chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Headache, Rash, Vomiting
Clinical narrative: VOMITING; DIFFICULTY IN SWALLOWING/ COULD NOT KEEP ANY FOOD DOWN; FACE HAS BROKEN OUT; HEADACHE; DIZZY; 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, intramuscular, batch number: Unknown) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced vomiting. On 10-MAR-2021, the subject experienced difficulty in swallowing/ could not keep any food down. On 10-MAR-2021, the subject experienced face has broken out. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, difficulty in swallowing/ could not keep any food down, face has broken out, headache and dizzy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: ARM SORENESS; ARM REDNESS; 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, intramuscular, batch number: Unknown) .5 ml, administered on 06-OCT-2020 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced arm soreness, and arm redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness and arm redness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: SORE ARM; FATIGUE; 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: Unk) 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 an unspecified date, the subject experienced sore arm, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, headache and sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210326425.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Injection site pain, Pain
Clinical narrative: SORE ARM AFTER RECEIVING THE VACCINE IN INJECTION ARM; FEVER; ACHES; CHILLS; TIRED; 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) dose was not reported, administered on 11-MAR-2021 19:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced sore arm after receiving the vaccine in injection arm. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced aches. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 100.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm after receiving the vaccine in injection arm, fever, aches, chills, and tired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SORE ARM AFTER RECEIVING THE VACCINE IN INJECTION ARM; FEVER; ACHES; CHILLS; TIRED; 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) dose was not reported, administered on 11-MAR-2021 19:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced sore arm after receiving the vaccine in injection arm. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced aches. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 100.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm after receiving the vaccine in injection arm, fever, aches, chills, and tired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Pain, Tremor
Clinical narrative: TREMBLING; HEADACHE; LOWER BACK PAIN; ACHING ALL OVER; CHILLS; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug or non drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) .5 ml, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced lower back pain. On 13-MAR-2021, the subject experienced aching all over. On 13-MAR-2021, the subject experienced chills. On an unspecified date, the subject experienced trembling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and trembling, was recovering from aching all over, and had not recovered from headache, and lower back pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER TEMP UNKNOWN; 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, intramuscular, batch number: Unknown) .5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-MAR-2021, the patient experienced fever temp unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever temp unknown. This report was non-serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a health care professional concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 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 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: F
Vaccine: COVID19
Symptoms: Blister, Body temperature, Chills, Fatigue, Headache
Clinical narrative: BLOTCHY RASH ON FOREARMS, BACK OF THIGHS, FOREHEAD, AND TRUNK; FLUID FILLED BUMPS ON REDDENED SKIN; CHILLS; HEADACHE; FEVER; FEELING TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included vicodin allergy, celebrex allergy, and flagyl allergy, and concurrent conditions included seasonal allergies, alcohol consumption, and non smoker, and other pre-existing medical conditions included no drug abuse/illicit drug use. The patient experienced drug allergy when treated with celecoxib, metronidazole, and hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 at 16:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced blotchy rash on forearms, back of thighs, forehead, and trunk. On 12-MAR-2021, the subject experienced fluid filled bumps on reddened skin. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced feeling tired. Treatment medications included: ibuprofen. On 13-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 103 units unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, fever, chills, feeling tired, blotchy rash on forearms, back of thighs, forehead, and trunk, and fluid filled bumps on reddened skin. This report was non-serious. This case, involving the same patient is linked to 20210330216.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash macular
Clinical narrative: BLOTCHY RASH ON FOREARMS, BACK OF THIGHS, FOREHEAD, AND TRUNK; FLUID FILLED BUMPS ON REDDENED SKIN; CHILLS; HEADACHE; FEVER; FEELING TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included vicodin allergy, celebrex allergy, and flagyl allergy, and concurrent conditions included seasonal allergies, alcohol consumption, and non smoker, and other pre-existing medical conditions included no drug abuse/illicit drug use. The patient experienced drug allergy when treated with celecoxib, metronidazole, and hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 at 16:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced blotchy rash on forearms, back of thighs, forehead, and trunk. On 12-MAR-2021, the subject experienced fluid filled bumps on reddened skin. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced feeling tired. Treatment medications included: ibuprofen. On 13-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 103 units unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, fever, chills, feeling tired, blotchy rash on forearms, back of thighs, forehead, and trunk, and fluid filled bumps on reddened skin. This report was non-serious. This case, involving the same patient is linked to 20210330216.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site rash, Myalgia, Nausea
