chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Flushing, Nausea, Skin warm
Clinical narrative: Felt lightheaded,  dizzy and nauseated.  Face became flush/red and felt warm.  However notes that she has felt nauseated since her miscarriage 5 days ago.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: We received a call from agent regarding this patient.  Patient stated they had not received a 2nd bivalent booster.  Patient in fact did receive the pfizer bivalent booster at a pharmacy and informed the staff here at pharmacy she did not.   She then asked for a Moderna Bivalent booster 2 days after her pfizer bivalent booster.   No signs and symptoms - just reporting that she received a 3rd bivalent booster when she should not have scheduled an appt for a 3rd.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: C-reactive protein, Cyanosis, Electrocardiogram, Full blood count, Hypopnoea
Clinical narrative: 4-5 hours after vaccination patient was in dad's arm and mom witnessed infant pallor/cyanosis and lethargy. and shallow breathing.  No seizure seen.  She did stimulation a few times and he started to breath more routinely but stayed pale/cyanosis.  EMS came and his oxygen saturations were 70s and oxygen applied and brought to ED.  In ED normal eval and exam and some basic labs done and observation overnight w/o further events.  Concern for BRUE - brief resoled unexplained event
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Influenza virus test negative, Lethargy, Metabolic function test, Pallor, Respiratory syncytial virus test negative
Clinical narrative: 4-5 hours after vaccination patient was in dad's arm and mom witnessed infant pallor/cyanosis and lethargy. and shallow breathing.  No seizure seen.  She did stimulation a few times and he started to breath more routinely but stayed pale/cyanosis.  EMS came and his oxygen saturations were 70s and oxygen applied and brought to ED.  In ED normal eval and exam and some basic labs done and observation overnight w/o further events.  Concern for BRUE - brief resoled unexplained event
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: SARS-CoV-2 test negative
Clinical narrative: 4-5 hours after vaccination patient was in dad's arm and mom witnessed infant pallor/cyanosis and lethargy. and shallow breathing.  No seizure seen.  She did stimulation a few times and he started to breath more routinely but stayed pale/cyanosis.  EMS came and his oxygen saturations were 70s and oxygen applied and brought to ED.  In ED normal eval and exam and some basic labs done and observation overnight w/o further events.  Concern for BRUE - brief resoled unexplained event
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy to vaccine, Bowel movement irregularity, Chills, Immunisation reaction, Tremor
Clinical narrative: Shortly after patient received the vaccine she started shaking / having rigors.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administered 12 year + dose to patient instead of correct dose (5-11 year). Mistakenly drew up the incorrect vial. Caught the mistake when charting the vaccination.  No known adverse reaction at this time.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation
Clinical narrative: patient claims area became red and inflammed
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Employee stated the patient received their 3rd dose approx 12 weeks after their 2nd dose.; No additional AE; This spontaneous report was received from other health professional referring to a female patient of unspecified age.  The patients' concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) only approximately 12 weeks after she received the 2nd dose (unspecified date) (inappropriate schedule of product administration) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). Patient did not had any symptoms. No adverse event was reported and there was not PQC reported.
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: PROQUAD and MMRII may have been administered after a temperature excursion.; no adverse event; This spontaneous report was received from  a registered nurse (R.N) regarding an unspecified number of patients of unknown ages and genders. Their medical history, historical drugs, known allergies, concurrent conditions, an concomitant therapies were not reported.  On an unknown dates the patients, were vaccinated with doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, both as prophylaxis (strengths, doses, frequencies, lot #'s, expiry dates, and routes of administration were unknown by the reporter) that went through a temperature excursion (Improper storage of product in use). No further adverse events (AE) or information were provided.
