chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: VOMITING; DIZZINESS; BODY ACHES; DIARRHEA; NAUSEA; TIREDNESS; FEVER; 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 past medical history included covid19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced diarrhea.  On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced tiredness. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, body aches, diarrhea, nausea, fever, and headache on 09-APR-2021, and the outcome of dizziness and tiredness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: CAN'T LIFT SHOULDERS; 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: Unk) dose was not reported, administered on 01-APR-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 APR-2021, the subject experienced can't lift shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of can't lift shoulders was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Chills, Fatigue, Headache
Clinical narrative: INTENSE BONE PAIN IN LOWER BODY; ACHES/PAINS; CHILLS; HEADACHE; FEVER OF 100F; TIREDNESS; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported.  The patient's past medical history included hormone replacement therapy, and concurrent conditions included tetracycline allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced intense bone pain in lower body. On 01-APR-2021, the subject experienced aches/pains. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced fever of 100f. On 01-APR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches/pains, chills, headache, and fever of 100f on 02-APR-2021, and tiredness on 03-APR-2021, and was recovering from intense bone pain in lower body. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: INTENSE BONE PAIN IN LOWER BODY; ACHES/PAINS; CHILLS; HEADACHE; FEVER OF 100F; TIREDNESS; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported.  The patient's past medical history included hormone replacement therapy, and concurrent conditions included tetracycline allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced intense bone pain in lower body. On 01-APR-2021, the subject experienced aches/pains. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced fever of 100f. On 01-APR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches/pains, chills, headache, and fever of 100f on 02-APR-2021, and tiredness on 03-APR-2021, and was recovering from intense bone pain in lower body. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain, Pyrexia
Clinical narrative: BODY HURT; DIZZINESS; CHILLS; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 06-APR-2021, the subject experienced body hurt. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body hurt, fever, chills and dizziness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Pain, Pregnancy test, Pyrexia
Clinical narrative: GENERAL BODY PAIN; VACCINE EXPOSURE DURING PREGNANCY; FEVER; CHILLS; This spontaneous pregnancy report received from a consumer concerned a 31 year old female. The patient's weight, height, and medical history were not reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the subject experienced general body pain. On 13-APR-2021, the subject experienced vaccine exposure during pregnancy. On 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced chills. The date of the subject's last menstrual period and expected delivery date were not reported. Laboratory data included: Pregnancy test (NR: not provided) positive. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from general body pain, fever, and chills, and the outcome of vaccine exposure during pregnancy was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: HEADACHE; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 72 year old female. 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 did not had no known allergies and no 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 2021, and the outcome of soreness at injection site was not reported. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Rash, Rash erythematous, Rash papular, Tenderness
Clinical narrative: I think shingles. I have a small patch of red, raised bumps on my right lower back. They don't hurt but I can constantly feel them. They hurt to touch. My front right torso is also slightly tingly in certain spots to touch. Forget this.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: WEAKNESS; FATIGUE; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included prostate enlargement, and concurrent conditions included over sized bladder, and compressed nerve in neck, and other pre-existing medical conditions included no known allergies, no illicit drug use/drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21/JUN/2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced weakness. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, and fatigue. This report was non-serious. This case, from the same reporter is linked to 20210428579.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pruritus, Rash, Skin exfoliation, Urticaria
Clinical narrative: Headache off and on from about 30 minutes after shot for 4 days. Very itchy skin rash all over chest, stomach, back, arms, abdomen, thighs that started the day after the shot and still continuing today, April 22. Have flareups with intense itching and hive type welts. Skin is starting to peel in some areas but still itchy.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Headache off and on from about 30 minutes after shot for 4 days. Very itchy skin rash all over chest, stomach, back, arms, abdomen, thighs that started the day after the shot and still continuing today, April 22. Have flareups with intense itching and hive type welts. Skin is starting to peel in some areas but still itchy.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting approx 18 hours after 2nd dose. Did not eat anything unusual or different and drank plenty of water and gatorade
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Hot flush, Nausea, Vomiting
Clinical narrative: severe headache, longer than 24 hours unalleviated with tylenol, nausea and vomiting, chills, hot flashes
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site swelling, Pain
Clinical narrative: 105.2 fever with Tylenol, fever 102 and above for 36 hours while taking Tylenol, chills, fatigue, headache, severe muscle aches, swelling at injection site
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 105.2 fever with Tylenol, fever 102 and above for 36 hours while taking Tylenol, chills, fatigue, headache, severe muscle aches, swelling at injection site
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dysmenorrhoea, Heavy menstrual bleeding, Menstruation delayed, Thrombosis
Clinical narrative: Delayed menstrual cycle by 4 days, when started very painful and heavy. Much more clots than usual and lasting longer than usual. Uncomfortable enough to require rest. Still going heavy when it should be tapering off.?
