chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had vaccine still got shingles / suspected vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a 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 provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient received Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: received the Shingrix vaccine and I had shingles at the time; This case was reported by a consumer via interactive digital media and described the occurrence of off label use in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were reported as follows: This case was reported by patient for himself/herself. The age at vaccination was not reported The patient received the Shingrix vaccine and had shingles at the time of vaccination, which led to off label use.  The patient did not notice the shingles for reasons to lengthy to go into here bit now and wondered if it would be the serious issue. Follow up was not possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: cannot remember if they received the first dose of the Shingrix vaccine; This case was reported by a consumer via  interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 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 reported as follows: The age at vaccination was not applicable for this report. The patient cannot remember if they have received the 1st dose of vaccine and was asking could they start over with the series, which led to incomplete course of vaccination. No further information was reported. Follow up was not possible as no contact details were provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chest discomfort, Extra dose administered, Feeling abnormal, Herpes zoster, Musculoskeletal discomfort
Clinical narrative: Had the vaccine on three different occasions and I still acquired the virus; Had the vaccine on three different occasions and I still acquired the virus; Felt like I was beaten about the back, chest; Rash on my back, neck and side of my face; Had the vaccine on three different occasions; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feels awful, rash and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles, feels awful, rash and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, feels awful and rash to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient received shingles vaccine on three different occasions, which led to extra dose administered and experienced shingles, felt like beaten on chest, back and neck and rash on back, neck and side of face. The patient stated in his/her case shingles could not be prevented as he/she still acquired the virus. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Vaccination failure
Clinical narrative: Had the vaccine on three different occasions and I still acquired the virus; Had the vaccine on three different occasions and I still acquired the virus; Felt like I was beaten about the back, chest; Rash on my back, neck and side of my face; Had the vaccine on three different occasions; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feels awful, rash and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles, feels awful, rash and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, feels awful and rash to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient received shingles vaccine on three different occasions, which led to extra dose administered and experienced shingles, felt like beaten on chest, back and neck and rash on back, neck and side of face. The patient stated in his/her case shingles could not be prevented as he/she still acquired the virus. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Malaise
Clinical narrative: was sick as hell / got so sick on the first shot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced sickness. Shingles vaccine was interrupted. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received dose of Shingles vaccine and was sick as hell. The patient was told to come back in 28 days for the shingles shot. The patient stated that there was no way he or she would be getting the 2nd shot.
Sex: U
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: received the Shingrix vaccine and I had shingles at the time; This case was reported by a consumer via interactive digital media and described the occurrence of off label use in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were reported as follows: This case was reported by patient herself/himself. The age at vaccination was not reported. Patient received the shingrix vaccine and had shingles at the time of vaccination, which led to off label use. Patient was asking how serious was this. No further information was reported. Follow up was not possible as no contact details were provided.
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Dyspnoea
Clinical narrative: hospitalized after receiving her flu shot / was admitted to the hospital / could not breath hours after the flu shot / admitted for 24 hours; hospitalized after receiving her flu shot / was admitted to the hospital / could not breath hours after the flu shot / admitted for 24 hours; This case was reported by a consumer via call center representative and described the occurrence of asthmatic attack in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concomitant products included budesonide, formoterol fumarate (Symbicort) and ipratropium + salbutamol (Albuterol And Ipratropium Nebule).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, several hours after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced asthmatic attack (serious criteria hospitalization) and difficulty breathing (serious criteria hospitalization). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the asthmatic attack and difficulty breathing were recovered/resolved.   It was unknown if the reporter considered the asthmatic attack and difficulty breathing to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: This case was reported by patient herself via an outbound call for the Program. The age at vaccination was not reported. 7 to 8 years prior the reporting date, the patient received flu vaccine and within hours she could not breath and was admitted to the hospital for approximately 24 hours and given steroids. The patient stated that the hospitalization was for asthma attack. The patient's symptoms resolved by the time she was discharged from the hospital. The patient had elected not to take Nucala due to the cost and stated she did not trust injections in general as she had twice been hospitalized after receiving her flu shot.  The patient consented to follow up with her physician The reporter consented to follow-up. For tolerance of further dose, refer link case US2021AMR130231.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR130231:same reporter, same patient , 2nd shot
