chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Frequent bowel movements
Clinical narrative: BOWEL MOVEMENT; 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 06-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 10-APR-2021, the subject experienced bowel movement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bowel movement was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Influenza like illness, Nausea, Rash
Clinical narrative: FLU LIKE SYMPTOMS; HORRIBLE FEELING; PROFUSE SWEATING; EXTREME NAUSEA; RASH ON STOMACH; 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 concurrent conditions included muscle disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced rash on stomach. On 09-APR-2021, the subject experienced flu like symptoms. On 09-APR-2021, the subject experienced horrible feeling. On 09-APR-2021, the subject experienced profuse sweating. On 09-APR-2021, the subject experienced extreme nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on stomach, extreme nausea, flu like symptoms, horrible feeling, and profuse sweating. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: VOMITING; NAUSEA; FEVER; HEADACHE; MUSCLE ACHE; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 10:45 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced muscle ache. On 10-APR-2021, the subject experienced fatigue. On 11-APR-2021 01:00, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, vomiting, fever, headache, muscle ache and fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; NAUSEA; FEVER; HEADACHE; MUSCLE ACHE; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 10:45 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced muscle ache. On 10-APR-2021, the subject experienced fatigue. On 11-APR-2021 01:00, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, vomiting, fever, headache, muscle ache and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHE; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow up will be requested for this case. On an unspecified date, the subject experienced body ache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and body ache was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Bursitis, Chills, Contusion
Clinical narrative: CHILLS; BURSITIS; BRUISING IN BLACK AND BLUE DISCOLOURATION AT RIGHT  ELBOW; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 10:55 for prophylactic vaccination. Non-company suspect drugs included: prednisone (tablet, oral, batch number: Unknown) 50 mg, 1 time every 1 day, from 02-APR-2021 for bursitis. No concomitant medications were reported. On 01-APR-2021 15:55, the subject experienced bursitis. On 01-APR-2021 15:55, the subject experienced bruising in black and blue discoloration at right elbow. On 02-APR-2021 04:30, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with prednisone was withdrawn. The patient recovered from chills on 02-APR-2021, had not recovered from bruising in black and blue discoloration at right elbow, and the outcome of bursitis was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS/ BODY ACHES/ SORE THROAT/ TROUBLE BREATHING; WEAKNESS; This spontaneous report received from a patient concerned a 41 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: 202A21A and  expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 to Left Arm for prophylactic vaccination.  No concomitant medications were reported. On 10-APR-2021, the subject experienced flu-like symptoms/ body aches/ sore throat/ trouble breathing. On 10-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from weakness, and flu-like symptoms/ body aches/ sore throat/ trouble breathing. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Headache, Pain
Clinical narrative: NOSE BLEED; BODY ACHES; CHILLS; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 31 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: 1808982, expiry: 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 body aches. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced severe headache. On 11-APR-2021, the subject experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and severe headache on 09-APR-2021, and had not recovered from nose bleed. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: BODY ACHE; HEADACHE; FEVER 102.7 F; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-APR-2021 15:00 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 11-APR-2021, the subject experienced body ache. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fever 102.7 f. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.7 F, and COVID-19 virus test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body ache, and fever 102.7 f. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: CHILLS; FEVER; FATIGUE; NAUSEA; 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 06-APR-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 side effects, chills, fever, fatigue, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, fatigue, nausea and side effects was not reported. This report was non-serious.20210428439.
