chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix on 18Nov2019 / 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 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th 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, patient did not received 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter did not had lot or expiration date. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Autoimmune hepatitis, Biopsy liver
Clinical narrative: Autoimmune hepatitis; This case was reported by a nurse and described the occurrence of autoimmune hepatitis in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced autoimmune hepatitis (serious criteria hospitalization and GSK medically significant). The patient was treated with prednisone. On an unknown date, the outcome of the autoimmune hepatitis was not recovered/not resolved.   It was unknown if the reporter considered the autoimmune hepatitis to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient was given the first dose of the shingrix vaccine and 1 week later he developed autoimmune hepatitis. He had to be hospitalized for several days and get a liver biopsy. The nurse did not know exactly how long he was hospitalized. While in the hospital he was treated with prednisone. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Chills, Pruritus, Pyrexia
Clinical narrative: weakness.; chills; Fever 102°F; itch; This case was reported by a consumer via call center representative and described the occurrence of chills in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on unknown date).   On 29th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a week after receiving Shingrix, the patient experienced chills, fever, pruritus and weakness. On an unknown date, the outcome of the chills, fever, pruritus and weakness were unknown.   It was unknown if the reporter considered the chills, fever, pruritus and weakness to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and presented chills, fever 102°F, itch and weakness.  No symptoms after getting the 1st dose. The reporter did not consent to follow up. No lot number and expiration date provided.  Facility information not provided.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: patient had covid 2-3 weeks ago; This case was reported by a nurse via call center representative and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was recovered/resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The nurse was looking for medical information for Shingrix dosing if a patient had covid 2 to 3 weeks ago. The patient was okay till the time of reporting and she was asking for Shingrix second dose. The reporter stated that interval between doses was okay.  The reporter did not consent to follow up.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: received, today 9 AM, an expired dose of Boostrix.; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 65-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 429H5, expiry date 7th February 2021) for prophylaxis.   On 30th March 2021 09:00, the patient received Boostrix. On 30th March 2021 09:00, unknown after receiving Boostrix, 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 patient received, an expired dose of Boostrix, which led to expired vaccine used. No further information reported. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Engerix B peds dose was given to an adult patient; Engerix B peds dose was given to an adult patient; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 51-year-old male patient who received HBV (Engerix B pediatric) (batch number 722KC, expiry date unknown) for prophylaxis.   Previously administered products included Engerix B (1st dose received on unknown date).   On 30th March 2021, the patient received the 2nd dose of Engerix B pediatric. On 30th March 2021, unknown after receiving Engerix B pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the pediatric dose instead of adult which led accidental underdose and adult use of a child product. The reporter inquired that could the 3rd adult dose would be given and when. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product prescribing error
Clinical narrative: 30 years old patient has a script from a doctor to receive the first dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 30-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced shingles on an unknown date last year).   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 age at vaccination was not applicable for this report. The pharmacist reported that this 30-year-old patient had a script from a doctor to receive the 1st dose of Shingrix as to the patient got shingles last year, which led to intercepted drug prescribing error. Till the time of reporting, the patient had not received any dose. The reporter did not consent to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: reconstituted with a no GSK adjuvant and given; reconstituted with a no GSK adjuvant and given; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number LN399, expiry date 9th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th November 2020).   On 29th March 2021, the patient received the 2nd dose of Shingrix. On 29th March 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details was reported as follows: Patient received Shingrix reconstituted with a no GlaxoSmithKline adjuvant which led to as inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. No other information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain
Clinical narrative: pain at the injection site; feeling dizzy; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 4RF5J, expiry date 25th April 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain and dizziness. On an unknown date, the outcome of the injection site pain and dizziness were recovered/resolved.   It was unknown if the reporter considered the injection site pain and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After the administration of Shingrix vaccine, the patient started feeling dizzy, condition lasted for a week and presented pain at the injection site the same day of the administration. The reporter did not consent to follow-up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 10/13/19 / 2nd dose 3/30/21; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13th October 2019).   On 30th March 2021, the patient received the 2nd dose of Shingrix. On 30th March 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows:  The patient received the 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix shot #1 / on 02-Sep-2019. More than 6 months has passed / not 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 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (received 1st dose on 2nd September 2019 batch number 9LG54 and expiry date 25th September 2021, intramuscularly at the retail pharmacy).   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. More than 6 months had passed and the patient had not received second dose which led to incomplete course of vaccination. The reporter wanted to know could 2nd dose be given now or does the series needs to be re-started. The reporter informed vaccine administration location same as reporter. The fax number of pharmacy was provided by patient but did not have work email account. No further details was provided. Consented to follow up was unknown.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received a menveo vaccine that was reconstituted incorrectly; Received a menveo vaccine that was reconstituted incorrectly; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 30th March 2021, the patient received Menveo. On 30th March 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of menveo and experienced received a menveo vaccine that was reconstituted incorrectly, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter inquired how to move forward with vaccination. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Dermatitis allergic
Clinical narrative: Experienced an allergic reaction / Doctor needs to run her some skin test; This case was reported by a consumer via call center representative and described the occurrence of allergic skin reaction in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than 9 months after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced allergic skin reaction. On an unknown date, the outcome of the allergic skin reaction was unknown.   It was unknown if the reporter considered the allergic skin reaction to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient after receiving Fluarix QIV vaccine she experienced an allergic reaction and now the doctor needed to run her some skin test. The patient wanted to know how to get a pharmacy to fill Fluarix without administrating it. She suggested the prescriber call VSC (vaccine service center) but caller said that prescriber just wanted one dose. The reporter had prescriber (allergist) follow up with VSC (vaccine service center). No further clarifications were made. The reporter did not mentioned (consent or denied) regarding consented to follow up.
Sex: M
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Got shingrix vaccine at an unknown time in the past / Diagnosed with shingles/Suspected vaccination failure; Diagnosed as shingles; Rash on his foot; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   On an unknown date, the patient received Shingrix, the 1st dose of COVID 19 VACCINE and the 2nd dose of COVID 19 VACCINE. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine at an unknown time in the past and had recently got Covid vaccine 1st and second dose. Two days after the second dose of coronavirus vaccine, the patient developed a rash on foot which provider diagnosed as shingles.  This case was considered as suspected vaccination failure, since the details regarding completion of the primary immunization for shingles, time to onset and laboratory confirmation for herpes zoster were not provided. The reporter had limited information and no other additional information was available. The reporter did not consent to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose - in 2018 / i would have to start over and got the shot in sep 2020.; This case was reported by a consumer and described the occurrence of drug dose administration interval too long in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2018).   In September 2020, the patient received the 2nd dose of Shingrix. In September 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient had reported the case for himself. The patient received 1st shot in September 2018 and never got the 2nd shot and he thought he would have to start over and got the shot in September 2020, delayed than the recommended interval, which led to lengthening of the vaccination schedule. The patient did not experience any side effects.  The patient asked if he need another shot or not. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Delayed second dose / has been over a year since the first 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 (received 1st dose over a year before 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 information was 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 inquired about a delayed second dose of Shingrix. It had been over a year since the first dose, reporter wanted to know should the series be continued or restarted. The reporter consented to follow up. Discrepancy: The patient's date of birth was not captured as it was future date.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose of Shingrix over a year ago / Never 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 male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020 year over a year ago from the reporting 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: The age at vaccination was not applicable for this report. The patient received 1st dose in his doctor's office and till the time of reporting never received the second dose, which led to incomplete course of vaccination. The health care professional did not provide more information about the patient since she received the question by phone. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019000163:same reporter
