chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Medical assistant reported ROTATEQ  was administered after temperature excursion. See full details below. No additional AE/no PQC.  ?    Names of vaccines involved ROTATEQ 1968393 05/24/2024 ?    Temperature 8.9°C (08/14/2023) and 9.4°C (08/28/; This spontaneous report was received from a medical assistant and refers to an unknown age and gender patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-SEP-2023, the patient received the improper storage vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1968393, has been verified to be a valid lot number, expiration date was reported as: 24-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided) (improper storage of product in use). The therapy was storaged 12 hours 20 minutes 0 seconds with temperature 8.9 degrees Celsius on 14-AUG-2023 and 8 hours 20 minutes 0 seconds with temperature 9.4 degrees Celsius on 28-AUG-2023. No additional AE/no PQC.
Sex: F
Vaccine: HPV9
Symptoms: HIV antibody positive, HIV antigen negative
Clinical narrative: patient is now having positive HIV antibody tests; This spontaneous report was received from a pharmacist and refers to female patient of unknown age. No information on patient's medical history, concurrent conditions and concomitant medications was provided.   On 23-SEP-2023, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (injection) (intramuscularly, exact dose, lot #, expiration date and anatomical location were not provided) for prophylaxis.  On unknown day in October 2023 (reported as 'approximately 2 weeks after completing the series'), patient was having positive human immunodeficiency virus (HIV) antibody tests. The patient's HIV antibody tests were positive, but the HIV antigen tests had come back negative. Outcome of the event was unknown.  The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient is fine. Confirmed no other symptoms or adverse events; administration of VARIVAX that was expired; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-OCT-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, once, lot #U030162 (lot number has been verified as valid for VARIVAX), expiration date: 28-SEP-2023 (strength, anatomical location, and route of administration were not provided) as prophylaxis. It was stated that the patient was fine. No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; not the correct schedule/ third dose was given earlier than recommended in the Prescribing Information; This spontaneous report was received from a staff from another company, who received an email from a nurse, referring to an adult female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 02-OCT-2019, the patient received her first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (product circular number: uspi-v503-i-2304r015; strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis. On 04-DEC-2019, the patient received her second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (product circular number: uspi-v503-i-2304r015; strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis. On 03-FEB-2020, the patient received her third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (product circular number: uspi-v503-i-2304r015; strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis, which was recorded as " clearly not the correct schedule" by the nurse. This third dose was given earlier than recommended in the prescribing information (inappropriate schedule of product administration). No additional adverse events (AE) were reported (no adverse event).
Age: 8.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; Caller is a nurse who reports GARDASIL 9 was administered to an 8 year old female patient on 10/11/2023.; This spontaneous report was received from a nurse referring to 8-year-old female patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 11-OCT-2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot #W031448 was valid for formulation pre-filled syringe, expiration date 12-FEB-2025, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Inappropriate age at vaccine administration). No additional adverse event (AE) or product quality complaint (PQC) reported (No adverse event).
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; HCP called to report inadvertent administration of GARDASIL 9 to a 6-year-old male patient on 10/13/2023. Limited patient demographics provided. No additional AE/PQC.; This spontaneous report was received from a medical assistant and refers to a 6-year-old male patient. No information on patient's medical history current conditions and concomitant medications was provided.  On 13-OCT-2023 the patient was vaccinated at inappropriate age with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # X005044 and expiration date 02-JAN-2025 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product administered to patient of inappropriate age and no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; VARIVAX was administered during a T/E; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 16-OCT-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (1 dosage form, lot #X010525, expiration date 11-APR-2025, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  On 13-OCT-2023, the suspect vaccine experienced a temperature excursion of 12.5 degrees Fahrenheit for 25 minutes. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event).
