chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: FLUA4, PNC20, RSV, VARZOS
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging, Muscular weakness
Clinical narrative: vaccine Flaud65+  RSV Arexvy -  Prevnar -  Shingrix . The Sunday following my 4 injections I had a stroke. I have no History of stroke or the Doctors have found no reason for the incident.
Age: 69.0
Sex: F
Vaccine: FLUA4, PNC20, RSV, VARZOS
Symptoms: Sluggishness
Clinical narrative: vaccine Flaud65+  RSV Arexvy -  Prevnar -  Shingrix . The Sunday following my 4 injections I had a stroke. I have no History of stroke or the Doctors have found no reason for the incident.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Erythema, Fatigue, Headache, Injection site pain
Clinical narrative: pain around the vaccine site, redness, swelling, along with headache, fatigue, muscle pain and joint pain
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Myalgia, Swelling
Clinical narrative: pain around the vaccine site, redness, swelling, along with headache, fatigue, muscle pain and joint pain
Age: 17.0
Sex: F
Vaccine: CHIK
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: large red/purple bruise/rash at site with pain and swelling , clobetasol topical cream prescribed
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fatigue, fever, headache, muscle joint pain
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF RERIGERATED
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired by 1 day (refrigerated)
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Bell's palsy, Facial paralysis
Clinical narrative: Pt received the covid booster on 12/30/23 and next day pt developed left side mouth drooping on outside/inside his mouth and difficulty with drinking/speech. Symptoms are present now and have been constant since 12/31/23.  Pt states he has had bells palsy before.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given a high dose flu vaccine in our office on 12/27/23. Pt had previously been given a high dose flu vaccine from another facility on 11/9/23. Pt had no adverse reaction from additional dose. No additional labs or tests were ordered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: patient with dizziness, nauseous, felt like room was closing in, syncopal.  Paramedics called and evaluated patient, symptoms improved
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Mother reported that the following day after vaccination, child's arm was hard to the touch, swollen, red, feverish, painful, and child could not move her arm it hurt so bad. Mother reported that swelling was down to her elbow.  Family took daughter to urgent care on 12/22/2023. Urgent Care reported that it was a reaction to the vaccine, gave her an antibiotic (UNK type) and a steroid (prednisone). About  5-6 days later child's arm returned to normal.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Mother reported that the following day after vaccination, child's arm was hard to the touch, swollen, red, feverish, painful, and child could not move her arm it hurt so bad. Mother reported that swelling was down to her elbow.  Family took daughter to urgent care on 12/22/2023. Urgent Care reported that it was a reaction to the vaccine, gave her an antibiotic (UNK type) and a steroid (prednisone). About  5-6 days later child's arm returned to normal.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Lethargy, Pain, Rash
Clinical narrative: Lethargy, body aches, and rash over face, chest, and arms.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTED OF REFRIGERATED
Age: 29.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired on 12/27/2023, given on 12/29/2023 - expiration date misread by myself (RN). patient had no adverse reaction.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 75.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Asthenia, Blood test, Guillain-Barre syndrome, Magnetic resonance imaging
Clinical narrative: I became very weak and sore especially in the upper legs.  Soreness in legs similar to the days following a hard workout or run.  Tried to work through the pain and weakness for several days.  Saw my doctor on November 10th.  Doctor reviewed my condition and sent me to Emergency Room after diagnosing Guillain-Barre Syndrome.  Admitted to hospital where several tests including MRIs and blood work-up were completed.  Pain has now settled in my left arm and wrist and has been that way for about four weeks.  Taking one 500 mg Tylenol to relieve pain (typically twice a day) and continuing physical therapy and work-out at a gym to try to regain strength.  Pain in the arm and wrist is worse in the mornings when I wake up. Other than the left arm my overall strength is about 70% of what it was before the shot on November 1st.
