chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein normal, Differential white blood cell count normal, Joint swelling, Oedema peripheral, Product administered to patient of inappropriate age
Clinical narrative: We have a 3 year old that had the Moderna vaccine, 1st shot, on July 18th. On Sat July 30, she woke up and couldn?t put weight on her left leg. They took to local ER who worked her up with blood work (neg ESR and CRP, nl WBC and diff) and radiographs ? no abnormalities seen ? but she did have some edema of the left knee. The sent her home on ibuprofen but told the parents they thought it was from the Moderna vaccine. I saw the girl yesterday and she does have some subtle swelling of the left knee with no warm, redness or bruising. She did favor it and said it hurt when I touched it.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate normal, Tenderness, Weight bearing difficulty, White blood cell count normal, X-ray normal
Clinical narrative: We have a 3 year old that had the Moderna vaccine, 1st shot, on July 18th. On Sat July 30, she woke up and couldn?t put weight on her left leg. They took to local ER who worked her up with blood work (neg ESR and CRP, nl WBC and diff) and radiographs ? no abnormalities seen ? but she did have some edema of the left knee. The sent her home on ibuprofen but told the parents they thought it was from the Moderna vaccine. I saw the girl yesterday and she does have some subtle swelling of the left knee with no warm, redness or bruising. She did favor it and said it hurt when I touched it.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Drug Allergy: Cipro"; Quinolones, reaction(s): "Drug allergy: quinolones". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: product-COVID 19 Treatment, brand-Paxlovid, Treatment start date-21Jul2022, Treatment stop date-25Jul2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: the patient did not experience any side effects or adverse events from the PNEUMOVAX 23.; Medical assistant calling in to report an AE for a patient. Per caller patient received a dose of PNEUMOVAX 23 on 14JUN22022 instead of PREVNAR 13. Caller states that the patient did not experience any side effects or adverse events from the PNEUMOVA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 14-JUN-2022, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter intramuscularly, lot # U010533, expiration date 29-OCT-2022 for prophylaxis; instead of the intended dose of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (wrong product administered). The patient did not experience any side effects or adverse events from the administered vaccine (no adverse event).
Sex: U
Vaccine: MMRV, UNK, VARCEL
Symptoms: Accidental overdose, No adverse event, Wrong product administered
Clinical narrative: PROQUAD was inadvertently administered with VARIVAX; No additional Adverse Event (AE) details; PROQUAD was inadvertently administered with VARIVAX instead of MMR-II; This spontaneous report was received from a health professional referring to an unknown age and gender patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 18-JUL-2022, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, lot number W004028, expiration date: 02-AUG-2023 was inadvertently administered with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number U016064, expiration date: 20-MAY-2023, and sterile diluent, solution for injection/infusion, lot number W000443 which was determined to be valid with expiration date: 20-APR-2024, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection; all vaccines were administered subcutaneously for prophylaxis (strength, dose and anatomical site were not provided) (wrong product administered) (accidental overdose).  No additional adverse event (AE) information was provided (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Accidental underdose, Device use error, No adverse event, Syringe issue
Clinical narrative: No Adverse Event; Due to the leaking the patient received a smaller than recommended dose; There was product leaking from where the needle attaches to the syringe.; There is a possibility the leaking was due to user error as there was no noticeable damage or issues; This spontaneous report was received from pharmacist and referring to a patient of an unknown age and gender.  The patient's pertinent medical history, current conditions, drugs reactions or allergies and concomitant medication was not provided.  On 16-JUL-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection,  for prophylaxis lot #U035117 validated upon internal review, expiration date: 18-AUG-2023 (strength, dose, frequency, anatomical location and route of administration were not provided).  That day after the administration was completed the health care professional (HCP) noticed there was product leaking from where the needle attaches to the syringe (syringe issue) (also reported as between the syringe hub/luer lock and the syringe needle). Caller stated due to the leaking the patient received a smaller than recommended dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (accidental underdose). Additionally, it was reported there was a possibility the leaking was due to user error as there was no noticeable damage or issues with the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe (device use error), but it could not be confirmed as the HCP did not check the tightness of the needle after administration. The reported confirmed the syringe needle was attached securely to the syringe tip before the leaking occurred (conflicting information, also reported as the HCP possible did not properly ensure the needle was tightly secured to the syringe). Caller stated this product was not available for retrieval nor are pictures able to be taken as the product had already been disposed of. No adverse events (AE) were reported.
