chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Fall, Gait disturbance, Loss of consciousness, Muscle spasms
Clinical narrative: Patient was given one shot in each arm, medical personnel left the exam room to get vaccine form, upon returning the patient was starting to stumble, fell to the ground with loss of consciousness and had some minor muscle spasms. Patient awoke within a minute, was provided water, endorsed feeling dizzy. After some resting she was able to stand and walk out of the clinic. We were not informed of any other adverse effects after this event.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2 X 1 CM AREA OF ERYTHEMA AND SWELLING ON RIGHT THIGH
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nasal congestion
Clinical narrative: Approximately 12 hours after the vaccination, I suffered severe chills (had to wear sweatshirt and sweat pants in addition to two blankets to stay warm), headache, abnormal sinus stuffiness, intense pain at site of injection (not present for 10 hours after injection and then gradually increased in intensity), difficulty sleeping and abnormal sleep interruption to urinate--appromiately every one and a half to two hours from 9:30pm until 5:30 am.  Injection site pain and chills began to subside around 3:30am which allowed me to remove sweat clothes.  After awakening my head stuffiness subsided and other than being extremely fatigued from lack of proper sleep, I returned to normal.  NOTE:  These are almost identical symptoms to what I experienced after my second does of the original Moderna Covid vaccine.  first does and subsequent doses had no side effects.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sleep disorder
Clinical narrative: Approximately 12 hours after the vaccination, I suffered severe chills (had to wear sweatshirt and sweat pants in addition to two blankets to stay warm), headache, abnormal sinus stuffiness, intense pain at site of injection (not present for 10 hours after injection and then gradually increased in intensity), difficulty sleeping and abnormal sleep interruption to urinate--appromiately every one and a half to two hours from 9:30pm until 5:30 am.  Injection site pain and chills began to subside around 3:30am which allowed me to remove sweat clothes.  After awakening my head stuffiness subsided and other than being extremely fatigued from lack of proper sleep, I returned to normal.  NOTE:  These are almost identical symptoms to what I experienced after my second does of the original Moderna Covid vaccine.  first does and subsequent doses had no side effects.
Age: 73.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Patient received the vaccination on 9/9 and presented to the pharmacy on 9/12 reporting bilateral shoulder aches and pains as well as bilateral neck pain and decreased range of motion. Concern for Guillain-Barre Syndrome. Told patient to seek medical attention should issue get worse or not get better.
Age: 11.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Per Father child has no adverse reactions to the vaccine for 12 years old and older dose.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Gait disturbance, Impaired work ability
Clinical narrative: I had cognitive difficulties, almost like I imagine a TIA (transient ischemic attack) would cause. I couldn't remember passwords that I typically use multiple times per day. I couldn't figure out how to do things on the computer that I typically do multiple times a day. As my symptoms progressed, I have difficulty putting thoughts together in a coherent way. I work as a physical therapist and I could not read my own note and understand it. My gait was awkward and stiff, as if I couldn't remember how to naturally walk. My symptoms progressed over a period of maybe 5 hours until I had to leave work as I truly couldn't think straight. After resting for a couple of hours, I was 95% better but very tired. Today ( the day after symptoms) I am very tired, but feel 99% cognitively
Age: 80.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Herpes zoster, Pruritus, Skin burning sensation
Clinical narrative: Approximately 9 days after the vaccine I began to have moderately severe burning and itching on the skin of my upper abdomen to the left of my navel in a band that was approximately 2X2 inches.. I did not  develop a rash or blisters. This seemed most compatible with Shinlges ( I am a physician)and my PCP agreed. I continue to have the same symptoms to date (  (Sept 12,2024).. .