Age: 7.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Healthcare worker reported that second dose of PROQUAD was given to a 7 year old patient.  Some fields were "Refused to Answer" because the healthcare worker did not want to continue with AE reporting and did not want a follow up.  This AE was filed; This spontaneous report was received from Other Health Professional and refers to a 7-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot #Refused to answer, administered for prophylaxis (strength, expiry date, and route of administration were not provided).  On an unknown date, healthcare worker reported that second dose of PROQUAD was given to a 7 year old patient. Some fields were "Refused to Answer" because the healthcare worker did not want to continue with AE reporting and did not want a follow up. This AE was filed as precaution because the patient received the second dose of PROQUAD older than the recommended age. No further information was available. No pqc.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; HCP called to report a TE with PROQUAD.  Improperly stored.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided.  On 28-AUG-2023, the patient was vaccinated with with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) injection, 0.5 milliliter (ml) (valid lot number W029555, expiration date 14-MAR-2024), administered for prophylaxis (dose number, frequency, and route of administration were not provided), after a temperature excursion (product storage error). No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse evetn; Pharmacist called to report TE for VARIVAX and informed product was administered.; This spontaneous report was received from Pharmacist and refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   The pharmacist reported that on 17-SEP-2023, a temperature excursion occurred with varicella virus vaccine live (oka/merck) (VARIVAX).  Furthermore, the reporter mentioned the excursion occurred during 3 hours at a temperature of 9.8 F. There was no previous temperature excursion.   Approximately in October 2023 (reported as a month later), the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dosage information was unknown; lot #W032507, expiration date: 11-OCT-2024) administered for prophylaxis; which was part of the temperature excursion. No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called to report a TE with PROQUAD.; This spontaneous report was received from a Healthcare professional and refers to a 14-month-old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   The pharmacist reported that on an unknown date, a temperature excursion occurred with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).  Further temperature excursion details were not provided.   On 28-JUL-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  (0.5 mL; #W029555, expiration date: 14-MAR-2024) administered for prophylaxis; which was part of the temperature excursion. No adverse events were reported.  This is one of several reports from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report a TE with PROQUAD.  Improperly stored. TE case reference 02490108.  No adverse effects reported.  Consent to contact is no. No additional AE/No PQC. AE cross reference cases 02490153, 02490133, 02490163, 02490160, 02490148, 02490; HCP called to report a TE with PROQUAD.  Improperly stored. TE case reference 02490108.  No adverse effects reported.  Consent to contact is no. No additional AE/No PQC. AE cross reference cases 02490153, 02490133, 02490163, 02490160, 02490148, 02490; This spontaneous report was received from  a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, lot #W029555, expiration date: 14-MAR-2024, administered as prophylaxis (strength, and route of administration were not provided). No adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; TE with PROQUAD.  Improperly stored; This spontaneous report was received from a medical assistant referring to a 12-month-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 10-JUL-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (0.5 ml, lot#: W029555, expiration date: 14-MAR-2024; strength, and route of administration were not reported) operated by a healthcare professional for prophylaxis. The vaccine administered was improperly stored and experienced temperature excursion (TE) (product storage error). No adverse effects were reported (no adverse event).    This case was received from the same reporter with another 20 cases.
Age: 45.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; HCP called to report inadvertent administration of a second dose of VAQTA to a patient earlier than recommended. The adult patient received a dose of VAQTA on 05/01/2023 and 09/30/2023. Limited patient demographics provided. No additional AE/PQC.; This spontaneous report was received from licensed practice nurse and refers to a 46-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-MAY-2023, the patient was vaccinated with first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 30-SEP-2023, the patient was vaccinated with inadvertent second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). The patient received a second dose elier than recomended (Inappropriate schedule of product administration). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller reporting temperature excursion. Vaccine has been administered. No PQC. No additional information.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 12-OCT-2023 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # X006982 and expiration date 07-MAR-2025, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (product storage error).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; HCP reports VARIVAX given during a TE.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies or past medical history provided.  On 27-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, one time, lot #X007373, expiration date: 12-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided); the vaccine was given during temperature excursion (Product storage error). There was no side effects, no further adverse event (AE).