Age: 75.0
Sex: M
Vaccine: FLUA4
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: I became very weak and sore especially in the upper legs.  Soreness in legs similar to the days following a hard workout or run.  Tried to work through the pain and weakness for several days.  Saw my doctor on November 10th.  Doctor reviewed my condition and sent me to Emergency Room after diagnosing Guillain-Barre Syndrome.  Admitted to hospital where several tests including MRIs and blood work-up were completed.  Pain has now settled in my left arm and wrist and has been that way for about four weeks.  Taking one 500 mg Tylenol to relieve pain (typically twice a day) and continuing physical therapy and work-out at a gym to try to regain strength.  Pain in the arm and wrist is worse in the mornings when I wake up. Other than the left arm my overall strength is about 70% of what it was before the shot on November 1st.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Dyskinesia, Electroencephalogram normal, Muscle rigidity, Pain in extremity
Clinical narrative: Shortly after the vaccine we notice episodes of abnormal movements. the vary in time and severity and progressively worsened over time. Her legs jackknife and get very rigid and her fist ball up. They sometimes seem to be painful to her.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Updated COVID-19 vaccine (2023-2024) indicated for patients 6mo-11yr was given to this 37 year-old patient. Nurse confirms the patient received a full 0.5 mL dose.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Spikevax 2023-2024 Formula.  Patient had no symptoms during the time of administration or until discharge. Patient is not aware of event yet.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Dizziness, Headache
Clinical narrative: Headache and woozy/dizzy/lightheaded
Age: 82.0
Sex: M
Vaccine: UNK
Symptoms: Atrial fibrillation, Pericardial effusion
Clinical narrative: Went into Afib.  Had fluid around heart. Had a major MI
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Spikevax 2023-2024 Formula. No known adverse reactions, patient is not aware of event.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test
Clinical narrative: Death after recent Covid illness
Age: 0.83
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse effects at the time of administration and 15 minutes after as patient did receive other vaccinations..
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: pain in neck
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Feeling hot, Flushing, Rash, Rash pruritic, Urticaria
Clinical narrative: Within 2 minutes he felt hot, was flushed with an urticarial rash on neck, arms, legs, trunk.  Given benadryl 50 mg about 8 min after vaccine was given and 20 min later had resolving rash, less itchy. Never had dizziness, syncope, lip/eye swelling, cough, trouble breathing, wheezing, v/d.  Had normal vitals throughout.
Age: 68.0
Sex: M
Vaccine: COVID19, PPV
Symptoms: C-reactive protein normal, Computerised tomogram head normal, Optic ischaemic neuropathy, Optical coherence tomography abnormal, Red blood cell sedimentation rate normal
Clinical narrative: Approx 2 weeks after COVID shot, and 1 week after flu shot, noticed painless, blurred vision in right eye.  Visual field constriction,
Age: 68.0
Sex: M
Vaccine: COVID19, PPV
Symptoms: Retinogram abnormal, Vision blurred, Visual field defect
Clinical narrative: Approx 2 weeks after COVID shot, and 1 week after flu shot, noticed painless, blurred vision in right eye.  Visual field constriction,
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Menstruation delayed
Clinical narrative: My menstrual period has been over two weeks late since getting the vaccine. I am 100% not pregnant. Late/missing periods are not normal for me.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE information; TE VARIVAX, and PROQUAD that occurred on three separate occasions since 11/27/2023. The caller stated that the vaccines had possibly been administered to multiple patients; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-NOV-2023, the patient was vaccinated with improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection lot # was reported as: X0808684, expiration date was reported as 05-JAN-2025 (exact dose, albumin status, site and route of administration were not provided) for prophylaxis. The stability evaluation revealed that excursion was supported and the vaccine had not been exposed to any prior excursions. Current excursion details: 5.6 degree Celsius (-10 degree Celsius to 8 degree Celsius ) for 0 hours 1 minute 0 seconds; 5.9 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds; 7.2 degree Celsius/ (-10 degree Celsius to 8 degree Celsius ) for 0 hours 2 minutes 0 seconds. There was no additional adverse event information reported.   This is one of several reports received from the same reporter.  Lot number X0808584 is not valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).; Sender's Comments:  US-009507513-2312USA003860:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE information; TE VARIVAX, and PROQUAD that occurred on three separate occasions since 11/27/2023. The caller stated that the vaccines had possibly been administered to multiple patients/given VARIVAX on 30-NOV-2023; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-NOV-2023, the patient was vaccinated with improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot # reported and confirmed as: X006982, expiration date reported and confirmed as: 07-MAR-2025 (site and route of administration were not provided) for prophylaxis. The stability evaluation revealed that excursion was supported and the vaccine had not been exposed to any prior excursions. Current excursion details: 5.6 degree Celsius (-10 degree Celsius to 8 degree Celsius ) for 0 hours 1 minute 0 seconds; 5.9 