Age: 39.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Troponin increased
Clinical narrative: Possible pericarditis with elevated troponin 3 weeks post vaccine
Age: 1.67
Sex: M
Vaccine: DTAPIPV, PNC20
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Incorrect immunization was given.  Patient too young for Quadracel.  No adverse reactions noted.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Mobility decreased, Neck pain
Clinical narrative: Patient received the vaccination 9/9/24 and her husband presented to the pharmacy on 9/12 stating that they had both developed bilateral shoulder pain and neck pain as well as decreased range of motion in the neck. At consultation, Guillain-Barre Syndrome was mentioned and I instructed them to seek medical attention if their pain/decreased range of motion gets worse or does not get better.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patients right leg began to swell the night he received the immunization.  Patient's mother called the clinic on 09/11/2024 to ask the nurse for advice.  She stated that her son's leg has continued to swell from groin to ankle and is warm to the touch.  RN advised the mother that most likely this is an excessive limb swelling reaction from the vaccine and the swelling will subside but if she were concerned to take her son to the ER.  Patient was taken to the emergency room where they were informed that this is excessive limb swelling and were prescribed benadryl allergy (12.5mg/5mL oral liquid).  Father followed up with the clinic on 9/12/2024 and stated that the swelling has begun to go down.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reported have about a 4 inch red swollen location on her left arm where she received the vaccine. She iced the spot yesterday and it is worse today than yesterday. She has been advised to continue ice and if no improvement or worsening to contact her MD.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: Pt described having red inflammation of arm that surrounded the injection site. it spread to about 4 inches in diameter wrapped around the arm. a little itchy and warm to the touch, not painful but bothersome.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 09/09/2024.  Client was notified and will be making an appointment to get another dose that is not expired.
Age: 0.75
Sex: F
Vaccine: FLUC4, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient
Clinical narrative: Patient inadvertently received sibling's HEPATITS A vaccine from Medical Assistant while they were both in the room.  No reactions.
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: C-reactive protein normal, Electrocardiogram normal, Full blood count normal, Generalised tonic-clonic seizure, Magnetic resonance imaging head normal
Clinical narrative: First time tonic clonic seizure lasting 30 seconds one day after Moderna Covid booster without other identifiable cause
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Metabolic function test normal, Troponin normal, Venogram normal
Clinical narrative: First time tonic clonic seizure lasting 30 seconds one day after Moderna Covid booster without other identifiable cause
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Single component of a two-component product administered
Clinical narrative: This variation of Menveo required "diluent" added to primary vial to complete the ACYW combination. The second vial of solution was not added to the first vial, so only partial vaccine was given. No adverse affects noted in client.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Incontinence, Myalgia, Nausea, Pyrexia
Clinical narrative: Starting 6-8 hours after receiving the 2024-2025 Comirnaty vaccine, the patient reports extreme fatigue, nausea, incontinence, fever, and muscle aches persisting at least 24 hours after the vaccine.
Age: 88.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Patient had severe redness and itching at injection site as well as some skin peeling at injection site.  The redness radiated from the injection site halfway down the arm towards the wrist.  patient said the injection site area was painful.
Age: 88.0
Sex: F
Vaccine: PNC20
Symptoms: Skin exfoliation
Clinical narrative: Patient had severe redness and itching at injection site as well as some skin peeling at injection site.  The redness radiated from the injection site halfway down the arm towards the wrist.  patient said the injection site area was painful.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; A MVCC representative transferred a medical assistant onto the line who reported an AE. The HCP said that a 19 year old patient was coming into their office to receive a dose GARDASIL 9. The HCP said the patient received one dose of GARDASIL 9 in 202; This spontaneous report was received from a medical assistant referring to a 19-year-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On an unknown date in 2020, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot number and expiration date not reported) for prophylaxis. On an unknown date in 2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration). No adverse event was reported.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; Customer called and reported that a dose of PROQUAD was administered to a 14-year-old consumer on 10AUG2024. No additional AE reported. No PQC reported. No additional information provided.   PROQUAD: administered to a 14 year old: August 10th X026597; This spontaneous report was received from a medical assistant referring to a 14-year-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 10-AUG-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number X026597, expiration date 11-MAY-2025 (route of administration and dose not provided) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs were reported; Received 1 dose on 6/18/2024 and another dose on 9/5/2024; This spontaneous report was received from a nurse practitioner and refers to a 4-year-old patient of unknown gender.  There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 18-JUN-2024, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (strength, dose, lot #, expiry date, and route of administration were not provided) for prophylaxis.  On 05-SEP-2024, the patient received another dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (strength, dose, lot #, expiry date, and route of administration were not provided) for prophylaxis (Inappropriate schedule of product administration). There was no adverse event reported.  Lot # is being requested and will be submitted if received.