Age: 49.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Site Leader calling to report administration of expired MMR II vaccine.; This spontaneous report was received from an office manager and refers to a 49-year-old male. The patient's concurrent conditions, medical history and concomitant therapies were not provided. There was no information regarding the patient's allergies or drug reactions.  On 25-JUL-2022, the patient was vaccinated  with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (M-M-R II) injection, 0.5 milliliter, once,  lot #T016198, expiration date: 11-MAY-2022,  (strength, dose number, route and site of administration were not provided) for prophylaxis (expired product administered). No additional adverse events was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects or other symptoms as a result of administration.; Caller is an office manager who reports vaccine was administered following multiple temperature excursions. Patient had no adverse effects or other symptoms as a result of administration. AE onset date in this case is the date of administration for t; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and drug reactions/ allergies were not reported. The patient's concomitant medication was reported as sterile diluent (DILUENT MRK), which was used to administer the suspect vaccine.  On 18-MAY-2022, the patient was vaccinated with improperly stored (on 11-MAY-2022 the vaccine underwent a temperature excursion of 5.7 Fahrenheit degrees, for 7 minutes) measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, dose 0.5 ml, once, lot number W006583 was found to be valid, expiration date: 23-AUG-2023 (strength, route of administration and vaccination site were not provided) for prophylaxis (product storage error). The patient had no adverse effects or other symptoms as a result of administration.; Sender's Comments:  US-009507513-2207USA007867: US-009507513-2207USA007928: US-009507513-2207USA007832: US-009507513-2207USA007847: US-009507513-2207USA007985: US-009507513-2207USA007826: US-009507513-2207USA008018: US-009507513-2207USA007975: US-009507513-2207USA008097:
Age: 1.08
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; an expired dose of VARIVAX was given to a patient today; 0.7 mL; This spontaneous report was received from a medical assistant and refers to a 13-month-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 25-JUL-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection for prophylaxis (lot #T024287, expiration date: 15-JUL-2022; strength and route of administration were not provided) with sterile diluent (MERCK STERILE DILUENT) (strength, lot #, expiry date, route of administration, and indication were not provided), 0.7 milliliter/once (expired product administered, incorrect dose administered). The vaccine had no history of temperature excursions. The patient had no adverse effects or symptoms from receiving this dose.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; multiple temperature excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 25-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter/once administered for prophylaxis (lot #W006583, expiration date: 23-AUG-2023; strength and route of administration were not provided) following temperature excursion on 11-MAY-2022 at 5.7 F for 7 minutes (product storage error). There was no excursion prior to 11-MAY-2022. The patient had no adverse effects or other symptoms as a result of administration.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007928: US-009507513-2207USA007832: US-009507513-2207USA007867: US-009507513-2207USA007847: US-009507513-2207USA007985: US-009507513-2207USA007729: US-009507513-2207USA007826: US-009507513-2207USA008018: US-009507513-2207USA007975: US-009507513-2207USA007928:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; ROTATEQ was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 13-JUL-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1837116, expiration date: 24-MAR-2023, administered for prophylaxis, orally (strength was not provided) after a temperature excursion (Product storage error) with a temperature of 10.8 degree Celsius for a time frame of 4 hours and 12 minutes. No previous temperature excursions were reported. No adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE details were provied; had been administered to a patient. Per caller the VAQTA experienced a prior excursion on 25JUL2022 of 46.5F for 15 minutes and then experienced excursion today 29JUL2022 of 48.2F for 15 minutes; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 29-JUL-2022, the patient was vaccinated with improperly stored (product storage error) dose of hepatitis a vaccine, inactivated (VAQTA) syringe, 0.5 milliliter, administered intramuscularly (IM), lot #: W002889, expiration date: 06-MAR-2023 (strength and site of administration were not provided) for prophylaxis. Temperature excursion information: on 25-JUL-2022 46.5 degree Fahrenheit and on 29-JUL-2022 48.2 degree Fahrenheit for 15 minutes. There was no additional adverse event reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My mother had the vaccine yet has a bad case right now; My mother had the vaccine yet has a bad case right now; 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. the reporter's mother had the vaccine yet had a bad case right now (at the time of reporting). Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got my shingles shot and got shingles; I got my shingles shot and got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient got his/ her shingles shot and got shingles so anyone could get shingles with or without the shot. The reporter's doctor was very surprised and so was he/ her.  The reporter guessed and asked he/ she was one of the lucky one. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shot, I still got shingles; I got the shot, I still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included SHINGRIX (received dose coupe of years before receiving double shot shingles vaccine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient got the original shot.  The patient also got the new shot that was a set of 2 and they had a shingle outbreak every month for the last 2 plus years.  The shots did not help everyone. The patient got the one shot for shingles.  Then patient got the double shot a couple of years later, but he/ she still got shingles, so it did not protect you against it.  It might make it less of a severe outbreak, but you could still get it regardless of the shots. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: was given and vaccine was 1 day expired; This case was reported by a consumer via interactive digital media and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero 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: 01-Aug-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that if a Bexsero was given and the vaccine was 1 day expired dose. The reporter asked that the dose need to be repeated. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired dose used. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Stem cell transplant
