chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: TYP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Urticaria limited to both forearms, onset several hours after receiving vaccine, still present 7 days after onset. Has been self-treating with topical and oral diphenhydramine, which temporarily relieves itching but has not improved the rash. Starting topical steroid cream today.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Developed Bells Palsy
Age: 78.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Erythema, Pain, Paraesthesia, Swelling
Clinical narrative: The patient had received the COVID vaccine several times previously with no adverse reaction and one dose of Shingrix with no adverse reaction. She received the COVID vaccine approx. 15 minutes prior to receiving the Shingrix dose and her reaction started within a couple minutes following the Shingrix dose . So we attribute her reaction to the Shingrix dose. Her reaction was a tingling/stinging sensation on her left arm with redness and some swelling. The reaction didn't worsen after observing the patient for another 15 minutes. The patient was told to follow up with us if anything worsened and to manage symptoms with OTC antihistamines.
Age: 87.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: RED AND ITCHY AREA ON THE ADMINISTRATION SITE
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: severe nausea, headache, dizzy, took more zofran
Age: 89.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: rash on both arms, torso and thighs. Has taken an antihistamine. No issues with breathing. Patient has had all COVID vaccines to date so I believe this is booster #5.
Age: 32.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered
Clinical narrative: During a mobile vaccination event, client stated that he had received one dose of Jynneos "about two years ago". Another dose was given to complete the series. However, upon checking Alert back at the office it was discovered that client had already received two doses in 2022 thus making this one the third (invalid) dose.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Device connection issue, Syringe issue, Underdose
Clinical narrative: Needle was not properly secured to the prefilled syringe upon administration. Contents of syringe were mostly wasted. A second vaccine was given in the other arm.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: No adverse reaction
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Given at Pharmacy,  Not dr's office
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood test normal, Encephalitis, Lumbar puncture normal, Mental status changes, Pyrexia
Clinical narrative: He developed fever and altered mental status. He was Diagnosed with Encephalitis. Stayed at the hospital for 7 days.
Age: 71.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events noted by patient but patient received 2 seasonal flu shots this year.  One shot (FLUAD)was given on 8/3/24 and the second one (FLUAD) was given on 9/3/24. Patient said he had no issues.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Client was given two doses of Fluarix two weeks apart
Age: 25.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccine given
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: Fever, acute body pains, headache, diarrhea
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: Currently pregnant with due date of 11/29/24.  Received Tdap vaccine at 28 weeks.  Vaccine had been stored in a refrigerator that had gotten too cold overnight so vaccine was non-viable.
Age: 74.0
Sex: M
Vaccine: COVID19-2, RSV
Symptoms: Arthralgia, Asthenia, Back pain, Headache, Pain
Clinical narrative: Overall body ache (5 to 6 on a scale of 10) , slight head ache, some weakness, some joint and back pain (beyond normal.)   I have had COVID-19 vaccines for the last four years, and only side effect has been a sore arm for a day or two.  This is the first time that I have had RSV vaccine.
