chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received Fluarix on left arm after being asked if she wanted the vaccine "contra la gripe). Patient stated yes and signed the 317 program forms. When Flu vaccine was being entered into EHR it was noted that earlier that day she had already received a flu vaccine. When I asked the patient about this, she stated she thought the Flu vaccine and gripe vaccine were 2 different vaccines. She is aware she received 2 flu vaccines on 10/9/24 and that we would call her on 10/11/24 to evaluate for any adverse effects (per recommendation of Dr). Patient also aware she is to go to ED if has any adverse reactions between 10/9-10/11. Pt verbalized understanding
Age: 98.0
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, Body temperature increased, Chest pain, Discomfort, Dyspnoea
Clinical narrative: Low grade temp 100.4; chest pain, SOB and generalized discomfort on 10/5. Low grade temp resolved with acetaminophen. She was sent out to the hospital on 10/5 and returned on 10/6. Hospital diagnosed with atrial fibrillation with RVR that had returned to sinus rhythm. This is what she originally admitted to the nursing home for so unclear on wehther the chest pains, SOB, or dicomfort are related to the vaccination.
Age: 98.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram abnormal
Clinical narrative: Low grade temp 100.4; chest pain, SOB and generalized discomfort on 10/5. Low grade temp resolved with acetaminophen. She was sent out to the hospital on 10/5 and returned on 10/6. Hospital diagnosed with atrial fibrillation with RVR that had returned to sinus rhythm. This is what she originally admitted to the nursing home for so unclear on wehther the chest pains, SOB, or dicomfort are related to the vaccination.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave the moderna 12+ year to a 10 year old
Age: 1.5
Sex: F
Vaccine: FLU3
Symptoms: Irritability, Lethargy, Pyrexia, Rash erythematous, Tremor
Clinical narrative: 10/7/24 @ 1300 pt became very fussy and then lethargic. At 1600 pt spiked a fever of 101, and tylenol was given. At 1700 pt began to have full body tremors, full body red patchy rash and temp was elevated to 102.5.
Age: 77.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Rash
Clinical narrative: patient got vaccines on 10/2/24, on 10/4/24 she reports she developed a rash on bilateral arms, then on 10/9/24 she developed a rash on chest and stomach . the rash was not raised and did not itch. She reports no new foods, medications, soaps, detergents during this period. She say MD on 10/10/24 and was given a Medrol dose pack to help with rash. She then reported event to pharmacy on the same day, today, 10/10/24. She has history of Fluzone HD and Pfizer COVID vaccine but not Arexvy.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I mistakenly gave High Dose Flu vaccine instead of regular flu vaccine because I misread her age.
Age: 35.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Rash erythematous, Rash papular, Skin warm, Tenderness
Clinical narrative: Hot red rash. Painful to touch. Noticed it about 2100 hrs Friday night. Went to walk in clinic and rash was marked with medical sharpie and was given hydrocortisone cream to put on it twice a day. Was directed to put ice on it to help with the swelling. At 2200 hard that night it spread beyond the border and was marked. Had a follow up with primary care and was told to use the hydrocortisone cream and was told not to get the second dose. Was also told to watch future vaccine and if there is another reaction I will need to contact pcp and schedule an appointment with allergy specialist to see if I?m allergic to any vaccine components. The red spot is now gone and no pain.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: about 1 day after receiving Comirnaty pfizer covid vaccine, patient developed rash that was all down her arm, on her back, and on her legs. She used benadryl topical spray to control the itch. Rash resolved after 1 week. She did not see Dr or seek medical care.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine 2024-2025 formula was not properly stored and was administered to member. Vaccine was not refrigerated and was administered at room temperature.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Facility only stocks 18 and up Twinrix injections. Kinrix given as second dose of dtap and ipv.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Pain
Clinical narrative: Patient received a shingrix vaccine (her 2nd one) on 10/8. Called us 10/10 afternoon and said she had a burning rash at the site of injection which popped a few hours ago, an inch wide and 2 inches long, warm to touch, arm soreness up to the shoulder. Has been taking tylenol otc for body aches resulting from the vaccine as well.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Asthenia, Intensive care, Pain, Trigeminal neuralgia
Clinical narrative: Severe trigeminal neuralgia with excruciating, debilitating pain.  Medications prescribed helped somewhat, but accidental overdose occurred which resulted in a ER visit and hospitalization in ICU.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: Patient received the vaccine in the right vastus lateralis, using a z-track method to help prevent leaking after injection. Later that day patient's mother became upset at the method of administration, believing the injection was given inappropriately. Patient was escorted by father to visit that day and was present at time of administration. No adverse effects reported to facility management team over the course of multiple separate contacts.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Pt became dizzy, pale, and began to perspire within 15 mins of receiving the vaccine. Laid flat w knee's elevated. Improved and returned to class ~15-20 mins later. About 30 mins later became pale again. Observed for an additional 10 mins. Ate lunch and began to feel better. Mother was on site. Mother reports patient was "not feeling 100% that morning" which may have contributed to this reaction.