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: BLUE COLOURED HANDS; This spontaneous report received from a pharmacist 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 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The reporter stated that, on 11-MAR-2021, after receiving the Janssen covid19 vaccine the patient had blue coloured hands. Pharmacy staff was monitoring the patient and, the patient was further instructed to go to ER if condition worsened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blue coloured hands. This report was serious (Other Medically Important Condition).  Additional information was received on 22-Mar-2021. The following information was updated and incorporated into the case narrative. Updated patient gender (from Unknown to Female).; Sender's Comments: V1: Additional information received in this version is regarding update on gender of patient. The follow up information does not change the previous causality assessment.  20210322152-covid-19 vaccine ad26.cov2.s -Blue coloured hands. This event is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative and concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient developed covid-19 infection.  On an unspecified date, the patient died from covid-19. It was unknown if an 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: A patient of unknown age and gender died an unknown time after receiving Janssen COVID-19 Vaccine Ad26.COV2.S (suspension for injection, route of administration not reported) for prophylactic vaccination. Medical history, concomitant medications, and details of the event were not reported. It was unknown if an autopsy was performed. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: COVID-19
Sex: U
Vaccine: COVID19
Symptoms: Acute pulmonary oedema, Body temperature, Echocardiogram, Pyrexia, Troponin
Clinical narrative: ACUTE PULMONARY EDEMA; FEVER; This spontaneous report received from a physician concerned a patient of unspecified age and unspecified sex. The patient's weight, height, and medical history were not reported.  The patient received JNJ78436735 (Ad26.COV2.S) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported by HCP that the patient was admitted to hospital on MAR-2021, the patient experienced acute pulmonary edema with symptoms (shortness of breath(SOB), questionable bloody sputum) and was intubated in emergency room (ER) where he developed troponin level of 65, ejection fraction of 30% baseline was 50 to 55%, and fever. Laboratory data included: Body temperature 101.7 tympanic, Echocardiogram ejection fraction of 30% baseline was 50 to 55%, and Troponin level of 65.  The treatment of intubation was administered for acute pulmonary edema. The days of hospitalization was not known.  The action taken with JNJ78436735 (Ad26.COV2.S) was not applicable. The outcome of the acute pulmonary edema and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: 20210331243-COVID-19 VACCINE AD26.COV2.S-Acute Pulmonary edema . 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(s). 20210331243-COVID-19 VACCINE AD26.COV2.S-Fever. This event is labeled and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Tremor
Clinical narrative: BP 255/105 / BP 212/84; SHAKING; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight was 105 pounds, and height was not reported. The patient's concurrent conditions included blood pressure disorder, and other pre-existing medical conditions included patient is on medication for bp .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced bp 255/105 / bp 212/84. On 20-MAR-2021, the subject experienced shaking. Laboratory data included: Blood pressure (NR: not provided) 255/105 mmHg, 212/84 mmHg. Husband calls to report wife's BP read 255/105 about 12 hours after receiving the Janssen COVID-19 vaccine. Also reports shaking. Wife reports that she was missed a dose of BP medicine but did take it at 9:30 or 10 pm PST. Had since decreased to 212/84. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bp 255/105 / bp 212/84, and shaking on 20-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210340054-COVID-19 VACCINE AD26.COV2.S -BP 255/105, BP 212/84. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Headache
Clinical narrative: COMPLETELY IMMOBILE; SWEATING; DIZZINESS; NECK PAIN; FAST HEARTBEAT; SHOULDER PAIN; CHILLS; JACKHAMMER HEADACHE; WEAKNESS IN BODYPARTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient had no allergies. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 19-MAR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-MAR-2021, subject received Covid vaccine. On MAR-2021, the patient was completely immobile, experienced sweating, dizziness, neck pain, fast heartbeat, shoulder pain, chills, jackhammer headache, weakness in body parts. Treatment medications (dates unspecified) included: ibuprofen. The patient could not do normal exercise that used to do earlier, because of headache.  The patient was in bed from friday, saturday and sunday and 22 march also included in it. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient had not recovered from jackhammer headache, and the outcome of chills, sweating, dizziness, weakness in body parts, completely immobile, shoulder pain, neck pain and fast heartbeat was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210340656-COVID-19 VACCINE AD26.COV2.S-completely immobile. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hyperhidrosis, Immobile, Neck pain
