chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Muscle spasms, Vomiting
Clinical narrative: Severe cramping followed by Vomiting and Diarrhea over about 5 hours, then very tired for the remainder of the day.  No appetite until almost midnight of the day of the event, 23 hours from the beginning of the symptoms.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Extreme fatigue, body aches,  Fever started 24 hrs after injection body aches worsen  2 days after : body aches and fatigue lessen, fever has lowered
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Muscle soreness at injection site lasting 36 hours
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Within 3 minutes of receiving the vaccination my Tongue began to tingle and then I began to lose felling in  it. This is normal to me consuming almonds. I took a Benadryl and it helped.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood creatinine increased, C-reactive protein, COVID-19, Cough
Clinical narrative: Patient is a 74 year old male with a history of afib who was admitted on 2/18/2021 with malaise, weakness, and poor appetite. Patient also reported a cough with mild shortness of breath. CRP was near normal but SCr was elevated above baseline likely due to dehydration. SCr trended down with IV fluids. Patient tested positive for COVID-19 on 2/15/2021. Steroids and remdesivir not indicated during admission. Patient discharged to home on 2/19/2021
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Dyspnoea, Malaise, SARS-CoV-2 test positive
Clinical narrative: Patient is a 74 year old male with a history of afib who was admitted on 2/18/2021 with malaise, weakness, and poor appetite. Patient also reported a cough with mild shortness of breath. CRP was near normal but SCr was elevated above baseline likely due to dehydration. SCr trended down with IV fluids. Patient tested positive for COVID-19 on 2/15/2021. Steroids and remdesivir not indicated during admission. Patient discharged to home on 2/19/2021
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Muscle and joint soreness, fatigue
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Headache, Fever ranging from 99-101 and achy.  Lasted about 24 hours
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Hyperaesthesia, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Lips and area around lips went numb about a half hour after the 2nd vaccine was administered.  Numbness migrated to my left cheek a couple of hours later and was gone by about noon.  Elevated temperature around 5pm (99.8) the day of vaccination.  Started taking Tylenol.  Temperature the following day (100.9) and whole body skin sensitivity.  Slight temperature returned the next day (99.8), and no additional symptoms so far after a week.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Pharyngeal swelling
Clinical narrative: Anaphylaxis - throat swelling
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, Bacterial infection, COVID-19 pneumonia, Chest X-ray abnormal
Clinical narrative: Patient is an 84 year old male with a PMH of psoriasis, DM2 on insulin, HTN, HLD, who was admitted on 2/9/2021 with COVID-19 pna, weakness, and AKI. Pneumonia due to COVID-19 likely had concurrent bacterial infection present. Patient received 5 days of IV dexamethasone and ceftriaxone during admission. He was not a candidate for remdesivir. On day of discharge, chest x-ray showed persisting infiltrates and pt was discahrged with additional 5 days of oral dexamethasone. Patient discharged to home on 2/16/2021
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Lung infiltration
Clinical narrative: Patient is an 84 year old male with a PMH of psoriasis, DM2 on insulin, HTN, HLD, who was admitted on 2/9/2021 with COVID-19 pna, weakness, and AKI. Pneumonia due to COVID-19 likely had concurrent bacterial infection present. Patient received 5 days of IV dexamethasone and ceftriaxone during admission. He was not a candidate for remdesivir. On day of discharge, chest x-ray showed persisting infiltrates and pt was discahrged with additional 5 days of oral dexamethasone. Patient discharged to home on 2/16/2021
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Aphasia, Bronchial hyperreactivity, Chest X-ray, Dyspnoea
Clinical narrative: *** Symptoms - Headache - 30 mins after shot - lips tingling some - fatigued and body aches ***** Shortness of breath that gradually became severe over a 24 hour period. Referred to Emergency Department by physician for evaluation. Pulmonary embolism ruled out - diagnosed with  reactive airway disease with acute reaction exacerbation due to virus  and dyspnea at Emergency Department.  Been severely SOB unable to talk without gasping until 4/14/21 - Eliquis was increased to 5mg twice  - along with the Prednisone and Ventolin inhaler - Now able to talk small conversations, but walking short distances still causes respiratory problems and strain on body.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Full blood count, Gait disturbance, Headache
Clinical narrative: *** Symptoms - Headache - 30 mins after shot - lips tingling some - fatigued and body aches ***** Shortness of breath that gradually became severe over a 24 hour period. Referred to Emergency Department by physician for evaluation. Pulmonary embolism ruled out - diagnosed with  reactive airway disease with acute reaction exacerbation due to virus  and dyspnea at Emergency Department.  Been severely SOB unable to talk without gasping until 4/14/21 - Eliquis was increased to 5mg twice  - along with the Prednisone and Ventolin inhaler - Now able to talk small conversations, but walking short distances still causes respiratory problems and strain on body.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Muscle strain, N-terminal prohormone brain natriuretic peptide, Pain, Paraesthesia oral
