chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to County Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by, CRNP. The vaccine was transported back to County Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to County Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into immprint for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. Patient has been notified on need to have vaccine repeated due to it going through a temperature excursion. No appointment has been scheduled yet. Her chart if flagged that she needs repeat HPV9 vaccine.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete vaccination given
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dysphagia, Immunisation reaction, Injection site rash, Rash
Clinical narrative: After Hours Call Note 03/28/24   HPI After hours call received from mother of pt regarding rash on arm.   Pt received covid and flu vaccine yesterday. Today has developed a red rash on the arm where shots were placed. Given a dose of his claritin today without change. He has said his throat is sore but not having airway issues or trouble swallowing. No fever. Appearing generally well aside from the rash.     OBJECTIVE Calm, speaking in full sentences, answers appropriately   ASSESSMENT/PLAN 1. Rash At site of vaccines, no red flags. Recommended change claritin and start benadryl. Red flags reviewed. Expect will resolve without issue.  HPI: Pt is a 7 year old male here w/mom for allergic reaction to vaccination.  He received COVID and Influenza vaccination on 3/27 and developed injection site redness same day before bedtime. Skin was hot to touch w/induration next AM and diffuse rash developed on back. Tried Benadryl and Zyrtec that improved the rash and there is no rash today Still has itchy skin on back and arms. Had T of 100.2 F this AM and mom gave him Ibuprofen  Denies having SOB.   ASSESSMENT/PLAN:   1. Adverse effect of vaccine, initial encounter (Primary) -     cetirizine (CHILDREN'S ZYRTEC ALLERGY) 1 mg/mL syrup; Take 5 mL by mouth once daily as needed for allergies, Disp-60 mL, R-0  e-Prescribing  Dispense: 60 mL; Refill: 0 Will consider having reaction to Moderna vaccine. Will continue taking daily Zyrtec Provided with ER instructions  RTC prn   Patient understands and agrees with plan of care.
Age: 8.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Dtap was given to 8-year-old patient which should have receive Tdap vaccine instead.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient stated that she had her HPV vaccine on 5/7/24 @ clinic in her right arm.  She stated that when the the nurse administered her vaccine the administered it in the upper part of her shoulder under the acromion but above the deltoid tuberosity. She stated that her arm was sore after the vaccine for about 48 and started to improve for a few days but then the pain worsened in her right shoulder with pain going down her right arm, throbbing and having DROM. Patient stated that she called the GYN 2 weeks post vaccine and was told that her pain was normal. On exam today her deltoid is tender to touch with DROM in her shoulder due to pain. Pain in her shoulder and arm is due to the administration of the vaccine being given to high in her arm and not a reaction to the hpv vaccine its self.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered at inappropriate site
Clinical narrative: Patient stated that she had her HPV vaccine on 5/7/24 @ clinic in her right arm.  She stated that when the the nurse administered her vaccine the administered it in the upper part of her shoulder under the acromion but above the deltoid tuberosity. She stated that her arm was sore after the vaccine for about 48 and started to improve for a few days but then the pain worsened in her right shoulder with pain going down her right arm, throbbing and having DROM. Patient stated that she called the GYN 2 weeks post vaccine and was told that her pain was normal. On exam today her deltoid is tender to touch with DROM in her shoulder due to pain. Pain in her shoulder and arm is due to the administration of the vaccine being given to high in her arm and not a reaction to the hpv vaccine its self.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Erythema, Fatigue, Pain, Pyrexia
Clinical narrative: Mild fever, soreness throughout body, arm showing signs of redness around the area of vaccine, fatigue and feeling low energy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered
Clinical narrative: proquad was expired at the time of administration - expiration date 4/7/24
Age: 53.0
Sex: M
Vaccine: HEPAB
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Patient received dose 1 of the Hep A/B series.  approximately 2 hours later the patients sister called in to pharmacy to relay that patient had passed out at home and hit his head and lost consciousness.  He was taking to a local ER by ambulance.  No information of outcomes at this time
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Ear swelling, Erythema, Injection site erythema, Injection site urticaria, Lip swelling
Clinical narrative: At home in the evening, she started with hives on legs, that spread to torso, face. Earlobe and lips had mild swelling. No resp distress but seemed to wheeze.; rash was itchy. Given Benadryl and resolved almost entirely. Today still with mild redness where hives occurred.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Rash pruritic, Urticaria, Wheezing
Clinical narrative: At home in the evening, she started with hives on legs, that spread to torso, face. Earlobe and lips had mild swelling. No resp distress but seemed to wheeze.; rash was itchy. Given Benadryl and resolved almost entirely. Today still with mild redness where hives occurred.
