experienced chills. On 19-MAR-2021 22:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning skin, hot flashes/feeling hot, chills, fever, and fatigue on 20-MAR-2021. This report was non-serious.  Additional information was received from the patient on 30-MAR-2021. Following information was updated into the case: other identification numbers added, patient's contact details added (address, city, zip code, email address and phone number), patient demographics added (age ,age group, gender, height, and weight), concurrent condition added ( seasonal allergy, non-smoker, alcoholic), event added (fatigue and hot flashes/feeling hot), past reaction added( reactions to vaccines), suspect drug route of administration added ((intramuscular), vaccination time added, past drug added (Tetanus and TDAP) and due diligence updated.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: 5TH NOSEBLEED IN A WEEK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced 5th nosebleed in a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 5th nosebleed in a week was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: SORE ARM THE DAY AFTER; VERY TIRED; SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not provided. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm the day after, very tired, and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight headache, very tired and sore arm the day after was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Insomnia, Pain, Pyrexia
Clinical narrative: WOKE UP IN PAIN; FEVER WAS 102-103; DIDN'T SLEEP AT ALL NIGHT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 26-MAR-2021, the subject experienced didn't sleep at all night. On an unspecified date, the subject experienced woke up in pain, and fever was 102-103. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102-103 F, 100-99 F. Treatment medications (dates unspecified) included: tramadol hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever was 102-103, and the outcome of didn't sleep at all night and woke up in pain was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210355949.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: LIGHT HEADEDNESS; 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 date: Unknown) dose was not reported, administered on 13-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 13-MAR-2021, the subject experienced light headedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headedness. This report was non-serious. This case, from the same reporter is linked to 20210354458.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness postural
Clinical narrative: LIGHT HEADED MOSTLY WHEN STAND UP; LOOSE BOWELS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure issues. 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 26-MAR-2021 in the left deltoid 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 light headed mostly when stand up. On MAR-2021, the subject experienced loose bowels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headed mostly when stand up and loose bowels was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Hyperhidrosis, Nausea
Clinical narrative: PROFUSE SWEATING; RESTLESSNESS; MISERABLE; CHILLS; BAD NAUSEA; BAD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, 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 26-MAR-2021, the subject experienced profuse sweating. On 26-MAR-2021, the subject experienced restlessness. On 26-MAR-2021, the subject experienced miserable. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced bad nausea. On 26-MAR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bad nausea, chills, profuse sweating, bad headache, restlessness, and miserable. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Restlessness
Clinical narrative: PROFUSE SWEATING; RESTLESSNESS; MISERABLE; CHILLS; BAD NAUSEA; BAD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, 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 26-MAR-2021, the subject experienced profuse sweating. On 26-MAR-2021, the subject experienced restlessness. On 26-MAR-2021, the subject experienced miserable. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced bad nausea. On 26-MAR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bad nausea, chills, profuse sweating, bad headache, restlessness, and miserable. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Body ache; Headache; Fever; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. 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 number.  No concomitant medications were reported. On an unspecified date, the subject experienced body ache, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever and body ache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: ACHY JOINTS; 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 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced achy joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of achy joints was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-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 25-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: A LITTLE FATIGUE; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (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 MAR-2021, the subject experienced a little fatigue. The action taken with covid-19 vaccine was not applicable. The outcome of a little fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Joint stiffness, SARS-CoV-2 test
Clinical narrative: STIFFNESS IN KNEES, HIPS, ANKLES; A LITTLE BIT OF LIGHT HEADEDNESS; KNEES AND HIPS A BIT ACHY LIGHT TO MODERATE; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included mould allergies, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, vaccinated at left deltoid, once a total administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAR-2021, the subject experienced a little bit of light headedness. On 28-MAR-2021, the subject experienced knees and hips a bit achy light to moderate. On 29-MAR-2021, the subject experienced stiffness in knees, hips, ankles. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from a little bit of light headedness, was recovering from knees and hips a bit achy light to moderate, and the outcome of stiffness in knees, hips, ankles was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: CHILLS; MUSCLE ACHE; 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 muscle ache, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle ache, and chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Discomfort, Fatigue, Headache