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received the diluent component alone without the powder portion; Received the diluent component alone without the powder portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 16th June 2021, the patient received Menveo. On 16th June 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 diluent component alone without the powder portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The healthcare professional did not have the patient information available. The reporter consent to follow up.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Patient received an expirated dose of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a medical assistant. The patient received an expirated dose of Pediarix, which led expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Dose 2 of havrix / given to a 21 year old patient / instead of the adult dose.; Dose 2 of havrix / given to a 21 year old patient / instead of the adult dose.; Dose 1 / administered on 06/23/2016 / Dose 2 was given on 6/17/2021; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 21-year-old female patient who received HAV (Havrix pediatric) (batch number 532H4, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (received 1st dose on 23rd June 2016).   On 14th June 2021, the patient received the 2nd dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On 14th June 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose, adult use of a child product and drug dose administration interval too long. On an unknown date, the outcome of the underdose, adult use of a child product and drug dose administration interval too long were 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 adult patient received pediatric dose of Havrix on 14th June 2021 which led to adult use of child product and underdose. The patient received 2nd dose of Havrix, more than the recommended interval, which led to lengthtening of vaccination schedule. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021133172:same reporter (FU1)
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: expired dose of Pediarix/ administered on 06/10/2021 / expired on 05/24/2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 8-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number K7TF9, expiry date 24th May 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 10th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: On 10th June 2021, patient received Pediarix, which was expired on 24th  May 2021. The reporter consented to follow up.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted Hiberix with a sterile diluent/  for Merck, Sharp, Dohme; live virus vaccine, sterile water/ instead of the accompanying diluent; reconstituted Hiberix with a sterile diluent/  for Merck, Sharp, Dohme; live virus vaccine, sterile water/ instead of the accompanying diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On 17th June 2021, the patient received Hiberix. On 17th June 2021, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that she reconstituted Hiberix with sterile diluent (1 single dose-0.7 ml sterile dileunt for live virus vaccine, sterile water) instead of the accompanying diluent, and administered it to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The Nurse reported that  she did not have any patient or vaccine information. The reporter consented to follow up via postal.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose /around Sept/Oct 2019 / 2nd dose in January 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on around September/October 2019).   In January 2021, the patient received the 2nd dose of Shingrix. In January 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 provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lengthening of vaccine schedule. The reporter mentioned that, patient received 1st dose around September/October in 2019. No symptoms reported. The health care practitioner did not have exact administration dates, lot, or expiration dates at the time of report. The reporter consent to follow up.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: 51 year old / inadvertently received an Engerix-B pediatric dose; 51 year old / inadvertently received an Engerix-B pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 51-year-old female patient who received HBV (Engerix B pediatric) (batch number 5DN72, expiry date 27th December 2022) for prophylaxis.   On 18th June 2021, the patient received the 1st dose of Engerix B pediatric (intramuscular). On 18th June 2021, unknown after receiving Engerix B pediatric, the patient experienced adult use of a child product and accidental underdose. On an unknown date, the outcome of the adult use of a child product and accidental underdose were unknown.  Additional details were provided as follows: The 51 years old female patient inadvertently received an Engerix-B pediatric dose in the left deltoid, which led to adult use of child product and accidental underdose. The reporter consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION (GOT VIRUS); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) start therapy date and end date were not reported, 1 total frequency dose was administered for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection (got virus). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection (got virus) was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000182759.; Sender's Comments: V0: 20210627140-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Ear pain, Feeling abnormal, Headache
