chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 2nd dose was an incorrect pediatric (0.5ml) dose; 2nd dose was an incorrect pediatric (0.5ml) dose; 1st dose of Engerix on 04Jun2021 / late 2nd dose on 03Dec2021; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 58-year-old female patient who received HBV (Engerix B pediatric) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (1st dose received on 4th June 2021).   On 3rd December 2021, the patient received the 2nd dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 3rd December 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose, adult use of a child product and drug dose administration interval too long. On an unknown date, the outcome of the accidental underdose, adult use of a child product and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. but it could be 57 or 58 years. The patient received the 2nd dose of Engerix later than the recommended interval, which led to lengthening of vaccination schedule. Also the 2nd dose was an incorrect pediatric (0.5ml) dose, which led to accidental underdose and adult use of child product. No symptoms reported. The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 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 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 20th December 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 20th December 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong 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 practice manager reported that, it was recently discovered that Kinrix vaccine was administered to the infant patient instead of Pediarix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. This is one of two cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022001230:same reporter.
Age: 0.25
Sex: F
Vaccine: DTAPIPV, DTAPIPV, DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix vaccines were administered to two infants; administered to two infants instead of Pediarix.; Kinrix vaccines were administered to two infants; administered to two infants instead of Pediarix.; Kinrix vaccines were administered to two infants; administered to two infants instead of Pediarix.; 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 3-month-old female patient who received DTPa-IPV (Kinrix) (batch number 273C4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) (batch number 273C4, expiry date 17th January 2023) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) (batch number 273C4, expiry date 17th January 2023) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th May 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 10th June 2021, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 11th August 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 4th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, not applicable after receiving Kinrix, Kinrix Pre-Filled Syringe Device and Kinrix and an unknown time after starting Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On 10th June 2021, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On 11th August 2021, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered, inappropriate age at vaccine administration, wrong vaccine administered, inappropriate age at vaccine administration and wrong 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 Practice Manager reports that, it was recently discovered that Kinrix vaccine was administered to the infant patient instead of Pediarix, which led to inappropriate age at vaccine administration, wrong vaccine administered.  The patient was administered three separate doses of Kinrix, all from lot number 273C4. The reporter consented to follow up. This case has been linked to US2022001229, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022001229:same reporter
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 19-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2KD4D, expiry date 8th May 2022) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Pediarix (previous 3 doses were administered on an unknown date). On 4th January 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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 nurse administered Pediarix for 4th time to the patient, which resulted in receiving an extra dose of Hep B and early dose of IPV to the patient, which led to extra dose administered. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got 1st dose Oct2021, currently has shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced shingles. No other details of patient or vaccine were provided. The reporter consented to follow-up.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Extra dose of IPV given; Got Kinrix at two months of age; Got Kinrix, months later got complete series of Pediarix; 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 2-month-old male patient who received DTPa-IPV (Kinrix) (batch number HN7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number J7X44, expiry date 11th May 2023) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DIPHTHERIA TOXOID + HEPATITIS B VACCINE + PERTUSSIS TOXOID + POLIOMYELITIS VACCINE + TETANUS TOXOID (PEDIARIX) and DIPHTHERIA TOXOID + HEPATITIS B VACCINE + PERTUSSIS TOXOID + POLIOMYELITIS VACCINE + TETANUS TOXOID (PEDIARIX).   