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds; 7.2 degree Celsius/ (-10 degree Celsius to 8 degree Celsius ) for 0 hours 2 minutes 0 seconds. There was no additional adverse event information reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2312USA003860:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE information; TE VARIVAX, and PROQUAD that occurred on three separate occasions since 11/27/2023. The caller stated that the vaccines had possibly been administered to multiple patients/VARIVAX given on 01-DEC-2023; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the patient was vaccinated with improperly stored dose (product storage error) of with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot # reported and confirmed as: X006982, expiration date reported and confirmed as: 07-MAR-2025 (site and route of administration were not provided) for prophylaxis. The stability evaluation revealed that excursion was supported and the vaccine had not been exposed to any prior excursions. Current excursion details: 5.6 degree Celsius (-10 degree Celsius to 8 degree Celsius ) for 0 hours 1 minute 0 seconds; 5.9 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds; 7.2 degree Celsius/ (-10 degree Celsius to 8 degree Celsius ) for 0 hours 2 minutes 0 seconds. There was no additional adverse event information reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2312USA003860:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE information; TE VARIVAX, and PROQUAD that occurred on three separate occasions since 11/27/2023. The caller stated that the vaccines had possibly been administered to multiple patients/given PROQUAD on 01-DEC-2023; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) injection, 0.5 milliliter, lot # reported and confirmed as: X018584, expiration date reported and confirmed as: 05-JAN-2025 (site and route of administration were not provided) for prophylaxis. The stability evaluation revealed that excursion was supported and the vaccine had not been exposed to any prior excursions. Current excursion details: 5.6 degree Celsius (-10 degree Celsius to 8 degree Celsius ) for 0 hours 1 minute 0 seconds; 5.9 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds; 7.2 degree Celsius/ (-10 degree Celsius to 8 degree Celsius ) for 0 hours 2 minutes 0 seconds. There was no additional adverse event information reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2312USA003860:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE information; TE VARIVAX, and PROQUAD that occurred on three separate occasions since 11/27/2023. The caller stated that the vaccines had possibly been administered to multiple patients/given VARIVAX on 01-DEC-2023; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the patient was vaccinated with improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot # reported and confirmed as: X006982, expiration date reported and confirmed as: 07-MAR-2025 (site and route of administration were not provided) for prophylaxis. The stability evaluation revealed that excursion was supported and the vaccine had not been exposed to any prior excursions. Current excursion details: 5.6 degree Celsius (-10 degree Celsius to 8 degree Celsius ) for 0 hours 1 minute 0 seconds; 5.9 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds; 7.2 degree Celsius/ (-10 degree Celsius to 8 degree Celsius ) for 0 hours 2 minutes 0 seconds. There was no additional adverse event information reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2312USA003860:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE information; TE VARIVAX, and PROQUAD that occurred on three separate occasions since 11/27/2023. The caller stated that the vaccines had possibly been administered to multiple patients/given VARIVAX on 01-DEC-2023; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the patient was vaccinated with improperly stored (product storage error) dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot # reported and confirmed as: X006982, expiration date reported and confirmed as: 07-MAR-2025 (site and route of administration were not provided) for prophylaxis. The stability evaluation revealed that excursion was supported and the vaccine had not been exposed to any prior excursions. Current excursion details: 5.6 degree Celsius (-10 degree Celsius to 8 degree Celsius ) for 0 hours 1 minute 0 seconds; 5.9 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds; 7.2 degree Celsius/ (-10 degree Celsius to 8 degree Celsius ) for 0 hours 2 minutes 0 seconds. There was no additional adverse event information reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2312USA003860:
Sex: U
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP called to report T/E. HCP stated ROTATEQ and VAXNEUVANCE were administered on 12/27/2023.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, historical drugs, pertinent medical history and drug reactions/allergies were not reported.  On 27-DEC-2023, the patient was vaccinated by a health professional with improper stored vaccines of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) strength: 0.5 milliliter injection (the first dose [1st dose], lot #X022028, expiration date: 22-OCT-2025; exact dose, route of administration and anatomical site of administration were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) strength 2 milliliter oral liquid (1st dose, administered orally, lot #X010217, expiration date: 05-NOV-2024; exact dose was not reported) for prophylaxis (product storage error). Both vaccines experienced temperature excursion with 48.2 degree Fahrenheit for 1 hour 32 minutes 0 seconds. It was reported that there was no previous temperature excursion. It was not a call because of a "data logger". No side effect was reported/no additional adverse events (AEs) were reported (no adverse event).
