chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Venogram, Weight decreased
Clinical narrative: LEFT ARM NUMBNESS; LEG CRAMPING; NUMBNESS UNDER LEFT EYE; NAUSEA; CHEST PRESSURE; SEVERE HEADACHES; This spontaneous report received from a parent concerned a 43 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) frequency 1 total, dose not reported, on approximately 08-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported.The patient was not pregnant at the time of report. Patient had the Janssen Covid-19 vaccine on approximately 08-APR-2021 and started experiencing side effects on 14-APR-2021 (six days later) which included severe headaches, nausea, left arm numbness, cramping in one leg, and chest pressure. Patient went to Emergency room several times for these symptoms and was discharged each time. Patient also had numbness under left eye and was admitted to hospital on or about 16-APR-2021 or 17-APR-2021 to rule out blood clot on MRI and was diagnosed with arachnoid granulation and released on 20-APR-2021. Patient was hospitalized for approximately 3-4 days. Patient then started with chest pressure, slight headache and leg cramping and went to Emergency room on evening of 02-MAY-2021.On an unspecified date in  APR-2021, Laboratory data included: MRI(Magnetic resonance imaging) (NR: not provided) arachnoid granulation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pressure, severe headaches, left arm numbness, leg cramping, numbness under left eye and nausea was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210504059- Covid-19 vaccine ad26.cov2.s- left arm numbness, leg cramping, numbness under left eye. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210504059-covid-19 vaccine ad26.cov2.s nausea. This event is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Migraine, Nausea
Clinical narrative: LEFT ARM NUMBNESS; LEG CRAMPING; NUMBNESS UNDER LEFT EYE; NAUSEA; CHEST PRESSURE; SEVERE HEADACHES; This spontaneous report received from a parent concerned a 43 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) frequency 1 total, dose not reported, on approximately 08-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported.The patient was not pregnant at the time of report. Patient had the Janssen Covid-19 vaccine on approximately 08-APR-2021 and started experiencing side effects on 14-APR-2021 (six days later) which included severe headaches, nausea, left arm numbness, cramping in one leg, and chest pressure. Patient went to Emergency room several times for these symptoms and was discharged each time. Patient also had numbness under left eye and was admitted to hospital on or about 16-APR-2021 or 17-APR-2021 to rule out blood clot on MRI and was diagnosed with arachnoid granulation and released on 20-APR-2021. Patient was hospitalized for approximately 3-4 days. Patient then started with chest pressure, slight headache and leg cramping and went to Emergency room on evening of 02-MAY-2021.On an unspecified date in  APR-2021, Laboratory data included: MRI(Magnetic resonance imaging) (NR: not provided) arachnoid granulation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pressure, severe headaches, left arm numbness, leg cramping, numbness under left eye and nausea was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210504059- Covid-19 vaccine ad26.cov2.s- left arm numbness, leg cramping, numbness under left eye. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210504059-covid-19 vaccine ad26.cov2.s nausea. This event is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Ocular hyperaemia
Clinical narrative: BLOOD IN EYE; DO NOT HAVE TOTAL VISION IN LEFT EYE; This spontaneous report received from a patient concerned a female of unspecified age. Initial information was processed along with the additional information received on 06-MAY-2021. 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, 1 total, administered on 05-MAR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On 22-MAR-2021, the patient experienced blood in eye. On an unspecified date, the patient experienced losing vision in left eye and reports she has not yet got back complete vision in the eye. It was reported that, the patient would love to get compensated for all the physician visits, blood test, prescriptions, and time out of work. He also said that he knew when he signed for the vaccination that they are not responsible. He also mentioned that he would never get another shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from don't have total vision in left eye, and the outcome of blood in eye was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210504249 -COVID-19 VACCINE AD26.COV2.S- Do not have total vision in left eye, Blood in eye. 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis chronic, Diarrhoea, Dizziness, Headache, Vomiting
