chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: male patient received an expired dose of havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 57-year-old male patient who received HAV (Havrix) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th June 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 20th June 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 Information: GSK receipt date: 21-Jun-2022 Reporters comment: The certified medical assistant reported that the patient received an expired dose of Havrix. The reporter consent for follow-up. Additional Supportive information: The patient received expired dose of Havrix vaccine, which led to expired vaccine used.
Age: 73.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 73-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 20th June 2022, the patient received Havrix. On 20th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-Jun-2022 Reporter's Comments: The reporter stated that a patient received Havrix expired vaccine. The reporter consented to follow up via email. Additional Supportive Information: The patient received Havrix expired vaccine with expiration date: 18th June 2022, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient 1st dose 26-Mar-2021 2nd dose on 12-Apr-2022; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) (batch number GK52A, expiry date unknown) and (batch number 7P2PS, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received first dose on 26th March 2021 from batch number 7S234 and P2J7E).   On 12th April 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 12th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 21-Jun-2022 Reporters comment: The reporter denied consent to follow up. Additional Supportive Information: The patient received two doses of Shingrix, 1 year apart which led to lengthening of vaccination schedule.
Age: 41.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 41-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva520a, expiry date 30th April 2022) for prophylaxis.   On 20th June 2022, the patient received Menveo (intramuscular) .5 ml. On 20th June 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-Jun-2022 Reporter's Comments: The reporter stated that the patient was given an expired dose of Menveo in an unknown arm. The reporter did not report that the patient was experiencing any side effects. The reporter consented to follow up. Additional Supportive Information: The patient was given an expired dose of Menveo, which led to expired vaccine used. This case has been linked to US2022095746, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022095746:Same reporter
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: diluted dose due to inappropriate reconstitution; diluted dose due to inappropriate reconstitution; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 14-months-old female patient who received Hib (Hiberix) (batch number 7325S, expiry date unknown) for prophylaxis.   Previously administered products included Hiberix (received 3 doses on an unknown date).   On 7th December 2021, the patient received the 4th dose of Hiberix. On 7th December 2021, unknown after receiving Hiberix, 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 Information: GSK receipt date: 21-JUN-2022 Reporter's comment: The nurse reported that a patient received a diluted dose of the Hiberix vaccine due to inappropriate reconstitution. The reporter was consented to follow up. Additional Supportive Information: The patient was administered diluted dose of the Hiberix vaccine due to inappropriate reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is one of 3 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022095743:Same reporter
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 34-year-old female patient who received HAV (Havrix 1440) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   On 21st June 2022, the patient received Havrix 1440. On 21st June 2022, unknown after receiving Havrix 1440, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 21-Jun-2022 Reporters comment: The patient received expired dose of Havrix. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Havrix 1440 which led to expired vaccine used.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient was administrated 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 47-year-old male patient who received HBV (Engerix B) (batch number 239tf, expiry date 6th June 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 20th June 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 20th June 2022, unknown after receiving Engerix B and Engerix B 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 Information: GSK Receipt Date: 21-Jun-2022 Reporter's Comments: The reporter stated that the patient was administered with an expired dose of Engerix-B on 20th June 2022. The vaccine was expired on 06th June 2022. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Engerix-B, which led to expired vaccine used.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered 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 58-year-old female patient who received HAV (Havrix) (batch number unknown, expiry date 24th May 2022) for prophylaxis.   On 10th June 2022, the patient received Havrix. On 10th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 21-JUN-2022 Reporter's comment:  The patient was administered expired doses of Havrix. The reporter was consented to follow up Additional Supportive Information: The patient was administered Havrix which was already expired in 24th May 2022, which led expired vaccine used. This was 1 of 3 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022095706:Same reporter US-GLAXOSMITHKLINE-US2022095754:Same reporter
