chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional adverse events reported.; the 3rd dose of RECOMBIVAX HB was administered to a patient less than 16 weeks from the first dose.; This spontaneous report was received from a nurse referring to a 3 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 08-DEC-2020, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (0.5 ml; strength, route, lot # and expiration date were unknown) for prophylaxis. On 07-JAN-2021, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (0.5 ml; strength, route, lot # and expiration date were unknown) for prophylaxis. On 26-MAR-2021, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (0.5 ml; strength, route, lot # and expiration date were unknown) for prophylaxis, which was administered to the patient less than 16 weeks from the first dose (inappropriate schedule of product administration). The reporter had very limited information, no other information known at reporting time. No additional adverse events reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No PQC or additional AEs reported.; expired dose of MMR II was given today; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.       On 14-MAY-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) (0.5 mg, strength and anatomical location were not reported, lot # S013539, expiration date 02-MAY-2021) intramuscularly (IM) for prophylaxis (expired vaccine used). No additional adverse events were reported. The reported asked if patient should be revaccinated.
Age: 25.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; administered dose of expired MMRll; This spontaneous report was received from a registered pharmacist and refers to a 25-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and drug reactions or allergies was provided. The patient's concomitant medications included sterile diluent.  On 14-MAY-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 ml, lot # R030806, expiration date 24-OCT-2020 (dose number, vaccination site and route of administration were not provided) for prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shots doesn't prevent you from getting shingles / got them in Oct & still have them /Suspected vaccination failure; Shingles / got them in Oct & still have them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In October 2020, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received Shingles vaccine and got shingles and till the time of reporting, the patient still had them. The patient stated that shots did not prevent you from getting shingles, but it reduces chances and severity if you get them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: she had it also after the shots/ Suspected vaccination failure; she had it also after the shots; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient had shingles after the Shingles vaccines. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked with US2021AMR103693 and US2021AMR103686, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR103693:same reporter US-GLAXOSMITHKLINE-US2021AMR103686:same reporter
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Decreased appetite, Diarrhoea, Pain
Clinical narrative: Experiencing aches and pain all over his body; Aches and pain within joints; Diarrhea; No appetite; Weakness / has had no energy / still weak; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included secukinumab (Cosentyx) for product used for unknown indication.   On 11th May 2021, the patient received Shingrix. On 13th May 2021, the patient started Cosentyx at an unknown dose and frequency. On 14th May 2021, 3 days after receiving Shingrix, the patient experienced general body pain, joint pain, diarrhea, appetite absent and weakness. The action taken with Cosentyx was unknown. On an unknown date, the outcome of the general body pain, joint pain and diarrhea were recovering/resolving and the outcome of the appetite absent and weakness were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, joint pain, diarrhea, appetite absent and weakness to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The patient received the Shingrix vaccine and then received his monthly dose of Cosentyx 2 days later. The patient started experiencing aches and pain all over his body and within joints, diarrhea, weakness, no appetite, and had no energy.  The patient had sent a message out to his health care professional who did not seem concerned and had not called the patient back.  On the reporting date, the patient's symptoms seemed better but was still weak and had no appetite.  The reporter had questioned if it could be from the shingrix vaccines or due to combination of both shots. The reporter consented to follow-up and gave consent to follow-up with health care professional. It was unknown if the reporter considered the general body pain, joint pain, diarrhea, appetite absent and weakness to be related to Cosentyx.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Received a dose of Pediarix on may 3rd, 2020 instead of Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2KD4D, expiry date 8th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Hib (Hiberix).   On 3rd May 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 3rd May 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device and an unknown time after receiving Hiberix, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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: The health care professional reported that the patient received a dose of Pediarix instead of Infanrix, which led to wrong vaccine administered and also received a dose of Hiberix on the same day of vaccination. The vaccines were given at her 15 month wellness visit. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the second dose of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   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: Age at vaccination was not applicable. The age group was selected as an adult as per vaccine indication. The patient missed the second dose of Shingrix, which led to incomplete course of vaccination. No lot number or expiration date provided. No additional information provided. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: 1st dose of Shingrix on 22Nov2019 and is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd 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 follow: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of SHingrix, which led to incomplete course of vaccination. No symptoms were reported. At the time of reporting, the reporter did not had lot an expiration date. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: A rash presented underneath both breasts; This case was reported by a physician via call center representative and described the occurrence of rash in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 18th May 2021, 3 days after receiving Shingrix, the patient experienced rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows:  The reporter was the patient's husband. The patient received 2nd dose of Shingrix vaccine in left arm and on the reporting date morning, a rash presented underneath both breasts. The reporter consented to follow-up with patient. The reporter provided permission to follow up with him.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of TWINRIX on the 4th January, 2021 / second dose was not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 24-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included TWINRIX (1st dose received in 4th January 2021 with lot number: 75C72, exp irydate 13th June 2022.).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: The age at vaccination was not applicable for this report. The patient received 1st dose of Twinrix vaccine at primary reporter's facility. The pharmacist reported that the patient was known out of schedule to get the 2nd dose of the Twinrix vaccine and till the time of reporting, the 2nd dose was not administered which led to incomplete course of vaccination. No further details or events were reported at the time of the call. The reporter consented to follow up by email.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix more than 2.5 years ago / second dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received more than 2.5 years ago from the date of 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 had not been administered 2nd dose of Shingrix which led to incomplete course of vaccination. The healthcare professional was in a hurry and did not had time to provide all the details concerning the patient. The reporter did not consent to follow-up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Fatigue, Gastrointestinal haemorrhage, Haemorrhage, SARS-CoV-2 test
Clinical narrative: SIGNIFICANT GI BLEED; DEATH; SUBORBITAL BLEEDING AROUND BILATERAL EYES; FATIGUE/ FEELING TIRED; This spontaneous report received from a consumer concerned a 55 year old male. The patient's weight was 240 pounds, and height was 60 inches. The patient's past medical history included thrombocytopenia, and concurrent conditions included cirrhosis of the liver, smoker, and non alcoholic, and other pre-existing medical conditions included patient had no known allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 02-APR-2021, the patient experienced fatigue/ feeling tired. On 15-APR-2021, the patient experienced suborbital bleeding around bilateral eyes. On 03-MAY-2021, the patient experienced death. On an unspecified date, the patient experienced significant GI bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died, and outcome of significant GI bleed, suborbital bleeding around bilateral eyes was unknown and not recovered from fatigue/ feeling tired. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210516526-covid-19 vaccine ad26.cov2.s-death. 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). 20210516526-covid-19 vaccine ad26.cov2.s-significant GI bleed, suborbital bleeding around bilateral eyes. 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: MEDICAL HISTORY
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypertension, Nervousness
Clinical narrative: HIGH BLOOD PRESSURE; PULSATING FEELING ALL OVER THE BODY; FAST HEART RATE; This spontaneous report received from a patient concerned a African American, Not Hispanic or Latino 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: 65A21A, and expiry: unknown) 1 total dose was, administered at right arm on 03-MAY-2021 for prophylactic vaccination and felt fine. No concomitant medications were reported. On unspecified date in MAY-2021, it was reported that her husband took the second shot of the Moderna vaccine and had symptoms. She took him to urgent care and told the nurse that she had the JNJ and the nurse said omg (oh my god) can't believe you had that. The patient was felt like her heart was beating extremely fast (first heart rate) but when her pulse were checked by the nurse at urgent care it was good, it had not stopped ever since. She experienced high blood pressure (high blood pressure) when they checked her blood pressure in the hospital it was like 216, it keeps going up and down. She did not know how long this would continue and if it was a side effect or not. It does not hurt but felt annoying as she developed a pulsating feeling all over the body (pulsating feeling all over the body). She was treated with blood pressure medication, blood thinners (unspecified) and was something (unspecified) to slow her heart rate down.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from first heart rate, and the outcome of high blood pressure and pulsating feeling all over the body was not reported. This report was serious (Other Medically Important Condition.; Sender's Comments: V0-20210526496-covid-19 vaccine ad26.cov2.s-High Blood Pressure. This event is considered Un assessable. 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: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Fatigue, Feeling abnormal, Lethargy, Malaise
