chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: Error: Bivalent vaccine administered instead of the 2023-2024 formulation.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Immediate pain in left deltoid, continued pain for over 4 weeks without resolution of symptoms
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at injection site Fatigue lasting more than 1 week
Age: 86.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Arm was red/swollen/tender. Was seen by routine doctor and nurse suggested to have arm looked at.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Skin odour abnormal
Clinical narrative: Vaccine administration Moderna booster on right arm.Pfizer arm previously with similar sx. Reported to VAERS last time.Had another COVID shot 2 weeks ago on Saturday  Flare up under axillary region of lymph node with significant swelling.  Swelling has since gone down. Patient is noticing increase in body odor since immunization. Has been experiencing ongoing sore throat since booster. Lymph node swelling is no longer occurring per report of patient. Swelling of lymph node occurred a few hours after the vaccine. Treatment: ibuprofen for fever that he also got with the vaccine No other sx occurring.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, Incorrect product formulation administered
Clinical narrative: Error: Bivalent vaccine administered instead of the 2023-2024 formulation.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Received the Spikevax vaccine for over 12 year old's (.5ml instead of .25 ml)
Age: 88.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient received Fluad on 10/11/2023 and accidentally received again today (11/7/2023)
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was given a flue shot after we talked about benefits of getting a flu shot. afterward she said she had one (flu shot) for the season and wanted a pneumonia shot.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product substitution error
Clinical narrative: Correct type of vaccine given to correct patient at correct time, but from incorrect funding source. Parent marked that child had X coverage, so vaccine was given although NP ordered vaccine from X supply. No symptoms affecting patient.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Abdominal pain, Arthralgia, Chills, Diarrhoea, Flatulence
Clinical narrative: Abdominal pain, gassy, diarrhea, headache, rash on arm leg foot, chills, joint ache swollen ankle.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Headache, Joint swelling, Rash
Clinical narrative: Abdominal pain, gassy, diarrhea, headache, rash on arm leg foot, chills, joint ache swollen ankle.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Amnesia, Blood test, Conversion disorder, Electrocardiogram, Electroencephalogram
Clinical narrative: Passing out, generalized seizure, myoclonic seizures, nodule in thyroid, tiredness, memory loss, starring seizures
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fatigue, Juvenile myoclonic epilepsy, Loss of consciousness, Magnetic resonance imaging, Myoclonic epilepsy
Clinical narrative: Passing out, generalized seizure, myoclonic seizures, nodule in thyroid, tiredness, memory loss, starring seizures
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Petit mal epilepsy, Seizure, Staring, Thyroid mass, Thyroidectomy
Clinical narrative: Passing out, generalized seizure, myoclonic seizures, nodule in thyroid, tiredness, memory loss, starring seizures
Sex: F
Vaccine: HEP
Symptoms: Haematuria, Pneumonia
Clinical narrative: Caller also states she developed gross hematuria twice after receiving unknown hepatitis B vaccine; Caller also states she developed gross hematuria twice after receiving unknown hepatitis B vaccine; pneumonia; This spontaneous report was received from a consumer, reporting on herself, who was a 74-year-old female patient.  Patient's medical history, concurrent conditions, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with unknown hepatitis B vaccine (potentially Hepatitis B Vaccine (Recombinant)) (manufacturer unknown) (dose, units, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis.  The patient stated she developed gross hematuria twice after receiving unknown hepatitis B vaccine (potentially Hepatitis B Vaccine (Recombinant) (manufacturer unknown). The patient also reported she believed she contracted pneumonia from her spouse who received an unknown pneumonia vaccine on an unknown day in October 2023 (reported as 3 weeks ago) (captured in #2311USA001866). At the reporting time, the patient has not recovered from the events.  The causality between the events and suspect vaccine was not provided.  Upon internal review, the event of pneumonia was considered to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Headache, Inappropriate schedule of product administration
Clinical narrative: HCP called to ask if a patient who had received their first dose of GARDASIL 9 during adolescence (10-12 years ago) and developed a headache afterward, should continue with the series?  This initial dose was administered between the ages of 14-16 yrs; Inappropriate schedule of vaccine administered; This spontaneous report was received from a nurse practitioner refers to a 26-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (reported as 10-12 years ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, route of administration and anatomical location were not reported), 0.5 milliliter for prevention of HPV (inappropriate schedule of product administration).   On an unknown date (reported as afterward), the patient experienced headache. The outcome of headache was unknown.  The causality assessment was not provided.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Head injury, Swelling face, Syncope
Clinical narrative: Merck FBE reported AE on behalf of HCP. HCP reported postpartum patient received first dose of GARDASIL 9 on 11/01/2023. Patient had a syncopal episode, post vaccination in office, and hit her head; patient then went to the ER (FBE did not believe pa; Patient also is now having facial swelling; This spontaneous report as received from a nurse and refers to a 34-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 01-NOV-2023 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided).  On 01-NOV-2023, the patient experienced a syncopal episode, post vaccination in office, and hit her head which resulted in facial swelling. The outcome of syncope and swelling face was unknown. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the events was not applicable.  The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not provided.  Upon internal review event syncope was considered medically significant based on ASTL list.