Sex: F
Vaccine: COVID19, RVX
Symptoms: Abdominal distension, Flatulence
Clinical narrative: experience large amounts of abdominal gas; bloating; This non-serious case was reported by a consumer and described the occurrence of gas in a 84-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis, TOZINAMERAN (COMIRNATY) for prophylaxis and COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   Concomitant products included levothyroxine (Levothyroxin), rosuvastatin and losartan potassium.   In SEP-2023, the patient received RSV vaccine and Flu vaccine. On 01-OCT-2023, the patient received COMIRNATY. In SEP-2023, the patient received COVID-19 BOOSTER. On 01-OCT-2023, less than a day after receiving RSV vaccine and Flu vaccine, the patient experienced gas (Verbatim: experience large amounts of abdominal gas). In OCT-2023, the patient experienced bloating (Verbatim: bloating).  The outcome of the gas was not resolved and the outcome of the bloating was not reported.   It was unknown if the reporter considered the gas and bloating to be related to RSV vaccine and Flu vaccine.     It was unknown if the company considered the gas and bloating to be related to RSV vaccine and Flu vaccine.   Additional Information: GSK Receipt date: 07-OCT-2023 The patient was self-reported. The patient got the RSV Vaccine on the same day she got the Flu vaccine and Covid-19 booster and about 6 days later she began to experience large amounts of abdominal gas and bloating. It was unknown if the reporter considered the gas and bloating to be related to comirnaty and covid-19 booster vaccine. The reporter had permission to contact.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizzy spells; This non-serious case was reported by a consumer and described the occurrence of dizzy spells in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-OCT-2023, the patient received Shingrix. On 06-OCT-2023, 2 days after receiving Shingrix, the patient experienced dizzy spells (Verbatim: Dizzy spells).  The outcome of the dizzy spells was not resolved.   It was unknown if the reporter considered the dizzy spells to be related to Shingrix.     It was unknown if the company considered the dizzy spells to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2023 It was reported that patient suffered from dizzy spells after Shingrix vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Toothache
Clinical narrative: bone pain, lasting 10 days; Tooth pain, lasting 10 days; This non-serious case was reported by a other health professional and described the occurrence of bone pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bone pain (Verbatim: bone pain, lasting 10 days) and toothache (Verbatim: Tooth pain, lasting 10 days).  The outcome of the bone pain and toothache were not resolved.   It was unknown if the reporter considered the bone pain and toothache to be related to Shingrix.     It was unknown if the company considered the bone pain and toothache to be related to Shingrix.   Additional Information: GSK receipt date: 10-Oct-2023 This report was submitted via the online direct entry reporting system The patient experienced tooth and bone pain, lasting 10 days. The symptoms were treated. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Illness, Upper respiratory tract infection
Clinical narrative: upper respiratory infection; sick; sick in bed; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of upper respiratory tract infection in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-JUL-2023, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced upper respiratory tract infection (Verbatim: upper respiratory infection), sickness (Verbatim: sick) and bedridden (Verbatim: sick in bed).  The outcome of the upper respiratory tract infection, sickness and bedridden were not reported.   It was unknown if the reporter considered the upper respiratory tract infection, sickness and bedridden to be related to Shingrix.     It was unknown if the company considered the upper respiratory tract infection, sickness and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2023 This case was reported via (social media) interactive digital media. The reporter informed that his/her mother was sick in bed with an upper respiratory infection plus side effects from Shingrix vaccine.  The follow-up could not be possible as no contact details were available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I missed the 2 to 6 month window; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st shot on 11th November 2022).   On 21-AUG-2023, the patient received the 2nd dose of Shingrix. On 21-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: I missed the 2 to 6 month window).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 11-Oct-2023 The patient stated that since she missed the 2 to 6 month window, she should get a follow-up shot between 21st October 2023 and 21st March 2024. The patient stated that the phone was a landline in the home, no texting, you may leave a message. The reporter did not want GlaxoSmithKline to contact her physician.  