Age: 68.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered 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 68-year-old male patient who received HAV (Havrix) (batch number 3a22r, expiry date 24th May 2022) for prophylaxis.   On 13th June 2022, the patient received Havrix. On 13th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 21-JUN-2022 Reporter's comment: The patient was administered expired doses of Havrix. The reporter was consented to follow up. Additional Supportive Information: The patient was administered expired doses of Havrix, which led expired vaccine used. This case is one of 3 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022095705:Same reporter US-GLAXOSMITHKLINE-US2022095754:Same reporter
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix: expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 15th June 2022, the patient received Havrix. On 15th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comment: The reporter was medical assistant. The reporter stated that, The patient was administered with expired dose of Havrix. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022095705:Same reporter US-GLAXOSMITHKLINE-US2022095706:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: didn´t receive 2nd dose, 1st dose given on 2020; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-Jun-2022. Reporter's Comments: The patient did not receive the 2nd dose of Shingrix and 1st dose was given in 2020. Consented to follow up was granted. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: administration of IV Boostrix; administration of IV Boostrix, another dose IM on the same day; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In May 2022, the patient received Boostrix, Boostrix Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device. In May 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device and not applicable after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route and overdose. On an unknown date, the outcome of the intramuscular formulation administered by other route and overdose 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 Information: GSK receipt date: 21-JUN-2022 Reporter's comment: The pharmacist reported that administration of intravenous Boostrix to a patient in early May 2022. The patient received another Boostrix dose intramuscular on the same day. The reporter did not have any patient demographics or specific details about the adverse event at the time of the call. The reporter was consented to follow up. Additional Supportive Information: The patient received Boostrix by intravenous route of administration and received another Boostrix dose intramuscular on the same day, which led to Intramuscular formulation administered by other route and overdose.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: receiving only the AS01B adjuvant; receiving only the AS01B adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 3N3GH, expiry date 28th January 2023) for prophylaxis.   On 21st June 2022, the patient received Shingrix. On 21st June 2022, 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 Information: GSK receipt date: 21-JUN-2022 Reporter's comment: The patient was administrated only the AS01B adjuvant of Shingrix. It was administered prior to reconstitution. The reporter was consented to follow up. Additional Supportive Information: The patient received only the AS01B adjuvant of Shingrix. It was administered prior to reconstitution, which led to inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient was administrated with a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number mr75g, expiry date 13th July 2023) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unkown date).   On 16th June 2022, the patient received the 3rd dose of Shingrix. On 16th June 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 21-JUN-2022 Reporter's comment: The patient was administrated with a 3rd dose of Shingrix on 16th June 2022. The vaccine administration facility was the same as primary reporter. The reporter was consented to follow up. No adverse event was reported. Additional Supportive Information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose was administered to an adult patient; Adult use of child product; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 35-year-old female patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31st March 2024) for prophylaxis.   On 17th June 2022, the patient received Engerix B pediatric. On 17th June 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 21-JUN-2022 Reporter's comment:  A pediatric dose was administered to an adult patient. The reporter was consented to follow up Additional Supportive Information: The adult patient was administered pediatric dose, which led to underdose and adult use of child product.
Age: 64.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: pt received 2nd dose 18 days after the 1st; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 64-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) 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.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 7th May 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 7th May 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-Jun-2022 Reporters comment: The patient received the 2nd dose of Twinrix 18 days after the 1st dose. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose Twinrix, earlier than the recommended schedule, which led to shortening of vaccination schedule.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient received expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   On 20th June 2022, the patient received Havrix. On 20th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-Jun-2022 Reporters comment: Pharmacist reported a patient received an expired dose of Havrix. The health care professional declined to provide patient demographics.  The health care professional declined follow up and did not want any contact details provided. The reporter did not consent to follow up. Additional Supportive Information: The patient received expired dose of Havrix which led to expired vaccine used.