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient had already received a dose of Prevnar 20 on 03/02/2023 and was given a repeat dose on 04/05/2024 by accident.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event, Product administration error
Clinical narrative: Pt was administered second dose of RSV - Arexvy in error on 8/27/2024.  It was not realized at the time of vaccine administration that she had received a prior dose on 9/16/2023.  The manufacturer was contacted.  The patient was contacted about the error - receiving second dose when only one dose is currently indicated.  Pt denied any adverse reactions to the immunization.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: C-reactive protein, Full blood count, Gait disturbance, Injection site pain, Pain in extremity
Clinical narrative: Pt complaining of leg pain bilaterally and has not been walking as much. Patient also seems to be limping.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Red blood cell sedimentation rate, X-ray limb
Clinical narrative: Pt complaining of leg pain bilaterally and has not been walking as much. Patient also seems to be limping.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was due for MMR #2, I administered MMR that was expired, Pt was informed & will get repeat MMR #2 in 4 weeks to meet school requirements, Pt felt well and agreed to f/u plan, he felt well, had no adverse effects
Age: 60.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient was given a Prevnar 20 on 04/25/2024.  Patient had already had a Prevnar 13 on 11/08/2016.  This dose was not needed.  Nurse did not know that patient had had a Prevnar 13 on 11/08/2016.   This is incident occurred before it was mandatory for clerical to include a copy of the flow sheet in the chart.  So Prevnar 13 was not on the patient's  screen in system.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Vaccination error
Clinical narrative: Per PCP review Please call pt's parents and relay the information regarding the mistake in vaccination during today's visit. I do not anticipate any significant adverse reactions. Recommend monitoring for next 24-48 hours and if any concerns, call the office or proceed to ER.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Disorientation, Loss of consciousness, Pallor
Clinical narrative: Patient was sitting on parent's lap for vaccine administration. Was given MenACWY immunization first, then HPV was administered in same arm at a separate inj. site. Pt began to lose consciousness. Mother was able to keep patient in her arms and prevent her from falling or injuring herself. She regained consciousness less than 1 minute after episode began - did "jump" and startle briefly, was pale and slightly disoriented. Myself and another nurse were able to assist mother in transfering patient from her lap to the exam table that was only 1 foot away. Patient was able to lay and was given water and a wet wash cloth. Tdap was given in right arm after pt was feeling better - remained laying while administered. Was able to remain laying down and resting under supervision roughly 30 minutes before leaving office independently and feeling back to normal.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: NO ADVERSE REACTION VACCINE WAS MIXED WITH A DIFFERNT DILUENT SPOKE WITH GSK MFG OF THE MENVEO THEY ADVISED US PER CDC RECOMMENDATION TO REDOSE THE PATIENT AS THERE IS NO SAFTEY ISSUE WITH IT IT WAS NOT THE FULL COVERAGE AS THE POWDER PART HAD ONLY THE A PART OF TE VACCINE AND THE REST OF IT WAS SITTING IN THE DILUENT
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Intermenstrual bleeding, Laboratory test abnormal, Menopause
Clinical narrative: Spotting after injections, after further testing because I was lot feeling ?right? tests confirm I am in menopause
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Swelling
Clinical narrative: Small bump on the right arm, incredibly painful. Happened within 10 minutes of receiving the vaccine. patient tried taking APAP
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: AFTER VACCINATION, NOTED THAT EXPIRED VACCINE GIVEN.  CONTACTED CLIENT'S MOTHER AND INFORMED OF EXPIRED VACCINE DOSE GIVEN AND RECOMMENDATION TO REPEAT DOSE. CLIENT MOTHER WILL REACH OUT TO CLIENT'S PEDIATRICIAN FOR GUIDANCE ON WHEN TO REPEAT DOSE
Age: 77.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Sensory disturbance
Clinical narrative: PT STATES HER LIPS FEEL LIKE THEY HAVE BLISTERS, BUT WHEN SHE TOUCHES THEM THERE ARE NO LUMPS OR SWELLING EVIDENT
Age: 69.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Back pain, Neck pain
Clinical narrative: neck pain the night of the vaccine, following morning and everyday since pt. has had neck and back pain
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Neuralgia, Pain in extremity
