chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: MMRV
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE.; HCP calling to report that 1 year old patient received less than the desired dose of PROQUAD on 4/7/2025. Caller states patient received approximately about 0.1 ml due to human error. No adverse effects reported. No other information provided. Confir; This spontaneous report was received from an other health professional and refers to a(n) 1-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 07-APR-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection, lot #Y019464, expiration date: 24-MAY-2026 for prophylaxis (exact dose, dose number, route and site of administration were not provided). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided). The patient received less than the desired dose of PROQUAD. Caller states patient received approximately about 0.1 ml due to human error (accidental underdose). No adverse effects reported (no adverse event).
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs/PQC reported; Caller reported VAQTA administered after expiration date.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 25-MAR-2025, the patient was vaccinated with Hepatitis A Vaccine, Inactivated Injection (lot #X024966 which was determined to be a valid lot number, expiration date: 23-Mar-2025) 1 mL (Dose: 1 mL), administered by Intramuscular route as prophylaxis (expired product administered). No additional adverse event provided.
Sex: F
Vaccine: PNC21, PNC21, UNK, UNK
Symptoms: Malaise
Clinical narrative: Patient reported that she does not feel good, and pharmacist stated he thinks patient is experiencing general malaise.; Patient reported that she does not feel good, and pharmacist stated he thinks patient is experiencing general malaise.; Pharmacist reported patient received a second dose of CAPVAXIVE on Apr 15, 2025. Pharmacist explained that patient received first dose of CAPVAXIVE in Colorado, so his electronic medical system did not notify him because it only picks up medications; Information has been received from Business Partner/CRO on 16-Apr-2025.  This spontaneous report was received from an Consumer or other non health professional and refers to a female patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 15-Apr-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (lot #Y019158, expiration date: 20-May-2026), dose number 2,. On Feb-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine, dose number 1, (lot # and expiration date were not reported). On 15-Apr-2025, the patient was vaccinated with two doses of non-product or non-Merck product (indication, expiration date, and lot # were not reported) (Extra dose administered).  On unknown date, the patient reported that she does not feel good, and pharmacist stated he thinks patient is experiencing general malaise.  At the reporting time, the outcome of all of the events was unknown.   The action taken with all of the vaccines was reported as not applicable.   The causal relationship between all of the events and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.  The causal relationship between all of the events and non-product or non-Merck product was unknown/not reported/not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head, Headache, Ophthalmic herpes zoster, Pain, Rash
Clinical narrative: shingles with ocular involvement; diagnosed with shingles; This spontaneous report was received from a consumer and refers to herself, a female patient of unknown age. The patient's medical history , concurrent conditions and concomitant therapies were not reported.   On 2015 (reported as  approximately 10 years ago), the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) for prophylaxis (strength, dose number, vaccination schedule, expiration date, and lot # were not reported).  On early March of 2025 (also reported as approximately 10 years later), the patient developed shingles with ocular involvement (ophthalmic herpes zoster). Her symptoms began with unilateral, L-sided headache, for which her PCP obtained a head CT (results not provided). Her pain significantly worsened to the point where she presented to the emergency room and was diagnosed with shingles (Herpes zoster). Patient had a small rash on her left forehead, and involvement of her L eye (but not the retina, conflicting information) and was started on steroids, antivirals and pain medication (gabapentin).  On an unspecified date in 2025, she was followed closely by XXX Hospital and her symptoms have now resolved aside from occasional mild headache (conflicting information). She denied any vision loss or chronic pain. Rash has resolved with slight scarring (recovered).   The causal relationship between the events and suspect vaccine were unknown/not reported/not provided.   As per internal review, the event ophthalmic herpes zoster was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Scar
Clinical narrative: shingles with ocular involvement; diagnosed with shingles; This spontaneous report was received from a consumer and refers to herself, a female patient of unknown age. The patient's medical history , concurrent conditions and concomitant therapies were not reported.   On 2015 (reported as  approximately 10 years ago), the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) for prophylaxis (strength, dose number, vaccination schedule, expiration date, and lot # were not reported).  On early March of 2025 (also reported as approximately 10 years later), the patient developed shingles with ocular involvement (ophthalmic herpes zoster). Her symptoms began with unilateral, L-sided headache, for which her PCP obtained a head CT (results not provided). Her pain significantly worsened to the point where she presented to the emergency room and was diagnosed with shingles (Herpes zoster). Patient had a small rash on her left forehead, and involvement of her L eye (but not the retina, conflicting information) and was started on steroids, antivirals and pain medication (gabapentin).  On an unspecified date in 2025, she was followed closely by XXX Hospital and her symptoms have now resolved aside from occasional mild headache (conflicting information). She denied any vision loss or chronic pain. Rash has resolved with slight scarring (recovered).   The causal relationship between the events and suspect vaccine were unknown/not reported/not provided.   As per internal review, the event ophthalmic herpes zoster was determined to be medically significant.