Age: 0.75
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine 2024-2025 Formula was improperly stored and was given to member. Vaccine was not refrigerated and was given to patient at room temperature.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: After injection, patient developed a welt looking swelling on her left arm at the injection site. The "welt" was about the size of a half dollar, and about 1/2" tall. Was not warm to the touch,  patient did not feel pain from the swelling, nor were any systemic reactions present. Patient remained in the vaccine room and spoke with pharmacy staff and was feeling totally fine and in good spirits. She was able to stand up under her own power and reported no dizziness or anything else wrong. She was able to walk off on her own power and continue with her day without interruption
Age: 8.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: Pt received 2024-2025 Sesonal Moderna vaccine and Influenza vaccine on 9/20/24, then come to drive thru event and received another dose.
Age: 1.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered
Clinical narrative: Varicella expired on 10/04/24, was given to patient on 10/07/24.  Spoke with Merck on 10/07/24 about varicella vaccine that was given today.  It was expired on 10/4/24.  Per Merck, after market studies show this lot number is still effective and vaccine does not need to be repeated.  Merck case #02685802
Age: 1.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Varicella expired on 10/04/24, was given to patient on 10/07/24.  Spoke with Merck on 10/07/24 about varicella vaccine that was given today.  It was expired on 10/4/24.  Per Merck, after market studies show this lot number is still effective and vaccine does not need to be repeated.  Merck case #02685802
Age: 0.33
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed to receive a Pediarix Vaccine but was given an Influenza vaccine. No current symptoms.
Age: 29.0
Sex: F
Vaccine: CHIK, CHIK
Symptoms: Flushing, Throat clearing
Clinical narrative: Within 10 min of administration of Ixchiq patient complained of feeling of needing to "clear her throat" along with feeling "flushed."  RN provided water and alerted patient she would be waiting for 30 min post vaccination to monitor for additional symptoms as a precaution.  RN took vitals at 3:55 pm and found patient  BP 120/78 HR: 78 and O2 at 99%.  Pt continued to inform that symptoms above did not improve.  At 4 pm 911 was called and informed of possible serious adverse event and PO diphenhydramine 50mg  given at same time. Prior to administration of diphenhydramine oral mucosa inspected and no swelling, inflammation, or signs of acute vaccine reaction and RN able to see back of throat.   Pulse OX was continuously monitored for aprox for 15 min until EMS arrived at 4:10 pm; O2 rate was at or above 98% and HR between 68-80.  Upon arrival of EMS, they conducted own assessment including vitals and found patient not to be in distress or acute vaccine reaction. Patient declined transport to hospital after symptoms did not progress further and waited with RN in office until patient husband transported patient home at approximately 4:45 pm without further intervention.  During the entire observation time by RN and EMS no hives, nor swelling of face, throat, eyes, lips nor itching, GI symptoms, wheezing, vomiting, tachycardia observed.
