chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient missed their 2nd dose; This case was reported by a other health professional and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (First dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. The reporter wanted to know if the patient missed their 2nd dose, whether he/she should restart the series of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash, Skin lesion
Clinical narrative: Mild eruption of shingles, clustered, linier; Itchy; eruption; Lesions; This case was reported by a nurse and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2022, the patient received the 1st dose of Shingrix. In February 2022, 2 weeks after receiving Shingrix, the patient experienced shingles, pruritus, eruption and skin lesion. On an unknown date, the outcome of the shingles, pruritus, eruption and skin lesion were unknown.   It was unknown if the reporter considered the shingles, pruritus, eruption and skin lesion to be related to Shingrix.  Additional details reported were as follows: This case was reported by the patient. The age at vaccination was not reported. Approximately 2 weeks later receiving Shingrix, the patient noted mild eruption of shingles mid back which was clustered, linier and itchy. The patient had seen many cases of shingles and quite sure that was what these lesions were.  The patient decided to not receive 2nd dose until closer to the 6 month deadline. The patient asked that if this was common and should I expect another eruption with 2nd dose or should I not get 2nd dose.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Hiatus hernia, Pain
Clinical narrative: hiatal hernia; condition aggravated; Was hospitalized for pain management; This case was reported by a nurse via sales rep and described the occurrence of hiatal hernia in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hiatal hernia.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hiatal hernia (serious criteria hospitalization), pain (serious criteria hospitalization) and condition aggravated (serious criteria hospitalization). On an unknown date, the outcome of the hiatal hernia, pain and condition aggravated were unknown.   It was unknown if the reporter considered the hiatal hernia, pain and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was unknown. The patient had hiatal hernia that acted up after second Shingrix dose. The patient was hospitalised for pain management for 7 days. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient had their first injection over a year ago; This case was reported by a other health professional 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 an unknown date over a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received first Shingrix injection over a year ago and the reporter enquired if patient had to restart the series or just get the second injection. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: HEP
Symptoms: Serology negative, Therapy non-responder
Clinical narrative: completed series, titer testing was negative; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   Linked case(s) involving the same patient: US2022043704  Additional details were provided as follows: This case was reported by the medical assistant. The age at vaccination was not reported. The patient completed the series of Engerix B but titer testing was negative, which led the patient to be therapy non-responder. Engerix B series was being re-administered, for tolerance of Engerix B 10 received by the patient, refer case US2022043704. This case was linked with US2022018153, reported by same reporter for different patient. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022018153:Same reporter, different patient US-GLAXOSMITHKLINE-US2022043704:Same patient, same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: two shots were one year apart; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose about 1 year ago from 2nd dose).   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 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 self-reported this case. The age at vaccination was not reported. The patient received two shots of Shingles vaccine exactly about one year apart, which led to lengthening of vaccination schedule. The patient stated that the store did not tell him/her there was a second shot nor did they reach out to got him/her to came in. The patient asked whether it still work. He/she did not want to get shingles. The patient also asked should he/she get a third shot in two months. Note: From the narrative it was not clear if the patient received shingrix vaccine hence shingles vaccine was coded as suspect  conservatively.
