chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Pain, Paraesthesia
Clinical narrative: Chest Pain, Shortness of Breathe, Increased Heart Rate, Left Arm numb from shoulder to middle of forearm, Tingling in jaw from ear to ear, Tingling in both right and left hand from wrist down, Tingling in both feet from ankle down. A month later I started to experience nose bleeds. First nose bleed occurred in Oct 2021. Other nose bleeds occurred: Dec 2021, Feb 2022, and Summer of 2022. Patient has encountered some pain around the heart area. At times it is a sharp pain, others are dull and shortness of breath.
Age: 4.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever; Headache; HCP called to report inadvertent administration of VARIVAX and PROQUAD to a patient. Patient was supposed to receive their second doses of VARIVAX and MMR-II but was instead given VARIVAX and PROQUAD simultaneously on 09/26/2023. No additional AE/PQC; This spontaneous report was received from a medical assistant, referring to a 4-year-old female patient. Concomitant therapies included diphtheria vaccine toxoid, pertussis vaccine acellular 2-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (TETRAXIM). The patient's pertinent medical history, concurrent conditions,previous drug reactions, or allergies were not reported.  On 26-SEP-2023, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) in the left lower thigh (strength and route of administration were not reported; lot number X018577 expiration date was reported and validated as 05-JAN-2025) and extra dose of varicella virus vaccine live (oka/merck) (VARIVAX) in the left uper thigh (strength and route of administration were not reported; lot number X006978, expiration date reported and validated as 07-MAR-2025) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (wrong product administered).  On 27-SEP-2023, the patient experienced fever (pyrexia) and headache. On the same date, the patient recovered from the events. No prescription drug treatment for the experience was required.  The causal relationship between the events and the suspect therapy was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQCs.; Nurse reported PROQUAD was administered after TE; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not reported.  On an unknown date in 2023, the patient was vaccinated with an incorrect storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dose, (lot # reported as X007537, which was an invalid lot # for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported as 08-SEP-2024), administered as prophylaxis (strength and route of administration were not provided).  On 19-SEP-2023, the vaccine was exposed to a temperature excursion of 8.1°F, during a time frame of 3 hours. There was no previous temperature excursion. No additional adverse events (AE), no product quality complaint (PQC) were reported.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B test negative, Inappropriate schedule of product administration, Viral titre
Clinical narrative: Hepatitis B titer was negative despite reports of vaccination; she got the first dose at birth, and then 2 month, 6 month; This spontaneous report was received from a physician and refers to a female patient currently 18 years old. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On an unknown date in 2005 (at birth), the patient  was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided). Then she got 2 shots at 2 months and 6 months (Inappropriate schedule of product administration).  On an unknown date, the patient experienced hepatitis B titer was negative despite reports of vaccination. At the time of reporting, the outcome of the event hepatitis B titer was negative was not known. Physician was asking if she need to re-vaccinate patient with hepatitis b vaccine (recombinant) (RECOMBIVAX HB). The causal relationship between hepatitis B titer was negative and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE for patient who received improperly stored VARIVAX on 11OCT2023. No side effects reported. No other medical information known. Operator of Device was a Healthcare Professional. HCP permission to contact obtained. See addition; HCP calling to report AE for patient who received improperly stored VARIVAX on 11OCT2023. No side effects reported. No other medical information known. Operator of Device was a Healthcare Professional. HCP permission to contact obtained. See addition; This spontaneous report was received from Other Health Professional and refers to a patient (age,gender and race were not reported).  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) (lot number X007372 has been confirmed to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported as 12-MAR-2025) subcutaneous injection (strength, route of administration, and indication were not provided).   On 11-OCT-2023, the HCP calling to report AE for patient who received improperly stored (Improper storage of product in use) varicella virus vaccine live (oka/merck) (VARIVAX).; Sender's Comments:  US-009507513-2310USA007934:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored; No adverse effects reported; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   was vaccinated with an improperly storage measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, rHA, 0.5 milliliter, lot #W029555, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No adverse effects reported  (No adverse event).
