chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Pain, Pruritus, Rash
Clinical narrative: TIRED; ITCHY; SCRATCH; TIGHTNESS IN CHEST; RASH; FATIGUE; BODY ACHES; 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, expiry: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  On 21-MAR-2021, the subject experienced body aches. On 21-MAR-2021, the subject experienced fatigue. On 22-MAR-2021, the subject experienced itchy. On 22-MAR-2021, the subject experienced scratch. On 22-MAR-2021, the subject experienced tightness in chest. On 22-MAR-2021, the subject experienced rash. On an unspecified date, the subject experienced tired. Treatment medications (dates unspecified) included: fexofenadine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fatigue, had not recovered from rash, itchy, and scratch, and the outcome of tightness in chest and tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Scratch
Clinical narrative: TIRED; ITCHY; SCRATCH; TIGHTNESS IN CHEST; RASH; FATIGUE; BODY ACHES; 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, expiry: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  On 21-MAR-2021, the subject experienced body aches. On 21-MAR-2021, the subject experienced fatigue. On 22-MAR-2021, the subject experienced itchy. On 22-MAR-2021, the subject experienced scratch. On 22-MAR-2021, the subject experienced tightness in chest. On 22-MAR-2021, the subject experienced rash. On an unspecified date, the subject experienced tired. Treatment medications (dates unspecified) included: fexofenadine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fatigue, had not recovered from rash, itchy, and scratch, and the outcome of tightness in chest and tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; 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, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210340596.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: MIGRAINE; 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 menstrual migraines, and neck issues.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of migraine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: BURN GOING IN AND FOR ABOUT 5 MINUTES AFTERWARDS; TIREDNESS; 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, 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 burn going in and for about 5 minutes afterwards, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness and burn going in and for about 5 minutes afterwards was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: MILD MALAISE; FEVER; HEADACHE; 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 20-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 mild malaise, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache and mild malaise was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Tremor
Clinical narrative: BRAIN FOG; HANDS TREMBLE; This spontaneous report received from a consumer via an unspecified company representative concerned a female of n 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 unspecified Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced brain fog. On MAR-2021, the subject experienced hands tremble. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, and hands tremble. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: DIZZINESS WHEN STANDING OR MOVING HEAD TOO QUICKLY; FATIGUE (VERY VERY TIRED AND HAS BEEN IN BED MOST OF THE DAY); This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 22-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 dizziness when standing or moving head too quickly. On MAR-2021, the subject experienced fatigue (very very tired and has been in bed most of the day). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue (very very tired and has been in bed most of the day) and dizziness when standing or moving head too quickly was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Headache
Clinical narrative: BODY ACHES / PAIN; SHAKES / SHAKING; SHIVERING; HEADACHE; NOT FEELING WELL / FEELING OFF; SHOULDERS GOT TIGHT; LOWER BACK ACHE; ACHE IN HIP; LEGS HURT/ SORENESS IN ARM; FEVER / TEMPERATURE; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 99 pounds, and height was 66 inches.  The patient's concurrent conditions included penicillin allergy, asthma, and trigeminal neuralgia, and other pre-existing medical conditions included type o positive blood. The patient was previously treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 10:00 to left arm for prophylactic vaccination. Concomitant medications included gabapentin for trigeminal neuralgia, ergocalciferol, and vitamin b12 nos.  On 10-MAR-2021, the subject experienced shoulders got tight. On 10-MAR-2021, the subject experienced lower back ache. On 10-MAR-2021, the subject experienced ache in hip. On 10-MAR-2021, the subject experienced legs hurt/ soreness in arm. On 10-MAR-2021, the subject experienced fever / temperature. On 10-MAR-2021 10:00, Laboratory data included: Body temperature (NR: not provided) 102.6 F. On 10-MAR-2021 16:00, the subject experienced not feeling well / feeling off. On 10-MAR-2021 18:00, the subject experienced shakes / shaking. On 10-MAR-2021 18:00, the subject experienced shivering. On 10-MAR-2021 18:00, the subject experienced headache. On 10-MAR-2021 18:30, the subject experienced body aches / pain. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97.2 F. On 11-MAR-2021 01:00, Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 11-MAR-2021 05:00, Laboratory data included: Body temperature (NR: not provided) 101.6F F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes / shaking, and shivering on 10-MAR-2021, body aches / pain, not feeling well / feeling off, and fever / temperature on 11-MAR-2021, and headache on 11-MAR-2021 10:00, was recovering from ache in hip, lower back ache, and legs hurt/ soreness in arm, and the outcome of shoulders got tight was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Musculoskeletal stiffness, Pain, Pain in extremity, Pyrexia
