chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis infected, Feeling hot, Hyperhidrosis
Clinical narrative: FEELING EXTRA HOT; SWEATING; INTERMITTENT RASH FROM SHOULDER TO ALL WAY DOWN ON BACK, RED BUMPS, LOOKS LIKE INFECTED; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, drug allergy (Flomax and Haldol) ,and non alcohol user. The patient had no history of drug abuse or illicit drug usage. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1 )( unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (Janssen, dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-NOV-2021 into left arm for prophylactic vaccination. No concomitant medications were reported.  On 12-NOV-2021 (started 3-4 days after), the patient experienced rash, from shoulder all the way down on the back, came in waves, got better, and then came back again, red bumps, looks like infected (coded as intermittent rash from shoulder to all way down on back, red bumps, looks like infected). The patient believed the rash was related to the JNJ vaccine. On an unspecified date, the patient started feeling extra hot, not feverish, but sweating in every room (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intermittent rash from shoulder to all way down on back, red bumps, looks like infected, and the outcome of feeling extra hot and sweating was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a 71-year-old elderly female. The patient's height, and weight were not reported.  The patient's past medical history included: tumors, hysterectomy, and breast surgery (SX), and concurrent conditions included: hypertension (HTN), arthritis, neurological issues, tendonitis, iodine allergy, red dye allergy, sulfa drugs allergy, mold allergy, seasonal allergies, some trees allergy, non-smoker, and non-alcoholic, and other pre-existing medical conditions included there was no drug abuse or illicit drug usage. Past medications were not reported. The patient previously received covid-19 vaccine ad26.cov2.s  (manufacturer unknown) (suspension for injection, route of admin, batch number: Unknown and expiry: unknown) 1 total, dose not reported, start therapy date were not reported for prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). No concomitant medications were reported. The patient received booster covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) 1 total, dose was not reported, administered at right arm on 18-NOV-2021 for prophylactic vaccination (dose number in series 2).  On 18-NOV-2021, the patient experienced sore arm (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 25-NOV-2021. This report was non-serious. This case, from the same reporter is linked to 20211233315.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000206735
Sex: U
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Dyspnoea, Headache
Clinical narrative: LIGHT HEADED; INABILITY TO CONCENTRATE; VERY SHORT OF BREATH; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood clotting disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced light headed, inability to concentrate, very short of breath, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headed, headache, inability to concentrate and very short of breath was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: HEART FAILURE; This spontaneous report received from a patient concerned an 81-year-old elderly female of unspecified race and ethnicity. The patient's weight, height was not reported. The patient's concurrent conditions included heart conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 04-MAR-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter mentioned that he and his wife had the vaccine administered at their home by vaccine provider. On 25-NOV-2021, his wife died of heart failure and also stated it was not from the vaccine. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211238044-Covid-19 vaccine ad26.cov2.s-Heart failure. 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).; Reported Cause(s) of Death: HEART FAILURE
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Chest pain, Diarrhoea, Fatigue
Clinical narrative: CHEST PAIN (HAS PACEMAKER); CHEST PRESSURE; LETHARGY; DRY HEAVES; FEELING TIRED; DIARRHEA; VOMITING; FEELING VERY WEAK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213021A expiry: UNKNOWN) dose was not reported, administered on 24-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-DEC-2021, the patient experienced chest pain (has pacemaker), chest pressure, lethargy, dry heaves, feeling tired, diarrhea, vomiting, and feeling very weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tired, diarrhea, chest pain (has pacemaker), and chest pressure, and the outcome of vomiting, lethargy, dry heaves and feeling very weak was not reported. This report was non-serious. This case, from the same reporter is linked to 20211237999.
