chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: has received the entire Engerix B series / still tests negative for titer; This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a 48-year-old female patient who received HBV (Engerix B) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis and HBV (Engerix B) (batch number 9X9ZT, expiry date 19th January 2020) for prophylaxis.   On 14th March 2021, the patient received the 3rd dose of Engerix B. On 14th October 2020, the patient received the 2nd dose of Engerix B. On 14th September 2020, the patient received the 1st dose of Engerix B. In May 2021, between 1 and 2 months after receiving Engerix B, between 6 and 7 months after receiving Engerix B and between 7 and 8 months after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The patient received the entire Engerix B series and still tested negative for titer, which led to therapy non-responder. The titer test was done in between 10th May 2021 to 14th May 2021. The reporter did not consent to follow up.  Note: As no further clarification was available, expiration date for 1st dose was kept as reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who received the Shingrix first dose at 2019; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 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. The medical assistant informed that, the patient received 1st dose of Shingrix and did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter asked for information about how to proceed. The reporter consented to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: below the injection site was red/had doubled in size/50 cent size area/spread further; inch below the injection site was/ swollen/had doubled in size/50 cent size area; tiny welt; It also felt hot.; She felt pain/ it stung like crazy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2021 09:00, the patient received the 1st dose of Shingrix. On 24th May 2021 05:00, immediately after receiving Shingrix, the patient experienced injection site pain. On 24th May 2021 17:00, the patient experienced localized erythema, local swelling, welts and skin warm. On an unknown date, the outcome of the injection site pain and local swelling were recovering/resolving and the outcome of the localized erythema and skin warm were not recovered/not resolved and the outcome of the welts was unknown.   It was unknown if the reporter considered the injection site pain, localized erythema, local swelling, welts and skin warm to be related to Shingrix.   Additional details were provided as follows: Case was reported that patient for herself. The patient received Shingrix in left arm. The patient felt pain as the vaccine was administered which she described as it stung like crazy. In the evening at arounf 5 PM, the area an inch below the injection site was red and swollen with tiny welt. It also felt hot. The next day, redness and swelling had doubled in size to a quarter and the day before reporting date, it doubled again to a 50 cent size area. The redness spread further measuring approximately 3 inch vertical by 2.5 inches wide. The patient said swelling and pain was resolving and did not hurt as much but area was still hot to touch, The patient did not consent to follow up .
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling, Urticaria
Clinical narrative: below the injection site was red/had doubled in size/50 cent size area/spread further; inch below the injection site was/ swollen/had doubled in size/50 cent size area; tiny welt; It also felt hot.; She felt pain/ it stung like crazy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2021 09:00, the patient received the 1st dose of Shingrix. On 24th May 2021 05:00, immediately after receiving Shingrix, the patient experienced injection site pain. On 24th May 2021 17:00, the patient experienced localized erythema, local swelling, welts and skin warm. On an unknown date, the outcome of the injection site pain and local swelling were recovering/resolving and the outcome of the localized erythema and skin warm were not recovered/not resolved and the outcome of the welts was unknown.   It was unknown if the reporter considered the injection site pain, localized erythema, local swelling, welts and skin warm to be related to Shingrix.   Additional details were provided as follows: Case was reported that patient for herself. The patient received Shingrix in left arm. The patient felt pain as the vaccine was administered which she described as it stung like crazy. In the evening at arounf 5 PM, the area an inch below the injection site was red and swollen with tiny welt. It also felt hot. The next day, redness and swelling had doubled in size to a quarter and the day before reporting date, it doubled again to a 50 cent size area. The redness spread further measuring approximately 3 inch vertical by 2.5 inches wide. The patient said swelling and pain was resolving and did not hurt as much but area was still hot to touch, The patient did not consent to follow up .