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no patient symptoms have been reported/No additional AE; patient received 1 dose of GARDASIL 9 after the product was involved in a temperature excursion.; This spontaneous report was received from a nurse and refers to a 17-year-old patient (gender not reported).  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-DEC-2023, the patient was vaccinated with an improperly stored  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot# X019863 which was found as a valid lot # for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe with expiration date 14-FEB-2025, administered for prophylaxis (strength, dose description and route of administration were not provided) following a temperature excursion of 13.08 degrees Celsius for 1 hour 15 minutes (Improper storage of product in use), it was stated that no previous temperature excursion occurred. No patient symptoms have been reported (no adverse event).  This is one from several cases received from the same reporter. ; Sender's Comments:  US-009507513-2312USA010597: US-009507513-2312USA010648: US-009507513-2312USA010641:
Age: 0.5
Sex: U
Vaccine: PNC15, RV5
Symptoms: Product storage error
Clinical narrative: No adverse event; HCP called to report TE. Caller is unaware if products were administered and did not have the products lot and expirations and will be calling back to provide further information. Precautionary AE. TE case number: 02526875.    13.08C for 1 hour 15 mi; This spontaneous report was received from a nurse regarding a 6-month-old patient.  The patient's relevant medical history, concurrent conditions, and concomitant therapies.   On 27-DEC-2023, there was a temperature excursion with a temperature of 13.06 degrees Celsius lasting 1 hour and 15 minutes. Then, on an unspecified date in December 2023, the patient was vaccinated with vaccines rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml, lot #1947628, expiration date: 11-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided); and  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5ml, administered for prophylaxis (strength and route of administration were not provided) (lot# X022026 exp 22-OCT-2025 or X022028 exp 22-OCT-2025; the reporter was unable to specified which one was). ; Sender's Comments:  US-009507513-2312USA010641: US-009507513-2312USA010597: US-009507513-2312USA010648:
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: administration of a pediatric dose of Engerix-B between doses; administration of a pediatric dose of Engerix-B between doses; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 60-year-old female patient who received HBV (Engerix B pediatric) (batch number KM444, expiry date 22-MAY-2024) for prophylaxis.   On 26-DEC-2023, the patient received the 1st dose of Engerix B pediatric. On 26-DEC-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: administration of a pediatric dose of Engerix-B between doses) and adult use of a child product (Verbatim: administration of a pediatric dose of Engerix-B between doses). The outcome of the underdose and adult use of a child product were 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: 26-DEC-2023 The reporter inquiring about Engerix-B and what information was available about the information available about the administration of a pediatric dose of Engerix-B between doses. The pediatric dose of Engerix-B given to adult patient, which led to underdose and adult use of a child product. The partial patient, vaccine and event information was given. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: The patient may have received the adjuvant only; The patient may have received the adjuvant only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 63-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number X7P97, expiry date 04-SEP-2026) for prophylaxis.   On 27-DEC-2023, the patient received Arexvy. On 27-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: The patient may have received the adjuvant only) and inappropriate dose of vaccine administered (Verbatim: The patient may have received the adjuvant only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 28-DEC-2023 The reporter reported that the patient may or may not had received a complete dose of Arexvy. The patient may had received the adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye haemorrhage, Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling on right side of neck all the way up face; numbness and tingling on right side of neck all the way up face; broken blood vessels in right eye at the same time frame; This non-serious case was reported by a consumer via call center representative and described the occurrence of numbness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-SEP-2023, the patient received the 1st dose of Shingrix (right arm). On 12-SEP-2023, 10 min after receiving Shingrix, the patient experienced numbness (Verbatim: numbness and tingling on right side of neck all the way up face), tingling (Verbatim: numbness and tingling on right side of neck all the way up face) and broken blood vessel in eye (Verbatim: broken blood vessels in right eye at the same time frame). The outcome of the numbness, tingling and broken blood vessel in eye were resolved.   