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: HEADACHE; DIZZINESS; NAUSEA; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 89 pounds, and height was not reported. The patient's past medical history included covid 19 infection, and concurrent conditions included migraine.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 05-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021 15:00, the subject experienced dizziness. On 06-MAR-2021 15:00, the subject experienced nausea. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and nausea on 06-MAR-2021 19:00, and the outcome of headache was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Severe headaches for the first 5 days, achy and started getting extremely tired around day 5 and I?m still exhausted. Started developing huge bruises on my arms around day 10 after vaccine. Reddish purple dots on a very large bruise on my forearm.  Still have bad headache muscle aches middle of back tender, like I have to pop it but can?t.   Very sore
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Severe headaches for the first 5 days, achy and started getting extremely tired around day 5 and I?m still exhausted. Started developing huge bruises on my arms around day 10 after vaccine. Reddish purple dots on a very large bruise on my forearm.  Still have bad headache muscle aches middle of back tender, like I have to pop it but can?t.   Very sore
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: HIGH BLOOD PRESSURE; This spontaneous report received from a consumer concerned a 77 year old female. The patient's height, and weight were not reported. The patient had medical history of high blood pressure. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09/JUN/2021) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included lisinopril for hypertension, acetylsalicylic acid, ergocalciferol, ibuprofen, magnesium, vitamins nos, and zinc.  On 12-APR-2021, the patient experienced high blood pressure, which had increased over 2 days. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 177/93 mmHg at 3:00, 172/86 mmHg before bed, 159/95 mmHg yesterday, and highest reading of 201/104 mmHg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210427613- COVID-19 VACCINE AD26.COV2.S- High Blood Pressure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Nausea, Pain, Somnolence
Clinical narrative: ACHE; SORE; GROGGY; TIRED; OCCASIONAL NAUSEA; This spontaneous report received from a patient concerned a 20 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced ache. On 13-APR-2021, the subject experienced sore. On 13-APR-2021, the subject experienced groggy. On 13-APR-2021, the subject experienced tired. On 13-APR-2021, the subject experienced occasional nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ache, sore, tired, groggy, and occasional nausea. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Needle issue
Clinical narrative: TIRED; NEEDLE TOO SHORT; This spontaneous report received from a consumer concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast cancer. 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 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced needle too short. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired and needle too short was not reported. This report was non-serious. The case was associated with a product quality complaint number. The suspected product quality complaint has been confirmed to be this complaint does not describe a product quality issue. therefore, it will be forwarded to pqv management for review for void approval. based on the PQC evaluation/investigation performed.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site nodule, Myalgia, Neck pain
Clinical narrative: HARD KNOT ON INJECTION SITE; NECK ACHE; JOINT  ACHES; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a 54 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced hard knot on injection site. On APR-2021, the subject experienced neck ache. On APR-2021, the subject experienced joint aches. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on APR-2021, and the outcome of hard knot on injection site, neck ache, joint aches and muscle aches was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Discomfort, Dizziness, Dyspnoea, Fatigue
Clinical narrative: SHORTNESS OF BREATH; FELT LIKE I TOOK SPEED; NAUSEA; FEVERISH; TIREDNESS; NUMBNESS; DIZZY; BACK PAIN; BODY HEAVY; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included fibroids, and endometriosis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 023AZIA expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced back pain. On 11-APR-2021, the subject experienced body heavy. On 11-APR-2021, the subject experienced numbness. On 11-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced tiredness. On 11-APR-2021, the subject experienced feverish. On 13-APR-2021, the subject experienced shortness of breath. On 13-APR-2021, the subject experienced felt like i took speed. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish on 12-APR-2021, was recovering from back pain, and body heavy, had not recovered from tiredness, dizzy, shortness of breath, numbness, and felt like i took speed, and the outcome of nausea was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea, Psychomotor hyperactivity, Pyrexia