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant portion / without reconstituting the powder with the gE antigen; received only the adjuvant portion / without reconstituting the powder with the gE antigen; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number 5XP9M, expiry date 15th October 2022) for prophylaxis.   On 17th May 2021, the patient received Shingrix. On 17th May 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 were provided as follows: The medical assistant informed that the patient received only the adjuvant portion from the shingrix without reconstituting the powder with the gE antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with the case US2021114069, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021114069:Same Reporter
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-month-old patient received Kinrix.; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 17-month-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th May 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 7th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 physician reported that the 17 months old patient received Kinrix, which led to inappropriate age at vaccine administration.  The reporter consented to follow up.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Engerix-B second dose 5 months after the first dose/First dose on Dic 30th 2020/Second dose on May 26th 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 22-year-old female patient who received HBV (Engerix B) (batch number P4DJ5, expiry date 15th December 2022) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 30th December 2020).   On 26th May 2021, the patient received the 2nd dose of Engerix B. On 26th May 2021, unknown after receiving Engerix B, 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 received the 2nd dose of Engerix B five  months after the first dose, which was later than recommended time interval and led to lengthening of the schedule. The pharmacist was looking for guidance on Engerix-B schedule. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Product prescribing error
Clinical narrative: first dose/on 29Sep2020 and the second dose is scheduled for 11Jun2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug schedule prescribing error in a 57-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 29th September 2020).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug schedule prescribing error. On an unknown date, the outcome of the drug schedule prescribing error 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 was reported as follows: The patient's 2nd dose of Twinrix was scheduled on 11th June 2021 which was approximately 9 months later than 1st dose, which led to drug schedule prescribing error. Lot number was not available to the caller. The second dose was scheduled at a specific date in the future at time of call. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2 years out from her first dose of Shingrix? looking for the guidance as far as resuming with her last dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-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 about 2 years ago, prior to reporting.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details was reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received the 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter mentioned that, they were looking for the guidance as far as resuming the patient with her last dose or if they need to restart the series.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: in 2019, the patient received the first dose / did not return within the recommended time frame to receive the second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date in 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 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 mentioned that, patient received 1st dose of Shingrix on an unknown date in 2019. The healthcare professional ended up the chat before providing demographics and patient/vaccine information.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / on 03Aug2019 and the second has not been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 3rd August 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 reported 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 Healthcare professional stated that they had no time to answer the questions so no patient or vaccine details provided. The reporter consented Follow up.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administered an expired Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA264A, expiry date 31st March 2021) for prophylaxis.   On an unknown date, the patient received Menveo .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist reported that she just administered an expired Menveo vaccine to the patient's left deltoid with standard dosing of the 0.5 ml dose in error, which led to expired vaccine used. The reporter consented to follow up
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the adjuvant was given to a patient / only the adjuvant was drawn up in the syringe; only the adjuvant was given to a patient / only the adjuvant was drawn up in the syringe; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number Z22C5, expiry date 6th November 2022) for prophylaxis.   On 27th May 2021, the patient received Shingrix. On 27th May 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 were provided as follows: The pharmacist reported that, only the adjuvant was administered to the patient due to emergency situation, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care professional was not aware that only the adjuvant was drawn up in the syringe. The reporter did not consented to follow up.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain upper, Diarrhoea, Feeling abnormal, Purulent discharge