Clinical narrative: BODY ACHES / PAIN; SHAKES / SHAKING; SHIVERING; HEADACHE; NOT FEELING WELL / FEELING OFF; SHOULDERS GOT TIGHT; LOWER BACK ACHE; ACHE IN HIP; LEGS HURT/ SORENESS IN ARM; FEVER / TEMPERATURE; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 99 pounds, and height was 66 inches.  The patient's concurrent conditions included penicillin allergy, asthma, and trigeminal neuralgia, and other pre-existing medical conditions included type o positive blood. The patient was previously treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 10:00 to left arm for prophylactic vaccination. Concomitant medications included gabapentin for trigeminal neuralgia, ergocalciferol, and vitamin b12 nos.  On 10-MAR-2021, the subject experienced shoulders got tight. On 10-MAR-2021, the subject experienced lower back ache. On 10-MAR-2021, the subject experienced ache in hip. On 10-MAR-2021, the subject experienced legs hurt/ soreness in arm. On 10-MAR-2021, the subject experienced fever / temperature. On 10-MAR-2021 10:00, Laboratory data included: Body temperature (NR: not provided) 102.6 F. On 10-MAR-2021 16:00, the subject experienced not feeling well / feeling off. On 10-MAR-2021 18:00, the subject experienced shakes / shaking. On 10-MAR-2021 18:00, the subject experienced shivering. On 10-MAR-2021 18:00, the subject experienced headache. On 10-MAR-2021 18:30, the subject experienced body aches / pain. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97.2 F. On 11-MAR-2021 01:00, Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 11-MAR-2021 05:00, Laboratory data included: Body temperature (NR: not provided) 101.6F F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes / shaking, and shivering on 10-MAR-2021, body aches / pain, not feeling well / feeling off, and fever / temperature on 11-MAR-2021, and headache on 11-MAR-2021 10:00, was recovering from ache in hip, lower back ache, and legs hurt/ soreness in arm, and the outcome of shoulders got tight was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: BODY ACHES / PAIN; SHAKES / SHAKING; SHIVERING; HEADACHE; NOT FEELING WELL / FEELING OFF; SHOULDERS GOT TIGHT; LOWER BACK ACHE; ACHE IN HIP; LEGS HURT/ SORENESS IN ARM; FEVER / TEMPERATURE; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 99 pounds, and height was 66 inches.  The patient's concurrent conditions included penicillin allergy, asthma, and trigeminal neuralgia, and other pre-existing medical conditions included type o positive blood. The patient was previously treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 10:00 to left arm for prophylactic vaccination. Concomitant medications included gabapentin for trigeminal neuralgia, ergocalciferol, and vitamin b12 nos.  On 10-MAR-2021, the subject experienced shoulders got tight. On 10-MAR-2021, the subject experienced lower back ache. On 10-MAR-2021, the subject experienced ache in hip. On 10-MAR-2021, the subject experienced legs hurt/ soreness in arm. On 10-MAR-2021, the subject experienced fever / temperature. On 10-MAR-2021 10:00, Laboratory data included: Body temperature (NR: not provided) 102.6 F. On 10-MAR-2021 16:00, the subject experienced not feeling well / feeling off. On 10-MAR-2021 18:00, the subject experienced shakes / shaking. On 10-MAR-2021 18:00, the subject experienced shivering. On 10-MAR-2021 18:00, the subject experienced headache. On 10-MAR-2021 18:30, the subject experienced body aches / pain. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97.2 F. On 11-MAR-2021 01:00, Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 11-MAR-2021 05:00, Laboratory data included: Body temperature (NR: not provided) 101.6F F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes / shaking, and shivering on 10-MAR-2021, body aches / pain, not feeling well / feeling off, and fever / temperature on 11-MAR-2021, and headache on 11-MAR-2021 10:00, was recovering from ache in hip, lower back ache, and legs hurt/ soreness in arm, and the outcome of shoulders got tight was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Injection site pain, Injection site pruritus
Clinical narrative: ITCHING AT THE INJECTION SITE; BURNING AT THE INJECTION SITE; SWELLING AT THE INJECTION SITE; PAIN AT THE INJECTION SITE; BODY ACHE; DIZZY; NUMBNESS IN MOUTH AND FACE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and seasonal allergy. The patient experienced drug allergy when treated with cefuroxime axetil, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced dizzy. On 19-MAR-2021, the subject experienced numbness in mouth and face. On 19-MAR-2021, the subject experienced fatigue. On 20-MAR-2021, the subject experienced body ache. Treatment medications included: paracetamol. On 22-MAR-2021, the subject experienced itching at the injection site. On 22-MAR-2021, the subject experienced burning at the injection site. On 22-MAR-2021, the subject experienced swelling at the injection site. On 22-MAR-2021, the subject experienced pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body ache, and the outcome of dizzy, fatigue, numbness in mouth and face, pain at the injection site, itching at the injection site, burning at the injection site and swelling at the injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain
Clinical narrative: ITCHING AT THE INJECTION SITE; BURNING AT THE INJECTION SITE; SWELLING AT THE INJECTION SITE; PAIN AT THE INJECTION SITE; BODY ACHE; DIZZY; NUMBNESS IN MOUTH AND FACE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and seasonal allergy. The patient experienced drug allergy when treated with cefuroxime axetil, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced dizzy. On 19-MAR-2021, the subject experienced numbness in mouth and face. On 19-MAR-2021, the subject experienced fatigue. On 20-MAR-2021, the subject experienced body ache. Treatment medications included: paracetamol. On 22-MAR-2021, the subject experienced itching at the injection site. On 22-MAR-2021, the subject experienced burning at the injection site. On 22-MAR-2021, the subject experienced swelling at the injection site. On 22-MAR-2021, the subject experienced pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body ache, and the outcome of dizzy, fatigue, numbness in mouth and face, pain at the injection site, itching at the injection site, burning at the injection site and swelling at the injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a consumer 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 21-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, headache and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: HEADACHE; EXTREME 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 concurrent conditions included no smoking, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and not any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced extreme tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and extreme tired. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain in extremity
Clinical narrative: FELT SICK; NAUSEA; SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced nausea. On 22-MAR-2021, the subject experienced felt sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, nausea and felt sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; 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, 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 chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash pustular
Clinical narrative: BUMP ON THE SIDE OF LEFT EYE FILLED WITH PUS; 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced bump on the side of left eye filled with pus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bump on the side of left eye filled with pus. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: TWO VACCINE ADMINISTERED FOR COVID-19; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, left arm administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On 21-MAR-2021, the subject experienced two vaccine administered for covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two vaccine administered for covid-19 was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Flatulence, Muscle spasms, Nausea
Clinical narrative: DIZZINESS; CHILLS; FEVER; NAUSEA; MUSCLE SPASMS; GAS PAIN; This spontaneous report received from a patient concerned a 67 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: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 13:00, in the left arm, for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced muscle spasms. On 24-MAR-2021, the subject experienced gas pain. On 24-MAR-2021 18:00, the subject experienced dizziness. On 24-MAR-2021 18:00, the subject experienced chills. On 24-MAR-2021 18:00, the subject experienced fever. On 24-MAR-2021 18:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 24-MAR-2021, and had not recovered from fever, nausea, dizziness, muscle spasms, and gas pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: DIZZINESS; CHILLS; FEVER; NAUSEA; MUSCLE SPASMS; GAS PAIN; This spontaneous report received from a patient concerned a 67 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: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 13:00, in the left arm, for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced muscle spasms. On 24-MAR-2021, the subject experienced gas pain. On 24-MAR-2021 18:00, the subject experienced dizziness. On 24-MAR-2021 18:00, the subject experienced chills. On 24-MAR-2021 18:00, the subject experienced fever. On 24-MAR-2021 18:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 24-MAR-2021, and had not recovered from fever, nausea, dizziness, muscle spasms, and gas pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; 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 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On 2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Hyperaesthesia, Pain, Pyrexia
Clinical narrative: ACHY; SENSITIVE TO TOUCH; COLD SWEATS; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-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. On MAR-2021, the subject experienced sensitive to touch. On MAR-2021, the subject experienced cold sweats. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the chills, sensitive to touch, cold sweats, fever and achy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Pyrexia
Clinical narrative: ITCHY; ARM SORENESS; LOW GRADE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry date: unknown) dose was not reported, 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 MAR-2021, the subject experienced arm soreness. On MAR-2021, the subject experienced itchy. On MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness, itchy and low grade fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: CHILLS; FEVER; NAUSEA; 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, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, and nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Hyperhidrosis
Clinical narrative: BODY ACHES; LOST APPETITE; SWEATS; HARD TIME SLEEPING; UP/DOWN ALL NIGHT; CHILLS; FEELING OK, JUST A LITTLE TIRED; ARM WAS BURNING AFTER INJECTION; LOW GRADE TEMPERATURE; NAUSEA; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 230 pounds, and height was 68 inches. The patient's past medical history included covid-19 positive, and concurrent conditions included diabetes mellitus, hypothyroidism, latex sensitivity, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021;14:00-15:00 on Right Arm. for prophylactic vaccination . No concomitant medications were reported. On 04-APR-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) POSITIVE. On 06-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced lost appetite. On 06-MAR-2021, the subject experienced sweats. On 06-MAR-2021, the subject experienced hard time sleeping. On 06-MAR-2021, the subject experienced up/down all night. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced feeling ok, just a little tired. On 06-MAR-2021, the subject experienced arm was burning after injection. On 06-MAR-2021, the subject experienced low grade temperature. On 06-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 98-99 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sweats, chills, low grade temperature, and nausea on 08-MAR-2021, lost appetite on 07-MAR-2021, feeling ok, just a little tired on 09-MAR-2021, and arm was burning after injection on 06-MAR-2021, and the outcome of hard time sleeping and up/down all night was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHES; LOST APPETITE; SWEATS; HARD TIME SLEEPING; UP/DOWN ALL NIGHT; CHILLS; FEELING OK, JUST A LITTLE TIRED; ARM WAS BURNING AFTER INJECTION; LOW GRADE TEMPERATURE; NAUSEA; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 230 pounds, and height was 68 inches. The patient's past medical history included covid-19 positive, and concurrent conditions included diabetes mellitus, hypothyroidism, latex sensitivity, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021;14:00-15:00 on Right Arm. for prophylactic vaccination . No concomitant medications were reported. On 04-APR-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) POSITIVE. On 06-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced lost appetite. On 06-MAR-2021, the subject experienced sweats. On 06-MAR-2021, the subject experienced hard time sleeping. On 06-MAR-2021, the subject experienced up/down all night. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced feeling ok, just a little tired. On 06-MAR-2021, the subject experienced arm was burning after injection. On 06-MAR-2021, the subject experienced low grade temperature. On 06-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 98-99 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sweats, chills, low grade temperature, and nausea on 08-MAR-2021, lost appetite on 07-MAR-2021, feeling ok, just a little tired on 09-MAR-2021, and arm was burning after injection on 06-MAR-2021, and the outcome of hard time sleeping and up/down all night was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, SARS-CoV-2 test positive
Clinical narrative: BODY ACHES; LOST APPETITE; SWEATS; HARD TIME SLEEPING; UP/DOWN ALL NIGHT; CHILLS; FEELING OK, JUST A LITTLE TIRED; ARM WAS BURNING AFTER INJECTION; LOW GRADE TEMPERATURE; NAUSEA; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 230 pounds, and height was 68 inches. The patient's past medical history included covid-19 positive, and concurrent conditions included diabetes mellitus, hypothyroidism, latex sensitivity, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021;14:00-15:00 on Right Arm. for prophylactic vaccination . No concomitant medications were reported. On 04-APR-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) POSITIVE. On 06-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced lost appetite. On 06-MAR-2021, the subject experienced sweats. On 06-MAR-2021, the subject experienced hard time sleeping. On 06-MAR-2021, the subject experienced up/down all night. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced feeling ok, just a little tired. On 06-MAR-2021, the subject experienced arm was burning after injection. On 06-MAR-2021, the subject experienced low grade temperature. On 06-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 98-99 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sweats, chills, low grade temperature, and nausea on 08-MAR-2021, lost appetite on 07-MAR-2021, feeling ok, just a little tired on 09-MAR-2021, and arm was burning after injection on 06-MAR-2021, and the outcome of hard time sleeping and up/down all night was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: I HAD EVERY SIDE AFFECT POSSIBLE; 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, once a total administered, 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 i had every side affect possible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of i had every side affect possible was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Nausea, Urticaria