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; BRAIN FOG; EAR ACHE; SINUS CONGESTION; FEVER; NAUSEA; SINUS PAIN; BOWELS ARE "FLOATING"; HEADACHE; MALAISE; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 146 pounds, and height was 63.5 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20-JUN-2021) dose was not reported, 1 total administered on 31-MAR-2021 around10:45 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 31-MAR-2021, 5 hours after vaccination patient got sick and did not reported this because it got better after couple of days. She experienced fever, malaise, nausea, headache, sinus pain and bowels movement were floating. Patient recovered in 3 days and was doing fine till 06-JUN-2021. On 06-JUN-2021 patient started really feeling bad. Patient's all joints, head and everything was hurting. On same day patient experienced fever, headache, chills, nausea, joint pain, brain fog, body aches, sore throat, ear ache, sinus pain, sinus congestion, productive cough (phlegm), and shortness of breath.  Patient's shortness of breath was not severe enough to go to emergency room. Patient experienced shortness of breath while talking and walking up the stairs. ON 08-JUN-2021 Patient experienced sharp pain in random body places and loss of taste and smell. Patient got herself tested on 08-JUN-2021, with an antigen test (nasal swab), and it was positive(confirmed clinical vaccination failure). It was reported that turned positive quickly without waiting. On an unspecified date, the patient experienced breakthrough infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ear ache, and sinus pain on JUN-2021, fever, and nausea on 02-APR-2021, and malaise, and headache on 03-APR-2021, had not recovered from bowels are "floating", confirmed covid-19 infection, brain fog, and sinus congestion, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  The suspected product quality complaint has been confirmed to be not voided based on the evaluation/investigation performed.; Sender's Comments: V0: 20210627726- covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia, SARS-CoV-2 test, Sinus congestion
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; BRAIN FOG; EAR ACHE; SINUS CONGESTION; FEVER; NAUSEA; SINUS PAIN; BOWELS ARE "FLOATING"; HEADACHE; MALAISE; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 146 pounds, and height was 63.5 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20-JUN-2021) dose was not reported, 1 total administered on 31-MAR-2021 around10:45 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 31-MAR-2021, 5 hours after vaccination patient got sick and did not reported this because it got better after couple of days. She experienced fever, malaise, nausea, headache, sinus pain and bowels movement were floating. Patient recovered in 3 days and was doing fine till 06-JUN-2021. On 06-JUN-2021 patient started really feeling bad. Patient's all joints, head and everything was hurting. On same day patient experienced fever, headache, chills, nausea, joint pain, brain fog, body aches, sore throat, ear ache, sinus pain, sinus congestion, productive cough (phlegm), and shortness of breath.  Patient's shortness of breath was not severe enough to go to emergency room. Patient experienced shortness of breath while talking and walking up the stairs. ON 08-JUN-2021 Patient experienced sharp pain in random body places and loss of taste and smell. Patient got herself tested on 08-JUN-2021, with an antigen test (nasal swab), and it was positive(confirmed clinical vaccination failure). It was reported that turned positive quickly without waiting. On an unspecified date, the patient experienced breakthrough infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ear ache, and sinus pain on JUN-2021, fever, and nausea on 02-APR-2021, and malaise, and headache on 03-APR-2021, had not recovered from bowels are "floating", confirmed covid-19 infection, brain fog, and sinus congestion, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  The suspected product quality complaint has been confirmed to be not voided based on the evaluation/investigation performed.; Sender's Comments: V0: 20210627726- covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus pain, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; BRAIN FOG; EAR ACHE; SINUS CONGESTION; FEVER; NAUSEA; SINUS PAIN; BOWELS ARE "FLOATING"; HEADACHE; MALAISE; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 146 pounds, and height was 63.5 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20-JUN-2021) dose was not reported, 1 total administered on 31-MAR-2021 around10:45 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 31-MAR-2021, 5 hours after vaccination patient got sick and did not reported this because it got better after couple of days. She experienced fever, malaise, nausea, headache, sinus pain and bowels movement were floating. Patient recovered in 3 days and was doing fine till 06-JUN-2021. On 06-JUN-2021 patient started really feeling bad. Patient's all joints, head and everything was hurting. On same day patient experienced fever, headache, chills, nausea, joint pain, brain fog, body aches, sore throat, ear ache, sinus pain, sinus congestion, productive cough (phlegm), and shortness of breath.  Patient's shortness of breath was not severe enough to go to emergency room. Patient experienced shortness of breath while talking and walking up the stairs. ON 08-JUN-2021 Patient experienced sharp pain in random body places and loss of taste and smell. Patient got herself tested on 08-JUN-2021, with an antigen test (nasal swab), and it was positive(confirmed clinical vaccination failure). It was reported that turned positive quickly without waiting. On an unspecified date, the patient experienced breakthrough infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ear ache, and sinus pain on JUN-2021, fever, and nausea on 02-APR-2021, and malaise, and headache on 03-APR-2021, had not recovered from bowels are "floating", confirmed covid-19 infection, brain fog, and sinus congestion, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  The suspected product quality complaint has been confirmed to be not voided based on the evaluation/investigation performed.; Sender's Comments: V0: 20210627726- covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Thrombosis
Clinical narrative: CLOT; COVID-19 POSITIVE; This spontaneous report was received from a patient (nurse) of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number and expiry date were unknown) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, following vaccination, the patient developed clot, and was coronavirus disease (COVID-19) positive. The patient underwent thrombectomy and was given Xarelto (rivaroxaban) for treatment of the clot. However, on an unspecified date, the patient developed another clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from clot, and the outcome of covid-19 positive was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210628109-covid-19 vaccine ad26.cov2.s-clot. 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: UNDERLYING DISEASE
Sex: F
Vaccine: COVID19
Symptoms: Aortic thrombosis