Sex: M
Vaccine: PNC15, PPV
Symptoms: Pneumonia
Clinical narrative: pneumonia; This spontaneous report was received from a consumer reporting on her spouse, who was of unknown age.   His medical history, concurrent conditions, and concomitant medications were not reported.  On an unknown day in October 2023 (reported as 3 weeks ago), the patient received an unknown pneumonia vaccine (potentially Pneumococcal Vaccine, Polyvalent (23-valent) or pneumococcal 15v conj vaccine (CRM197)) (dose, units, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis.  On an unknown date in 2023, the patient experienced pneumonia. The consumer reported she believed she contracted pneumonia from her spouse (captured in MARRS# 2311USA001033). The outcome of the event was not provided.  The causality between pneumonia and suspect vaccine was not provided.  Upon internal review, the event of pneumonia was considered to be medically significant.
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Discontinued product administered, Drug ineffective, Influenza
Clinical narrative: AFTER BEING VACCINATED WITH FLUMIST, PATIENT GOT SICK WITH THE FLU.; PATIENT WAS VACCINATED USING FLUMIST FOR TWO YEARS IN A ROW, IN THE THIRD YEAR HE WAS NOT OFFERED FLUMIST FROM HIS HCP AGAIN BECAUSE HIS HCP SAID FLUMIST DID NOT HAVE A HIGH ENOUGH LEFT OF EFFICACY TO CONTINUE USAGE.; A spontaneous report has been received from a consumer. The report concerns a male patient of ethnic origin (age 19 years).    No medical history was reported.  The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist (influenza vaccine live reassort 3v) (batch number Unknown), via nasal route, on an unknown date. The patient received Flumist (influenza vaccine live reassort 3v) (batch number Unknown), via nasal route, on an unknown date.     A Unknown administered FLUMIST. No malfunction has been reported for this combination product.   A Unknown administered FLUMIST. No malfunction has been reported for this combination product.    The report described lack of effect for Flumist and Flumist. The reported term was "patient was vaccinated using flumist for two years in a row, in the third year he was not offered flumist from his hcp again because his hcp said flumist did not have a high enough left of efficacy to continue usage." (Preferred term: Drug ineffective).     On an unknown date, the patient experienced after being vaccinated with flumist, patient got sick with the flu. (preferred term: Influenza).     Treatment with Flumist (influenza vaccine live reassort 3v) and Flumist (influenza vaccine live reassort 3v) was discontinued.     The patient recovered from the event(s) of patient was vaccinated using flumist for two years in a row, in the third year he was not offered flumist from his hcp again because his hcp said flumist did not have a high enough left of efficacy to continue usage. and after being vaccinated with flumist, patient got sick with the flu. on an unspecified date.     The events were considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Minor correction 07-Nov-2023: Association updated. Narrative updated.