Clinical narrative: Received stem cell transplant after 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of stem cell transplant in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced stem cell transplant. On an unknown date, the outcome of the stem cell transplant was unknown.   It was unknown if the reporter considered the stem cell transplant to be related to Shingrix.     Additional Information: GSK receipt date: 26-Jul-2022 Reporters comment: The patient received stem cell transplant after receiving dose of Shingrix. The reporter consent to follow-up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: left leg swelling; This case was reported by a pharmacist via call center representative and described the occurrence of swelling of legs in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number X54CN, expiry date 27th May 2023) for prophylaxis.   On 27th July 2022, the patient received the 1st dose of Shingrix. On 28th July 2022, 1 days after receiving Shingrix, the patient experienced swelling of legs. On an unknown date, the outcome of the swelling of legs was not recovered/not resolved.   It was unknown if the reporter considered the swelling of legs to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jul-2022 Reporter's Comments: The pharmacist reported a patient received her dose of Shingrix late morning/early afternoon in left arm. The patient reported when she woke up she had left leg swelling. The Vaccine Administration Facility was the same as Primary Reporter. The follow consented to follow up via HCP email.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired Pediarixadministered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2KD4D, expiry date 8th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th July 2022, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 28th July 2022, unknown after receiving Pediarix and Pediarix 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 was made by GSK without prejudice and did not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 28-Jul-2022. Reporter's Comments: The nurse reported that a patient was administered a dose of Pediarix on 28th July 2022, which had an expiration date of 8th May 2022. This was the patient's third dose in the series. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Pediarix on 28th July 2022, which was already expired in 8th May 2022, which led to Expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Injection site discoloration; injection site became swollen with a reddish purple circle around; injection site became swollen with a reddish purple circle around; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingrix .5 ml. In July 2022, less than 2 weeks after receiving Shingrix, the patient experienced injection site discoloration, injection site swelling, injection site erythema and fever. On an unknown date, the outcome of the injection site discoloration, injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the injection site discoloration, injection site swelling, injection site erythema and fever to be related to Shingrix.     Additional Information: GSK receipt date: 29-Jul-2022 Reporter comment: The case was self reported by the patient. The patient received first dose of Shingrix vaccine 2 weeks ago. The patient experienced a fever and injection site reaction. The patient stated that the injection site became swollen with a reddish purple circle around the site. The patient stated that the fever had recovered and the redness at the injection site was improving, but still it was there. The caller disconnected prior to getting further information about the event and vaccine itself. The reporter did not consented to follow up.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: received a third dose of bexsero; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st and 2nd dose received on an unknown date).   On 29th July 2022, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 29th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-JUL-2022 Reporter's Comments: The health care professional reported that the patient received a third dose of bexsero. Additional supportive information: The patient received third dose of Bexsero, which led extra dose administered. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st vaccine in 11/19 and 2nd today (29Jul2022); This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in November  2019).   On 29th July 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 29th July 2022, the dose was .5 mg/ml (.5 mg/ml daily). On 29th 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: 29-Jul-2022 Reporter's Comments: The patient stating that she got her first shingrix vaccine in November 2019 and then just got her second vaccine on 29th July 2022 (greater than 6 months later). The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix 2 month after 1st dose, later than the recommended standard schedule, which led to lengthening of the vaccination schedule. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022112810:Same reporter