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on 5/10/17, second dose on 6/21/17 and third dose on 9/24/18; This spontaneous report has been received from a consumer, regarding herself, a female patient of unknown age.  The patient's pertinent medical history, concurrent conditions, drug allergies or concomitant medications were not reported.  On 10-May-2017, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (lot #M040412, expiration date: 30-Jun-2019), dose number 1, on 21-Jun-2017, the dose number 2, and on 24-Sep-2018, dose number 3 (inappropriate schedule of product administration); all at a dose of 0.5 mL for prophylaxis.
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details reported.; was inadvertently administered expired VAQTA on 04/25/2025; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 25-APR-2025, the patient was inadvertently administered dose of expired hepatitis A vaccine, inactivated (VAQTA) (0.5 ml/dose; lot # X025908, expiration date: 24-APR-2025; strength, formulation, dose #, route and anatomical site were unknown) for prophylaxis (expired product administered). No additional adverse event details reported (no adverse event). The outcome of the event was unknown.
Age: 4.0
Sex: M
Vaccine: MMR, UNK, UNK, UNK, VARCEL
Symptoms: Product storage error
Clinical narrative: No other information provided. No additional AEs/PQC reported.; vaccines administered after temperature excursion; This spontaneous report was received from a medical assistant and refers to a(n) 4-year-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 17-APR-2025, the patient was vaccinated with vaccines that suffered temperature excursion with a temperature - 9.8 C, for a time frame of 2 hours 3 minutes, with digital data logger: dose number 2Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) solution for injection (lot #Y000225, expiration date: 03-JAN-2026), administered by Subcutaneous route in Left Thigh; dose # 2 of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection (lot #Y011019, expiration date: 18-JUN-2026), administered by subcutaneous route in Left Thigh, both as prophylaxis (exact doses not reported), reconstituted with sterile diluent. Also received on the same date, Diphtheria vaccine toxoid (+) Pertussis vaccine acellular (+) Tetanus vaccine toxoid (Dtap) (lot #3CA20C1, expiration date: 28-FEB-2026) (Previous doses: 4, administered right thigh), administered by Intramuscular route; Ipv (Polio vaccine inact) (lot #NIC74IM, expiration date: 17-NOV-2025) (Number of previous doses: 3, administered right thigh), administered by Intramuscular route; and Influenza vaccine (Influenza vaccine) (lot #U8442BA, expiration date: 30-JUN-2025) (Number of previous doses: 4, administered Right thigh), administered by Intramuscular route (doses, indications were not reported). No previous temperature excursions were reported. No other information provided. No additional adverse events (AEs)/product quality complaints (PQC) reported.
Vaccine: MMR, MMR, MMR, MMR
Symptoms: Ill-defined disorder
Clinical narrative: Inbound call from HCP requesting MIR. HCP did mention that her patient received the second dose of MMR-II today and patient has a bilateral simple mastectomy and bilateral axillary lymph node biopsy scheduled for 20MAY2025.; This spontaneous report has been received from a consumer regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), administered as prophylaxis (strength, dose, route of administration, anatomical site of injection, lot number, and expiration date were not reported). On 28-APR-2025, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), administered as prophylaxis (strength, dose, route of administration, anatomical site of injection, lot number, and expiration date were not reported).  Both doses were reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number and expiration date were not reported).  On an unknown date, the patient experienced ill-defined disorder. The reporter mentioned that her patient had a bilateral simple mastectomy and bilateral axillary lymph node biopsy scheduled for 20-MAY-2025. The outcome of the event was unknown.   The causal relationship between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not reported.