Clinical narrative: *** Symptoms - Headache - 30 mins after shot - lips tingling some - fatigued and body aches ***** Shortness of breath that gradually became severe over a 24 hour period. Referred to Emergency Department by physician for evaluation. Pulmonary embolism ruled out - diagnosed with  reactive airway disease with acute reaction exacerbation due to virus  and dyspnea at Emergency Department.  Been severely SOB unable to talk without gasping until 4/14/21 - Eliquis was increased to 5mg twice  - along with the Prednisone and Ventolin inhaler - Now able to talk small conversations, but walking short distances still causes respiratory problems and strain on body.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Troponin
Clinical narrative: *** Symptoms - Headache - 30 mins after shot - lips tingling some - fatigued and body aches ***** Shortness of breath that gradually became severe over a 24 hour period. Referred to Emergency Department by physician for evaluation. Pulmonary embolism ruled out - diagnosed with  reactive airway disease with acute reaction exacerbation due to virus  and dyspnea at Emergency Department.  Been severely SOB unable to talk without gasping until 4/14/21 - Eliquis was increased to 5mg twice  - along with the Prednisone and Ventolin inhaler - Now able to talk small conversations, but walking short distances still causes respiratory problems and strain on body.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Nausea
Clinical narrative: Nausea, lightheadedness, hypotension.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, C-reactive protein increased, COVID-19, Diarrhoea, SARS-CoV-2 test positive
Clinical narrative: Patient is a 70 year old female with a PMH of TBI with residual memory loss, visual deficits and unsteadiness who was admitted on 2/18/2021 with diarrhea and weakness. Patient tested positive for COVID-19 on 2/18/2021. She was not hypoxic and CRP was mildly elevated. Steroids and remdesivir were not indicated during the admission. Diarrhea improved overnight with IV fluids. Patient was discharged to home on 2/19/2021
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain
Clinical narrative: GENERAL ACHES AND PAINS; SEVERE BACK SPASMS; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included back spasms.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 10-APR-2021, the subject experienced general aches and pains. On 10-APR-2021, the subject experienced severe back spasms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general aches and pains on 11-APR-2021, and had not recovered from severe back spasms. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Lip swelling
Clinical narrative: pt experienced a metalic taste in mouth at the site,  and the 24 hours later experienced lip swelling.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Chest X-ray, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Patient is a 74 year old female with PMH of morbid obesity and seizure disorder who presented to the ER on 2/13/2021 with weakness and fever.  Patient tested positive for COVID-19 on 2/13 and was treated with a five day course of oral dexamethasone and remdesivir. Antibiotics were started on admission, but serial chest x-rays were mostly stable and all culture results remained negative. Antibiotics were discontinued on 2/15. Patient discharged to home on 2/18/2021
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Malaise, Pain
Clinical narrative: EXCESS SWEATING; PAIN AND SORENESS UNDER ARMS; FEELING REALLY BAD AND LIKE A TRUCK RUN OVER HER; FEELING CRAPPY / FEELING ABNORMAL; 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced feeling crappy / feeling abnormal. On an unspecified date, the subject experienced excess sweating, pain and soreness under arms, and feeling really bad and like a truck run over her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling crappy / feeling abnormal, and the outcome of feeling really bad and like a truck run over her, excess sweating and pain and soreness under arms was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Migraine
Clinical narrative: SEVERE MIGRAINE; SWELLING ON SITE OF INJECTION; SORENESS ON SITE OF INJECTION; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced severe migraine. On 08-APR-2021, the subject experienced swelling on site of injection. On 08-APR-2021, the subject experienced soreness on site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe migraine, and had not recovered from swelling on site of injection, and soreness on site of injection. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Tendon pain
Clinical narrative: ACHILLES HEEL IS FEELING SORE; LIMPING; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol user, non smoker, hay fever allergy, and allergic to Dilantin, and other pre-existing medical conditions included does not abuse drug or illicit drug use. The patient was previously treated with phenytoin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and  expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced Achilles heel is feeling sore. On 12-APR-2021, the subject experienced limping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from Achilles heel is feeling sore, and limping. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Feeling cold, Headache, Influenza like illness, Injection site pain
