chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2021, the patient received the 1st dose of Shingrix. In May 2021, between 3 and 5 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. Pharmacist reported that the patient received 1st dose of Shingrix and experienced shingles. The HCP did not have any vaccine information at the time of the call.  No further details were reported. The HCP was interested in getting the medical information letter, so she did not consent nor declined follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received her first dose in 2028 but missed her second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received an expired dose /expired on 31Mar2021/administered on 25Jun2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA266A, expiry date 31st March 2021) for prophylaxis.   On 25th June 2021, the patient received Menveo. On 25th June 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. On 25th June 2021,  patient received Menveo, which was expired on 31st March 2021. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix: patient missed the 2nd dose. First dose was given a year ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix, a year ago, prior to reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, patient received 1st dose of Shingrix, a year ago and date was not provided. No other details of vaccine/patient was provided. The VAERS details for 1st dose were provided. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / on 10Nov2019 / Second dose had not been given at time of call; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received from 10th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that, vaccine information was not available at time of call and patient information was shared limitedly. The reporter also mentioned that, 2nd dose was not been given at the time of call. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: firs dose was administrated ob November 2019 / late for the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. No adverse event was reported. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose / has not received the 2nd dose yet / Suspect Vaccine Start Date:September 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that the patient received the first dose of Shingrix at her doctor's office and had not received the 2nd dose yet, which led to incomplete course of vaccination. The pharmacist wanted to verify if they should restart vaccination or administer the 2nd dose immediately. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: the patient is past due for dose two of Shingrix.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th July 2020, batch number- 5TH3L, expiry 19 November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: forgot to come back for their 2nd shot/ Vaccine Start Date:August 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up The reporter asked for guidance if a patient forgot to come back for their 2nd shot
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 10/18/2018 and had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th October 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further events were reported. The reporter consented to follow up
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 9/27/2019 / had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further events were reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: 23 years old patient has a prescription to receive / vaccine / has not received it yet; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 23-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were provided as follows: The 23 years old female patient has a prescription to receive Shingrix vaccine but she has not received it yet, which led to intercepted drug prescribing error. The reporter consented to follow up.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Got a shot of Pediarix / after the expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 7-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th June 2021, the patient received Pediarix (intramuscular) and Pediarix Pre-Filled Syringe Device. On 17th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: On 17th June 2021, patient received Pediarix, which was expired on 14th June 2021. The reporter did not have information about the patient. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BLURRED VISION; 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blurred vision was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE STORED 40 F TO 41.8 F RANGE FOR 4 DAYS; PUNCTURED VIAL USED AFTER 4 DAYS; This spontaneous report received from a pharmacist concerned a 69 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, intramuscular, batch number: Unknown) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-JUN-2021, the subject experienced vaccine stored 40 f to 41.8 f range for 4 days. On 05-JUN-2021, the subject experienced punctured vial used after 4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine stored 40 f to 41.8 f range for 4 days and punctured vial used after 4 days was not reported. This report was non-serious.
