chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; Medical Assistant reports that VAQTA was administered to a patient on January 25, 2023 after the product expired on January 16,; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-JAN-2023, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #W007382, expiration date: 16-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). The vaccine was properly stored prior to administration and had no temperature excursions. There was no adverse event reported.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered to a patient in error; This spontaneous report was received from a nurse and refers to a 13-month-old male patient.  The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 07-FEB-2023, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U002394, was confirmed to be a valid lot number, expiration date: 22-JAN-2023, administered subcutaneously for prophylaxis (strength, dose, and anatomical site injection were not provided) (expired product administered). No additional AE reported.
Age: 3.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC reported.; a healthcare provider administered her 3 year old granddaughter the GARDASIL 9 dosage that was intended for her 18 year old daughter; This spontaneous report has been received from a consumer referring to a 3-year-old female patient. The information about the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On an unspicified date in 2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot# and expiry date were not reported) for prophylaxis (product administered to patient of inappropriate age) that was intended to 18-year-old woman. The patient had not had any side effects. No additional adverse event (AE) reported (no adverse event).
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered on 06FEB2023 while improperly stored during temperature excursion.; LPN calling for stability evaluation of vaccines with multiple TEs dating back to 03FEB2023. Caller reports that vaccines were administered. No additional AEs. no PQCs reported.; This spontaneous report was received from a nurse and refers to a 71-year-old male patient.  There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 06-FEB-2023, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml/once, lot # U034712, expiration date 30-JUL-2023, strength was not provided) for prophylaxis (Product storage error). There were multiple temperature excursions dating back to 03-FEB-2023. No additional adverse event was reported.  This is one of multiple reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA004511: US-009507513-2302USA004361: US-009507513-2302USA004369: US-009507513-2302USA004552:
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Polymyalgia rheumatica
Clinical narrative: Polymyalgia rheumatica; Numbness; This case was reported by a consumer and described the occurrence of polymyalgia rheumatica in a 7-decade-old female 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 polymyalgia rheumatica (serious criteria GSK medically significant) and numbness. On an unknown date, the outcome of the polymyalgia rheumatica and numbness were unknown.   It was unknown if the reporter considered the polymyalgia rheumatica and numbness to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comment: The case was reported by the patient's friend who was the epidemiologist. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got vaccines, shingles every two months / suspected Vaccination failure; shingles every two months in same spot; This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.     Additional Information: GSK Receipt Date: 10-FEB-2023 Reporter's comment: The patient was in her late 50s. The nurse had stated that, after the patient had received Shingrix vaccines, she had been getting shingles every two months in the same spot. The reporter had consented to follow-up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19, Cough, Pruritus, Rash
Clinical narrative: Covid; Rash on back and trunk; Itching on back and trunk; Covid cough; This case was reported by a consumer and described the occurrence of covid-19 in a 81-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27th January 2023, the patient received Shingles vaccine. On 28th January 2023, 1 days after receiving Shingles vaccine, the patient experienced covid-19, rash, pruritus and cough. The patient was treated with codeine + promethazine (Promethazine-Codeine) and nirmatrelvir + ritonavir (Paxlovid). On an unknown date, the outcome of the covid-19 was not recovered/not resolved and the outcome of the rash and pruritus were recovered/resolved and the outcome of the cough was unknown.   It was unknown if the reporter considered the covid-19, rash, pruritus and cough to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-FEB-2023 Reporter's comments: This report was submitted and was submitted by public reporting reference via the online direct entry reporting system. The reporter reported that his wife and he took the new Shingles vaccine and from 28th January 2023 to the date for by January 29th both had covid, plus had rash and itching on back and trunk. The patient received other products paxlovid and promethazine-codeine syrup. The itching and rash were gone at the time of reporting and was just left with Covid.  The reporter had consented to follow-up. Additional supportive information: This case was linked with US2023AMR018937 which was reported by same reporter. Note: The cough was coded as event based on drug indication as after vaccination patient had covid cough for which received treatment.  Onset date for Covid kept as 28th January 2023 as reported from 28th but by 29th both had means we are not sure who experienced 1st.; Sender's Comments:  US-GSK-US2023AMR018937:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Cough, Pruritus, Rash, SARS-CoV-2 test positive