It was unknown if the reporter considered the numbness, tingling and broken blood vessel in eye to be related to Shingrix.     It was unknown if the company considered the numbness, tingling and broken blood vessel in eye to be related to Shingrix.   Additional Information: GSK Receipt date: 28-DEC-2023 The reporter was a patient. The patient reported that she received Shingrix vaccine and 10 minutes later she experienced numbness and tingling on right side of neck all the way up face (on right side). Also mentioned broken blood vessels in right eye at the same time frame. Patient stated that all symptoms only lasted a few hours. The reporter did not consent to follow-up.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Received Extra dose of arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 93E7Z, expiry date 27-MAR-2025) for prophylaxis.   Concomitant products included RSVPreF3 adjuvanted (Arexvy).   On 28-DEC-2023, the patient received the 2nd dose of Arexvy. On 28-DEC-2023, 45 days after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Received Extra dose of arexvy). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 28-DEC-2023 The pharmacist reported that the. The pharmacist reported that patient received a second dose of Arexvy today (on reporting day) and afterwards uncovered documentation that patient received a first dose of Arevxy on 13th November 2023, which led to extra dose administered. Patient did not recall receiving the dose on 13th November 2023.  The reporter did not consent to follow-up.
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Supposed to receive a flu vaccine but reportedly asked for a dose of Arexvy by mistake; Supposed to receive a flu vaccine but reportedly asked for a dose of Arexvy by mistake; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 66-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number PK74B, expiry date 02-JUL-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY) and COVID-19 vaccine.   On 27-DEC-2023, the patient received the 2nd dose of Arexvy. On 27-DEC-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Supposed to receive a flu vaccine but reportedly asked for a dose of Arexvy by mistake) and wrong vaccine administered (Verbatim: Supposed to receive a flu vaccine but reportedly asked for a dose of Arexvy by mistake). The outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-DEC-2023 A pharmacist stated that a patient received a dose of Arexvy and the Pfizer COVID-19 vaccine.  Two weeks later, the patient was supposed to receive a flu vaccine but reportedly asked for a dose of Arexvy by mistake which led to extra dose administered and wrong vaccine administered. The reporter did not consent to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered Arexvy under the age of 60 years; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in unspecified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.  On an unknown date, the patient received Arexvy (intramuscular). On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Administered Arexvy under the age of 60 years). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 29-DEC-2023 The pharmacist reported that from health and human services reporting several patients around 117 patients from long term care facility was administered arexvy under the age of 60 years, which led to inappropriate age at vaccine administration.  The reporter was not sure how many among the 117 patient where under 60 years and some over. Found out during October and stopped administering since then.  The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Liquid component administration only; patient may have received the liquid conjugate portion only of the 2 vial Menveo dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA771A, expiry date 31-JAN-2024) for prophylaxis.   On 08-NOV-2023, the patient received Menveo. On 08-NOV-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Liquid component administration only) and inappropriate dose of vaccine administered (Verbatim: patient may have received the liquid conjugate portion only of the 2 vial Menveo dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-DEC-2023 The reporter reported that the patient had received the liquid conjugate portion only of the 2 vial Menveo dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 017F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy, Blood pressure high (Since vaccine) since 2012, Non-sustained ventricular tachycardia since 17-Oct-2023, Dizziness since 17-Oct-2023 and Aneurysm (2 aneurysms) since 17-Oct-2023.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported.  The patient had COVID-19 again on 11-APR-2023 and on an unknown date in 2023. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-753450 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (First dose lot number 011L20A) on 08-Jan-2021, Moderna covid-19 vaccine (Second dose lot number 043L20A) on 05-Feb-2021 and Moderna covid-19 vaccine (Third dose lot number 035C21A) since 06-Oct-2021. Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine.    On 10-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Oct-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.            No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2023-755360 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Vertigo