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Kinrix on 10 weeks old; due for DTaP vaccine, and nurse inadvertently pulled and administered Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-week-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 18th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 18th July 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: 29-JUL-2022 Reporter's Comments: The clinic supervisor reported that, the 9 weeks old infant was due for DTaP vaccine, and nurse inadvertently pulled and administered Kinrix. The patient not had any prior DTaP vaccines. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient was 9 week old at the time of vaccination, which led to inappropriate age at vaccine administration and inadvertently received Kinrix instead of DTaP vaccine, which led to wrong vaccine administered.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the MenCYW-135 liquid conjugate vaccine component of the Menveo vaccine without the the MenA lyophilized conjugate vaccine component; patient received only  diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA659A, expiry date 31st January 2023) for prophylaxis.   On 29th July 2022, the patient received Menveo. On 29th July 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: 29-Jul-2022 Reporter's comment: It was reported that patient received only the MenCYW-135 liquid conjugate vaccine component of the Menveo vaccine without the the MenA lyophilized conjugate vaccine component. The Vaccine Administration Facility is the same as Primary Reporter. Outside phone number for GlaxoSmithKline Medical Information given for future reference and warm transfer provided. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of only the liquid conjugate vaccine component of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: accidentally given third dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose in 2021).   In February 2022, the patient received the 3rd dose of Shingrix. In February 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 29-JUL-2022 Reporter's Comments: The office staff member reported that the patient was accidently received a third dose of Shingrix, a year after patient had received his second dose. Staff member declined to provide any contact information, declined to provide patient details, and reported that the lot number of the dose was not available. The reporter did not consent to follow up. Additional Supportive Information: The patient accidently received a third dose of Shingrix, which led to extra dose administered.
Age: 55.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Decreased appetite, Headache, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: Fever; Nausea; Lack of appetite; Muscle ache; Arm pain; Swollen lymph nodes; Headache; Malaise; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included doxycycline for prophylaxis.   Concurrent medical conditions included acne.   On 28th July 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient started doxycycline at an unknown dose and frequency. In July 2022, less than a week after receiving Shingrix, the patient experienced fever, nausea, appetite absent, muscle pain, pain in arm, swollen lymph nodes, headache and malaise. The action taken with doxycycline was unknown. On an unknown date, the outcome of the fever, nausea, appetite absent, muscle pain, pain in arm, swollen lymph nodes, headache and malaise were not recovered/not resolved.   It was unknown if the reporter considered the fever, nausea, appetite absent, muscle pain, pain in arm, swollen lymph nodes, headache and malaise to be related to Shingrix.     Additional Information: GSK receipt date: 29-Jul-2022 Reporter comment: This case was self-reported by the patient. The patient received Shingrix and experienced headache, swollen lymph nodes, mylasis, arm pain, muscle ache, lack of appetite, nausea, and fever. The patient referred to healthcare professional. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever; Nausea; Lack of appetite; Muscle ache; Arm pain; Swollen lymph nodes; Headache; Malaise; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included doxycycline for prophylaxis.   Concurrent medical conditions included acne.   On 28th July 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient started doxycycline at an unknown dose and frequency. In July 2022, less than a week after receiving Shingrix, the patient experienced fever, nausea, appetite absent, muscle pain, pain in arm, swollen lymph nodes, headache and malaise. The action taken with doxycycline was unknown. On an unknown date, the outcome of the fever, nausea, appetite absent, muscle pain, pain in arm, swollen lymph nodes, headache and malaise were not recovered/not resolved.   It was unknown if the reporter considered the fever, nausea, appetite absent, muscle pain, pain in arm, swollen lymph nodes, headache and malaise to be related to Shingrix.     Additional Information: GSK receipt date: 29-Jul-2022 Reporter comment: This case was self-reported by the patient. The patient received Shingrix and experienced headache, swollen lymph nodes, mylasis, arm pain, muscle ache, lack of appetite, nausea, and fever. The patient referred to healthcare professional. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose February 2022, second 28-JUL-2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix-B (received 1st dose in February 2022).   On 28th July 2022, the patient received the 2nd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 28th July 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, 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.   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: 29-Jul-2022 Reporter' comment: The patient received 2nd dose of Engerix-B later than the recommended interval. The patient had nothing else to report. The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Engerix-B later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 72.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 01Dec2021, second dose 17Jun2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 72-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.   Previously administered products included Twinrix (received 1st dose on 1st December 2021).   On 17th June 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 17th June 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, 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.   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: 29-Jul-2022 Reporter's comment: The pharmacist stated that the patient received her 1st dose of Twinrix series and did not receive second dose until 17th June 2022.   The 1st dose was given at a different facility so reporter did not had the lot number information.   The 2nd dose was administered from lot number 4F3YY (expiration date 01st January 2023).   At the time of reporting, third dose has not been administered. The reporter consented to follow-up. Additional supportive information: The patient received the 2nd dose later than the recommended interval, which led to lengthening of vaccine schedule. As per local schedule for 3rd dose patient had valid time to receive therefore 3rd dose was not captured as suspect with event incomplete course of vaccination.