Clinical narrative: CHRONIC BRONCHITIS; DIZZINESS; DIARRHEA; VOMITING; HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included bacteria (took antibiotic) and concurrent conditions included bronchitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, 1 total administered on 04-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included azithromycin, and fexofenadine hydrochloride/pseudoephedrine hydrochloride.  On 06-APR-2021, the patient experienced coughing, chills, hard to breathe. On 06-APR-2021, the patient experienced vomiting and had more coughing. Patient started coughing blood and called the insurance company for an urgent care. On 01-MAY-2021, patient diagnosed with chronic bronchitis and started on Zpak and prescribed Allegra D.  The patient recovered from vomiting, had not recovered from dizziness, diarrhea, and headache, and the outcome of chronic bronchitis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210505177-covid-19 vaccine ad26.cov2.s-chronic bronchitis. 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
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: DIDN'T RECEIVE THE FULL DOSE; 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: 204A21A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced didn't receive the full dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of didn't receive the full dose was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Gait disturbance, Influenza like illness, Pain
Clinical narrative: ACHES; FLU-LIKE SYMPTOMS; HARD TO WALK; This spontaneous report received from a consumer concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced aches. On 03-MAY-2021, the subject experienced flu-like symptoms. On 03-MAY-2021, the subject experienced hard to walk. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches, flu-like symptoms, and hard to walk. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle twitching, Myalgia, Pyrexia
Clinical narrative: MUSCLE TWITCHING ON THE RIGHT LEG; TWITCHING IN THE BRAIN; CHILLS; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, high cholesterol, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced muscle twitching on the right leg. On 02-MAY-2021, the subject experienced twitching in the brain. On 02-MAY-2021, the subject experienced chills. On 02-MAY-2021, the subject experienced muscle aches. On 02-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from twitching in the brain, and fever on MAY-2021, was recovering from muscle twitching on the right leg, and the outcome of muscle aches and chills was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Insomnia, Limb discomfort, Pyrexia
Clinical narrative: DIDN'T SLEEP WELL; SHIVERING A LOT; ARM SORE; EXHAUSTED; LOW 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: 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 didn't sleep well, shivering a lot, arm sore, exhausted, and low fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from didn't sleep well, shivering a lot, exhausted, and low fever, and the outcome of arm sore was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Mouth swelling, Nausea, Rash
Clinical narrative: SHORTNESS OF BREATH; SWOLLEN MOUTH; BUMPS  IN DIFFERENT PARTS OF THE BODY; CONSTANT HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced shortness of breath. On 2021, the subject experienced swollen mouth. On 2021, the subject experienced bumps in different parts of the body. On 2021, the subject experienced constant headache. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the constant headache, nausea, shortness of breath, swollen mouth and bumps in different parts of the body was not reported. This report was non-serious. This case is a duplicate of 20210505746.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient via a company representative concerned a 52 or 53 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, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-APR-2021, the patient experienced stroke and another stroke was on 28-APR-2021. Patient was hospitalized on unspecified date and discharge date was not provided.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210505957-Covid-19 Vaccine.Ad 26.Cov2.S-Stroke. 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).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Immobile, Movement disorder
Clinical narrative: STROKE; This spontaneous report received from a patient via a company representative concerned a 52 or 53 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, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-APR-2021, the patient experienced stroke and another stroke was on 28-APR-2021. Patient was hospitalized on unspecified date and discharge date was not provided.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210505957-Covid-19 Vaccine.Ad 26.Cov2.S-Stroke. 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: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a social media via company representative concerned a 38 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was on more medication due to event. 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 unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unspecified adverse event. This report was non-serious.; Sender's Comments: V0:Medical assessment comments not required as per standard procedure, as the case is assessed non serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Body temperature, Chills, Decreased appetite