Clinical narrative: vertigo; pre syncope; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) and PRESYNCOPE (pre syncope) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 05-Dec-2023, the patient experienced VERTIGO (vertigo) (seriousness criterion medically significant) and PRESYNCOPE (pre syncope) (seriousness criterion medically significant). At the time of the report, VERTIGO (vertigo) and PRESYNCOPE (pre syncope) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Company Comment This spontaneous case concerns a 66 year-old female patient with no medical history  reported who experienced the unexpected seriousness criteria medically significant events of vertigo and presyncope  28 days after a dose of mRNA-1273.815 vaccine. Concomitant medication nor Treatment details were reported. At the time of the report, the events had resolved.    The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Human papilloma virus test, Mammogram, Papilloma viral infection
Clinical narrative: I have tested positive for HPV after getting vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAPILLOMA VIRAL INFECTION (I have tested positive for HPV after getting vaccine) in a 46-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAPILLOMA VIRAL INFECTION (I have tested positive for HPV after getting vaccine). At the time of the report, PAPILLOMA VIRAL INFECTION (I have tested positive for HPV after getting vaccine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Human papilloma virus test: Positive. On an unknown date, Mammogram: abnormal mammograms.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. Patient received 1st and second dose. The patient had no concomitant disease or risk factor. No treatment medications provided by the reporter.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient started having Urticaria; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Patient started having Urticaria) in a 39-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3914B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose-1, Lot 029L20A) on 19-Jan-2021, Moderna COVID-19 Vaccine (Dose-2, Lot 024M20A) on 19-Jan-2021, Moderna COVID-19 Vaccine (Dose-2, Lot 024M20A) on 16-Feb-2021, Moderna COVID-19 Vaccine (Dose 3 and Lot 022321A) on 23-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 06-Dec-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced URTICARIA (Patient started having Urticaria). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Urticaria, at a dose of PO Twice a day and TRIAMCINOLONE for Urticaria, at a dose of 0.1% Cream. At the time of the report, URTICARIA (Patient started having Urticaria) had not resolved.            The concomitant medication was not reported by reporter. It was reported that patient brakes out on random parts of the body. It disappears from that part and pops up in another area. Patient visited a dermatologist and was diagnosed with urticaria on 26-DEC-2023.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. NASK) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Dec-2023, the patient experienced COVID-19 (covid 19). On 10-Dec-2023, COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2023, SARS-CoV-2 test: Positive. On 10-Dec-2023, SARS-CoV-2 test: Negative.         She had all her previous vaccinations as Moderna COVID-19 vaccines.  The concomitant medication was not reported by reporter.   The treatment medication was not reported by reporter.   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Elevated tachycardic heart rate; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (Elevated tachycardic heart rate) in a 72-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (First dose lot number 011L20A) on 08-Jan-2021, Moderna covid-19 vaccine (Second dose lot number 043L20A) on 05-Feb-2021 and Moderna covid-19 vaccine (Third dose lot number 035C21A) on 06-Oct-2021; for Product used for unknown indication: Flu vaccine in 2023. Past adverse reactions to the above products included No adverse event with Flu vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine.    In December 2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced HEART RATE INCREASED (Elevated tachycardic heart rate). At the time of the report, HEART RATE INCREASED (Elevated tachycardic heart rate) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Heart rate: Increased.         Patient did receive covid-19 vaccination on OCT-2023.  No concomitant medication was reported.  Patient was experiencing an elevated tachycardic heart rate. It started 30 hours ago and has continued. Patient didn't take any medications or treatments. He did not drink as much coffee. No treatment information was reported.   This case was linked to MOD-2023-755361 (Patient Link).