Clinical narrative: When patient came back today to get her next COVID vaccine (the new 24-25 version) she mentioned that with her last COVID vaccine about a year ago, she felt like the immunizer hit a nerve. Per patient, the nerve going into her pinky became painful, and her arm experienced some pain and numbness that is still in the process of improving. She can still point to the injection site because she says it still hurts sometimes. According to where she's pointing, it may have been administered too far to the side of the deltoid, more towards the back of the arm. She did say she asked her doctor about it at her next usual visit and they agreed that the immunizer probably hit a nerve. She says it is improving, but is still somewhat there.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Notification from Department of Health on 8/26/24 stated that from 8/22/24, current 2023-2024 COVID vaccine should not be administered anymore due to the recent approval of new COVID vaccine formulation that is not yet available. Any doses given after 8/22/24 was requested to be reported to VAERS. Patient received the 2023-2024 Pfizer COVID vaccine on 8/25/24.  Patient did not have any allergic or adverse event from the vaccine.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Scab
Clinical narrative: Pt reports have an extended reaction of an unknown breakout all over her body, does not describe it as hives or shingles. They have crusted over at this time and is taking Benadryl. In consult with immunology at this time.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Haematochezia
Clinical narrative: Bloody stool - bright red steaks/globs of blood mixed into normal yellow/seedy baby stool. Mild degree of illness. Most consistent with an infant milk protein colitis; but timing is concerning for vaccine reaction, especially with regards to rotavirus vaccine.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A nurse accidentally administered PROQUAD instead of MMR II and VARIVAX to a 14 year old male patient.; No additional AE reported.; This spontaneous report was received from a medical assistance via company representative and referred to a 14-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was accidentally vaccinated by a nurse with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), which was administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (indication: prophylaxis) (Wrong product administered). No additional adverse event (AE) details were available, no additional AE reported (No adverse event), no product quality complaint (PQC).  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; a patient received ROTATEQ after its labeled expiration date (05/24/2024); This spontaneous report was received from a nurse and refers to a 4-month-old female patient. Her medical history, concomitant medications, concurrent conditions, drug reactions and allergies were not provided.  On 30-MAY-2024, the patient was vaccinated  with expired dose of a rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, orally,  lot #1947642, expiration date: 26-MAY-2024, (strength was not provided) for prophylaxis (Expired product administered). The vaccine did not undergo a temperature excursion. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles 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 to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 29-AUG-2024  This case was reported by a patient via interactive digital media. The patient received two doses of the shingles vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding 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 (1st dose)and Shingrix(2nd dose)
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; on my 5th week with shingles; 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 (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) and shingles (Verbatim: on my 5th week with shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 The case was received from the patient via interactive digital media. The patient self reported this case for himself/herself. The patient had the shingles vaccine, 2 shots. The patient was on his/her 5th week with shingles.  The patient reported it was not pretty. This case was considered as suspected vaccination failure as details regarding 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 (1st dose)and Shingrix(2nd dose).
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Neuralgia, Pain in extremity, Paraesthesia, Rash
Clinical narrative: Itchy rash all over legs, back, arms, bust,; stomach with tingling; nerve endings hurt and this just seems to keep spreading.; pain/nerve ending hurt and this just seems to keep spreading because it is spreading down my arms.; upset; disappointed; This non-serious case was reported by a consumer and described the occurrence of itchy rash in a 51-year-old female patient who received Herpes zoster (Zoster vaccine) for prophylaxis.   Concurrent medical conditions included cholesterol. Concomitant products included rosuvastatin calcium (Crestor).   