Sex: U
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 via a company representative via social media 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 not reported, batch number: unknown) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 26-JUN-2021, the patient was diagnosed as COVID positive by positive COVID test (suspected clinical vaccination failure and suspected COVID-19 infection). Laboratory data 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 the suspected COVID-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210702601-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
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Mental impairment, Paraesthesia
Clinical narrative: DIFFICULT TIME THINKING/FOGGY THINKING; WEIRD SENSE OF TOUCH/COULD NOT FEEL RIGHT; NUMB RIGHT SHOULDER; VERY WEAK; This spontaneous report received from a patient concerned a female of unspecified age, 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 (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: Unknown) dose was not reported, 1 total, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced difficult time thinking, felt very weak, felt her sense of touch was weird, couldn't feel right. She also experienced numbness in her right shoulder, and foggy thinking. She was upset, at one point, sounded like she was beginning to cry. She stated that the weakness and foggy thinking was the worse. The patient was poor and did not have a primary care doctor. She had been to the hospital and they could not figure it out. The patient wanted to know what to do or who to call. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficult time thinking/foggy thinking, very weak, weird sense of touch/could not feel right, and numb right shoulder. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210702657-COVID-19 VACCINE AD26.COV2.S -Difficult Time Thinking/Foggy Thinking. 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.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chest discomfort, Computerised tomogram head, Contusion, Feeling abnormal, Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS; UTERINE BLEEDING; SEVERE BRUISING; TIGHTNESS IN CHEST; STRANGE FEELING IN HEAD; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anemic, menopausal since 2006, asthma, and irritable bowel syndrome. The patient was not pregnant at the time of reporting. The patient had a history of steroid shots in shoulders, knees and back. The patient had never experienced any uterine bleeding or bruising after receiving the Kenalog (triamcinolone) in the past. The patient never had any of these symptoms in the past. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid on 26-MAR-2021 for prophylactic vaccination.  Non-company suspect drugs included: triamcinolone acetonide (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On 26-MAR-2021, the patient experienced severe bruising and uterine bleeding after receiving the Janssen COVID-19 vaccine. The bruising and bleeding started after she received a Kenalog (triamcinolone) shot. The patient experienced tightness in the chest the same day she received the vaccine and her head felt very strange like it was not part of her body. On 27-MAR-2021, the patient felt fatigue, flu-like symptoms and fever. The fever lasted for 5 days. The patient also had a headache for 2 weeks. The patient recently observed the bruising which had continued to increase. She reported this to her HCP who did some testing. The patient received a Computerised tomogram head scan which showed no blood clots. She used her Albuterol (salbutamol) inhaler and nebulizer to help with chest tightness which resolved. The patient would receive the test results sometime next week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with triamcinolone acetonide was not reported. The patient recovered from tightness in chest, had not recovered from severe bruising, and the outcome of uterine bleeding, strange feeling in head and flu-like symptoms was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210702690-covid-19 vaccine ad26.cov2.s-uterine bleeding. 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: CONMEDS-OTHER SUSPECT DRUGS
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Laboratory test, Uterine haemorrhage
Clinical narrative: FLU-LIKE SYMPTOMS; UTERINE BLEEDING; SEVERE BRUISING; TIGHTNESS IN CHEST; STRANGE FEELING IN HEAD; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anemic, menopausal since 2006, asthma, and irritable bowel syndrome. The patient was not pregnant at the time of reporting. The patient had a history of steroid shots in shoulders, knees and back. The patient had never experienced any uterine bleeding or bruising after receiving the Kenalog (triamcinolone) in the past. The patient never had any of these symptoms in the past. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid on 26-MAR-2021 for prophylactic vaccination.  Non-company suspect drugs included: triamcinolone acetonide (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On 26-MAR-2021, the patient experienced severe bruising and uterine bleeding after receiving the Janssen COVID-19 vaccine. The bruising and bleeding started after she received a Kenalog (triamcinolone) shot. The patient experienced tightness in the chest the same day she received the vaccine and her head felt very strange like it was not part of her body. On 27-MAR-2021, the patient felt fatigue, flu-like symptoms and fever. The fever lasted for 5 days. The patient also had a headache for 2 weeks. The patient recently observed the bruising which had continued to increase. She reported this to her HCP who did some testing. The patient received a Computerised tomogram head scan which showed no blood clots. She used her Albuterol (salbutamol) inhaler and nebulizer to help with chest tightness which resolved. The patient would receive the test results sometime next week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with triamcinolone acetonide was not reported. The patient recovered from tightness in chest, had not recovered from severe bruising, and the outcome of uterine bleeding, strange feeling in head and flu-like symptoms was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210702690-covid-19 vaccine ad26.cov2.s-uterine bleeding. 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: CONMEDS-OTHER SUSPECT DRUGS
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE GIVEN 6 HOURS AFTER THE FIRST PUNCTURE OF THE VIAL; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional 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 not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced vaccine given 6 hours after the first puncture of the vial. On 01-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and vaccine given 6 hours after the first puncture of the vial was not reported. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Feeling abnormal, Feeling hot, Pain
Clinical narrative: LOST MY TASTE BUDS A LITTLE BIT CINNAMON STICKS PUT IN MOUTH BUT COULD NOT TASTE IT AT ALL; BODY ACHES OCCURRING HERE AND THERE THEY COME AND GO; LEFT ARM SORE/ACHES IN LEGS; TEMPERATURE OF 101.9-102.1; FELT HOT; FEELS UNDER THE WEATHER; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 180 pounds, and height was 67 inches. The patient's concurrent conditions included non-smoker, and alcohol user, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug usage and no past medical history not with covid or anything like that.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 30-JUN-2021 18:00 for prophylactic vaccination. Concomitant medications included ibuprofen, paracetamol, tramadol, and venlafaxine. On 30-JUN-2021, the subject experienced felt hot. On 30-JUN-2021, the subject experienced feels under the weather. On 30-JUN-2021, the subject experienced temperature of 101.9-102.1. Laboratory data included: Body temperature (NR: not provided) 101.9-102.1. On an unspecified date, the subject experienced lost my taste buds a little bit cinnamon sticks put in mouth but could not taste it at all, body aches occurring here and there they come and go, and left arm sore/aches in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm sore/aches in legs, and body aches occurring here and there they come and go, and the outcome of temperature of 101.9-102.1, feels under the weather, lost my taste buds a little bit cinnamon sticks put in mouth but could not taste it at all and felt hot was not reported. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: LOST MY TASTE BUDS A LITTLE BIT CINNAMON STICKS PUT IN MOUTH BUT COULD NOT TASTE IT AT ALL; BODY ACHES OCCURRING HERE AND THERE THEY COME AND GO; LEFT ARM SORE/ACHES IN LEGS; TEMPERATURE OF 101.9-102.1; FELT HOT; FEELS UNDER THE WEATHER; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 180 pounds, and height was 67 inches. The patient's concurrent conditions included non-smoker, and alcohol user, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug usage and no past medical history not with covid or anything like that.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 30-JUN-2021 18:00 for prophylactic vaccination. Concomitant medications included ibuprofen, paracetamol, tramadol, and venlafaxine. On 30-JUN-2021, the subject experienced felt hot. On 30-JUN-2021, the subject experienced feels under the weather. On 30-JUN-2021, the subject experienced temperature of 101.9-102.1. Laboratory data included: Body temperature (NR: not provided) 101.9-102.1. On an unspecified date, the subject experienced lost my taste buds a little bit cinnamon sticks put in mouth but could not taste it at all, body aches occurring here and there they come and go, and left arm sore/aches in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm sore/aches in legs, and body aches occurring here and there they come and go, and the outcome of temperature of 101.9-102.1, feels under the weather, lost my taste buds a little bit cinnamon sticks put in mouth but could not taste it at all and felt hot was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac monitoring, Chest X-ray, Chest discomfort, Electrocardiogram
