chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: few days over 6 months for 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose of shingles vaccine received on unknown date).   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: 10-JAN-2023 Reporter's Comments: This case was reported by a patient via (Shingrix GSK) interactive digital media. The reporter asked that if he/she was a few days over six months for getting his/her second dose of Shingles vaccine, could he/she still got it. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Concussion, Incomplete course of vaccination
Clinical narrative: Unusual symptoms due to a concussion; Never got the 2nd dose, Dr advised; This case was reported by a consumer and described the occurrence of concussion 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 did not receive the 2nd dose of Shingrix. On 15th October 2018, the patient received the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and less than a month after receiving Shingrix, the patient experienced concussion and incomplete course of vaccination. On an unknown date, the outcome of the concussion and incomplete course of vaccination were unknown.   The reporter considered the concussion to be unrelated to Shingrix.   Additional Information: GSK Receipt date: 12-JAN-2023 Reporter comment: The patient received 1st dose of shingrix and then patient doctor advised that not to get the second dose because patient was having some unusual symptoms nearly a month after that. The month later they found that the symptoms patient was experiencing were related to a concussion and not a reaction to the Shingrix, but then patient never received the second dose. The patient wanted to know if he/she get the second dose now after so much time time has elapsed. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
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 storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) (batch number ZL33B, expiry date 25th November 2024) and (batch number KP547, expiry date 29th November 2024) for prophylaxis.   On an unknown date, the patients received Boostrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Boostrix, the patients experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 17-Jan-2023 Reporter's comment: A nursing director reported that  there was a temperature excursion for several GlaxoSmithKline vaccines (Boostrix, Engerix-B, Havrix and Flulaval quadrivalent) and some of them were administered to patients.  The Boostrix (TDaps) was excursed from 23th August 2022 to 17th November 2022 and the highest temperature reached was 12.5 degree Celsius for 3 months.  The TDaps was administered to 35 or 36 patient. There were no other information available at the moment of the call regarding patient´s information. The reporter consented to follow-up via email. This 1 of 3 linked cases reported by same reporter. Additional supportive information: The patients received Boostrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023006949:Same reporter / FluLaval case US-GSK-US2023AMR007430:Same reporter / Engerix-B Havrix case
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose was administered to an adult; pediatric dose was administered to an adult; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult female patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comments: The reporter stated that a pediatric dose of Engerix B was administered to an adult patient.  The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The adult patient received pediatric dose of Engerix B, which led to underdose and adult use of a child product.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: Patient didn't receive full dose; Leakage from needle to arm; Leakage from needle to arm; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 44-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number GF3N2, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2023, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 4th January 2023, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine 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: 09 JAN 2023 Reporters comment: Registered Nurse called to inquire should patient repeat the dose. The nurse reported that the patient administered a Flulaval dose. The nurse administered the dose and withdrew the needle from the patient's arm, vaccine came out.  The patient did not receive the full dose of vaccine. RN confirmed not the leakage from prefilled syringe portion but from needle to arm. The reporter did not consent to follow up. Additional supportive information: As patient didn't receive the full dose of vaccine, which led to  incomplete dose administered,  exposure via skin contact and inadvertent exposure to vaccine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal sensation in eye, Dry eye, Eye swelling, Pain in extremity, Swelling of eyelid
Clinical narrative: eyelid swelling, both eyes, bottom eyelid; strange feeling when blinked; Sore; dry eyes; Eye swelling; This case was reported by a consumer via call center representative and described the occurrence of eye dryness in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 11th July 2022 , the patient received 1st dose of Shingrix in left arm).   On 5th January 2023, the patient received the 2nd dose of Shingrix. On 5th January 2023, less than a day after receiving Shingrix, the patient experienced abnormal sensation in eye and pain in arm. On 6th January 2023, the patient experienced swelling of eyelid. In January 2023, the patient experienced eye dryness and eye swelling. The patient was treated with ophthalmologicals (nos) (Eye Drops (Ingredients Unknown)). On an unknown date, the outcome of the eye dryness and swelling of eyelid were not recovered/not resolved and the outcome of the abnormal sensation in eye, eye swelling and pain in arm were unknown.   