chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TYP
Symptoms: Abdominal pain upper
Clinical narrative: Stomach cramping; A spontaneous report was received from the nurse on 05DEC2022. It described a patient (age and gender unknown) who had "stomach cramping" (PT: Abdominal pain upper) following the administration of Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that on an unknown date, the patient received Vivotif and experienced stomach cramping as a side effect after taking three doses of Vivotif capsules. Reportedly, the last dose of Vivotif has not been administered yet to the patient. The outcome of the reported event was unknown, at the time of this report.  Action taken with Vivotif was unknown with respect to the reported event.  The concurrent conditions, medical history, and concomitant medications of the patient were not reported.  No additional information was reported.  Company comment: It was reported that a patient had stomach cramping (abdominal pain upper) following the administration of Vivotif for immunisation. Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of abdominal pain upper is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: t was reported that a patient had stomach cramping (abdominal pain upper) following the administration of Vivotif for immunisation. Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of abdominal pain upper is assessed as possible. The case is considered non serious as per medical assessment
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Rash
Clinical narrative: Rash all over her body; Diarrhea; A spontaneous report was received from the patient on 08DEC2022 along with additional information received on 12DEC2022. It described a 19-year-old female patient who had "rash all over her body" (PT: Rash) and "diarrhea" (PT: Diarrhoea) following the administration of Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient had administered Vivotif as scheduled. Reportedly, on an unknown date in DEC2022 (for two days), the patient had a rash all over her body and diarrhea. Furthermore, the patient was prescribed levocetirizine for rash and dicyclomine for diarrhea as treatment medications. Additionally, it was reported that the last dose of Vivotif was administered on 08DEC2022 to the patient. Reportedly the patient stopped taking levocetirizine. On an unknown date in DEC2022, the patient had recovered from "diarrhea" while had not recovered from the event of "rash all over her body" at the time of this report.  No action taken was taken with Vivotif with respect to the reported events.  The patient had a history of drug allergies to Oxybutynin, which presented as rash and did not have a history of other medical conditions and did not other take any other medications.  No additional information was reported.  Company comment: It was reported that a consumer had rash all over her body (rash) and diarrhea (diarrhoea) following the administration of Vivotif. This patient had a history of drug allergy. Considering the case information, the causality of rash and  diarrhoea is assessed as possible with Vivotif (its role cannot be ruled out and confounded by allergy to Oxybutynin). The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer had rash all over her body (rash) and diarrhea (diarrhoea) following the administration of Vivotif. This patient had a history of drug allergy. Considering the case information, the causality of rash and  diarrhoea is assessed as possible with Vivotif (its role cannot be ruled out and confounded by allergy to Oxybutynin). The case is considered non-serious as per medical assessment.
Sex: M
Vaccine: UNK
Symptoms: Dyspnoea, Endotracheal intubation, Erythema, Headache, Intensive care
Clinical narrative: Difficulty breathing (hospitalized at ICU); Turned very red (hospitalized at ICU); Severe headaches (icy pick) (hospitalized at ICU); Fever of 105 degrees (hospitalized at ICU); This case was reported by a consumer via market research programs and described the occurrence of difficulty breathing in a adult male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Concurrent medical conditions included asthma (Severe). Concomitant products included salbutamol (Albuterol Neb).   On an unknown date, the patient received the 1st dose of Hz/su + AS01B. On an unknown date, 1 hr after receiving Hz/su + AS01B, the patient experienced difficulty breathing (serious criteria hospitalization), erythema (serious criteria hospitalization), headache (serious criteria hospitalization) and fever (serious criteria hospitalization). On an unknown date, the outcome of the difficulty breathing, erythema, headache and fever were recovered/resolved.   The reporter considered the difficulty breathing, erythema, headache and fever to be possibly related to Hz/su + AS01B.   Additional Information: GSK Receipt Date: 22-DEC-2022 Reporter's comments: The patient had reported that, in 2019 he does not remembered in which month, while he had severe asthma was given the first shot of Shingrix vaccine and within 1-2 hours after taking the shot, the patient had experienced difficulty breathing, had a fever of 105 degree Fahrenheit, he had turned very red and had severe headaches to which he had referred it as ick prick headaches.  He was hospitalized in the ICU and was Intubated. He was then discharged after 10 days and the issue was fully recovered. He did not remembered any other details during his hospitalization. The reporter had consented to follow-up. Additional supportive information: Concomitant products included  Oral and topical corticosteroids.
Sex: M
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Difficulty breathing (hospitalized at ICU); Turned very red (hospitalized at ICU); Severe headaches (icy pick) (hospitalized at ICU); Fever of 105 degrees (hospitalized at ICU); This case was reported by a consumer via market research programs and described the occurrence of difficulty breathing in a adult male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Concurrent medical conditions included asthma (Severe). Concomitant products included salbutamol (Albuterol Neb).   On an unknown date, the patient received the 1st dose of Hz/su + AS01B. On an unknown date, 1 hr after receiving Hz/su + AS01B, the patient experienced difficulty breathing (serious criteria hospitalization), erythema (serious criteria hospitalization), headache (serious criteria hospitalization) and fever (serious criteria hospitalization). On an unknown date, the outcome of the difficulty breathing, erythema, headache and fever were recovered/resolved.   The reporter considered the difficulty breathing, erythema, headache and fever to be possibly related to Hz/su + AS01B.   Additional Information: GSK Receipt Date: 22-DEC-2022 Reporter's comments: The patient had reported that, in 2019 he does not remembered in which month, while he had severe asthma was given the first shot of Shingrix vaccine and within 1-2 hours after taking the shot, the patient had experienced difficulty breathing, had a fever of 105 degree Fahrenheit, he had turned very red and had severe headaches to which he had referred it as ick prick headaches.  He was hospitalized in the ICU and was Intubated. He was then discharged after 10 days and the issue was fully recovered. He did not remembered any other details during his hospitalization. The reporter had consented to follow-up. Additional supportive information: Concomitant products included  Oral and topical corticosteroids.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the vaccine and I got shingles/Suspected vaccination failure; Shingles/ i got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient asked that what happened if you got the vaccine and then got shingles. The patient had the vaccine and got shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure/Had 2 doses last year, had shingles in June; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received on an unknown date several years ago from reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In June 2022, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 23-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient received the new Shingles vaccine (2 doses) last year (in 2021) and he/she still had shingles back this June. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Received only the liquid component; Received only the liquid component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA758A, expiry date 30th November 2023) for prophylaxis.   On 12th December 2022, the patient received the 1st dose of Menveo. On 12th December 2022, unknown after receiving Menveo, 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: 14-DEC-2022 Reporter's comment: The nurse reported that the patient received only the liquid conjugated component of Menveo (without the powder). The vaccine administration facility was the same as primary reporter. The reporter consented to follow up by fax. Additional Supportive Information: The patient received only the liquid conjugated component of Menveo (without the powder), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.   Follow-up information received on 23-DEC-2022 Reporter's Comment: The reporter reported that they were in doubt about the patient involved on this adverse event. Additional Supportive Information: This case had been linked to the case US2022AMR192847, reported by the same reporter. Summary of Changes: Narrative updated.; Sender's Comments:  US-GSK-US2022AMR192847:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: extended pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   The reporter considered the pain to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received first dose of Shingles vaccine and caused side effects like pain for years (extended pain). The reporter reported that the shot might be dangerous for you, too. The reporter reported that she would never take another vaccine after reading the book. The reporter reported that what had been injected into them was criminal. The reporter did not consent to follow up. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: don't feel terrible, just little off; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2022, the patient received Shingles vaccine. In December 2022, less than a day after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-DEC-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient asked could he or she take ibuprofen after getting shingles vaccine. It was 16 hours. He/she did not feel terrible just a little off. Additional supportive information: Follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: Late 2nd dose due to vaccine availability/way beyond the approved scheduled time due to vaccine availability during that time; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 to 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.   Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: No additional information was provided. Lot, expiration and dates of vaccines were not provided. The customer wanted to disconnect from call. The customer did not provide additional information or demographics.  The customer just only wanted her question to be answered and disconnect from call. Additional supportive information: The patient got her 2nd dose of Shingrix way beyond the approved scheduled time due to vaccine availability during that time, which led to product supply issue.
Age: 0.33
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 months old received Havrix; 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 4-month-old female patient who received HAV (Havrix) (batch number CN3G5, expiry date 19th November 2023) for prophylaxis.   On 19th December 2022, the patient received Havrix. On 19th December 2022, unknown after receiving Havrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: The office manager called in to report that a Havrix dose was given to a patient under the recommended age for the Havrix vaccine.  The vaccine was administered at the same location from where it was reported. The patient's information was collected.  The vaccine administration facility was the same as primary reporter. The case was escalated to second line. The reporter consented to follow up. Additional supportive information: The patient received a dose of Havrix at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Arm was sore/sore right arm; Broke out in hives (ER visit); This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   In December 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and PNEUMONIA VACCINE (intramuscular). In December 2022, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm and hives. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: The patient was self-reported this case. The patient reported that 2 weeks ago he started to took oral cholesterol medication and also received Shingrix vaccine and pneumonia vaccine around the same time. The patient stated that after received Shingrix vaccine and pneumonia vaccine he experienced sore arm and he broke out in hives about 1.5 weeks later of received these two vaccines and starting of new cholesterol medication. The patient was ended up going to the emergency room, but were treated and released.  The patient reported that the hives are better, but still not gone. The emergency room doctor thought it was the cholesterol versus the Shingrix vaccine. It was unknown if the reporter considered the injection site pain and hives to be related to Pneumococcal vaccine The reporter did not consent to follow up.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Received 3rd dose of Menveo; Received Menveo instead of MenB; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA824A, expiry date 31st January 2024) for prophylaxis.   Previously administered products included Menveo  (had completed a 2 dose series of Menveo in past ).   On 19th December 2022, the patient received the 3rd dose of Menveo. On 19th December 2022, unknown after receiving Menveo, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient had completed a 2 dose series of Menveo in the past, the day of the incident health care professional was planning on giving Meningococcal B but mistakenly gave Menveo, which led to extra dose administered and wrong vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Polymerase chain reaction positive, Varicella virus test positive
Clinical narrative: Shingles (QCR positive for zoster ); This case was reported by a physician via call center representative and described the occurrence of shingles in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number OID21A, expiry date unknown) for prophylaxis.   On 5th December 2022, the patient received the 1st dose of Shingrix. In December 2022, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-DEC-2022 Reporter's Comments: The reporter reported that the patient developed shingles a week later after receiving first dose of Shingrix. QCR positive for zoster. The vaccine administration facility was the same as primary reporter The reporter was consented to follow up. Note: QCR test coded as PCR as per confirmation.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix-B administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 45-year-old female patient who received HBV (Engerix B adult) (batch number AN599, expiry date 8th November 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 19th December 2022, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 19th December 2022, unknown after receiving Engerix B adult 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: 19-Dec-2022 Reporter's comment: The reporter relayed information for adverse event report yet declined to be sent the medical information or package insert.  Accepted to be contacted to follow-up the event. The vaccine administration facility was the same as primary reporter. Information was given but reporter declined it being sent to them. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Engerix-B adult, which led to expired vaccine used.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: not reconstituted with antigen; Only adjuvant was administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 24R7T, expiry date 26th January 2024) for prophylaxis.   On 28th November 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 28th November 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: 19-Dec-2022 Reporter's comment: No other information was provided. The reporter did not consent to follow-up. This is 1 of 2 linked cases reported by same reporter. Additional supportive information: The patient received only received adjuvant vial of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022189762:Same reporter
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Not reconstituted with antigen; Only adjuvant was administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 24R7T, expiry date 26th January 2024) for prophylaxis.   On 28th November 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 28th November 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: 19-Dec-2022 Reporter's comment: No other information was provided. The reporter did not consent to follow-up. This is 2 of 2 linked cases reported by same reporter. Additional supportive information: The patient received only received adjuvant vial of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022189761:Same reporter
Age: 0.17
Sex: F
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FluLaval administered to a 2 months-old; 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 Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 957A7, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 18th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra 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 Information: GSK receipt date: 19-Dec-2022 Reporter's comment: The medical assistant reported that there was documentation in medical record that a 2 month old patient was administered FluLaval QIV vaccine. Clinic was unsure if the patient actually received the dose, or if it was documented as given in error.   The patient had been seen in clinic since that date and has had no ill effects noted.  The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. Additional supportive information: The patient received a dose of Flulaval QIV vaccine at inappropriate age, which led to inappropriate age at vaccine administration.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the adjuvant was used; Only the adjuvant was administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number dj455, expiry date 26th January 2024) for prophylaxis.   On 16th December 2022, the patient received Shingrix. On 16th December 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: 20-Dec-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient was administered only the adjuvant vial of SHINGRIX instead of the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 4.0
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4YO was given Boostrix instead of Infanrix; 4YO was given Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old patient who received DTPa (Reduced antigen) (Boostrix) (batch number 92K5T, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 20-Dec-2022 Reporter's comment: Only lot number was provided by health care professional, the reporter was unable to provide additional details.  LOT number shows no results when searched from Medical information screen.  Adverse event contains all reported information. The reporter gave consent for safety team follow up.  The reporter consented to follow-up. Additional supportive information: The patient received Boostrix instead of Infanrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: Back pain, Feels like shingles; This case was reported by a consumer via call center representative and described the occurrence of back pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In December 2022, the patient received Shingrix. In December 2022, less than a week after receiving Shingrix, the patient experienced back pain. On an unknown date, the outcome of the back pain was not recovered/not resolved.   It was unknown if the reporter considered the back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: The case was reported by the daughter on behalf of the mother. The patient received a dose of Shingrix vaccine a week ago and the patient was complaining about back pain and stated the pain was same as if she was having shingles. It was unknown if the patient had been diagnosed with shingles by healthcare professional post vaccination.  The reporter denied to answer any questions to file a safety report. Therefore, very limited information collect to file adverse event.  The consent to follow up with HCP, HCP contact information, if the vaccine administered last week was a first or second dose, lot/expiry date, day/site of administration, date of birth, mailing address, and email address could not be collected. Due to very limited information shared by the reporter and denying to answer any questions, consent to follow-up with HCP and HCP contact information were not collected.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 9 YO was given Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9ZK5T, expiry date 7th October 2024) for prophylaxis.   On 20th December 2022, the patient received Boostrix. On 20th December 2022, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 20-Dec-2022 Reporter's comment: The reporter confirmed administered at alternate facility (at a school). The reporter called to inquired about any guidance or recommendation. The expert mentioned additional details that given intentionally as a catch up dose but health care professional did not realize it was not to be given to a patient under 10 years of age. The reporter did not consent to follow-up. Additional supportive information: The patient was inadvertently administered Boostrix on the day of reporting about 4 hours ago at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Only diluent administered; Only diluent administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 21st December 2022, the patient received Menveo. On 21st December 2022, unknown after receiving Menveo, 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-Dec-2022 Reporter's comment: A Certified Medical Assistant (CMA) informed that only the diluent of Menveo had been administered to a patient earlier on the same month. The health care professional (HCP) did not had information on lot number, also not gave consent for follow-up since no adverse reactions had been observed. The reporter did not consent to follow-up. Additional supportive information: A Certified Medical Assistant (CMA) informed that only the diluent of Menveo had been administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 1 YO recived Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd November 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 Information: GSK receipt date: 22-DEC-2022 Reporter's comment: The licensed practical nurse (LPN) stated that Kinrix was inadvertently administered to a 1 year old patient. No side effects so far. The reporter consented to follow up via postal. Additional supportive information: 1-year-old patient received Kinrix, which led to inappropriate age at vaccine administration.
Age: 64.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Itching on shoulder and neck (left side); Redness on shoulder and neck (left side); This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 31st October 2022, the patient received the 1st dose of Shingrix and the 1st dose of Flu vaccine (intramuscular). On an unknown date, unknown after receiving Shingrix and Flu vaccine, the patient experienced pruritus and erythema. On an unknown date, the outcome of the pruritus and erythema were not recovered/not resolved.   It was unknown if the reporter considered the pruritus and erythema to be related to Shingrix and Flu vaccine.     Additional Information: GSK receipt date: 22-DEC-2022 Reporter's comment: The case was self-reported by the patient. The patient received a dose of Shingrix into unknown arm and Flu shot into opposite arm and experienced redness and itching on left side, shoulder and neck, which began approximately two months ago after vaccination. The reporter reported that the symptoms had not resolved. The patient was referred to healthcare professional. The reporter consented to follow up.
Age: 41.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 41-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 22nd December 2022, the patient received Havrix. On 22nd December 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-DEC-2022 Reporter's Comments: The nurse reported that a patient received a Havrix expired dose by error. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 62.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: pt received an expired dose; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 62-year-old male patient who received HAV (Havrix 1440) (batch number 2BA 99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd December 2022, the patient received Havrix 1440 (intramuscular) 1 ml and Havrix Pre-Filled Syringe Device. On 23rd December 2022, unknown after receiving Havrix 1440 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: 23-DEC-2022 Reporter's Comment: The physician reported that the patient received an expired dose of Havrix into right deltoid. The reporter consented to follow up. Additional Supportive Information: The use of Havrix dose, which was already expired on 16th December 2022, which led to expired vaccine used.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient was vaccinated with an expired Havrix dose.; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd December 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 22nd December 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: 23-DEC-2022 Reporters comment: The reporter reported that patient was vaccinated with an expired Havrix dose. The vaccine administration facility was the same as primary reporter The reporter consent to follow-up via email. Additional Supportive information: The patient was vaccinated with an expired Havrix dose, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the adjuvant component of Shingrix was administered to a patient on that same day; only the adjuvant component of Shingrix was administered to a patient on that same day; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd December 2022, the patient received Shingrix. On 23rd December 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: 23-DEC-2022 Reporters comment: The pharmacist reported that the only the adjuvant component of Shingrix was administered to a patient. The vaccine administration facility was the same as primary reporter. Health care professional was called on behalf of another health care professional so no information on the patient was available, neither information on the vaccine.  The reporter consent to follow-up. Additional Supportive information: The only the adjuvant component of Shingrix was administered to a patient, which led inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure/Shingles after 2nd dose of Shingrix; Shingles; little Skin rash; Itchiness; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, rash and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pruritus to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 23-Dec-2022 Reporter's comment: A pharmacist reported about the development of shingles after the administration of the second dose of Shingrix.  The reporter mentioned that after the administration of Shingrix patient suffered from little skin rash and itchiness.  The reporter did not share information about the patient and the Shingrix vaccine.  The reporter did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Cough, SARS-CoV-2 test
Clinical narrative: PERSISTENT COUGH; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other company (Pfizer) concerned a 35 year old female. Initial information was processed along with the additional information received on 23-DEC-2022.  The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. Patient had no other illnesses. The patient had not received any other vaccines within 4 weeks or any other medications within 2 weeks prior to the covid-19 vaccine. Patient had never before prior to the vaccine had an issue getting over a cough. The patient received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: 1855191 expiry: UNKNOWN) dose was not reported, 1 total administered on 15-DEC-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 34 years old. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient also received dose 2 with non-company suspect vaccine Pfizer Biontech Covid-19 Vaccine (tozinameran), (Dose number in series 2), (batch number: GJ6665 expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 06-OCT-2022 to left arm deltoid for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (Dose number in series 2). On 04-NOV-2022, Since getting booster shot patient had developed a cough (persistent cough), (Dose number in series 2) and had been treated with antibiotics, advent inhaler, albuterol, breathing treatments, and cough medications and her cough was not going away. On 09-DEC-2022, Laboratory data included: COVID-19 virus test Negative. Treatment medications (dates unspecified) included: salbutamol. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from persistent cough, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000264514.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM FOR HALF A DAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm for half a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm for half a day. This report was non-serious.