chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Presyncope, Pyrexia
Clinical narrative: Fever 100.6 - given tylenol  Near fainting - mother called medical facility and spoke and was advised by a Triage nurse
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Eczema flare, nausea, dizziness, itching
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Eczema, Nausea, Pruritus
Clinical narrative: Eczema flare, nausea, dizziness, itching
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Burning sensation, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Burning in upper right thigh, spread to other leg; Pins and needles in hands and feet; General feeing of being unwell; This is a spontaneous report from a contactable consumer (patient). This 62-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the right arm on 08Mar2021 at 11:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and Factor V Leiden: high cholesterol, both from unknown dates and unknown if ongoing. The patient had no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and did not receive any other vaccines in the 4 weeks prior to vaccination. The patient reported that on 08Mar2021 at 13:00, two hours post-injection she experienced burning in upper right thigh that spread to the other leg, and also experienced pins and needles in hands and feet and general feeling of being unwell. The events were reported as non-serious and did not require hospitalization; the events did require a doctor or other healthcare professional office/clinic visit. No treatment was provided for the events. The clinical outcomes of burning in upper right thigh, spread to other leg; pins and needles in hands and feet; and general feeling of being unwell were not recovered. It was also reported that since vaccination the patient had not been tested for COVID.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Ultrasound scan
Clinical narrative: Burning in upper right thigh, spread to other leg; Pins and needles in hands and feet; General feeing of being unwell; This is a spontaneous report from a contactable consumer (patient). This 62-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the right arm on 08Mar2021 at 11:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and Factor V Leiden: high cholesterol, both from unknown dates and unknown if ongoing. The patient had no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and did not receive any other vaccines in the 4 weeks prior to vaccination. The patient reported that on 08Mar2021 at 13:00, two hours post-injection she experienced burning in upper right thigh that spread to the other leg, and also experienced pins and needles in hands and feet and general feeling of being unwell. The events were reported as non-serious and did not require hospitalization; the events did require a doctor or other healthcare professional office/clinic visit. No treatment was provided for the events. The clinical outcomes of burning in upper right thigh, spread to other leg; pins and needles in hands and feet; and general feeling of being unwell were not recovered. It was also reported that since vaccination the patient had not been tested for COVID.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Malaise, Paraesthesia
Clinical narrative: Burning in upper right thigh, spread to other leg; Pins and needles in hands and feet; General feeing of being unwell; This is a spontaneous report from a contactable consumer (patient). This 62-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the right arm on 08Mar2021 at 11:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and Factor V Leiden: high cholesterol, both from unknown dates and unknown if ongoing. The patient had no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and did not receive any other vaccines in the 4 weeks prior to vaccination. The patient reported that on 08Mar2021 at 13:00, two hours post-injection she experienced burning in upper right thigh that spread to the other leg, and also experienced pins and needles in hands and feet and general feeling of being unwell. The events were reported as non-serious and did not require hospitalization; the events did require a doctor or other healthcare professional office/clinic visit. No treatment was provided for the events. The clinical outcomes of burning in upper right thigh, spread to other leg; pins and needles in hands and feet; and general feeling of being unwell were not recovered. It was also reported that since vaccination the patient had not been tested for COVID.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient was seen in the ED/hospitalized within 6 weeks of COVID vaccine
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Confusional state, Dizziness, Flushing
