chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Painful respiration, Pulmonary congestion, Pyrexia, Vomiting
Clinical narrative: FELT BILATERAL LUNG CONGESTION; BILATERAL SIDE PAIN; VOMITING; DIFFICULTY BREATHING; PAIN WHEN BREATHS; FEVER OF 100 F; FATIGUE; MISSED WORK TODAY; LEFT ARM PAIN; This spontaneous report received from a patient concerned a 52 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, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021 (mentioned as yesterday), the symptoms of the patient started, and he missed work today (loss of personal independence in daily activities) and left arm pain (painful L arm) because he was not feeling well. The reporter advised him to contact his primary care provider, but he said he called and they are not able to see him without an appointment also advised him to seek medical attention by going to the emergency room. The patient agrees to go to the Emergency Room. On 11-MAR-2021, the patient experienced bilateral side pain (flank pain), vomiting, felt bilateral lung congestion (lung congestion), difficulty breathing, fever of 100 F, fatigue, pain when breaths (painful respiration).  Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 100 f, had not recovered from bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, and pain when breaths, and the outcome of missed work today was not reported. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, pain when breaths, fever of 100 f and missed work today as possible. Company causality between Covid-19 vaccine ad26.cov2.s  and event bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, pain when breaths, fever of 100 f and of missed work today as possible.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210325415- Covid-19 vaccine ad26.cov2.S- bilateral lung congestion. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Rash, Seizure
Clinical narrative: RASH ON ARMS AND HANDS; EXTREME PAIN IN BOTH HANDS AND ARMS; SEIZURE; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient is not on any medication and has no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. patient got the Janssen Covid shot on March 9th Tuesday and then experienced headache started same day and Wednesday10th march, took Tylenol and headache recovered, then seizure on 11th mar, went to the ER and spoke to the doctor on reporting day. consumer also started patient experiencing rash and extreme pain on both arms and hands on reporting day 12th mar and getting worse. On 09-MAR-2021, the subject experienced headache Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, and headache, and had not recovered from rash on arms and hands, and extreme pain in both hands and arms. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210325468 - Covid-19 Vaccine Ad26.Cov2.S - Seizure. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal
Clinical narrative: FEELS BAD; Initial information received on 03-MAR-2021 was processed with additional information received on 09-MAR-2021. The case was reassessed as serious based upon new information received on 09-MAR-2021. This spontaneous case was received from a patient and concerned a 76 year old female. The patient's weight was reported as 90 kilograms, and height was not reported. The patient's concurrent conditions included pulmonary arterial hypertension. The patient received treatment with COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported; the Company is unable to perform follow-up to request batch/lot numbers), dose was not reported for prophylactic vaccination on 02-MAR-2021. The concomitant medications included macitentan and apixaban.  On 03-MAR-2021, the patient reported feeling bad after taking the COVID shot and was considering going to the hospital. On an unspecified date in MAR-2021, the patient was hospitalized. No details were provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feels bad was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210108619.; Sender's Comments: V0 A 76-year-old female patient reported feeling bad next day after receiving Janssen COVID-19 Vaccine Ad26.COV2.S (suspension for injection, route of administration not reported) for prophylactic vaccination. The patient's concurrent conditions included pulmonary arterial hypertension. concomitant medications, and details of the event were not reported. On an unspecified date the patient was hospitalized. This case has insufficient information to make a meaningful medical assessment.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dehydration, Vertigo
Clinical narrative: DEHYDRATED/ DIZZY SPELLS IN MORNING; VERTIGO; This spontaneous report received from a patient concerned a 65 year old male. The patient's weight was 238 pounds, and height was 155.7 centimeters. The patient's concurrent conditions included abstains from alcohol, non-smoker, and cholesterol, and other pre-existing medical conditions included no known allergy and no history of drug abuse. 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-MAR-2021 13:00 at left arm for prophylactic vaccination. The batch number was not reported in follow-up information. Concomitant medications included atorvastatin to control cholesterol.  On 10-MAR-2021, the patient experienced vertigo. On 12-MAR-2021, the patient was dehydrated (dizzy spells) in morning. And patient took IV treatment for dehydration. Laboratory data (dates unspecified) included: Blood test (NR: not provided) all good. It was reported that the patient was not ill at the time of vaccination. The patient did not have pre-existing acute illness 30 days prior to vaccination. The patient did not have history of hospitalization in last 30 days prior to vaccination. The patient did not have any family history of any disease (relevant to vaccination) or allergy. It was also stated that the product was properly stored from receipt to administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vertigo, and the outcome of dehydrated/ dizzy spells in morning was not reported. This report was serious (Other Medically Important Condition).  Additional information was received as follow-up 30/MAR/2021. The following information was updated and incorporated into the case narrative: Patient demographic (height, weight, age), medical history, lab test, reporter (contact), concomitant medication, event of dehydration/dizzy spell in morning and administered IV treatment for dehydration.; Sender's Comments: V1 20210327793-covid-19 vaccine ad26.cov2.s.-Dehydration. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Cerebrovascular accident