Clinical narrative: LOSS OF APPETITE; VOMITING; SLEEPING; CHILLS; LOW FEVER; SEVERE HEADACHE; STOMACH PAIN ON RIGHT SIDE; BACK ACHE; BODY ACHES; HOT/COLD SENSATIONS; 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 birth control.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021  for prophylactic vaccination. Concomitant medications included etonogestrel for birth control. On 03-MAY-2021, the subject experienced stomach pain on right side. On 03-MAY-2021, the subject experienced back ache. On 03-MAY-2021, the subject experienced body aches. On 03-MAY-2021, the subject experienced hot/cold sensations. On 03-MAY-2021, the subject experienced chills. On 03-MAY-2021, the subject experienced sleeping. On 03-MAY-2021, the subject experienced low fever. On 03-MAY-2021, the subject experienced severe headache.  Laboratory data included: Body temperature (NR: not provided) 97 F. Treatment medications included: ibuprofen. On 03-MAY-2021 05:00, the subject experienced vomiting. On 04-MAY-2021, the subject experienced loss of appetite. Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach pain on right side, severe headache, back ache, body aches, hot/cold sensations, chills, and vomiting, and the outcome of sleeping, low fever and loss of appetite was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Hypersomnia, Pain, Pyrexia
Clinical narrative: LOSS OF APPETITE; VOMITING; SLEEPING; CHILLS; LOW FEVER; SEVERE HEADACHE; STOMACH PAIN ON RIGHT SIDE; BACK ACHE; BODY ACHES; HOT/COLD SENSATIONS; 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 birth control.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021  for prophylactic vaccination. Concomitant medications included etonogestrel for birth control. On 03-MAY-2021, the subject experienced stomach pain on right side. On 03-MAY-2021, the subject experienced back ache. On 03-MAY-2021, the subject experienced body aches. On 03-MAY-2021, the subject experienced hot/cold sensations. On 03-MAY-2021, the subject experienced chills. On 03-MAY-2021, the subject experienced sleeping. On 03-MAY-2021, the subject experienced low fever. On 03-MAY-2021, the subject experienced severe headache.  Laboratory data included: Body temperature (NR: not provided) 97 F. Treatment medications included: ibuprofen. On 03-MAY-2021 05:00, the subject experienced vomiting. On 04-MAY-2021, the subject experienced loss of appetite. Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach pain on right side, severe headache, back ache, body aches, hot/cold sensations, chills, and vomiting, and the outcome of sleeping, low fever and loss of appetite was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: LOSS OF APPETITE; VOMITING; SLEEPING; CHILLS; LOW FEVER; SEVERE HEADACHE; STOMACH PAIN ON RIGHT SIDE; BACK ACHE; BODY ACHES; HOT/COLD SENSATIONS; 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 birth control.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021  for prophylactic vaccination. Concomitant medications included etonogestrel for birth control. On 03-MAY-2021, the subject experienced stomach pain on right side. On 03-MAY-2021, the subject experienced back ache. On 03-MAY-2021, the subject experienced body aches. On 03-MAY-2021, the subject experienced hot/cold sensations. On 03-MAY-2021, the subject experienced chills. On 03-MAY-2021, the subject experienced sleeping. On 03-MAY-2021, the subject experienced low fever. On 03-MAY-2021, the subject experienced severe headache.  Laboratory data included: Body temperature (NR: not provided) 97 F. Treatment medications included: ibuprofen. On 03-MAY-2021 05:00, the subject experienced vomiting. On 04-MAY-2021, the subject experienced loss of appetite. Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach pain on right side, severe headache, back ache, body aches, hot/cold sensations, chills, and vomiting, and the outcome of sleeping, low fever and loss of appetite was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Sensory disturbance
Clinical narrative: PAINFUL ARM; WEAKNESS OF ARM; FELT LIKE HIT BY TRUCK; 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 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced felt like hit by truck. On an unspecified date, the subject experienced painful arm, and weakness of arm. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like hit by truck, and the outcome of painful arm and weakness of arm was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, X-ray