Sex: U
Vaccine: COVID19
Symptoms: Medication error, Underdose
Clinical narrative: PARTIAL DOSE ADMINISTRATION; MEDICATION ERROR; This spontaneous report received from a pharmacist 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 reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced partial dose administration, and medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial dose administration and medication error was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Nasopharyngitis, Rash
Clinical narrative: SHORTNESS OF BREATH; BAD COLD/HEADACHE/SORE THROAT; RAISED RED BUMP ON ARM; WEAK; TIGHTNESS IN THE CHEST; This spontaneous report received from a patient concerned a 48 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: 1808982, 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 tightness in the chest. On APR-2021, the subject experienced raised red bump on arm. On APR-2021, the subject experienced weak. On 10-APR-2021, the subject experienced bad cold/headache/sore throat. On an unspecified date, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weak, shortness of breath, tightness in the chest, raised red bump on arm and bad cold/headache/sore throat was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lip pain, Lip swelling
Clinical narrative: SWELLING LIPS; LIP PAIN; 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, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced swelling lips, and lip pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling lips and lip pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Neck pain
Clinical narrative: NECK NUMBNESS; SHOULDER PAIN; NECK PAIN; This spontaneous report received from a patient concerned a 37 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: Unknown) dose was not reported, administered on 12-APR-2021 to Left Arm 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 neck numbness. On 12-APR-2021, the subject experienced shoulder pain. On 12-APR-2021, the subject experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck pain, shoulder pain, and neck numbness. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Fatigue, Headache, Pain
Clinical narrative: BAD TASTE IN MOUTH AND THROAT; STOMACH PAIN; BODY ACHE; FEVER; FATIGUE; HEADACHE; FEELS LIKE KNOT RIGHT BELOW HEART; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included high blood pressure, and hypothyroidism. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feels like knot right below heart. Laboratory data included: Body temperature (NR: not provided) 99.9. On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced bad taste in mouth and throat. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, fever, and fatigue on 09-APR-2021, had not recovered from stomach pain, and bad taste in mouth and throat, and the outcome of headache and feels like knot right below heart was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sensory disturbance, Taste disorder
Clinical narrative: BAD TASTE IN MOUTH AND THROAT; STOMACH PAIN; BODY ACHE; FEVER; FATIGUE; HEADACHE; FEELS LIKE KNOT RIGHT BELOW HEART; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included high blood pressure, and hypothyroidism. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feels like knot right below heart. Laboratory data included: Body temperature (NR: not provided) 99.9. On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced bad taste in mouth and throat. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, fever, and fatigue on 09-APR-2021, had not recovered from stomach pain, and bad taste in mouth and throat, and the outcome of headache and feels like knot right below heart was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: FATIGUE; NECKACHE; CHILLS; MUSCLE ACHES; HEADACHE; DRENCHED IN SWEAT; This spontaneous report received from a patient via a company representative concerned a 51 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included hypertension, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 15:45 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced drenched in sweat. On 13-APR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 13-APR-2021 01:00, the subject experienced chills. On 13-APR-2021 01:00, the subject experienced muscle aches. On 13-APR-2021 05:00, the subject experienced neckache. On 13-APR-2021 06:00, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drenched in sweat, chills, and muscle aches on 13-APR-2021, was recovering from neckache, and had not recovered from headache, and fatigue. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: FATIGUE; NECKACHE; CHILLS; MUSCLE ACHES; HEADACHE; DRENCHED IN SWEAT; This spontaneous report received from a patient via a company representative concerned a 51 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included hypertension, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 15:45 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced drenched in sweat. On 13-APR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 13-APR-2021 01:00, the subject experienced chills. On 13-APR-2021 01:00, the subject experienced muscle aches. On 13-APR-2021 05:00, the subject experienced neckache. On 13-APR-2021 06:00, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drenched in sweat, chills, and muscle aches on 13-APR-2021, was recovering from neckache, and had not recovered from headache, and fatigue. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Muscle spasms, Nausea