Age: 1.92
Sex: M
Vaccine: MMR
Symptoms: Coagulation test, Full blood count, Metabolic function test, Petechiae, Pyrexia
Clinical narrative: Rash and high fever began 8 days after vaccine (expected) and on day 10 petechiae appeared to ear lobes
Age: 1.92
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash and high fever began 8 days after vaccine (expected) and on day 10 petechiae appeared to ear lobes
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC20, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: MMRV and VAR both administered on same day into same leg. MMRV mistaken for MMR.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by CRNP. The vaccine was transported back to Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into system for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. 04/30/2024-Mother of child contacted by phone. She agreed to have DTAP repeated as recommended. Informed mom Daptacel that child was given was involved in a temperature excursion. Child was revaccinated on 05/15/2024
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Dyspnoea, Muscle twitching, Staring
Clinical narrative: Approximately 8:45 pm, Mom states "She just woke up her entire body was twitching so hard. She was making this weird gasping sound in her throat & her eyes were open but almost seemed fixed. Lasted approx 2 mins & is acting fine now. No fever. Pulse normal, 103." Mom then took child to local ER for evaluation.
Age: 10.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Pt presented to clinic for vaccines. Mother was present with child. Interpreter services were used.  No previous shot record available per parent at time of visit.     Vaccines given as per catch up schedule for child to enroll in school.   Vaccines given without incident.  It was discovered later, several weeks later, that child did have shot record in system.  According to record review child was up to date and did not need any vaccines that day.  All vaccines given were extras.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Extra dose administered
Clinical narrative: Child given dose of hep A. Provider dr.notified.  Informed parent to place "baby" on bed, parent placed child on bed I gave hep A vaccine to leg, then when parent picked up child I saw child was the 4 year child "patient" and not the 2yr old child.   Explained to parent the vaccine Hep A was given. Parent verbalized understanding. I informed provider dr.. Parent asked if there was a side effect, per dr.informed parent no harm would come from the extra hep A vaccine given. Parent verbalized understanding. Updated vaccine record given to paren
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: Patient asked if tingling was normal in lower arm/hand post vaccination (while we were discussing other recommended vaccines). no other issues (swelling, gi, SOB, chest pain, etc). But due to nature of complaint, age of pt and timing of vaccine, called EMS for emt to further evaluate. while discussing with operator, pt described pain as something he has had while riding a bike.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given this vaccine 6 days past expiration date. It expired on 5-23-24 and today is 5-29-24.  Pt had no reaction.