Age: 0.33
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; GARDASIL 9 was administered to a 4 month old.; This spontaneous report has been received from a nurse, regarding to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 09-SEP-2024 ( at 4-month-old) (product administered to patient of inappropriate age), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at 1 dose (1 dosage form), administered as prophylaxis (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not provided).   No additional adverse events were reported in the patient.  Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symtoms reported. No aditional AE; MMR vaccine that expired on 09/08/2024 was administered today (09/10/2024).; This spontaneous report was received from a medical assistant regarding a patient of an unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-SEP-2024 (also reported as "today"), the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) injection, lot# W028735; which have been verified to be valid, expiration date reported and established as 08-SEP-2024 (strength, route and anatomical site of administration were not provided) for prophylaxis. No symptoms and no additional adverse event reported. The medical assistant inquired if the vaccination dose was valid, and reported there were no prior temperature excursions.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC; HCP called to report inadvertent administration of expired PEDVAX HIB to a patient; This spontaneous report was received from  Other Health Professional regarding to a patient of unspecified age and gender (limited patient demographics provided). The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 03-OCT-2022, the patient was vaccinated with an expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, (lot# UJ521AA, which was an invalid lot number for haemophilus b conjugate vaccine [meningococcal protein conjugate] (LIQUID PEDVAXHIB), expiry date reported as : 23-JUL-2022)(dose, strength, and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse event was reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Swelling, Vaccination failure
Clinical narrative: Suspected vaccination failure/got the vaccine, after I come down with shingles; I had shingles in 2017/got the vaccine, after I come down with shingles; pain; itchy bump/the itchy skin; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/got the vaccine, after I come down with shingles) (serious criteria GSK medically significant), shingles (Verbatim: I had shingles in 2017/got the vaccine, after I come down with shingles), pain (Verbatim: pain) and itchy skin (Verbatim: itchy bump/the itchy skin). The outcome of the vaccination failure and shingles were not reported and the outcome of the pain and itchy skin were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and itchy skin 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, pain and itchy skin to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 05-SEP-2024 The case was received from the patient via interactive digital media. The patient got the vaccine, after the patient come down with shingles the 2 dose one like her husband.  The patient had shingles in 2017 and still have pain and every now and then the patient had an itchy bump that appears. The patient was hoping that she did not ever had them again, so painful, still suffer the itchy skin and pain. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. This case has been linked to the US2024AMR111615 case reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccine schedule, clinical description, medical history and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 and 2). US-GSK-US2024AMR111615:same reporter different  patient
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Vaccination failure
Clinical narrative: Suspected vaccination failure; now has them after 3 years down his arm and his hand; His fingers and his hand is numb; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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, 3 years after receiving Shingles vaccine and more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: now has them after 3 years down his arm and his hand) and numbness in hand (Verbatim: His fingers and his hand is numb). The outcome of the vaccination failure and numbness in hand were not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and numbness in hand to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and numbness in hand to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 05-SEP-2024 This case was reported by a patient's wife via interactive digital media. The patient had the Shingles vaccine and he now had them (shingles) after 3 years down his arm and his hand. His finger and hand was numb. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles was unknown at the time of reporting. This case had been linked to the case US2024AMR111612, reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine (Dose 1 and dose 2). US-GLAXOSMITHKLINE-US2024AMR111612:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Shingles; still get periodic pain from it; This serious case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: still get periodic pain from it). The outcome of the vaccination failure was not reported and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-SEP-2024 The patient self-reported this case. The patient had shingles without the rash. It was not diagnosed as shingles, so they still got periodically pain from it. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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 Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: got it really bad on their face and eyes/suspected vaccination failure; Shingles on eye; Shingles on face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: got it really bad on their face and eyes/suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles on eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: Shingles on face). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and facial herpes zoster were not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster to be related to Shingrix.     The company considered the vaccination failure to be related to Shingrix. The company considered the ophthalmic herpes zoster and facial herpes zoster to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 This case was reported by a consumer via interactive digital media. The reporter knew people who had Shingles shot and got it (shingles) really bad on their face and eyes. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix. Ophtalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: patient of ours received a dose yesterday, the product had an expiration date of August 20, 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (expiry date 20-AUG-2024) for prophylaxis.   On 04-SEP-2024, the patient received Shingrix. On 04-SEP-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: patient of ours received a dose yesterday, the product had an expiration date of August 20, 2024). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 05-SEP-2024 The pharmacist reported that a patient of theirs received a dose of Shingrix day before reporting, the product had an expiration date of 20th August 2024 which led to expired vaccine used.  The pharmacist asked for some information on re-vaccination for the patient.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: received her second dose of RSV vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose about one year ago (in 2023) ).   On 03-SEP-2024, the patient received the 2nd dose of Arexvy. On 03-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received her second dose of RSV vaccine). The outcome of the extra dose administered was not reported.   Additional Information: GSK Receipt Date: 03-SEP-2024 The reporter reported that the patient received her second dose of Arexvy on the day of reporting, which led to extra dose administered. The reporter believed this would count as a missed dose. She did not know who was the manufacturer for Arexvy vaccine one year ago.