Clinical narrative: COMPLETELY IMMOBILE; SWEATING; DIZZINESS; NECK PAIN; FAST HEARTBEAT; SHOULDER PAIN; CHILLS; JACKHAMMER HEADACHE; WEAKNESS IN BODYPARTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient had no allergies. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 19-MAR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-MAR-2021, subject received Covid vaccine. On MAR-2021, the patient was completely immobile, experienced sweating, dizziness, neck pain, fast heartbeat, shoulder pain, chills, jackhammer headache, weakness in body parts. Treatment medications (dates unspecified) included: ibuprofen. The patient could not do normal exercise that used to do earlier, because of headache.  The patient was in bed from friday, saturday and sunday and 22 march also included in it. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient had not recovered from jackhammer headache, and the outcome of chills, sweating, dizziness, weakness in body parts, completely immobile, shoulder pain, neck pain and fast heartbeat was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210340656-COVID-19 VACCINE AD26.COV2.S-completely immobile. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Uterine haemorrhage
Clinical narrative: MORE BLEEDING AND PASSING MORE CLOTS THAN NORMAL ONE HOUR POST GETTING THE SHOT; This spontaneous report received from a patient concerned a 79 year female. The patient's height, and weight were not reported. The patient's concurrent conditions included uterine cancer, high blood pressure, seasonal allergy, and thyroid, and other pre-existing medical conditions included the patient had no known drug allergies. The patient had no DM and no cholesterol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported,1 total, administered on 19-MAR-2021 12:05 to right arm for prophylactic vaccination. Concomitant medications included unspecified thyroid pill. On 19-MAR-2021, one hour post getting the shot the patient noticed more bleeding and passing more clots than normal. The patient denies abdominal pain or any other symptoms of concern. The patient also mentioned that uterine cancer - surgery planned for end of March 2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from more bleeding and passing more clots than normal one hour post getting the shot. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210340677-Covid-19 vaccine ad26.cov2.s-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: MEDICAL HISTORY, UNDERLYING DISEASE
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on FEB-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced suspected immunological vaccine failure. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210340782-COVID-19 VACCINE AD26.COV2.S - Suspected Immunological Vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Troponin T
Clinical narrative: CARDIAC SYMPTOMS, CHEST PAINS, FEELS NOT GOOD, HR IS FAST; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, one total, administered on 17-MAR-2021 in left deltoid for prophylactic vaccination. Concomitant medications included glyceryl trinitrate. On 18-MAR-2021, the patient experienced chest pain and called emergency services. On 24-MAR-2021, the patient reported to have heart attack, confirmed and experienced the following symptoms including cardiac symptoms, chest pains, feels not good, heart rate is fast, and was hospitalized. The patient stated that the ambulance came on 24-MAR-2021 and was admitted to hospital on 24-MAR-2021 and was discharged on 26-MAR-2021. The patient was hospitalized for 3 days. The patient reported that she have cardiac concerns prior to injection with the Janssen covid-19 vaccine and reported to have past medical history as 2007- by pass, 2008- single by pass, 2015 double by pass. The patient stated that she is going to have a stents by consulting Dr. The patient also reported that she is now on 8 more medications. (medications not reported). Laboratory data included: Troponin T (NR: not provided) 5.9 to 12.2. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cardiac symptoms, chest pains, feels not good, hr is fast. This report was serious (Hospitalization Caused / Prolonged).  Additional information was received from patient on 28-MAR-2021. The following information was updated and incorporated into the case. The patient's past medical history included bypass (2007), single bypass (2008), and double bypass (2015). The patient reported additional events as heart attack, heart rate is fast,  and feels not good. The seriousness criteria of 'chest pain' was updated to serious. The patient had visit to emergency room. The patient was hospitalized on 24-MAR-2021 and discharged on 26-MAR-2021. The number of days hospitalized is 3 days.; Sender's Comments: V1 Additional information received in this version is regarding medical history (bypass (2007), single bypass (2008), and double bypass (2015)), events (heart attack, heart rate is fast and feeling not good), seriousness criteria and hospitalization details.  20210340970- Covid-19 vaccine ad26.cov2.s -Heart attack. Follow-up received regarding Clinical Details. 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, UNDERLYING DISEASE
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Circulatory collapse, Headache, Oxygen therapy
