chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: Myocarditis; Chest pain; Pain in jaw; Neck pain; Dizziness; Hyperhidrosis; Impaired work ability; Malaise; This case was received. (Reference number: 1423608) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This regulatory authority case was reported by a health care professional and describes the occurrence of MYOCARDITIS (Myocarditis), CHEST PAIN (Chest pain), PAIN IN JAW (Pain in jaw), NECK PAIN (Neck pain), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), IMPAIRED WORK ABILITY (Impaired work ability) and MALAISE (Malaise) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054czia) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia. Concurrent medical conditions included Hypothyroidism, Hypercholesterolemia and Arthritis. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), OMEPRAZOLE, MICONAZOLE and ROSUVASTATIN for an unknown indication.    On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization, medically significant and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), PAIN IN JAW (Pain in jaw) (seriousness criteria hospitalization and life threatening), NECK PAIN (Neck pain) (seriousness criteria hospitalization and life threatening), DIZZINESS (Dizziness) (seriousness criteria hospitalization and life threatening), HYPERHIDROSIS (Hyperhidrosis) (seriousness criteria hospitalization and life threatening), IMPAIRED WORK ABILITY (Impaired work ability) (seriousness criteria hospitalization and life threatening) and MALAISE (Malaise) (seriousness criteria hospitalization and life threatening). At the time of the report, MYOCARDITIS (Myocarditis), CHEST PAIN (Chest pain), PAIN IN JAW (Pain in jaw), NECK PAIN (Neck pain), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), IMPAIRED WORK ABILITY (Impaired work ability) and MALAISE (Malaise) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2021, Catheterisation cardiac: abnormal (abnormal) abnormal. On 14-Jun-2021, Electrocardiogram: abnormal (abnormal) abnormal at Urgent Care and abnormal (abnormal) abnormal in Emergency Room. On 16-Jun-2021, Echocardiogram: confirmed myocarditis (abnormal) Confirmed myocarditis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medications were listed as armor thyroid. No treatment was reported for these events. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose of Shingrix vac in November 2020 / Do I need to start over; This case was reported by a consumer via 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 (received first dose on an unknown date in November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not applicable for this report. The patient had not received the second dose for more than 8 months, which led to incomplete course of vaccination. The reporter enquired if he/ she had to start over and get two more doses.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: passed my / booster timeframe; 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 (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not applicable for this report. The patient just realized that he/she had passed Shingrix booster timeframe, which led to incomplete course of vaccination. The reporter asked what he/she could do. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Condition aggravated, Osteomyelitis, Red blood cell sedimentation rate increased
Clinical narrative: osteomyelitis/ immune stimulation post-Shingrix /may have helped to reveal this underlying infection.; lower back pain prior to Shingrix/ Post one dose / extreme pain at the lower back; This case was reported by a physician via sales rep and described the occurrence of osteomyelitis in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included low back pain (ongoing prior to Shingrix vaccination).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced osteomyelitis (serious criteria GSK medically significant) and back pain aggravated. On an unknown date, the outcome of the osteomyelitis and back pain aggravated were unknown.   It was unknown if the reporter considered the osteomyelitis and back pain aggravated to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient's ESR (Red blood cell sedimentation rate) was a little elevated but no telling tales of an infection. Post one dose of Shingrix, patient developed extreme pain at the lower back that eventually revealed osteomyelitis. The patient and MD thought the immune stimulation post Shingrix vaccination might had helped to reveal this underlying infection. The consent to follow-up was granted.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: because of covid, was not able to get the second one within the time frame; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details provided were as follows: Till the time of reporting, patient did not received 2nd dose of Shingrix, due to covid. The patient enquired and asked about his/her friend that what to do if he/she had shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My arm hurt for a week after each vaccination shot; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case US2021AMR149439).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient reported that after every Shingle shot, his/her arm hurts for a week. The patient stated that he/she could not imagine how painful shingles were. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR149439:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm/ I also had it (worse I might add); This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case US2021AMR149435).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself/himself. The age at vaccination was not reported. The patient received shingrix vaccine and experienced sore arm, which was worst case. The patient was alive and did not had covid 19.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR149435:Same reporter
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: instead of using the liquid conjugate component/ they used a diluent instead / had been improperly reconstituted with non-GSK approved diluent; Menveo, second dose to patient / administered only one vial of Menveo vaccine to a 16 year old male patient, mentioned it vaccine number 2 in the series; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA415A, expiry date 20th September 2021) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, 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 preparing of the vaccine ended up being in error as instead of using the liquid conjugate component of the vaccine to mix both vials, they used a diluent instead, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Centers for Disease Control and Prevention (CDC) recommended meningococcal vaccination for all preteens and teens - all 11 to 12 years old should receive a single dose of a MenACWY vaccine. Since protection decreases over time, CDC recommends a booster at age 16 years and as this patient was 16 years old, and therefore receiving the second dose (booster) in the series as recommended by the CDC in this case as reported by the customer. The reporter did not consent to follow-up.   Follow up information received via nurse on 8th July 2021: The age at vaccination was updated as 16 years. On 7th July 2021, Menveo injection had been improperly reconstituted with non-GSK approved diluent.  The nurse reported that a diluent from MMR vaccine was used and so the patient only received the lyophilized portion of Menveo and only one vial of Menveo vaccine was given. The batch number and expiry date were updated. The VAERS details was updated. The reporter consented to follow up.  No further information was available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got / first dose of Shingrix on 11/27/20 but could not get the 2nd dose; 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 27th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient reported this case for herself/himself. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wanted to know if he/she should get the 2nd dose only or get the first dose again. The reporter consent to follow up. This case has been linked with case US2021AMR150814, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR150814:same repoter (husband´s case)
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: My husband /got / first dose of Shingrix on 11/27/20 but could not get the 2nd dose; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient was the reporter's hudband. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter wanted to know if the patient should get the 2nd dose only or get the first dose again. The follow up would not be possible as no contact details were available. This case has been linked with case US2021AMR150813, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR150813:same repoter (reporter´s case)
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: given a dose /nonviable after a temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 18-year-old male patient who received HAV (Havrix) (batch number 7HJ74, 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.   On 11th June 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 11th June 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 case details were reported as follows: The patient was given a dose of Havrix that was deemed nonviable after a temperature excursion, which led to incorrect storage of drug.  No symptoms reported. The reporter consented to follow up. This case was 1st of 6 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142818:Same reporter US-GLAXOSMITHKLINE-US2021142817:Same reporter US-GLAXOSMITHKLINE-US2021142816:Same reporter US-GLAXOSMITHKLINE-US2021142815:Same reporter US-GLAXOSMITHKLINE-US2021142813:Same reporter
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered an expired /BEXSERO (exp date: 05/31/2021) on the 24th June, 2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st May 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th June 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 24th June 2021, unknown after receiving Bexsero and Bexsero 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 age at vaccination was not reported. The patient was administered an expired dose of Bexsero, which led to expired vaccine used. No further details were provided at the time of call. The reporter did not have the lot number of the vaccine, date of birth or age of the patient.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: might have administered/lyophilized vial without the adjuvant/not sure about it yet and did not mention any other diluent; might have administered/lyophilized vial without the adjuvant/not sure about it yet and did not mention any other diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 pharmacist reported on a voicemail that they might have administered Shingrix lyophilized vial without the adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered, they were not sure about it yet and did not mention any other diluent either. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose / on 05May2021 / second dose / on 05Jun2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number EZ4TD, expiry date 4th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th June 2021, the patient received the 2nd dose of Shingrix. On 5th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. On 5th May 2021, the patient received 1st dose of Shingrix. The patient received the 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Product administered at inappropriate site
Clinical narrative: not given in the deltoid muscle but just below; Redness; Pain; This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date 13th November 2022) for prophylaxis.   On 2nd July 2021, the patient received Shingrix (intramuscular). On 2nd July 2021, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. In July 2021, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema, pain and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the erythema and pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by pharmacy intern. The reporter stated that, Shingrix vaccine was not given in the deltoid muscle but just below, which led to vaccine administered at inappropriate site. The patient developed redness and pain after a dose of Shingrix. The reporter consented to follow up. No additional information was provided.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose / January / 2021 / went / 6 of July 2021 to get the second dose / not administered at time of report; 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 male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received first dose on 18 january 2021).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The patient went to the facility on 6th July 2021 to get the second dose. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The health care professional did not provide lot number neither expiration date of the first dose of Engerix B. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Incomplete course of vaccination, Pyrexia
Clinical narrative: fever of 103 which lasted a short time; first Shingrix vaccine about 2 years ago/she never received the second dose of Shingrix; did not feel well and this lasted for 2 weeks; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 2nd dose of Shingrix. On an unknown date, several days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the fever and feeling bad were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fever and feeling bad to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient received first dose of shingrix 2 years ago of reporting date. The patient experienced fever of 103 degrees and was recovered in short time. Also after couple of days patient did not feel well which was recovered within 2 weeks. Till now patient did not receive second dose of shingrix,which led to incomplete course of vaccination. Did not consent to follow-up.