Age: 29.0
Sex: F
Vaccine: CHIK, CHIK
Symptoms: Dysphonia, Flushing, Respiratory symptom, Throat clearing
Clinical narrative: Within 10 min of administration of Ixchiq patient complained of feeling of needing to "clear her throat" along with feeling "flushed."  RN provided water and alerted patient she would be waiting for 30 min post vaccination to monitor for additional symptoms as a precaution.  RN took vitals at 3:55 pm and found patient  BP 120/78 HR: 78 and O2 at 99%.  Pt continued to inform that symptoms above did not improve.  At 4 pm 911 was called and informed of possible serious adverse event and PO diphenhydramine 50mg  given at same time. Prior to administration of diphenhydramine oral mucosa inspected and no swelling, inflammation, or signs of acute vaccine reaction and RN able to see back of throat.   Pulse OX was continuously monitored for aprox for 15 min until EMS arrived at 4:10 pm; O2 rate was at or above 98% and HR between 68-80.  Upon arrival of EMS, they conducted own assessment including vitals and found patient not to be in distress or acute vaccine reaction. Patient declined transport to hospital after symptoms did not progress further and waited with RN in office until patient husband transported patient home at approximately 4:45 pm without further intervention.  During the entire observation time by RN and EMS no hives, nor swelling of face, throat, eyes, lips nor itching, GI symptoms, wheezing, vomiting, tachycardia observed.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Body temperature increased, Confusional state, Feeling cold, Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient received both doses together. Patient admitted to being extremely nervous and hated needles. After both vaccinations given, patient passed out in the chair. She awoke and was confused to where she was/what day it was. Patient's body temperature increased and she began sweating profusely. She laid down on the ground on her own. Patient was monitored/ice placed around her neck. Patient laid on the ground being monitored for about 15 minutes and began to get up, and promptly vomited. Patient laid back down. Body temperature began returning to normal, but after 30 minutes patient still could not sit up without vomiting. She did not claim to be dehydrated. After 45 minutes she still could not sit up without vomiting and then claimed she was very cold and began shaking uncontrollably, at which point the paramedics were called. They arrived approximately 7 minutes later and assessed patient, placed her on a stretcher, and took her to the ambulance for assessment. For clarification, COVID vaccine was seasonal Spikevax.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: Patient received both doses together. Patient admitted to being extremely nervous and hated needles. After both vaccinations given, patient passed out in the chair. She awoke and was confused to where she was/what day it was. Patient's body temperature increased and she began sweating profusely. She laid down on the ground on her own. Patient was monitored/ice placed around her neck. Patient laid on the ground being monitored for about 15 minutes and began to get up, and promptly vomited. Patient laid back down. Body temperature began returning to normal, but after 30 minutes patient still could not sit up without vomiting. She did not claim to be dehydrated. After 45 minutes she still could not sit up without vomiting and then claimed she was very cold and began shaking uncontrollably, at which point the paramedics were called. They arrived approximately 7 minutes later and assessed patient, placed her on a stretcher, and took her to the ambulance for assessment. For clarification, COVID vaccine was seasonal Spikevax.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 11 year old pt was given adolescent vaccines and was inadvertently given 12+ vaccine with routine adolescent vaccines. No adverse outcome noted at reporting time.  Father of pt was notified of adverse event by phone directly after event occurrence.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site: 2 inch wide raised bump, red, swollen, warm to touch, painful and itchy.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain and swelling at the injection site and full body ache. Bump on arm lasted 5-6 days. Not sure if pain was near joint but feels like there is a bone or something that moves around in there. Pain continues today 10-10-24.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Abdominal discomfort, Diarrhoea, Illness, Irritability, Sleep disorder
Clinical narrative: GI distress; overall sickness; watery diarrhea; disrupted sleep; fussiness; This spontaneous report was received from a Consumer via a Company Representative and refers to a 4-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-AUG-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, dose, frequency, lot #, and expiry date were not provided).  The patient had been experiencing GI distress and overall sickness since received the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine on 06-AUG-2024.  Symptoms were mostly watery diarrhea, disrupted sleep, and fussiness.  The outcome of all the events was not reported.  The causal relationship between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: no adverse reaction reported; Improper storage of product in use; This spontaneous report was received from a nurse and refers to a 16-month-old female patient. No information on patient's medical history and current conditions was provided. Concomitant therapies included pneumococcal vaccine conj 20v (crm197) (PREVENAR 20) and hepatitis a vaccine inact (HAVRIX).  On 18-SEP-2024 the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: rHA) lot # X020654 and expiration date 21-OCT-2024, subcutaneously in the left thigh for prophylaxis (exact dose and dose number were not provided). The storage temperature was higher than 8 Celsius degrees for 10 hours (product storage error). No adverse reaction was reported (no adverse event).; Sender's Comments:  US-009507513-2409USA007895:
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No other information provided.  No additional AEs or PQC reported.; Caller reported GARDASIL 9 was administered to pregnant patient.; This spontaneous report has been received from other health care professional, regarding a 39-year-old pregnant female patient. The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 24-SEP-2024 at the pregnancy gestations of 30 weeks and 4 days, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, intramuscularly administrated (strength, dose, frequency, site of vaccination, vaccination scheme were not provided; lot # 2018414 which has been verified to be a valid number, expiration date reported as 11-DEC-2024 but upon internal review it was established as 11-DEC-2025) as a vaccination against human papillomavirus virus (HPV) (exposure during pregnancy). No treatment was given to the patient. No other information provided. No additional AEs or PQC
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Sleep disorder
Clinical narrative: Pruritus; interrupt sleep; This non-serious case was reported by a physician via sales rep and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Nucala with an associated reaction of pruritus (received several courses of Nucala a year prior to Shingrix administration).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pruritus (Verbatim: Pruritus) and sleep disturbance (Verbatim: interrupt sleep). The outcome of the pruritus and sleep disturbance were resolved.   It was unknown if the reporter considered the pruritus and sleep disturbance to be related to Shingrix.     It was unknown if the company considered the pruritus and sleep disturbance to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-SEP-2024 The patient received Shingrix and experienced pruritus. The patient had received several courses of Nucala a year prior to Shingrix vaccine administration experienced similar pruritus around Nucala as well. Provider was wondering what about Shingrix may had reactivated the pruritus. Also stated that it was significant enough to interrupt sleep. Resolved relatively quickly in 2 to 3 days.
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Pain in extremity, Respiratory symptom, Rhinorrhoea
Clinical narrative: Runny nose; fatigue; pain in the entire arm; upper respiratory symptoms; This non-serious case was reported by a consumer and described the occurrence of runny nose in a 23-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2024-2025 season) for prophylaxis.   On 29-SEP-2024, the patient received Fluarix Tetra 2024-2025 season (intramuscular) .5 ml. In SEP-2024, an unknown time after receiving Fluarix Tetra 2024-2025 season, the patient experienced upper respiratory symptom (Verbatim: upper respiratory symptoms). On 30-SEP-2024, the patient experienced runny nose (Verbatim: Runny nose), fatigue (Verbatim: fatigue) and pain in arm (Verbatim: pain in the entire arm). The outcome of the runny nose, fatigue and pain in arm were not resolved and the outcome of the upper respiratory symptom was not reported.   It was unknown if the reporter considered the runny nose, fatigue, pain in arm and upper respiratory symptom to be related to Fluarix Tetra 2024-2025 season and Fluarix Pre-Filled Syringe Device.     It was unknown if the company considered the runny nose, fatigue, pain in arm and upper respiratory symptom to be related to Fluarix Tetra 2024-2025 season and Fluarix 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: 30-SEP-2024 This case was self-reported by patient. The patient received Fluarix vaccine and experienced runny nose, fatigue and pain in the entire arm. The runny nose and pain in the arm was severe. Flu shot was intended to prevent flu and its symptoms, but seems it caused severe runny nose and upper respiratory symptoms.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Fatigue