On 18th February 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 30th December 2021, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 18th February 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On 30th December 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and extra dose 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: Clinical Supervisor reported that, the patient received a dose of Kinrix at two months of age, which led to inappropriate age at vaccine administration. Several months later, the patient received a complete series of Pediarix. The 1st dose of Pediarix was given on 19th April 2021 (batch number 4977T, expiry date 5th September 2022) and 2nd dose on 21st June 2021 (Batch number 4977T, expiry date 28th November 2021) The patient received 3rd dose of Pediarix leaving him with an extra dose of IPV given which led to inappropriate schedule of vaccine administered and extra dose administered. Pediarix was given on the correct schedule, but started at the incorrect age. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 2-year-old male patient who received HAV (Havrix 1440 adult) for an unknown indication. On 4th January 2022, the patient received the 1st dose of Havrix 1440 adult. On 4th January 2022, unknown after receiving Havrix 1440 adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown. Additional details were provided as follows: A healthcare professional enquired if there were any side effects after giving a Havrix vaccine 1440 units to a child 2 years of age and what was the earliest age they could give the Havrix 1440 Units. The healthcare professional disconnected the chat after he/she was asked for credentials and before was able to confirm that there was or was not patient involvement. Later a nurse reported that a 2 year-old patient was given an adult dose of Havrix as a first dose of the immunization schedule, which led to adult product administered to child and overdose. The reporter consented to follow-up.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 23 month old patient got a dose of Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 23-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: A nurse reported that a 23 month old male patient accidentally received a dose of Kinrix, which led to inappropriate age at vaccine administration. No symptoms were reported. The reporter consented to follow up.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 79-year-old male patient who received Herpes zoster (shingrix) for prophylaxis. Concurrent medical conditions included chronic fatigue syndrome. On 1st January 2022, the patient received the 1st dose of shingrix. In January 2022, less than a week after receiving shingrix, the patient experienced unexpected therapeutic effect and pain in arm. On an unknown date, the outcome of the unexpected therapeutic effect was unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the unexpected therapeutic effect and pain in arm to be related to shingrix. Additional details were provided as follows: The case was reported by the patient. The reporter stated that he had chronic fatigue syndrome. The reporter stated that he was feeling much better than normal and this was the best he felt in a long time after taking the first dose.  The reporter also experienced a sore arm for a day which had since resolved. The reporter did not consent to follow-up. The case has been linked to US2022001254,US2022AMR001808,US2022001255, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022001254:Same reporter; US-GLAXOSMITHKLINE-US2022AMR001808:Same reporter; US-GLAXOSMITHKLINE-US2022001255:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: sore arm; swollen arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm and swelling arm were recovered/resolved.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's father The age at vaccination was not reported. Reporter stated that patient experienced sore arm and swollen arm after dose of Shingrix which she received a year ago. Symptoms lasted for a few days. It was unknown if she received second dose. The reporter did not consent to follow-up. This case had been linked with cases US2022001255 and US2022001252, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022001255:Same reporter US-GLAXOSMITHKLINE-US2022001252:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received Herpes zoster (shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of shingrix. On an unknown date, less than a year after receiving shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to shingrix. Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not reported. The reporter stated that the patient received dose of Shingrix last year and experienced flu-like symptoms for a day. The reporter did not consent to follow-up. For tolerance of 2nd dose, refer case US2022AMR001808. This is 1 of 4 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022001254:Same reporter; US-GLAXOSMITHKLINE-US2022001252:Same reporter; US-GLAXOSMITHKLINE-US2022AMR001808: Different dose.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain at injection site; Redness injection site, upper arm/Injection site/upper arm redness hot to touch; Injection site hotness, upper arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2021, the patient received the 1st dose of Shingrix .5 ml. In August 2021, 24 hrs after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site warmth. In August 2021, the outcome of the injection site pain, injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received her first dose of the Shingrix vaccine and 24 hours later she experienced redness and pain and hotness at the injection site.   The patient reported that the injection site and the redness on her upper arm was hot to the touch.   The redness at the injection site spread over 7 days across her upper arm.   The patient reported that all symptoms were resolved after 7 days.   The patient was also unsure if the vaccine was administered intramuscularly or not as the location she received it seemed to be more anterior on her arm. The reporter did not consent to follow-up.