Clinical narrative: CHEST PRESSURE; FAST HEART RATE; TEETH PAIN; GUM PAIN; JAW PAIN; LOW BLOOD PRESSURE; MUSCLE ACHES; FATIGUE; SLIGHT HEADACHE; This spontaneous report was received from a 41-year-old, female patient of other (unspecified) race. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, non alcohol user, and non smoker. The patient had no known allergies and no drug abuse/illicit drug use. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 2021421A, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021 (1 day post vaccination), the patient experienced symptoms of fatigue, muscle aches, chest pressure, fast heart rate, teeth/gums/jaw pain, low blood pressure, slight headache. The patient's doctor had a suspicion of blood clots and hence, on 14-APR-2021, the patient was hospitalized. The patient got her blood work, chest X-ray, electrocardiogram (EKG), and heart monitoring done and results of all tests were normal and she was cleared. No blood clots were found. On 14-APR-2021, the patient was discharged from the hospital. On 15-APR-2021, she felt a little bit better and then on 16-APR-2021 (two days post hospitalization), her symptoms completely subsided. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, fast heart rate, teeth pain, gum pain, jaw pain, low blood pressure, muscle aches, fatigue, and slight headache on 16-APR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210702888-COVID-19 VACCINE AD26.COV2.S-chest pressure, fast heart rate, teeth pain, gum pain, jaw pain, low 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). 20210702888-COVID-19 VACCINE AD26.COV2.S-muscle aches, fatigue, slight headache. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gingival pain, Headache, Heart rate increased, Hypotension
Clinical narrative: CHEST PRESSURE; FAST HEART RATE; TEETH PAIN; GUM PAIN; JAW PAIN; LOW BLOOD PRESSURE; MUSCLE ACHES; FATIGUE; SLIGHT HEADACHE; This spontaneous report was received from a 41-year-old, female patient of other (unspecified) race. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, non alcohol user, and non smoker. The patient had no known allergies and no drug abuse/illicit drug use. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 2021421A, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021 (1 day post vaccination), the patient experienced symptoms of fatigue, muscle aches, chest pressure, fast heart rate, teeth/gums/jaw pain, low blood pressure, slight headache. The patient's doctor had a suspicion of blood clots and hence, on 14-APR-2021, the patient was hospitalized. The patient got her blood work, chest X-ray, electrocardiogram (EKG), and heart monitoring done and results of all tests were normal and she was cleared. No blood clots were found. On 14-APR-2021, the patient was discharged from the hospital. On 15-APR-2021, she felt a little bit better and then on 16-APR-2021 (two days post hospitalization), her symptoms completely subsided. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, fast heart rate, teeth pain, gum pain, jaw pain, low blood pressure, muscle aches, fatigue, and slight headache on 16-APR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210702888-COVID-19 VACCINE AD26.COV2.S-chest pressure, fast heart rate, teeth pain, gum pain, jaw pain, low 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). 20210702888-COVID-19 VACCINE AD26.COV2.S-muscle aches, fatigue, slight headache. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in jaw, Toothache
Clinical narrative: CHEST PRESSURE; FAST HEART RATE; TEETH PAIN; GUM PAIN; JAW PAIN; LOW BLOOD PRESSURE; MUSCLE ACHES; FATIGUE; SLIGHT HEADACHE; This spontaneous report was received from a 41-year-old, female patient of other (unspecified) race. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, non alcohol user, and non smoker. The patient had no known allergies and no drug abuse/illicit drug use. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 2021421A, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021 (1 day post vaccination), the patient experienced symptoms of fatigue, muscle aches, chest pressure, fast heart rate, teeth/gums/jaw pain, low blood pressure, slight headache. The patient's doctor had a suspicion of blood clots and hence, on 14-APR-2021, the patient was hospitalized. The patient got her blood work, chest X-ray, electrocardiogram (EKG), and heart monitoring done and results of all tests were normal and she was cleared. No blood clots were found. On 14-APR-2021, the patient was discharged from the hospital. On 15-APR-2021, she felt a little bit better and then on 16-APR-2021 (two days post hospitalization), her symptoms completely subsided. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, fast heart rate, teeth pain, gum pain, jaw pain, low blood pressure, muscle aches, fatigue, and slight headache on 16-APR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210702888-COVID-19 VACCINE AD26.COV2.S-chest pressure, fast heart rate, teeth pain, gum pain, jaw pain, low 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). 20210702888-COVID-19 VACCINE AD26.COV2.S-muscle aches, fatigue, slight headache. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bronchitis, Chest X-ray, Cough, Culture