Clinical narrative: SORE; CHILLS; FEVER; HEADACHE; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced sore. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on MAR-2021, had not recovered from headache, and the outcome of chills, sore and tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SORE; CHILLS; FEVER; HEADACHE; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced sore. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on MAR-2021, had not recovered from headache, and the outcome of chills, sore and tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: CHRONIC HEADACHES; This spontaneous report received from a patient via a company representative . 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, the batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced chronic headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chronic headaches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: ACHES/PAINS; FEVER; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 25-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 25-MAR-2021, the subject experienced aches/pains. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches/pains, fever, and nausea on 26-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vertigo
Clinical narrative: VERTIGO; MUSCLE PAINS; NAUSEA; This spontaneous report received from a patient . 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, once a total administered, start therapy date 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 vertigo, muscle pains, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pains, nausea and vertigo was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: ACHES; CHILLS; LOW GRADE FEVER; NASTY HEADACHES; NAUSEA; This spontaneous report received from a consumer via a company representative 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, 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 MAR-2021, the subject experienced aches. On MAR-2021, the subject experienced low grade fever. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced nasty headaches. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nasty headaches, chills, low grade fever, aches, and nausea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: HAD STRONG REACTIONS; This spontaneous report received from a patient concerned multiple patients. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced had strong reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had strong reactions was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNSPECIFIED SIDE EFFECTS; 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, once a total administered on 23-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 an unspecified date, the subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: HEADACHE; TIREDNESS; QUEASY STOMACH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 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 headache. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced queasy stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, tiredness, and queasy stomach on 26-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SLIGHT SORENESS AT THE INJECTION SITE; 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 ulcerative colitis.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 and has been requested. Concomitant medications included vedolizumab for ulcerative colitis. On an unspecified date, the subject experienced slight soreness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight soreness at the injection site was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH; This solicited report received from a patient: concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient initiated treatment with 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. Concomitant medications included macitentan. On an unspecified date, the patient experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and rash as possible.  This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Pyrexia
Clinical narrative: LIGHTHEADEDNESS; CHILLS; FEVER 8 HOURS AFTER VACCINATION; 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 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 lightheadedness. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever 8 hours after vaccination. Laboratory data included: Body temperature (NR: not provided) 100 + (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever 8 hours after vaccination on MAR-2021, and the outcome of chills and lightheadedness was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Joint stiffness, Nausea
Clinical narrative: STIFF KNEES; DIFFICULTY IN STANDING; SICK TO HER STOMACH; This spontaneous report received from a patient concerned a 71 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: 1805022, and expiry: UNKNOWN) dose was not reported, administered to left arm on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced sick to her stomach. On 27-MAR-2021, the subject experienced stiff knees. On 27-MAR-2021, the subject experienced difficulty in standing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick to her stomach on 25-MAR-2021, and had not recovered from stiff knees, and difficulty in standing. 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: Pain in extremity
Clinical narrative: 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 administration not reported, batch number: Unknown) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to # 20210355432.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Hyperhidrosis, Myalgia, Sciatica
Clinical narrative: SCIATIC PAIN; BROKE OUT IN SWEAT; JOINT PAIN; MUSCLE PAIN; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered, start therapy date 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 sciatic pain, broke out in sweat, joint pain, and muscle pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from muscle pain, joint pain, and sciatic pain, and the outcome of broke out in sweat was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Unevaluable event
Clinical narrative: REACTION; CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 55 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: Unkown) 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 reaction, chills, and injection site pain. Treatment medications (dates unspecified) included: electrolytes nos, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and injection site pain, and the outcome of reaction was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gout
Clinical narrative: GOUT FLARE UP ON RIGHT FEET; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included HBP, 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: 1802068, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced gout flare up on right feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gout flare up on right feet. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood uric acid increased, Gout, X-ray