Clinical narrative: NERVES ACTING UP; THROAT FELT SWOLLEN; CHILLS; NAUSEA; ITCHING; TINGLING; BULLS-EYE RASH AND AND RAISED BUMP AROUND THE INJECTION SITE; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines with nausea and blurred vision, lyme disease, pneumonia, bronchitis, anaphylactic reaction to eggs, anaphylactic reaction to red dye, penicillin allergy, alcohol user, and non smoker. The patient experienced drug allergy when treated with phenazopyridine hydrochloride, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced muscle aches. On 07-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced itching. On 09-MAR-2021, the subject experienced tingling. On 09-MAR-2021, the subject experienced bulls-eye rash and and raised bump around the injection site. On 11-MAR-2021, the subject experienced nerves acting up. On 11-MAR-2021, the subject experienced throat felt swollen. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nerves acting up on MAR-2021, chills, nausea, and headache on 11-MAR-2021, and muscle aches on 09-MAR-2021, and was recovering from bulls-eye rash and and raised bump around the injection site, itching, tingling, and throat felt swollen. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Paraesthesia, Pharyngeal swelling, Pruritus
Clinical narrative: NERVES ACTING UP; THROAT FELT SWOLLEN; CHILLS; NAUSEA; ITCHING; TINGLING; BULLS-EYE RASH AND AND RAISED BUMP AROUND THE INJECTION SITE; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines with nausea and blurred vision, lyme disease, pneumonia, bronchitis, anaphylactic reaction to eggs, anaphylactic reaction to red dye, penicillin allergy, alcohol user, and non smoker. The patient experienced drug allergy when treated with phenazopyridine hydrochloride, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced muscle aches. On 07-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced itching. On 09-MAR-2021, the subject experienced tingling. On 09-MAR-2021, the subject experienced bulls-eye rash and and raised bump around the injection site. On 11-MAR-2021, the subject experienced nerves acting up. On 11-MAR-2021, the subject experienced throat felt swollen. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nerves acting up on MAR-2021, chills, nausea, and headache on 11-MAR-2021, and muscle aches on 09-MAR-2021, and was recovering from bulls-eye rash and and raised bump around the injection site, itching, tingling, and throat felt swollen. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; 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, and batch number: JJ1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diarrhea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Headache, Pain, Pyrexia
Clinical narrative: FEVER; HEADACHE; ACHES; DEHYDRATION; 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, intramuscular, batch number: 1805031, and expiry: not reported) .5 ml, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced dehydration. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydration on 12-MAR-2021, and had not recovered from fever, headache, and aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: SWOLLEN THROAT; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported. The batch number was not reported and has been requested. On 10-MAR-2021, the patient  experienced swollen throat. reporter report that after 4 days of vaccination suffering from throat swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swollen throat was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and swollen throat was related  .Company causality between covid-19 vaccine ad26.cov2.s and swollen throat was related . This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 at 10:00 am for prophylactic vaccination.  The batch number was not reported and has been requested. 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.
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Chills, Fatigue, Head discomfort, Pain
Clinical narrative: LEFT ARM, UNDERNEATH THE ARMPIT FELT LUMP; ACHE/BODY ACHES; CHILLS; PRESSURE ON THE FOREHEAD (TIGHT FEELING); TIRED; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sleep apnea, and alcohol use, 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, intramuscular, batch number: 1805031, and expiry: not reported) .5 ml, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced tired. On 11-MAR-2021 22:00, the subject experienced ache/body aches. On 11-MAR-2021 22:00, the subject experienced chills. On 11-MAR-2021 22:00, the subject experienced pressure on the forehead (tight feeling). On 12-MAR-2021, the subject experienced left arm, underneath the armpit felt lump. On 12-MAR-2021 14:00, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, pressure on the forehead (tight feeling), and tired on 12-MAR-2021, was recovering from ache/body aches, and the outcome of left arm, underneath the armpit felt lump was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Sinus headache
Clinical narrative: BODY ACHES; SINUS HEADACHE; CHILLS; TIREDNESS; This spontaneous report received from a consumer concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart attack, and concurrent conditions included heart condition, no alcohol use, and non smoker, and other pre-existing medical conditions included 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced body aches. On 11-MAR-2021, the subject experienced sinus headache. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced tiredness. Treatment medications included: ibuprofen. On 12-MAR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sinus headache, and chills on 12-MAR-2021, and was recovering from tiredness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Nausea, Pain, Poor quality sleep, Psychomotor retardation