Clinical narrative: FLU LIKE SYMPTOMS (CHILLS AND FELT TIRED EXHAUSTED); SORE ARM AFTER VACCINATION; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 130 pounds, and height was 61.5 inches. The patient's past medical history included foot surgery, and pain in injection site, and concurrent conditions included rheumatoid arthritis, auto-immune hives as a reaction to heat, alcohol user, no tobacco use, bone spurs got worse, hypothyroidism, dry eyes, chronic urticaria, calcium depletion, joint pain, morton's neuroma, limping, numbness, and weak ankle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1808609 expiry: UNNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. Concomitant medications included amitriptyline hydrochloride for autoimmune disorder, omalizumab for chronic urticaria, ciclosporin for dry eyes, levothyroxine sodium for hypothyroidism, liothyronine for hypothyroidism, conjugated linoleic acid/linum usitatissimum seed oil/ubidecarenone for supplement, and calcium/colecalciferol for supplement, calcium depletion, and joint pain. On MAR-2021, the subject experienced flu like symptoms (chills and felt tired exhausted). On MAR-2021, the subject experienced sore arm after vaccination. Laboratory data (dates unspecified) included: X-ray (NR: not provided) No significant findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm after vaccination on MAR-2021, and the outcome of flu like symptoms (chills and felt tired exhausted) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died after getting Janssen vaccine. The patient died from an unknown cause of death. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210507041-covid-19 vaccine ad26.cov2.s-Death. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myocardial infarction, Pain
Clinical narrative: HEART ATTACK; SEVERE PAIN; SEVERE HEADACHE; This spontaneous report received from a parent concerned a 56 year old female. The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included was that the patient had lot of medical problems but the caller was unable to elaborate (unspecified medical problems). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered to left arm on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021, right after the vaccination the patient experienced severe headache. The patient also had a heart attack couple of days after vaccination. It was reported that the patient made it through the heart attack. On follow up with the parent, it was reported  that the patient did not had a heart attack diagnosed by a doctor and was not hospitalized or seen in an emergency room (ER). It was also reported that the patient did not like to go to hospital and just stayed in bed. The patient experienced severe pain, started in her head as a real deep pain. The reporter was not sure about the symptoms of the reported event heart attack.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart attack on an unspecified date in 2021, and the outcome of severe headache and severe pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210507105-COVID-19 VACCINE AD26.COV2.S -Heart attack,severe pain,severe headache.. 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).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Peripheral swelling
Clinical narrative: SWOLLEN ARM; RED ARM; TIRED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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 swollen arm, red arm, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen arm, tired, and red arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: DIZZINESS; FEEL LIKE LEGS WERE GOING TO COLLAPSE; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 23-JUNE-2021) dose was not reported, administered on 04-MAY-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced dizziness. On 05-MAY-2021, the subject experienced feel like legs were going to collapse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel like legs were going to collapse, and dizziness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: BLOOD ABOUT THE SIZE OF A PENNY FROM NOSE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAY-2021, the subject experienced blood about the size of a penny from nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood about the size of a penny from nose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 4 decade 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: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced incorrect product storage. On 05-MAY-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and poor quality vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509988.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Hypokinesia, Influenza like illness, Pain in extremity
Clinical narrative: SHAKES AND CHILLS LIKE THE FLU; UNABLE TO MOVE LEFT SHOULDER AND ARM; LOWER BACK PAIN; STABBING PAIN LIKE IN LEFT SHOULDER AND ARM; This spontaneous report received from a patient concerned an 84 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sciatica, slight asthma in summertime, and seasonal allergy, and other pre-existing medical conditions included patient is taking vitamins (unspecified).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 07-APR-2021 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced unable to move left shoulder and arm. On APR-2021, the subject experienced lower back pain. On APR-2021, the subject experienced stabbing pain like in left shoulder and arm. On 07-APR-2021, the subject experienced shakes and chills like the flu. Treatment medications (dates unspecified) included: menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes and chills like the flu on 08-APR-2021, and unable to move left shoulder and arm, and was recovering from stabbing pain like in left shoulder and arm, and lower back pain. This report was non-serious.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Diarrhoea, Injection site pain, Joint range of motion decreased