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; expired dose of ROTATEQ.  Expired on 10/9/2023 and was administered today 10/16/2023.; This spontaneous report was received from a nurse and referred to a 9-week-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 16-OCT-2023, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milligram, lot #W004502, expiration date: 09-OCT-2023, administered orally for prophylaxis (strength was not provided) (expired vaccine used). No adverse effects reported (no adverse event).
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Incorrect dose administered, No adverse event
Clinical narrative: No additional AE; PROQUAD and VARIVAX inadvertently administered to a 1 year old patient concomitantly; 0.25 mls subcutaneously/ first dose; This spontaneous report has been received from a nurse and refers to a 1-year-old male patient. The patient's pertinent medical history included plagiocephaly. Concurrent conditions and concomitant medications were not reported.  On 11-OCT-2023, the patient was inadvertently concomitantly administered with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (0.25 mL, subcutaneously, lot #x18570 was not valid, expiration date was reported as 05-JAN-2025) (Incorrect dose administered) and first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (0.5 mL, subcutaneously, lot #x010534, expiration date 11-APR-2025) for prophylaxis (Accidental overdose). Patient did not experience any symptoms. No additional details provided. No additional adverse event (AE) or product quality complaint (PQC) (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HBP calling to report AE for improperly stored VARIVAX administered to a patient.; Spontaneous information has been received from a physician via office manager, regarding a female patient of unknown age. Information regarding her medical history, concurrent conditions and concomitant medications was not provided.   On 24-AUG-2023, the patient was vaccinated with an improperly stored (product storage error) varicella virus vaccine live (Oka/Merck) (VARIVAX III) (reported as varicella zoster vaccine live) (lot# X007373 valid, expiration date on 12-MAR-2025) with a previous temperature excursion of 9.5 degree Fahrenheit for 2 hours and 10 minutes and a temperature of 6.9 degree Fahrenheit with a time frame of 1 hour and 30 minutes. No side effects reported.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Injury, Syncope
Clinical narrative: Syncope; This spontaneous report was received from an unspecified reporter via company representative referring to 9 to 18 years old patients of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  It was a rapid-fire poster presentation.  Vaccination was associated with syncope in adolescents. However, incidence of vaccine-associated syncope and resulting injury, and how it compared to syncope incidence following other medical procedures, was not known. Therefore, it was describing the incidence of syncope and syncope-related injury in adolescents following vaccination and routine venipuncture.  There were identified all Center for Health Research members ages 9 to 18 years with a vaccination or routine venipuncture and a same-day International Classification of Diseases (ICD) diagnosis of syncope and collapse from 2013 through 2019. All cases were chart reviewed to establish chronology of events (vaccination, venipuncture, syncope, and injury, as applicable) and determine whether the event was attributed to vaccination or venipuncture. Incidence rates for vaccine- and venipuncture associated syncope were calculated overall and by sex and age group. Incidence rates for vaccine-associated syncope were also calculated by vaccine type (Human Papillomavirus (HPV): hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown)/ Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) vs. non-HPV).  The results showed: Of 197,642 vaccination and 12,246 venipuncture events identified, 549 vaccination and 67 venipuncture events had same-day codes for syncope. Chart validation confirmed 59/549 (10.7%) and 20/67 (29.9%) as vaccine-associated and venipuncture-associated syncope, respectively. Overall rates of syncope were 2.99 per 10,000 vaccination events (95% CI: 2.27- 3.85) and 16.33 per 10,000 venipuncture events (95% CI: 9.98-25.21), yielding an incidence rate ratio of 0.18 (95% CI: 0.11-0.31). The incidence of vaccine-associated syncope increased with each additional simultaneously administered vaccine, from 1.51 (95% CI: 0.93-2.30) following a single vaccine to 9.94 (95% CI: 6.43-14.67) following 3 or more vaccines. When stratified by the number of vaccines received, rates of syncope were similar following vaccination events with and without the HPV vaccine. Among those with syncope events, documented injury occurred in about 15% of both vaccine and venipuncture events. It was concluded syncope occurred more commonly following venipuncture than vaccination. A higher number of simultaneously administered vaccines was a risk factor for post-vaccination syncope in adolescents.  