Clinical narrative: joint pain; Tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain 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 joint pain (Verbatim: joint pain) and tiredness (Verbatim: Tiredness). The outcome of the joint pain and tiredness were not reported.   It was unknown if the reporter considered the joint pain and tiredness to be related to Arexvy.     It was unknown if the company considered the joint pain and tiredness to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-SEP-2024 The case was received from the patient via (Open field AE monitoring) interactive digital media. The patient had tiredness and joint pain.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles/Few months later came down with another shingles; It looked more like chickenpox/clusters on my feet and toes; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 6 years after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles/Few months later came down with another shingles) and varicella-like rash (Verbatim: It looked more like chickenpox/clusters on my feet and toes). The outcome of the vaccination failure was not reported and the outcome of the shingles and varicella-like rash were resolved.   It was unknown if the reporter considered the vaccination failure, shingles and varicella-like rash to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and varicella-like rash to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 02-OCT-2024 The reporter reported that a patient vaccinated with shingles vaccine shots and six years later came down with wide spread shingles, they were spread all over body including face. It was look like chickenpox and it was lasted for almost two months. Few months later came down with another shingles attack.  The second outbreak was not as pervasive but lasted again almost two months.  The reporter could not wear shoes because had clusters on feet and toes. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: potential adverse effects could happen to a 3 week old who received a Flulaval vaccine"; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-week-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis.   On an unknown date, the patient received FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: potential adverse effects could happen to a 3 week old who received a Flulaval vaccine"). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-SEP-2024 The reporter would need to know what potential adverse effects could happen to a 3 week old who received a Flulaval vaccine. 3 week old patient received flulaval, which led to inappropriate age at vaccine administration. Consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: new schedule in patient 6 years and over, because in that area; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: new schedule in patient 6 years and over, because in that area). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-SEP-2024 The doctor contacted via phone Medical Information Team in order to get some guidance on how to proceed with Bexsero with the new schedule in patient 6 years and over, because in that area (state), they usually start at that age, which led to inappropriate age at vaccine administration The reporter asked if they need to administer Bexsero second dose 6 month later. HCP was not aware about Bexsero 2 or 3 dose series.
Sex: U
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: First Dose needle leaked and some vaccine was lost/patient received half of that dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced underdose (Verbatim: First Dose needle leaked and some vaccine was lost/patient received half of that dose). The outcome of the underdose was unknown.   Additional Information: GSK receipt date: 24-SEP-2024 Medical Assistant asked about a first dose given to a patient, that dose apparently leaked, and this patient received half of that dose, which led to underdose. Once she came to receive that second dose, would that patient be covered. Did not consent to follow-up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity, Sleep disorder
Clinical narrative: thigh pain; hip pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in thigh in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included stroke (25 years ago).   On 19-SEP-2024, the patient received the 1st dose of Shingrix (intraparietal, left arm). On 24-SEP-2024, 5 days after receiving Shingrix, the patient experienced pain in thigh (Verbatim: thigh pain) and pain in hip (Verbatim: hip pain). The outcome of the pain in thigh and pain in hip were not resolved.   It was unknown if the reporter considered the pain in thigh and pain in hip to be related to Shingrix.     It was unknown if the company considered the pain in thigh and pain in hip to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-SEP-2024 The patient's hips and thighs hurt really bad, the patient was waking up in the middle of the night. It did not go away. It calms down and at night it was worse. The patient inquired, could it be guillain-barre syndrome disease. No additional event was reported.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: suspected vaccination failure; she might have shingles; has itchy blisters on her arms, side, and upper back.; itchy blisters; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: she might have shingles), blister (Verbatim: has itchy blisters on her arms, side, and upper back.) and pruritus (Verbatim: itchy blisters). The outcome of the vaccination failure, shingles and pruritus were not reported and the outcome of the blister was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister and pruritus to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, blister and pruritus to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 25-SEP-2024 The patient received both doses of Shingrix in 2023.  She did not know the dates (or lot numbers) of the doses but did provide the name of the pharmacy where she received the shots. The patient was concerned that she might had shingles. The patient has itchy blisters on her arms, side, and upper back.  