Sex: F
Vaccine: RVX
Symptoms: Fatigue, Headache, Illness, Nausea, Tinnitus
Clinical narrative: sick; fatigue; headaches; Ear pounding; nausea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a elderly female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: sick), fatigue (Verbatim: fatigue), headache (Verbatim: headaches), ear noises (Verbatim: Ear pounding) and nausea (Verbatim: nausea). The outcome of the sickness, fatigue, headache, ear noises and nausea were not reported.   It was unknown if the reporter considered the sickness, fatigue, headache, ear noises and nausea to be related to RSV vaccine.     It was unknown if the company considered the sickness, fatigue, headache, ear noises and nausea to be related to RSV vaccine.   Additional Information: GSK receipt date: 01-SEP-2024 This case was reported by a patient via interactive digital media. The patient reported that she and her husband had received RSV vaccine and experienced sick, intense fatigue, headaches ear pounding and nausea. The reporter mentioned that they was 76 and 80s. The reporter mentioned it was terrible more responsible research must be initiated. This case had been link with US2024AMR110396, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: blisters on torso/back on right side; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of blister in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 15 years ago) and blister.   On an unknown date, the patient received Shingles vaccine. On 31-AUG-2024, an unknown time after receiving Shingles vaccine, the patient experienced blister (Verbatim: blisters on torso/back on right side). The patient was treated with diazepam;isopropamide iodide (Valtrax). The outcome of the blister was not resolved.   It was unknown if the reporter considered the blister to be related to Shingles vaccine.     It was unknown if the company considered the blister to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-SEP-2024 This case was reported by a patient via interactive digital media. The patient had shingles 15 years ago in left ear/neck. The patient had a single shot after the first round of symptoms. Physician prescribed Valtrax and 2 days before reporting. The patient apparently had a second of blisters on torso/back on the right side. The patient questioned what was the treatment for this apparently ongoing issues. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Hepatitis A virus test positive, Incomplete course of vaccination, Vaccination failure
Clinical narrative: Suspected vaccination failure; tested positive for Hepatitis A; Potential late for 3rd dose of Engerix B; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 50-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 2 doses in 2017).   On an unknown date, the patient received the 1st dose of Havrix and did not receive the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Havrix and not applicable after receiving Engerix B, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), hepatitis a (Verbatim: tested positive for Hepatitis A) and incomplete course of vaccination (Verbatim: Potential late for 3rd dose of Engerix B). The outcome of the vaccination failure was not reported and the outcome of the hepatitis a was not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the vaccination failure and hepatitis a to be related to Havrix and Havrix Pre-Filled Syringe Device.     The company considered the vaccination failure to be related to Havrix, Havrix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device. It was unknown if the company considered the hepatitis a to be related to Havrix and Havrix 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: 03-SEP-2024 The pharmacist reported that in 2017, he needed to be vaccinated for Hepatitis A and Hepatitis B before he could leave. At that time, she was at the pharmacy manager so he had gotten his 1st shot of Havrix and then the first 2 of Engerix-B vaccine and had on his calendar on 23rd October 2017 that he was to get his 2nd shot of Havrix and 3rd of Engerix-B.  The state monitor did not have any record that he did, that he got it and have no evidence to support that he got it and due to a blood test that he got the other day and he now tested positive for Hepatitis A. The reporter also mentioned failure of Hepatitis B vaccine (Engerix-B). Till the time of reporting, the patient did not receive 3rd dose of Engerix B, which led to incomplete course of vaccination. This case was considered as suspected vaccination failure since the details regarding the time to onset of hepatitis A were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Havrix, Havrix PRE-FILLED SYRINGE DEVICE, Engerix B and Engerix B PRE-FILLED SYRINGE DEVICE.