Clinical narrative: STROKE; BLINDNESS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination.  No concomitant medications were reported. The batch number was not reported and has been requested On MAR-2021, the subject experienced stroke. On MAR-2021, the subject experienced blindness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and blindness was not reported. The reporter did not report causality between covid-19 vaccine ad26.cov2.s and stroke ,blindness .Company causality between covid-19 vaccine ad26.cov2.s and stroke and blindness was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210331088-Covid-19 vaccine ad26.cov2.s-Stroke , Blindness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: SEIZURE; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported.  On an unspecified date, after administration of vaccine the patient started having a seizure and ended up going to hospital (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  20210333412 - JANSSEN COVID-19 VACCINE Ad26.COV2.S - Seizure. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabelled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Computerised tomogram, Echocardiogram, Heart rate
Clinical narrative: SEIZURE/CONVULSION; LOW BLOOD PRESSURE; SORE ARM; FEVER; This spontaneous report received from a patient concerned a 21 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, expiry: UNKNOWN)) dose was not reported, administered on 16-MAR-2021 at 17:00 in the right deltoid for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On 20-MAR-2021,The caller called to report that her daughter developed some rare side effects. The patient reported that she got the shot on 16-MAR-2021 and went home and went to bed at 23:15 PM experienced convulsing/seizure, chills, shaking, low blood pressure, heart rate increased. The police came to take her to the Emergency room. The patient was hospitalized on 16-MAR-2021. On an unspecified date in MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 70/20 mmHg, 80/30 mmHg, and Heart rate (NR: not provided) 110 OR 115 BPM. The patient has no fever then was given an unspecified IV. At 06:00 On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 98/38 mmHg, COVID-19 virus test (NR: not provided) NEGATIVE, CT scan (NR: not provided) NORMAL, Echocardiogram (NR: not provided) FINE, and Echocardiography (NR: not provided) FINE. Overall she took 6 Liters of IV fluid. The patient was discharged on 17-MAR-2021 at 14:00PM. The duration of hospitalization was two days. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 120/90 mmHg, and Heart rate (NR: not provided) 70 BPM. On an unspecified date, the patient experienced dizzy, lethargic, sore arm and fever. The patient gave permission to speak with her doctor who treated her there and was told to follow up with Primary Care Physician which she did on 18-MAR-2021. No medications were given at discharge. According to her, Blood pressure and Heart Rate was normal when she saw her Primary Care Physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking on 19-MAR-2021, low blood pressure and heart rate increased on 18-MAR-2021, was recovering from, chills and the outcome of, convulsing/seizure, dizzy, sore arm, lethargic and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210339790 - COVID-19 VACCINE AD26.COV2.S - Seizure, Blood Pressure Low. 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Pain in extremity, Pyrexia, SARS-CoV-2 test, Seizure
Clinical narrative: SEIZURE/CONVULSION; LOW BLOOD PRESSURE; SORE ARM; FEVER; This spontaneous report received from a patient concerned a 21 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, expiry: UNKNOWN)) dose was not reported, administered on 16-MAR-2021 at 17:00 in the right deltoid for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On 20-MAR-2021,The caller called to report that her daughter developed some rare side effects. The patient reported that she got the shot on 16-MAR-2021 and went home and went to bed at 23:15 PM experienced convulsing/seizure, chills, shaking, low blood pressure, heart rate increased. The police came to take her to the Emergency room. The patient was hospitalized on 16-MAR-2021. On an unspecified date in MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 70/20 mmHg, 80/30 mmHg, and Heart rate (NR: not provided) 110 OR 115 BPM. The patient has no fever then was given an unspecified IV. At 06:00 On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 98/38 mmHg, COVID-19 virus test (NR: not provided) NEGATIVE, CT scan (NR: not provided) NORMAL, Echocardiogram (NR: not provided) FINE, and Echocardiography (NR: not provided) FINE. Overall she took 6 Liters of IV fluid. The patient was discharged on 17-MAR-2021 at 14:00PM. The duration of hospitalization was two days. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 120/90 mmHg, and Heart rate (NR: not provided) 70 BPM. On an unspecified date, the patient experienced dizzy, lethargic, sore arm and fever. The patient gave permission to speak with her doctor who treated her there and was told to follow up with Primary Care Physician which she did on 18-MAR-2021. No medications were given at discharge. According to her, Blood pressure and Heart Rate was normal when she saw her Primary Care Physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking on 19-MAR-2021, low blood pressure and heart rate increased on 18-MAR-2021, was recovering from, chills and the outcome of, convulsing/seizure, dizzy, sore arm, lethargic and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210339790 - COVID-19 VACCINE AD26.COV2.S - Seizure, Blood Pressure Low. 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: Blood glucose abnormal, Blood glucose increased, Chills, Headache, Nausea