Age: 44.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered an expired Twinrix vaccine.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 44-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) 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.   On 28th February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 28th February 2022, unknown after receiving Twinrix and Twinrix 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: Nurse reported that the patient was administered an expired Twinrix vaccine, which led to expired vaccine used. The reporter consented to follow-up.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 1 yearold given Kinrix; fourth dose for DTaP and IPV series; 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-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTAP vaccine  (received 1st dose 19th April 2021), DTAP vaccine (received 2nd dose on 25th June 2021), DTAP vaccine (received 3rd dose on 15th September 2021), IPV vaccine (received 1st dose on 19th April 2021), IPV vaccine (received 2nd dose on 25th June 2021) and IPV vaccine (received 3rd dose on 15th September 2021).   On 28th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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 staff member at pediatrician office stated that the patient was accidentally given the fourth dose of Kinrix early, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.  The reporter consented to follow up via email. Note: It was unknown if the patient received DTAP vaccine and IPV vaccine as separate dosage, it was coded separately considering received on same day.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient developed redness in the arm after 1st dose administration; Patient developed swelling in the arm after 1st dose administration; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 3B55B, expiry date 18th December 2022) for prophylaxis.   On 24th December 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were unknown.   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was unknown. The patient receive dose of Shingrix vaccine and experienced redness and swelling in the arm. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant; received only the adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number H54CA, expiry date 18th May 2023) 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 reported as follows: The age at vaccination was not reported. The reporter reported that 6 patients were administered Shingrix from 28th January 2022 and 2nd March 2022 and one of them received only the adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. For 5 of the 6 patients, this would had been the patients' second dose. For one patient, it would had been their first dose. 1 of 6 patient had possible adverse events. The reported lot number was for the powder component.  HCP did not have lot for adjuvant. Consented to follow up was provided. The reporter stated that out of 6 patients only 1 experienced the medication error, but the reporter was not certain which of the patients experienced it. Therefore, 1 case would be considered as valid (US2022042592) while the other 5 would be kept invalid.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022042597:Same reporter US-GLAXOSMITHKLINE-US2022042594:Same reporter US-GLAXOSMITHKLINE-US2022042599:Same reporter US-GLAXOSMITHKLINE-US2022042600:Same reporter US-GLAXOSMITHKLINE-US2022042601:Same reporter
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This case was reported by a physician via call center representative and described the occurrence of diarrhea in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced diarrhea. On 7th March 2022, the outcome of the diarrhea was resolved with sequelae.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient developed diarrhea after 1st dose of Shingrix and might not receive 2nd dose of Shingrix. The reporter enquired about effectiveness of 1 dose of Shingrix and stated that it was not the time for 2nd Shingrix vaccine yet. The reporter did not consent to follow-up. Note: Outcome was captured as resolved with sequelae as per clarification mail.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Rash, Rash pruritic
Clinical narrative: first dose on 30-AUG-21, should receive second dose?; generalized itchy rash all over her body; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 3rd September 2021, 4 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with antihistamine (Antihistamines) and steroids nos (Steroids). On an unknown date, the outcome of the itchy rash was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine and experienced generalized itchy rash all over her body. The patient was advised that 4 days after she developed a generalized itchy rash all over her body. The patient visited an urgent care where they prescribed antihistamines and a course of steroids. The rash went away after 5 days and was now resolved.  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 she should receive second dose.   The patient was given medical advise disclaimer. Emergency room visit required. The patient gave permission to contact HCP(health care professional). The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Has an outbreak of shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included ZOSTERVAX (received about 6 years before reporting).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case, he was member of public. The age at vaccination was not reported. The patient reported that he received both doses of Shingrix within the recommended 6 months' time frame, 6 years before reporting and wanted to know if he needed a booster dose. The patient was unable to provide the specific dates of the vaccines. The patient went to see his doctor last week from the day of reporting for other problems and when the doctor looked at his back, he stated that he was getting shingles/ outbreak of shingles. The reporter declined to provide healthcare professional information, he said he would provide the details if safety contact him.  The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 46-year-old female patient who received HAV (Havrix) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th March 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th March 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that a patient received an expired dose of Havrix, which led to expired vaccine used. The reporter consented for follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th March 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th March 2022, unknown after receiving Kinrix and Kinrix 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 patient was vaccinated with an expired dose of Kinrix, which led to expired vaccine used.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: dose 1 on 2018, and never received dose 2.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 92-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th June 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter consented to follow up.