Sex: F
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: 34 year old / patient / was inadvertently given a pediatric dose instead of an adult dose; 34 year old / patient / was inadvertently given a pediatric dose instead of an adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 34-year-old female patient who received HBV (Engerix B pediatric) (batch number 77B59, expiry date 22nd September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th July 2021, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 6th July 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient was inadvertently given a pediatric dose instead of an adult dose.  Pharmacist believed this was the patient's first dose in the series, which led to adult use of child product and accidental underdose. The reporter consent to follow up via email. Pharmacist granted permission for safety to follow up via email.
Age: 12.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Shingrix / was given / by error to a 12-year old female patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date 16th November 2022) for prophylaxis.   On 9th July 2021, the patient received the 1st dose of Shingrix. On 9th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were reported as follows: This case was reported by a clinic coordinator and a nurse. The Shingrix vaccine was given by error to a 12-year old female patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 and expiry: Unknown) dose was not reported,1 total administered on 09-MAR-2021 to the left arm for prophylactic vaccination. The patient received infliximab, recombinant (solution for infusion, route of admin not reported, batch number: Unknown) dose and frequency were not reported from 02-MAR-2021, dose and frequency were not reported from 31-MAR-2021, dose and frequency were not reported from 28-APR-2021, dose and frequency were not reported from 26-MAY-2021, and dose and frequency were not reported from 23-JUN-2021 for an unspecified indication. No concomitant medications were reported. The patient was complaining about three negative spike protein antibody tests that she has received since receiving JNJ COVID-19 vaccine on 09-MAR-2021. On 31-MAR-2021 the first negative antibody test was performed and after four weeks later on 28-APR-2021 second negative antibody test done and the last negative antibody was done on 23-JUN-2021(confirmed immunological vaccine failure).Remicade doses were given on 02-MAR-2021 which was a week before obtaining the JNJ vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of infliximab, and recombinant was not changed. 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 number 90000184875.  Additional information was received from product quality vigilance on 02-JUL-2021. The following information was updated and incorporated into the case narrative: PQC number added, narrative updated. Upon review following information was amended: The event onset date added.; Sender's Comments: V1 - This version is created to amend and update additional information received from product quality vigilance on 02-JUL-2021: PQC number added ; event onset date added. This does not change causality of previously reported events.  20210667208-covid-19 vaccine ad26.cov2.s-Confirmed immunological 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  20210667208-Remicade-Confirmed immunological 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: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient 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: 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 30-JUN-2021, the subject experienced chills. On 30-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Chest pain, Chills, Dizziness, Hot flush
Clinical narrative: BRONCHITIS AND DIFFICULTY BREATHING; SHARP BURNING PAIN IN CHEST; DIZZINESS; HOT FLASHES; NERVE PAIN IN LEGS; CHILLS; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included hospitalized, and electrocardiogram, and concurrent conditions included prinzmetal variant angina, myocardial bridge, non-obstructive coronary disease, vasospasm, alcohol user, smoker, and marijuana abuse, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281 and expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 12:00 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, amlodipine, atorvastatin, clonidine, glyceryl trinitrate, and metoprolol tartrate.  On 03-JUL-2021, the subject experienced bronchitis and difficulty breathing. On 03-JUL-2021, the subject experienced sharp burning pain in chest. On 03-JUL-2021, the subject experienced dizziness. On 03-JUL-2021, the subject experienced hot flashes. On 03-JUL-2021, the subject experienced nerve pain in legs. On 03-JUL-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nerve pain in legs on 03-JUL-2021, was recovering from chills, and hot flashes, and had not recovered from bronchitis and difficulty breathing, sharp burning pain in chest, and dizziness. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: BRONCHITIS AND DIFFICULTY BREATHING; SHARP BURNING PAIN IN CHEST; DIZZINESS; HOT FLASHES; NERVE PAIN IN LEGS; CHILLS; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included hospitalized, and electrocardiogram, and concurrent conditions included prinzmetal variant angina, myocardial bridge, non-obstructive coronary disease, vasospasm, alcohol user, smoker, and marijuana abuse, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281 and expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 12:00 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, amlodipine, atorvastatin, clonidine, glyceryl trinitrate, and metoprolol tartrate.  On 03-JUL-2021, the subject experienced bronchitis and difficulty breathing. On 03-JUL-2021, the subject experienced sharp burning pain in chest. On 03-JUL-2021, the subject experienced dizziness. On 03-JUL-2021, the subject experienced hot flashes. On 03-JUL-2021, the subject experienced nerve pain in legs. On 03-JUL-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nerve pain in legs on 03-JUL-2021, was recovering from chills, and hot flashes, and had not recovered from bronchitis and difficulty breathing, sharp burning pain in chest, and dizziness. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Dizziness
Clinical narrative: DIZZINESS OR LIGHT HEADEDNESS; PAIN LOWER BACK; WEAKNESS; This spontaneous report received from a patient concerned a 45 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: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUL-2021, the subject experienced dizziness or light headedness. On 03-JUL-2021, the subject experienced pain lower back. On 03-JUL-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness or light headedness, weakness, and pain lower back. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain, Sleep disorder
Clinical narrative: STIFFNESS IN BACK OF NECK OR STIFFNESS OF SHOULDER; PAIN IN NECK; WOKE ME UP; SHOULDERS PAIN; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, diabetic, non smoker, non alcohol user, and arthritis, and other pre-existing medical conditions included the patient had no known allergies, 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: 204N21A, expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. Concomitant medications included paracetamol for arthritis, metformin for diabetic, and lisinopril for high blood pressure. On 26-JUN-2021, the subject experienced stiffness in back of neck or stiffness of shoulder. On 26-JUN-2021, the subject experienced pain in neck. On 26-JUN-2021, the subject experienced woke me up. On 26-JUN-2021, the subject experienced shoulders pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiffness in back of neck or stiffness of shoulder, pain in neck, woke me up, and shoulders pain on 26-JUN-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Paraesthesia
Clinical narrative: NUMBNESS IN FEET AND HAND; TINGLING IN NERVES; CHILLS; 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: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced numbness in feet and hand. On APR-2021, the subject experienced tingling in nerves. On APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, numbness in feet and hand, and tingling in nerves. This report was non-serious. This report was associated with product quality complaint: 90000185026. The suspected product quality complaint has been confirmed to be confirmed no pqc was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210710749 and 20210711353.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED AFTER RECEIVING YOUR VACCINE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) 1 total 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 14-APR-2021, the patient died after receiving vaccine and cause of death was unknown. It was unspecified if autopsy performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210710773-covid-19 vaccine ad26.cov2.s - DIED AFTER RECEIVING YOUR VACCINE. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: EXTREME BODY ACHE; JOINT PAIN; CHILLS; BAD FEVER; EXTREME HEADACHE; TIRED; This spontaneous report received from a consumer concerned a 21 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:1821286 and expiry: UNKNOWN) dose was not reported, administered on 04-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUL-2021, the subject experienced extreme headache. On 04-JUL-2021, the subject experienced tired. On 05-JUL-2021, the subject experienced extreme body ache. On 05-JUL-2021, the subject experienced joint pain. On 05-JUL-2021, the subject experienced chills. On 05-JUL-2021, the subject experienced bad fever. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad fever, extreme body ache, joint pain, chills, extreme headache, and tired. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: EXTREME BODY ACHE; JOINT PAIN; CHILLS; BAD FEVER; EXTREME HEADACHE; TIRED; This spontaneous report received from a consumer concerned a 21 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:1821286 and expiry: UNKNOWN) dose was not reported, administered on 04-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUL-2021, the subject experienced extreme headache. On 04-JUL-2021, the subject experienced tired. On 05-JUL-2021, the subject experienced extreme body ache. On 05-JUL-2021, the subject experienced joint pain. On 05-JUL-2021, the subject experienced chills. On 05-JUL-2021, the subject experienced bad fever. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad fever, extreme body ache, joint pain, chills, extreme headache, and tired. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Feeling abnormal, Nasopharyngitis, Nausea, Pulmonary embolism
Clinical narrative: NAUSEOUS; PULMONARY EMBOLISM; FELT LIKE TRYING TO GET SICK; FELT LIKE COMING DOWN WITH A COLD; This spontaneous report received from a patient concerned a 41 year old African American, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and the patient did not have any history of previous clots and no medical condition reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: 05-AUG-2021) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, after vaccination, the patient felt like she was trying to get sick, and felt like she was coming down with a cold but did not really get sick. On 30-MAY-2021, the patient was working and ended up getting admitted in the hospital on 17-JUN-2021 night at 7 PM. On an unspecified date in JUN-2021, laboratory data included: chest X-ray (NR: not provided) multiple clots in both the lungs, and scan with contrast (NR: not provided) multiple clots in both the lungs and was diagnosed with pulmonary embolism. The physician were not sure if it was because of the vaccine. The patient was hospitalized until 28-JUN-2021 or 29-JUN-2021. The duration of hospitalization was 12 days. On an unspecified date, the patient felt like there was something sitting on her chest, was nauseous so she thought she had food poisoning. The patient had been a little short of breath, thought it was because she just started working out but it was not much noticeable.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, and the outcome of felt like coming down with a cold, nauseous and felt like trying to get sick was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210713153-COVID-19 VACCINE AD26.COV2.S-Pulmonary Embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210713153-COVID-19 VACCINE AD26.COV2.S-Nauseous. This event(s) is labeled and is therefore considered potentially related.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast
Clinical narrative: NAUSEOUS; PULMONARY EMBOLISM; FELT LIKE TRYING TO GET SICK; FELT LIKE COMING DOWN WITH A COLD; This spontaneous report received from a patient concerned a 41 year old African American, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and the patient did not have any history of previous clots and no medical condition reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: 05-AUG-2021) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, after vaccination, the patient felt like she was trying to get sick, and felt like she was coming down with a cold but did not really get sick. On 30-MAY-2021, the patient was working and ended up getting admitted in the hospital on 17-JUN-2021 night at 7 PM. On an unspecified date in JUN-2021, laboratory data included: chest X-ray (NR: not provided) multiple clots in both the lungs, and scan with contrast (NR: not provided) multiple clots in both the lungs and was diagnosed with pulmonary embolism. The physician were not sure if it was because of the vaccine. The patient was hospitalized until 28-JUN-2021 or 29-JUN-2021. The duration of hospitalization was 12 days. On an unspecified date, the patient felt like there was something sitting on her chest, was nauseous so she thought she had food poisoning. The patient had been a little short of breath, thought it was because she just started working out but it was not much noticeable.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, and the outcome of felt like coming down with a cold, nauseous and felt like trying to get sick was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210713153-COVID-19 VACCINE AD26.COV2.S-Pulmonary Embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210713153-COVID-19 VACCINE AD26.COV2.S-Nauseous. This event(s) is labeled and is therefore considered potentially related.