Clinical narrative: SPASMS ON LEGS, ARMS AND HEAD; SLIGHT HEADACHE; EXTREME TIREDNESS; SLIGHT FEVER; NAUSEA; BODY ACHES; PROFUSE SWEATING; POSSIBLE SEIZURE; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included food allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: unknown) dose was not reported, 1 total administered on 11-APR-2021 around 11:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, after vaccination patient had done lower body workout. On 11-APR-2021, the patient experienced nausea, extreme tiredness, slight fever, slight headache, body aches, and profuse sweating by evening. She took some children's liquid paracetamol (Tylenol). On 12-APR-2021 about 02:00, she also had spasms of her arms, legs, and head that lasted about 20 minutes. She took paracetamol (Tylenol) at about 03:00 and was pretty out of it. The patient's mother was concerned that it could had been a seizure (possible seizure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spasms on legs, arms and head on 12-APR-2021, and the outcome of nausea, extreme tiredness, slight fever, slight headache, body aches, profuse sweating and possible seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210423951-Covid-19 vaccine ad26.cov2.s-seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Seizure
Clinical narrative: SPASMS ON LEGS, ARMS AND HEAD; SLIGHT HEADACHE; EXTREME TIREDNESS; SLIGHT FEVER; NAUSEA; BODY ACHES; PROFUSE SWEATING; POSSIBLE SEIZURE; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included food allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: unknown) dose was not reported, 1 total administered on 11-APR-2021 around 11:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, after vaccination patient had done lower body workout. On 11-APR-2021, the patient experienced nausea, extreme tiredness, slight fever, slight headache, body aches, and profuse sweating by evening. She took some children's liquid paracetamol (Tylenol). On 12-APR-2021 about 02:00, she also had spasms of her arms, legs, and head that lasted about 20 minutes. She took paracetamol (Tylenol) at about 03:00 and was pretty out of it. The patient's mother was concerned that it could had been a seizure (possible seizure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spasms on legs, arms and head on 12-APR-2021, and the outcome of nausea, extreme tiredness, slight fever, slight headache, body aches, profuse sweating and possible seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210423951-Covid-19 vaccine ad26.cov2.s-seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chills, Computerised tomogram head, Facial bones fracture
Clinical narrative: BLACKED OUT; VERTIGO AGGRAVATED; BROKEN NOSE; FALL; BUSTED LIPS; COULD NOT EAT ANYTHING; CHILLS; FEVER; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vertigo, non-alcohol user, and non-smoker. The patient was not pregnant at the time of reporting. The patient had no known drug allergies and no history of 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: 042A21A, expiry: 21-JUN-2021) dose was not reported, 1 total, administered on right arm on 03-APR-2021 13:30 for prophylactic vaccination. Concomitant medications included meclozine hydrochloride for vertigo.  On 03-APR-2021, 15 minutes after vaccination the patient felt dizzy. On the same evening, the patient experienced fever, vomiting, sweating, dizziness and chills. On 04-APR-2021, the patient could not eat anything and experienced black out and fell from which the patient experienced busted lips and broken nose. The patient was taken to the emergency room and was hospitalized on 04-APR-2021. During hospitalization the patient had blood test and chest X-ray which was normal and COVID-19 virus test was negative. At the hospital the patient was diagnosed with aggravated vertigo due to vaccination but according to the patient it was not her vertigo since she did not get her usual vertigo symptoms before blacking out (dizziness, room spinning, or feeling like about to fall). The duration of hospitalization was 1 day. On 07-APR-2021, the patient went back to the hospital to follow-up and the patient's physician ran tests for blood work and computed tomography (CT) scan of her head with no abnormal findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blacked out, vertigo aggravated, broken nose, fall, busted lips, could not eat anything, chills and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210423964-covid-19 vaccine ad26.cov2.s -Vertigo aggravated. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: MEDICAL HISTORY   VO:20210423964-covid-19 vaccine ad26.cov2.s-broken nose, black out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Feeding disorder, Lip injury, Loss of consciousness, Pyrexia
Clinical narrative: BLACKED OUT; VERTIGO AGGRAVATED; BROKEN NOSE; FALL; BUSTED LIPS; COULD NOT EAT ANYTHING; CHILLS; FEVER; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vertigo, non-alcohol user, and non-smoker. The patient was not pregnant at the time of reporting. The patient had no known drug allergies and no history of 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: 042A21A, expiry: 21-JUN-2021) dose was not reported, 1 total, administered on right arm on 03-APR-2021 13:30 for prophylactic vaccination. Concomitant medications included meclozine hydrochloride for vertigo.  On 03-APR-2021, 15 minutes after vaccination the patient felt dizzy. On the same evening, the patient experienced fever, vomiting, sweating, dizziness and chills. On 04-APR-2021, the patient could not eat anything and experienced black out and fell from which the patient experienced busted lips and broken nose. The patient was taken to the emergency room and was hospitalized on 04-APR-2021. During hospitalization the patient had blood test and chest X-ray which was normal and COVID-19 virus test was negative. At the hospital the patient was diagnosed with aggravated vertigo due to vaccination but according to the patient it was not her vertigo since she did not get her usual vertigo symptoms before blacking out (dizziness, room spinning, or feeling like about to fall). The duration of hospitalization was 1 day. On 07-APR-2021, the patient went back to the hospital to follow-up and the patient's physician ran tests for blood work and computed tomography (CT) scan of her head with no abnormal findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blacked out, vertigo aggravated, broken nose, fall, busted lips, could not eat anything, chills and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210423964-covid-19 vaccine ad26.cov2.s -Vertigo aggravated. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: MEDICAL HISTORY   VO:20210423964-covid-19 vaccine ad26.cov2.s-broken nose, black out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: BLACKED OUT; VERTIGO AGGRAVATED; BROKEN NOSE; FALL; BUSTED LIPS; COULD NOT EAT ANYTHING; CHILLS; FEVER; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vertigo, non-alcohol user, and non-smoker. The patient was not pregnant at the time of reporting. The patient had no known drug allergies and no history of 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: 042A21A, expiry: 21-JUN-2021) dose was not reported, 1 total, administered on right arm on 03-APR-2021 13:30 for prophylactic vaccination. Concomitant medications included meclozine hydrochloride for vertigo.  On 03-APR-2021, 15 minutes after vaccination the patient felt dizzy. On the same evening, the patient experienced fever, vomiting, sweating, dizziness and chills. On 04-APR-2021, the patient could not eat anything and experienced black out and fell from which the patient experienced busted lips and broken nose. The patient was taken to the emergency room and was hospitalized on 04-APR-2021. During hospitalization the patient had blood test and chest X-ray which was normal and COVID-19 virus test was negative. At the hospital the patient was diagnosed with aggravated vertigo due to vaccination but according to the patient it was not her vertigo since she did not get her usual vertigo symptoms before blacking out (dizziness, room spinning, or feeling like about to fall). The duration of hospitalization was 1 day. On 07-APR-2021, the patient went back to the hospital to follow-up and the patient's physician ran tests for blood work and computed tomography (CT) scan of her head with no abnormal findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blacked out, vertigo aggravated, broken nose, fall, busted lips, could not eat anything, chills and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210423964-covid-19 vaccine ad26.cov2.s -Vertigo aggravated. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: MEDICAL HISTORY   VO:20210423964-covid-19 vaccine ad26.cov2.s-broken nose, black out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vision blurred
Clinical narrative: BLURRY VISION; RINGING IN BOTH EARS START IN ONE AND SWITCHES TO OTHER EAR; This spontaneous report received from a patient via a company representative concerned a 59 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: 1802072, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced blurry vision, and ringing in both ears start in one and switches to other ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurry vision, and ringing in both ears start in one and switches to other ear. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 100 DEGREE 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, 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 100 degree fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 100 degree fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: FEVER; MUSCLE PAIN; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNWON) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and muscle pain. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: HEADACHE; INJECTION SITE PAIN; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 150 pounds, and height was 63 inches. The patient's concurrent conditions included psoriatic arthritis, occasional alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no known drug allergies. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included folic acid, methotrexate, and tofacitinib citrate. On 12-APR-2021, the subject experienced extreme fatigue. On 12-APR-2021, the subject experienced injection site pain. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain, and had not recovered from extreme fatigue, and headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Migraine, Pain in extremity
Clinical narrative: ARM PAIN; MIGRAINE; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 an unspecified date, the subject experienced migraine, trouble sleeping, and pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, trouble sleeping and pain in arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Pyrexia
Clinical narrative: ARM SORENESS AT INJECTION SITE; HEADACHE; FEVER THAT SLOWLY  ROSE/6 HOURS AFTER FEVER REACHED  101.3/ FINALLY 28 HOURS AFTER TEMP  WENT DOWN TO NORMAL; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced arm soreness at injection site, headache, and fever that slowly rose/6 hours after fever reached 101.3/ finally 28 hours after temp went down to normal. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.3 F The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever that slowly rose/6 hours after fever reached 101.3/ finally 28 hours after temp went down to normal, had not recovered from headache, and the outcome of arm soreness at injection site was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Mass, Pain, Pain in extremity, Pruritus
Clinical narrative: LUMP UNDER THE JAW; ITCHY; PAIN; 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 and batch number: 180A9A0 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the patient experienced lump under the jaw. On 11-APR-2021, the patient experienced itchy. On 11-APR-2021, the patient experienced pain. On 11-APR-2021, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump under the jaw, sore arm, itchy, and pain. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye discharge, Eye swelling, Hyperhidrosis, Pain in extremity