Sex: F
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a physician and refers to a 13-month-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Hepatitis A Vaccine, Inactivated (VAQTA), Diphtheria vaccine toxoid (+) HIB vaccine conj (tet tox) (+)Pertussis vaccine acellular 5-component (+)Polio vaccine inact 3v (MRC 5) (+) Tetanus vaccine toxoid (PENTACEL), Hepatitis b vaccine and Pneumococcal vaccine conj 20v (CRM197) (PREVENAR 20) .  On 31-Mar-2025, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA [recombinant Human albumin]) administered subcutaneous on the right thigh as prophylaxis (Lot No. Y017511 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported and but upon internal validation established as 15-Apr-2026; that was reconstituted with sterile diluent, administered subcutaneous (indication, Lot No., and expiration date was not provided) (product storage error). No additional adverse event was reported (no adverse event). This is one of several reports received from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-04-28 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : , Central date : 2025-04-28 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This serious case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In FEB-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (Verbatim: Bell's palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.     The company considered the bell's palsy to be unrelated to Shingrix.   Additional Information: GSK receipt date: 25-APR-2025 The patient is the reporter. The patient received the first dose of Shingrix about 2.5 months ago in February 2025, and developed Bell's Palsy. This is 1 of the 2 cases reported by the same reporter.; Sender's Comments: Bell's palsy  is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GSK-US2025050413:Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This serious case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several weeks after receiving Shingrix, the patient experienced bell's palsy (Verbatim: Bell's palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.     The company considered the bell's palsy to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 25-APR-2025 The patient was an acquaintance of the reporter. A couple weeks after receiving Shingrix, the patient developed Bell's Palsy. The date of vaccination was not provided and which dose of Shingrix was not provided.; Sender's Comments: Bell's palsy is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GSK-US2025050407:Different patient
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: Pain in arm; general soreness / between my toes and web of hands hurt and thumbs; miserable; In bed all day; Muscle pain; This non-serious case was reported by a consumer via sales rep and described the occurrence of feeling miserable in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received first dose on an unknown date (refer case US2025AMR048591)). Concurrent medical conditions included migraine headache (since child).   On 19-APR-2025, the patient received the 2nd dose of Shingrix. On 20-APR-2025, 1 days after receiving Shingrix, the patient experienced feeling miserable (Verbatim: miserable), bedridden (Verbatim: In bed all day) and muscle pain (Verbatim: Muscle pain). On 21-APR-2025, the patient experienced pain in arm (Verbatim: Pain in arm) and general body pain (Verbatim: general soreness / between my toes and web of hands hurt and thumbs). The outcome of the feeling miserable, bedridden and muscle pain were resolving and the outcome of the pain in arm and general body pain were not resolved.   The reporter considered the feeling miserable and bedridden to be related to Shingrix. It was unknown if the reporter considered the muscle pain, pain in arm and general body pain to be related to Shingrix.     The company considered the feeling miserable and bedridden to be related to Shingrix. It was unknown if the company considered the muscle pain, pain in arm and general body pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR048591   Additional Information: GSK Receipt Date: 21-APR-2025 The reporter received a text message this morning from a friend (patient) who had received the Shingrix vaccine.  The patient mentioned that she was miserable and in bed all day suffering from the effects of vaccination. The patient also mentioned that she got vaccine on Saturday and on Sunday morning she did not had a single muscle that did not hurt.  The patient stated it was the worst reaction to any vaccine she ever had. She slept all day in between moaning in pain and only thing she did was feed cats and that was Herculean effort. The patient was hurt on the first one too but yesterday was just awful and still sore but can handle today so far.  She meant in between the toes and web of hands hurt and thumbs and you name it, there was nothing which did not hurt.  The patient stated that today her arm does which is to be expected and general soreness like survived a battle. She has had migraine headaches since she was a child.; Sender's Comments:  US-GSK-US2025AMR048591:Same patient/Diffrent dose