Sex: M
Vaccine: RSV
Symptoms: Death, Vaccine interaction
Clinical narrative: Death NOS; Vaccine-vaccine interaction; This serious case was reported by a consumer and described the occurrence of unknown cause of death in a 85-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 18-OCT-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced unknown cause of death (Verbatim: Death NOS) (serious criteria death, hospitalization and GSK medically significant) and vaccine-vaccine interaction (Verbatim: Vaccine-vaccine interaction) (serious criteria clinically significant/intervention required). The outcome of the vaccine-vaccine interaction was unknown. The reported cause of death was unknown.   The reporter considered the unknown cause of death and vaccine-vaccine interaction to be related to Arexvy.     The company considered the unknown cause of death and vaccine-vaccine interaction to be related to Arexvy.   Additional Information: GSK Receipt Date: 03-NOV-2023 The reporter was caregiver. The reporter reported that Arexvy vaccine was killing people and GSK should stop advertising it on television. The patient was in hospital for death NOS. Reporter would report GSK to the authorities and to the FCC (Federal Communications Commission) for promoting a vaccine that was killing people. Reporter reported that GSK was killing people with its vaccines. God Almighty would punish all the employees working for GSK money hungry company and all would be punished very soon and everything that worked for company should be thrown in jail. The reporter did not consent to follow up.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: RSV, RSV
Symptoms: Body temperature increased, Influenza like illness, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen arm; achy legs/sore arm; elevated temperature; sore injection site; flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included heartburn and migraine. Concomitant products included sumatriptan succinate and pantoprazole sodium.   On 24-OCT-2023, the patient received Arexvy .5 ml. On 25-OCT-2023, 1 days after receiving Arexvy, the patient experienced injection site pain (Verbatim: sore injection site), influenza-like symptoms (Verbatim: flu like symptoms), leg pain (Verbatim: achy legs/sore arm) and body temperature increased (Verbatim: elevated temperature). On 28-OCT-2023, the patient experienced swelling arm (Verbatim: Swollen arm). The patient was treated with cetirizine hydrochloride (Zyrtec). On 26-OCT-2023, the outcome of the influenza-like symptoms was not resolved. The outcome of the injection site pain, swelling arm, leg pain and body temperature increased were not resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, swelling arm, leg pain and body temperature increased to be related to Arexvy.     It was unknown if the company considered the injection site pain, influenza-like symptoms, swelling arm, leg pain and body temperature increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-OCT-2023 and 31-OCT-2023 The patient took Pantoprazole sodium delayed-release (DR) tablets daily. The patient received 120 mcg/0.5ml Arexvy injection. The patient had swollen sore arm and elevated temperature. The patient experienced flu like symptoms, achy legs, arms and sore injection site. Time to onset of swelling arm was 4 day. The consumer also stated that one doctor recommended that she initiate medication therapy with Zyrtec, however, she only took two doses of Zyrtec because the medication made her feel loopy. The symptoms were treated. The reporter consented to follow-up.
Sex: F
Vaccine: RSV, RSV
Symptoms: Asthenia, Condition aggravated, Erythema, Lymphadenopathy, Migraine
Clinical narrative: Swollen arm; achy legs/sore arm; elevated temperature; sore injection site; flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included heartburn and migraine. Concomitant products included sumatriptan succinate and pantoprazole sodium.   On 24-OCT-2023, the patient received Arexvy .5 ml. On 25-OCT-2023, 1 days after receiving Arexvy, the patient experienced injection site pain (Verbatim: sore injection site), influenza-like symptoms (Verbatim: flu like symptoms), leg pain (Verbatim: achy legs/sore arm) and body temperature increased (Verbatim: elevated temperature). On 28-OCT-2023, the patient experienced swelling arm (Verbatim: Swollen arm). The patient was treated with cetirizine hydrochloride (Zyrtec). On 26-OCT-2023, the outcome of the influenza-like symptoms was not resolved. The outcome of the injection site pain, swelling arm, leg pain and body temperature increased were not resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, swelling arm, leg pain and body temperature increased to be related to Arexvy.     It was unknown if the company considered the injection site pain, influenza-like symptoms, swelling arm, leg pain and body temperature increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-OCT-2023 and 31-OCT-2023 The patient took Pantoprazole sodium delayed-release (DR) tablets daily. The patient received 120 mcg/0.5ml Arexvy injection. The patient had swollen sore arm and elevated temperature. The patient experienced flu like symptoms, achy legs, arms and sore injection site. Time to onset of swelling arm was 4 day. The consumer also stated that one doctor recommended that she initiate medication therapy with Zyrtec, however, she only took two doses of Zyrtec because the medication made her feel loopy. The symptoms were treated. The reporter consented to follow-up.