On 30-JUL-2024, the patient received the 2nd dose of Zoster vaccine. On 08-AUG-2024, 9 days after receiving Zoster vaccine, the patient experienced itchy rash (Verbatim: Itchy rash all over legs, back, arms, bust,), tingling (Verbatim: stomach with tingling), nerve pain (Verbatim: nerve endings hurt and this just seems to keep spreading.) and pain in arm (Verbatim: pain/nerve ending hurt and this just seems to keep spreading because it is spreading down my arms.). In AUG-2024, the patient experienced emotional distress (Verbatim: upset) and frustration (Verbatim: disappointed). The patient was treated with ibuprofen (Advil). The outcome of the itchy rash, tingling, nerve pain and pain in arm were not resolved and the outcome of the emotional distress and frustration were not reported.   It was unknown if the reporter considered the itchy rash, tingling, nerve pain, pain in arm, emotional distress and frustration to be related to Zoster vaccine.     It was unknown if the company considered the itchy rash, tingling, nerve pain, pain in arm, emotional distress and frustration to be related to Zoster vaccine.   Additional Information: GSK Receipt Date: 25-AUG-2024 The patient self-reported this case. The received her second shingles vaccine (Zoster vaccine) as a preventive measure and now she was in pain, constantly itchy, at times her nerve endings hurted and that just seemed kept spreading.  The patient was so disappointed and upset and did not knew what to do.  It looked horrible too because it was spreading down her arms and did not knew what to do. The patient received Advil and Crestor drugs and was ongoing The patient experienced itchy rash all over legs, back, arms, bust, stomach with tingling and pain and was ongoing. The reporter consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Itchy rash all over legs, back, arms, bust,; stomach with tingling; nerve endings hurt and this just seems to keep spreading.; pain/nerve ending hurt and this just seems to keep spreading because it is spreading down my arms.; upset; disappointed; This non-serious case was reported by a consumer and described the occurrence of itchy rash in a 51-year-old female patient who received Herpes zoster (Zoster vaccine) for prophylaxis.   Concurrent medical conditions included cholesterol. Concomitant products included rosuvastatin calcium (Crestor).   On 30-JUL-2024, the patient received the 2nd dose of Zoster vaccine. On 08-AUG-2024, 9 days after receiving Zoster vaccine, the patient experienced itchy rash (Verbatim: Itchy rash all over legs, back, arms, bust,), tingling (Verbatim: stomach with tingling), nerve pain (Verbatim: nerve endings hurt and this just seems to keep spreading.) and pain in arm (Verbatim: pain/nerve ending hurt and this just seems to keep spreading because it is spreading down my arms.). In AUG-2024, the patient experienced emotional distress (Verbatim: upset) and frustration (Verbatim: disappointed). The patient was treated with ibuprofen (Advil). The outcome of the itchy rash, tingling, nerve pain and pain in arm were not resolved and the outcome of the emotional distress and frustration were not reported.   It was unknown if the reporter considered the itchy rash, tingling, nerve pain, pain in arm, emotional distress and frustration to be related to Zoster vaccine.     It was unknown if the company considered the itchy rash, tingling, nerve pain, pain in arm, emotional distress and frustration to be related to Zoster vaccine.   Additional Information: GSK Receipt Date: 25-AUG-2024 The patient self-reported this case. The received her second shingles vaccine (Zoster vaccine) as a preventive measure and now she was in pain, constantly itchy, at times her nerve endings hurted and that just seemed kept spreading.  The patient was so disappointed and upset and did not knew what to do.  It looked horrible too because it was spreading down her arms and did not knew what to do. The patient received Advil and Crestor drugs and was ongoing The patient experienced itchy rash all over legs, back, arms, bust, stomach with tingling and pain and was ongoing. The reporter consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: experienced a sore arm for several days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: experienced a sore arm for several days). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 This case was reported the patient via (social media) interactive digital media. The patient mentioned that after receiving the vaccine he/she experienced a sore arm for several days. The patient stated that was for him/her.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: they do not have BEXSERO and administered MENVEO instead; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 24-AUG-2024, the patient received the 1st dose of Menveo. On 24-AUG-2024, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: they do not have BEXSERO and administered MENVEO instead). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 26-AUG-2024  The patient's grandmother states that they went to get Bexsero for her granddaughter who was collegebound. The pharmacy did not inform them they did not have Bexsero and administered Menveo instead, which led wrong vaccine administered. The reporter did not consent to follow-up.