Clinical narrative: STOMACH CRAMPS; BODY FEELS LIKE BREAKING DOWN RAPIDLY WITHOUT THE MEDICINE; DIARRHOEA; PUS IN BODY; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 195 pounds, and height was 164 centimeters. The patient's concurrent conditions included crohn's disease, non alcoholic, non smoker, diabetes, blood pressure, cholesterol, and vertigo, and other pre-existing medical conditions included the patient had no history of allergies and drug abuse or illicit drug use. 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 patient received ustekinumab (solution for injection, intravenous, batch number: UNKNOWN expiry: UNKNOWN) 90 mg, 1 time every 10 months, therapy dates were not reported for drug used for unknown indication. No concomitant medications were reported.  On an unspecified date, the subject experienced stomach cramps, body feels like breaking down rapidly without the medicine, diarrhoea, and pus in body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ustekinumab was not reported. The outcome of the body feels like breaking down rapidly without the medicine, stomach cramps, diarrhoea and pus in body was not reported. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue, SARS-CoV-2 antibody test, SARS-CoV-2 test, SARS-CoV-2 test positive, Therapy partial responder
Clinical narrative: SARS-COV-2 IGG ANTIBODY TEST RESULT (1.49); COVID-19 TEST POSITIVE; PREFILLED SYRINGES WAS KEPT OUT OF THE REFRIGERATOR FOR MORE THAN 2 HOURS; This spontaneous report received from a consumer concerned multiple patients (employees). The patients weight, height, and medical history were not reported.  The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that the physician was providing antibody test named as test to all the office staffs and immunosuppressed patients 4 to 6 weeks after receiving the Janssen Covid-19 vaccine. Test report 1.49, which was borderline nothing. The company, tested regularly with the nasal swabs. It was reported many of the employees received the Janssen COVID-19 vaccine and then tested positive for COVID-19. According to the physician, the patients functioned as if they never got the vaccine at all. It was also reported that the physician knew that the vaccine did not have to go in the freezer, but it could only be out of the fridge for 2 hours. The physician suspected that the people got vaccines that were in prefilled syringes and kept out of the refrigerator for more than 2 hours, thus rendering them useless. He wanted these patients to be able to get a booster of Pfizer or Moderna as the patients who received Pfizer and Moderna produced strong results. On an unknown date, COVID-19 nasal swab was done. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive and COVID-19 antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 test positive, sars-cov-2 igg antibody test result (1.49) and prefilled syringes was kept out of the refrigerator for more than 2 hours was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. The suspected product quality complaint has been confirmed to be void: N based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210545141 and 20210545098.; Sender's Comments: V0 20210544684-COVID-19 VACCINE AD26.COV2.S-SARS-COV-2 IGG antibody test result (1.49). This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: SOME CHILLS; 100.4 FEVER; VERY LOW ENERGY; LITTLE TIRED; This spontaneous report received from a patient concerned a 48 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, and batch number were not reported) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced little tired. On 25-MAY-2021, the subject experienced some chills. On 25-MAY-2021, the subject experienced 100.4 fever. On 25-MAY-2021, the subject experienced very low energy. Laboratory data included: Body temperature (NR: not provided) 100.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 100.4 fever, some chills, and very low energy, and the outcome of little tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Hypokinesia, Muscle strain, Musculoskeletal injury, Scan
Clinical narrative: Intensive convulsion; unable to turn torso; severe back pain; musculoskeletal injury; muscle tear of some sort; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient never had any conditions or issues, nor any record of chronic pain or back pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number :Unknown and expiry: Unknown) 1 total , administered on APR-2021 for prophylactic vaccination. The Batch no was not reported and has been requested,  No concomitant medications were reported. On APR-2021, the Patient experienced intensive convulsion, unable to turn torso, severe back pain and discharge with musculoskeletal injury. On APR-2021, the Patient experienced muscle tear of some sort.  Laboratory data included: Scan (NR: not provided) No internal Issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intensive convulsion, severe back pain, unable to turn torso, musculoskeletal injury, and muscle tear of some sort. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210549341- covid-19 vaccine ad26.cov2.s-Intensive Convulsion-This event is considered Un assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Intensive convulsion; unable to turn torso; severe back pain; musculoskeletal injury; muscle tear of some sort; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient never had any conditions or issues, nor any record of chronic pain or back pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number :Unknown and expiry: Unknown) 1 total , administered on APR-2021 for prophylactic vaccination. The Batch no was not reported and has been requested,  No concomitant medications were reported. On APR-2021, the Patient experienced intensive convulsion, unable to turn torso, severe back pain and discharge with musculoskeletal injury. On APR-2021, the Patient experienced muscle tear of some sort.  Laboratory data included: Scan (NR: not provided) No internal Issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intensive convulsion, severe back pain, unable to turn torso, musculoskeletal injury, and muscle tear of some sort. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210549341- covid-19 vaccine ad26.cov2.s-Intensive Convulsion-This event is considered Un assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site bruising, Injection site discomfort, Injection site erythema, Lip swelling