Clinical narrative: UNABLE TO DO ANYTHING; FEVER; BODY HURTS; WOKE UP MANY TIMES IN THE NIGHT; NAUSEA; DRY MOUTH; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included had no medical history. Patient reported healthy. 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 on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced body hurts. On 13-MAR-2021, the subject experienced woke up many times in the night. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced dry mouth. Treatment medications included: paracetamol. On 13-MAR-2021 18:00, the subject experienced fever. On 14-MAR-2021, the subject experienced unable to do anything. Treatment medications included: paracetamol. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from body hurts, nausea, unable to do anything, and dry mouth, and the outcome of woke up many times in the night was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: UNABLE TO DO ANYTHING; FEVER; BODY HURTS; WOKE UP MANY TIMES IN THE NIGHT; NAUSEA; DRY MOUTH; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included had no medical history. Patient reported healthy. 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 on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced body hurts. On 13-MAR-2021, the subject experienced woke up many times in the night. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced dry mouth. Treatment medications included: paracetamol. On 13-MAR-2021 18:00, the subject experienced fever. On 14-MAR-2021, the subject experienced unable to do anything. Treatment medications included: paracetamol. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from body hurts, nausea, unable to do anything, and dry mouth, and the outcome of woke up many times in the night was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: HEADACHE; FATIGUE; CHILLS; 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: 1805029, and expiry: not reported) dose was not reported, administered on 12-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fatigue. On 12-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, headache, and fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known drug allergies and no dug abuse/illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: INJECTION SITE WARMNESS WHICH WAS DESCRIBED AS FEVER IN ARM; INJECTION SITE SWELLING WHICH WAS DESCRIBED AS ARM SWELLING; BODY ACHE; ARM SORENESS WHICH WAS DESCRIBED AS ARM PAIN; FATIGUE; INJECTION SITE REDNESS; 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 17:00 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced arm soreness which was described as arm pain. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced injection site redness. On 12-MAR-2021, the subject experienced injection site warmness which was described as fever in arm. On 12-MAR-2021, the subject experienced injection site swelling which was described as arm swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fatigue on MAR-2021, was recovering from arm soreness which was described as arm pain, and had not recovered from injection site redness, injection site swelling which was described as arm swelling, and injection site warmness which was described as fever in arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: INJECTION SITE WARMNESS WHICH WAS DESCRIBED AS FEVER IN ARM; INJECTION SITE SWELLING WHICH WAS DESCRIBED AS ARM SWELLING; BODY ACHE; ARM SORENESS WHICH WAS DESCRIBED AS ARM PAIN; FATIGUE; INJECTION SITE REDNESS; 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 17:00 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced arm soreness which was described as arm pain. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced injection site redness. On 12-MAR-2021, the subject experienced injection site warmness which was described as fever in arm. On 12-MAR-2021, the subject experienced injection site swelling which was described as arm swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fatigue on MAR-2021, was recovering from arm soreness which was described as arm pain, and had not recovered from injection site redness, injection site swelling which was described as arm swelling, and injection site warmness which was described as fever in arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Injection site swelling, Skin warm
Clinical narrative: SWOLLEN ARM; WARM  TO TOUCH; REDNESS; 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, intramuscular, batch number: 1805029 and expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced swollen arm. On 14-MAR-2021, the subject experienced skin warm. On 14-MAR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen arm, injection site redness and skin warm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Pain in extremity, Psychomotor hyperactivity
Clinical narrative: FREQUENT DIARRHEA; STOMACH ACHE; FEELING HYPER; MILD ARM SORENESS; 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: 1805029, and  expiry: not reported) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced frequent diarrhea, stomach ache, feeling hyper, and mild arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild arm soreness, stomach ache, frequent diarrhea and feeling hyper was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side effects. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: COLD SWEATS LEADING TO SOAKING WET; ACHES; HIGH FEVER; CHILLS; This spontaneous report received from a consumer concerned a White (Not Hispanic/Latino)  female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and  expiry: 13-MAR-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced cold sweats leading to soaking wet. On 14-MAR-2021, the subject experienced aches. On 14-MAR-2021, the subject experienced high fever. On 14-MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) HIGH. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high fever, chills, aches, and cold sweats leading to soaking wet. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pruritus, Urticaria