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: pt vaccinated with an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received HAV (Havrix) (batch number HA9Y9, expiry date 17th June 2022) for prophylaxis.   On 21st June 2022, the patient received Havrix. On 21st June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comments: The reporter stated that that the patient was vaccinated with an expired dose of Havrix.  The reporter gave consent to follow up. Additional supportive Information: The patient was vaccinated with an expired dose of Havrix which, led to expired vaccine used.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Therapeutic response decreased
Clinical narrative: titers came back low; This case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.       Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comments: The patient needs a booster dose because her titers came back low, and when she tried to get it from the pharmacy, they would not administer the 1 ml dose because she was not 20 years of age.  The patient received all 3 doses 3 doses in 2003 and 2004. The titers were checked on the 18th and were 6.8. The reporter give consent to follow up. Additional supportive information: The patient received all 3 doses and titers was 6.8, which led to therapeutic response decreased. The lab test date and TTO was not captured since Month and year of titer check was not provided.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient received the improperly reconstituted dose; Patient received the improperly reconstituted dose; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   In 2022, the patient received Menveo. In 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comments: The reporter stated that a patient that received a dose of Menveo that was reconstituted with sterile water instead of the supplied CWY diluent.   The office had narrowed it down to five patients, but they were unsure which one of those five was the one that received the improperly reconstituted dose.  The dose was given sometime between 26th May 2022 and 7th June 2022. At the time of reporting, pharmacist did not have lot number or expiration date and patient information available.   A repeat dose had not been administered. The reporter gave permission for follow-up. Additional supportive Information: patient that received a dose of Menveo that was reconstituted with sterile water instead of the supplied which leads to Wrong solution used in drug reconstitution.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient yesterday (June 20, 2022) received an expired dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a unk patient who received HAV (Havrix) (batch number Km72c, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th June 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 20th June 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 Information: GSK receipt date:21-Jun-2022 Reporters comment: This case was reported by a medical assistant. The reporter did not consent for follow-up and did not provide patient information Additional Supportive information: The patient received an expired dose of Havrix vaccine, which led to expired vaccine used.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: pt vaccinated with a dose of MENVEO that expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA467A, expiry date 31st March 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comments: The reporter stated that a patient was vaccinated with a dose of Menveo that expired on March 2022. The reporter give consent to follow up. Additional supportive Information: The patient was vaccinated with a dose of Menveo which was already expired on March 2022 which leads to Expired vaccine used. This case has been linked to the case US2022000434 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022000434:Same reporter
Age: 55.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Nurse administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received HAV (Havrix) (batch number unknown, expiry date 14th June 2022) for prophylaxis.   On 21st June 2022, the patient received Havrix. On 21st June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-Jun-2022 Reporters comment: The reporter could not find the lot number at time of call. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix which was already expired in 14th June 2022 which led to expired vaccine used.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain at the injection site; Redness and warmth at the injection site; Swelling at the injection site; warmth at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd June 2022 11:00, the patient received the 1st dose of Shingrix. In June 2022, 24 hrs after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling and injection site warmth. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine into right arm at approximately 11 am and experienced pain, redness, swelling and warmth at the injection site approximately 24 hours later. The patient stated that all symptoms got gradually worked over the next few days.  The patient also stated that redness at injection site spread until it was wider than the width of their hand.  The patient was taking Tylenol and applying ice to the site to relieved symptoms.  The patient also stated that as soon as effects of Tylenol wore off and ice was removed, all symptoms were back at full intensity.  The events pain, swelling, and warmth resolved approximately two weeks after dose was received and redness resolved approximately three weeks after dose was received.  The reporter did not consent to follow-up.