The reporter considered the eye dryness, swelling of eyelid and eye swelling to be related to Shingrix. It was unknown if the reporter considered the abnormal sensation in eye and pain in arm to be related to Shingrix.  Additional Information: GSK Receipt Date: 09- JAN- 2023 Reporters comment: The case was reported by the patient. She reported that receiving both Shingrix doses in her left arm.  The patient did not know the lot number/expiration dates for the Shingrix vaccines she received.  The patient reported that her left arm had been sore since she received the second Shingrix dose. The patient reported that she started a new face cream 4-5 days before receiving the second shingrix dose.  The patient said she was watching tv (television) after receiving her Shingrix dose and she had a strange feeling when she blinked.  She reported that the next day (on 6th January 2023) she had eyelid swelling in both of her eyes.  She said that the eyelid swelling was not dramatic but there was swelling present, especially in the bottom eyelid.  She also said she had dry eyes in both of her eyes that started sometime after getting the Shingrix dose.  She said that she was using eye drops to treat the eye swelling and dryness. The patient said that she believed the eye swelling and dryness were from the Shingrix vaccine. Healthcare professional consent for follow up was declined. The reporter did not consent to follow-up.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: 3rd dose 06Jan2023; This case was reported by a nurse 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 AMZA759A, expiry date 30th November 2023) for prophylaxis.   Previously administered products included Menveo (1st dose received on 15th December 2011) and Menveo (2nd dose received on 15th December 2020).   On 6th January 2023, the patient received the 3rd dose of Menveo. On 6th January 2023, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 09-JAN-2023 Reporter's comment: The licensed practical nurse (LPN) enquired about any harmful side effects and what to look for if they had inadvertently administered a third dose of Menveo (2 vial) to a patient. The reporter did not consent to follow-up. Additional supportive information: The patient received 3rd dose of Menveo, which led to extra dose administered.
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient received Fluarix; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received Flu Seasonal QIV  (Fluarix Quadrivalent 2022-2023 season) (batch number 53y2g, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th January 2023, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2022-2023 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.     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-Jan-2023 Reporter's comment: The nurse reported that it was unknown what trimester the patient was in, the estimated delivery date, date of last period and any concomitant medications. The reporter did not know date of birth of the patient. No other information was reported to governance, risk and compliance agent by the reporter. The reporter consented to follow-up. Additional supportive information: A pregnant patient received a dose of Fluarix in left arm on the day of reporting, which led to vaccine exposure during pregnancy.
Age: 0.25
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 1st dose 12dec2022, 2nd 09Jan2023; 1st dose received  at  3 Months of age; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 4-month-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th January 2023, the patient received the 2nd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 12th December 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 12th December 2022, not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device and unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 9th January 2023, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short and inappropriate age at vaccine administration 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: 09-JAN-2023 Reporter's Comments: The Registered Nurse (RN) enquired on how to proceed, two doses of Infanrix were given 28 days apart to a patient. The reporter consented to follow-up. Additional Supportive Information: The patient received 1st dose at inappropriate age, which led to inappropriate age at vaccine administration. The patient received 2nd dose of Infanrix earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: F
Vaccine: HEP, HEPA, HEPAB
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: Administered Havrix instead of Twinrix; Engerix-B Pediatric dose administered to a 45 year-old; Engerix-BPediatric dose administered to a 45 year-old; 1st dose on 24Jun2018, 2nd on 28Aug2018; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 45-year-old female patient who received HBV (Engerix B pediatric) (batch number F22EZ, expiry date 3rd June 2023) for prophylaxis.   Co-suspect products included HAV (Havrix adult) for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 6th January 2023, the patient received Engerix B pediatric and Havrix adult. On 28th August 2018, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 28th August 2018, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 6th January 2023, the patient experienced wrong vaccine administered, underdose and adult use of a child product. On an unknown date, the outcome of the drug dose administration interval too long, wrong vaccine administered, 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-Jan-2023 Reporter's comment: The reporter was a Medical assistant. At time of reporting, no additional doses had been administered. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. Additional supportive information: The patient received the second dose of Twinirx later than the recommended interval, which led to lengthening of vaccination schedule. Instead of receiving a third dose of Twinrix, the patient was given an adult dose of Havrix, and inadvertently administered a pediatric dose of Engerix-B, which led to wrong vaccine administered, underdose and adult use a child product.