Clinical narrative: REDNESS/HIVES ON THE BODY COMES AND GOES, BUT NOT AT ONCE. EVERY TIME IT'S IN A  DIFFERENT SPOT, IT CAN BE ROUND OR LONG (UNDER THE BREAST AS WELL) THEY ARE AS LARGE AS A QUARTER, NICKEL, DIME OR PENNY. IT CAN BE A "BOTCH" IN THE "CREASE" AS WELL; SWELLING IN THE LIPS; INJECTION SITE BRUISING; INJECTION SITE MILD DISCOMFORT; INJECTION SITE REDNESS (2-3INCH); This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 237 pounds, and height was 61 inches. The patient's concurrent conditions included penicilline allergy, and other pre-existing medical conditions included high sensitivity to many things (hcp is aware of the situation). The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25/MAY/2021) dose was not reported, administered on 19-MAR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced injection site bruising. On 19-MAR-2021, the subject experienced injection site mild discomfort. On 19-MAR-2021, the subject experienced injection site redness (2-3inch). On APR-2021, the subject experienced redness/hives on the body comes and goes, but not at once. every time it's in a different spot, it can be round or long (under the breast as well) they are as large as a quarter, nickel, dime or penny. it can be a "botch" in the "crease" as well. On APR-2021, the subject experienced swelling in the lips. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness/hives on the body comes and goes, but not at once. every time it's in a different spot, it can be round or long (under the breast as well) they are as large as a quarter, nickel, dime or penny. it can be a "botch" in the "crease" as well, and the outcome of injection site bruising, injection site redness (2-3inch), injection site mild discomfort and swelling in the lips was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age, 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 admin not reported, and batch number: 206A21A expiry: unknown) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, the patient had an antibody test done and the result was negative (confirmed immunological vaccine failure). The test name was SARS COV2 AB (IGG). The test was done at facility. For result, less than 1, which means negative and have no antibodies.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000180817. The suspected product quality complaint has been confirmed to be void: N based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210551477 and 20210551575.; Sender's Comments: V0: 20210550960-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES OVER WHOLE BODY LIKE A WALKING RASH DESCRIBED AS ALLERGIC REACTION; This spontaneous report received from a patient concerned a 56 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: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced hives over whole body like a walking rash described as allergic reaction. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives over whole body like a walking rash described as allergic reaction. 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT IN LEG; This spontaneous report received from a consumer concerned a 73 year old female unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13- MAY-2021, the patient was taken to the emergency room (ER). On 14-MAY-2021, she was hospitalized with a clot/clots in her leg(s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in leg was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210551429 - Covid-19 vaccine ad26.cov2.s-Blood clots in leg. This case concerns with 73 years old female. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a pharmacist concerned 3 patients.  The patient's weight, height, and medical history 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, with frequency 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the pharmacist reported that 3 patients called in pharmacy to ask why their antibodies tests were found negatives after receiving the Janssen covid19 vaccine. The pharmacist stated that she had no other information on the patients to make the report at this time. Laboratory data (dates unspecified) included: antibody test (NR: not provided) negative (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210551549-covid-19 vaccine ad26.cov2.s -Suspected immunological 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 63 year old female. Initial information was processed along with additional information on 27-MAY-2021. The patient's weight was 175 pounds, and height was 63 centimeters. The patient's past medical history included high cholesterol, and concurrent conditions included alcohol user, and non-smoker. The patient had no known drug allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) 1 total, dose was not reported, administered on left arm on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the patient had negative (1.00 index) SARS-CoV-2 IgG antibody test (confirmed immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000180894. The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210551579-COVID-19 VACCINE AD26.COV2.S -confirmed 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: Bedridden, Hypersomnia, Illness