Clinical narrative: SHORTNESS OF BREATH; FELT LIKE I TOOK SPEED; NAUSEA; FEVERISH; TIREDNESS; NUMBNESS; DIZZY; BACK PAIN; BODY HEAVY; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included fibroids, and endometriosis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 023AZIA expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced back pain. On 11-APR-2021, the subject experienced body heavy. On 11-APR-2021, the subject experienced numbness. On 11-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced tiredness. On 11-APR-2021, the subject experienced feverish. On 13-APR-2021, the subject experienced shortness of breath. On 13-APR-2021, the subject experienced felt like i took speed. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish on 12-APR-2021, was recovering from back pain, and body heavy, had not recovered from tiredness, dizzy, shortness of breath, numbness, and felt like i took speed, and the outcome of nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: SWOLLEN ARMPIT LYMPH NODE OF THE ARM I GOT SHOT IN; SORE ARMPIT LYMPH NODE OF THE ARM I GOT SHOT IN; This spontaneous report received from a patient concerned a patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced swollen armpit lymph node of the arm i got shot in. On 2021, the subject experienced sore armpit lymph node of the arm i got shot in. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen armpit lymph node of the arm i got shot in and sore armpit lymph node of the arm i got shot in was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Blood urine present, Chills, Computerised tomogram
Clinical narrative: BLOOD IN URINE; ABDOMINAL PAIN; ACUTE,SHARP STOMACH PAIN; INDIGESTION; ARM SORENESS; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and other pre-existing medical conditions included had no medical history except back surgery in 1999 and no concurrent medications. no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 28-FEB-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced fatigue. On 29-MAR-2021, the subject experienced arm soreness. On 02-APR-2021, the subject experienced blood in urine. On 02-APR-2021, the subject experienced abdominal pain. On 02-APR-2021, the subject experienced acute, sharp stomach pain. On 02-APR-2021, the subject experienced indigestion. On 13-APR-2021, Laboratory data included: CT scan (NR: not provided) results came back clear., and Prostate examination (NR: not provided) results came back clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm soreness, chills, and fatigue, had not recovered from blood in urine, abdominal pain, and acute, sharp stomach pain, and the outcome of indigestion was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Fatigue, Pain in extremity, Prostate examination
Clinical narrative: BLOOD IN URINE; ABDOMINAL PAIN; ACUTE,SHARP STOMACH PAIN; INDIGESTION; ARM SORENESS; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and other pre-existing medical conditions included had no medical history except back surgery in 1999 and no concurrent medications. no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 28-FEB-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced fatigue. On 29-MAR-2021, the subject experienced arm soreness. On 02-APR-2021, the subject experienced blood in urine. On 02-APR-2021, the subject experienced abdominal pain. On 02-APR-2021, the subject experienced acute, sharp stomach pain. On 02-APR-2021, the subject experienced indigestion. On 13-APR-2021, Laboratory data included: CT scan (NR: not provided) results came back clear., and Prostate examination (NR: not provided) results came back clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm soreness, chills, and fatigue, had not recovered from blood in urine, abdominal pain, and acute, sharp stomach pain, and the outcome of indigestion was not reported. This report was non-serious.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Pain
Clinical narrative: CRASHED IN FELL ASLEEP; NIGHT CHILLS; FATIGUE; HIGH TEMPERATURE; TEMPORAL HEADACHE; PAIN; This spontaneous report received from a patient concerned a 4 decade old of unspecified sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 10-APR-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 APR-2021, the subject experienced pain. On APR-2021, the subject experienced night chills. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced high temperature. On APR-2021, the subject experienced temporal headache. On 13-APR-2021, the subject experienced crashed in fell asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain, fatigue, high temperature, temporal headache, and night chills, and the outcome of crashed in fell asleep was not reported. This report was non-serious.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: CRASHED IN FELL ASLEEP; NIGHT CHILLS; FATIGUE; HIGH TEMPERATURE; TEMPORAL HEADACHE; PAIN; This spontaneous report received from a patient concerned a 4 decade old of unspecified sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 10-APR-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 APR-2021, the subject experienced pain. On APR-2021, the subject experienced night chills. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced high temperature. On APR-2021, the subject experienced temporal headache. On 13-APR-2021, the subject experienced crashed in fell asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain, fatigue, high temperature, temporal headache, and night chills, and the outcome of crashed in fell asleep was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Dizziness, Feeling cold, Feeling hot