Clinical narrative: FEVER; COLD  SWEAT FLASHES; SORE; BOTH LEGS HURT; BOTH LEG HURT WITH MUSCLE ACHE; BODY ACHE; HEADACHE; CHARLIE HORSES; INJECTION SITE PAIN; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, high cholesterol, COPD, cigarette smoker (1 pack per week), non alcoholic, and iodine in raw shell fish. 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced Charlie horses. On 08-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced flu-like symptoms. On 09-APR-2021, the subject experienced body ache. On an unspecified date, the subject experienced fever, cold sweat flashes, sore, both legs hurt, and both leg hurt with muscle ache. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fever on 13-APR-2021, and flu-like symptoms, and cold sweat flashes, was recovering from sore, and had not recovered from both leg hurt with muscle ache, body ache, Charlie horses, both legs hurt, and injection site pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: FEVER; COLD  SWEAT FLASHES; SORE; BOTH LEGS HURT; BOTH LEG HURT WITH MUSCLE ACHE; BODY ACHE; HEADACHE; CHARLIE HORSES; INJECTION SITE PAIN; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, high cholesterol, COPD, cigarette smoker (1 pack per week), non alcoholic, and iodine in raw shell fish. 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced Charlie horses. On 08-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced flu-like symptoms. On 09-APR-2021, the subject experienced body ache. On an unspecified date, the subject experienced fever, cold sweat flashes, sore, both legs hurt, and both leg hurt with muscle ache. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fever on 13-APR-2021, and flu-like symptoms, and cold sweat flashes, was recovering from sore, and had not recovered from both leg hurt with muscle ache, body ache, Charlie horses, both legs hurt, and injection site pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Headache, Nausea
Clinical narrative: CHEST PAIN; CHILLS; MILD AND SEVERE HEADACHE; MILD SORE THROAT; BODY ACHE; PAIN BEHIND THE KNEES; NAUSEA; This spontaneous report received from a patient concerned a 40 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: 041A21A, and  expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced pain behind the knees. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021 17:30, the subject experienced mild sore throat. On 07-APR-2021 17:30, the subject experienced mild and severe headache. On 08-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild sore throat, body ache, chest pain, pain behind the knees, mild and severe headache, and chills, and nausea on 09-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: CHEST PAIN; CHILLS; MILD AND SEVERE HEADACHE; MILD SORE THROAT; BODY ACHE; PAIN BEHIND THE KNEES; NAUSEA; This spontaneous report received from a patient concerned a 40 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: 041A21A, and  expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced pain behind the knees. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021 17:30, the subject experienced mild sore throat. On 07-APR-2021 17:30, the subject experienced mild and severe headache. On 08-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild sore throat, body ache, chest pain, pain behind the knees, mild and severe headache, and chills, and nausea on 09-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Hot flush
Clinical narrative: 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: 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 APR-2021, the subject experienced chills. On APR-2021, the subject experienced hot flashes. On APR-2021, the subject experienced back hurts. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, hot flashes, and back hurts. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Rash
Clinical narrative: RASH; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2620278, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced rash. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash, and headache on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Nausea, Pyrexia
Clinical narrative: CHILLS; WEAKNESS; NAUSEA; FELT LIKE HAD A FEVER/FEVER; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 16:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced felt like had a fever/fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, chills, nausea, and felt like had a fever/fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: SWOLLEN SITE AT INJECTION/SWOLLEN AREA AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 24 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced swollen site at injection/swollen area at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen site at injection/swollen area at the injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on MAR-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 MAR-2021, the subject experienced mild after effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild after effects on MAR-2021. This report was non-serious.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF-LABEL USE; This spontaneous report received from a patient concerned a 17 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, 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 drug administered to subject of inappropriate age, and off-label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administered to patient of inappropriate age and off-label use was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Chills, Faeces soft, Fatigue, Feeling abnormal