Sex: U
Vaccine: RSV
Symptoms: Device breakage, Device leakage
Clinical narrative: Vial adapter was broken and the vaccine leaked out of the bottle; Vial adapter was broken and the vaccine leaked out of the bottle; This is a spontaneous report received from a Pharmacist from product quality group, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF7708, Expiration Date: 28Feb2025) for immunisation, Device Lot Number: F659, Device Expiration Date: 01Jun2027. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE LEAKAGE (non-serious), outcome "unknown" and all described as "Vial adapter was broken and the vaccine leaked out of the bottle". Additional information: The pharmacist vial adapter was broken and the vaccine leaked out of the bottle and now he was requesting for the replacement. The adapter went into the vial ok, but when the vaccine was being drawn from the vial, the tip broke, and the solution spilled out. It was not administered to the patient.   The reporter considered "vial adapter was broken and the vaccine leaked out of the bottle" not related to rsv vaccine prot.subunit pref 2v. Causality for "vial adapter was broken and the vaccine leaked out of the bottle" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.  Product Quality Group provided investigational results on 15Dec2023 for rsv vaccine prot.subunit pref 2v (device constituent): The complaint for ''The vial adapter was broken'' of Abrysvo Injectable (Vaccine) was investigated. The investigation included reviewing the involved batch records, deviation investigation, complaint sample, complaint sample pictures and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lots of the reported lot HF7708. The reported defect was present on the returned complaint sample. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation, stability and patient safety. RA (site name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could be confirmed on the returned complaint sample. No root cause or CAPA (corrective and preventive actions) were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release.  Batch/lot number is not provided, and it cannot be obtained.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral
Clinical narrative: Patient came in for second dose and reported having redness & swelling from first shot, i asked her if rash was local or anywhere else, she stated just on the arm. gave second shot and pt called few minutes later and stated she called ER and told them her tongue was numb from second shot. The ER suggested she come in. She asked me if she should. I asked if she had any other symptoms, she said no "just my tongue feels like when the dentist gives you a shot". I said to be on the safe side to go in.
Sex: U
Vaccine: RSV
Symptoms: Device connection issue
Clinical narrative: just gave you is the one that is defective/ Vial is damaged/ Plastic from the syringe barrel that one came off/ Plastic from the syringe barrel that one came off/ not able to screw on a new syringe to that barrel; This is a spontaneous report received from a Pharmacist.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose numer unknown, single (Lot number: HF5012, Expiration Date: Jan2025) and as dose numer unknown, single (Lot number: GY5655, Expiration Date: Feb2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE DEFECTIVE (non-serious), described as "just gave you is the one that is defective/ Vial is damaged/ Plastic from the syringe barrel that one came off/ Plastic from the syringe barrel that one came off/ not able to screw on a new syringe to that barrel".  Additional information: He was reporting that the vial of the Abrysvo that he trying to reconstitute has a problem, the plastic on the top vial pop up and the vial is damaged. So, it was not reconstituted at all. The  plastic for the vial was fine but the plastic from the syringe barrel that one came off. So, we were not able to screw on a new syringe to that barrel.  The reporter considered "just gave you is the one that is defective/ vial is damaged/ plastic from the syringe barrel that one came off/ plastic from the syringe barrel that one came off/ not able to screw on a new syringe to that barrel" not related to rsv vaccine prot.subunit pref 2v. Causality for "just gave you is the one that is defective/ vial is damaged/ plastic from the syringe barrel that one came off/ plastic from the syringe barrel that one came off/ not able to screw on a new syringe to that barrel" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.