Age: 53.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MNQ, PNC20, VARZOS
Symptoms: Underdose
Clinical narrative: Patient was given pediatric Hepatitis B vaccine, instead of adult Hepatitis B vaccine. Pt was being re-vaccinated after having a bone marrow transplant and was receiving other pediatric vaccines. Patient was notified and wanted to have the adult Hepatitis B vaccine administered at the next scheduled interval for her vaccines.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Left arm became red  8x15cm & swollen, also itchy. Warm to touch & non tender. Recommend cold compress, Tylenol & Benadryl
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Rash erythematous, Skin burning sensation
Clinical narrative: BEGAN WITH A BURNING FEELING OF SKIN ON LEFT HIP THAT SPREAD TWO DAYS LATER TO ABDOMEN FOLLOWED SHORTLY BY A STINGING RED RASH.  LOCATION OF BURNING AND RASH IS THE SAME LOCATION WHERE I HAD SHINGLES 9 YEARS AGO.  RECEIVED ZOSTAVAX A FEW YEARS PRIOR TO GETTING SHINGLES
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Joint swelling, Muscle tightness, Pain in extremity
Clinical narrative: First Shingrix vaccine (12/14/2023) - felt run down the day after, very sore arm.  Second Shingrix vaccine (5-8-2024) - flue like symptoms the day after, very sore arm.  The next morning I noticed my knees were a bit swollen (this does not happen to me normally).  The next day my ankles & feet were swollen (I've never had swollen ankles and/or feet).  Feet, ankles & toes were swollen worse the next day.  I have small ankles with long skinny toes so the swelling was freaky looking.  The backs of my calves even felt tight around day 9.  The swelling last for 11 days.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: First Shingrix vaccine (12/14/2023) - felt run down the day after, very sore arm.  Second Shingrix vaccine (5-8-2024) - flue like symptoms the day after, very sore arm.  The next morning I noticed my knees were a bit swollen (this does not happen to me normally).  The next day my ankles & feet were swollen (I've never had swollen ankles and/or feet).  Feet, ankles & toes were swollen worse the next day.  I have small ankles with long skinny toes so the swelling was freaky looking.  The backs of my calves even felt tight around day 9.  The swelling last for 11 days.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: First Shingrix vaccine (12/14/2023) - felt run down the day after, very sore arm.  Second Shingrix vaccine (5-8-2024) - flue like symptoms the day after, very sore arm.  The next morning I noticed my knees were a bit swollen (this does not happen to me normally).  The next day my ankles & feet were swollen (I've never had swollen ankles and/or feet).  Feet, ankles & toes were swollen worse the next day.  I have small ankles with long skinny toes so the swelling was freaky looking.  The backs of my calves even felt tight around day 9.  The swelling last for 11 days.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: ALDACEL ADMINITERED TO 70-YEAR-OLD PATIENT
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular period
Age: 11.0
Sex: F
Vaccine: HPV9, PPV, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse symptoms
Age: 50.0
Sex: M
Vaccine: HIBV, PNC20
Symptoms: Atypical haemolytic uraemic syndrome, Blood creatinine normal, Diarrhoea, Escherichia test positive, Hypertension
Clinical narrative: Altered mental status - development of atypical hemolytic uremic syndrome vs thrombotic microangiopathy
Age: 50.0
Sex: M
Vaccine: HIBV, PNC20
Symptoms: Mental status changes, Red blood cell schistocytes present, Thrombotic microangiopathy
Clinical narrative: Altered mental status - development of atypical hemolytic uremic syndrome vs thrombotic microangiopathy
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Two days after injection, intermittent sharp pain started to appear near site of the injection at right mid-lateral deltoid and radiated approximately 3 inches anteriorly on the deltoid. Pain described as "a catch" or "sharp grabbing pain" that could not be reproduced on command-- was only intermittent and without warning. No redness, swelling, motion limitation, or joint irritation noted by patient. Intermittent pains have continued for approximately 17 days as of the date of this report. Treatments have included rest and over-the-counter pain-reducing medications. Medical evaluation will now be sought by patient per report of 5/28/24.