Age: 69.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient was administered with an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 69-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 22nd June 2022, the patient received Havrix. On 22nd June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. The action taken with Havrix was unknown. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's comment: Nurse reported that today(day of reporting) a patient was administered with an expired dose of Havrix. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Patient received a 1 day 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 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3E52S, expiry date 21st June 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd June 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 22nd June 2022, unknown after receiving Boostrix and Boostrix 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 Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comment: Medical assistant reported that a patient received a 1 day expired dose of Boostrix. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Boostrix vaccine which was already expired in 21st June 2022, which led to expired vaccine used.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received four doses; Patient received four doses; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 26th November 2019) and Shingrix (2nd dose received on 22nd January 2020).   On 1st November 2020, the patient received the 4th dose of Shingrix. On 1st September 2020, the patient received the 3rd dose of Shingrix. On 1st September 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. On 1st November 2020, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comment: Pharmacist reported that the patient received four doses of Shingrix. Health Care Professional did not have the lot number or expiration date for any of the doses. The reporter consented to follow-up. Additional Supportive Information:  The patient received four doses of Shingrix vaccine, which led to extra doses administered.
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: adult accidentally received INFANRIX; received INFANRIX instead of BOOSTRIX; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 59-year-old female patient who received DTPa (Infanrix) (batch number 7ec55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd June 2022, the patient received Infanrix (intramuscular) and Infanrix Pre-Filled Syringe Device. On 22nd June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced adult use of a child product and wrong vaccine administered. On an unknown date, the outcome of the adult use of a child product 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 Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comments:  The nurse stated that an adult patient accidentally received Infanrix instead of Boostrix. The reporter gave consent to follow up. Additional supportive Information: The patient accidentally received Infanrix instead of Boostrix which leads to Wrong vaccine administered and adult use of child product.
Sex: U
Vaccine: FLUX
Symptoms: Bell's palsy, Herpes zoster
Clinical narrative: Bell's palsy; shingles (3x's); This case was reported by a consumer via market research programs and described the occurrence of bell's palsy in a patient who received Flu unspecified (Flu vaccine unspecified) for prophylaxis.   On an unknown date, the patient received Flu vaccine unspecified. On an unknown date, unknown after receiving Flu vaccine unspecified, the patient experienced bell's palsy (serious criteria GSK medically significant) and shingles. Flu vaccine unspecified was discontinued. On an unknown date, the outcome of the bell's palsy and shingles were recovered/resolved.   It was unknown if the reporter considered the bell's palsy and shingles to be related to Flu vaccine unspecified.  Additional Information: GSK Receipt Date: 19-May-2022. Reporter's Comments: This case was reported by the patient. The patient used to get seasonal flu shots until the patient started having reactions shingles (3x's), Bell's palsy. So, the patient stopped getting vaccinations and the patient stopped having problems. Additional Supportive Information: The follow-up would not possible as no contact details were available.  This was 1 of the 18 cases reported by same reporter.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drainage, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; DRAINAGE ISSUES; This spontaneous report received from a patient concerned a 52 year male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and non-alcoholic, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no any 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, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 04-MAY-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (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: 211D21A, expiry: unknown) dose was not reported, 1 total, administered on 19-JAN-2022 in right arm for prophylactic vaccination. Age at time of vaccination 52 years old. No concomitant medications were reported.  On 13-JUN-2022, the patient was not feeling well and had some drainage issues and itchy throat. On 14-JUN-2022 and 15-JUN-2022, he had a fever and did not felt well. On 16-JUN-2022 he did covid test and got result as he had covid. On 18-JUN-2022, the patient had head congestion. Thus patient had confirmed clinical vaccination failure and confirmed covid-19 infection. Patient reported that, he was still sick with covid (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of drainage issues and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000236384.; Sender's Comments: V0: 20220638632- covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 63 year old female. Initial information was processed along with additional information received on 23-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: myositis, interstitial lung disease, hypertension, and drug allergy (Drug name was not reported), and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. 