Sex: U
Vaccine: HIBV
Symptoms: Intercepted product prescribing error
Clinical narrative: order Hiberix for our adult oncology pts; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of intercepted product prescribing error in an unspecified number of patients who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient did not receive Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced intercepted product prescribing error (Verbatim: order Hiberix for our adult oncology pts). The outcome of the intercepted product prescribing error was unknown.   Additional Information: GSK Receipt Date: 26-AUG-2024 The pharmacist had a question regarding Hiberix.  The pharmacist was asked by their oncology department to order Hiberix for their adult oncology patients. The pharmacist ordered from their supplier but the box stated for use from 6 years through 4 years of age which led to intercepted product prescribing error. The pharmacist asked was this the same for adults or was there an adult formulation. No further details are available to Medical Information team.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient had only the first dose of Shingrix in August 2021; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in August 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient had only the first dose of Shingrix in August 2021). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-AUG-2024 The pharmacy intern stated that at the time of the call, the 2nd dose had not been administered, but regardless of that, due to the Shingrix dosing schedule, the 2nd dose should be administered 2 to 6 months after the 1st dose, so the dose was already late, whether it was given or not. So it was an adverse event for inappropriate dosing schedule. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter.
Age: 8.0
Sex: M
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Twinrix to an 8 year-old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received HAB (Twinrix) (batch number 2PG39, expiry date 19-SEP-2025) for prophylaxis.   On 28-JUN-2024, the patient received Twinrix. On 28-JUN-2024, an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Twinrix to an 8 year-old patient). 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: 28-AUG-2024 Health Care professional (HCP) called to report the administration of Twinrix to an 8 year-old patient, which led to inappropriate age at vaccine administered. HCP asked for recommendations on this situation. Consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Incorrect dose administered, Injection site discharge
Clinical narrative: vaccine came "weeping" out of the patient; Accidental exposure to product; incomplete dose- possible; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of exposure via skin contact in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number X333C, expiry date 19-JUN-2026) for prophylaxis.   On 26-AUG-2024, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 26-AUG-2024, an unknown time after receiving Shingrix, the patient experienced exposure via skin contact (Verbatim: vaccine came "weeping" out of the patient), accidental exposure to product (Verbatim: Accidental exposure to product) and incomplete dose administered (Verbatim: incomplete dose- possible). The outcome of the exposure via skin contact and accidental exposure to product were not reported and the outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 28-AUG-2024 The reporter reported that she administered Shingrix, but that some of the reconstituted vaccine came weeping out  of the patient during the injection, which led to incomplete dose administered and accidental skin exposure. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient has not yet received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on October 2023).   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: The patient has not yet received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-AUG-2024 The patient received the first dose of Shingrix but had not yet received the second dose, which led to incomplete course of vaccination.  Did not consent to follow-up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Vaccination failure
Clinical narrative: RETURN A FEW MONTHS LATER; I HAVE NOW HAD 4 VACCINES; COVID; This spontaneous report received from a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. Non-company suspect vaccine included: elasomeran (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis; and tozinameran ( form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported, and dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported. The patient had Long Covid for the past three and a half years. The patient had 4 vaccines (J&J, Moderna, and 2 Pfizer) (coded as covid-19 immunisation) (Dose in series 1) and all of them had presented similar results and all symptoms resolved within two weeks, but then returned a few months later (coded as Vaccination failure), (Dose in series 1) and covid-19 (Dose in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the return a few months later, i have now had 4 vaccines and covid was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: Vaccination failure. The event is a special reporting situation and owing to its own nature, it is not possible to attribute this occurrence to the suspect drug. Hence, the causality is considered INCONSISTENT with vaccine administration.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic steatosis, Influenza like illness
Clinical narrative: fatty liver; Flu like symptoms; This spontaneous case was reported by a patient and describes the occurrence of HEPATIC STEATOSIS (fatty liver) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A, 033321A and 045J12A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEPATIC STEATOSIS (fatty liver) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, HEPATIC STEATOSIS (fatty liver) and INFLUENZA LIKE ILLNESS (Flu like symptoms) was resolving.            No concomitant medication was reported. The caller stated to be healthy prior to receiving the last dose. The caller further elaborated that the caller was not on medication, not drinking, and not eating unhealthily. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-773179 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773179:Same patient different dose (Spikevax NOS Case)
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: felt crappy for a day and a half with two days of fever; felt crappy for a day and a half with two days of fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt crappy for a day and a half with two days of fever) and PYREXIA (felt crappy for a day and a half with two days of fever) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 80777-0102-96) for COVID-19 prophylaxis.     The patient's past medical history included Hypoxic, Comatose on 31-Mar-2020 and COVID-19. Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 1) on 10-Feb-2021, Moderna covid-19 vaccine (Dose 2) on 11-Mar-2021, Moderna covid-19 vaccine (Dose 3, a full vaccine dose instead of a booster because of the comorbidity) on 12-Oct-2021, Moderna covid-19 vaccine (Dose 4) on 15-Apr-2022, Moderna covid-19 vaccine (Dose 5) on 12-Sep-2022 and Moderna covid-19 vaccine (Dose 6) on 14-Aug-2023. Past adverse reactions to the above products included No adverse effect with Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine.    On 17-Nov-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt crappy for a day and a half with two days of fever) and PYREXIA (felt crappy for a day and a half with two days of fever). At the time of the report, MALAISE (felt crappy for a day and a half with two days of fever) and PYREXIA (felt crappy for a day and a half with two days of fever) had resolved.            Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that patient felt crappy for a day and a half with two days of fever.  Treatment information was not provided.  Reporter causality was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747062 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747062:same reporter husband case
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: hellishly excruciatingly painful; fever of 102.9; chills; painful burning, It was injected into her left arm; super bad headaches; experienced a lot of fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN (hellishly excruciatingly painful), PYREXIA (fever of 102.9), FATIGUE (experienced a lot of fatigue), CHILLS (chills) and HEADACHE (super bad headaches) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PAIN (hellishly excruciatingly painful), PYREXIA (fever of 102.9), FATIGUE (experienced a lot of fatigue), CHILLS (chills), HEADACHE (super bad headaches) and VACCINATION SITE PAIN (painful burning, It was injected into her left arm). At the time of the report, PAIN (hellishly excruciatingly painful), PYREXIA (fever of 102.9) and VACCINATION SITE PAIN (painful burning, It was injected into her left arm) outcome was unknown, FATIGUE (experienced a lot of fatigue) and HEADACHE (super bad headaches) had resolved and CHILLS (chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: fever of 102.9.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient felt like she had been ran over by a train but the fever was the worst part. She stated that for 24 hours after these vaccines, she experienced a lot of fatigue and super bad headaches. She stated it would last 8 hours. She would get chills in the morning around 9am and start feeling better around 4-5pm that afternoon. For her second dose specifically, she experienced ' hellishly excruciatingly painful and she thought she was going to faint.' She states that it was not a great experience and made her 'gun shy'. She thought that the pharmacist may have chosen the wrong needle and chose an 'incredibly large needle'. She stated that she doesn't believe it was Moderna's product but that it was the pharmacist's technique. She states it was painful all the way through, coming in and out she experienced painful burning. It was injected into her left arm No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-773265 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773265:Same patient with different product
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: hellishly excruciatingly painful; fever of 102.9; chills; painful burning, It was injected into her left arm; super bad headaches; experienced a lot of fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN (hellishly excruciatingly painful), PYREXIA (fever of 102.9), FATIGUE (experienced a lot of fatigue), CHILLS (chills) and HEADACHE (super bad headaches) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PAIN (hellishly excruciatingly painful), PYREXIA (fever of 102.9), FATIGUE (experienced a lot of fatigue), CHILLS (chills), HEADACHE (super bad headaches) and VACCINATION SITE PAIN (painful burning, It was injected into her left arm). At the time of the report, PAIN (hellishly excruciatingly painful), PYREXIA (fever of 102.9) and VACCINATION SITE PAIN (painful burning, It was injected into her left arm) outcome was unknown, FATIGUE (experienced a lot of fatigue) and HEADACHE (super bad headaches) had resolved and CHILLS (chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: fever of 102.9.