Clinical narrative: BLOOD CLOTS GALORE; FEELING SICK (NOT FEELING WELL); FEELING OF WOULD NOT MAKE IT AND SAYING GOODBYE TOMORROW; MUSCLE ACHES; TIRED; LETHARGIC; BODY ACHES; This spontaneous report received from a consumer concerned a 55 year old female of unknown race and ethnicity. 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 16-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-APR-2021 after vaccination, the patient got tired, lethargic, was not "feeling well" and body and muscles started to ache and progressed further. The consumer reported that on 08-MAY-2021, the patient was feeling sick and drove herself into the hospital. On 11-MAY-2021, the patient had blood clots galore and was on dialysis. On 12-MAY-2021, the consumer had one note stating the patient was holding steady and during night the consumer stated there's no change in patient's condition. On 13-MAY-2021, patient was going through with computerised tomography scan and told later that patient would not make it and would be saying goodbye tomorrow. On 13-MAY-2021, Laboratory data included: CT scan (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots galore, and the outcome of tired, lethargic, body aches, feeling sick (not feeling well) and muscle aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210529809 - Covid-19 vaccine ad26.cov2.s- blood clots galore. 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: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain, Thrombosis
Clinical narrative: BLOOD CLOTS GALORE; FEELING SICK (NOT FEELING WELL); FEELING OF WOULD NOT MAKE IT AND SAYING GOODBYE TOMORROW; MUSCLE ACHES; TIRED; LETHARGIC; BODY ACHES; This spontaneous report received from a consumer concerned a 55 year old female of unknown race and ethnicity. 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 16-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-APR-2021 after vaccination, the patient got tired, lethargic, was not "feeling well" and body and muscles started to ache and progressed further. The consumer reported that on 08-MAY-2021, the patient was feeling sick and drove herself into the hospital. On 11-MAY-2021, the patient had blood clots galore and was on dialysis. On 12-MAY-2021, the consumer had one note stating the patient was holding steady and during night the consumer stated there's no change in patient's condition. On 13-MAY-2021, patient was going through with computerised tomography scan and told later that patient would not make it and would be saying goodbye tomorrow. On 13-MAY-2021, Laboratory data included: CT scan (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots galore, and the outcome of tired, lethargic, body aches, feeling sick (not feeling well) and muscle aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210529809 - Covid-19 vaccine ad26.cov2.s- blood clots galore. 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: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Angiogram pulmonary, Angiogram pulmonary abnormal, Brain injury, Brain oedema
Clinical narrative: BLOOD CLOTS GALORE; FEELING SICK (NOT FEELING WELL); FEELING OF WOULD NOT MAKE IT AND SAYING GOODBYE TOMORROW; MUSCLE ACHES; TIRED; LETHARGIC; BODY ACHES; This spontaneous report received from a consumer concerned a 55 year old female of unknown race and ethnicity. 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 16-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-APR-2021 after vaccination, the patient got tired, lethargic, was not "feeling well" and body and muscles started to ache and progressed further. The consumer reported that on 08-MAY-2021, the patient was feeling sick and drove herself into the hospital. On 11-MAY-2021, the patient had blood clots galore and was on dialysis. On 12-MAY-2021, the consumer had one note stating the patient was holding steady and during night the consumer stated there's no change in patient's condition. On 13-MAY-2021, patient was going through with computerised tomography scan and told later that patient would not make it and would be saying goodbye tomorrow. On 13-MAY-2021, Laboratory data included: CT scan (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots galore, and the outcome of tired, lethargic, body aches, feeling sick (not feeling well) and muscle aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210529809 - Covid-19 vaccine ad26.cov2.s- blood clots galore. 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: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Computerised tomogram head abnormal, Continuous haemodiafiltration, Death, Deep vein thrombosis
Clinical narrative: BLOOD CLOTS GALORE; FEELING SICK (NOT FEELING WELL); FEELING OF WOULD NOT MAKE IT AND SAYING GOODBYE TOMORROW; MUSCLE ACHES; TIRED; LETHARGIC; BODY ACHES; This spontaneous report received from a consumer concerned a 55 year old female of unknown race and ethnicity. 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 16-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-APR-2021 after vaccination, the patient got tired, lethargic, was not "feeling well" and body and muscles started to ache and progressed further. The consumer reported that on 08-MAY-2021, the patient was feeling sick and drove herself into the hospital. On 11-MAY-2021, the patient had blood clots galore and was on dialysis. On 12-MAY-2021, the consumer had one note stating the patient was holding steady and during night the consumer stated there's no change in patient's condition. On 13-MAY-2021, patient was going through with computerised tomography scan and told later that patient would not make it and would be saying goodbye tomorrow. On 13-MAY-2021, Laboratory data included: CT scan (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots galore, and the outcome of tired, lethargic, body aches, feeling sick (not feeling well) and muscle aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210529809 - Covid-19 vaccine ad26.cov2.s- blood clots galore. 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: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Hepatic steatosis, Hypotension, Hypoxia