Clinical narrative: COLLAPSED; HEADACHE; This spontaneous report received from a consumer concerned a 70 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced headache, was clammy to the touch. On same day at 14:00, checked blood pressure (BP) and it was 145/75 and his oxygen level read in the 90's. At 18:00, he collapsed while getting up out of his chair and emergency medical services (EMS) was called performed cardiopulmonary resuscitation (CPR) but never got him back. On 10-MAR-2021, the patient died from cause unknown. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of collapsed on 10-MAR-2021, and the outcome of headache was not reported. This report was serious (Death, and Other Medically Important Condition). The suspected product quality complaint has been confirmed to be no product quality complaint identified within the reported. Complaint is approved for void, based on the PQC evaluation/investigation performed. This report was associated with product quality complaint :90000173895.; Sender's Comments: V0: 20210341940-COVID-19 VACCINE AD26.COV2.S- COLLAPSED. 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: Cause unknown
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait inability, Muscular weakness
Clinical narrative: MUSCLE WEAKNESS; TIREDNESS; UNABLE TO WALK; This spontaneous report received from a patient concerned a white Not Hispanic or Latino female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included MS. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, vaccinated at right arm, once total, administered on 08-MAR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, 09:00 AM the patient received Janssen Covid-19 vaccine and at 16:00 PM, the patient started feeling really, tired and at 21:00 PM feeling not well with muscle weakness. On 09-MAR-2021, at midnight, patient had called to go to the emergency room and patient was unable to get up at all and was hospitalized on 09-Mar-2021 for 3.5 days and on 12-MAR-2021, the patient was discharged from the hospital. The patient had physical therapy coming to house.  The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient was recovering from tiredness, muscle weakness, and unable to walk. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210342113-COVID-19 VACCINE AD26.COV2.S-Tiredness and muscular weakness. These events are labeled and are therefore considered potentially related. 20210342113-COVID-19 VACCINE AD26.COV2.S-unable to walk. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Loss of consciousness, Rash
Clinical narrative: PASSED OUT ABOUT 15 MINUTES; DOES NOT REMEMBER ANY OF IT; RASH ALL OVER HIS BODY; This spontaneous report received from a patient concerned a 70 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once in total administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. In MAR-2021, the patient broke out in a rash all over his body and passed out and was out for about 15 minutes or more. The patient's neighbor helped to get into bed. The patient does not remember any of it and don't know if it was vaccine or whatever was wrong with him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash all over his body, does not remember any of it and passed out about 15 minutes was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210347765 and 20210347766.  Version created to amend previously reported information on 21-MAR-2021. Upon review, following information was amended: The case upgraded to serious and new event passed out about 15 minutes added in case.; Sender's Comments: V1: Version created to upgrade case to serious with event (passed out about 15 minutes added). 20210342307-Covid-19 vaccine ad26.cov2.s-passed out for about 15 minutes or more. 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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Oxygen saturation
Clinical narrative: CARDIAC ARREST; This spontaneous report received from a consumer concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, picc line, and diabetic foot ulcer. The patient had no known allergies. The patient had no previous history of heart conditions. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included Ceftriaxone for diabetic foot ulcer, and Heparin for picc line prophylaxis.  On Saturday, 20-MAR-2021, the patient reported that his chest felt funny but he wasn't sure about the cause. On Monday, 22-MAR-2021 morning; the patient had collapsed when he got out of the shower and yelled for help. The patient was gasping for breath and reading on pulse oximeter dropped into the 70's and also reported that he felt light headed. It was unknown weather the patient died in ambulance or at hospital. It was unspecified if an autopsy was performed. Laboratory data included: Oxygen saturation decreased (NR: not provided) Dropped to 70's.  On 22-MAR-2021, the subject died from cardiac arrest.  The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210342361 -COVID-19 VACCINE AD26.COV2.S- Cardiac Arrest. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.; Reported Cause(s) of Death: CARDIAC ARREST
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Flushing, Generalised tonic-clonic seizure, Seizure, Syncope
Clinical narrative: GRAND MAL; SEIZURES; FAINT; CHEST PAIN; FLUSHED; This spontaneous report received from a health care professional concerned 49 patients of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2019, post-vaccination many patients needed to be seen by EMS for various medical incidents such as faint, flushed, chest pain. Later it was 49 people needing EMS attention and several seizures and 1 grand mal experienced took place after covid-19 vaccine ad26.cov2.s vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures, faint, flushed, chest pain and grand mal was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210342978-Covid-19 vaccine ad26.cov2.s-Grand mal, seizure and faint. These events are 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 events.