The patient received 2nd shot of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not received 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 01 March 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not received 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-OCT-2023 The patient reported that he/she took Shingrix vaccine on 1st March 2022 and did not had the second dose. The patient would like to complete the treatment and enquired to recommend taking the final dose now or restart with 1st dose and then also take 2nd dose (total of 3 doses). Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose given 07/02/2023 and second dose given 07/21/2023; 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 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 21-JUL-2023, the patient received Shingrix. On 21-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: First dose given 07/02/2023 and second dose given 07/21/2023).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 09-OCT-2023 The pharmacist reported 1st and 2nd doses of Shingrix given 2 weeks apart. The first dose was given on 02-JUL-2023 and second dose given on 21-JUL-2023. Healthcare professional did not have information for lot number/expiration date for 2nd dose. Healthcare professional did not have further patient information. No additional AE information available. HCP gave consent for Safety team to follow up, via phone or email. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Lymphadenopathy, Pain in extremity
Clinical narrative: sense of an internal heavy feeling under her armpits; lymph node swelling  under her armpit; her arm was sore the next day; This non-serious case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 94X3P, expiry date 28-MAY-2024) for prophylaxis.   On 07-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 08-AUG-2023, 1 days after receiving Shingrix, the patient experienced enlargement of lymph nodes (Verbatim: lymph node swelling  under her armpit) and pain in arm (Verbatim: her arm was sore the next day). On an unknown date, the patient experienced axillary pain (Verbatim: sense of an internal heavy feeling under her armpits).  The outcome of the enlargement of lymph nodes and axillary pain were not resolved and the outcome of the pain in arm was resolved.   It was unknown if the reporter considered the enlargement of lymph nodes, pain in arm and axillary pain to be related to Shingrix.     It was unknown if the company considered the enlargement of lymph nodes, pain in arm and axillary pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-OCT-2023 The reporter was a female patient that received her 1st dose of Shingrix from pharmacy and reported that her arm was sore the next day. The patient did not remember exactly how long the arm was sore but maybe for 2 to 3 days. The patient also reported that starting the next day after the 1st dose of Shingrix, she started having lymph node swelling under her armpit. The patient was not sure which side this started on and she still had this issue at the time of reporting, under both armpits but primarily on the right side. The patient stated that the lymph node issue was a gradual concern and she could not see any swelling or touch the issue but she had a sense of an internal heavy feeling under her armpits. The patient had not been to her doctor yet, but was making an appointment. The reporter consented to follow up.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Erythema, Illness, Pyrexia
Clinical narrative: Redness in the torso; Feeling sick; probably had a fever; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of erythema in a elderly female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Influenza vaccine and COVID-19 VACCINE. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced erythema (Verbatim: Redness in the torso), sickness (Verbatim: Feeling sick) and fever (Verbatim: probably had a fever). The outcome of the erythema, sickness and fever were not reported.   It was unknown if the reporter considered the erythema, sickness and fever to be related to Influenza vaccine.     It was unknown if the company considered the erythema, sickness and fever to be related to Influenza vaccine.   Linked case(s) involving the same patient:  US2023138520   Additional Information: GSK receipt date: 10-Oct-2023 The reporter was a pharmacist. The patient got both covid-19 and Influenza vaccine last year in 2022 and  developed a redness in the torso only, up to her neck, not affecting legs, arms or back.  The reporter stated she felt a little bit sick, and she probably had fever but she was not sure. The reporter did not consent to follow-up.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain, Muscular weakness, Pain, Pain in extremity