Clinical narrative: just left with covid. By Jan 29th we both had covid; Itching and rash are gone now; Itching and rash are gone now; Covid cough; This case was reported by a consumer and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27th January 2023, the patient received Shingles vaccine. In January 2023, less than a week after receiving Shingles vaccine, the patient experienced cough. On 28th January 2023, the patient experienced covid-19, pruritus and rash. The patient was treated with codeine + promethazine (Promethazine-Codeine) and nirmatrelvir + ritonavir (Paxlovid). On an unknown date, the outcome of the covid-19 was not recovered/not resolved and the outcome of the pruritus and rash were recovered/resolved and the outcome of the cough was unknown.   It was unknown if the reporter considered the covid-19, pruritus, cough and rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-FEB-2023 Reporter's comments: This report was submitted and was submitted by public reporting reference via the online direct entry reporting system. The reporter reported that his wife and he took the new Shingles vaccine and from 28th January 2023 to the date for by January 29th both had covid, plus had rash and itching on back and trunk. The patient received other products paxlovid and promethazine-codeine syrup. The itching and rash were gone at the time of reporting and was just left with Covid. The reporter had consented to follow-up. Additional supportive information: This case was linked with US2023017485 which was reported by same reporter. Note: The cough was coded as event based on drug indication as after vaccination patient had covid cough for which received treatment.  Onset date for Covid kept as 28th January 2023 as reported from 28th but by 29th both had means we are not sure who experienced 1st. One day after receiving Shingles vaccine, the patient experienced covid-19, pruritus and rash.; Sender's Comments:  US-GSK-US2023017485:Same reporter
Age: 64.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 64 YO received Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 64-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA859A, expiry date 31st January 2024) for prophylaxis.   On 2nd February 2023, the patient received Menveo. On 2nd February 2023, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 6-Feb-2023 Reporter's comment: The pharmacist called to inquired that any complications to look for. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Menveo at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Nov2020, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received first shot in November 2020).   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: 6-Feb-2023 Reporter's comment: The patient reported that she has the intention to receive a second dose soon. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle tightness
Clinical narrative: tightness in left leg muscles; This case was reported by a consumer via call center representative and described the occurrence of muscle tightness in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included thrombosis leg.   On 4th February 2023, the patient received the 1st dose of Shingrix. On 5th February 2023, 1 days after receiving Shingrix, the patient experienced muscle tightness. On an unknown date, the outcome of the muscle tightness was not recovered/not resolved.   It was unknown if the reporter considered the muscle tightness to be related to Shingrix.     Additional Information: GSK receipt date: 06-FEB-2023 Reporter's comment: The patient got his first Shingrix vaccine 2 days ago.  The patient stated that the follow day his left leg muscles started to get really tight.  The patient symptoms were not resolved yet.  The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Sep2021, 2nd 06feb2023/LATE SECOND DOSE; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 73PP9, expiry date 30th May 2024) for prophylaxis.   Previously administered products included Shingrix (received the first dose in September 2021).   On 6th February 2023, the patient received the 2nd dose of Shingrix. On 6th February 2023, 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: 06-Feb-2023 Reporter's Comments: The patient received the first dose but not at that pharmacy.  The patient lost insurance or something and visited to receive the second dose on the same day prior reporting. The reporter gave the permission to follow up. Additional Supportive Information: The patient had received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Got really sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-Feb-2023: Reporter's Comment: The reporter was the patient's sister-in-law. The patient received the second dose. The reporter listed to the recording and this was word for word what she said. The reporter reported that, the patient (sister in law) was little bit older than reporter. The reporter had the same, had the exact, it was like clockwork. The patient had the exact same second shot that it was a little bit worse but was delayed like 10 hours.  The reporter said to patient that like at 10:00  you would going to get really sick. The reporter told her that would have to file a report on her sister in law's experience and asked if  could ask a few questions and she declined. This case had been linked with US2023AMR018964, US2023AMR018960 same reporter.; Sender's Comments:  US-GSK-US2023AMR018964:Same reporter US-GSK-US2023AMR018960:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2018, no 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose around 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: 6-Feb-2023 Reporter's comment: The reporter consented to follow-up. The case was linked with case US2023018227, reported by same reporter for different patient. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix yet, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023018227:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received only the adjuvant and not the antigen portion; Patient received only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2023, the patient received Shingrix (intramuscular). On 6th February 2023, 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: 7-Feb-2023 Reporter's comment: Transferred to medical information to address her questions as what should happen next. The reporter consented to follow-up. Additional supportive information: The patient was given the adjuvant only and not the antigen portion of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received Kinrix either under age 4 or after their 7th birthday; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patients received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patients experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Feb-2023 Reporter's comment: The patient safety associate (non-health care professional) mentioned that multiple children received Kinrix either under age 4 or after their 7th birthday. Nothing else was reported. Unknown patient identifiers. The reporter declined to give her contact information or details of adverse event. Additional supportive information: The patients received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 06Jun2022, did not get the 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received the first dose of Shingrix on 06/06/2022).   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: 7-Feb-2023 Reporter's comment: The consumer did not wish to provide demographic, adverse event details, or health care professional information. The consumer indicated that she will be getting the second dose as soon as possible. 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.