Clinical narrative: RIGHT EYE CLEAR LIQUID SECRETION; RIGHT EYE WAS SWOLLEN SHUT; ARM SORENESS; REDNESS OF FACE; SWEATING; This spontaneous report received from a patient concerned a 45 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 and batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced redness of face. On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced arm soreness. On 12-APR-2021, the subject experienced right eye clear liquid secretion. On 12-APR-2021, the subject experienced right eye was swollen shut. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right eye clear liquid secretion, and right eye was swollen shut on 12-APR-2021, and redness of face, and sweating on 11-APR-2021, and was recovering from arm soreness. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Anaphylactic shock, Blood thyroid stimulating hormone, Chest X-ray, Chest scan
Clinical narrative: Anaphylaxis or anaphylactic shock  Treatment: Epinephrine, Benadryl and steroids
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Differential white blood cell count, Electrocardiogram, Fibrin D dimer, Full blood count, Laboratory test
Clinical narrative: Anaphylaxis or anaphylactic shock  Treatment: Epinephrine, Benadryl and steroids
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Red blood cell morphology, SARS-CoV-2 test, Troponin I, Ultrasound Doppler
Clinical narrative: Anaphylaxis or anaphylactic shock  Treatment: Epinephrine, Benadryl and steroids
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Injection site pain, Neck pain
Clinical narrative: Frontal lobe headache to start within a few hrs of vaccine. Back of the head to lower neck headache 8 hrs after. Every tooth in my mouth started throbbing at around 11 hrs  and continued for about 5 more hours. Also during that time, waves of nausea but no vomiting, also uncontrollable shivering but I wasn't cold and I wasn't hot but weird shivering. I did not take my temperature as I didn't feel like I had a fever. Around 13 hrs after a stabbing pain in front of thighs like hot pokers started and around 14 hrs thigh pain was still present but then the calves on both legs started to get the same stabbing pain.   At around 24 hrs after - headache remained, pulsating teeth stopped, thigh pain stopped but calf pain remained. Headache remained off and on for several days. General brain fog also lasted for about 1 week. The calf pain comes and goes even after 2 weeks. Arm where shot was administered was very tender to the touch for the last 2 weeks.   Lastly, I wouldn't say I had shortness of breath but at times I just felt like I needed to stop and force myself to take a very deep breath.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Toothache
Clinical narrative: Frontal lobe headache to start within a few hrs of vaccine. Back of the head to lower neck headache 8 hrs after. Every tooth in my mouth started throbbing at around 11 hrs  and continued for about 5 more hours. Also during that time, waves of nausea but no vomiting, also uncontrollable shivering but I wasn't cold and I wasn't hot but weird shivering. I did not take my temperature as I didn't feel like I had a fever. Around 13 hrs after a stabbing pain in front of thighs like hot pokers started and around 14 hrs thigh pain was still present but then the calves on both legs started to get the same stabbing pain.   At around 24 hrs after - headache remained, pulsating teeth stopped, thigh pain stopped but calf pain remained. Headache remained off and on for several days. General brain fog also lasted for about 1 week. The calf pain comes and goes even after 2 weeks. Arm where shot was administered was very tender to the touch for the last 2 weeks.   Lastly, I wouldn't say I had shortness of breath but at times I just felt like I needed to stop and force myself to take a very deep breath.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: IN ICU WITH CLOTS; This spontaneous report was received from social media via a company representative and concerned a male 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, intramuscular, batch number: Unknown) dose, start therapy date were not reported, for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient was hospitalized in the intensive care unit (ICU) with clots (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for the event of clots was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: v0 This report involves a male patient of unspecified age who received the Janssen COVID-19 Vaccine Ad26.COV2 and, after an unspecified period of time, was hospitalized in the intensive care unit (ICU) with "clots" (site unspecified).  Medical history, concomitant medications, and details of the event were not reported. This case has insufficient information to make a meaningful medical assessment. The case will be assessed further when additional information is received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Blindness unilateral, Blood test, Chest pain
Clinical narrative: Immediately had flu symptoms the same night as vaccine that went away within 2 days. HOWEVER,  twenty-one (21) days later, both eyes were extremely painful to move. Then I lost vision in right eye with extreme blurriness & partial blind spots resulting in a diagnosis of Optic Neuritis by Ophthalmologist and Neurologist. Confirmed optic Neuritis on MRI scan.  Twenty-four (24) days later, numbness in legs, feet and right arm started. Hard to walk up and down stairs. Twenty-six (26) days later, extreme pain in in muscles and skin along with tingles all over and numbness. Weakness and Chest pain. Flu like symptoms without fever ie: aches, pains, skin pain, confusion. Dizziness, feeling of being extremely anxious and out of sorts in space. Had to complete round of Steroids and numbness and tingles got better, but did not dissolve. After completion of IV steroids, thirty-four (34) days later all symptoms returned full force and worsening. Checked into ER 4/10 and admitted into hospital. Have not been able to complete normal routine or work level since March 27th due to neurological disturbance and symptoms.   Two (2) Eye exams, 3/30/21 confirming swollen optic nerves.  MRI 3/31/21 Blood work 4/2/21 CoVid Test 4/9/21 Negative  Hospital: April 10-12th.  MRI Extensive Blood work Spinal Tap Neuro-Opt exam  Outcome pending and further treatment pending results.