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, 1 total administered in left arm for prophylactic vaccination. The batch number was not reported and has been requested. On 01-JUN-2022, the patient also received Pfizer drug (unspecified name) for treatment of covid-19 till 05-JUN-2022. Concomitant medications included celebrex (celecoxib), cardura (doxazosin mesilate), prednisone, and verapamil for drug used for unknown indication.  On 05-JUN-2022, Laboratory data included: COVID-19 virus test Negative. On 08-JUN-2022, the patient tested positive 3 days after testing negative (suspected covid-19 infection), and had suspected clinical vaccination failure. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The case is associated with Product quality complaint number: 90000237123.; Sender's Comments: V0: 20220640915-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has an unknown/unclear 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. Therefore, this event(s) is considered not related.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: REBOUND COVID; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: COPD (Chronic obstructive pulmonary disease), and non-hodgkins lymphoma remission for 10 years, and other pre-existing medical conditions included: patient had none allergy. 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 was not reported, 1 total, administered at right arm on 25-MAR-2021 for prophylactic vaccination. Age at time of vaccination 54 years old. The batch number was not reported and has been requested. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1). No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient received booster dose of non-company suspect vaccine included: Pfizer covid-19 vaccine (Tozinameran) (Dose number in series 2) (form of admin, route of admin was not reported, batch number: unknown expiry: unknown) dose was not reported, administered on an unspecified date in Nov-2021 for prophylactic vaccination. Treatment medications included: Paxlovid (ritonavir/nirmatrelvir) from 25-MAY-2022 to 30-MAY-2022 for the treatment of covid-19. On 07-JUN-2022, the patient experienced rebound covid (Dose number in series 2). The action taken with tozinameran (Pfizer covid-19 vaccine) was not applicable. The patient was recovering from rebound covid. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Ear pain, Insomnia, Neck pain
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; CONSTANTLY NEEDING TO URINATE; TROUBLE SLEEPING; KIDNEY PAIN; BAD STOMACH CRAMPS; SHOOTING PAIN AT BACK OF NECK/NECK ACHES; SHOOTING PAIN IN EARS; LOW BACK PAIN; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 72 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy, and other pre-existing medical conditions included: Patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose, 1 total, start therapy date were not reported on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-JUN-2022, the patient experienced horrible taste in mouth, neck and body aches, shooting pain at back of neck and in ears, temporal headache, bad stomach cramps, low back and kidney pain, nausea, occasional vomiting, fluid diarrhea, no appetite, trouble sleeping, constantly needing to urinate and had diarrhea movements which indicates suspected covid-19 infection. On an unspecified date, the symptoms resulted into suspected clinical vaccination failure. The patient took non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 11-JUN-2022 and last dose on JUN-2022 for treatment of covid 19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with Paxlovid was drug discontinued. The patient had not recovered from suspected covid-19 infection, constantly needing to urinate, trouble sleeping, kidney pain, bad stomach cramps, shooting pain at back of neck/neck aches, shooting pain in ears, and low back pain, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000237104.; Sender's Comments: 20220642549- COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. The event(s) has an unknown/unclear 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. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria, Renal pain, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; CONSTANTLY NEEDING TO URINATE; TROUBLE SLEEPING; KIDNEY PAIN; BAD STOMACH CRAMPS; SHOOTING PAIN AT BACK OF NECK/NECK ACHES; SHOOTING PAIN IN EARS; LOW BACK PAIN; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 72 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy, and other pre-existing medical conditions included: Patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose, 1 total, start therapy date were not reported on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-JUN-2022, the patient experienced horrible taste in mouth, neck and body aches, shooting pain at back of neck and in ears, temporal headache, bad stomach cramps, low back and kidney pain, nausea, occasional vomiting, fluid diarrhea, no appetite, trouble sleeping, constantly needing to urinate and had diarrhea movements which indicates suspected covid-19 infection. On an unspecified date, the symptoms resulted into suspected clinical vaccination failure. The patient took non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 11-JUN-2022 and last dose on JUN-2022 for treatment of covid 19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with Paxlovid was drug discontinued. The patient had not recovered from suspected covid-19 infection, constantly needing to urinate, trouble sleeping, kidney pain, bad stomach cramps, shooting pain at back of neck/neck aches, shooting pain in ears, and low back pain, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000237104.; Sender's Comments: 20220642549- COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. The event(s) has an unknown/unclear 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. Therefore, this event(s) is considered not related.