Age: 33.0
Sex: M
Vaccine: HEP, HEPA, MMR, TD
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Hep B was given inadvertently to soon from dose 2 to dose 3.  MMR was also given inadvertently, dose # 3, patient already had 2 doses and was complete.  No report of any symptoms or adverse reaction by patient.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pruritus, Pyrexia, Skin irritation
Clinical narrative: pt initially developed bodyaches/fever/sore arm/itchy faces (cheeks)/ prickly (irritating cheeks).  she took cetirizine and symptoms have improved, only still have minor irritation from itchy cheeks/irritating cheeks.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no ill effects; vaccine that had been administered after its labeled expiration date. Vaccine was administered on 12/27/2023, expired on 12/4/2023.; This spontaneous report was received from a registered nurse referring to a male patient of unknown age (also reported as 39 [age unit not provided]). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-DEC-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 (unit not reported), lot #W009105, expiration date: 04-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided). The reporter called to report this expired dose of vaccine that was administered to the patient on that day about 45 minutes before calling (Expired product administered). Vaccine had not undergone any temperature excursion. As far as the reporter was aware, there had been no ill effects (No adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist called to report an adult patient who received their first dose of GARDASIL 9 on 20APR2024 and inadvertently received a second dose of GARDASIL 9 on 27APR2024. Limited patient demographics provided. No additional AE/PQC.; Pharmacist called to report an adult patient who received their first dose of GARDASIL 9 on 20APR2024 and inadvertently received a second dose of GARDASIL 9 on 27APR2024. Limited patient demographics provided. No additional AE/PQC.; This spontaneous report was received from a pharmacist referring to a 34-year-old female patient. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 20-APR-2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter/per dose, administered for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported). Later, on 27-APR-2024, the patient inadvertently was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter/per dose, administered for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported) (inappropriate schedule of product administration). No additional adverse event was reported.  Lot # is being requested and will be submitted if received.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Therapeutic response decreased
Clinical narrative: poor response to pneumovax; This literature marketed information has been received from the authors of a published article, title as below, regarding a 5-year-old male patient with myelodysplasia, infection, restriction of growth, adrenal hypoplasia, genital phenotypes, and enteropathy(MIRAGE) Syndrome driven by a novel SAMD9 variant (p.Asn658Asp), presumed gain-of-function given the clinical presentation of myelodysplasia, infections, restricted growth, chronic diarrhea, achalasia, alacrimia, and chronic hypoxemic lung disease diagnosed as neuroendocrine cell hyperplasia of infancy (NEHI). It was noted that he had no genital abnormalities and the adrenal insufficiency present in this patient was ultimately thought secondary to frequent exogenous corticosteroids for pulmonary disease, and had resolved. The patient also had a second, presumed somatic, loss-of-function SAMD9 variant (p.Gln30). It was noted that the patient had normal cytogenetics across serial bone marrow evaluations.  The patient also had frequent hospitalizations for recurrent episodes of fever, often in the absence of an identified infectious source and concerning sterile autoinflammation.  On an unknown date, the patient had been vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient had normal immunoglobulin levels with poor response to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23). At the time of reporting, the outcome of the event poor response to the pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.    The reporter considered poor response to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) to be related to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23).  A copy of the published article is attached as further documentation of the patient's experience.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; HCP calling to report that patient received inappropriately stored PROQUAD.; This spontaneous report was received from a medical assistant, referring to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 21-MAY-2024, the patient received the inappropriately stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, single dose, lot #Y003143, expiration date: 27-JUL-2025, administered by health professional for prophylaxis (strength, and route of administration were not provided) (product storage error). The vaccine was exposed to 19.8 Fahrenheit degrees (F) for 20 Hours 15 Minutes. There was no previous temperature excursion (TE). No adverse effects were reported (no adverse event).  This is one of the reports from the same reporter.; Sender's Comments:  US-009507513-2405USA007600: US-009507513-2405USA007924:2405USA007833
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; HCP calling to report that patient received inappropriately stored VARIVAX.; This spontaneous report was received from a medical assistant, referring to a 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 08-MAY-2024, the patient received the inappropriately stored vaccine of varicella virus vaccine live (oka/merck) (VARIVAX) injection, single dose, lot #X026789, expiration date: 14-NOV-2025, administered by health professional for prophylaxis (strength, and route of administration were not provided) (product storage error). The vaccine was exposed to 19.8 Fahrenheit degrees (F) for 20 Hours 15 Minutes. There was no previous temperature excursion (TE). No adverse effects were reported (no adverse event).    This is one of the reports from the same reporter.; Sender's Comments:  US-009507513-2405USA007600: US-009507513-2405USA007924:2405USA007841