Age: 74.0
Sex: M
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Pruritus, Rash
Clinical narrative: mild case of  Shingles; rash in chest above sternum, fist size; itching; first dose around February of 2020; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE (MANUFACTURER UNKNOWN)) for prophylaxis.   Previously administered products included Covid Vaccine.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix and COVID 19 VACCINE (MANUFACTURER UNKNOWN). On an unknown date, between 1 and 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, rash, pruritus and incomplete course of vaccination. The patient was treated with dermatologicals nos (Lotion Unknown) and hydrocortisone. On an unknown date, the outcome of the shingles, rash and pruritus were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles, rash and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received his 1st dose of Shingrix vaccine around February 2020 and he now had a mild case of Shingles. He stated that he received the first dose of Shingrix at his work site as they were also doing COVID-19 vaccinations, he received both Shingrix and COVID-19 vaccine at the same time. The patient did not recall which arm he received the Shingrix vaccine, but he stated he received both the COVID and Shingrix vaccine on the same arm. The patient stated that he had a mild case of shingles for approximately 1 month, in which he experienced rash and itching. The rash was located in the center of his chest above the sternum and it was about the size of a fist, he used medicated skin lotion and hydrocortisone ointment which eased the itching. The patient did not receive the second dose of Shingrix vaccine till the time of reporting, which led to incomplete course of vaccination. The reporter was given medical advice disclaimer and referred to health care professional. The patient had limited information. He stated he did not have a primary physician. The reporter did not consent to follow-up. It was unknown if the reporter considered the shingles, rash and pruritus to be related to COVID-19 vaccine.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult received pediatric Engerix-B; adult received pediatric Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 20-year-old male patient who received HBV (Engerix B pediatric) (batch number MY3RA, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd December 2021, the patient received the 1st dose of Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 22nd December 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown. 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 health care professional reported adult refugee patient aged 20 year and 6 months inadvertently received the dose of pediatric Engerix-b (10 mcg), which led to accidental underdose and adult use of a child. The reporter consented to follow up. This case has been linked to the case US2022001259 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022001259:Same reporter US-GLAXOSMITHKLINE-US2022001260:Same reporter - Deleted US-GLAXOSMITHKLINE-US2022001262:Same reporter
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 41-year-old male patient who received HBV (Engerix B pediatric) (batch number MY3RA, expiry date unknown) for prophylaxis. Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis. On 22nd December 2021, the patient received the 1st dose of Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 22nd December 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced accidental under dose and adult use of a child product. On an unknown date, the outcome of the accidental under dose and adult use of a child product 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 reporter reported that 2 adult refugee patients and 41 years inadvertantenly received the dose of pediatric Engerix B (10 mcg), which led to accidental underdose and adult use of a child product. The reporter consented to follow up. The case has been linked to US2022001258, US2022001262,reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022001258:Same reporter; US-GLAXOSMITHKLINE-US2022001262:Same reporter; US-GLAXOSMITHKLINE-US2022001260:Same reporter -Deleted.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Fluarix on Oct2021 and a dose of FluLaval on Jan2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 42M9S, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX QUADRIVALENT 2021-2022 SEASON).   On 4th January 2022, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 4th January 2022, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device and an unknown time after receiving FLUARIX QUADRIVALENT 2021-2022 SEASON, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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 reported as follows: The patient received a dose of Fluarix Quadrivalent on 26th October 2021 and then received a dose of FluLaval Quadrivalent on 04th January 2022, which led to extra dose administered. The reporter consented to follow up. This case was reported by a medical assistant.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Occupational exposure to product
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female nurse who was administering Herpes zoster (shingrix) (batch number 72P9H, expiry date 9th April 2023) for prophylaxis. On 4th January 2022, the patient received shingrix. On 4th January 2022, unknown after receiving shingrix, the patient experienced occupational exposure while preparing product for administration and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while preparing product for administration and exposure via eye contact were unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Nurse reported while mixing up shingrix, sprayed a small amount into right eye, washed eye out at eye rinse station, which led to occupational exposure while preparing product for administration and exposure via eye contact. The reporter consented to follow up. No additional details regarding reporter available at time of filing adverse event.