Clinical narrative: SEIZURE; VERY LOW BLOOD PRESSURE; ACHING BONE; FLU SYMPTOMS; DID NOT FEEL COMFORTABLE; NOT FEELING WELL; LEGS WERE SORE; GENERALIZED FATIGUE; This spontaneous report received from a physician concerned a 27 year male. The patient's height, and weight were not reported. The patient's concurrent conditions included generalized allergy to fish (but not to crustaceans or shellfish).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: unknown) dose was not reported, 1 total administered on 05-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. It was reported that the patient had the covid-19 vaccine ad26.cov2.s on 05-APR-2021, 6 minutes after, he was not feeling well and his father found him on the floor having seizure. Emergency unit was called. They found he had a very low blood pressure and did not feel comfortable releasing him so they took him to the hospital. Laboratory data included: Blood pressure (NR: not provided) very low. The patient was provided with intravenous line and did EKG (electrocardiogram). Laboratory data included: EKG (NR: not provided) not reported. He was discharged the same day. He did not had seizure since then. On  05-APR-2021, he experienced the flu symptoms, aching bone, generalized fatigue and legs were sore for 48 hours and then they were cleared. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, and very low blood pressure on 05-APR-2021, and aching bone, flu symptoms, not feeling well, legs were sore, and generalized fatigue on 07-APR-2021, and the outcome of did not feel comfortable was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210435573 -covid-19 vaccine ad26.cov2.s-Seizures. 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: Hyperhidrosis, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: SEIZURE; VERY LOW BLOOD PRESSURE; ACHING BONE; FLU SYMPTOMS; DID NOT FEEL COMFORTABLE; NOT FEELING WELL; LEGS WERE SORE; GENERALIZED FATIGUE; This spontaneous report received from a physician concerned a 27 year male. The patient's height, and weight were not reported. The patient's concurrent conditions included generalized allergy to fish (but not to crustaceans or shellfish).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: unknown) dose was not reported, 1 total administered on 05-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. It was reported that the patient had the covid-19 vaccine ad26.cov2.s on 05-APR-2021, 6 minutes after, he was not feeling well and his father found him on the floor having seizure. Emergency unit was called. They found he had a very low blood pressure and did not feel comfortable releasing him so they took him to the hospital. Laboratory data included: Blood pressure (NR: not provided) very low. The patient was provided with intravenous line and did EKG (electrocardiogram). Laboratory data included: EKG (NR: not provided) not reported. He was discharged the same day. He did not had seizure since then. On  05-APR-2021, he experienced the flu symptoms, aching bone, generalized fatigue and legs were sore for 48 hours and then they were cleared. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, and very low blood pressure on 05-APR-2021, and aching bone, flu symptoms, not feeling well, legs were sore, and generalized fatigue on 07-APR-2021, and the outcome of did not feel comfortable was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210435573 -covid-19 vaccine ad26.cov2.s-Seizures. 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: Blood pressure measurement, Bone pain, Discomfort, Electrocardiogram, Fatigue
Clinical narrative: SEIZURE; VERY LOW BLOOD PRESSURE; ACHING BONE; FLU SYMPTOMS; DID NOT FEEL COMFORTABLE; NOT FEELING WELL; LEGS WERE SORE; GENERALIZED FATIGUE; This spontaneous report received from a physician concerned a 27 year male. The patient's height, and weight were not reported. The patient's concurrent conditions included generalized allergy to fish (but not to crustaceans or shellfish).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: unknown) dose was not reported, 1 total administered on 05-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. It was reported that the patient had the covid-19 vaccine ad26.cov2.s on 05-APR-2021, 6 minutes after, he was not feeling well and his father found him on the floor having seizure. Emergency unit was called. They found he had a very low blood pressure and did not feel comfortable releasing him so they took him to the hospital. Laboratory data included: Blood pressure (NR: not provided) very low. The patient was provided with intravenous line and did EKG (electrocardiogram). Laboratory data included: EKG (NR: not provided) not reported. He was discharged the same day. He did not had seizure since then. On  05-APR-2021, he experienced the flu symptoms, aching bone, generalized fatigue and legs were sore for 48 hours and then they were cleared. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, and very low blood pressure on 05-APR-2021, and aching bone, flu symptoms, not feeling well, legs were sore, and generalized fatigue on 07-APR-2021, and the outcome of did not feel comfortable was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210435573 -covid-19 vaccine ad26.cov2.s-Seizures. 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: Hypotension, Influenza, Malaise, Pain in extremity, Seizure
Clinical narrative: SEIZURE; VERY LOW BLOOD PRESSURE; ACHING BONE; FLU SYMPTOMS; DID NOT FEEL COMFORTABLE; NOT FEELING WELL; LEGS WERE SORE; GENERALIZED FATIGUE; This spontaneous report received from a physician concerned a 27 year male. The patient's height, and weight were not reported. The patient's concurrent conditions included generalized allergy to fish (but not to crustaceans or shellfish).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: unknown) dose was not reported, 1 total administered on 05-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. It was reported that the patient had the covid-19 vaccine ad26.cov2.s on 05-APR-2021, 6 minutes after, he was not feeling well and his father found him on the floor having seizure. Emergency unit was called. They found he had a very low blood pressure and did not feel comfortable releasing him so they took him to the hospital. Laboratory data included: Blood pressure (NR: not provided) very low. The patient was provided with intravenous line and did EKG (electrocardiogram). Laboratory data included: EKG (NR: not provided) not reported. He was discharged the same day. He did not had seizure since then. On  05-APR-2021, he experienced the flu symptoms, aching bone, generalized fatigue and legs were sore for 48 hours and then they were cleared. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, and very low blood pressure on 05-APR-2021, and aching bone, flu symptoms, not feeling well, legs were sore, and generalized fatigue on 07-APR-2021, and the outcome of did not feel comfortable was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210435573 -covid-19 vaccine ad26.cov2.s-Seizures. 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: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Presyncope