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; HCP calling to report that patient received inappropriately stored PROQUAD/Temp: 19.8 F Time: 20 Hours 15 Minu; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-MAY-2024, the patient was vaccinated with a single dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #Y003143, expiration date reported as and upon inter review confirmed as: 27-JUL-2025 (exact dose, route of administration and vaccination stie were not provided) administered for prophylaxis. The patient received inappropriately stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (temperature: 19.8 F, time: 20 hours 15 minutes) (product storage error). No Previous temperature excursion (TE) was noted. No adverse effects were reported (no adverse event). No product quality complaint (PQC) was noted.; Sender's Comments:  US-009507513-2405USA007600: US-009507513-2405USA007924:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported. No PQC; HCP calling to report that patient received inappropriately stored VARIVAX.  No adverse effects reported.  No PQC.; This spontaneous report was received from an other health professional (medical assistant) and refers to an 1-year-old patient of an unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-MAY-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, single dose, lot #X026789, expiration date: 14-NOV-2025, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  Administered dose of suspect vaccine was exposed to the temperature excursion on an unknown date: 19.8 Fahrenheit (F) for 20 hours 15 minutes (product storage error, onset date: 13-MAY-2024). Previous temperature excursion was reported as no. No adverse effects were reported (no adverse event).  This is one of the several reports received from the same reporter (34 associated cases).; Sender's Comments:  US-009507513-2405USA007600: US-009507513-2405USA007924:2405USA007935
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; HCP calling to report that patient received inappropriately stored PROQUAD.  No adverse effects reported.  No PQC. Please see case 02607099 note section for 34 associated AE cases.  PROQUAD  LOT Y003143   7/27/2025 Temp: 19.8 F Time: 20 Hours 15 Minu; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 09-MAY-2024, the patient was vaccinated with improperly stored single dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #Y003143, expiration date was 27-JUL-2025, (strength, exact dose, route of administration, and anatomical site of vaccination were not provided) for prophylaxis (product storage error). The suspect vaccine underwent a temperature excursion of 19.8 Fahrenheit (F) degrees for 20 hours and 15 minutes. No previous temperature excursion (TE) was reported, No adverse effects was reported (no adverse event).; Sender's Comments:  US-009507513-2405USA007600: US-009507513-2405USA007924:2405USA008015
Age: 12.0
Sex: M
Vaccine: HPV9, MEN
Symptoms: Syncope
Clinical narrative: a few moments after receiving the vaccines, the patient had a syncopal episode; This spontaneous report as received from a medical assistant referring to a 12-year-old male patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 21-MAY-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1967338, expiration date 26-JAN-2026 (dose and route of administration not provided) and meningococcal vaccine (dose, route of administration, lot number and expiration date not reported) both for prophylaxis.      On the same date, a few moments after receiving the vaccines, the patient had a syncopal episode that lasted for an unspecified amount of time (syncope). Patient was monitored in the clinic and discharged to home the same day.  The outcome of syncope was reported as resolved in May 2024. The causal relationship between the event and the vaccines was not reported.  Upon internal review, syncope was considered medically significant
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; patient received an expired dose of MMR-II on 5/24/2024; This spontaneous report has been received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 24-MAY-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, at a dose of 0.5 mL, lot number W017555 that was verified to be a valid lot number (expiration date reported and validated as 24-DEC-2023) administered as prophylaxis (scheme, route and anatomical location of administration were not provided) (expired product administered). There were no temperature excursions (TE). No symptoms and no additional adverse event were reported.
Age: 63.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Pneumonia, X-ray
Clinical narrative: Consumer called to report he had Pneumonia a few weeks ago and was previously vaccinated with PREVNAR 13 and PNEUMOVAX 23. Patient states he was not hospitalized.; This spontaneous report was received from a consumer and refers to himself, a 73-year-old male patient.  The patient's medical history was not reported. His concurrent conditions included basal cell carcinoma. Concomitant medications included amlodipine (+) benazepril, hydrochlorothiazide, tadalafil (reported as tidalofil), and vitamins not otherwise specified (NOS) (MULTIVITAMINUM).   On 09-DEC-2013, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered intramuscularly for prevention of pneumococcal disease (exact dose, dose number, lot #, and expiry date were not provided). On an unknown date, the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), administered for prophylaxis (formulation, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2024 (reported as few weeks ago), the patient experienced pneumonia and was previously vaccinated with suspect vaccines. The patient stated he was not hospitalized due to the event. X-ray was performed but result was not provided. As a treatment for the event, he was treated with doxycycline. On an unknown date in 2024, the patient recovered from the event of pneumonia. The action taken with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) regarding the event was not applicable.  The causal relationship between the event and suspect vaccines was not provided.   Upon internal review, the event of pneumonia was determined to be medically significant.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: RSV