Clinical narrative: BLOOD SUGAR LEVEL INCREASED; VOMITING 10 TIMES; CHILLS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's past medical history included type-1 diabetes for last 32 years, taking insulin Humalog 15 iu bd and Lancetan 40 iu once daily, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug use, no alcohol consumption and no smoking.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808609) dose was not reported, frequency 1 total, administered on 20-MAR-2021 09:00 for prophylactic vaccination on right arm. Concomitant medications included insulin lispro for type 1 diabetes, and plantago major extract. Blood Sugar level was tested on (Saturday) March 20, 2021 with test result 86, (Sunday) March 21, 2021 with test result 79 and 106 and (Monday morning at 7 am) March 22, 2021 with test result 286 On 22-MAR-2021, the patient experienced blood sugar level increased. On 22-MAR-2021, the patient experienced vomiting, chills, nausea and headache. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the nausea, vomiting, headache, chills and blood sugar level increased was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210342051-COVID-19 VACCINE AD26.COV2.S - Blood Sugar Level Increased. This event is considered not related. The event 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 than the drug. Specifically: MEDICAL HISTORY.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: BLOOD SUGAR LEVEL INCREASED; VOMITING 10 TIMES; CHILLS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's past medical history included type-1 diabetes for last 32 years, taking insulin Humalog 15 iu bd and Lancetan 40 iu once daily, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug use, no alcohol consumption and no smoking.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808609) dose was not reported, frequency 1 total, administered on 20-MAR-2021 09:00 for prophylactic vaccination on right arm. Concomitant medications included insulin lispro for type 1 diabetes, and plantago major extract. Blood Sugar level was tested on (Saturday) March 20, 2021 with test result 86, (Sunday) March 21, 2021 with test result 79 and 106 and (Monday morning at 7 am) March 22, 2021 with test result 286 On 22-MAR-2021, the patient experienced blood sugar level increased. On 22-MAR-2021, the patient experienced vomiting, chills, nausea and headache. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the nausea, vomiting, headache, chills and blood sugar level increased was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210342051-COVID-19 VACCINE AD26.COV2.S - Blood Sugar Level Increased. This event is considered not related. The event 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 than the drug. Specifically: MEDICAL HISTORY.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTERED VACCINE OUT OF TEMPERATURE RANGE; This spontaneous report received from a pharmacist concerned multiple patients. 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: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  The reporter stated that, on 22-MAR-2021, they administered 2 doses of product to the 2 patients at their facility, However these 2 doses was exposed at the room temperature for more than 2 hours recommended (10-15 mins past the recommended 2 hours) (administered vaccine out of temperature range).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered vaccine out of temperature range was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210343668-covid-19 vaccine ad26.cov2.s-administered vaccine out of temp range. 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
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Nervous system disorder
Clinical narrative: WAS NOT ABLE TO WALK; NEUROLGICAL PROBLEMS WITH HIS LEGS; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight was 90.5 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included warfarin.  On an unspecified date, the patient experienced possible reaction to the Covid vaccine, patient was not able to walk and neurolgical problems with his legs. The patient was hospitalized since 14-MAR-2021.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neurolgical problems with his legs and was not able to walk was not reported. This report was serious (Hospitalization Caused / Prolonged).  This case, involving the same patient is linked to 20210132481, 20201218555, 20201109402, 20201033394, A-NJ2017-162166, A-US2016-145072, A-NJ2016-130161, A-US2015-129188, A-US2014-94192, A-US2019-188952 and A-NJ2014-109450.; Sender's Comments: V0: 20210343964-COVID-19 VACCINE AD26.COV2.S - Was Not Able To Walk, Neurological Problems With His 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hemiparesis, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: ACHES; CHEST PAIN; FEVER; SORENESS AT INJECTION SITE; STIFFNESS; WEAKNESS ON THE ENTIRE LEFT SIDE OF BODY; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 196 pounds, and height was 63 inches. The patient's concurrent conditions included sulfas allergy, penicillin allergy and alcohol consumption. The patient does not smoke and does not have any drug abuse or illicit drug usage. The patient stated that she has a general good health.  