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Retching, Vomiting
Clinical narrative: CHEST PAIN (HAS PACEMAKER); CHEST PRESSURE; LETHARGY; DRY HEAVES; FEELING TIRED; DIARRHEA; VOMITING; FEELING VERY WEAK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213021A expiry: UNKNOWN) dose was not reported, administered on 24-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-DEC-2021, the patient experienced chest pain (has pacemaker), chest pressure, lethargy, dry heaves, feeling tired, diarrhea, vomiting, and feeling very weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tired, diarrhea, chest pain (has pacemaker), and chest pressure, and the outcome of vomiting, lethargy, dry heaves and feeling very weak was not reported. This report was non-serious. This case, from the same reporter is linked to 20211237999.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: BLOOD CLOT IN LUNG; BLOOD CLOT IN CALF; This spontaneous report received from a patient concerned a 49 year old  male of unknown ethnic origin. The patient's weight, height, and medical history were not reported. The patient at the age of 48 years received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 07-AUG-2021) dose was not reported, 1 total administered to left arm on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-AUG-2021, a week after vaccination the patient could not breathe and had experienced blood clot in lung and calf, due to which the patient was going through hematologist and physician and was hospitalized for two nights. It was reported that hematologist and physician said that the patient was fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot in lung, and blood clot in calf. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211238393 -JANSSEN COVID-19 VACCINE Ad26.COV2.S -blood clot in lung, blood clot in calf. 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: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: INJECTED PATIENT WITH 5/8 SIZE SYRINGE (WRONG SIZE SYRINGE); This spontaneous report received from a pharmacist concerned a 30 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 15-DEC-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced injected patient with 5/8 size syringe (wrong size syringe). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injected patient with 5/8 size syringe (wrong size syringe) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a female of unspecified age. Initial information was processed with the additional information received on 17-DEC-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 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 reporter stated her friend had got the Janssen COVID-19 vaccine and was hospitalized afterwards. She initially thought that the friend got it in NOV-2021 but then stated it could be in MAR-2021. She stated that it was possible the friend was hospitalized due to COVID-19 symptoms which primarily was the difficulty breathing resulted in suspected clinical vaccination failure, and suspected covid-19 infection (unspecified treatment administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with regulatory authority: 90000207703; Sender's Comments: V0- 20211239318-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. 20211239318-COVID-19 VACCINE AD26.COV2.S- Suspected covid-19 infection. 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
Symptoms: Arthralgia, Myalgia
Clinical narrative: JOINT PAIN IN BOTH LEGS AND SHOULDERS; MUSCLE PAIN IN BOTH LEGS AND SHOULDERS; This spontaneous report received from a consumer concerned a 54 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 MAY-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 an unspecified date, the patient experienced joint pain in both legs and shoulders, and muscle pain in both legs and shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the joint pain in both legs and shoulders and muscle pain in both legs and shoulders was not reported. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Thrombosis
Clinical narrative: BLOOD CLOTS IN BOTH LEGS; This spontaneous report received from a patient concerned an elderly  male of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: unknown) dose was not reported, 1 total administered to left arm on 09-APR-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported.  The patient stated that after vaccination he had quite few blood clots in both legs and he had tests (unspecified test) done and was diagnosed by the hospital. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in both legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211240250-Covid-19 vaccine ad26.cov2.s-Blood clots in both legs . 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: BLACK AND BLUE INJECTION SITE; INJECTION SITE PAIN; INJECTION REDNESS; INJECTION SITE TENDERNESS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 11-APR-2022) dose was not reported, administered on 13-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-DEC-2021, the patient experienced black and blue injection site. On 14-DEC-2021, the patient experienced injection site pain. On 14-DEC-2021, the patient experienced injection redness. On 14-DEC-2021, the patient experienced injection site tenderness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, injection redness, injection site tenderness, and black and blue injection site. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neurological examination, Pain in extremity, Paraesthesia, Plantar fasciitis