Clinical narrative: HTN sent to ER.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypertension
Clinical narrative: HTN sent to ER.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Immediate post-injection reaction, Rash
Clinical narrative: pneumonia; tching and small bumps like hives on arm I got injection in and shoulder; itching and small bumps like hives on arm I got injection in and shoulder/Maybe a dozen in total from elbow to back of shoulder; itching and small bumps like hives on arm I got injection in and shoulder/Maybe a dozen in total from elbow to back of shoulder; Extremely dizzy within minutes after (I had already filled out the Vsafe & noticed dizziness when I was done); they gave me an orange tasted awful; made me stay for a little over hour.; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (lot number: EW0150), via an unspecified route of administration in arm left on 06Apr2021 15:45 at single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS), horseshoe kidney, chronic obstructive airways disease (COAD), hypertension, and low potassium. The patient's concomitant medications were not reported. The patient previously took glatiramer acetate (COPAXONE), and interferon beta-1a (AVONEX) and experienced drug allergy. On 06Apr2021 16:15, the patient experienced extremely dizzy within minutes after (patient had already filled out the Vsafe and noticed dizziness when was done) and was given an orange tasted awful, which made her stay for a little over hour. Patient did not feel good so went home. A few hours later, patient noticed itching and small bumps like hives on arm she got injection in and shoulder. Maybe a dozen in total from elbow to back of shoulder; still a bit dizzy 6 days later bumps starting to go away. Patient thought she had COVID a year before but was tested 23 days after she got sick and had pneumonia. Outcome of the events was not resolved.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Pneumonia, Pruritus, Urticaria, Vaccination site pruritus
Clinical narrative: pneumonia; tching and small bumps like hives on arm I got injection in and shoulder; itching and small bumps like hives on arm I got injection in and shoulder/Maybe a dozen in total from elbow to back of shoulder; itching and small bumps like hives on arm I got injection in and shoulder/Maybe a dozen in total from elbow to back of shoulder; Extremely dizzy within minutes after (I had already filled out the Vsafe & noticed dizziness when I was done); they gave me an orange tasted awful; made me stay for a little over hour.; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (lot number: EW0150), via an unspecified route of administration in arm left on 06Apr2021 15:45 at single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS), horseshoe kidney, chronic obstructive airways disease (COAD), hypertension, and low potassium. The patient's concomitant medications were not reported. The patient previously took glatiramer acetate (COPAXONE), and interferon beta-1a (AVONEX) and experienced drug allergy. On 06Apr2021 16:15, the patient experienced extremely dizzy within minutes after (patient had already filled out the Vsafe and noticed dizziness when was done) and was given an orange tasted awful, which made her stay for a little over hour. Patient did not feel good so went home. A few hours later, patient noticed itching and small bumps like hives on arm she got injection in and shoulder. Maybe a dozen in total from elbow to back of shoulder; still a bit dizzy 6 days later bumps starting to go away. Patient thought she had COVID a year before but was tested 23 days after she got sick and had pneumonia. Outcome of the events was not resolved.
Age: 35.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Tinnitus
Clinical narrative: Tennitus in left ear/ears feel like they have fluid in them. Tennitis got worse and now have in both ears; Muscle aches in neck/ shoulders; headaches; Warm feeling in ears.; Tired; brain fog; ear pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (Pfizer, lot number: EN6207) first dose on 04Apr2021 11:00 AM on left arm at single dose for COVID-19 immunisation. Medical history included Childhood asthma. Allergies to cats and dust. Concomitant medications were none. No other vaccine in four weeks. No Other medications in two weeks. The patient previously took Ibuprofen and experienced allergy. Day after getting vaccine (05Apr2021 04:00 PM) started to get tinnitus in left ear. Muscle aches in neck/ shoulders headaches mild vertigo. Warm feeling in ears. Tinnitis got worse and now have in both ears. Also ears feel like they have fluid in them. Some minor ear pain. Tired feeling and brain fog. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The outcome of the events was not recovered. No treatment for events. No Covid prior vaccination. No Covid tested post vaccination.