Clinical narrative: ITCHY RASH OR ITCHING ON ARM AND THIGHS; RED BLOTCHY HIVES ON THIGHS, BUTTOCKS AND ARMS; SORE ARM; MILD HEADACHE; This spontaneous report received from a patient concerned a 69 year old male. The patient's weight was 185 pounds, and height was 69 inches. The patient's concurrent conditions included copd, emphysema, smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies and no history of hives/rash ad did not have drug abuse history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin, levothyroxine sodium, metoprolol, and paroxetine hydrochloride.  On 05-MAR-2021, the subject experienced mild headache. On 06-MAR-2021, the subject experienced sore arm. On 13-MAR-2021, the subject experienced itchy rash or itching on arm and thighs. On 13-MAR-2021, the subject experienced red blotchy hives on thighs, buttocks and arms. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy rash or itching on arm and thighs, red blotchy hives on thighs, buttocks and arms, and mild headache on MAR-2021, and sore arm on 07-MAR-2021. This report was non-serious. This case, involving the same patient is linked to 20210330252.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: SICK; FEEL LIKE HIT BY A TRUCK; This spontaneous report received from the reporter via news article concerned a patient of unspecified age and sex. 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. No concomitant medications were reported. On an unspecified date, the subject experienced sick, and feel like hit by a truck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feel like hit by a truck and sick was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Headache, Pyrexia
Clinical narrative: HEADACHE; FEVER; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included yeast infection.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 to the left arm, on 01-APR-2021 10:40 for prophylactic vaccination. The  batch number was reported and has been requested. Concomitant medications included fluconazole for yeast infection. On MAR-2021, Laboratory data included: Yeast infection (NR: not provided) Positive. On 01-APR-2021 17:00, the subject experienced headache. On 01-APR-2021 17:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fever on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Dizziness, Feeding disorder
Clinical narrative: COULD NOT EAT; MUSCLE ACHE; HIGH FEVER 101.1; HEAVY LEGS; TEETH CHATTERING; COUGH; LIGHT HEADED; HEADACHE; 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 02-APR-2021, the subject experienced heavy legs. On 02-APR-2021, the subject experienced teeth chattering. On 02-APR-2021, the subject experienced cough. On 02-APR-2021, the subject experienced light headed. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced high fever 101.1. Laboratory data included: Body temperature (NR: not provided) 101.1 high fever. On 03-APR-2021, the subject experienced could not eat. On 03-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teeth chattering on APR-2021, and headache, and high fever 101.1 on 05-APR-2021, was recovering from heavy legs, could not eat, and cough, and had not recovered from muscle ache, and light headed. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the cases is assessed non serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Myalgia, Pyrexia
Clinical narrative: COULD NOT EAT; MUSCLE ACHE; HIGH FEVER 101.1; HEAVY LEGS; TEETH CHATTERING; COUGH; LIGHT HEADED; HEADACHE; 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 02-APR-2021, the subject experienced heavy legs. On 02-APR-2021, the subject experienced teeth chattering. On 02-APR-2021, the subject experienced cough. On 02-APR-2021, the subject experienced light headed. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced high fever 101.1. Laboratory data included: Body temperature (NR: not provided) 101.1 high fever. On 03-APR-2021, the subject experienced could not eat. On 03-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teeth chattering on APR-2021, and headache, and high fever 101.1 on 05-APR-2021, was recovering from heavy legs, could not eat, and cough, and had not recovered from muscle ache, and light headed. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the cases is assessed non serious.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Pain in extremity, Pyrexia, Tachycardia
Clinical narrative: TACHYCARDIA; TINNITUS; CHEST TIGHTNESS; LEG PAIN; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 tachycardia, tinnitus, chest tightness, leg pain, low grade fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tachycardia, tinnitus, low grade fever, headache, chest tightness, and leg pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: TACHYCARDIA; TINNITUS; CHEST TIGHTNESS; LEG PAIN; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 tachycardia, tinnitus, chest tightness, leg pain, low grade fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tachycardia, tinnitus, low grade fever, headache, chest tightness, and leg pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHING; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-APR-2021, the subject experienced aching. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching on 05-APR-2021. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Myalgia, Nausea
Clinical narrative: CHILLS; SORE ARM; MUSCLE ACHES; NAUSEA; This spontaneous report received from a health care professional concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, every 1 total from 06-APR-2021 09:00 to 06-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced chills, sore arm, muscle aches, and nausea. On 07-APR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, sore arm, muscle aches, and nausea on APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise, SARS-CoV-2 test positive
Clinical narrative: 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) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021, the subject experienced general malaise. On 16-MAR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced tested positive for covid 19. Laboratory data included: COVID-19 virus test positive (NR: not provided) POSITIVE. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general malaise, and headache on 17-MAR-2021, and had not recovered from tested positive for covid 19. 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: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: CHILLS; SEVERE HEADACHE; MUSCLE ACHES; This spontaneous report received from a consumer concerned a 52 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, non medicated episodes of high blood pressure, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 11:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021 22:30, the subject experienced chills. On 06-APR-2021 22:30, the subject experienced severe headache. On 06-APR-2021 22:30, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, muscle aches, and chills. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.