Age: 70.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix B administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 70-year-old female patient who received HBV (Engerix B) (batch number P4DJ5, expiry date 15th December 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 10th January 2023, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 10th January 2023, an unknown time after receiving Engerix B and unknown after starting 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: 10-Jan-2023 Reporter's comment: The registered nurse asked how to proceed. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional Supportive Information: The patient received a dose of Engerix B that had expired on 15th December 2022, which led to expired vaccine used.
Age: 53.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received HAB (Twinrix) (batch number 4f3yy, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 10th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's Comment: The reporter called to report that a patient was inadvertently given an expired dose of Twinrix.  The patient information and vaccine information provided, but reporter wished to not give information about themselves. The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 54.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 54-year-old male patient who received HAV (Havrix adult) (batch number 7ya99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2023, the patient received Havrix adult (intramuscular) 1 ml and Havrix Pre-Filled Syringe Device. On 11th January 2023, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-Jan-2023 Reporter's Comment: The pharmacist reported that a patient was given an expired dose of Havrix today into right arm.   The pharmacist did not report that the patient had any side effects. The reporter gave consent to follow up. Additional Supportive Information: The patient was given an expired dose of Havrix, which led to expired vaccine used.
Age: 0.42
Sex: M
Vaccine: RV1, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2nd dose of Rotarix vaccine at 9 month age; 1st dose of Rotarix vaccine at 5 month age; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 7L2D7, expiry date 24th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 11th January 2023, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 21st September 2022, the patient received the 1st dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 21st September 2022, not applicable after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device and unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate age at vaccine administration. On 11th January 2023, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration 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: 11-JAN-2023 Reporter's Comment: The reporter was a nurse. The reporter reported that on 21st September 2022 the patient received first dose of Rotarix vaccine at a age of 5 months. The patient received second dose of Rotarix vaccine on 11th January 2023 at the age of 9 months who was behind on immunization. The reporter was not sure what to do. The reporter did not consent to follow up. Additional supportive information: According to disease control the 1st dose of Rotarix vaccine should be received before a child is 15 weeks of age but the patient received 1st dose of Rotarix vaccine at the age of 5 month which, led to inappropriate age at vaccine administration According to disease control the patient should receive all doses of rotavirus vaccine before they turn 8 months old but the patient received 2nd dose of Rotarix vaccine at the age of 9 months, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Skin exfoliation
Clinical narrative: dry flaky skin on face and ears; dry skin on face and ears; This case was reported by a consumer via call center representative and described the occurrence of flaking skin in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 months after receiving Shingrix, the patient experienced flaking skin and dry skin. On an unknown date, the outcome of the flaking skin and dry skin were not recovered/not resolved.   It was unknown if the reporter considered the flaking skin and dry skin to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comment: The patient self-reported this case. The patient reported that she received Shingrix vaccine. The patient stated that 2 months after receiving Shingrix vaccine she experienced dry flaky skin on her face and ears. The reporter did not consent to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 48-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2023, the patient received the 2nd dose of Twinrix 1 ml and Twinrix Pre-Filled Syringe Device. On 4th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient received an expired dose of Twinrix vaccine on 4th January 2023. The reporter stated that the Twinrix vaccine was expired on 1st January 2023. The vaccine administration facility was the same as the primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received a Twinrix which was already expired, which led to expired vaccine used.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: Patient received adult dose; patient was accidentally given an 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 HAV (Havrix adult) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 11th January 2023, the patient received Havrix adult. On 11th January 2023, unknown after receiving Havrix adult, 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.   Additional Information: GSK Receipt Date: 11-Jan-2023 Reporter's Comment: The reporter stated that a patient was accidentally given an adult dose of Havrix.  The reporter stated that information for the adverse event was given, including the vaccine information and patients details.  