Age: 35.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Ear pain, Fatigue, Feeling abnormal, Feeling hot, Headache
Clinical narrative: Tennitus in left ear/ears feel like they have fluid in them. Tennitis got worse and now have in both ears; Muscle aches in neck/ shoulders; headaches; Warm feeling in ears.; Tired; brain fog; ear pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (Pfizer, lot number: EN6207) first dose on 04Apr2021 11:00 AM on left arm at single dose for COVID-19 immunisation. Medical history included Childhood asthma. Allergies to cats and dust. Concomitant medications were none. No other vaccine in four weeks. No Other medications in two weeks. The patient previously took Ibuprofen and experienced allergy. Day after getting vaccine (05Apr2021 04:00 PM) started to get tinnitus in left ear. Muscle aches in neck/ shoulders headaches mild vertigo. Warm feeling in ears. Tinnitis got worse and now have in both ears. Also ears feel like they have fluid in them. Some minor ear pain. Tired feeling and brain fog. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The outcome of the events was not recovered. No treatment for events. No Covid prior vaccination. No Covid tested post vaccination.
Age: 35.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Myalgia, Tinnitus
Clinical narrative: Tennitus in left ear/ears feel like they have fluid in them. Tennitis got worse and now have in both ears; Muscle aches in neck/ shoulders; headaches; Warm feeling in ears.; Tired; brain fog; ear pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (Pfizer, lot number: EN6207) first dose on 04Apr2021 11:00 AM on left arm at single dose for COVID-19 immunisation. Medical history included Childhood asthma. Allergies to cats and dust. Concomitant medications were none. No other vaccine in four weeks. No Other medications in two weeks. The patient previously took Ibuprofen and experienced allergy. Day after getting vaccine (05Apr2021 04:00 PM) started to get tinnitus in left ear. Muscle aches in neck/ shoulders headaches mild vertigo. Warm feeling in ears. Tinnitis got worse and now have in both ears. Also ears feel like they have fluid in them. Some minor ear pain. Tired feeling and brain fog. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The outcome of the events was not recovered. No treatment for events. No Covid prior vaccination. No Covid tested post vaccination.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hypersensitivity, Nausea
Clinical narrative: SHORTNESS OF BREATH; CHEST HEAVINESS; DIAPHORETIC; PALPITATIONS; SWELLING IN FACE; SWELLING IN NECK; DIZZINESS; FLUSHED; CHEST PAIN; PAIN; SEVERE HEADACHE; This spontaneous report received from a parent concerned a 19-year-old female. The patient's height, and weight were not reported. The patient's past medical history included migraines, and tachycardia, and concurrent conditions included fibromyalgia, dystonia, neuropathy, chronic pain syndrome, postural tachycardia syndrome, and autoimmune disorder.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported On 07-APR-2021, 10-15 minutes after vaccination the patient became diaphoretic, with palpitations, experienced swelling in face and neck, shortness of breath, dizziness, and chest heaviness. Pharmacist administered her Epinephrine, and the patient was hospitalized. Patient received Solumedrol and Benadryl at hospital, and was sent home on Benadryl for 24 hours. Patient has continued to have a severe headaches and felt dizzy, flushed, diaphoretic, and short of breath. Patient visited her PCP (primary care physician). She got clearance to return at work. Patient also visited ED (emergency department) to check for possible blood clots and where cardiac workup was also performed. Patient continued to complain of shortness of breath and chest pain particularly on exertion and ambulation, and dizzy during these activities. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, epinephrine, and methylprednisolone sodium succinate non-company. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and chest pain, and the outcome of diaphoretic, palpitations, swelling in face, swelling in neck, dizziness, chest heaviness, severe headache, flushed and pain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210429351- covid-19 vaccine ad26.cov2.s-shortness of breath, chest heaviness. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Vertigo