The patient received COVID-19 vaccine AD26.COV2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on left deltoid on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAR-2021, the patient experienced weakness on the entire left side of her body. On the same day, the patient experienced stiffness, fever, and soreness at injection site and also recovered from the left side body weakness. On 23-MAR-2021, the subject experienced aches and chest pain. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient recovered from weakness on the entire left side of body on 22-MAR-2021, was recovering from soreness at injection site, aches, stiffness, and chest pain, and had not recovered from fever. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210345029-Covid-19 Vaccine Ad26.Cov2.S - Weakness On The Entire Left Side Of Her Body. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ACHES; CHEST PAIN; FEVER; SORENESS AT INJECTION SITE; STIFFNESS; WEAKNESS ON THE ENTIRE LEFT SIDE OF BODY; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 196 pounds, and height was 63 inches. The patient's concurrent conditions included sulfas allergy, penicillin allergy and alcohol consumption. The patient does not smoke and does not have any drug abuse or illicit drug usage. The patient stated that she has a general good health.  The patient received COVID-19 vaccine AD26.COV2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on left deltoid on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAR-2021, the patient experienced weakness on the entire left side of her body. On the same day, the patient experienced stiffness, fever, and soreness at injection site and also recovered from the left side body weakness. On 23-MAR-2021, the subject experienced aches and chest pain. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient recovered from weakness on the entire left side of body on 22-MAR-2021, was recovering from soreness at injection site, aches, stiffness, and chest pain, and had not recovered from fever. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210345029-Covid-19 Vaccine Ad26.Cov2.S - Weakness On The Entire Left Side Of Her Body. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: RAISED BLOOD SUGAR TO DANGEROUS HIGH LEVEL, 400 AND GOING STRAIGHT UP; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry date: UNKNOWN) dose was not reported, 1 total, administered on MAR-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 MAR-2021, after vaccination the patient did not have any flu reaction but the vaccine raised blood sugar to dangerous high level. It was 400 and going straight up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of raised blood sugar to dangerous high level, 400 and going straight up was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210347311-JANSSEN COVID-19 VACCINE Ad26.COV2. S - Blood sugar increased. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Lethargy, Pain, Pyrexia
Clinical narrative: BODY ACHES; LETHARGY; CHILLS; INJECTION SITE PAIN; FEVER; This spontaneous report received from a patient concerned a 58 year old (White, not Hispanic or Latino) 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: 1805025 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination on Right deltoid. No concomitant medications were reported. On 26-MAR-2021, the subject experienced body aches. On 26-MAR-2021, the subject experienced lethargy. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced injection site pain. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and chills, and had not recovered from body aches, injection site pain, and lethargy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210354457-Covid-19 vaccine ad26.cov2.s-Bodyache, Lethargy,. 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). 20210354457-Covid-19 vaccine ad26.cov2.s-chills, injection site pain and fever. This event(s) is labeled and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Cholera, Pain in extremity, Pyrexia
Clinical narrative: CHOLERA; SORE ARM; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 patient experienced cholera, sore arm, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, sore arm and cholera was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210355547-Covid-19 vaccine ad26.cov2.s-Cholera. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: SEVERE ANAPHYLACTIC REACTION; This solicited report received from a patient via RRA-4549: PriCara social media Account concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cancer, and immunocompromised. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total administered on 27-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 27-MAR-2021, the patient experienced severe anaphylactic reaction and went twice to emergency room by an ambulance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe anaphylactic reaction was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and severe anaphylactic reaction as related. Company causality between covid-19 vaccine ad26.cov2.s, and severe anaphylactic reaction was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: Covid-19 vaccine ad26.cov2.s-Severe anaphylactic reaction. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hallucination, Headache, Hyperhidrosis, Muscle tightness
Clinical narrative: FEELING HOT; SWEAT; TOOTHACHE; HEART RACING; FEVER; POUNDING HEAD; TENSION IN NECK; SORENESS IN BODY; SORE ARM; FEELING ROOM ON FIRE/PARANOIA/SEEING SPIDER/POSSIBLE HALLUCINATION; 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 fibromyalgia, high blood pressure, and depression. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: unknown) dose was not reported, administered on 27-MAR-2021 on right arm for prophylactic vaccination. Concomitant medications included tramadol for fibromyalgia. On 27-MAR-2021, the patient experienced possible hallucination, tension in neck, soreness in body, sore arm and pounding head. On 28-MAR-2021, the patient experienced heart racing, toothache, fever and feeling hot and sweat. Treatment medications included: amoxicillin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from possible hallucination, paranoia, heart racing, seeing spiders, tension in neck, soreness in body, feeling hot, felt like room was on fire, sore arm, fever, and pounding head on 29-MAR-2021, and sweat, and the outcome of toothache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210356720-COVID-19 VACCINE AD26.COV2.S-Possible hallucination. This event 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Palpitations, Pyrexia, Toothache