The outcome of syncope was not reported. The reporter considered syncope to be related to vaccine type (Human Papillomavirus (HPV).  This is a non-valid report due to the lack of patient's identifiers.   Upon internal review, syncope was determined to be medically significant.; Sender Comments: Keywords : MUL
Age: 0.33
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Poor quality device used, Syringe issue, Underdose
Clinical narrative: No one was injured as a result of the breakage/ No additional AE; VAXNEUVANCE broke during administration to a patient; VAXNEUVANCE broke at the top of the syringe, right at the luer lock, while it was being administered; the patient received "most" of the dose that was being administered; This spontaneous report was received from a registered nurse referring to a 4-month-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported.   On 23-OCT-2023, the patient was vaccinated with a dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) 0.5 milliliters (mL) injection administered intramuscularly (IM) injection, at a dosage of 0.5 mL (dose number, vaccination scheme frequency, and anatomical site of vaccination were not reported; lot# X020693 has been verified to be valid, expiration date reported and established as 18-OCT-2025) for prophylaxis (reported as vaccination). It was reported that they inspected the pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prior to the administration, they did not see any defects and the syringe was intact; however, the syringe broke into 2 pieces at the top, right at the luer lock while giving the vaccine (syringe issue, poor quality device used).   The reporter stated that they believed the patient received "most" of the dose that was being administered (incorrect dose administered). No one was injured as a result of the breakage, and no additional adverse event was reported (no adverse event).
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE.; Patient received extra dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a 6-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 23-MAR-2023, the patient was vaccinated with a first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) single dose, lot # X018576, expiration date 05-JAN-2025 (exact dose, route of administration and anatomical location were not reported). On 24-OCT-2023, the patient received second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose, route of administration, anatomical location, lot # and expiration date were not provided) (extra dose administered). Both doses were administered for prophylaxis. There was no additional adverse event reported.
Sex: M
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered
Clinical narrative: No additional AE; HCP calling to report a child inadvertently received RECOMBIVAX HB and PEDIARIX.; This spontaneous report was received from a medical assistant and refers to a 6-month-old male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-OCT-2023, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 0.5 milliliter, lot #W002938, expiration date: 18-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided); and  diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX), administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided).  On 23-OCT-2023, the patient experienced HCP calling to report a child inadvertently received RECOMBIVAX HB and PEDIARIX (Accidental overdose). No site effects were reported. No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC.; HCP calling to report AE for expired dose of PNEUMOVAX 23 PFS that was administered to a patient on 25OCT2023. Product expired 29JAN2023. Product did not have any previous temperature excursions. No side effects were reported. No other medical inform; This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 25-OCT-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # U022984, expiration date 29-JAN-2023 (dose, route of administration and anatomical location were not reported) for prophylaxis (Expired product administered). The suspect vaccine did not undergo temperature excursion. No side effects were reported (No adverse event).