Clinical narrative: SHORTNESS OF BREATH; CHEST HEAVINESS; DIAPHORETIC; PALPITATIONS; SWELLING IN FACE; SWELLING IN NECK; DIZZINESS; FLUSHED; CHEST PAIN; PAIN; SEVERE HEADACHE; This spontaneous report received from a parent concerned a 19-year-old female. The patient's height, and weight were not reported. The patient's past medical history included migraines, and tachycardia, and concurrent conditions included fibromyalgia, dystonia, neuropathy, chronic pain syndrome, postural tachycardia syndrome, and autoimmune disorder.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported On 07-APR-2021, 10-15 minutes after vaccination the patient became diaphoretic, with palpitations, experienced swelling in face and neck, shortness of breath, dizziness, and chest heaviness. Pharmacist administered her Epinephrine, and the patient was hospitalized. Patient received Solumedrol and Benadryl at hospital, and was sent home on Benadryl for 24 hours. Patient has continued to have a severe headaches and felt dizzy, flushed, diaphoretic, and short of breath. Patient visited her PCP (primary care physician). She got clearance to return at work. Patient also visited ED (emergency department) to check for possible blood clots and where cardiac workup was also performed. Patient continued to complain of shortness of breath and chest pain particularly on exertion and ambulation, and dizzy during these activities. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, epinephrine, and methylprednisolone sodium succinate non-company. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and chest pain, and the outcome of diaphoretic, palpitations, swelling in face, swelling in neck, dizziness, chest heaviness, severe headache, flushed and pain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210429351- covid-19 vaccine ad26.cov2.s-shortness of breath, chest heaviness. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Dyspnoea, Flushing
Clinical narrative: SHORTNESS OF BREATH; CHEST HEAVINESS; DIAPHORETIC; PALPITATIONS; SWELLING IN FACE; SWELLING IN NECK; DIZZINESS; FLUSHED; CHEST PAIN; PAIN; SEVERE HEADACHE; This spontaneous report received from a parent concerned a 19-year-old female. The patient's height, and weight were not reported. The patient's past medical history included migraines, and tachycardia, and concurrent conditions included fibromyalgia, dystonia, neuropathy, chronic pain syndrome, postural tachycardia syndrome, and autoimmune disorder.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported On 07-APR-2021, 10-15 minutes after vaccination the patient became diaphoretic, with palpitations, experienced swelling in face and neck, shortness of breath, dizziness, and chest heaviness. Pharmacist administered her Epinephrine, and the patient was hospitalized. Patient received Solumedrol and Benadryl at hospital, and was sent home on Benadryl for 24 hours. Patient has continued to have a severe headaches and felt dizzy, flushed, diaphoretic, and short of breath. Patient visited her PCP (primary care physician). She got clearance to return at work. Patient also visited ED (emergency department) to check for possible blood clots and where cardiac workup was also performed. Patient continued to complain of shortness of breath and chest pain particularly on exertion and ambulation, and dizzy during these activities. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, epinephrine, and methylprednisolone sodium succinate non-company. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and chest pain, and the outcome of diaphoretic, palpitations, swelling in face, swelling in neck, dizziness, chest heaviness, severe headache, flushed and pain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210429351- covid-19 vaccine ad26.cov2.s-shortness of breath, chest heaviness. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperhidrosis, Pain, Palpitations, Swelling
Clinical narrative: SHORTNESS OF BREATH; CHEST HEAVINESS; DIAPHORETIC; PALPITATIONS; SWELLING IN FACE; SWELLING IN NECK; DIZZINESS; FLUSHED; CHEST PAIN; PAIN; SEVERE HEADACHE; This spontaneous report received from a parent concerned a 19-year-old female. The patient's height, and weight were not reported. The patient's past medical history included migraines, and tachycardia, and concurrent conditions included fibromyalgia, dystonia, neuropathy, chronic pain syndrome, postural tachycardia syndrome, and autoimmune disorder.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported On 07-APR-2021, 10-15 minutes after vaccination the patient became diaphoretic, with palpitations, experienced swelling in face and neck, shortness of breath, dizziness, and chest heaviness. Pharmacist administered her Epinephrine, and the patient was hospitalized. Patient received Solumedrol and Benadryl at hospital, and was sent home on Benadryl for 24 hours. Patient has continued to have a severe headaches and felt dizzy, flushed, diaphoretic, and short of breath. Patient visited her PCP (primary care physician). She got clearance to return at work. Patient also visited ED (emergency department) to check for possible blood clots and where cardiac workup was also performed. Patient continued to complain of shortness of breath and chest pain particularly on exertion and ambulation, and dizzy during these activities. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, epinephrine, and methylprednisolone sodium succinate non-company. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and chest pain, and the outcome of diaphoretic, palpitations, swelling in face, swelling in neck, dizziness, chest heaviness, severe headache, flushed and pain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210429351- covid-19 vaccine ad26.cov2.s-shortness of breath, chest heaviness. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: SHORTNESS OF BREATH; CHEST HEAVINESS; DIAPHORETIC; PALPITATIONS; SWELLING IN FACE; SWELLING IN NECK; DIZZINESS; FLUSHED; CHEST PAIN; PAIN; SEVERE HEADACHE; This spontaneous report received from a parent concerned a 19-year-old female. The patient's height, and weight were not reported. The patient's past medical history included migraines, and tachycardia, and concurrent conditions included fibromyalgia, dystonia, neuropathy, chronic pain syndrome, postural tachycardia syndrome, and autoimmune disorder.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported On 07-APR-2021, 10-15 minutes after vaccination the patient became diaphoretic, with palpitations, experienced swelling in face and neck, shortness of breath, dizziness, and chest heaviness. Pharmacist administered her Epinephrine, and the patient was hospitalized. Patient received Solumedrol and Benadryl at hospital, and was sent home on Benadryl for 24 hours. Patient has continued to have a severe headaches and felt dizzy, flushed, diaphoretic, and short of breath. Patient visited her PCP (primary care physician). She got clearance to return at work. Patient also visited ED (emergency department) to check for possible blood clots and where cardiac workup was also performed. Patient continued to complain of shortness of breath and chest pain particularly on exertion and ambulation, and dizzy during these activities. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, epinephrine, and methylprednisolone sodium succinate non-company. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and chest pain, and the outcome of diaphoretic, palpitations, swelling in face, swelling in neck, dizziness, chest heaviness, severe headache, flushed and pain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210429351- covid-19 vaccine ad26.cov2.s-shortness of breath, chest heaviness. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient via the VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1186290) concerned a 47 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies, other illnesses at the time vaccination and up to one month prior and chronic or long standing health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total administered on 25-MAR-2021 16:00 at left arm via syringe as prophylactic vaccination. Concomitant medications included atorvastatin, calcitriol, hydrochlorothiazide/triamterene, and losartan.  On 30-MAR-2021 12:45, the patient experienced stroke, and was hospitalized (date unspecified). The patient was hospitalized for 4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Hospitalization Caused / Prolonged, and Disability Or Permanent Damage).; Sender's Comments: V0: 20210440866-covid-19 vaccine ad26.cov2.s-stroke. 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: 94.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Deep vein thrombosis, Pain in extremity
Clinical narrative: DEEP VEIN THROMBOSIS, CONDITION AGGRAVATED; This spontaneous report received from a patient concerned a 94-year old female. Initial information received on 20-APR-2021 was processed together with additional information obtained on 23-APR-2021, VAERS number 1186558. The patient's height, and weight were not reported. The patient's past medical history included: deep vein thrombosis. Concurrent conditions were not reported. No known allergies to medications, food, or other products.  On 08-APR-2021, at 08:30 hours, the patient was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number: 043A21A) dose  not reported, left arm, for prophylactic vaccination. Concomitant medications included apixaban.  On 08-APR-2021, at 20:00 hours, the patient experienced deep vein thrombosis, condition aggravated and was hospitalized (date unspecified). The patient was transported to the hospital with complain of pain in her legs. She was diagnosed with a deep vein thrombosis (DVT). It was reported that the patient had not had an adverse event following any previous vaccine. Medical tests and laboratory results were unknown. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The outcome of deep vein thrombosis was not reported (unknown). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This report was obtained via VAERS (VAERS ID 1186558) and concerns a 94 year-old female patient with history of deep vein thrombosis who was hospitalized for deep vein thrombosis in her leg on the same day that she received the Janssen Covid-19 vaccine. Concomitant medications included apixaban. She was transported to the hospital after complaining of leg pain. No other information was provided (e.g. diagnostic tests, and outcome). Considering the patient's age, prior history, and inconsistent time to onset, the relationship to vaccination is considered inconsistent. Additional information will be requested when contact information becomes available.