Clinical narrative: SHAKES AND CHILLS LIKE THE FLU; UNABLE TO MOVE LEFT SHOULDER AND ARM; LOWER BACK PAIN; STABBING PAIN LIKE IN LEFT SHOULDER AND ARM; This spontaneous report received from a patient concerned an 84 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sciatica, slight asthma in summertime, and seasonal allergy, and other pre-existing medical conditions included patient is taking vitamins (unspecified).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 07-APR-2021 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced unable to move left shoulder and arm. On APR-2021, the subject experienced lower back pain. On APR-2021, the subject experienced stabbing pain like in left shoulder and arm. On 07-APR-2021, the subject experienced shakes and chills like the flu. Treatment medications (dates unspecified) included: menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes and chills like the flu on 08-APR-2021, and unable to move left shoulder and arm, and was recovering from stabbing pain like in left shoulder and arm, and lower back pain. This report was non-serious.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, X-ray
Clinical narrative: SHAKES AND CHILLS LIKE THE FLU; UNABLE TO MOVE LEFT SHOULDER AND ARM; LOWER BACK PAIN; STABBING PAIN LIKE IN LEFT SHOULDER AND ARM; This spontaneous report received from a patient concerned an 84 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sciatica, slight asthma in summertime, and seasonal allergy, and other pre-existing medical conditions included patient is taking vitamins (unspecified).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 07-APR-2021 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced unable to move left shoulder and arm. On APR-2021, the subject experienced lower back pain. On APR-2021, the subject experienced stabbing pain like in left shoulder and arm. On 07-APR-2021, the subject experienced shakes and chills like the flu. Treatment medications (dates unspecified) included: menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes and chills like the flu on 08-APR-2021, and unable to move left shoulder and arm, and was recovering from stabbing pain like in left shoulder and arm, and lower back pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: LEFT AND RIGHT LEG PAIN; FEVER MAXIMUM OF 100 DEGREE F; HEADACHE; SORE BODY; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no health conditions, the patient has no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown exp 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 14:00 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On 04-MAY-2021, the subject experienced sore body. On 04-MAY-2021, the subject experienced fever maximum of 100 degree f. On 04-MAY-2021, the subject experienced headache. On 05-MAY-2021, the subject experienced left and right leg pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever maximum of 100 degree f, sore body, and headache, and had not recovered from left and right leg pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Tendon disorder
Clinical narrative: PAIN IN HAMSTRINGS; PAIN IN BUTT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 pain in hamstrings, and pain in butt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in hamstrings and pain in butt was not reported. This report was non-serious. This case, from the same reporter is linked to 20210510142.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Oropharyngeal discomfort, Sensory disturbance, Spinal pain
Clinical narrative: NOT CLEAR VISION; SENSATION IN RIGHT SIDE OF THROAT; SENSATION ON TOP OF HEAD; DIZZY SPELLS; SORENESS UP SPINE; SORENESS IN JOINTS (HIPS, PELVIC, AND LEGS DOWN TO KNEES); This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included half thyroid removed.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 43AZIA expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced soreness up spine. On APR-2021, the subject experienced soreness in joints (hips, pelvic, and legs down to knees). Treatment medications included: paracetamol. On 10-APR-2021, the subject experienced sensation in right side of throat. On 10-APR-2021, the subject experienced sensation on top of head. On 10-APR-2021, the subject experienced dizzy spells. On MAY-2021, the subject experienced not clear vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensation in right side of throat, sensation on top of head, and dizzy spells on APR-2021, and the outcome of soreness in joints (hips, pelvic, and legs down to knees), soreness up spine and not clear vision was not reported. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: NOT CLEAR VISION; SENSATION IN RIGHT SIDE OF THROAT; SENSATION ON TOP OF HEAD; DIZZY SPELLS; SORENESS UP SPINE; SORENESS IN JOINTS (HIPS, PELVIC, AND LEGS DOWN TO KNEES); This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included half thyroid removed.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 43AZIA expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced soreness up spine. On APR-2021, the subject experienced soreness in joints (hips, pelvic, and legs down to knees). Treatment medications included: paracetamol. On 10-APR-2021, the subject experienced sensation in right side of throat. On 10-APR-2021, the subject experienced sensation on top of head. On 10-APR-2021, the subject experienced dizzy spells. On MAY-2021, the subject experienced not clear vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensation in right side of throat, sensation on top of head, and dizzy spells on APR-2021, and the outcome of soreness in joints (hips, pelvic, and legs down to knees), soreness up spine and not clear vision was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PARTIAL DOSE ADMINISTERED; This spontaneous report received from a health care professional 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 05-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administered was not reported. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Irritability, Pain in extremity, Somnolence
Clinical narrative: VERY SLEEPY; FEELING IRRITABLE; SOAR ARM; FEELING TIRED AND FATIGUE; This spontaneous report received from a patient concerned a 61 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, expiry: unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced very sleepy, feeling irritable, soar arm, and feeling tired and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soar arm on 03-MAY-2021, and had not recovered from feeling irritable, feeling tired and fatigue, and very sleepy. This report was non-serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Light to medium muscle soreness
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Angioedema, Arthralgia, Brain natriuretic peptide, C-reactive protein
Clinical narrative: Severe pain at site, arm, fingers, and shoulders for the first couple of days; and then itchiness of legs.  April 27- manifestation of rash behind both knees and upper calves.  April 30 swelling and edema in both calves.   May 1- Swelling to left foot. Symmetrical pain in pressure points.  May 2- Severe swelling to both feet, and both calves (left side, which was injection side, was worst on lower extremities). Right eye was almost swollen shut. Left eye was beginning to swell. Severe swelling to face, neck, jaw, and throat, as well as tightness of throat. Anaphylactic reaction. Emergency room visit on the May 2,   May 3 was a bad day, filled with pain in joints and pressure points, as well as swelling in feet and calves.  Followed up visit to pcp on May 4. Still have rash, itchiness, and swelling of lower extremities.  Today, May 8, still experiencing swelling, pressure point pain, and manifestation of rash, as well as it's itchiness.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Injection site pain, Laboratory test, Oedema peripheral, Pain
Clinical narrative: Severe pain at site, arm, fingers, and shoulders for the first couple of days; and then itchiness of legs.  April 27- manifestation of rash behind both knees and upper calves.  April 30 swelling and edema in both calves.   May 1- Swelling to left foot. Symmetrical pain in pressure points.  May 2- Severe swelling to both feet, and both calves (left side, which was injection side, was worst on lower extremities). Right eye was almost swollen shut. Left eye was beginning to swell. Severe swelling to face, neck, jaw, and throat, as well as tightness of throat. Anaphylactic reaction. Emergency room visit on the May 2,   May 3 was a bad day, filled with pain in joints and pressure points, as well as swelling in feet and calves.  Followed up visit to pcp on May 4. Still have rash, itchiness, and swelling of lower extremities.  Today, May 8, still experiencing swelling, pressure point pain, and manifestation of rash, as well as it's itchiness.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pharyngeal swelling, Pruritus, Rash
Clinical narrative: Severe pain at site, arm, fingers, and shoulders for the first couple of days; and then itchiness of legs.  April 27- manifestation of rash behind both knees and upper calves.  April 30 swelling and edema in both calves.   May 1- Swelling to left foot. Symmetrical pain in pressure points.  May 2- Severe swelling to both feet, and both calves (left side, which was injection side, was worst on lower extremities). Right eye was almost swollen shut. Left eye was beginning to swell. Severe swelling to face, neck, jaw, and throat, as well as tightness of throat. Anaphylactic reaction. Emergency room visit on the May 2,   May 3 was a bad day, filled with pain in joints and pressure points, as well as swelling in feet and calves.  Followed up visit to pcp on May 4. Still have rash, itchiness, and swelling of lower extremities.  Today, May 8, still experiencing swelling, pressure point pain, and manifestation of rash, as well as it's itchiness.