Symptoms: Chills
Clinical narrative: I also have the shivers; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shivers in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced shivers (Verbatim: I also have the shivers). The outcome of the shivers was not reported.   It was unknown if the reporter considered the shivers to be related to Arexvy.     It was unknown if the company considered the shivers to be related to Arexvy.   Additional Information: GSK Receipt Date: 15-JAN-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient had shivers. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Hypersensitivity, Hypotension, Lethargy, Malaise
Clinical narrative: got very sick; doctor says I was allergic to it; vomiting; DIARHEA; fever; low blood pressure; LETHERGY; This non-serious case was reported by a consumer via call center representative and described the occurrence of vomiting in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included osteoporosis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced vomiting (Verbatim: vomiting), diarrhea (Verbatim: DIARHEA), fever (Verbatim: fever), low blood pressure (Verbatim: low blood pressure), lethargy (Verbatim: LETHERGY), sickness (Verbatim: got very sick) and allergic reaction (Verbatim: doctor says I was allergic to it). The outcome of the vomiting, diarrhea, fever, low blood pressure and lethargy were resolved (duration 3 hrs) and the outcome of the sickness and allergic reaction were not reported.   It was unknown if the reporter considered the vomiting, diarrhea, fever, low blood pressure, lethargy, sickness and allergic reaction to be related to Shingrix.     It was unknown if the company considered the vomiting, diarrhea, fever, low blood pressure, lethargy, sickness and allergic reaction to be related to Shingrix.   Additional Information: GSK receipt date:15-JAN-2024 and 16-JAN-2024 The reporter was consumer who received both doses of Shingrix.  12 hours after her second dose she experienced, vomiting, diarrhea, low blood pressure, fever and lethargy.   The reporter stated that her husband called an ambulance due to these symptoms but she was never taken to the hospital.   She stated that they did not take her to the hospital because she was started to feel better.   Reporter states the symptoms resolved approximately 3 hours after they started.   Reporter was said she received her Shingrix doses a long time ago and does not have any detailed information.   Her physician said the symptoms above seems to be an allergic reaction to the Shingrix vaccine.  The patient got very sick and her physician stated that she was allergic to the vaccine. Reporter was call on the day of reporting to request PI information listed in the description section. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: got very sick; doctor says I was allergic to it; vomiting; DIARHEA; fever; low blood pressure; LETHERGY; This non-serious case was reported by a consumer via call center representative and described the occurrence of vomiting in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included osteoporosis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced vomiting (Verbatim: vomiting), diarrhea (Verbatim: DIARHEA), fever (Verbatim: fever), low blood pressure (Verbatim: low blood pressure), lethargy (Verbatim: LETHERGY), sickness (Verbatim: got very sick) and allergic reaction (Verbatim: doctor says I was allergic to it). The outcome of the vomiting, diarrhea, fever, low blood pressure and lethargy were resolved (duration 3 hrs) and the outcome of the sickness and allergic reaction were not reported.   It was unknown if the reporter considered the vomiting, diarrhea, fever, low blood pressure, lethargy, sickness and allergic reaction to be related to Shingrix.     It was unknown if the company considered the vomiting, diarrhea, fever, low blood pressure, lethargy, sickness and allergic reaction to be related to Shingrix.   Additional Information: GSK receipt date:15-JAN-2024 and 16-JAN-2024 The reporter was consumer who received both doses of Shingrix.  12 hours after her second dose she experienced, vomiting, diarrhea, low blood pressure, fever and lethargy.   The reporter stated that her husband called an ambulance due to these symptoms but she was never taken to the hospital.   She stated that they did not take her to the hospital because she was started to feel better.   Reporter states the symptoms resolved approximately 3 hours after they started.   Reporter was said she received her Shingrix doses a long time ago and does not have any detailed information.   Her physician said the symptoms above seems to be an allergic reaction to the Shingrix vaccine.  The patient got very sick and her physician stated that she was allergic to the vaccine. Reporter was call on the day of reporting to request PI information listed in the description section. The reporter did not consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Arexvy given to a patient under 30 years of age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Arexvy given to a patient under 30 years of age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 18-JAN-2024 The Pharmacist called to ask medical information in the case of Arexvy given to a patient under 30 years of age, which led to inappropriate age at vaccine administration. When asked if a patient was administered Arexvy the pharmacist was not sure, he received the question from the patient and was unsure if the vaccine had been administered or not. No follow up because hcp declined contact information be saved. Caller was unsure if the vaccine was administered or not, doing the adverse event (AE) reported proactively. The reporter did not consent to follow-up.