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Additional AE.  No PQC; HCP calling to report AE for patient that received expired (10/20/2023) dose of PNEUMOVAX 23.  No previous TE.; This spontaneous report has been received from a nurse, regarding a 71-years-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 24-OCT-2023, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PENUMOVAX23) injection, as a single dose of prophylaxis (lot number: W007035, which was determined to be valid as syringe formulation, with an expiration date on 20-OCT-2023) (strength, dose, route and anatomical location of administration were not reported) (Expired product administered).  No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: no adverse effects reported; inadvertent concomitant administration of PROQUAD and VARIVAX; This spontaneous report was received from a nurse and refers to a 12-month-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-OCT-2023, the patient was inadvertent vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #W039697, expiration date: 13-DEC-2024 (strength, and route of administration were not provided); concomitantly with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #X013911, expiration date: 10-NOV-2024 (strength, and route of administration were not provided) both administered for prophylaxis (accidental overdose). The patient experienced no adverse effects reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired dose of MMR-II at her doctor's office.; This spontaneous report was received from Pharmacist who is also the patient (no age or gender reported).  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-OCT-2023, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, lot #W034714, expiration date reported as 10-OCT-2023, but upon validation set as 18-OCT-2023, administered for prophylaxis (strength, anatomical location, and route of administration were not provided) (Expired vaccine used), the patient experienced No additional adverse event.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE/ no PQC reported; Medical Assistant called to report that an expired dose of PNEUMOVAX 23 was administered to a patient. The dose expired on 10/20/2023 and was administered on 10/25/2023. Caller stated the patient does not have any symptoms.; This spontaneous report as received from a medical assistant and refers to a patient of unknown age or gender.  Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.   On 25-OCT-2023, the patient was vaccinated with and expired Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (with valid lot # W015900, expiration date reported on 20-OCT-2023) for prophylaxis. The patient did not have any symptoms, no additional adverse event nor PQC were reported. The reported stated that the product had never experienced a temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; HCP called to report inadvertent administration of PROQUAD after a temperature excursion that occurred on 10/12/2023 and the patient received the dose of PROQUAD on 10/19/2023. Limited patient demographics provided. .         ?; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient"s pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 12-OCT-2023, a vial of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot number: X007087, which was determined to be valid, with an expiration date on 04-SEP-2024) underwent a temperature excursion of -12.4 degrees Celsius for 18 minutes.  Then on 19-OCT-2023, the patient was vaccinated with a the improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, as prophylaxis (lot number: X007087, which was determined to be valid, with an expiration date on 04-SEP-2024) (strength, dose, scheme, route and anatomical location of administration were not reported).  No previous temperature excursion was reported.  No additional adverse event was reported.
Sex: F
Vaccine: RSV
Symptoms: Lip swelling
Clinical narrative: patient began feeling like her lips were swelling; This non-serious case was reported by a consumer and described the occurrence of lip swelling in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number F59KR) for prophylaxis.   On 16-OCT-2023, the patient received Arexvy. On 19-OCT-2023, 3 days after receiving Arexvy, the patient experienced lip swelling (Verbatim: patient began feeling like her lips were swelling). The patient was treated with prednisone. The outcome of the lip swelling was not reported.   It was unknown if the reporter considered the lip swelling to be related to Arexvy.   It was unknown if the company considered the lip swelling to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-OCT-2023 The patient received Arexvy vaccine. The reporter stated that 2 days later had swollen lips and they continued to swell and the patient visited an urgent care facility,who gave her prednisone to combat the swelling. The reporter wanted to know if the vaccine had a preservative and was it Thimerosal.
Age: 42.0
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Heart rate increased
Clinical narrative: increased heart rate; Dizziness/light headed; This non-serious case was reported by a consumer via sales rep and described the occurrence of dizziness in a 42-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunosuppression.   On 17-FEB-2023, the patient received the 1st dose of Shingrix (unknown arm). On 17-FEB-2023, less than a day after receiving Shingrix, the patient experienced dizziness (Verbatim: Dizziness/light headed). On 18-FEB-2023, the patient experienced heart rate increased (Verbatim: increased heart rate). On 18-FEB-2023, the outcome of the heart rate increased was resolved.  On 20-FEB-2023, the outcome of the dizziness was resolved.   The reporter considered the dizziness and heart rate increased to be related to Shingrix.     The company considered the dizziness and heart rate increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-OCT-2023 The patient self-reported this case. From 18th February 2023 to 19th February 2023, the patient experienced lightheaded. The reporter consented to follow up.