Age: 39.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 39-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA657A, expiry date 31st January 2023) for prophylaxis.   On 2nd February 2023, the patient received Menveo. On 2nd February 2023, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 7-Feb-2023 Reporter's comment: No specific date was given. The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Menveo, which led to expired vaccine used.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received HAV (Havrix pediatric) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2023, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 7th February 2023, unknown after receiving Havrix pediatric 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: 07-FEB-2023 Reporter's Comment: The reporter reported that a pediatric patient was administered with a one day expired dose of Havrix. The reporter consented to follow up. Additional Supportive Information: The reporter reported that a pediatric patient was administered with a one day expired dose of Havrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose a year ago, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix over a year ago).   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: 07-FEB-2023 Reporter's Comment: The reporter reported a patient had yet to receive the Shingrix . The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to complete course of vaccination. The case had been linked to US2023019040, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023019040:Same reporter / male Case
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only Menveo diluent portion used; Only received  diluent portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA660A, expiry date 31st March 2024) for prophylaxis.   On 6th February 2023, the patient received Menveo. On 6th February 2023, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 07-FEB-2023 Reporter's Comment: The reporter from a doctor´s office reported that a patient received Menveo diluent portion (grey cap) alone. Inadvertent Administration of Only the MenCYW-135 Liquid Conjugate Component of the 2-vial Presentation of Menveo. The patient information was not available. The reporter consented to follow up via email. Additional Supportive Information: The patient received Menveo diluent portion (grey cap) alone, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; one dose of PEDVAXHIB was administered during an ongoing temperature excursion; This spontaneous report was received from a registered nurse and refers to a patient of unkonwn age and gender.  The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 23-JAN-2023, the patient was vaccinated with one dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, at dose of 0.5 milliliter (lot number U024091 was verified to be a valid number, expiration date reported and established as 29-OCT-2023) administered for prophylaxis (strength, route of administration and anatomical location of vaccination were not provided); that underwent a temperature excursion of 34.8 Fahrenheit degrees for 144 hours, which started on 12-JAN-2023 (product storage error). There was a previous temperature excursion of 54.14 Fahrenheit degrees for 2 hours and 12 minutes. No additional adverse events were reported.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Pulmonary embolism
Clinical narrative: HCP REPORTED LACK OF EFFICACY IN PATIENT WITH RECURRENT BILATERAL PE ON ELIQUIS; RECURRENT BILATERAL PE ON ELIQUIS; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative and License Party (RA). Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2023-019213 (RA).  This case was received via {BP} Pfizer Inc (Reference number: 202300024515) on 07-Feb-2023.Information was received from a Health Professional concerning a patient, who received Suspect product APIXABAN for product used for unknown indication, lot number: Unknown; Suspect product COVID-19 VACCINE for COVID-19 immunization, lot number:  Unknown. On an unknown date, the patient had pulmonary embolism (recurrent bilateral PE on eliquis), which met the following seriousness criteria: medical significance. It is unknown if treatment was provided. The outcome of the pulmonary embolism was unknown. On an unknown date, the patient had drug ineffective (HCP reported lack of efficacy in patient with recurrent bilateral PE on eliquis), which was considered non-serious. It is unknown if treatment was provided. The outcome of the drug ineffective was unknown.  The action taken with APIXABAN medication was unknown. The action taken with COVID-19 VACCINE medication was unknown. Concomitant medications were not reported.  The reporter did not provide a causality assessment for events pulmonary embolism and drug ineffective to APIXABAN. The reporter considered events pulmonary embolism and drug ineffective related to COVID-19 VACCINE. HCP reported lack of efficacy in patient with recurrent bilateral PE on Eliquis within one month of treatment initiation. Patient had been vaccinated and boosted with Covid vaccine and provider believes there was a connection between the two events. Reporter does not wish to be contacted for follow-up.  Consent to contact health professional for follow-up information was denied.  Eliquis is under agreement with RA.; Sender's Comments:  Comments: This patient had pulmonary embolism after receiving apixaban therapy along with COVID- 19 vaccine. Based on the limited information available regarding the therapy details, event onset date, action taken with the suspects, treatment given and outcome of the event, it cannot be ascertained with the reasonable possibility that the apixaban/ COVID- 19 vaccine could have contributed to the event pulmonary embolism.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st on 3/4/2019 and 2nd on 2/6/23; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 7KR4T, expiry date 21st May 2024) for prophylaxis.   