Clinical narrative: pain from right shoulder radiating down to fingers; pain from right shoulder radiating down to fingers; Fingers on right hand tingling; right arm weakness; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 18-SEP-2023, the patient received Arexvy (intramuscular, right arm). On an unknown date, several days after receiving Arexvy, the patient experienced shoulder pain (Verbatim: pain from right shoulder radiating down to fingers), pain in fingers (Verbatim: pain from right shoulder radiating down to fingers), tingling of extremity (Verbatim: Fingers on right hand tingling) and weakness of arms (Verbatim: right arm weakness).  The patient was treated with paracetamol (Tylenol) and ibuprofen (Advil). The outcome of the shoulder pain, pain in fingers, tingling of extremity and weakness of arms were not resolved.   It was unknown if the reporter considered the shoulder pain, pain in fingers, tingling of extremity and weakness of arms to be related to Arexvy.     It was unknown if the company considered the shoulder pain, pain in fingers, tingling of extremity and weakness of arms to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-OCT-2023 The patient stated she received Arexvy in right arm on September 18, 2023. She stated days later she experienced pain from right shoulder radiating down to fingers. The fingers on the right hand were tingling. She went to urgent care and they recommended a sling for her arm. She mentioned she had been taking Tylenol and Advil for pain. This had gone unresolved and she asked if there was anything else she can do and was referred to healthcare professional.  The reporter did not consent to follow up.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Paraesthesia
Clinical narrative: pain from right shoulder radiating down to fingers; pain from right shoulder radiating down to fingers; Fingers on right hand tingling; right arm weakness; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 18-SEP-2023, the patient received Arexvy (intramuscular, right arm). On an unknown date, several days after receiving Arexvy, the patient experienced shoulder pain (Verbatim: pain from right shoulder radiating down to fingers), pain in fingers (Verbatim: pain from right shoulder radiating down to fingers), tingling of extremity (Verbatim: Fingers on right hand tingling) and weakness of arms (Verbatim: right arm weakness).  The patient was treated with paracetamol (Tylenol) and ibuprofen (Advil). The outcome of the shoulder pain, pain in fingers, tingling of extremity and weakness of arms were not resolved.   It was unknown if the reporter considered the shoulder pain, pain in fingers, tingling of extremity and weakness of arms to be related to Arexvy.     It was unknown if the company considered the shoulder pain, pain in fingers, tingling of extremity and weakness of arms to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-OCT-2023 The patient stated she received Arexvy in right arm on September 18, 2023. She stated days later she experienced pain from right shoulder radiating down to fingers. The fingers on the right hand were tingling. She went to urgent care and they recommended a sling for her arm. She mentioned she had been taking Tylenol and Advil for pain. This had gone unresolved and she asked if there was anything else she can do and was referred to healthcare professional.  The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 1st and 2nd dose more than 6 months apart; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   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 drug dose administration interval too long (Verbatim: received 1st and 2nd dose more than 6 months apart).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter was the patient's wife who stated her husband received first and second dose of Shingrix more than 6 months apart last year. The reporter refused to provided address, date of birth, phone number and any other information missing in this report. The suspect product start date was reported as 2022. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days. The reporter did not consent to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Shingrix expired on 10/08/2023 and was administered on 10/10/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 2459T, expiry date 08-OCT-2023) for prophylaxis.   On 10-OCT-2023, the patient received Shingrix. On 10-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Shingrix expired on 10/08/2023 and was administered on 10/10/2023).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2023 The health care professional (HCP) reported that a Shingrix expired on 08th October 2023 and was administered on 10th October 2023, which led to expired vaccine used. The reporter consented to follow up via email
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles on eye; Shingles on ear; shingles on her head, right side of her face; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (dose received on December 2014), Flu vaccine (dose received on an unknown date) and COVID vaccine (dose received on an unknown date).   In FEB-2019, the patient received the 2nd dose of Shingrix. In SEP-2018, the patient received the 1st dose of Shingrix. In JAN-2023, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles on eye) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: Shingles on ear) (serious criteria GSK medically significant) and shingles (Verbatim: shingles on her head, right side of her face).  The outcome of the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter reported that the patient received Shingrix vaccine and experienced on her head, right side of her face, eye and ear. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: given a Shingrix Vaccine and then the nurse discovered it was expired; Dispensing an expired medication; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number E99E7, expiry date 11-MAY-2023) for prophylaxis.   