Clinical narrative: FEELING HOT; SWEAT; TOOTHACHE; HEART RACING; FEVER; POUNDING HEAD; TENSION IN NECK; SORENESS IN BODY; SORE ARM; FEELING ROOM ON FIRE/PARANOIA/SEEING SPIDER/POSSIBLE HALLUCINATION; 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 fibromyalgia, high blood pressure, and depression. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: unknown) dose was not reported, administered on 27-MAR-2021 on right arm for prophylactic vaccination. Concomitant medications included tramadol for fibromyalgia. On 27-MAR-2021, the patient experienced possible hallucination, tension in neck, soreness in body, sore arm and pounding head. On 28-MAR-2021, the patient experienced heart racing, toothache, fever and feeling hot and sweat. Treatment medications included: amoxicillin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from possible hallucination, paranoia, heart racing, seeing spiders, tension in neck, soreness in body, feeling hot, felt like room was on fire, sore arm, fever, and pounding head on 29-MAR-2021, and sweat, and the outcome of toothache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210356720-COVID-19 VACCINE AD26.COV2.S-Possible hallucination. This event 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.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin)total 1 dose, start therapy date were not reported for prophylactic vaccination. The Batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced death. On an unspecified date, the patient died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210356723- Covid-19 vaccine ad26.cov2.s-Death. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Immune-mediated adverse reaction
Clinical narrative: SEVERE VERY DANGEROUS IMMUNE  RESPONSE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported.  On 12-MAR-2021, the patient experienced severe, very dangerous immune response. On an unspecified date the patient was hospitalized for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe, very dangerous immune response. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: 20210357960-Covid-19 vaccine ad26.cov2.s - severe, very dangerous immune response. 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: COVID-19, Death, SARS-CoV-2 test
Clinical narrative: DEATH; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced confirmed covid-19 infection. On 29-MAR-2021, the subject experienced death. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. On 29-MAR-2021, the subject died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the patient died from unknown cause of death, and the outcome of confirmed covid-19 infection was not reported. It was unknown if an autopsy was performed This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210358262-COVID-19 VACCINE AD26.COV2.S- Death, Confirmed 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; 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 had no known drug or non-drug allergy. The patient had no history of drug abuse or illicit drug use. The patient was non-smoker and non-alcohol user.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the patient experienced suspected immunological vaccine failure. Laboratory data included: Antibody test (NR: not provided) Negative Antibodies (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210358301-Covid-19 vaccine ad26.cov2.s-Suspected Immunological Vaccination Failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Hypertension, Pyrexia
Clinical narrative: HIGH BLOOD PRESSURE; CHILLS; 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: Unk) dose was not reported, administered on 16-MAR-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 18-MAR-2021, the patient experienced high blood pressure. On 18-MAR-2021, the patient experienced chills. On 18-MAR-2021, the patient experienced fever. Laboratory data included: Blood pressure (NR: not provided) 189/101, and Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high blood pressure, fever and chills was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210358958-COVID-19 VACCINE AD26.COV2.S-High blood pressure. 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: Hospitalisation
Clinical narrative: HOSPITALIZED AFTER FIRST DOSE; This spontaneous report received from a consumer via a company representative 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: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced hospitalized after first dose, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalized after first dose was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210400286-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Hospitalization. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 66 year old of unspecified 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) dose, were not reported for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s more than 3 weeks ago. The batch number was not reported and has been requested. No concomitant medications were reported. On an unknown date, the patient experienced suspected immunological vaccine failure. The patient had no side effects. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Negative, SARS-CoV-2 IgG antibody test (NR: not provided) negative, and SARS-CoV-2 IgM antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210400318-covid-19 vaccine ad26.cov2.s -Suspected Immunological failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS