chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the shots, have shingles/Suspected vaccination failure; Shingles/ sitting here with painful shingles; Painful shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shots and was sitting here with painful shingles. The reporter denied for the follow-up. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: now it is in my eye; Chronic cases of shingles, now it is in eyes; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2022, the patient received Shingles vaccine. In December 2022, 2 weeks after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient just got his/her shingles vaccination about 2 weeks ago and less than 2 weeks after vaccination, the patient have had chronic cases of shingles and now it was in the patient's eye. The patient asked that how badly could it affect them. Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Hand is hurting; This case was reported by a consumer via interactive digital media and described the occurrence of pain in hand in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 5th December 2022, the patient received Shingles vaccine. In December 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in hand. On an unknown date, the outcome of the pain in hand was unknown.   It was unknown if the reporter considered the pain in hand to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-December-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received Shingles shot on Monday (from the date of reporting) and his/her hand was hurting and asked was it normal. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: broke out in hives; This case was reported by a nurse via sales rep and described the occurrence of hives in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingrix. In October 2022, immediately after receiving Shingrix, the patient experienced hives. The patient was treated with allergy medication {nos} (Allergy Medication). On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 08 DEC 2022 Reporter's comment: The reporter stated that the patient was administered the first dose of Shingrix 2 months ago from reporting and broke out hives shortly thereafter. The patient continues to experience hives 2 months after receiving Shingrix and the hives were only controlled with daily allergy medication. The reporter consented to follow up
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Got real sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date : 08-DEC-2022 Reporter's Comment: The patient self-reported this case. The patient recently had shingles vaccine and got real sick for about 3 days. The patient asked was it possible that he/she could shed the virus and gave it to someone else.  Additional Supportive Information: The case had been linked to US2022AMR184546, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2022AMR184546:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: Not comfortable, like having covid symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a 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 discomfort. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR185059   Additional Information: GSK receipt date :08-DEC2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient received his/her 2nd shot and stated that same as the 1st shot it was not comfortable that's like a covid symptoms once again. But he/she was glad to be protected. Additional Supportive information: For tolerance of 2nd dose US2022AMR185059, reported by same reporter. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR185059:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Have Shingles vaccine in 2019; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received first dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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: 9-Dec-2022 Reporter's comment: The reporter was inquiring for the patient (wife of reporter). The reporter stated that the medical record did not clearly stated if the patient had Shingrix, but the physician  did not knew which vaccine.  The reporter asked that would it be harmful to the patient to get a two-shot Shingrix series if actually did have Shingrix in 2019. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: PNC20, VARZOS
Symptoms: Myalgia
Clinical narrative: muscle tenderness; This case was reported by a consumer via interactive digital media and described the occurrence of tenderness muscle in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for prophylaxis.   On an unknown date, the patient received Shingrix and PREVNAR 20. On an unknown date, unknown after receiving Shingrix, the patient experienced tenderness muscle. On an unknown date, the outcome of the tenderness muscle was unknown.   It was unknown if the reporter considered the tenderness muscle to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-DEC-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter had asked that was it ok to take Aleve for muscle tenderness after the Shingrix and Prevnar 20 vaccines. It was unknown if the reporter had considered the tenderness muscle to be related to Prevnar 20. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes virus infection
Clinical narrative: Herpes on skin; This case was reported by a consumer via interactive digital media and described the occurrence of herpes virus infection 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 herpes virus infection. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved.   It was unknown if the reporter considered the herpes virus infection to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had taken a dose of the shingles vaccine and a herpes had appeared on his/her skin.  The reporter wanted to know if he/she should take the antiviral. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling cold, Influenza like illness, Malaise
Clinical narrative: feel like total crap; Symptoms just like the flu; Can't get warm; joint pain; 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.   On 7th December 2022, the patient received the 1st dose of Shingles vaccine. In December 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling unwell, influenza-like symptoms, coldness and joint pain. On an unknown date, the outcome of the feeling unwell, influenza-like symptoms, coldness and joint pain were unknown.   It was unknown if the reporter considered the feeling unwell, influenza-like symptoms, coldness and joint pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 09-DEC-2022 Reporters comment: This case was reported by a consumer interactive digital media via . The patient received dose of Shingle vaccine 2 days ago (2 day before the day of reporting) and felt like total crap, symptoms just like the flu, can't get warm and the joint pain. Additional Supportive information: As per narrative can't get warm , conservatively the event was coded as feeling cold.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Redness on abdomen; Itchy on abdomen; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 6th December 2022, the patient received Shingles vaccine and Flu vaccine. In December 2022, less than a week after receiving Shingles vaccine and Flu vaccine, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the erythema and pruritus to be related to Shingles vaccine and Flu vaccine.     Additional Information: GSK Receipt Date: 09-DEC-2022 Reporter's Comment: This case was reported by a patient via (Shingrix GSK) interactive digital media. The reporter reported that her husband patient received Shingles and Flu vaccine on Tuesday. The reporter stated that after received Shingles vaccine and Flu vaccine the patient experienced redness that was itchy on his abdomen. The reporter wanted to know is this normal. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pain, Pyrexia
Clinical narrative: I also got sick, had a fever and body pain. But I overcame it.; I also got sick, had a fever and body pain. But I overcame it.; I also got sick, had a fever and body pain. But I overcame it.; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the got shingles 9 years ago), blister, infected of face, neck and scalp except eye (it had started inside his/her mouth and went up the right side of his/her face), burning sensation and pruritus. Previously administered products included Cream, Antibiotics and Shingles vaccine. Concurrent medical conditions included pain, hearing decreased and ear discomfort.   On 11th December 2022, the patient received the 2nd dose of Shingles vaccine. On 11th December 2022, less than a day after receiving Shingles vaccine, the patient experienced fever, sickness and general body pain. On an unknown date, the outcome of the fever, sickness and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, sickness and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-DEC-2022 Reporter's comment: This case was reported by the patient via  interactive digital media. The reporter stated that the patient 9 years ago.  It had come in through his/her ear and came out through his/her head halfway down his/her scalp. His/her physician had prescribed an antibiotic and cream to apply to the bags of water that were formed. The reporter stated that was terrible. The burning sensation was like they were burning your face and when the bags start to dry, the itching starts and the pain never goes away.  You could barely sleep. His/Her right ear still bothers him/her after 8 years and his/her hearing had been decreased. At the time of reporting, he/she have had already been vaccinated with two doses. He/She had also fallen sick, had a fever and body pain, but he/she had overcome it.  He/She had been encouraging everyone to get vaccinated because if they did not have had the vaccine, this could happen to them also and for those who had chickenpox as child. Additional supportive information: This case was linked with US2022AMR186394  which was reported by same reporter. Follow-up would not possible, as no contact, details were available. This case - US2022AMR186394  was found to be duplicate of the case - US2022AMR186390.  All the information from  the case - US2022AMR186394 was copied into the case - US2022AMR186390 and the case - US2022AMR186394 was deleted from the database as it was created in error.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Migraine, Vomiting
Clinical narrative: migraine; Vomiting; Bad reaction, really sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 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 sickness, migraine and vomiting. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the migraine and vomiting were unknown.   It was unknown if the reporter considered the sickness, migraine and vomiting to be related to Shingles vaccine.     Additional Information: GSK receipt date: 13-DEC-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient had a bad reaction, really sick for two days, migraine and vomiting. The patient said no way he/she would be taking 2nd shot. Additional supportive information: The duration of event sickness was 2 days. As per narrative, no way I am taking second shot, so conservatively this case is processed for first dose
Sex: U
Vaccine: VARZOS
Symptoms: Ageusia
Clinical narrative: Loss of taste; This case was reported by a consumer via interactive digital media and described the occurrence of taste loss 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 taste loss. On an unknown date, the outcome of the taste loss was unknown.   It was unknown if the reporter considered the taste loss to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and had a loss of taste. The patient asked was that normal. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Tired for two days; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that be prepared for the booster of Shingles vaccine and the patient was really tired for two days after vaccination. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: low grade temp; body aches; soreness in  arm; got a really bad headache; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th December 2022 14:30, the patient received the 1st dose of Shingles vaccine. On 13th December 2022, 1 days after receiving Shingles vaccine, the patient experienced slight temperature and general body pain. In December 2022, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the headache, slight temperature and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, headache, slight temperature and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that patient had 1st shingles vaccine yesterday at 2:30pm. The patient experienced soreness my arm which was expected but about 13th DEC 2022 at 12 noon today, got a really bad headache and now this evening low grade temperature and body aches. The reporter wanted to know was this normal. Additional supportive information: The follow-up could not be possible as no contact details were available. Note: For headache event onset date was reported as 13th Dec 2022 12:00 pm, however partial date was captured to calculate precise time to onset in field.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Havrix given 3 months apart; This case was reported by a pharmacist via sales rep and described the occurrence of drug dose administration interval too short in a male patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 15-DEC-2022 Reporter's comment: The pharmacist noticed when the patient came in to get Havrix that on state registry that the patient was given dose of Havrix three months apart instead of six. The reporter consented to follow up. Additional supportive information: The patient received the dose of Havrix earlier than the recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Malaise, Myalgia
Clinical narrative: Don't feel well; muscles hurt; headache; 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 week after receiving Shingles vaccine, the patient experienced feeling unwell, muscle pain and headache. On an unknown date, the outcome of the feeling unwell, muscle pain and headache were unknown.   It was unknown if the reporter considered the feeling unwell, muscle pain and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter was the patient. The patient got shingles shot about 1 week ago and experienced feeling unwell, muscles hurt and headache. The follow-up could not be possible as no contact details were available.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old male patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th December 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix 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: 07-DEC-2022 Reporter's Comments: Registered Nurse called to inquire if any harm to patient or was this dose valid. The reporter also inquired would the patient need to be revaccinated. The reporter reported in their facility, they inadvertently administered Infanrix on 6th December 2022, which was expired on 25th November 2022. The reporter did not consent to follow-up. Additional Supportive Information: the patient received vaccine, which was already expired on 25th November 2022, which led to expired vaccine administered.