Age: 94.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DEEP VEIN THROMBOSIS, CONDITION AGGRAVATED; This spontaneous report received from a patient concerned a 94-year old female. Initial information received on 20-APR-2021 was processed together with additional information obtained on 23-APR-2021, VAERS number 1186558. The patient's height, and weight were not reported. The patient's past medical history included: deep vein thrombosis. Concurrent conditions were not reported. No known allergies to medications, food, or other products.  On 08-APR-2021, at 08:30 hours, the patient was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number: 043A21A) dose  not reported, left arm, for prophylactic vaccination. Concomitant medications included apixaban.  On 08-APR-2021, at 20:00 hours, the patient experienced deep vein thrombosis, condition aggravated and was hospitalized (date unspecified). The patient was transported to the hospital with complain of pain in her legs. She was diagnosed with a deep vein thrombosis (DVT). It was reported that the patient had not had an adverse event following any previous vaccine. Medical tests and laboratory results were unknown. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The outcome of deep vein thrombosis was not reported (unknown). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This report was obtained via VAERS (VAERS ID 1186558) and concerns a 94 year-old female patient with history of deep vein thrombosis who was hospitalized for deep vein thrombosis in her leg on the same day that she received the Janssen Covid-19 vaccine. Concomitant medications included apixaban. She was transported to the hospital after complaining of leg pain. No other information was provided (e.g. diagnostic tests, and outcome). Considering the patient's age, prior history, and inconsistent time to onset, the relationship to vaccination is considered inconsistent. Additional information will be requested when contact information becomes available.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Joint stiffness, Pain, Rash, Skin atrophy
Clinical narrative: Vaccine was administered on 3/26/21. On 3/28/21, started experiencing symptoms which included hives, joint pain, and difficulty walking.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin exfoliation
Clinical narrative: Vaccine was administered on 3/26/21. On 3/28/21, started experiencing symptoms which included hives, joint pain, and difficulty walking.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance, Joint fluid drainage, Joint swelling, Urticaria
Clinical narrative: Vaccine was administered on 3/26/21. On 3/28/21, started experiencing symptoms which included hives, joint pain, and difficulty walking.
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Tremor
Clinical narrative: DEATH OF AN UNKNOW CAUSE; SHAKING; This spontaneous report was received from a pharmacist and concerned an 89 year old white and not Hispanic or Latino male. The reporter reported to VAERS. 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: 205A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 at 12:00 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient was observed for 15 minutes after the vaccination, and then left vaccination site with his son without any problem. On the same day, at 17:50, the daughter reported that the patient all of a sudden began shaking and died right after. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient outcome was fatal, and the outcome of shaking was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0 This report concerns an 89-year-old white male patient who died on the same day of receiving Jansen COVID-19 vaccine.  After vaccination the patient was observed for 15 minutes and left the vaccination site without any problem.  About six hours later, the patient started shaking, and died right after. This case has insufficient information to make a meaningful medical assessment. Additional information has been requested.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Erythema, Exophthalmos, Loss of consciousness, Malaise
Clinical narrative: FEELING HOT; SWEATY; NAUSEA; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and severe anaphylactic to penicillin. The patient experienced rash when treated with cefalexin, and headache and vomiting when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and  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 feeling hot. On 09-APR-2021, the subject experienced sweaty. On 09-APR-2021, the subject experienced nausea. Laboratory data included: EKG (NR: not provided) Unknown. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling hot, sweaty, and nausea on 11-APR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Staring, Unresponsive to stimuli
Clinical narrative: FEELING HOT; SWEATY; NAUSEA; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and severe anaphylactic to penicillin. The patient experienced rash when treated with cefalexin, and headache and vomiting when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and  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 feeling hot. On 09-APR-2021, the subject experienced sweaty. On 09-APR-2021, the subject experienced nausea. Laboratory data included: EKG (NR: not provided) Unknown. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling hot, sweaty, and nausea on 11-APR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: FEELING HOT; SWEATY; NAUSEA; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and severe anaphylactic to penicillin. The patient experienced rash when treated with cefalexin, and headache and vomiting when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and  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 feeling hot. On 09-APR-2021, the subject experienced sweaty. On 09-APR-2021, the subject experienced nausea. Laboratory data included: EKG (NR: not provided) Unknown. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling hot, sweaty, and nausea on 11-APR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.