Previously administered products included Shingrix  (1st dose received on 4th March 2019 from lot number 7L355 and expiry date 28th August 2021).   On 6th February 2023, the patient received the 2nd dose of Shingrix. On 6th February 2023, 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: 07-FEB-2023 Reporter's Comment: Pharmacist called to inquire and asked how to proceed. The reporter stated that the it had been long between first and second dose of the Shingrix vaccine. The reporter wanted to know does the patient need to restart series. Did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix later than recommended time frame, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st in late 2021, early 2022. 2nd on 26NOV2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in late 2021 or early 2022).   On 26th November 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 26th November 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: 07-FEB-2023 Reporter's Comment: The patient was self-reported this case. The patient reported that she received the first dose of Shingrix vaccine in late 2021 or in early 2022. The patient stated that after greater than six months, on 26th November 2022 she received her second dose. The patient reported that the second dose was delayed because she did not know it was a two dose series.  Nothing else was reported. The reporter did not consent to follow up. Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Eye swelling
Clinical narrative: Dizziness; Swelling underneath eyes, eye swelling; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2023, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th February 2023, 4 days after receiving Shingrix, the patient experienced dizziness and eye swelling. On an unknown date, the outcome of the dizziness was recovering/resolving and the outcome of the eye swelling was not recovered/not resolved.   It was unknown if the reporter considered the dizziness and eye swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-Feb-2023: Reporter comment: This case was self reported by the patient. The patient received first Shingrix vaccine on the left arm.  On 6th February 2023, the patient woke up dizzy and swelling underneath eyes.  The patient reported on the day of reporting the dizziness had gotten better but not completely resolved and the eye swelling appeared to be worse.  The patient would contact the healthcare professional who administered the Shingrix vaccine.  The reporter consented to follow up.  The patient reported a nurse gave her the Shingrix vaccine.  The patient did not have a specific healthcare professional that she saw. Additional supportive information: The outcome of the event dizziness was captured as recovering as per information given in the narrative.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 55-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th November 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 30th November 2022, 30 min after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. 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: 08-Feb-2023: Reporter's comment: This case was self reported by the patient. The patient received dose of Fluarix. After a half hour later, the patient experienced a headache.  The headaches vary in intensity but had headaches since dose and it had not resolved.  The reporter consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: A patient was given expired Havrix; This case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-FEB-2023 Reporter's Comment: The reporter was a healthcare professional. The reporter reported that she learned today that a patient was given an expired Havrix vaccine yesterday. The reporter stated that the administered vaccine was discarded in the sharps container. The reporter was not clarified if whether  Havrix vaccine was for pediatric or adult use. The vaccine administration facility is the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix admiistered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 28-year-old patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 4th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Feb-2023 Reporter's comment:  The health care professional reported that the patient was administered a dose of Havrix that had expired on 30th January 2023. The Vaccine Administration Facility was the same as Primary Reporter. Consented to follow up. Additional supportive information: As patient received vaccine which was already expired.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 08Sep2020, no 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 8th September 2020).   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: 09-FEB-2023 Reporter's Comments:  The reporter reported that a patient was late for the second dose.  The HCP did not have the lot number or expiry date.  The reporter was consented to follow up via email. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.  This case is linked with case US2023021215 reported by the same reporter.; Sender's Comments:  US-GSK-US2023021215:Same reporter.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 5 months 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 63-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received the first dose of Engerix B 5 months ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, 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-FEB-2023  Reporter's Comments: The pharmacist reported that the patient never got the second dose of Engerix B.  The reporter asked how to proceed with this patient. The reporter did not have data about the first dose given to the patient like lot number or expiry date. The administration date of the first dose of Engerix B was not provided.  The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Engerix B, which led to incomplete course of vaccination.