The patient had not yet been seen by a physician to determine the diagnosis. This case was considered as suspected vaccination failure as details time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter consented to follow up.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about time to onset for shingles, completion of primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the diluent portion of the Arexvy vaccine was administered without the lyophilized antigen portion of the vaccine; only the diluent portion of the Arexvy vaccine was administered without the lyophilized antigen portion of the vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number Z9I9Y, expiry date 29-JUN-2026) for prophylaxis.   On 25-SEP-2024, the patient received Arexvy. On 25-SEP-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: only the diluent portion of the Arexvy vaccine was administered without the lyophilized antigen portion of the vaccine) and inappropriate dose of vaccine administered (Verbatim: only the diluent portion of the Arexvy vaccine was administered without the lyophilized antigen portion of the vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-SEP-2024 The pharmacist calls to report only the diluent portion of the Arexvy vaccine was administered without the lyophilized antigen portion of the vaccine, which led inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Skin warm
Clinical narrative: Rash in right arm/ terrible rash; rash is itchy; The rash is itchy and warm; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-SEP-2024, the patient received the 1st dose of Shingrix (right arm). In SEP-2024, an unknown time after receiving Shingrix, the patient experienced itchy rash (Verbatim: rash is itchy) and feeling of warmth (Verbatim: The rash is itchy and warm). On 24-SEP-2024, the patient experienced rash (Verbatim: Rash in right arm/ terrible rash). The outcome of the rash, itchy rash and feeling of warmth were not reported.   It was unknown if the reporter considered the rash, itchy rash and feeling of warmth to be related to Shingrix.     It was unknown if the company considered the rash, itchy rash and feeling of warmth to be related to Shingrix.   Additional Information: GSK receipt date: 26-SEP-2024 and 27-SEP-2024 The reporter reported that she had received Shingrix vaccine at her pharmacy and the dose was administered in her right arm. 3 day before reporting she developed a rash with shingles vaccine and the rash was itchy and warm, and the rash was about an inch below the injection site. The reporter want to know what to do. She did not had the lot number and did not provide her date of birth but she said that she was older than 50 years old.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody normal, Inappropriate schedule of product administration
Clinical narrative: Drug dose administration interval too long/possible late dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included havrix (2 doses of Havrix received in 2003), Engerix B adult (1st dose received on 14th September 1999 of batch number ENG2953A4) and Engerix B adult (2nd dose received on 14th October 1999 of batch number ENG2953A4).   On an unknown date, the patient received the 3rd dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long/possible late dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 30-SEP-2024 The pharmacist stated that he was pretty sure that he received a booster dose of Hepatitis B in 2010 but could not found the record of it.  He stated that he had titers for Hepatitis B surface antibody tested in 2021 and it showed that he had immunity to Hep B virus. The patient received 3rd dose of Engerix B later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered/Engerix-B that already expired; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 29-year-old male patient who received HBV (Engerix B adult) (batch number DZ747, expiry date 12-JUL-2024) for prophylaxis.   On 25-AUG-2024, the patient received the 1st dose of Engerix B adult. On 25-AUG-2024, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: Expired dose administered/Engerix-B that already expired). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 30-SEP-2024 Pharmacist explained that on August 25th 2024 they accidentally administered a patient with their first dose of Engerix-B that already expired on July 12th 2024, which led to expired vaccine used The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: had given a patient her RSV vaccine on Friday 9/27/2024 but didn't realize she already had received one from us last year on 10/31/2023; This non-serious case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a 89-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included AREXVY (1st dose received on 31-OCT-2023).   On 27-SEP-2024, the patient received Arexvy. On 27-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: had given a patient her RSV vaccine on Friday 9/27/2024 but didn't realize she already had received one from us last year on 10/31/2023). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 30-SEP-2024 and 01-OCT-2024 The patient received RSV vaccine but did not realize she already had received one last year, which led extra dose administered.  The patient who's in good health, active, and no chronic health conditions.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral artery thrombosis, Cerebrovascular accident, Renal failure