Clinical narrative: MALAISE; TIREDNESS; NAUSEA; BOWEL MOVEMENT IRREGULARITY IN TEXTURE; CHILLS; INTENSE HEADACHE; FELT REALLY BAD; 3 OR 4 BOWEL MOVEMENTS EACH OF DAY; SOFTER TEXTURE THAN NORMAL STOOL; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced 3 or 4 bowel movements each of day. On APR-2021, the subject experienced softer texture than normal stool. On 08-APR-2021, the subject experienced felt really bad. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced intense headache. On 09-APR-2021, the subject experienced bowel movement irregularity in texture. On 11-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced malaise. On 12-APR-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and intense headache on 09-APR-2021, and had not recovered from bowel movement irregularity in texture, nausea, malaise, tiredness, felt really bad, 3 or 4 bowel movements each of day, and softer texture than normal stool. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Frequent bowel movements, Headache, Malaise, Nausea
Clinical narrative: MALAISE; TIREDNESS; NAUSEA; BOWEL MOVEMENT IRREGULARITY IN TEXTURE; CHILLS; INTENSE HEADACHE; FELT REALLY BAD; 3 OR 4 BOWEL MOVEMENTS EACH OF DAY; SOFTER TEXTURE THAN NORMAL STOOL; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced 3 or 4 bowel movements each of day. On APR-2021, the subject experienced softer texture than normal stool. On 08-APR-2021, the subject experienced felt really bad. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced intense headache. On 09-APR-2021, the subject experienced bowel movement irregularity in texture. On 11-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced malaise. On 12-APR-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and intense headache on 09-APR-2021, and had not recovered from bowel movement irregularity in texture, nausea, malaise, tiredness, felt really bad, 3 or 4 bowel movements each of day, and softer texture than normal stool. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: FEVER; BODY ACHES; HEADACHE; 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 hypothyroidism, asthma, seasonal allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever on 09-APR-2021, and had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS AND RINGING IN EARS; 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced tinnitus and ringing in ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus and ringing in ears. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: LOST ALMOST COMPLETE FEELING IN ARM, PARTS OF FACE, EAR LOBES, CHEEKS, TIP OF NOSE,; LOST ALMOST COMPLETE FEELING IN OUT SIDE OF LIPS; This spontaneous report received from a patient concerned a 46 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: 201A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced lost almost complete feeling in arm, parts of face, ear lobes, cheeks, tip of nose. On 06-APR-2021, the subject experienced lost almost complete feeling in out side of lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost almost complete feeling in arm, parts of face, ear lobes, cheeks, tip of nose, and lost almost complete feeling in out side of lips on 06-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: DIZZINESS AND LIGHTHEADEDNESS; TIREDNESS THAN USUAL; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced dizziness and lightheadedness. On APR-2021, the subject experienced tiredness than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness and lightheadedness, and tiredness than usual. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Thirst
Clinical narrative: FELT VERY THIRSTY; CHILLS; FELT LIKE GOT A HIGH FEVER; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight was 255 pounds, and height was 69 inches. The patient's concurrent conditions included seasonal bronchitis, heat intolerance, and seasonal asthma. 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 16-MAR-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amoxicillin for chronic bronchitis.  On MAR-2021, treatment medications included: naproxen. On 16-MAR-2021 22:00, the subject experienced felt very thirsty. On 16-MAR-2021 22:00, the subject experienced chills. On 16-MAR-2021 22:00, the subject experienced felt like got a high fever. On 16-MAR-2021 22:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt very thirsty, chills, felt like got a high fever, and headache on 18-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Swelling face, Urticaria
Clinical narrative: SWOLLEN EYES; SWOLLEN MOUTH; SWOLLEN FACE; HIVES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced swollen eyes, swollen mouth, swollen face, and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen eyes, swollen mouth, swollen face, and hives. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Hypoaesthesia, Muscle spasms, Paraesthesia