Age: 41.0
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 41-year-old male patient who received HAV (Havrix 1440 adult) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th February 2023, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 13th February 2023, unknown after receiving Havrix 1440 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: 13-FEB-2023 Reporter's comment: The reporter was the pharmacist.  The reporter stated that a patient received Havrix Adult which was expired on 30th Jan 2023. No additional information was provided. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix adult, which led to expired vaccine used.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: 1. Fatigue 2. Tired 3. Headache in the night.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram abnormal, Cogwheel rigidity, Influenza, Magnetic resonance imaging abnormal, Meningioma
Clinical narrative: Patient has developed migraines and also had lower extremity weakness. When she got influenza A she developed left deviation of the tongue and had temporary cogwheeling in the left leg
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Muscular weakness, Tongue paralysis
Clinical narrative: Patient has developed migraines and also had lower extremity weakness. When she got influenza A she developed left deviation of the tongue and had temporary cogwheeling in the left leg
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest pain, Cough, Discomfort, Headache, Impaired work ability
Clinical narrative: I had a splitting headache on January 7, 2023. I had photophobia and could not get comfortable. I was sensitive to smells. It was more severe than my usual migraine and didn't respond to ibuprofen as usual. I called my dad; he is a neurologist. He advised me to go to the emergency department, but I declined. I finally went to sleep. The headache went away after I woke up. Now, I have an upper respiratory infection and I have tested negative for COVID-19. I have not had a fever. I have had a cough that includes pain in my throat and now in my chest. I have a runny nose with nasal congested. I've had to work from home for two days because the symptoms were severe.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Migraine, Nasal congestion, Oropharyngeal pain, Parosmia, Photophobia
Clinical narrative: I had a splitting headache on January 7, 2023. I had photophobia and could not get comfortable. I was sensitive to smells. It was more severe than my usual migraine and didn't respond to ibuprofen as usual. I called my dad; he is a neurologist. He advised me to go to the emergency department, but I declined. I finally went to sleep. The headache went away after I woke up. Now, I have an upper respiratory infection and I have tested negative for COVID-19. I have not had a fever. I have had a cough that includes pain in my throat and now in my chest. I have a runny nose with nasal congested. I've had to work from home for two days because the symptoms were severe.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test negative, Upper respiratory tract infection
Clinical narrative: I had a splitting headache on January 7, 2023. I had photophobia and could not get comfortable. I was sensitive to smells. It was more severe than my usual migraine and didn't respond to ibuprofen as usual. I called my dad; he is a neurologist. He advised me to go to the emergency department, but I declined. I finally went to sleep. The headache went away after I woke up. Now, I have an upper respiratory infection and I have tested negative for COVID-19. I have not had a fever. I have had a cough that includes pain in my throat and now in my chest. I have a runny nose with nasal congested. I've had to work from home for two days because the symptoms were severe.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Periarthritis
Clinical narrative: Frozen shoulder Pain through left arm  Tingle to fingers
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Age: 22.0
Sex: F
Vaccine: YF
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received a Yellow Fever vaccine after receiving a MMR vaccine on 2/7/2023. The Yellow Fever vaccine is considered not a valid dose due to not being 28 days after the MMR.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: light headedness immediately after vaccination, feeling faint
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Palpitations
Clinical narrative: Woke up this morning with shortness of breath. Progressing during the day and am now having constant substernal chest pain and palpitations.
Age: 26.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Blood test normal, Exfoliative rash, Herpes simplex test negative, Pityriasis rosea, Rash
Clinical narrative: Red scaly rash developed on December 31, 2022 on chest, then spread to arms, stomach, and back in the days and weeks following. On January 17th, 2023 I saw my doctor, and it was then diagnosed as pityriasis rosea. As of February 15, 2023 the rash is still present, but getting better. Some scarring is occurring with the rash spots, but the color is fading to skin tone on the first of the spots. The rash spots that did not develop initially are still red.
Age: 26.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Rash erythematous, Scar
Clinical narrative: Red scaly rash developed on December 31, 2022 on chest, then spread to arms, stomach, and back in the days and weeks following. On January 17th, 2023 I saw my doctor, and it was then diagnosed as pityriasis rosea. As of February 15, 2023 the rash is still present, but getting better. Some scarring is occurring with the rash spots, but the color is fading to skin tone on the first of the spots. The rash spots that did not develop initially are still red.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Loud tinnitus in left ear
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.