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Injection site warmth, Loss of personal independence in daily activities
Clinical narrative: Joint pain/Elbow pain; pain in her entire upper right arm, radiating all the way from the top of her arm into her elbow.; had soreness at injection site/Injection site pain; Injection site warmth; unable to bring her arm up; unable to bring her arm up far enough to don a pair of earrings or come hair due to the pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypothyroidism, diabetes, blood cholesterol increased (Cholesterol high), gastroesophageal reflux (gastric reflux), energy decreased, anxiety and depression. Concomitant products included levothyroxine sodium (Euthyrox), tirzepatide (Mounjaro), rosuvastatin, omeprazole, magnesium oxide, clonazepam, duloxetine hydrochloride (Cymbalta), citric acid, inositol, magnesium citrate, musa x paradisiaca, pyridoxine hydrochloride (Kidney Cop) and aspirin.   On 15-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On 15-APR-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: had soreness at injection site/Injection site pain) and injection site warmth (Verbatim: Injection site warmth). In APR-2025, the patient experienced mobility decreased (Verbatim: unable to bring her arm up) and activities of daily living impaired (Verbatim: unable to bring her arm up far enough to don a pair of earrings or come hair due to the pain). On 20-APR-2025, the patient experienced arthralgia (Verbatim: Joint pain/Elbow pain) and pain in arm (Verbatim: pain in her entire upper right arm, radiating all the way from the top of her arm into her elbow.). The outcome of the injection site pain, injection site warmth, arthralgia, pain in arm, mobility decreased and activities of daily living impaired were resolving.   It was unknown if the reporter considered the injection site pain, injection site warmth, arthralgia, pain in arm, mobility decreased and activities of daily living impaired to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site warmth, arthralgia, pain in arm, mobility decreased and activities of daily living impaired to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-APR-2025 The patient self-reported this case for herself.  The reporter received her first Shingrix in her right deltoid.  She reported that the same day, she had soreness and warmth at the injection site, which still persists but was improving.  At beginning 20th April 2025 she noted pain in her entire upper right arm, radiating all the way from the top of her arm into her elbow.  She stated that she was unable to bring her arm up far enough to done a pair of earrings or come hair due to the pain.  She stated that it may be a little better on the day of reporting.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Joint pain/Elbow pain; pain in her entire upper right arm, radiating all the way from the top of her arm into her elbow.; had soreness at injection site/Injection site pain; Injection site warmth; unable to bring her arm up; unable to bring her arm up far enough to don a pair of earrings or come hair due to the pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypothyroidism, diabetes, blood cholesterol increased (Cholesterol high), gastroesophageal reflux (gastric reflux), energy decreased, anxiety and depression. Concomitant products included levothyroxine sodium (Euthyrox), tirzepatide (Mounjaro), rosuvastatin, omeprazole, magnesium oxide, clonazepam, duloxetine hydrochloride (Cymbalta), citric acid, inositol, magnesium citrate, musa x paradisiaca, pyridoxine hydrochloride (Kidney Cop) and aspirin.   On 15-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On 15-APR-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: had soreness at injection site/Injection site pain) and injection site warmth (Verbatim: Injection site warmth). In APR-2025, the patient experienced mobility decreased (Verbatim: unable to bring her arm up) and activities of daily living impaired (Verbatim: unable to bring her arm up far enough to don a pair of earrings or come hair due to the pain). On 20-APR-2025, the patient experienced arthralgia (Verbatim: Joint pain/Elbow pain) and pain in arm (Verbatim: pain in her entire upper right arm, radiating all the way from the top of her arm into her elbow.). The outcome of the injection site pain, injection site warmth, arthralgia, pain in arm, mobility decreased and activities of daily living impaired were resolving.   It was unknown if the reporter considered the injection site pain, injection site warmth, arthralgia, pain in arm, mobility decreased and activities of daily living impaired to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site warmth, arthralgia, pain in arm, mobility decreased and activities of daily living impaired to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-APR-2025 The patient self-reported this case for herself.  The reporter received her first Shingrix in her right deltoid.  She reported that the same day, she had soreness and warmth at the injection site, which still persists but was improving.  At beginning 20th April 2025 she noted pain in her entire upper right arm, radiating all the way from the top of her arm into her elbow.  