On 10-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular). On 10-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: given a Shingrix Vaccine and then the nurse discovered it was expired) and drug dispensing error (Verbatim: Dispensing an expired medication).The outcome of the expired vaccine used and drug dispensing error were unknown.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter called to report that a patient was given a Shingrix vaccine and then the nurse discovered (dispensing an expired medication) it was expired, which led to expired vaccine used and drug dispensing error. The patient had not called with any side effects from this expired vaccine, however adverse event was filed on the pharmacy behalf.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st October 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2023 Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only adjuvant portion of Shingrix without reconstitution; received only adjuvant portion of Shingrix without reconstitution; 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 patient who received Herpes zoster (Shingrix) (batch number 7532P, expiry date 18-AUG-2024) for prophylaxis.   On 05-OCT-2023, the patient received Shingrix. On 05-OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received only adjuvant portion of Shingrix without reconstitution) and inappropriate dose of vaccine administered (Verbatim: received only adjuvant portion of Shingrix without reconstitution).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-OCT-2023 The pharmacy manager requested data on the administration of adjuvant portion of Shingrix without reconstitution. They had 4 patients (unknown) to received Shingrix between Oct 5, 2023 and Oct 6, 2023 and one of the patients did not receive a full dose because there was an extra lyophilized vial. The pharmacy manager requested additional data if they revaccinate all 4 of the patients, was there any harm in giving 3 doses of Shingrix vaccine. The patients were unknown to the pharmacy manager at time of call to medical information. No patient was re-administered a dose of Shingrix at the time of the call, per the call, the pharmacy manager was going to wait 2 months prior to have each patient return for another Shingrix vaccine. Patients were potentially going to receive 3 total doses by the end of the Shingrix series. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Pruritus
Clinical narrative: itchy all over his body; stomach upset for days; chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced generalized pruritus (Verbatim: itchy all over his body), upset stomach (Verbatim: stomach upset for days) and chills (Verbatim: chills).  The outcome of the generalized pruritus, upset stomach and chills were not resolved.   It was unknown if the reporter considered the generalized pruritus, upset stomach and chills to be related to Shingrix.     It was unknown if the company considered the generalized pruritus, upset stomach and chills to be related to Shingrix.   Additional Information: GSK receipt date: 11-Oct-2023 The patient reported that he received 2 doses of Shingrix, last dose about 6 months ago (in left arm). The patient stated that he had been itchy all over his body, chills and stomach upset for days and had not resolved.  Referred to health care professional. Did not consent to follow-up
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea, Hallucination, auditory, Head injury
Clinical narrative: babbling nonsense; hearing things; elevated liver enzymes; hit her head; abdominal pain; vomiting; diarrhea; shaking; shivering; heart racing; fever; This non-serious case was reported by a nurse via call center representative and described the occurrence of abdominal pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 2tl27, expiry date 23-AUG-2025) for prophylaxis.   On 25-SEP-2023, the patient received the 2nd dose of Shingrix (left arm). In SEP-2023, 24 hrs after receiving Shingrix, the patient experienced abdominal pain (Verbatim: abdominal pain), vomiting (Verbatim: vomiting), diarrhea (Verbatim: diarrhea), tremor (Verbatim: shaking), shivering (Verbatim: shivering), heart racing (Verbatim: heart racing) and fever (Verbatim: fever). On an unknown date, the patient experienced speech disorder (Verbatim: babbling nonsense), hearing impaired (Verbatim: hearing things), elevated liver enzymes (Verbatim: elevated liver enzymes) and head injury (Verbatim: hit her head).  The outcome of the abdominal pain, vomiting, diarrhea, tremor, shivering, heart racing, fever, speech disorder, hearing impaired, elevated liver enzymes and head injury were resolving.   It was unknown if the reporter considered the abdominal pain, vomiting, diarrhea, tremor, shivering, heart racing, fever, speech disorder, hearing impaired, elevated liver enzymes and head injury to be related to Shingrix.     It was unknown if the company considered the abdominal pain, vomiting, diarrhea, tremor, shivering, heart racing, fever, speech disorder, hearing impaired, elevated liver enzymes and head injury to be related to Shingrix.   Additional Information: GSK receipt date: 11-Oct-2023 Nurse called on behalf of a patient.  A patient received her second dose of Shingrix and within 24 hours of the dose, the patient experienced abdominal pain, vomiting, diarrhea, shaking, shivering, heart racing, and fever.  According to patient's husband, the patient was also babbling nonsense and hearing things.  A recent visit to the office showed that she also had elevated liver enzymes.  The patient hit her head on something while she was vomiting and went to the emergency room.  Per the health care professional, the patient's symptoms were improving. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hepatic enzyme increased, Palpitations, Pyrexia, Speech disorder, Tremor