Clinical narrative: BLOOD CLOTS GALORE; FEELING SICK (NOT FEELING WELL); FEELING OF WOULD NOT MAKE IT AND SAYING GOODBYE TOMORROW; MUSCLE ACHES; TIRED; LETHARGIC; BODY ACHES; This spontaneous report received from a consumer concerned a 55 year old female of unknown race and ethnicity. 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 16-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-APR-2021 after vaccination, the patient got tired, lethargic, was not "feeling well" and body and muscles started to ache and progressed further. The consumer reported that on 08-MAY-2021, the patient was feeling sick and drove herself into the hospital. On 11-MAY-2021, the patient had blood clots galore and was on dialysis. On 12-MAY-2021, the consumer had one note stating the patient was holding steady and during night the consumer stated there's no change in patient's condition. On 13-MAY-2021, patient was going through with computerised tomography scan and told later that patient would not make it and would be saying goodbye tomorrow. On 13-MAY-2021, Laboratory data included: CT scan (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots galore, and the outcome of tired, lethargic, body aches, feeling sick (not feeling well) and muscle aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210529809 - Covid-19 vaccine ad26.cov2.s- blood clots galore. 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: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoxic-ischaemic encephalopathy, Lung assist device therapy, Mental impairment, Multiple organ dysfunction syndrome, Pain in extremity
Clinical narrative: BLOOD CLOTS GALORE; FEELING SICK (NOT FEELING WELL); FEELING OF WOULD NOT MAKE IT AND SAYING GOODBYE TOMORROW; MUSCLE ACHES; TIRED; LETHARGIC; BODY ACHES; This spontaneous report received from a consumer concerned a 55 year old female of unknown race and ethnicity. 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 16-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-APR-2021 after vaccination, the patient got tired, lethargic, was not "feeling well" and body and muscles started to ache and progressed further. The consumer reported that on 08-MAY-2021, the patient was feeling sick and drove herself into the hospital. On 11-MAY-2021, the patient had blood clots galore and was on dialysis. On 12-MAY-2021, the consumer had one note stating the patient was holding steady and during night the consumer stated there's no change in patient's condition. On 13-MAY-2021, patient was going through with computerised tomography scan and told later that patient would not make it and would be saying goodbye tomorrow. On 13-MAY-2021, Laboratory data included: CT scan (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots galore, and the outcome of tired, lethargic, body aches, feeling sick (not feeling well) and muscle aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210529809 - Covid-19 vaccine ad26.cov2.s- blood clots galore. 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: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pulmonary embolism, Pulmonary infarction, Right ventricular dysfunction, Thrombectomy
Clinical narrative: BLOOD CLOTS GALORE; FEELING SICK (NOT FEELING WELL); FEELING OF WOULD NOT MAKE IT AND SAYING GOODBYE TOMORROW; MUSCLE ACHES; TIRED; LETHARGIC; BODY ACHES; This spontaneous report received from a consumer concerned a 55 year old female of unknown race and ethnicity. 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 16-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-APR-2021 after vaccination, the patient got tired, lethargic, was not "feeling well" and body and muscles started to ache and progressed further. The consumer reported that on 08-MAY-2021, the patient was feeling sick and drove herself into the hospital. On 11-MAY-2021, the patient had blood clots galore and was on dialysis. On 12-MAY-2021, the consumer had one note stating the patient was holding steady and during night the consumer stated there's no change in patient's condition. On 13-MAY-2021, patient was going through with computerised tomography scan and told later that patient would not make it and would be saying goodbye tomorrow. On 13-MAY-2021, Laboratory data included: CT scan (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots galore, and the outcome of tired, lethargic, body aches, feeling sick (not feeling well) and muscle aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210529809 - Covid-19 vaccine ad26.cov2.s- blood clots galore. 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: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler, Ultrasound Doppler abnormal, Withdrawal of life support
Clinical narrative: BLOOD CLOTS GALORE; FEELING SICK (NOT FEELING WELL); FEELING OF WOULD NOT MAKE IT AND SAYING GOODBYE TOMORROW; MUSCLE ACHES; TIRED; LETHARGIC; BODY ACHES; This spontaneous report received from a consumer concerned a 55 year old female of unknown race and ethnicity. 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 16-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-APR-2021 after vaccination, the patient got tired, lethargic, was not "feeling well" and body and muscles started to ache and progressed further. The consumer reported that on 08-MAY-2021, the patient was feeling sick and drove herself into the hospital. On 11-MAY-2021, the patient had blood clots galore and was on dialysis. On 12-MAY-2021, the consumer had one note stating the patient was holding steady and during night the consumer stated there's no change in patient's condition. On 13-MAY-2021, patient was going through with computerised tomography scan and told later that patient would not make it and would be saying goodbye tomorrow. On 13-MAY-2021, Laboratory data included: CT scan (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots galore, and the outcome of tired, lethargic, body aches, feeling sick (not feeling well) and muscle aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210529809 - Covid-19 vaccine ad26.cov2.s- blood clots galore. 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Syncope