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient felt like she had been ran over by a train but the fever was the worst part. She stated that for 24 hours after these vaccines, she experienced a lot of fatigue and super bad headaches. She stated it would last 8 hours. She would get chills in the morning around 9am and start feeling better around 4-5pm that afternoon. For her second dose specifically, she experienced ' hellishly excruciatingly painful and she thought she was going to faint.' She states that it was not a great experience and made her 'gun shy'. She thought that the pharmacist may have chosen the wrong needle and chose an 'incredibly large needle'. She stated that she doesn't believe it was Moderna's product but that it was the pharmacist's technique. She states it was painful all the way through, coming in and out she experienced painful burning. It was injected into her left arm No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-773265 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773265:Same patient with different product
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Food allergy, Migraine, Vomiting
Clinical narrative: About once a week I would experience severe vomiting and later found out that I can no longer eat anything that contains eggs after getting the vaccine.; About once a week I would experience severe vomiting; Migraines; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Migraines), FOOD ALLERGY (About once a week I would experience severe vomiting and later found out that I can no longer eat anything that contains eggs after getting the vaccine.) and VOMITING (About once a week I would experience severe vomiting) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 08-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (Migraines). On an unknown date, the patient experienced FOOD ALLERGY (About once a week I would experience severe vomiting and later found out that I can no longer eat anything that contains eggs after getting the vaccine.) and VOMITING (About once a week I would experience severe vomiting). At the time of the report, MIGRAINE (Migraines) had not resolved and FOOD ALLERGY (About once a week I would experience severe vomiting and later found out that I can no longer eat anything that contains eggs after getting the vaccine.) and VOMITING (About once a week I would experience severe vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       Concomitant medication was not provided. Patient reported that after receiving the first dose, she began getting migraines one day after. They would last for days at a time then go away for a few days. Additionally, about once a week she would experience severe vomiting and later found out that she can no longer eat anything that contains eggs after getting the vaccine. That day she still experienced both of those symptoms. She also reported that prior to receiving the vaccine she never had even a minor headache nor had any issues eating eggs.  Treatment information was not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Vocal cord paralysis
Clinical narrative: having a difficult time talking; Left vocal cord closed; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 at 10:00 as dose 2, single (Lot number: EW0150) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: VOCAL CORD PARALYSIS (disability) with onset 12May2021 at 10:00, outcome "not recovered", described as "Left vocal cord closed"; SPEECH DISORDER (disability), outcome "not recovered", described as "having a difficult time talking". The events "left vocal cord closed" and "having a difficult time talking" required physician office visit. Therapeutic measures were taken as a result of vocal cord paralysis, speech disorder included Shot in vocal cord. Clinical course: No other vaccine on same date or in four weeks. Left vocal cord closed; subsequently now, patient was having a difficult time talking. Patient has seen an ENT and have acupuncture treatment as well however nothing seems to help.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown". Clinical course: Covid vaccine gave patient Myocarditis. Patient was perfectly healthy until patient took vaccine.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 4.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administering adacel to the wrong age group (4-year-old) with no reported adverse event; inadvertently administered ADACEL, instead of Daptacel, with no reported adverse event; Initial information received on 22-Aug-2024 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 4 years old male patient who was inadvertently administered Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel], instead of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr); and Polio vaccine inact 3v (Vero) (Ipol).  On an unknown date, the 4 years old patient was administered with (0.5 ml) dose 4 of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, (Suspension for injection) (Adacel) (lot: 3CA07C1, Expiry date: 31-Dec-2025) instead of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] (Suspension for injection), with no reported adverse event (Product administered to patient of inappropriate age) and (wrong product administered) (latency: same day) via intramuscular route in left thigh for prophylactic vaccination (immunization).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.