Clinical narrative: babbling nonsense; hearing things; elevated liver enzymes; hit her head; abdominal pain; vomiting; diarrhea; shaking; shivering; heart racing; fever; This non-serious case was reported by a nurse via call center representative and described the occurrence of abdominal pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 2tl27, expiry date 23-AUG-2025) for prophylaxis.   On 25-SEP-2023, the patient received the 2nd dose of Shingrix (left arm). In SEP-2023, 24 hrs after receiving Shingrix, the patient experienced abdominal pain (Verbatim: abdominal pain), vomiting (Verbatim: vomiting), diarrhea (Verbatim: diarrhea), tremor (Verbatim: shaking), shivering (Verbatim: shivering), heart racing (Verbatim: heart racing) and fever (Verbatim: fever). On an unknown date, the patient experienced speech disorder (Verbatim: babbling nonsense), hearing impaired (Verbatim: hearing things), elevated liver enzymes (Verbatim: elevated liver enzymes) and head injury (Verbatim: hit her head).  The outcome of the abdominal pain, vomiting, diarrhea, tremor, shivering, heart racing, fever, speech disorder, hearing impaired, elevated liver enzymes and head injury were resolving.   It was unknown if the reporter considered the abdominal pain, vomiting, diarrhea, tremor, shivering, heart racing, fever, speech disorder, hearing impaired, elevated liver enzymes and head injury to be related to Shingrix.     It was unknown if the company considered the abdominal pain, vomiting, diarrhea, tremor, shivering, heart racing, fever, speech disorder, hearing impaired, elevated liver enzymes and head injury to be related to Shingrix.   Additional Information: GSK receipt date: 11-Oct-2023 Nurse called on behalf of a patient.  A patient received her second dose of Shingrix and within 24 hours of the dose, the patient experienced abdominal pain, vomiting, diarrhea, shaking, shivering, heart racing, and fever.  According to patient's husband, the patient was also babbling nonsense and hearing things.  A recent visit to the office showed that she also had elevated liver enzymes.  The patient hit her head on something while she was vomiting and went to the emergency room.  Per the health care professional, the patient's symptoms were improving. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: babbling nonsense; hearing things; elevated liver enzymes; hit her head; abdominal pain; vomiting; diarrhea; shaking; shivering; heart racing; fever; This non-serious case was reported by a nurse via call center representative and described the occurrence of abdominal pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 2tl27, expiry date 23-AUG-2025) for prophylaxis.   On 25-SEP-2023, the patient received the 2nd dose of Shingrix (left arm). In SEP-2023, 24 hrs after receiving Shingrix, the patient experienced abdominal pain (Verbatim: abdominal pain), vomiting (Verbatim: vomiting), diarrhea (Verbatim: diarrhea), tremor (Verbatim: shaking), shivering (Verbatim: shivering), heart racing (Verbatim: heart racing) and fever (Verbatim: fever). On an unknown date, the patient experienced speech disorder (Verbatim: babbling nonsense), hearing impaired (Verbatim: hearing things), elevated liver enzymes (Verbatim: elevated liver enzymes) and head injury (Verbatim: hit her head).  The outcome of the abdominal pain, vomiting, diarrhea, tremor, shivering, heart racing, fever, speech disorder, hearing impaired, elevated liver enzymes and head injury were resolving.   It was unknown if the reporter considered the abdominal pain, vomiting, diarrhea, tremor, shivering, heart racing, fever, speech disorder, hearing impaired, elevated liver enzymes and head injury to be related to Shingrix.     It was unknown if the company considered the abdominal pain, vomiting, diarrhea, tremor, shivering, heart racing, fever, speech disorder, hearing impaired, elevated liver enzymes and head injury to be related to Shingrix.   Additional Information: GSK receipt date: 11-Oct-2023 Nurse called on behalf of a patient.  A patient received her second dose of Shingrix and within 24 hours of the dose, the patient experienced abdominal pain, vomiting, diarrhea, shaking, shivering, heart racing, and fever.  According to patient's husband, the patient was also babbling nonsense and hearing things.  A recent visit to the office showed that she also had elevated liver enzymes.  The patient hit her head on something while she was vomiting and went to the emergency room.  Per the health care professional, the patient's symptoms were improving. The reporter consented to follow up.