Clinical narrative: NUMBNESS ON THE RIGHT SIDE OF THE FACE; LOSS OF TASTE ON THE RIGHT SIDE OF THE TONGUE; TINGLING ON THE RIGHT SIDE OF THE FACE; CRAMPING ON THE RIGHT SIDE OF THE FACE CLOSE TO THE NOSE UNDER THE EYE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 10-APR-2021, the subject experienced numbness on the right side of the face. On 10-APR-2021, the subject experienced loss of taste on the right side of the tongue. On 10-APR-2021, the subject experienced tingling on the right side of the face. On 10-APR-2021, the subject experienced cramping on the right side of the face close to the nose under the eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on the right side of the face, loss of taste on the right side of the tongue, tingling on the right side of the face, and cramping on the right side of the face close to the nose under the eye. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: LITTLE DEHYDRATED; ARM HURTS; HEADACHE; FEVERISH; REALLY TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 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 10-APR-2021, the subject experienced little dehydrated. On 10-APR-2021, the subject experienced arm hurts. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced feverish. On 10-APR-2021, the subject experienced really tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, feverish, little dehydrated, really tired and arm hurts was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, SARS-CoV-2 test negative
Clinical narrative: CHILLS; HEADACHE; 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-APR-2021 13:00, the subject experienced chills. On 12-APR-2021 13:00, the subject experienced headache.  Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and chills was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced fever. On 12-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Sinus headache
Clinical narrative: SEVERE SINUS HEADACHE; FEVER; FATIGUE; This spontaneous report received from a consumer concerned a 27 year old male. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced severe sinus headache. Treatment medications (dates unspecified) included: paracetamol, pseudoephedrine hydrochloride and guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever and fatigue on 11-APR-2021 and had not recovered from severe sinus headache. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cold sweat, Cough, Fatigue, Headache
Clinical narrative: COUGH; CONGESTION; BACK PAIN; FEVER; FATIGUE; NAUSEA; SEVERE HEADACHE; COLD SWEATS; MUSCLE CRAMPS; GENERALIZED PAIN; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy, and antibiotic allergy, and other pre-existing medical conditions included the patient had allergy to pain medication (except toradol and ibuprofen). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 20-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced cold sweats. On 09-APR-2021, the subject experienced muscle cramps. On 09-APR-2021, the subject experienced generalized pain. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced severe headache. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced congestion. On 10-APR-2021, the subject experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, muscle cramps, and fever on 13-APR-2021, was recovering from severe headache, and had not recovered from generalized pain, fatigue, back pain, cough, nausea, and congestion. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nasal congestion, Nausea, Pain, Pyrexia
Clinical narrative: COUGH; CONGESTION; BACK PAIN; FEVER; FATIGUE; NAUSEA; SEVERE HEADACHE; COLD SWEATS; MUSCLE CRAMPS; GENERALIZED PAIN; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy, and antibiotic allergy, and other pre-existing medical conditions included the patient had allergy to pain medication (except toradol and ibuprofen). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 20-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced cold sweats. On 09-APR-2021, the subject experienced muscle cramps. On 09-APR-2021, the subject experienced generalized pain. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced severe headache. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced congestion. On 10-APR-2021, the subject experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, muscle cramps, and fever on 13-APR-2021, was recovering from severe headache, and had not recovered from generalized pain, fatigue, back pain, cough, nausea, and congestion. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Malaise, Pain
Clinical narrative: ACHY; HURT TO MOVE EYES FOR ABOUT  60 HOURS; RUNDOWN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced achy, hurt to move eyes, and rundown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, hurt to move eyes, and rundown. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal
Clinical narrative: NO POWER TO GET OUT OF BED; FEELING TERRIBLY BAD; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-APR-2021, the subject experienced feeling terribly bad. On 13-APR-2021, the subject experienced no power to get out of bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling terribly bad, and no power to get out of bed. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: HEADACHE; TIRED; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cerebral venous sinus thrombosis, diabetic, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with estradiol, and progesterone.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced injection site pain. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 19-MAR-2021, and tired on 26-MAR-2021, and was recovering from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Eye irritation, Fatigue, Photosensitivity reaction, Pyrexia
Clinical narrative: SUNLIGHT SENSITIVITY; EYES BURNING; TIREDNESS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced sunlight sensitivity. On APR-2021, the subject experienced eyes burning. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sunlight sensitivity, eyes burning, tiredness, and fever on APR-2021. This report was non-serious.