Clinical narrative: BLOOD CLOT IN AORTIC ARTERY; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose not reported, 1 total administered on 27-MAR-202 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced a massive blood clot in her aortic artery blocking all the blood flow to her legs then, pieces broke off and went to her brain and heart. On 28-MAY-2021 13:45 in afternoon the patient's life support was stopped. On 29-MAY-2021 at 2:01, 9 weeks after vaccination the patient died from blood clot in aortic artery. It was unspecified 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:  This spontaneous report from consumer concerns a female patient of unspecified age/race/ethnicity who developed "massive blood clot in her aortic artery blocking all the blood flow to her legs then, pieces broke off and went to her brain and heart" 62 days after receiving Janssen COVID-19 vaccine.  The patient died on 63rd day post vaccination.  No other details reported.  The information available precludes a complete and meaningful assessment.  Considering the temporal relationship, the events are assessed to have an indeterminate relationship with the vaccination.; Reported Cause(s) of Death: BLOOD CLOT IN AORTIC ARTERY
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 height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected immunological vaccine failure and reported no antibodies in recent COVID-19 antibody test. 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 associated with product complaint number: 90000182923. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210632871- JANSSEN 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: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED A VACCINE THAT WAS STORED AT 65 F FOR MORE THAT TWO HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced administered a vaccine that was stored at 65 f for more that two hours. On 15-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and administered a vaccine that was stored at 65 f for more that two hours was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be the suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed. This report was associated with a product quality compliant : 90000182926.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Hypersomnia, Mobility decreased, Pain
Clinical narrative: IMMOBILIZED LEFT ARM; SLEEPING; COUGHING; ACHES AND PAINS; LIKE DEAD FOR A WHOLE WEEK; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced immobilized left arm, sleeping, coughing, aches and pains, like dead for a whole week, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sleeping, coughing, fever, aches and pains, immobilized left arm and like dead for a whole week was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: IMMOBILIZED LEFT ARM; SLEEPING; COUGHING; ACHES AND PAINS; LIKE DEAD FOR A WHOLE WEEK; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced immobilized left arm, sleeping, coughing, aches and pains, like dead for a whole week, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sleeping, coughing, fever, aches and pains, immobilized left arm and like dead for a whole week was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: TIRED; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: SEIZURES; This spontaneous report received from a pharmacist concerned multiple patients of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no medical history. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, pharmacist called for a follow up on a precious case, wherein the 2 patients experienced seizures after getting J and J vaccine with no medical history, while speaking to nurse she mentioned there was total 4 cases, total 2 patients on 3-Jun-2021 and a week prior was other patient and patient on 12-Jun-2021, all experienced seizures. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizures was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210629430.; Sender's Comments: V0:20210638870-covid-19 vaccine ad26.cov2.s -Seizures. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN/BURNING SENSATION IN THE ARM AT INJECTION SITE RIGHT AWAY FROM INSERTION OF THE NEEDLE TO PULLING OUT OF THE NEEDLE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included unspecified allergies. 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 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAY-2021, the subject experienced pain/burning sensation in the arm at injection site right away from insertion of the needle to pulling out of the needle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain/burning sensation in the arm at injection site right away from insertion of the needle to pulling out of the needle on 20-MAY-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site bruising, Pain, Pain assessment, Pain in extremity
Clinical narrative: DULL THROBBING PAIN THAT COMES AND GO; ARM HURTS IF SLEEP ON IT; BRUISE AROUND INJECTION SITE (ABOUT A QUARTER IN DIAMETER OVAL SHAPED); SHOULDER PAIN AT A LEVEL 4; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 31-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAY-2021, the subject experienced low grade fever. On 02-JUN-2021, the subject experienced shoulder pain at a level 4. On 18-JUN-2021, the subject experienced bruise around injection site (about a quarter in diameter oval shaped). On an unspecified date, the subject experienced dull throbbing pain that comes and go, and arm hurts if sleep on it. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) Pain level of a 4 at times at the shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever on 31-MAY-2021, was recovering from bruise around injection site (about a quarter in diameter oval shaped), had not recovered from shoulder pain at a level 4, and the outcome of dull throbbing pain that comes and go and arm hurts if sleep on it was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: DULL THROBBING PAIN THAT COMES AND GO; ARM HURTS IF SLEEP ON IT; BRUISE AROUND INJECTION SITE (ABOUT A QUARTER IN DIAMETER OVAL SHAPED); SHOULDER PAIN AT A LEVEL 4; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 31-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAY-2021, the subject experienced low grade fever. On 02-JUN-2021, the subject experienced shoulder pain at a level 4. On 18-JUN-2021, the subject experienced bruise around injection site (about a quarter in diameter oval shaped). On an unspecified date, the subject experienced dull throbbing pain that comes and go, and arm hurts if sleep on it. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) Pain level of a 4 at times at the shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever on 31-MAY-2021, was recovering from bruise around injection site (about a quarter in diameter oval shaped), had not recovered from shoulder pain at a level 4, and the outcome of dull throbbing pain that comes and go and arm hurts if sleep on it was not reported. This report was non-serious.