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: administered an pediatric dose to an adult patient; administered an pediatric dose to an adult patient; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 41-year-old male patient who received HBV (Engerix B pediatric) (batch number 9KJ7R, expiry date 9th May 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th March 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 7th March 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and 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 patient received Engerix B pediatric in right deltoid. The patient inadvertently received a pediatric dose of Engerix B at the age of 41 years, which led to adult use of a child product and underdose. The reporter inquired as what dose to proceed with. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th March 2022, the patient received the 1st dose of Shingrix. On 8th March 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. 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 Shingrix.  Additional details reported were as follows: This case was reported by the patient for herself. The age at vaccination was not reported. After receiving Shingrix, the patient had a sore arm that lasted for 20 minutes. The patient enquired that for patients 50 years or older, was there a time that was preferred in the 2 to 6 month time-frame to get second dose of Shingrix.  The patient did not wish to provide any further details. The consent to follow-up was not given.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 71-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 53bf4, expiry date 14th August 2021) for prophylaxis.   On 8th March 2022, the patient received Boostrix. On 8th March 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received an expired dose of Boostrix, which led to expired vaccine used. The reporter was contacted after the call to get follow up consent but could not reach out to the reporter.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA92AZ, expiry date 28th February 2022) 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 1st March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st March 2022, 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 patient received an expired dose of Bexsero, which led to expired vaccine used. The reporter consented to follow up via email.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: received dose that had expired; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number unknown, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th March 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 4th March 2022, unknown after receiving Kinrix and Kinrix 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 received a dose of Kinrix that had expired on 31st January 2022, which led to expired vaccine used. The reporter did not want to answer questions before speaking to the patient but agreed to follow up by safety. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Incorrect route of product administration
Clinical narrative: Bexsero administered subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Men B NVS (Bexsero) (batch number ABXB60BA, expiry date 30th September 2022) 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 9th March 2022, the patient received Bexsero (subcutaneous) and Bexsero Pre-Filled Syringe Device. On 9th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route 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 received dose of Bexsero subcutaneously into the left arm, which led to intramuscular formulation administered by other route. The reporter did not provide patient information at time of call. The reporter consented to follow-up via mail.
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness neurosensory
Clinical narrative: This spontaneous report was received from literature: Assessment of Sudden Sensorineural Hearing Loss After COVID-19 Vaccination. This report concerned a 9 decade old female of unspecified race and ethnicity. The objective of this study was to examine the potential association between COVID-19 vaccination and SSNHL (sudden sensorineural hearing loss). 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, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sudden sensorineural hearing loss, 7 days after vaccination. Laboratory data (dates unspecified) before treatment included: Hearing test (NR: not provided) 46 dB HL (decibel hearing level). The patient received treatment of intratympanic steroid. Laboratory data (dates unspecified) after treatment included: Hearing test (NR: not provided) 40 dB HL (decibel hearing level), and word recognition score was 90 % and 100 %. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sudden sensorineural hearing loss was not reported. It was concluded that in this cross-sectional study, findings from an updated analysis of VAERS data and a case series of patients who experienced SSNHL (sudden sensorineural hearing loss) after COVID-19 vaccination did not suggest an association between COVID-19 vaccination and an increased incidence of hearing loss compared with the expected incidence in the general population. This report was serious (Other Medically Important Condition). Sender's Comments: V0- 20220260763-Covid-19 vaccine ad26.cov2.s-Sudden sensorineural hearing loss. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY (elderly age). Therefore, this event(s) is considered not related.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for rheumatoid arthritis. No concomitant medications were reported. On JAN-2022, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from covid-19. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Pain
Clinical narrative: SORENESS THROUGHOUT BODY AND JOINTS; WORKING AND ACTIVITIES DIFFICULT; This spontaneous report received from a patient via a company representative concerned a 70 year old male. 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the patient experienced soreness throughout body and joints, and working and activities difficult. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness throughout body and joints, and had not recovered from working and activities difficult. This report was non-serious. This case, involving the same patient is linked to 20220320745.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 03-MAR-2022. 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 (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total administered on an unspecified date 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 02-MAR-2022, the patient experienced covid-19 test positive (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on an unspecified date for prophylactic vaccination. It was unknown if the patient experienced any adverse event after vaccination with covid-19 vaccine (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint 90000219964. The suspected product quality complaint has been confirmed to be voided this case does not meet the definition for a  since the only indication is that the patient had covid but does not refer to any symptoms or PCR tests. Based on the  evaluation/investigation performed.