Sex: F
Vaccine: COVID19, FLUX, RSV
Symptoms: Asthenia, Fall
Clinical narrative: weakness down one side of her body; Fell; This non-serious case was reported by a physician via sales rep and described the occurrence of weakness in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included COVID 19 VACCINE for prophylaxis and INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis.   On an unknown date, the patient received Arexvy, COVID 19 VACCINE and FLU VACCINE (NAME UNKNOWN). On an unknown date, an unknown time after receiving Arexvy, the patient experienced weakness (Verbatim: weakness down one side of her body) and fall (Verbatim: Fell). The outcome of the weakness and fall were not reported.   It was unknown if the reporter considered the weakness and fall to be related to Arexvy.     It was unknown if the company considered the weakness and fall to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-OCT-2023 The patient was in her 80s. The patient was vaccinated at pharmacy with covid, flu and Arexvy at the same time. The patient reported weakness down one side of her body and she fell. Doctor was wondering if the combination of these 3 vaccines (covid, flu and Arexvy) caused the side effect. It was unknown if the reporter considered the weakness and fall to be related to Covid vaccine and Flu vaccine.    The reporter consented to follow up. This case was linked with US2023AMR147038, same reporter different patient.; Sender's Comments:  US-GSK-US2023AMR147038:Same reporter
Sex: F
Vaccine: COVID19, FLUX, RSV
Symptoms: Paraesthesia
Clinical narrative: tingling in her face on one side; This non-serious case was reported by a physician via sales rep and described the occurrence of tingling in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   On an unknown date, the patient received Arexvy, FLU VACCINE (NAME UNKNOWN) and COVID 19 VACCINE. On an unknown date, an unknown time after receiving Arexvy and an unknown time after receiving FLU VACCINE (NAME UNKNOWN), the patient experienced tingling (Verbatim: tingling in her face on one side). The outcome of the tingling was not reported.   It was unknown if the reporter considered the tingling to be related to Arexvy.     It was unknown if the company considered the tingling to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-OCT-2023 The patient was in her 80s. The patient was vaccinated at pharmacy with covid, flu and Arexvy at the same time. The patient reported tingling in her face on one side. Doctor was wondering if the combination of these 3 vaccines (covid, flu and Arexvy) caused the side effect. It was unknown if the reporter considered the tingling to be related to Covid vaccine and Flu vaccine.    The reporter consented to follow up. This case was linked with US2023AMR147002, same reporter different patient.; Sender's Comments:  US-GSK-US2023AMR147002:same reporter
Sex: U
Vaccine: RVX
Symptoms: Product storage error
Clinical narrative: The pharmacist pulled the box of vials out of a styrofoam cooler on the counter; This non-serious case was reported by a consumer and described the occurrence of incorrect storage of drug in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced incorrect storage of drug (Verbatim: The pharmacist pulled the box of vials out of a styrofoam cooler on the counter). The outcome of the incorrect storage of drug was unknown.  Additional Information: GSK Receipt Date: 16-OCT-2023 The reporter went on Sunday to inquire about GSK RSV vaccine. The reporter wanted to make sure they had GSK's and not Pfizer's. The pharmacist pulled the box of vials out of a styrofoam cooler on the counter, which led to incorrect storage of drug. The reporter asked, shouldn't it be stored in a freezer or refrigerator. They were not actively unpacking it.  The reporter just wanted to let GSK know.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: IV administration of Fluarix to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 66-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 5KT78, expiry date 30-JUN-2024) for prophylaxis.   On 20-OCT-2023, the patient received Fluarix Quadrivalent 2022-2023 season (intravenous). On 20-OCT-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced intramuscular formulation administered by other route (Verbatim: IV administration of Fluarix to a patient). The outcome of the intramuscular formulation administered by other route 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: 20-Oct-2023 The reporter consented to follow-up. The patient received Fluarix quadrivalent intravenously, which led to intramuscular formulation administered by other route.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Vaccination site reaction