She stated that she was unable to bring her arm up far enough to done a pair of earrings or come hair due to the pain.  She stated that it may be a little better on the day of reporting.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: administered two doses of SHINGRIX in the consumers right arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of overdose in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer, lung nodule and lung neoplasm surgery. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 28-DEC-2024, the patient received the 2nd dose of Shingrix (intramuscular, right arm) .5 ml. On 28-DEC-2024, an unknown time after receiving Shingrix, the patient experienced overdose (Verbatim: administered two doses of SHINGRIX in the consumers right arm). On 28-DEC-2024, the outcome of the overdose was not applicable.   Additional Information: GSK Receipt Date: 22-APR-2025 On 28 December 2024 the patient presented to the pharmacy for her first dose of Shingrix. The vaccinating healthcare professional administered two doses of Shingrix in the patient's right arm which led to overdose. The consumer reported that she was diagnosed with breast cancer in 2016 and also reported she had a nodule was removed from her lung in 2012. Other Products were reported as no
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling
Clinical narrative: Left eye Swollen; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of eye swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number F95YS, expiry date 31-MAR-2027) for prophylaxis.   On 23-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 23-APR-2025, less than a day after receiving Shingrix, the patient experienced eye swelling (Verbatim: Left eye Swollen). The outcome of the eye swelling was not resolved.   It was unknown if the reporter considered the eye swelling to be related to Shingrix.     It was unknown if the company considered the eye swelling to be related to Shingrix.   Additional Information: GSK receipt date: 23-APR-2025 The pharmacist called on behalf of the patient who had received her first Shingrix vaccine today in her left arm and came back 2 hours later same day with her swollen left eye.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: inadvertently gave Priorix intramuscularly instead of Subcutaneous; This non-serious case was reported by a consumer via sales rep and described the occurrence of subcutaneous injection formulation administered by other route in a female patient who received MMR (Priorix) for prophylaxis.   On 23-APR-2025, the patient received Priorix. On 23-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: inadvertently gave Priorix intramuscularly instead of Subcutaneous). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   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: 23-APR-2025 Nurse inadvertently gave Priorix intramuscularly instead of subcutaneous, which led to subcutaneous injection formulation administered by other route.
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: injection site pain; Arm pain; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site pain in an unspecified number of patients 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 injection site pain (Verbatim: injection site pain) and pain in arm (Verbatim: Arm pain). The outcome of the injection site pain and pain in arm were resolved.   The reporter considered the injection site pain and pain in arm to be related to Shingrix.     The company considered the injection site pain and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-APR-2025 The reporter was Respriatory Therapists. During group presentation, multiple audience members (HCPs) shared experience with receiving Shingrix including injection site pain and arm pain. Pain described as very painful and hesitation to receive second dose as a result.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: swollen 6 in. by 2 in swelling starting just below the injection site; Very painful; Hot; Red; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 64-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included paracetamol (Tylenol) and levocabastine hydrochloride (Zyrtec).   On 24-APR-2025, the patient received the 1st dose of Shingles vaccine. On 24-APR-2025, less than a day after receiving Shingles vaccine, the patient experienced injection site swelling (Verbatim: swollen 6 in. by 2 in swelling starting just below the injection site), pain (Verbatim: Very painful), feeling hot (Verbatim: Hot) and erythema (Verbatim: Red). The outcome of the injection site swelling, pain, feeling hot and erythema were not resolved.   It was unknown if the reporter considered the injection site swelling, pain, feeling hot and erythema to be related to Shingles vaccine.     It was unknown if the company considered the injection site swelling, pain, feeling hot and erythema to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-APR-2025 This report was submitted via the online direct entry reporting system. The patient had very painful, hot red swollen 6 inch by 2 inch swelling starting just below the injection site. The patient had never before had a reaction like this to a vaccine.