Clinical narrative: FAINTED POST IMMUNIZATION; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 26 year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included needle phobia, alcohol use (Social - 1-2 drinks per week; very light drinker) and non-smoker. The product was stored in appropriate temperature conditions (it was stored properly from receipt to administration). The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) administered on 07-MAY-2021 to left arm as 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 07-MAY-2021, the patient fainted post immunization. On the same day, she was feeling exhausted and had headache. On 08-MAY-2021, she experienced low grade fever and lethargy. Till 10-MAY-2021, she was feeling exhausted and had headaches. On 13-MAY-2021, she identified lack of smell while cleaning house (cleaning products). On the same day, she had positive rapid home test for COVID 19 and she tested negative at health care professional (HCP). On 14-MAY-2021, she was tested positive polymerase chain reaction (PCR) for Covid 19 (headache, exhausted, low grade fever, lack of smell and lethargy). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted post immunization on 07-MAY-2021, and was recovering from confirmed covid-19 infection. This report was associated with product quality complaint: 90000179636 This report was serious (Other Medically Important Condition).  The narrative states the patient received the vaccine on 07-May-2021 and had a positive Covid-19 test on 14-May-2021 with 7 days elapsed between vaccine and test. There was not sufficient time elapsed for the patient to achieve immunity therefore this report was not considered a lack of effect. The suspected product quality complaint has been confirmed to be voided there was no PQC identified within the reported complaint. Voided based on the PQC evaluation/investigation performed".; Sender's Comments: V0:20210530216-covid-19 vaccine ad26.cov2.s-Fainted post immunisation. 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: Cardiac disorder
Clinical narrative: HEART ISSUES; 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: Unk) dose was not reported, administered on 14-MAY-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 14-MAY-2021, the subject experienced heart issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart issues. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hemiplegia
Clinical narrative: STROKE; LEFT SIDED PARALYSIS ( (INCLUDES FACE AND BODY); This spontaneous report received from a consumer concerned a white and Not Hispanic or Latino, 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included down's syndrome. 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,1 total, administered on left arm on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-MAY-2021 stroke and left sided paralysis on face and body. Ambulance was arrived around 20:00. The patient was hospitalized over night.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke, and left sided paralysis. This report was serious (Other Important Medical Condition).; Sender's Comments: V0: 20210532320- Covid-19 vaccine ad26.cov2.s- Stroke, left sided paralysis- 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.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cerebral thrombosis
Clinical narrative: BLOOD CLOT IN BRAIN; LOWER LEFT BACK PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, she experienced blood clot in brain, and lower left back pain, and was hospitalized (date unspecified)  for about 12 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in brain and lower left back pain was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0 20210532694-COVID-19 VACCINE AD26.COV2.S-Blood clot in brain, Lower left back pain. 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling hot, Hyperhidrosis, Migraine
Clinical narrative: EXHAUSTION; MIGRAINE; BODY WARMTH; SWEATING; GENERALISED ACHING; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included fibromyalgia, compressed l side, s/p rotator cuff surgery (r) shoulder, post-traumatic stress disorder, and irritable bowel syndrome, and concurrent conditions included rheumatoid arthritis, amoxicillin and ceftin allergy, and trazadone allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included oxycodone/paracetamol for body temperature increased to 97, and2 f. On 15-MAY-2021, the subject experienced migraine. On 15-MAY-2021, the subject experienced body warmth. On 15-MAY-2021, the subject experienced sweating. On 15-MAY-2021, the subject experienced generalised aching. Laboratory data included: Body temperature (NR: not provided) 97.2 F. On 17-MAY-2021, the subject experienced exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, body warmth, and sweating on 17-MAY-2021, and was recovering from exhaustion, and generalised aching. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: EXHAUSTION; MIGRAINE; BODY WARMTH; SWEATING; GENERALISED ACHING; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included fibromyalgia, compressed l side, s/p rotator cuff surgery (r) shoulder, post-traumatic stress disorder, and irritable bowel syndrome, and concurrent conditions included rheumatoid arthritis, amoxicillin and ceftin allergy, and trazadone allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included oxycodone/paracetamol for body temperature increased to 97, and2 f. On 15-MAY-2021, the subject experienced migraine. On 15-MAY-2021, the subject experienced body warmth. On 15-MAY-2021, the subject experienced sweating. On 15-MAY-2021, the subject experienced generalised aching. Laboratory data included: Body temperature (NR: not provided) 97.2 F. On 17-MAY-2021, the subject experienced exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, body warmth, and sweating on 17-MAY-2021, and was recovering from exhaustion, and generalised aching. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple patients (8 patients) Patients weight, height, and medical history were not reported. Patients 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, 8 patients got blood clots so they stopped using JANSSEN COVID VACCINE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210533746-COVID-19 VACCINE AD26.COV2.S-Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).