Clinical narrative: warm-hot Injection site; itching Injection site; Redness at Injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 15-OCT-2023, the patient received Arexvy (intramuscular, right arm). On 19-OCT-2023, 4 days after receiving Arexvy, the patient experienced injection site warmth (Verbatim: warm-hot Injection site), injection site itching (Verbatim: itching Injection site) and injection site erythema (Verbatim: Redness at Injection site). The outcome of the injection site warmth, injection site itching and injection site erythema were not resolved.   It was unknown if the reporter considered the injection site warmth, injection site itching and injection site erythema to be related to Arexvy.     It was unknown if the company considered the injection site warmth, injection site itching and injection site erythema to be related to Arexvy.   Additional Information: GSK receipt date: 30-Oct-2023 The patient reported that she received the Arexvy and had a delay reaction 4 days after the vaccine. The patient had redness, itching and warm-hot to touch at injection site. The vaccine was provided at a local pharmacy.   Lot and expiration date were unknown.   The patient wanted to point out that her concern was the delay in the reactions. Patient provided consent to follow up with her through email correspondence.  Not all information was available.  Patient declined to provide full address.  No consent for follow up with HCP was provided. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient has only received one dose of Shingrix/ did not receive 2nd dose; This non-serious 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 (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient has only received one dose of Shingrix/ did not receive 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-OCT-2023 The pharmacist reported a patient had only received one dose of Shingrix. Pharmacist could not provide lot number, expiration date, patient demographics, or date of administration.  No additional details provided. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: RSV
Symptoms: Intercepted product prescribing error
Clinical narrative: dr. prescribed Arexvy to 56 yp patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 56-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included asthma, rheumatoid arthritis, sjoegren's syndrome, fibromyalgia and hypothyroidism.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted drug prescribing error (Verbatim: dr. prescribed Arexvy to 56 yp patient). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK receipt date 20 Oct 2023: The pharmacist reported that physician prescribed Arexvy to 56 year patient with severe asthma, rheumatoid arthritis, Sjogren syndrome, fibromyalgia, and hypothyroidism.  The pharmacist stated that she was not going to administer, which led to intercepted drug prescribing error. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: Negative serology testing for Hep A and Hep B; This non-serious case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included risankizumab (Skyrizi).   On an unknown date, the patient received Twinrix. On an unknown date, more than 2 years after receiving Twinrix, the patient experienced therapy non-responder (Verbatim: Negative serology testing for Hep A and Hep B). The outcome of the therapy non-responder 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: 20-OCT-2023 The retired physician noted that his wife completed the Twinrix series about 8 to 10 years ago. His wife was currently taking Skyrizi and recent serology testing for Hep A and Hep B came back negative so she had been given an extra dose of the Twinrix. The reporter consented to follow up via email, not postal mail. No further details provided at time of call.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient received a pediatric dose of Engerix B; adult patient received a pediatric dose of Engerix B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 35-year-old male patient who received HBV (Engerix B pediatric) (batch number X9FT7, expiry date 31-MAR-2024) for prophylaxis.   On 06-OCT-2023, the patient received Engerix B pediatric. On 06-OCT-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult patient received a pediatric dose of Engerix B) and adult use of a child product (Verbatim: adult patient received a pediatric dose of Engerix B). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 20-OCT-2023 The pharmacist reported that an adult patient received a pediatric dose of Engerix B which led to underdose and adult use of a child product. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo - Reconstitution with a different diluent.; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA956A, expiry date 31-JUL-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo - Reconstitution with a different diluent.) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 20-OCT-2023 A nurse called to report the administration of Menveo vaccines that were reconstituted with a different diluent other than the supplied meningococcal CYW-135 (MenCYW-135) liquid conjugate vaccine component. The vaccines were probably reconstituted with a diluent from MERCK, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.  The patients who received the improperly reconstituted vaccine have not been identified. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Arthralgia