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain
Clinical narrative: About 5 days later I noticed a weird sensation on my right thigh that has been persistent for 8 days now; It feels like any time my hair follicles move, there is a stinging kind of pain; It knocked me on my butt for 2 days but i got better; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of weird feeling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced weird feeling (Verbatim: About 5 days later I noticed a weird sensation on my right thigh that has been persistent for 8 days now), pain (Verbatim: It feels like any time my hair follicles move, there is a stinging kind of pain) and unwell (Verbatim: It knocked me on my butt for 2 days but i got better). The outcome of the weird feeling was not resolved and the outcome of the pain was not reported and the outcome of the unwell was resolved.   It was unknown if the reporter considered the weird feeling, pain and unwell to be related to Shingrix.     It was unknown if the company considered the weird feeling, pain and unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that recently got second Shingrix shot, (about two weeks ago, in right arm it knocked on my butt for 2 days, but the reporter got better. About 5 days later reporter noticed a weird sensation on right thigh that has been persistent for 8 days now. It felt like any time reporter hair follicles move, there was a stinging kind of pain. It had been very distracting.; Sender's Comments:  US-GSK-US2025AMR049026:same reporter different patient US-GSK-US2025AMR049051:same reporter different patient US-GSK-US2025AMR049045:same reporter different patient
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chemotherapy, Herpes zoster, Herpes zoster oticus, Pain
Clinical narrative: Suspected vaccination failure; dealing with Ramsay Hunt Syndrome; Mine is on the left side of my face and head with ear involvement and blisters all around my eye; PHN right now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included c-section, knee replacement and neck surgery (with titanium plates and screws).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ramsay-hunt syndrome (Verbatim: dealing with Ramsay Hunt Syndrome) (serious criteria GSK medically significant), shingles (Verbatim: Mine is on the left side of my face and head with ear involvement and blisters all around my eye) and post herpetic neuralgia (Verbatim: PHN right now). The outcome of the vaccination failure and shingles were not reported and the outcome of the ramsay-hunt syndrome and post herpetic neuralgia were not resolved.   It was unknown if the reporter considered the vaccination failure, ramsay-hunt syndrome, shingles and post herpetic neuralgia to be related to Shingles vaccine.     The company considered the vaccination failure and ramsay-hunt syndrome to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 22-APR-2025 This case was reported by a patient via interactive digital media. The patient was dealing with Ramsay Hunt Syndrome and post herpetic neuralgia right now and she never experienced pain like this in her life.  She had three children, one was a C-section, two total knee replacements, neck surgery with titanium plates and screws and more but none of it compared to the pain she had been experienced for two months.  Her was on the left side of her face and head with ear involvement and blisters all around her eye.  She got the vaccine but chemo treatments wiped out the vaccine.  The reporter stated that to get vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; dealing with Ramsay Hunt Syndrome; Mine is on the left side of my face and head with ear involvement and blisters all around my eye; PHN right now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included c-section, knee replacement and neck surgery (with titanium plates and screws).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ramsay-hunt syndrome (Verbatim: dealing with Ramsay Hunt Syndrome) (serious criteria GSK medically significant), shingles (Verbatim: Mine is on the left side of my face and head with ear involvement and blisters all around my eye) and post herpetic neuralgia (Verbatim: PHN right now). The outcome of the vaccination failure and shingles were not reported and the outcome of the ramsay-hunt syndrome and post herpetic neuralgia were not resolved.   It was unknown if the reporter considered the vaccination failure, ramsay-hunt syndrome, shingles and post herpetic neuralgia to be related to Shingles vaccine.     The company considered the vaccination failure and ramsay-hunt syndrome to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 22-APR-2025 This case was reported by a patient via interactive digital media. The patient was dealing with Ramsay Hunt Syndrome and post herpetic neuralgia right now and she never experienced pain like this in her life.  She had three children, one was a C-section, two total knee replacements, neck surgery with titanium plates and screws and more but none of it compared to the pain she had been experienced for two months.  Her was on the left side of her face and head with ear involvement and blisters all around her eye.  She got the vaccine but chemo treatments wiped out the vaccine.  The reporter stated that to get vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; and nowhave the Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In DEC-2024, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: and nowhave the Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that got the shot in December and now  have the Shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I never got my second shingles shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: I never got my second shingles shot). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date : 23-APR-2025 The patient never got her/his second shingles shot. It's been over a year since he/she had first one. The patient asked what should he/she did. Till the time of reporting the patient had not received the second dose of Shingles vaccine, which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got shingles two months after getting the vaccine.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 months after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got shingles two months after getting the vaccine.). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that patient got shingles two months after getting the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix
Vaccine: VARZOS
Symptoms: Hypersomnia
Clinical narrative: slept a lot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sleep excessive in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sleep excessive (Verbatim: slept a lot). The outcome of the sleep excessive was resolved.   It was unknown if the reporter considered the sleep excessive to be related to Shingles vaccine.     It was unknown if the company considered the sleep excessive to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-APR-2025 This case was reported by a patient via interactive digital media. The patient had both shots and first had no problem and after the second slept a lot and patient was good.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got the shingle shot to an still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the shingle shot to an still got them). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. The patient got the shingle shot and still got them even the mild case hurts. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.