Sex: F
Vaccine: RSV, RSV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Swollen arm; achy legs/sore arm; elevated temperature; sore injection site; flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included heartburn and migraine. Concomitant products included sumatriptan succinate and pantoprazole sodium.   On 24-OCT-2023, the patient received Arexvy .5 ml. On 25-OCT-2023, 1 days after receiving Arexvy, the patient experienced injection site pain (Verbatim: sore injection site), influenza-like symptoms (Verbatim: flu like symptoms), leg pain (Verbatim: achy legs/sore arm) and body temperature increased (Verbatim: elevated temperature). On 28-OCT-2023, the patient experienced swelling arm (Verbatim: Swollen arm). The patient was treated with cetirizine hydrochloride (Zyrtec). On 26-OCT-2023, the outcome of the influenza-like symptoms was not resolved. The outcome of the injection site pain, swelling arm, leg pain and body temperature increased were not resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, swelling arm, leg pain and body temperature increased to be related to Arexvy.     It was unknown if the company considered the injection site pain, influenza-like symptoms, swelling arm, leg pain and body temperature increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-OCT-2023 and 31-OCT-2023 The patient took Pantoprazole sodium delayed-release (DR) tablets daily. The patient received 120 mcg/0.5ml Arexvy injection. The patient had swollen sore arm and elevated temperature. The patient experienced flu like symptoms, achy legs, arms and sore injection site. Time to onset of swelling arm was 4 day. The consumer also stated that one doctor recommended that she initiate medication therapy with Zyrtec, however, she only took two doses of Zyrtec because the medication made her feel loopy. The symptoms were treated. The reporter consented to follow-up.
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Pain
Clinical narrative: Body aches and pain; severe fatigue; This non-serious case was reported by a consumer and described the occurrence of general body pain in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 25-OCT-2023, the patient received Arexvy. On 27-OCT-2023, 2 days after receiving Arexvy, the patient experienced general body pain (Verbatim: Body aches and pain) and fatigue (Verbatim: severe fatigue). The outcome of the general body pain and fatigue were resolved.   It was unknown if the reporter considered the general body pain and fatigue to be related to Arexvy.     It was unknown if the company considered the general body pain and fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-OCT-2023 It was reported that patient suffered from body aches, pain and severe fatigue after receiving Arexvy vaccine. The reporter consented to follow up.
Sex: F
Vaccine: RVX
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: joint pain; Stiff neck; This non-serious case was reported by a consumer and described the occurrence of joint pain in a 76-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 22-SEP-2023, the patient received RSV vaccine. On 23-SEP-2023, 1 days after receiving RSV vaccine, the patient experienced joint pain (Verbatim: joint pain) and stiff neck (Verbatim: Stiff neck). The outcome of the joint pain and stiff neck were not resolved.   It was unknown if the reporter considered the joint pain and stiff neck to be related to RSV vaccine.     It was unknown if the company considered the joint pain and stiff neck to be related to RSV vaccine.   Additional Information: GSK receipt date: 30-OCT-2023 The patient had stiff neck and joint pain. The reporter requested to follow up.