Clinical narrative: GOUT FLARE UP ON RIGHT FEET; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included HBP, 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: 1802068, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced gout flare up on right feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gout flare up on right feet. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FELT TIRED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Eating disorder, Headache, Nausea
Clinical narrative: NOT BEING ABLE TO EAT; NAUSEA; DIARRHEA; HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease. The patient received Covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN),vaccinated at right arm, dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. Concomitant medications included varicella zoster vaccine. On 28-MAR-2021, the subject experienced headache. On 28-MAR-2021 03:00, the subject experienced diarrhea, nausea. On an unspecified date, the subject experienced not being able to eat. The action taken with Covid-19 vaccine was not applicable. The patient recovered from diarrhea, and nausea on 29-MAR-2021, was recovering from headache, and the outcome of not being able to eat was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included reaction to high does flu shot, and concurrent conditions included allergic to shell fish. 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 MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: SORE NECK; 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: 1805020, and expiry: UNKNOWN) dose was not reported, administered on left arm on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced sore neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore neck. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Fatigue, Pain in extremity
Clinical narrative: LOW TEMPERATURE 97F; FATIGUE; COLD SWEATS; TEETH CHATTERING AND FREEZING; SORE ARM; This spontaneous report received from a consumer concerned a 51 year old male. The patient's height, and weight were not reported. The patient's past medical history included coronavirus. 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 26-MAR-2021 in Left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97 F. On 26-MAR-2021, the subject experienced sore arm. On 27-MAR-2021, the subject experienced cold sweats. On 27-MAR-2021, the subject experienced teeth chattering and freezing. On 27-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced low temperature 97F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, cold sweats, teeth chattering and freezing, and fatigue, and had not recovered from low temperature 97F. This report was non-serious. This case, from the same reporter is linked to 20210356641.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: LOW TEMPERATURE 97F; FATIGUE; COLD SWEATS; TEETH CHATTERING AND FREEZING; SORE ARM; This spontaneous report received from a consumer concerned a 51 year old male. The patient's height, and weight were not reported. The patient's past medical history included coronavirus. 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 26-MAR-2021 in Left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97 F. On 26-MAR-2021, the subject experienced sore arm. On 27-MAR-2021, the subject experienced cold sweats. On 27-MAR-2021, the subject experienced teeth chattering and freezing. On 27-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced low temperature 97F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, cold sweats, teeth chattering and freezing, and fatigue, and had not recovered from low temperature 97F. This report was non-serious. This case, from the same reporter is linked to 20210356641.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) once a total dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch no/Lot no. No concomitant medications were reported. On 28-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101. 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.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Chills, Fatigue, Headache, Nausea
Clinical narrative: SIDE EFFECTS HAVE DEFINITELY BEEN KICKING MY BEHIND; ACHES; CHILLS; NAUSEA; HEADACHE; 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) dose was not reported, administered on 25-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 an unspecified date, the subject experienced side effects have definitely been kicking my behind, aches, chills, nausea, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the side effects have definitely been kicking my behind, nausea, headache, aches, chills and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: SIDE EFFECTS HAVE DEFINITELY BEEN KICKING MY BEHIND; ACHES; CHILLS; NAUSEA; HEADACHE; 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) dose was not reported, administered on 25-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 an unspecified date, the subject experienced side effects have definitely been kicking my behind, aches, chills, nausea, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the side effects have definitely been kicking my behind, nausea, headache, aches, chills and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY ACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 25-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Fatigue, Pruritus
Clinical narrative: HEAVY BREATHING/SHORTNESS OF BREATH; MILD CHEST PAIN; INCREASED FATIGUE; ITCHINESS TO RIGHT LEG; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included hospitalisation, and blood transfusion, and concurrent conditions included cardiac blockage, non smoker, non alcohol user, and low hemoglobin (3/10), and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered to left arm on 18-MAR-2021 15:00 for covid 19 prevention. Concomitant medications included fexofenadine hydrochloride for drug allergy.  On 18-MAR-2021, Laboratory data included: Blood test (NR: not provided) not reported. On 18-MAR-2021 15:00, the subject experienced itchiness to right leg. On 19-MAR-2021, the subject experienced heavy breathing/shortness of breath. On 19-MAR-2021, the subject experienced mild chest pain. On 19-MAR-2021, the subject experienced increased fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchiness to right leg on 18-MAR-2021, and had not recovered from increased fatigue, heavy breathing/shortness of breath, and mild chest pain. 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.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Pyrexia
Clinical narrative: CHEST TIGHTNESS; FEVER OF 101.1 F; This spontaneous report received from a consumer concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 3580333, and expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.1 F. On MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 28-MAR-2021, the subject experienced chest tightness. On 28-MAR-2021, the subject experienced fever of 101.1 F. The action taken with covid-19 vaccine was not applicable. The outcome of the fever of 101.1 f and chest tightness 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.