Clinical narrative: BRONCHITIS; SHORTNESS OF BREATH; BODY ACHES; COUGHING; HEADACHE; FEVER; This spontaneous report received from a patient by a Business partner on 24-JUN-2021 was received on 24-JUN-2021 and concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included incision and drainage, covid-19, covid-19 pneumonia, cyst on middle of breast, slurred speech, difficulty in walking, and several ear infection, and concurrent conditions included penicillin allergy, moderate to severe rheumatoid arthritis, heart murmur, no tobacco use, abstains from alcohol, high blood pressure, back pain, and diabetes, and other pre-existing medical conditions included the patient had sulpha drugs allergy manifested by difficulty of breathing. The patient experienced drug allergy (cannot breathe/chest pain, bronchitis) when treated with infliximab.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included tramadol for back pain, glimepiride for diabetes, metformin for diabetes, lisinopril for high blood pressure, and adalimumab for moderate to severe rheumatoid arthritis.  On 22-JUL-2020, Laboratory data included: Body temperature (NR: not provided) 104 F, Chest X-ray (NR: not provided) Pneumonia, and Culture nose (NR: not provided) Positive for covid-19. On JUN-2021, the subject experienced bronchitis. On JUN-2021, the subject experienced shortness of breath. On JUN-2021, the subject experienced body aches. On JUN-2021, the subject experienced coughing. On JUN-2021, the subject experienced headache. On JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath, bronchitis, headache, coughing, fever and body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pain, Pyrexia
Clinical narrative: BRONCHITIS; SHORTNESS OF BREATH; BODY ACHES; COUGHING; HEADACHE; FEVER; This spontaneous report received from a patient by a Business partner on 24-JUN-2021 was received on 24-JUN-2021 and concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included incision and drainage, covid-19, covid-19 pneumonia, cyst on middle of breast, slurred speech, difficulty in walking, and several ear infection, and concurrent conditions included penicillin allergy, moderate to severe rheumatoid arthritis, heart murmur, no tobacco use, abstains from alcohol, high blood pressure, back pain, and diabetes, and other pre-existing medical conditions included the patient had sulpha drugs allergy manifested by difficulty of breathing. The patient experienced drug allergy (cannot breathe/chest pain, bronchitis) when treated with infliximab.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included tramadol for back pain, glimepiride for diabetes, metformin for diabetes, lisinopril for high blood pressure, and adalimumab for moderate to severe rheumatoid arthritis.  On 22-JUL-2020, Laboratory data included: Body temperature (NR: not provided) 104 F, Chest X-ray (NR: not provided) Pneumonia, and Culture nose (NR: not provided) Positive for covid-19. On JUN-2021, the subject experienced bronchitis. On JUN-2021, the subject experienced shortness of breath. On JUN-2021, the subject experienced body aches. On JUN-2021, the subject experienced coughing. On JUN-2021, the subject experienced headache. On JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath, bronchitis, headache, coughing, fever and body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Cough, Musculoskeletal discomfort, Nasopharyngitis, Pain in extremity
Clinical narrative: COLD; COUGH; FEVERISH; FEELING LIKE KNEES BENDING WHEN STANDS UP; CAN NOT SIT TOO LONG IN TOILET AND CHAIR; SEVERE PAIN IN LEGS BEHIND THE KNEES; This spontaneous report received from a patient concerned a 43 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced feeling like knees bending when stands up. On JUN-2021, the subject experienced can not sit too long in toilet and chair. On JUN-2021, the subject experienced severe pain in legs behind the knees. Treatment medications included: paracetamol. On 16-JUN-2021, the subject experienced feverish. On 17-JUN-2021, the subject experienced cough. On 18-JUN-2021, the subject experienced cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, and feverish on JUN-2021, had not recovered from cough, feeling like knees bending when stands up, and severe pain in legs behind the knees, and the outcome of can not sit too long in toilet and chair was not reported. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: COLD; COUGH; FEVERISH; FEELING LIKE KNEES BENDING WHEN STANDS UP; CAN NOT SIT TOO LONG IN TOILET AND CHAIR; SEVERE PAIN IN LEGS BEHIND THE KNEES; This spontaneous report received from a patient concerned a 43 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced feeling like knees bending when stands up. On JUN-2021, the subject experienced can not sit too long in toilet and chair. On JUN-2021, the subject experienced severe pain in legs behind the knees. Treatment medications included: paracetamol. On 16-JUN-2021, the subject experienced feverish. On 17-JUN-2021, the subject experienced cough. On 18-JUN-2021, the subject experienced cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, and feverish on JUN-2021, had not recovered from cough, feeling like knees bending when stands up, and severe pain in legs behind the knees, and the outcome of can not sit too long in toilet and chair was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative via social media 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 not reported, batch number: Unknown) one total, dose not reported, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced died. On an unspecified date, the patient was died from unknown cause of death. It was unknown whether the 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 20210703030-JANSSEN COVID-19 VACCINE-died. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: FEELING LOW ENERGY; This spontaneous report received from a patient 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: 1808980 and expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced feeling low energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling low energy. This report was non-serious.