Clinical narrative: DIZZY; LOW GRADE FEVER; FREEZING COLD; FEEL EXTREMELY HOT; SLEEP LESS; This spontaneous report received from a patient concerned a 20 year old female. The patient's weight was 120 pounds, and height was 160.02 centimeters. The patient's concurrent conditions included penicillin allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included no medical history and had no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, Laboratory data included: Blood test (NR: not provided) Low progesterone level. On APR-2021, the subject experienced sleep less. On 09-APR-2021, the subject experienced feel extremely hot. On 09-APR-2021 20:00, the subject experienced freezing cold. On 10-APR-2021, the subject experienced dizzy. On 10-APR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99.2 or 99.3. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feel extremely hot, and freezing cold on 09-APR-2021, and low grade fever on 10-APR-2021, and the outcome of dizzy and sleep less was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pyrexia
Clinical narrative: DIZZY; LOW GRADE FEVER; FREEZING COLD; FEEL EXTREMELY HOT; SLEEP LESS; This spontaneous report received from a patient concerned a 20 year old female. The patient's weight was 120 pounds, and height was 160.02 centimeters. The patient's concurrent conditions included penicillin allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included no medical history and had no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, Laboratory data included: Blood test (NR: not provided) Low progesterone level. On APR-2021, the subject experienced sleep less. On 09-APR-2021, the subject experienced feel extremely hot. On 09-APR-2021 20:00, the subject experienced freezing cold. On 10-APR-2021, the subject experienced dizzy. On 10-APR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99.2 or 99.3. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feel extremely hot, and freezing cold on 09-APR-2021, and low grade fever on 10-APR-2021, and the outcome of dizzy and sleep less was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Migraine, Nasal congestion
Clinical narrative: BODY ACHES; CONGESTION; LABORED BREATHING; MIGRAINE SYMPTOMS; 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, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced congestion. On APR-2021, the subject experienced labored breathing. On APR-2021, the subject experienced migraine symptoms. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On APR-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, chills, congestion, labored breathing, fatigue and migraine symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; CONGESTION; LABORED BREATHING; MIGRAINE SYMPTOMS; 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, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced congestion. On APR-2021, the subject experienced labored breathing. On APR-2021, the subject experienced migraine symptoms. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On APR-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, chills, congestion, labored breathing, fatigue and migraine symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: HEAD COLD; 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced head cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of head cold was not reported. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: FEVER; HEADACHE; FELT TERRIBLE; BODY ACHE; SWEATING; CHILLS; FATIGUE; This spontaneous report received from a consumer concerned a 26 year old female. The patient's weight was 190 pounds, and height was 59 inches. The patient's concurrent conditions included asthma, non alcohol user, and electronic cigarette user, and other pre-existing medical conditions included no known allergies and no 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced felt terrible. On 12-APR-2021, the subject experienced body ache. On 12-APR-2021, the subject experienced sweating. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, felt terrible, body ache, fever, and sweating, and had not recovered from fatigue, and headache. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain, Pyrexia
Clinical narrative: FEVER; HEADACHE; FELT TERRIBLE; BODY ACHE; SWEATING; CHILLS; FATIGUE; This spontaneous report received from a consumer concerned a 26 year old female. The patient's weight was 190 pounds, and height was 59 inches. The patient's concurrent conditions included asthma, non alcohol user, and electronic cigarette user, and other pre-existing medical conditions included no known allergies and no 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced felt terrible. On 12-APR-2021, the subject experienced body ache. On 12-APR-2021, the subject experienced sweating. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, felt terrible, body ache, fever, and sweating, and had not recovered from fatigue, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: NAUSEA; 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, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and tiredness on 2021. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality sleep
Clinical narrative: SLEEP RESTLESS; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A71A, 04321A, and 043Z1A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced sleep restless. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleep restless on 04-APR-2021. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: INJECTION SITE LUMP; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-MAR-2021, the subject experienced injection site lump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site lump. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Injection site hypersensitivity, Lethargy, Rash pruritic, Wound haemorrhage
Clinical narrative: UPPER ARMS BLEEDING; RED ITCHY SPOTS; INJECTION SITE SENSITIVE; WEAKNESS; LETHARGIC; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced lethargic. On 12-APR-2021, the subject experienced upper arms bleeding. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced red itchy spots. On 12-APR-2021, the subject experienced injection site sensitive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red itchy spots, lethargic, weakness, upper arms bleeding, and injection site sensitive. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Deep vein thrombosis, Headache, Pain in extremity, Paraesthesia
Clinical narrative: TINGLING IN LEGS; CHILLS; FEVER; HEADACHE; LOWER LEG PAIN; This spontaneous report received from a patient concerned a 50 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, and batch number were not reported) dose was not reported, administered on 12-APR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-APR-2021, the subject experienced lower leg pain. Laboratory data included: Fever (NR: not provided) 101. Treatment medications included: ibuprofen. On 12-APR-2021 15:30, the subject experienced chills. On 12-APR-2021 15:30, the subject experienced fever. On 12-APR-2021 15:30, the subject experienced headache. On 13-APR-2021, Laboratory data included: DVT (NR: not provided) 1.46 H. On 14-APR-2021, the subject experienced tingling in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 13-APR-2021, was recovering from lower leg pain, and had not recovered from headache, and tingling in legs. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: TINGLING IN LEGS; CHILLS; FEVER; HEADACHE; LOWER LEG PAIN; This spontaneous report received from a patient concerned a 50 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, and batch number were not reported) dose was not reported, administered on 12-APR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-APR-2021, the subject experienced lower leg pain. Laboratory data included: Fever (NR: not provided) 101. Treatment medications included: ibuprofen. On 12-APR-2021 15:30, the subject experienced chills. On 12-APR-2021 15:30, the subject experienced fever. On 12-APR-2021 15:30, the subject experienced headache. On 13-APR-2021, Laboratory data included: DVT (NR: not provided) 1.46 H. On 14-APR-2021, the subject experienced tingling in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 13-APR-2021, was recovering from lower leg pain, and had not recovered from headache, and tingling in legs. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SEVERE SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced severe side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe side effects was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Tremor
Clinical narrative: PROFUSE SWEATING; CYCLES OF SHAKING; SEVERE HIP AND JOINT PAIN; CYCLES OF CHILLS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced profuse sweating. On 10-APR-2021, the subject experienced cycles of shaking. On 10-APR-2021, the subject experienced severe hip and joint pain. On 10-APR-2021, the subject experienced cycles of chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from profuse sweating on 12-APR-2021, and cycles of shaking, and cycles of chills on 11-APR-2021, and had not recovered from severe hip and joint pain. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Vomiting
Clinical narrative: VOMITING; DIARRHEA; NAUSEA; HEADACHES; TIREDNESS; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced vomiting. On 09-APR-2021, the subject experienced diarrhea. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced headaches. On 09-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches on 11-APR-2021, and tiredness on APR-2021, and had not recovered from nausea, vomiting, and diarrhea. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: FLU-LIKE SYMPTOMS; MUSCLE PAIN; FATIGUE; FEVER; NAUSEA; HEADACHE; INJECTION SITE PAIN; DIZZINESS; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced injection site pain. On 09-APR-2021 20:00, the subject experienced flu-like symptoms. On 09-APR-2021 20:00, the subject experienced muscle pain. On 09-APR-2021 20:00, the subject experienced fatigue. On 09-APR-2021 20:00, the subject experienced fever. On 09-APR-2021 20:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, muscle pain, fever, and nausea on 13-APR-2021, and was recovering from fatigue, dizziness, headache, and injection site pain. This report was non-serious.