Age: 39.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Endometriosis, Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; BLEEDING AND OTHER SYMPTOMS OF ENDOMETRIOSIS HAD RETURNED; This spontaneous report received from a patient concerned a 40 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: endometriosis. 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 05-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: elagolix sodium (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On 2022, bleeding and other symptoms of endometriosis had returned. On 09-FEB-2022, the patient took to hospital via ambulance and diagnosed with pulmonary embolism, and was hospitalized for an unspecified days. Reporter also reported that she had orilissa (elagolix sodium) interaction with blood thinner.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with elagolix sodium was withdrawn. The patient had not recovered from pulmonary embolism and other symptoms of endometriosis had returned was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220307432-Covid-19 vaccine ad26.cov2.s- Pulmonary embolism. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHINESS; This spontaneous report received from a patient 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced itchiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itchiness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Chills, Inappropriate schedule of product administration, Off label use
Clinical narrative: LITTLE CHILLY; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (dose number in series 1), (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered for prophylactic vaccination. No adverse events reported following vaccination (dose number in series 1). The patient received tylenol unspecified (coated tablet, route of admin, and batch number and expiry date were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication.  The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (dose number in series 2), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination which was off label use, and inappropriate schedule of vaccine administered (dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced little chilly (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tylenol unspecified was not reported. The outcome of the little chilly, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Illness
Clinical narrative: ILL POST COVID VACCINE; This solicited report received from a patient via RRA-18356: Nurse  from Janssen for STELARA Crohns 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 was treated with Ustekinumab (solution for infusion, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, therapy start date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient became ill post covid-19 vaccine. The patient was hospitalized from 26-FEB-2022 to 28-FEB-2022. It was reported that the health professional was aware about it. The number of days of hospitalization was reported as 2. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with ustekinumab was not reported. The outcome of ill post covid-19 vaccine was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and ill post covid vaccine was not related; and between ustekinumab, and ill post covid vaccine was not related. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220310725-covid-19 vaccine ad26.cov2.s-ill post covid vaccine. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered not related. 20220310725-Stelara-ill post covid vaccine. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; 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. The patient's past medical history included: stroke, and concurrent conditions included: many allergies, and allergic to chromium in needles. The patient was previously treated with acetylsalicylic acid for stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: SORENESS AT INJECTION SITE; TIRED; This spontaneous report received from a consumer concerned a 19 year old male. The patient's weight was 117 kilograms, and height was 187 centimeters. The patient's concurrent conditions included: seasonal allergy, and non smoker, and other pre-existing medical conditions included: The patient had no pre-existing illness (no prior history of autoimmune disease, arrhythmias, myocarditis, pericarditis, seizure disorder, brain disorder, Guillain-Barre syndrome, other nervous system problem, chronic condition or long term health problem), no family history of cardiovascular and metabolic diseases, no illness at the time of vaccination, and no adverse event after any previous vaccinations. The patient had never received the pneumonia vaccine or shingles vaccine. The patient' brother was allergic to kiwi. The patient was not on home infusions, weekly injections, steroid therapy, anti-cancer drugs, radiation therapy, aspirin or aspirin containing therapy. The patient had not received a transfusion of blood or blood products or immune globulin in the past year. The patient experienced hives when treated with cefprozil. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808482 expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced soreness at injection site, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site and tired was not reported. This report was non-serious. This case, involving the same patient is linked to 20220253441.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Joint range of motion decreased, Muscular weakness, Pain
Clinical narrative: FEELS LIKE A SHARD OF GLASS AT THE INJECTION SITE; DECREASED RANGE OF MOTION; CANT SLEEP ON THAT SIDE BECAUSE OF PAIN; MUSCLE WEAKNESS; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced feels like a shard of glass at the injection site, decreased range of motion, muscle weakness, and cant sleep on that side because of pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feels like a shard of glass at the injection site, decreased range of motion, muscle weakness, and cant sleep on that side because of pain. This report was non-serious. This case, from the same reporter is linked to 20220316497.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SOME SIDE EFFECTS; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced some side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of some side effects was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: PROBLEM WITH TONGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced problem with tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of problem with tongue was not reported. This report was non-serious.