Clinical narrative: CHILLS; TIREDNESS; NAUSEA; DIFFICULTY BREATHING; HIVES; 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 asthma, and allergy to grass and trees.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 13:00 to left arm for prophylactic vaccination. Concomitant medications included salbutamol for asthma. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 20-MAR-2021, the subject experienced difficulty breathing. On 20-MAR-2021, the subject experienced hives. On 20-MAR-2021, the subject experienced tiredness. On 20-MAR-2021, the subject experienced nausea. On 20-MAR-2021 20:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and nausea on 23-MAR-2021, recovered with sequelae from hives on 21-MAR-2021, and had not recovered from difficulty breathing, and tiredness. 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: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: MILD FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18052025, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild fever on 16-MAR-2021. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: PAIN IN THE ARMPIT OF VACCINATED ARM; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced pain in the armpit of vaccinated arm. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in the armpit of vaccinated arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; LOW GRADE FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 chills, and low grade fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and low grade fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: VOMITED; COVID 19 (SMELLS AND TASTES WAS ALTERED); NAUSEA; 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: 1805020,  expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination on Left Deltoid. No concomitant medications were reported. On 09-DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the subject experienced vomited, covid 19 (smells and tastes was altered), feels like getting worse everyday, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, vomited, and covid 19 (smells and tastes was altered), and the outcome of feels like getting worse everyday was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Fatigue, Heart rate
Clinical narrative: EXTREME DIZZINESS; ELEVATED BLOOD PRESSURE; HEART RATE 80; FATIGUE; MUSCULAR PAIN IN ARM; 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 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced elevated blood pressure. On 23-MAR-2021, the subject experienced heart rate 80. On 23-MAR-2021, the subject experienced fatigue. On 23-MAR-2021, the subject experienced muscular pain in arm. Laboratory data included: Blood pressure (NR: not provided) 137/80 mmHg, and Heart rate (NR: not provided) 80 BPM (units unspecified). On 24-MAR-2021, the subject experienced extreme dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscular pain in arm, fatigue, extreme dizziness, elevated blood pressure, and heart rate 80. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate abnormal, Myalgia
Clinical narrative: EXTREME DIZZINESS; ELEVATED BLOOD PRESSURE; HEART RATE 80; FATIGUE; MUSCULAR PAIN IN ARM; 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 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced elevated blood pressure. On 23-MAR-2021, the subject experienced heart rate 80. On 23-MAR-2021, the subject experienced fatigue. On 23-MAR-2021, the subject experienced muscular pain in arm. Laboratory data included: Blood pressure (NR: not provided) 137/80 mmHg, and Heart rate (NR: not provided) 80 BPM (units unspecified). On 24-MAR-2021, the subject experienced extreme dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscular pain in arm, fatigue, extreme dizziness, elevated blood pressure, and heart rate 80. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.  Version created to amend previously reported information on 23-MAR-2021. Upon review, the following information was amended: Reporter type in tab and narrative, medically confirm tab  and due diligence corrected.
Sex: U
Vaccine: COVID19
Symptoms: Anosmia, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: ACHE; LOSS OF SENSE OF SMELL; FEVER; 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 13-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 ache. On MAR-2021, the subject experienced loss of sense of smell. On MAR-2021, the subject experienced fever. Laboratory data included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, ache and loss of sense of smell was not reported. This report was non-serious.