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pediatric patient received adult dose; Pediatric patient received adult dose; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 5-year-old male patient who received HBV (Engerix B adult) (batch number NT9X3, expiry date 9th September 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th December 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 7th December 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child 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: 07-DEC-2022 Reporter's Comments: Registered nurse called in to report that a pediatric patient was wrongfully administered the adult dose of Engerix-B on 7th December 2022.  The event took place at the site from where the report was made.  Patients information was also disclosed. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the pediatric patient was wrongfully administered the adult dose of Engerix-B, which led to accidental overdose and Adult product administered to child.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Only liquid component given; Only liquid component given; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA733A, expiry date 31st October 2023) for prophylaxis.   On 6th December 2022, the patient received Menveo (intramuscular). On an unknown date, 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: 07-DEC-2022 Reporter's Comments: The nurse to report an adverse event for Menveo.  The reporter reports just the MenCYW-135 liquid conjugate was given to the patient on 6th December 2022, in the right deltoid.  It was not mixed with the MenA lyophilized conjugate component.  The reporter gives permission to be contacted by GSK. Additional Supportive Information: the patient was administered with Menveo, where he only received liquid conjugate without mixing with lyophilized conjugate component, which led to inappropriate preparation of medication and inappropriate dose of vaccine
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: 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 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA638A, expiry date 30th November 2022) for prophylaxis.   On 7th December 2022, the patient received the 1st dose of Menveo. On 7th December 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: 07-DEC-2022 Reporter's Comments: Medical Assistant called in to report that on 7th December 2022, a patient was inadvertently administered an expired dose of Menveo.  Patient's information for adverse event was disclosed and medical information about the maladministration of Menveo after the expiration date was given.  They requested the information be sent to their email account. The reporter consented to follow up.  The Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patient received vaccine, which was already expired on 30th  November 2022, which led to expired vaccine administered.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a 41-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 997K5, expiry date 7th April 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage 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: 07-DEC-2022 Reporter's Comments: Registered nurse reports that a patient was vaccinated with Boostrix on 30th August 2022 that had been undergoing a temperature excursion on and off since 23rd August 2022 (highest temperature reached was 47.9 F).  The reporter was currently doing an analysis to determine the total time outside of range and to see if other patients were possibly administered GSK vaccines during the 54 days of on and off excursions.  At this time only this one patient was identified.  To the RN's knowledge, there were no prior excursions. The reporter consented to follow up. The reporter was confirmed presentation was PFS via lot number. Additional Supportive Information: the patient received vaccine, which had been undergoing a temperature excursion on and off, which led to incorrect product storage.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: just Liquid Conjugate was used; just Liquid Conjugate 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 patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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: 9-Dec-2022 Reporter's comment: The reporter chatted via Web and stopped responding after stating adverse event, no demographics for health care professional or patient were provided. No additional communication outside of stated adverse event. No additional details were available. Additional supportive information: The patient inadvertently administered the liquid conjugate component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only liquid portion only of Menveo used; Only liquid portion only of Menveo administered; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amxa724z, expiry date 30th September 2023) for prophylaxis.   On 8th December 2022, the patient received Menveo. On 8th 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: 9-Dec-2022 Reporter's comment: The reporter reported that was not aware that both portions should be mixed before the administration and the nurse in charge was no available at the time of the administration.  The vaccine administration facility was the same as primary reporter. Did not consent to follow-up. Additional supportive information: The patient was administered the liquid portion only of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 2019, 2nd July2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 0.5 ml of first dose in unknown arm intramuscularly in 2019).   In July 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 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: 9-Dec-2022 Reporter's comment: The caller did not gave permission to contact her health care professional. The caller did not consent to follow-up. Additional supportive information: The patient received second dose of Shingrix in unknown arm later than recommended interval, which led to lengthening of vaccine schedule.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose administered to adult; Pediatric dose administered to adult; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 33-year-old male patient who received HBV (Engerix B pediatric) (batch number 25n39, expiry date 16th March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th December 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 7th December 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, 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.     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: 9-Dec-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient inadvertently administered pediatric dose of Engerix-B instead of an adult dose, which led to underdose and adult use of a child product.
Age: 0.83
Sex: M
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2 doses less than 4 weeks apart; 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 10-month-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 5es77, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT).   On 9th December 2022, the patient received the 2nd dose of Fluarix Quadrivalent 2022-2023 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. On 9th December 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra 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: 9-Dec-2022 Reporter's comment: The medical assistant that a patient received two doses of Fluarix less than 4 weeks apart in left thigh. The vaccine administration facility was the same as primary reporter. The reporter was someone from safety may follow-up with her, she did not object. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Fluarix earlier than the recommended interval, which led to shortening of vaccine schedule.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 7 YO; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th November 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 14th 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: 9-Dec-2022 Reporter's comment: The reporter consented to follow-up via email. The case is for 2 of 2 linked patients reported by same reporter. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022185120:Same reporter
Age: 9.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix adminstered to a 9YO; 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 female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th November 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 14th 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: 9-Dec-2022 Reporter's comment: The reporter consented to follow-up via email. The case is for 1 of 2 linked patients reported by same reporter. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022185121:Same reporter
Age: 1.17
Sex: U
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 13Oct2022, 2nd 02Nov2022; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 14-month-old patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 333N4, 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.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 2nd November 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 2nd November 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra 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: 9-Dec-2022 Reporter's comment: The reporter gave consent for safety team follow-up. Adverse event contains all reported information. The reporter consented to follow-up. Additional supportive information: The patient received second dose of Flulaval earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in Sept-2022, 2nd dose not given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received HAB (Twinrix adult) 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.   Previously administered products included Twinrix adult  (received 1st dose on 29th September 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 9-Dec-2022 Reporter's comment: The reporter reported that it had been more than 30 days since the 1st dose of the series. No additional information was provided. Not all information was available.  Lot and expiry date of the vaccine was unknown because it was administered at a different location. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Twinrix adult, which led to incomplete course of vaccination.
Age: 0.33
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the liquid component used; only the liquid component administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA750A, expiry date 30th November 2023) for prophylaxis.   On 7th December 2022, the patient received the 1st dose of Menveo. On 7th 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: 9-Dec-2022 Reporter's comment: The reporter inquired that the patient need to be revaccinated. The reporter consented to follow-up. Additional supportive information: The patient received only the liquid component of Menveo, which led to inappropriate preparation medication and inappropriate dose of vaccine administered.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given less than a month apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number P39N2, expiry date 25th September 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 9th December 2022, the patient received the 2nd dose of Shingrix. On 9th December 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 9-Dec-2022 Reporter's comment: The patient was immunocompetent. The reporter consented to follow-up by email. Additional supportive information: The patient received second dose of Shingrix earlier than recommended interval, which led to shortening of vaccine schedule.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 27 months old received Kinrix; Kinrix instead of Infanrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 27-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix (received 3 doses of Infanrix on an unknown date).   On 9th December 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 9th December 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Dec-2022 Reporter's comment: The reporter reported that a patient inadvertently received a dose of Kinrix instead of being given Dtap (Infanrix) and wanted to know how to proceed.  Details for the adverse event were collected except for the patient's name.  The vaccine information was given. The vaccine administration facility was the same as primary reporter. The call was forwarded to second line. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix instead of being given Dtap (Infanrix) at inappropriate age, which led wrong vaccine administered and inappropriate age at vaccine administration.