Sex: U
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: another dose of Boostrix was administered June 21st of 2024 by mistake; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Boostrix (received on March 2024).   On 21-JUN-2024, the patient received Boostrix. On 21-JUN-2024, an unknown time after receiving Boostrix, the patient experienced drug dose administration interval too short (Verbatim: another dose of Boostrix was administered June 21st of 2024 by mistake). The outcome of the drug dose administration interval too short 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: 03-SEP-2024 Reporter stated that they are the patient.   The patient reported a dose of Boostrix was administered to them in the beginning of March 2024.   Then another dose of Boostrix was administered by mistake, which led to shortening of vaccination schedule. States he knows the name of the vaccine because it was written on a piece of paper from the pharmacy.   The patient also stated, did not want to give any information because was feeling fine. Did not consent to follow-up.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 6-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 25L32, expiry date 08-MAR-2025) for prophylaxis.   On 27-AUG-2024, the patient received the 1st dose of Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: Vaccine administered after temperature excursion). 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: 03-SEP-2024 The Pediarix vaccine was administered to a patient after it experienced a temperature excursion below the normal range down to  minus 7.6 degree Celsius, which led incorrect storage of drug. The reporter mentioned that the patient received a prior dose of a sanofi vaccine back on 15th June 2018 but brand name was unknown. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has been 5 years since a patient's first dose of Shingrix/inappropriate schedule of vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has been 5 years since a patient's first dose of Shingrix/inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-SEP-2024 The pharmacist reported that the patient had not receive 2nd dose yet. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: gave a patient a Shingrix vaccine yesterday that expired on 8/5/24; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 3A3TC, expiry date 05-AUG-2024) for prophylaxis.   On 03-SEP-2024, the patient received Shingrix. On 03-SEP-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: gave a patient a Shingrix vaccine yesterday that expired on 8/5/24). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 04-SEP-2024 The reporter was office manager. The patient gave a Shingrix that expired, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain
Clinical narrative: pain in her left axillary/ arm pit pain; This non-serious case was reported by a nurse via call center representative and described the occurrence of axillary pain in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 4N9PF, expiry date 12-DEC-2025) for prophylaxis.   On 06-AUG-2024, the patient received the 1st dose of Shingrix (injection, left deltoid). In AUG-2024, 1 week after receiving Shingrix, the patient experienced axillary pain (Verbatim: pain in her left axillary/ arm pit pain). The patient was treated with ibuprofen. The outcome of the axillary pain was not resolved.   It was unknown if the reporter considered the axillary pain to be related to Shingrix.     It was unknown if the company considered the axillary pain to be related to Shingrix.   Additional Information: GSK receipt date: 05-SEP-2024 The patient had pain in her left axillary 1 week after receiving suspect product that has not resolved.   The patient had been taking Ibuprofen 800mg PO with negative pain relief.   The reporter had seen a physician and no diagnosis had been made. The lady spoke was very helpful and trying to find out the reason for the arm pit pain. Did not consent to follow-up.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: Vaccine Exposure During Pregnancy; was administered a 23-24 Fluarix (expired); This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 5ME77, expiry date 30-JUN-2024) for prophylaxis.   On 04-SEP-2024, the patient received Fluarix Quadrivalent 2023-2024 season. On 04-SEP-2024, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced expired vaccine used (Verbatim: was administered a 23-24 Fluarix (expired)). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Vaccine Exposure During Pregnancy). The outcome of the vaccine exposure during pregnancy and expired vaccine used were unknown.   Pregnancy exposure: Gestation time at first exposure (Fluarix Quadrivalent 2023-2024 season): 21 Weeks Pregnancy Exposure (Fluarix Quadrivalent 2023-2024 season): To mother in second trimester Estimated Delivery/Due date: 15-JAN-2025 Pregnancy Outcome: Pregnancy was ongoing   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: 05-SEP-2024 The reporter calling because a prenatal patient inadvertently was administered a 23-24 Fluarix (expired), which led to vaccine exposure during pregnancy and expired vaccine used.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event following immunisation, COVID-19 immunisation, Heart rate, Interchange of vaccine products