Sex: U
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Very sore arm and not getting better; 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 RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: Very sore arm and not getting better). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-OCT-2023 The case was received from the consumer via interactive digital media The patient received Arexvy and had very sore arm and not getting better. The follow-up could not be possible as no contact details were available. This case was linked with US2023AMR151214 and US2023AMR151220, reported by the same reporter for different patients.; Sender's Comments:  US-GSK-US2023AMR151214:Same reporter US-GSK-US2023AMR151220:Same reporter
Sex: F
Vaccine: RSV
Symptoms: Injection site cellulitis, Injection site rash, Pain in extremity
Clinical narrative: rashes near injection site; cellulitis near injection site; 2 weeks arm still sore; This non-serious case was reported by a physician via sales rep and described the occurrence of rash in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced rash (Verbatim: rashes near injection site), cellulitis (Verbatim: cellulitis near injection site) and pain in arm (Verbatim: 2 weeks arm still sore). The outcome of the rash and cellulitis were not reported and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the rash, cellulitis and pain in arm to be related to Arexvy.   It was unknown if the company considered the rash, cellulitis and pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-NOV-2023 The patient received Arexvy at pharmacy.  The doctors examined patient after complaints of rashes/cellulitis near injection site and 2 weeks arm still sore. The reporter agreed to follow up from GlaxoSmithKline. The case had been linked to US2023AMR151909, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR151909:same reporter, different patient
Sex: F
Vaccine: RSV
Symptoms: Injection site cellulitis, Injection site rash, Pain in extremity
Clinical narrative: rashes near injection site; cellulitis near injection site; 2 weeks arm still sore; This non-serious case was reported by a physician via sales rep and described the occurrence of rash in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced rash (Verbatim: rashes near injection site), cellulitis (Verbatim: cellulitis near injection site) and pain in arm (Verbatim: 2 weeks arm still sore). The outcome of the rash and cellulitis were not reported and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the rash, cellulitis and pain in arm to be related to Arexvy.   It was unknown if the company considered the rash, cellulitis and pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-NOV-2023 The patient received Arexvy at pharmacy.  The doctors examined patient after complaints of rashes/cellulitis near injection site and 2 weeks arm still sore. The reporter agreed to follow up from GlaxoSmithKline. The case had been linked to US2023AMR151896, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR151896:same reporter, different patient
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: to get his second dose but he never came back; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had 1st dose of shingrix administered on 08 APR 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: to get his second dose but he never came back). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-Oct-2023 A pharmacist tried repeatedly to get the patient back in pharmacy to get his second dose but he never came back.  The physician sent in a prescription this week for the Shingrix vaccine so the reporter was not sure whether to just give him a second dose or need to do the series again. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow-up.
Sex: M
Vaccine: COVID19, RSV
Symptoms: Vocal cord paralysis
Clinical narrative: vocal cord paralysis; This non-serious case was reported by a physician via sales rep and described the occurrence of vocal cord paralysis in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included ELASOMERAN (MODERNA COVID VACCINE) for prophylaxis.   Concurrent medical conditions included pulmonary fibrosis and rheumatoid arthritis.   On 18-SEP-2023, the patient received Arexvy and MODERNA COVID VACCINE. In SEP-2023, 10 days after receiving Arexvy, the patient experienced vocal cord paralysis (Verbatim: vocal cord paralysis). The patient was treated with non-drug therapy (Physiotherapy). The outcome of the vocal cord paralysis was resolving.   It was unknown if the reporter considered the vocal cord paralysis to be related to Arexvy.     It was unknown if the company considered the vocal cord paralysis to be related to Arexvy.   Additional Information: GSK Receipt Date 31-OCT-2023: The reporter stated the 10 days after both vaccines patient got vocal cord paralysis. The patient was undergoing (Physiotherapy) PT for it (vocal cord paralysis) and doing better.  The patient also has comorbidities including pulmonary fibrosis and rheumatoid arthritis. It was unknown if the reporter considered the pulmonary fibrosis, rheumatoid arthritis and vocal cord paralysis to be related to Moderna Covid Vaccine.   The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't received a second dose yet; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (received 1st dose on 1st July 2023).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: hasn't received a second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-Oct-2023 No lot number was reported, the reporter stated vaccination happened in a different facility. The reporter consented to follow-up via email. Till the time of reporting, the patient did not receive second dose of Engerix-B, which led to incomplete course of vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, Product dispensing error
Clinical narrative: expired dose of Shingrix was dispensed; Shingrix had expired on 23Sept2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired drug dispensed in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 5CE5S, expiry date 23-SEP-2023) for prophylaxis.   On 30-OCT-2023, the patient received the 1st dose of Shingrix. On 30-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired drug dispensed (Verbatim: expired dose of Shingrix was dispensed) and expired vaccine used (Verbatim: Shingrix had expired on 23Sept2023). The outcome of the expired drug dispensed and expired vaccine used were unknown.   Additional Information: GSK receipt date: 30-Oct-2023 Pharmacy technician reported that an expired dose of Shingrix was dispensed and administered to a patient, which led to expired drug dispensed and expired vaccine used. Mailing address was provided in health care professional's details. The reporter consented to follow-up.