Clinical narrative: STROKE; KIDNEY FAILURE; BLOOD CLOT IN MIDDLE CEREBRAL ARTERY; This spontaneous report received from a patient via managed social media concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose (dose series 1), start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  The patient suffered stroke caused by blood clot in his middle cerebral artery, within four hours of getting the 1 dose shot of J&J vaccine. He had 2 strokes in hospital and has also goes into kidney failure. He is unable to walk on his own. On an unspecified date, the patient experienced stroke, blood clot in middle cerebral artery and kidney failure, and was hospitalized (date unspecified) (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, kidney failure and blood clot in middle cerebral artery was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: Cerebrovascular accident, Cerebral artery thrombosis, Renal failure -Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasal congestion, Pain, Pain in extremity
Clinical narrative: aches; stuffy; chills; aching arm that radiates down to elbow; This spontaneous case was reported by a patient and describes the occurrence of PAIN (aches), NASAL CONGESTION (stuffy), CHILLS (chills) and PAIN IN EXTREMITY (aching arm that radiates down to elbow) in a 57-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 04-Oct-2024, the patient experienced PAIN (aches), NASAL CONGESTION (stuffy), CHILLS (chills) and PAIN IN EXTREMITY (aching arm that radiates down to elbow). At the time of the report, PAIN (aches), NASAL CONGESTION (stuffy), CHILLS (chills) and PAIN IN EXTREMITY (aching arm that radiates down to elbow) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. It was unknown if the patient experienced any additional symptoms/events.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Illness
Clinical narrative: really sick; weakness; fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (really sick), ASTHENIA (weakness) and FATIGUE (fatigue) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     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 ILLNESS (really sick), ASTHENIA (weakness) and FATIGUE (fatigue). At the time of the report, ILLNESS (really sick), ASTHENIA (weakness) and FATIGUE (fatigue) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-774933 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774933:Reporter's case (Master case)
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Diagnosis of COVID on 15Jan2023 after having received doses of Pfizer and Moderna vaccines (NOS) from 2020 through 2 years ago.) /Sneezing/Coughing; Diagnosis of COVID on 15Jan2023 after having received doses of Pfizer and Moderna vaccines (NOS) from 2020 through 2 years ago.) /Sneezing/Coughing; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-774202 (Moderna).  A female patient received BNT162b2 (BNT162B2), in 2020 as dose 2, single (Batch/Lot number: unknown), in 2020 as dose 1, single (Batch/Lot number: unknown) and in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), in 2022 as dose number unknown (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Food allergy" (ongoing), notes: reactions only last for 24-48 hours; "Pollen allergy" (ongoing), notes: allergies to trees, reactions only last for 24-48 hours. The patient's family history included: "COVID-19" (unspecified if ongoing), notes: Patient lost her mother to COVID whom had at least 3 times tested positive from Oct2020 to Feb2022, and uncle also died of COVID. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jan2023, outcome "recovered" and all described as "Diagnosis of COVID on 15Jan2023 after having received doses of Pfizer and Moderna vaccines (NOS) from 2020 through 2 years ago.) /Sneezing/Coughing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jan2023) Positive. Additional information: Patient was hardly sick with COVID. For Spikevax Nos (Spikevax No) unknown, the reporter considered COVID-19 (Diagnosis of COVID on 15JAN2023 after having received doses of Pfizer and Moderna vaccines (NOS) from 2020 through "2 years ago.")/Sneezing/Coughing) to be not related.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400130003 Same patient, different drug and event.;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she was diagnosed with covid the same day she was to receive her booster; she was diagnosed with covid the same day she was to receive her booster; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 69-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she was diagnosed with covid the same day she was to receive her booster".  Clinical course: Reporter stated that she has previously received all Pfizer Covid-19 vaccines, religiously since Covid started, stated that she was diagnosed with covid the same day she was to receive her booster. Caller stated that it had been 6 months since she had received her last Pfizer Covid-19 vaccine, which was in March or April, and she was due for another one. Caller is asking about the information regarding the 3 month delay that may be considered after a covid infection. Caller is needing to receive a covid vaccine prior to her travel plans on 11Nov.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400130529 same patient, different dose, same event;