Age: 33.0
Sex: F
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 other health professional via call center representative and described the occurrence of underdose in a 33-year-old female patient who received HBV (Engerix B pediatric) (batch number 7B2YL, expiry date 25-FEB-2024) for prophylaxis.   On 06-JAN-2024, the patient received Engerix B pediatric. On 06-JAN-2024, 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: 19-Jan-2024 The reporter was a medical assistant. The reporter reported that an adult female patient received a pediatric dose of Engerix-B vaccine, which led to underdose and adult use of a child product. The reporter consented to follow up via email.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Administration of Flulaval to patient post excursion 22C x 74 hours.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 78-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 2XT9D, expiry date 30-JUN-2024) for prophylaxis.   On 15-JAN-2024, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: Administration of Flulaval to patient post excursion 22C x 74 hours.). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-Jan-2024 The reporter reported that the patient received Flulaval vaccine post excursion to 22 degree C for 74 hours, which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 5 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2024009515:Different patient US-GSK-US2024009520:Different patient US-GSK-US2024009518:Different patient US-GSK-US2024009516:Different patient
Age: 65.0
Sex: F
Vaccine: RVX
Symptoms: Injection site mass, Injection site nodule, Injection site pain
Clinical narrative: the patient noticed a lump/nodule under the injection site; the patient noticed a lump/nodule under the injection site; patient noticed a lump/nodule under the injection site which was painful; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site nodule in a 65-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   The patient's past medical history included cancer. Previously administered products included Covid-19 vaccine and Varicella zoster vaccine (Shingles vaccine received on an unknown date).   On 12-MAY-2024, the patient received RSV vaccine (left deltoid). In MAY-2024, less than a week after receiving RSV vaccine, the patient experienced injection site nodule (Verbatim: the patient noticed a lump/nodule under the injection site), injection site lump (Verbatim: the patient noticed a lump/nodule under the injection site) and injection site pain (Verbatim: patient noticed a lump/nodule under the injection site which was painful). The outcome of the injection site nodule and injection site lump were resolving and the outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site nodule, injection site lump and injection site pain to be related to RSV vaccine.     It was unknown if the company considered the injection site nodule, injection site lump and injection site pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 16-MAY-2024 The patient self-reported this case. The patient had many other vaccines in the past and had never experienced a lump. The patient received the RSV vaccine, and she could not specify if it was GSK's Arexvy vaccine.   When the patient got home after receiving the RSV vaccine, the patient noticed a lump or nodule under the injection site, which was painful.   The lump had gone down each day and was now (during the reporting days) about the size of a nickle. The lump was no longer painful. The reporter consent to follow up with both the pharmacy and her health care professional contact information (Pharmacy).
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Metal poisoning, Speech disorder
Clinical narrative: Aluminum toxicity; Speech problems; This serious case was reported by a consumer via call center representative and described the occurrence of toxic effect of unspecified metal in a male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced toxic effect of unspecified metal (Verbatim: Aluminum toxicity) (serious criteria GSK medically significant) and speech disorder (Verbatim: Speech problems). The outcome of the toxic effect of unspecified metal and speech disorder were unknown.   The reporter considered the toxic effect of unspecified metal and speech disorder to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   The company considered the toxic effect of unspecified metal and speech disorder to be related to Pediarix and Pediarix 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: 21-MAY-2024 The reporter was the mother of the patient who stated the patient received Pediarix in 2017, 3 doses following the normal schedule 2-4-6 months. According to the reporter the patient, who at the time of reporting was 7 years ago was presenting an aluminum toxicity and speech problems which she strongly believed was caused by the aluminum present in the Pediarix vaccine. Reporter did not provide specific dates of vaccinations or the diagnosis dates. The reporter did not consent to follow-up.