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: a pregnant 35-year-old patient inadvertently received a dose of Arexvy; a pregnant 35-year-old patient inadvertently received a dose of Arexvy. The patient was around 35-36 weeks gestation; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-OCT-2023, the patient received Arexvy. On 20-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: a pregnant 35-year-old patient inadvertently received a dose of Arexvy. The patient was around 35-36 weeks gestation). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: a pregnant 35-year-old patient inadvertently received a dose of Arexvy). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date 30-OCT-2023 The pharmacist called to inform that, a pregnant patient inadvertently received a dose of Arexvy.  The patient was around 35-36 weeks gestation according to the reporter. The vaccine administration facility was the same as primary reporter The 35 year old patient received Arexvy, which led to inappropriate age at vaccine administration The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: 3rd dose of Shingrix on 28/Oct/2023; the first dose of Shingrix on 12/Jun/2018, the 2nd on 4/Dec/2021; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 7S7MF, expiry date 27-SEP-2025) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (1st dose received on 12th June 2018).   On 28-OCT-2023, the patient received the 3rd dose of Shingrix. On 04-DEC-2021, the patient received the 2nd dose of Shingrix. On 04-DEC-2021, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: the first dose of Shingrix on 12/Jun/2018, the 2nd on 4/Dec/2021). On 28-OCT-2023, the patient experienced extra dose administered (Verbatim: 3rd dose of Shingrix on 28/Oct/2023). The outcome of the drug dose administration interval too long and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 30-OCT-2023 A pharmacist called to inform that a patient that that received the 2nd dose of Shingrix later than recommended schedule which led to lengthening of vaccination schedule. The patient received a 3rd dose of Shingrix which led to extra dose administered.  The reporter did not consent to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Sensitive skin
Clinical narrative: last week he has been experiencing skin sensitivity all over his body; This non-serious case was reported by a consumer via call center representative and described the occurrence of sensitive skin in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). In OCT-2023, an unknown time after receiving Shingrix, the patient experienced sensitive skin (Verbatim: last week he has been experiencing skin sensitivity all over his body). The outcome of the sensitive skin was not resolved.   It was unknown if the reporter considered the sensitive skin to be related to Shingrix.     It was unknown if the company considered the sensitive skin to be related to Shingrix.   Additional Information: GSK Receipt Date - 30-OCT-2023 The reporter was the patient. The patient received Shingrix shot.  The patient did not recall which arm the injection was given in. He did not have the lot number but did provide his physician's contact information. He received the injection at his physician's office (not at a pharmacy). He reports that from reporting last week he has been experiencing skin sensitivity all over his body. He stated that when his clothes touch his skin or when he touches his skin it was kind of sensitive. The patient was wondering if that was a side effect from Shingrix. The reporter consented to follow.
Age: 37.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received Shingrix 1st dose 08/03/2023 and 2nd dose 08/23/2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 37-year-old male patient who received Herpes zoster (Shingrix) (batch number 4KG45, expiry date 13-JUL-2025) for prophylaxis.   Concurrent medical conditions included immunocompromised. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 23-AUG-2023, the patient received the 2nd dose of Shingrix. On 23-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: received Shingrix 1st dose 08/03/2023 and 2nd dose 08/23/2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 30-Oct-2023 No reactions were reported. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: has not had dose two; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 44-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (received dose one over two months ago).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: has not had dose two). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 31-Oct-2023 The pharmacist could not provide patient initials, lot number, expiration date, or vaccine administration date.  No additional information were provided. The reporter consented to follow-up. Till the time of reporting, the patient did not received second dose of Engerix-B, which led to incomplete course of vaccination.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: inadvertently was administered a second FluLaval dose on 30Oct2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 5EK43, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLULAVAL QUADRIVALENT).   On 30-OCT-2023, the patient received the 2nd dose of FluLaval Quadrivalent 2023-2024 season. On 30-OCT-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: inadvertently was administered a second FluLaval dose on 30Oct2023). The outcome of the extra dose administered 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: 30-OCT-2023 Medical Assistant reports 17 year old patient received a dose of FluLaval on 11th September 2023 (lot 2MA3K, expiration date 30th June 2024) and then inadvertently was administered a second FluLaval dose on 30th October 2023 (lot 5EK43, expiration date 30th June 20240) which led to extra dose administered. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: 2 diluent of Arexvy  was mixed together  and was administered to a patient. lot# and expiration same for both diluent.; 2 diluent of Arexvy  was mixed together  and was administered to a patient. lot# and expiration same for both diluent.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7539N, expiry date 24-APR-2026) for prophylaxis.   On 31-OCT-2023, the patient received Arexvy. On 31-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: 2 diluent of Arexvy  was mixed together  and was administered to a patient. lot# and expiration same for both diluent.) and inappropriate dose of vaccine administered (Verbatim: 2 diluent of Arexvy  was mixed together  and was administered to a patient. lot# and expiration same for both diluent.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 31 Oct 2023: The pharmacist reported 2 diluent of Arexvy  was mixed together  and was administered to a patient. lot and expiration same for both diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Stevens Johnson Syndrome; This serious case was reported by a pharmacist via call center representative and described the occurrence of stevens johnson syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced stevens johnson syndrome (Verbatim: Stevens Johnson Syndrome) (serious criteria GSK medically significant). The outcome of the stevens johnson syndrome was unknown.   It was unknown if the reporter considered the stevens johnson syndrome to be related to Shingrix.     It was unknown if the company considered the stevens johnson syndrome to be related to Shingrix.   Additional Information: GSK Receipt Date- 01-NOV-2023 The pharmacist inquiring about use of Shingrix following Stevens Johnson Syndrome. The patient had Shingrix vaccine about 6 months ago and developed Stevens Johnson Syndrome.  The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Seizure
Clinical narrative: had mild seizures; This serious case was reported by a consumer via call center representative and described the occurrence of seizure in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Lamictal (had been on Lamictal for several years).   In SEP-2023, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced seizure (Verbatim: had mild seizures) (serious criteria GSK medically significant). The outcome of the seizure was resolved.   It was unknown if the reporter considered the seizure to be related to Arexvy.     It was unknown if the company considered the seizure to be related to Arexvy.   Additional Information: GSK receipt date: 1-Nov-2023 The case was received from the patient's sister. According to the reporter the patient received Arexvy vaccine in September 2023 and recently had mild seizures for a couple of days, one seizure last Saturday and two the following day on Sunday.  Reporter would talk to the physician before providing consent to them to contact him. Reporter refused to provide zip code, address, initials for the patient and date of birth. Reporter provided consent to be contacted by GlaxoSmithKline.
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: patient had received only the adjuvant portion of Arexvy; only adjuvant administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: patient had received only the adjuvant portion of Arexvy) and inappropriate dose of vaccine administered (Verbatim: only adjuvant administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-NOV-2023 The pharmacist called to inform that a patient had received only the adjuvant portion of Arexvy, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient under the age of 4 that was due for both Dtap and IPV was administered the Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 31-OCT-2023, the patient received Kinrix. On 31-OCT-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient under the age of 4 that was due for both Dtap and IPV was administered the Kinrix). 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: 01-NOV-2023 The HCP (health care professional) reported that patient under the age of 4 that was due for both Dtap and IPV was administered the Kinrix, which led to inappropriate age at vaccine administration. No reactions reported. The reporter consented to follow up.
Age: 0.75
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered to a 9 month old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old patient who received DTPa-IPV (Kinrix) for an unknown indication.   On 01-NOV-2023, the patient received Kinrix. On 01-NOV-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 9 month old). 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: 02-NOV-2023 Pharmacy Intern states Kinrix was administered to a 9 month old on the day before reporting which led to inappropriate age at vaccine administration. The reporter consented to follow up via postal. The vaccine administration facility is the same as primary reporter. HCP did not have any additional information at the time of call.
Age: 0.08
Sex: M
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration of the Rotarix Diluent Alone; Administration of the Rotarix Diluent Alone; 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 8-week-old male patient who received Rota (Rotarix lyophilized formulation) (batch number KB7FJ, expiry date 19-SEP-2024) for prophylaxis.   On 25-OCT-2023, the patient received Rotarix lyophilized formulation. On 25-OCT-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Administration of the Rotarix Diluent Alone) and inappropriate dose of vaccine administered (Verbatim: Administration of the Rotarix Diluent Alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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: 02-NOV-2023 Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email. This case is 1 out of 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023152365:Different patient US-GSK-US2023152368:Different patient US-GSK-US2023152370:Different patient US-GSK-US2023152371:Different patient US-GSK-US2023152373:Different patient