Clinical narrative: SICK AS A DOG; CAN'T GET OUT OF BED; SLEPT OVER A HUNDRED HOURS AND 6 DAYS; 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 was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAY-2021, the subject experienced sick as a dog. On MAY-2021, the subject experienced can't get out of bed. On MAY-2021, the subject experienced slept over a hundred hours and 6 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick as a dog, and the outcome of can't get out of bed and slept over a hundred hours and 6 days was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: BLOOD SUGAR WAS OVER 200; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, allergy to penicillin, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. Concomitant medications included insulin for type 2 diabetic. On 25-MAY-2021, the subject experienced blood sugar was over 200. Laboratory data included: Blood glucose (NR: not provided) over 200 (unit unspecified). On 26-MAY-2021, Laboratory data included: Blood glucose (NR: not provided) before breakfast blood sugar was 150 (unit unspecified), after eating blood sugar was 200 (unit unspecified). Laboratory data (dates unspecified) included: Blood glucose (NR: not provided) normally was 100-150 (unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood sugar was over 200. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE ADMINISTERED 12 HOURS POST  EXPIRATION DATE; This spontaneous report received from a pharmacist concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with glatiramer acetate for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: 25/MAY/2021) dose was not reported, administered on 26-MAY-2021 12:09 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced vaccine administered 12 hours post expiration date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered 12 hours post expiration date was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Burning sensation, Chills, Crying
Clinical narrative: DYING FROM PAIN; FEVER 99-100.8 F AS IF GOT THE SHOT AGAIN; CHILLS AGAIN; SEVERE PAIN IN THE LEFT LEG FROM HIP TO KNEE, THE WHOLE LEFT SIDE; FUNCTIONABLE DURING THE DAY  BUT NOT AT NIGHT; CAN NOT SLEEP AT NIGHT; BOTH LEGS HURT AT GROIN; CRIES FROM THE SEVER PAIN; INCREASE IN THE BLOOD PRESSURE; DEHYDRATION WHICH MADE HER VERY THIRSTY; FELT BURNING IN THE RIGHT ARM WHILE GETTING THE SHOT; SWOLLEN FACE; SEVER CHILLS; FELT EXHAUSTED; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip implant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Blood pressure measurement (NR: not provided) increased, COVID-19 virus test (NR: not provided) negative, Hip X-ray (NR: not provided) normal, and Investigation (NR: not provided) Negative. On 31-MAR-2021, the subject experienced increase in the blood pressure. On 31-MAR-2021, the subject experienced dehydration which made her very thirsty. On 31-MAR-2021, the subject experienced felt burning in the right arm while getting the shot. On 31-MAR-2021, the subject experienced swollen face. On 31-MAR-2021, the subject experienced sever chills. On 31-MAR-2021, the subject experienced felt exhausted. On 14-APR-2021, the subject experienced functionable during the day but not at night. On 14-APR-2021, the subject experienced can not sleep at night. On 14-APR-2021, the subject experienced both legs hurt at groin. On 14-APR-2021, the subject experienced cries from the sever pain. On 14-APR-2021, the subject experienced severe pain in the left leg from hip to knee, the whole left side. On 16-MAY-2021, the subject experienced fever 99-100.8 f as if got the shot again. On 16-MAY-2021, the subject experienced chills again. On an unspecified date, the subject experienced dying from pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increase in the blood pressure, and dehydration which made her very thirsty on 05-APR-2021, felt burning in the right arm while getting the shot on 2021, swollen face, sever chills, and felt exhausted on 14-APR-2021, and fever 99-100.8 f as if got the shot again, and chills again on 21-MAY-2021, had not recovered from severe pain in the left leg from hip to knee, the whole left side, functionable during the day but not at night, can not sleep at night, and cries from the sever pain, and the outcome of both legs hurt at groin and dying from pain was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Feeling abnormal, Groin pain, Insomnia
Clinical narrative: DYING FROM PAIN; FEVER 99-100.8 F AS IF GOT THE SHOT AGAIN; CHILLS AGAIN; SEVERE PAIN IN THE LEFT LEG FROM HIP TO KNEE, THE WHOLE LEFT SIDE; FUNCTIONABLE DURING THE DAY  BUT NOT AT NIGHT; CAN NOT SLEEP AT NIGHT; BOTH LEGS HURT AT GROIN; CRIES FROM THE SEVER PAIN; INCREASE IN THE BLOOD PRESSURE; DEHYDRATION WHICH MADE HER VERY THIRSTY; FELT BURNING IN THE RIGHT ARM WHILE GETTING THE SHOT; SWOLLEN FACE; SEVER CHILLS; FELT EXHAUSTED; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip implant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Blood pressure measurement (NR: not provided) increased, COVID-19 virus test (NR: not provided) negative, Hip X-ray (NR: not provided) normal, and Investigation (NR: not provided) Negative. On 31-MAR-2021, the subject experienced increase in the blood pressure. On 31-MAR-2021, the subject experienced dehydration which made her very thirsty. On 31-MAR-2021, the subject experienced felt burning in the right arm while getting the shot. On 31-MAR-2021, the subject experienced swollen face. On 31-MAR-2021, the subject experienced sever chills. On 31-MAR-2021, the subject experienced felt exhausted. On 14-APR-2021, the subject experienced functionable during the day but not at night. On 14-APR-2021, the subject experienced can not sleep at night. On 14-APR-2021, the subject experienced both legs hurt at groin. On 14-APR-2021, the subject experienced cries from the sever pain. On 14-APR-2021, the subject experienced severe pain in the left leg from hip to knee, the whole left side. On 16-MAY-2021, the subject experienced fever 99-100.8 f as if got the shot again. On 16-MAY-2021, the subject experienced chills again. On an unspecified date, the subject experienced dying from pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increase in the blood pressure, and dehydration which made her very thirsty on 05-APR-2021, felt burning in the right arm while getting the shot on 2021, swollen face, sever chills, and felt exhausted on 14-APR-2021, and fever 99-100.8 f as if got the shot again, and chills again on 21-MAY-2021, had not recovered from severe pain in the left leg from hip to knee, the whole left side, functionable during the day but not at night, can not sleep at night, and cries from the sever pain, and the outcome of both legs hurt at groin and dying from pain was not reported. This report was non-serious.