The reporter did not know which dose it was. The vaccine administration facility was the same as primary reporter. The reporter gave consent to follow up. Additional Supportive Information: The patient was accidentally given an adult dose of Havrix, which led to accidental overdose and adult product administered to child.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: since 1st dose, no exacerbation of his conditions; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic drug effect in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included pseudogout and rheumatoid arthritis. Concomitant products included colchicine.   On 12th October 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced unexpected therapeutic drug effect. On an unknown date, the outcome of the unexpected therapeutic drug effect was unknown.   Additional Information: GSK Receipt Date: 13-JAN-2023 and 16-JAN-2023 Reporter's Comment: The reporter called at the time of reporting and stated that he had been diagnosed with rheumatoid arthritis and pseudo gout for over 12 years.  The reporter stated that since his diagnosis previously about every 8 to 12 days he had debilitating exacerbations of pain and swelling in his joints.  The reporter stated that since Shingrix he had not had a single exacerbation of his conditions.  Adverse event was filed. The reporter consented to follow up.  Additional Supportive Information: The reporter stated that since Shingrix he had not had a single exacerbation of his conditions, which led to unexpected therapeutic drug effect.
Age: 77.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: ExpiredTwinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 77-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 13th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date :13 JAN 2023 Reporters comment: The pharmacist reported that dose of Twinrix that expired on 1st January 2023 was administered to a patient. The vaccine administration facility is the same as primary reporter. Reporter consented to follow up. Additional supportive information: As patient received the expired Twinrix vaccine which led to expired vaccine used.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; Rash on thigh and butt; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2022, the patient received the 1st dose of Shingrix. In August 2022, 4 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comment: The reporter was the patient. The patient received dose of Shingrix and stated that 4 days after vaccination patient developed a rash on her left thigh and butt which was confirmed as shingles by her doctor. The reporter consent to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st and 2nd dose in 2018, never received the 3rd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) 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 (on 23rd April 2018 received 1st dose, batch number Z75Y2) and Twinrix (on 23rd May 2018 received 2nd dose, batch number LG325).   On an unknown date, the patient did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix 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: 17-JAN-2023 Reporter's Comment: The medical assistant called to inquire and wanted to know do we need to start the vaccine series all over again or any guidance on administering the third dose. The reporter reported that patient received the first dose and the second dose of Twinrix and never received the 3rd dose.  The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 3rd dose, which led to incomplete course of vaccination.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received the liquid component not powder; received the liquid component not powder; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA799A, expiry date 31st January 2024) 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: 17-JAN-2023 Reporter's Comment: The medical assistance reported that patient received only the liquid component of the Menveo and not powder. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patients received Menveo vaccines without the powder portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose administered; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number LG374, expiry date 28th May 2024) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 06th June 2022) and Shingrix (2nd dose received on 14th October 2022).   On 16th January 2023, the patient received the 3rd dose of Shingrix. On 16th January 2023, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comment: The reporter was a practice administrator. The reporter reported that the patient inadvertently received third dose of Shingrix vaccine. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received extra dose of Shingrix in error, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3 years ago, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years prior to the reporting).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 03-Jan-2023. Reporter's Comments: The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting, patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 07Oct2019, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose over 2 years ago on 7th October 2019). Concomitant products included NIRMATRELVIR + RITONAVIR (PAXLOVID).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 17-Jan-2023 Reporter's comment: The pharmacist called to inquired any guidance or information regarding Shingrix and Paxlovid. The reporter mentioned that the patient received Paxolvid over a month ago and came in on the day of reporting to get a second dose of Shingrix. The reporter asked that any guidance on administering. The reporter reported that no second dose of Shingrix was administered and called to gather information on guidance of the second dose. The reporter was unable to provide vaccine details. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Liquid portion given to patient; Liquid portion given to patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 9K2MA, expiry date 24th September 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17-Jan-2023 Reporter's comment: An anonymous reporter called in to inquire about the possibility of using a diluent other than the one provided in the Shingrix package. Only one patient received the dose and she was calling in to ask if there were a way to use another diluent to reconstitute a dose for the second patient, but had not given it yet. The reporter explicitly stated that she wished her information not be stored in their database.  The initial reporter continued the call, yet upon receiving medical information interrupted the operator, stating that she already knew and had the data, and that she wanted to know if it were possible to receive a replacement for the diluent for Shingrix.  It was clarified that she was speaking to the medical information department and than in order to continue, she would need to speak to the vaccine service center.  Before being transferred, she was told that information needed to be collected for the adverse event report, to which she answered by asking if it were possible to place the call o hold and when the call continued, a second anonymous reporter spoke, whom gave information about the patient and vaccine, did not know about the specific details of how, when and where the event unfolded.  The second reporter was consented. The consent for follow-up was marked as not available because during the call, both health care professionals that were contacted refused to provide their contact information or for information to be stored in internal database, yet, they did agree for follow-up by safety. Due to this paradox this parameter could not be completed. Additional supportive information: The patient received the liquid portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: UNK
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 storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number J7C77, expiry date 26th 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 an unknown date, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 17-Jan-2023 Reporter's comment:A nursing director reported that  there was a temperature excursion for several GlaxoSmithKline vaccines (Boostrix, Engerix-B, Havrix and Flulaval quadrivalent) and some of them were administered to patients.  The Fluaval quadrivalent was excursed from 23th August 2022 to 17th November 2022 and the highest temperature reached was 12.5 degree Celsius for 3 months.  Only one Flulaval quadrivalent was administered during this period. There were no other information available at the moment of the call regarding patient´s information. The reporter consented to follow-up via email. This 1 of 3 linked cases reported by same reporter. Additional supportive information: The patient received the Flulaval quadrivalent after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023AMR007425:Same reporter / Boostrix case US-GSK-US2023AMR007430:Same reporter / Engerix-B / Havrix case
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation
Clinical narrative: REBOUND COVID(COVID-19); REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 67 year old female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, hypertension, penicillin allergy, and shellfish allergy, and other pre-existing medical conditions included: Patient was not pregnant at time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 077j21-2A expiry: UNKNOWN) dose was not reported, 1 total administered on 06-MAR-2021 10:00 at right arm for covid-19 prophylaxis. Age at time of vaccination 65 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). Concomitant medications included losartan potassium, montelukast, and Hydrochloride(thiamine hydrochloride).  The patient additionally received non-company suspect vaccine Moderna (elasomeran) (dose number in series 2) (form of admin, and route of admin were not reported, dose was not reported, batch number: 1805025 expiry: UNKNOWN) administered on 01-APR-2022 10:00 at right arm for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2).  On unspecified date in DEC-2022, patient experienced covid-19 infection(dose number in series 2). The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered from 21-DEC-2022 to 26-DEC-2022 for treatment of COVID-19. On 31-DEC-2022 08:00, the patient experienced rebound covid(covid-19) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran was not applicable, and with paxlovid was treatment discontinued. The patient was recovering from rebound covid(covid-19), and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain
Clinical narrative: Swelling at injection site; Burning sensation in that area; certain arm movements; This case was reported by a consumer and described the occurrence of injection site swelling in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, dose was fine with only typical side effects that went away after 24 hours, refer link case US2023AMR001997). Concurrent medical conditions included atrial fibrillation. Concomitant products included apixaban (Eliquis), losartan and metoprolol (Metoprol).   On 22nd December 2022, the patient received the 2nd dose of Shingrix. On 22nd December 2022, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site burning and injected limb mobility decreased. On an unknown date, the outcome of the injection site swelling, injection site burning and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site burning and injected limb mobility decreased to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR001997   Additional Information: GSK receipt date: 09-JAN-2023 Reporter's comment: The patient self-reported this case. Three weeks after injection still had swelling at injection site. In addition, over the past week, the patient had started having a burning sensation in that area with certain arm movements. The symptoms were not treated. The reporter gave permission to contact. Additional Supportive information: This is one of 2 link cases reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR001997:Same reporter