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number G327T, expiry date 12th May 2023) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received on an unknown date).   On 30th December 2021, the patient received the 3rd dose of Shingrix. On 30th December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: Nurse practitioner reported that patient received three doses of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HAV (Havrix 1440 adult) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 5th January 2022, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 5th January 2022, unknown after receiving Havrix 1440 adult 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: Pharmacy technician reported that the patient received expired dose of Havrix, which led to expired vaccine used. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose three weeks after the 1st; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised. Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 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. The reporter was a pharmacist, who was calling on behalf of a colleague from a different facility who had an instance where an immunocompromised patient received second dose of Shingrix series three weeks after receiving the first dose, which led to shortening of vaccinations schedule.  The pharmacist did not have any further patient information, dosing dates, or lot number or expiration date information.  The reporter consented to follow up. The health care professional gave permission for follow-up and states she would try to find out patient and dosing information.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Dermatomyositis, Discomfort, Myalgia, Polymyositis, Pyrexia
Clinical narrative: Flare up of dermatomyositis; Flare up of polymyositis; Myalgia; Pyrexia; Rash; Discomfort; This case was reported by a consumer via other manufacturer and described the occurrence of dermatomyositis in a 49-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   In September 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season. On an unknown date, less than 5 months after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced dermatomyositis (serious criteria GSK medically significant), polymyositis (serious criteria GSK medically significant), myalgia, fever, rash and discomfort. On an unknown date, the outcome of the dermatomyositis, polymyositis, myalgia, fever, rash and discomfort were unknown.   It was unknown if the reporter considered the dermatomyositis, polymyositis, myalgia, fever, rash and discomfort to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: The patient received flu vaccine and experienced flare up of dermatomyositis and polymyositis, myalgia, pyrexia, rash and discomfort. No contact details reported.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Flare up of dermatomyositis; Flare up of polymyositis; Myalgia; Pyrexia; Rash; Discomfort; This case was reported by a consumer via other manufacturer and described the occurrence of dermatomyositis in a 49-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   In September 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season. On an unknown date, less than 5 months after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced dermatomyositis (serious criteria GSK medically significant), polymyositis (serious criteria GSK medically significant), myalgia, fever, rash and discomfort. On an unknown date, the outcome of the dermatomyositis, polymyositis, myalgia, fever, rash and discomfort were unknown.   It was unknown if the reporter considered the dermatomyositis, polymyositis, myalgia, fever, rash and discomfort to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: The patient received flu vaccine and experienced flare up of dermatomyositis and polymyositis, myalgia, pyrexia, rash and discomfort. No contact details reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; 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 initially received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination as primary vaccination (dose number in series 1). It was unknown whether patient had any adverse event following vaccination with first dose. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on NOV-2021 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 sore arm (Dose number in series 2).  On an unspecified date the patient reported that he was exposed to delta variant and quarantined but did not get sick. No additional information was provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was unknown. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED 36 HOURS AFTER BOOSTER; This spontaneous report received from a consumer via social media through company representative concerned a 54 year old of unspecified sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (dose number in series 1), (suspension for injection, route of admin, and batch number: Unknown, expiry: unknown) dose was not reported, 01 in total administered for prophylactic vaccination.  No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin, and batch number: Unknown, expiry: unknown) dose was not reported, 1 in total administered on unspecified date (therapy start date and therapy end date were not provided) 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.  The reporter stated that his friend died 36 hours after booster (dose number in series 2). The cause of death was not reported. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211256303-covid-19 vaccine ad26.cov2.s -died 36 hours after booster. 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: DEATH