Clinical narrative: POSSIBLE PLANTAR FASCIITIS; SOMETIMES SHARP PAINS ON THE BOTTOM OF THE FEET/FEEL PAIN IN THE RIGHT LEG; LEFT LEG HAD NUMBNESS ON THE BOTTOM OF THE FOOT; TINGLING IN BOTH FEET; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 23-AUG-2021) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the patient experienced sometimes sharp pains on the bottom of the feet/feel pain in the right leg, left leg had numbness on the bottom of the foot, and tingling in both feet. Laboratory data included: Diagnostic ultrasound (NR: not provided) Normal. On 07-MAY-2021, the patient experienced possible plantar fasciitis. Laboratory data included: Neurological examination (NR: not provided) plantar fasciitis. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left leg had numbness on the bottom of the foot, and sometimes sharp pains on the bottom of the feet/feel pain in the right leg, and the outcome of tingling in both feet and possible plantar fasciitis was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: POSSIBLE PLANTAR FASCIITIS; SOMETIMES SHARP PAINS ON THE BOTTOM OF THE FEET/FEEL PAIN IN THE RIGHT LEG; LEFT LEG HAD NUMBNESS ON THE BOTTOM OF THE FOOT; TINGLING IN BOTH FEET; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 23-AUG-2021) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the patient experienced sometimes sharp pains on the bottom of the feet/feel pain in the right leg, left leg had numbness on the bottom of the foot, and tingling in both feet. Laboratory data included: Diagnostic ultrasound (NR: not provided) Normal. On 07-MAY-2021, the patient experienced possible plantar fasciitis. Laboratory data included: Neurological examination (NR: not provided) plantar fasciitis. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left leg had numbness on the bottom of the foot, and sometimes sharp pains on the bottom of the feet/feel pain in the right leg, and the outcome of tingling in both feet and possible plantar fasciitis was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: JOINT PAIN IN BOTH LEGS AND SHOULDERS; MUSCLE PAIN IN BOTH LEGS AND SHOULDERS; This spontaneous report received from a consumer concerned a 47 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced joint pain in both legs and shoulders, and muscle pain in both legs and shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain in legs and shoulders and joint pain in legs and shoulders was not reported. This report was non-serious. This case, from the same reporter is linked to 20211240211, 20211240486, 20211240436 and 20211241144.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Colonoscopy
Clinical narrative: ATRIAL FIBRILLATION; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included: left sided stroke 2 years ago, and colon resection in 2002/2004, and concurrent conditions included: neurofibromatosis nf1, and other pre-existing medical conditions included: The patient did not have any known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (The dose number in series 1) (suspension for injection, route of admin not reported and batch number: LO3A21A expiry: unknown) dose was not reported, 1 total, administered on 04-MAY-2021, to left arm for prophylactic vaccination. Concomitant medications included atorvastatin, clopidogrel, Flonaze (fluticasone propionate), hydrochlorothiazide, Levothyroxin (levothyroxine sodium), Ativan (lorazepam), Meclizine (meclozine), metoprolol, nortriptyline, and omeprazole for drug used for unknown indication.  On an unspecified date, she stated of being unaware about her heart problems. On 22-NOV-2021, she underwent Colonoscopy and fast heart rate was noted which was further diagnosed with atrial fibrillation. Laboratory data included: Colonoscopy (NR: not provided) atrial fibrillation. She also further stated that, she did not took metoprolol on the morning of the procedure and was administered the dose during the time of the colonoscopy. She has a cardiologist appointment on 13-DEC-2021, and was ordered to undergo holter monitor testing on 20-DEC-2021 and TEE (transesophageal echocardiogram) on 12-JAN-2022. She was not prescribed any medications by the cardiologist.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of atrial fibrillation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211240438-JANSSEN COVID-19 VACCINE Ad26.COV2.S- atrial fibrillation .This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: FELT LIGHTHEADED WHEN STOOD UP AND EVEN WHILE WALKING; BODY FELT DIFFERENT; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 patient experienced felt lightheaded when stood up and even while walking, and body felt different. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt lightheaded when stood up and even while walking, and body felt different. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: MINIMAL SIDE EFFECTS; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 patient experienced minimal side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of minimal side effects was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID- 19 INFECTION; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 206A21A and expiry: unknown) dose was not reported, frequency time 1 total administered at right arm on 16-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-SEP-2021, patient tested positive via rapid test (suspected clinical vaccination failure and and suspected covid-19 infection). On 16-SEP-2021, he received infusion (of an unspecified medication). On unspecified date he noted mild symptoms including, slight fever, could not taste and low energy.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid- 19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0. 20211240687-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS  20211240687-covid-19 vaccine ad26.cov2.s -suspected Covid- 19 infection . 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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Migraine, Muscular weakness, Pyrexia
Clinical narrative: MIGRAINE HEADACHE; RESTLESS LEG SYNDROME; MUSCLE WEAKNESS; EXTREME TIREDNESS; SLIGHT FEVER; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no heart problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the patient experienced migraine headache, restless leg syndrome, muscle weakness, extreme tiredness, and slight fever. Laboratory data included: Body temperature (NR: not provided) 100 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine headache, restless leg syndrome, muscle weakness, extreme tiredness, and slight fever on 12-APR-2021. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Restless legs syndrome
Clinical narrative: MIGRAINE HEADACHE; RESTLESS LEG SYNDROME; MUSCLE WEAKNESS; EXTREME TIREDNESS; SLIGHT FEVER; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no heart problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the patient experienced migraine headache, restless leg syndrome, muscle weakness, extreme tiredness, and slight fever. Laboratory data included: Body temperature (NR: not provided) 100 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine headache, restless leg syndrome, muscle weakness, extreme tiredness, and slight fever on 12-APR-2021. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF JANSSEN COVID 19 VACCINE THAT WERE EXPIRED BY TWO DAYS; This spontaneous report received from a health care professional concerned a 72 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, administered on 16-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-DEC-2021, the patient experienced administration of janssen covid 19 vaccine that were expired by two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of janssen covid 19 vaccine that were expired by two days was not reported. This report was non-serious. This case, from the same reporter is linked to 20211240943.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF JANSSEN COVID 19 VACCINE THAT EXPIRED BY TWO DAYS; This spontaneous report received from a health care professional concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 16-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-DEC-2021, the patient experienced administration of janssen covid 19 vaccine that expired by two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of janssen covid 19 vaccine that expired by two days was not reported. This report was non-serious. This case, from the same reporter is linked to 20211240774.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a patient via Social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s  (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose,1 total administered start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient reported " one month after I got the J&J Covid shot I was in the hospital with blood clots" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211241127-Covid-19 vaccine ad26.cov2.s -Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: ARM HURT; FELT LITTLE UNDER THE WEATHER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the patient experienced felt little under the weather. On an unspecified date, the patient experienced arm hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt little under the weather on MAR-2021, and arm hurt. This report was non-serious. This case, from the same reporter is linked to 20211242175.
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Ageusia, Body temperature, Chills, Dizziness
Clinical narrative: STOMACH ACHE; BODY ACHES; HARD TO BREATH; NASAL CONGESTION; SHAKES; LIGHT HEADED; LOST TASTE FOR A LITTLE BIT; BODY CHILLS; FEVER; This spontaneous report received from a patient concerned a 21 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: spinach allergy, alcohol consumer, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 17-DEC-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 17-DEC-2021, the patient experienced stomach ache, body aches, hard to breath, nasal congestion, shakes, light headed, lost taste for a little bit, body chills, and fever. Laboratory data included: Body temperature (NR: not provided) 100.5 degrees F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from stomach ache, body aches, hard to breath, nasal congestion, light headed, body chills, lost taste for a little bit, and shakes. This report was non-serious.