Sex: F
Vaccine: HEP, UNK
Symptoms: Incomplete course of vaccination, Interchange of vaccine products
Clinical narrative: incomplete course for 3rd dose of HepB and HepA 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 75-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis and HEPATITIS B VACCINE (HEPLISAV B VACCINE) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B) and HEPATITIS A VACCINE.   On an unknown date, the patient received the 2nd dose of Engerix B, Engerix B Pre-Filled Syringe Device and the 2nd dose of HEPLISAV B VACCINE. In February 2022, an unknown time after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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: 01-Aug-2022 Reporter's Comments: The patient received first dose of Hepatitis A and B (Engerix B) vaccines separately.  The 2nd dose received was Heplisav B (February 2022). The Vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 1st dose of Engerix B vaccine and 2nd dose of Heplisav B vaccine, which led to interchange of vaccine products.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Jan 2020, never got the 2nd; This case was reported by a nurse 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 (1st dose received in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-Aug-2022 Reporter's Comments: The nurse reported a patient that received the first dose in January 2020, shingrix never got the second. The reporter gave permission for follow up.  No other info available. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received the liquid portion only; received the liquid portion only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA6378, expiry date 1st May 2023) for prophylaxis.   On 27th July 2022, the patient received Menveo. On 27th July 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: 01-Aug-2022 Reporter's Comments: The nurse reported on 1st August 2022, that the patient received the liquid portion of Menveo only on 27th July 2022. The reporter consented for follow up.  Additional Supportive Information: the patient received received the liquid portion of Menveo only on 27th July 2022, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: reconstituted the lyophilized component with another sterile diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA656A, expiry date 31st January 2023) for prophylaxis.   On 28th July 2022, the patient received the 1st dose of Menveo. On 28th July 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 01-Aug-2022 Reporter's Comments: Registered nurse (RN) stated that a CMA reconstituted the lyophilized component of Menveo with another sterile diluent than the one supplied. The reporter consented for follow up via postal.  Additional Supportive Information: the patient received the Menveo which was reconstituted the lyophilized component with another sterile diluent than the one supplied, which led Wrong solution used in drug reconstitution.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st Shingrix on 25May2018, 2nd will be today (01Aug2022); This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (the patient received 1st dose of Shingrix by intramuscularly on unknown arm on 25th May 2018).   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: 1-Aug-2022 Reporter comment:  The reporter stated that he was not told he need a second Shingrix vaccine to complete the series. The reporter also mentioned would go today for his second vaccine. The reporter did not gave consent to follow up. Additional Supportive Information: The patient was not told they need a second Shingrix vaccine to complete the series, which led to incomplete course of vaccination. This case was linked to the case US2022AMR114084, reported by the same reporter for her wife.; Sender's Comments:  US-GSK-US2022AMR114084:Same reporter
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: was vaccinated with an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB36AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st August 2022, unknown after receiving Bexsero and Bexsero 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: 01-August-2022 Reporter's comment: A nurse reported that a patient was vaccinated today on 1st August 2022 with an expired dose of Bexsero.  The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.