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race, ethnicity. The patient's height, and weight were not reported. No past medical history. Concurrent conditions were reported from spouse as "physical issues" (captured as physical disability). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  After receiving the vaccine, the patient go COVID (captured as suspected COVID-19 Infection), felt mild symptoms along with suspected clinical vaccination failure (dose number in series 1). The outcome of the suspected clinical vaccination failure and suspected covid-19 infection were unknown (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number and expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. No concomitant medications were reported.   After receiving booster patient did not experienced any adverse events and stated as good (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000208740. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed a manufacturing related root cause could not be identified, based on the regulatory authority evaluation/investigation performed.; Sender's Comments: V0: 20211256561-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hyperhidrosis, Pain
Clinical narrative: STRONG ACHES AND PAINS; SWEATS; CHILLS; FEVER 99.8; TIRED; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis, alcohol use, non smoker, penicillin allergy (PCN), and wheat products allergy, llosone allergy, drug allergy (codeine), influenza vaccine allergy and diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid vaccine allerggy. and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, dose number in series 1, 1 total, administered on 18-JUL-2021 to left arm for prophylactic vaccination. Subject was recovered from event. On 18-JUL-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced aches and pains (mild) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, dose number in series 2, 1 total, administered on 02-DEC-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 02-DEC-2021, the patient experienced strong aches and pains, sweats, chills, fever 99.8, and tired. These symptoms lasted for 24 hours (dose number in series 2). On 02-DEC-2021, Laboratory data included: Body temperature (NR: not provided) 99.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from strong aches and pains, sweats, chills, fever 99.8, and tired on 03-DEC-2021. This report was non-serious. This case, involving the same patient is linked to 20211258204. This case, from the same reporter is linked to 20211258945 and 20211258986.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: STRONG ACHES AND PAINS; SWEATS; CHILLS; FEVER 99.8; TIRED; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis, alcohol use, non smoker, penicillin allergy (PCN), and wheat products allergy, llosone allergy, drug allergy (codeine), influenza vaccine allergy and diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid vaccine allerggy. and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, dose number in series 1, 1 total, administered on 18-JUL-2021 to left arm for prophylactic vaccination. Subject was recovered from event. On 18-JUL-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced aches and pains (mild) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, dose number in series 2, 1 total, administered on 02-DEC-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 02-DEC-2021, the patient experienced strong aches and pains, sweats, chills, fever 99.8, and tired. These symptoms lasted for 24 hours (dose number in series 2). On 02-DEC-2021, Laboratory data included: Body temperature (NR: not provided) 99.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from strong aches and pains, sweats, chills, fever 99.8, and tired on 03-DEC-2021. This report was non-serious. This case, involving the same patient is linked to 20211258204. This case, from the same reporter is linked to 20211258945 and 20211258986.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHES AND PAINS (MILD); 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: arthritis, alcohol use occasionally, non smoker, penicillin allergy, wheat products allergy, and drug allergy (T-dap, ilisone, codeine, flu-vaccine), and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1)(suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 18-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUL-2021, the patient experienced aches and pains (mild).(Dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches and pains (mild) on 18-JUL-2021. This report was non-serious. This case, involving the same patient is linked to 20211258107.(Dose series in number 2 case) This case, from the same reporter is linked to 20211258945 and 20211258986.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Heart rate, Oxygen therapy
Clinical narrative: CHEST PAIN; CHILLS; FEVER; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received non-company bnt 162 vaccine (dose number in series was 1) (form of admin, route of admin not reported, batch number: FW0161) dose was not reported, administered on 19-APR-2021 for prophylactic vaccination. On an unspecified date, the patient experienced chest pain following vaccination with non-company bnt 162 vaccine (dose number in series was 1). The patient previously received non-company bnt 162 vaccine (dose number in series was 1) (form of admin, route of admin not reported, batch number: ER8736) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. On an unspecified date, the patient experienced chest pain following vaccination with non-company bnt 162 vaccine (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, route of admin not reported, batch number: 1855191 expiry: 11-APR-2022) dose was not reported, 1 total, administered on 24-DEC-2021 to Left Deltoid for prophylactic vaccination. Concomitant medications included naproxen. On 24-DEC-2021, within 6 hours from vaccination, the patient experienced fever, chest pain and chills following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series was 2). Laboratory data (dates unspecified) included: Body temperature (not provided) 100.5 (units unspecified), Oxygen supplementation (not provided) 98 %, and Pulse rate (not provided) 90's. The patient received treatment with Aleve. Patient's chest pain symptom was faded. Patient's health care professional (HCP) suspected that the vaccination causes chest pain. Patient did not go to emergency room (ER) and was discussed with an ER doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 25-DEC-2021, and fever, and was recovering from chest pain. This report was non-serious.