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Nasal congestion, Pain, Pyrexia, Tremor
Clinical narrative: STOMACH ACHE; BODY ACHES; HARD TO BREATH; NASAL CONGESTION; SHAKES; LIGHT HEADED; LOST TASTE FOR A LITTLE BIT; BODY CHILLS; FEVER; This spontaneous report received from a patient concerned a 21 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: spinach allergy, alcohol consumer, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 17-DEC-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 17-DEC-2021, the patient experienced stomach ache, body aches, hard to breath, nasal congestion, shakes, light headed, lost taste for a little bit, body chills, and fever. Laboratory data included: Body temperature (NR: not provided) 100.5 degrees F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from stomach ache, body aches, hard to breath, nasal congestion, light headed, body chills, lost taste for a little bit, and shakes. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Pyrexia
Clinical narrative: DISCOMFORT; A COUPLE HOURS OF FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced discomfort, and a couple hours of fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from discomfort, and a couple hours of fever. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Autoscopy, Cough, Euphoric mood, Headache
Clinical narrative: OUT OF BODY FEELING; FEELS HIGH LIKE FROM MARIJUANA; DRY COUGH; BRUTAL HEADACHE; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: 09-APR-2022) dose was not reported, administered on 15-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On DEC-2021, the patient experienced dry cough, and brutal headache. On 15-DEC-2021, the patient experienced feels high like from marijuana. On 17-DEC-2021, the patient experienced out of body feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feels high like from marijuana, brutal headache, dry cough and out of body feeling was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Contusion, Fatigue, Headache
Clinical narrative: BRUISING/BLOOD SPOTS ON SKIN AND HAD BUMPS ON IT; CHILLS; BAD HEADACHE; REAL TIRED/FATIGUE; BURNING SENSATION AT INJECTION SITE; BODY ACHES; ARM BURNED; 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: antibiotic allergy, no alcohol use, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 10-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-DEC-2021, the patient experienced body aches, arm burned, and burning sensation at injection site. On 11-DEC-2021, the patient experienced chills, bad headache, and real tired/fatigue. On 18-DEC-2021, the patient experienced bruising/blood spots on skin and had bumps on it. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, burning sensation at injection site, bad headache, and real tired/fatigue on 12-DEC-2021, and arm burned, and had not recovered from bruising/blood spots on skin and had bumps on it. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: BRUISING/BLOOD SPOTS ON SKIN AND HAD BUMPS ON IT; CHILLS; BAD HEADACHE; REAL TIRED/FATIGUE; BURNING SENSATION AT INJECTION SITE; BODY ACHES; ARM BURNED; 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: antibiotic allergy, no alcohol use, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 10-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-DEC-2021, the patient experienced body aches, arm burned, and burning sensation at injection site. On 11-DEC-2021, the patient experienced chills, bad headache, and real tired/fatigue. On 18-DEC-2021, the patient experienced bruising/blood spots on skin and had bumps on it. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, burning sensation at injection site, bad headache, and real tired/fatigue on 12-DEC-2021, and arm burned, and had not recovered from bruising/blood spots on skin and had bumps on it. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: FELT A LITTLE UNDER THE WEATHER THE NEXT DAY AFTER VACCINATION FOR THE DAY; ARM HURT FOR A COUPLE OF DAYS; 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 past medical history included: covid-19, and concurrent conditions included: high blood pressure, and high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805108, and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced arm hurt for a couple of days. On 15-MAR-2021, the patient experienced felt a little under the weather the next day after vaccination for the day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt a little under the weather the next day after vaccination for the day on 15-MAR-2021, and arm hurt for a couple of days. This report was non-serious. This case, from the same reporter is linked to 20211241901.
Sex: U
Vaccine: COVID19
Symptoms: Nightmare
Clinical narrative: HAVING NIGHTMARES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced having nightmares. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of having nightmares was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain in extremity, Paranasal sinus discomfort
Clinical narrative: SINUS PRESSURE; FELT FOGGY, A LITTLE BIT OUT OF IT; LEFT SORE ARM; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies/ 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: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the patient experienced left sore arm, and fatigue. On 02-AUG-2021, the patient experienced felt foggy, a little bit out of it. On 06-AUG-2021, the patient experienced sinus pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt foggy, a little bit out of it on 04-AUG-2021, sinus pressure on 20-AUG-2021, left sore arm on 02-AUG-2021, and fatigue on 03-AUG-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID POSITIVE BUT IT WAS NOT TOO BAD; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced covid positive but it was not too bad. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid positive but it was not too bad was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: ARM PAIN; SOME CHILLS; FATIGUE; 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 pre-existing medical conditions included: The patient never got covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced arm pain, some chills, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain, some chills, and fatigue. This report was non-serious.