Clinical narrative: She first had Moderna covid vaccine in 2021, it didn't work well; She first had Moderna covid vaccine in 2021, it didn't work well, switched to Pfizer; She first had Moderna covid vaccine in 2021, it didn't work well, switched to Pfizer; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (She first had Moderna covid vaccine in 2021, it didn't work well), COVID-19 IMMUNISATION (She first had Moderna covid vaccine in 2021, it didn't work well, switched to Pfizer) and INTERCHANGE OF VACCINE PRODUCTS (She first had Moderna covid vaccine in 2021, it didn't work well, switched to Pfizer) in a 5-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (She first had Moderna covid vaccine in 2021, it didn't work well), COVID-19 IMMUNISATION (She first had Moderna covid vaccine in 2021, it didn't work well, switched to Pfizer) and INTERCHANGE OF VACCINE PRODUCTS (She first had Moderna covid vaccine in 2021, it didn't work well, switched to Pfizer). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (She first had Moderna covid vaccine in 2021, it didn't work well), COVID-19 IMMUNISATION (She first had Moderna covid vaccine in 2021, it didn't work well, switched to Pfizer) and INTERCHANGE OF VACCINE PRODUCTS (She first had Moderna covid vaccine in 2021, it didn't work well, switched to Pfizer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: went up too high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.  It was reported that the patient had cardiac effects from Pfizer Covid 19 vaccine. Patient's heart rate went up too high. Patient first had Moderna Covid vaccine in 2021, and it did not work well, then switched to Pfizer, for second dose, and after that switched to Novavax vaccine which did not cause the heart rate to go up. Patient was in mid to late 40's.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Chills, Extra dose administered, Fatigue, Headache
Clinical narrative: sick; fatigue; muscle aches; headaches; chills / teeth chattering; Her first dose ever was Pfizer in 2021, but every dose after that was Moderna; Her first dose ever was Pfizer in 2021, but every dose after that was Moderna; She said that is why she has stuck with Moderna and has gotten everything (every vaccine) plus her 'unauthorized one'; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sick), FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches) and CHILLS (chills / teeth chattering) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1) in September 2021. Past adverse reactions to the above products included No adverse effect with Pfizer vaccine.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches), CHILLS (chills / teeth chattering), INTERCHANGE OF VACCINE PRODUCTS (Her first dose ever was Pfizer in 2021, but every dose after that was Moderna), COVID-19 IMMUNISATION (Her first dose ever was Pfizer in 2021, but every dose after that was Moderna) and EXTRA DOSE ADMINISTERED (She said that is why she has stuck with Moderna and has gotten everything (every vaccine) plus her 'unauthorized one'). At the time of the report, ILLNESS (sick) had resolved and FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches), CHILLS (chills / teeth chattering), INTERCHANGE OF VACCINE PRODUCTS (Her first dose ever was Pfizer in 2021, but every dose after that was Moderna), COVID-19 IMMUNISATION (Her first dose ever was Pfizer in 2021, but every dose after that was Moderna) and EXTRA DOSE ADMINISTERED (She said that is why she has stuck with Moderna and has gotten everything (every vaccine) plus her 'unauthorized one') outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-773529 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773529:Same patient different product (Spikevax 2023-2024 XBB.1.5)
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Interchange of vaccine products, Myalgia
Clinical narrative: sick; fatigue; muscle aches; headaches; chills / teeth chattering; Her first dose ever was Pfizer in 2021, but every dose after that was Moderna; Her first dose ever was Pfizer in 2021, but every dose after that was Moderna; She said that is why she has stuck with Moderna and has gotten everything (every vaccine) plus her 'unauthorized one'; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sick), FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches) and CHILLS (chills / teeth chattering) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1) in September 2021. Past adverse reactions to the above products included No adverse effect with Pfizer vaccine.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches), CHILLS (chills / teeth chattering), INTERCHANGE OF VACCINE PRODUCTS (Her first dose ever was Pfizer in 2021, but every dose after that was Moderna), COVID-19 IMMUNISATION (Her first dose ever was Pfizer in 2021, but every dose after that was Moderna) and EXTRA DOSE ADMINISTERED (She said that is why she has stuck with Moderna and has gotten everything (every vaccine) plus her 'unauthorized one'). At the time of the report, ILLNESS (sick) had resolved and FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches), CHILLS (chills / teeth chattering), INTERCHANGE OF VACCINE PRODUCTS (Her first dose ever was Pfizer in 2021, but every dose after that was Moderna), COVID-19 IMMUNISATION (Her first dose ever was Pfizer in 2021, but every dose after that was Moderna) and EXTRA DOSE ADMINISTERED (She said that is why she has stuck with Moderna and has gotten everything (every vaccine) plus her 'unauthorized one') outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-773529 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773529:Same patient different product (Spikevax 2023-2024 XBB.1.5)