Clinical narrative: general arthralgia; This non-serious case was reported by a nurse via call center representative and described the occurrence of arthralgia in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number HF5016) for prophylaxis.   On 18-SEP-2023, the patient received Arexvy. In SEP-2023, 1 week after receiving Arexvy, the patient experienced arthralgia (Verbatim: general arthralgia). The outcome of the arthralgia was unknown.   It was unknown if the reporter considered the arthralgia to be related to Arexvy.     It was unknown if the company considered the arthralgia to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-OCT-2023 A nurse practitioner called to inform that a patient that got a dose of RSV vaccine a week after the patient reported general arthralgia. The reporter said that it was unknown if the dose of the vaccine was from GlaxoSmithKline or from Pfizer. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: report the administration of a pediatric Engerix-B dose to a 60-year-old patient; report the administration of a pediatric Engerix-B dose to a 60-year-old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 60-year-old male patient who received HBV (Engerix B pediatric) (batch number 25N39, expiry date 16-MAR-2024) for prophylaxis.   On 18-OCT-2023, the patient received Engerix B pediatric. On 18-OCT-2023, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: report the administration of a pediatric Engerix-B dose to a 60-year-old patient) and underdose (Verbatim: report the administration of a pediatric Engerix-B dose to a 60-year-old patient). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK receipt date 20 Oct 2023 A pharmacist called to report the administration of a pediatric Engerix-B dose to a 60-year-old patient. The HCP asked for guidance on this situation, which led to adult use of a child product and underdose . The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient did not receive second dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 09-JUL-2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient did not receive second dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-OCT-2023 The pharmacist reported that, patient did not receive a second dose of Shingrix. Pharmacist could not provide lot number or expiration date of the dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: the dose was of lot number 93CP5, which had an expiration date of 30Jun2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 53-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 93CP5, expiry date 30-JUN-2023) for prophylaxis.   On 19-OCT-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On 19-OCT-2023, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: the dose was of lot number 93CP5, which had an expiration date of 30Jun2023). 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: 20-Oct-2023 Medical Assistant reported that a dose of FluLaval QIV was administered to a patient one day before the reporting date.   The dose was pulled from carton lot number 82L45 (expiration date 30th June 2024), however when they went to enter the dose into the computer it was realized that the dose was lot number 93CP5, which had an expiration date of 30th June 2023.   The reporter stated that they did not had any remaining doses of last season's FluLaval on site, so she believed it arrived in the carton this way.   The product was ordered via wholesaler.   At the time of reporting, a repeat dose has not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The patient received an expired dose of Flulaval QIV, which led to expired vaccine used.
Sex: U
Vaccine: COVID19
Symptoms: Chronic lymphocytic leukaemia, Illness
Clinical narrative: CLL (leukemia); After each Moderna shot, except the first one, I have been quite sick; This spontaneous case was reported by a patient and describes the occurrence of CHRONIC LYMPHOCYTIC LEUKAEMIA (CLL (leukemia)) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHRONIC LYMPHOCYTIC LEUKAEMIA (CLL (leukemia)) (seriousness criterion medically significant) and ILLNESS (After each Moderna shot, except the first one, I have been quite sick). The patient was treated with OBINUTUZUMAB for CLL, at an unspecified dose and frequency; VENETOCLAX ongoing since an unknown date for CLL, at a dose of 400 milligram once a day; ACYCLOVIR [ACICLOVIR] at an unspecified dose and frequency and ATOVAQUONE at an unspecified dose and frequency. At the time of the report, CHRONIC LYMPHOCYTIC LEUKAEMIA (CLL (leukemia)) and ILLNESS (After each Moderna shot, except the first one, I have been quite sick) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided. Patient scheduled for a COVID vax next day at the reporting time and had cold feet. Patient finished Obinutuzumab infusions the end of June but continued on 400 mg of Venetoclax daily. After each Moderna shot, except the first one, patient had been quite sick. These were all before treatment. Patient also took acyclovir and atovaquone. Patient was worried about the dreadful reaction.   Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of Chronic lymphocytic leukaemia, and a non-serious unexpected event of Ilness. The events occurred on an unknown date after a dose of SPIKEVAX COVID-19 VACCINE NOS (dates for vaccine administration, dose number and onset date were not provided). Clinical course and diagnostic procedures were not provided. The patient was treated with obinutuzumab and venetoclax. The outcome of the events was not reported. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2023: Live follow-up received.
Sex: F
Vaccine: UNK
Symptoms: Insomnia, Urinary retention
Clinical narrative: she hardly sleeps; can't urinate; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (she hardly sleeps) and DYSURIA (can't urinate) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (she hardly sleeps) and DYSURIA (can't urinate). At the time of the report, INSOMNIA (she hardly sleeps) and DYSURIA (can't urinate) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient was not a participant of clinical trial.  No treatment information was provided.