Age: 71.0
Sex: M
Vaccine: PNC15
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further AE; expired vaccine given; This spontaneous report was received from a nurse referring to a 71-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-OCT-2023, the patient was vaccinated with an expired dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (lot #W021512, expiration date: 08-OCT-2023), 0.5 milliliter administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No further adverse events (AE) were reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Back pain, Herpes zoster, Pain, Sensitive skin
Clinical narrative: Suspected vaccination failure; Shingles; burning throbbing pain in the right lower back radiating to the right abdomen; hypersensitivity of the skin in this area; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 69-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number L63B4, expiry date 08-APR-2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) (batch number N3755) for prophylaxis.   Concurrent medical conditions included diabetes, hypertension, hyperlipidemia, hypothyroidism and peripheral vascular disease. Concomitant products included metformin, valsartan, bisoprolol fumarate, rosuvastatin, levothyroxine, cilostazol (Pletal) and clopidogrel bisulfate (Plavix).   On 26-JUN-2022, the patient received the 2nd dose of Shingles vaccine 50 ug. On 15-MAR-2022, the patient received the 1st dose of Shingles vaccine 50 ug. On 14-SEP-2023, 445 days after receiving Shingles vaccine and 548 days after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: burning throbbing pain in the right lower back radiating to the right abdomen) and hypersensitivity (Verbatim: hypersensitivity of the skin in this area).  The patient was treated with methylprednisolone (Medrol) and valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and hypersensitivity were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and hypersensitivity to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and hypersensitivity to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 12-OCT-2023 This report was submitted via the online direct entry reporting system.  The patient was not pregnant. The patient self-reported this case. The patient received other products concomitantly. The patient received Shingrix and had burning throbbing pain in the right lower back radiating to the right abdomen with hypersensitivity of the skin in this area and shingles. The patient had no rash. The symptoms were treated with Medrol dosepack and currently on Valtrex for almost a week. The symptoms began from 14-SEP-2023 and still ongoing. The symptoms were treated. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; burning throbbing pain in the right lower back radiating to the right abdomen; hypersensitivity of the skin in this area; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 69-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number L63B4, expiry date 08-APR-2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) (batch number N3755) for prophylaxis.   Concurrent medical conditions included diabetes, hypertension, hyperlipidemia, hypothyroidism and peripheral vascular disease. Concomitant products included metformin, valsartan, bisoprolol fumarate, rosuvastatin, levothyroxine, cilostazol (Pletal) and clopidogrel bisulfate (Plavix).   On 26-JUN-2022, the patient received the 2nd dose of Shingles vaccine 50 ug. On 15-MAR-2022, the patient received the 1st dose of Shingles vaccine 50 ug. On 14-SEP-2023, 445 days after receiving Shingles vaccine and 548 days after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: burning throbbing pain in the right lower back radiating to the right abdomen) and hypersensitivity (Verbatim: hypersensitivity of the skin in this area).  The patient was treated with methylprednisolone (Medrol) and valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and hypersensitivity were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and hypersensitivity to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and hypersensitivity to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 12-OCT-2023 This report was submitted via the online direct entry reporting system.  The patient was not pregnant. The patient self-reported this case. The patient received other products concomitantly. The patient received Shingrix and had burning throbbing pain in the right lower back radiating to the right abdomen with hypersensitivity of the skin in this area and shingles. The patient had no rash. The symptoms were treated with Medrol dosepack and currently on Valtrex for almost a week. The symptoms began from 14-SEP-2023 and still ongoing. The symptoms were treated. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: breaking out in a lone shingle on my trunk/suspected vaccination failure; breaking out in a lone shingle on my trunk; mild itching; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   Additional patient notes included had received the Merck single dose vaccine in 2020.   On an unknown date, the patient received Shingrix and INFLUENZA VACCINE. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: breaking out in a lone shingle on my trunk/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: breaking out in a lone shingle on my trunk) and pruritus (Verbatim: mild itching).  The patient was treated with hydrocortisone (Hydrocortisone Cream). The outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and pruritus to be related to Shingrix.   Additional Information: GSK receipt date:12-Oct-2023 The patient received Shingrix in 2021 and recently went to a new practice and was given both the high-dose flu vaccine and Pneumovax-20 in a single day. The patient's body responded to the double dutch vaccines by breaking out in a lone shingle on the trunk no nerve pain, mild itching, controlled with hydrocortisone topical cream. All this to say that Shingrix works. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to influenza vaccine.
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia, Pharyngeal hypoaesthesia, Product after taste
Clinical narrative: Right side of face and throat went numb, felt as if I could taste the vaccine as it was being administered; Tingling feeling in face; This non-serious case was reported by a consumer and described the occurrence of numbness facial in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 9XL7N) for prophylaxis.   Previously administered products included Flu vaccine (received every year).   On 03-DEC-2022, the patient received Fluarix Quadrivalent 2022-2023 season (intramuscular) .5 ml. On 03-DEC-2022, less than a day after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced numbness facial (Verbatim: Right side of face and throat went numb, felt as if I could taste the vaccine as it was being administered) and tingling sensation (Verbatim: Tingling feeling in face). The outcome of the numbness facial and tingling sensation were resolved with sequelae.   It was unknown if the reporter considered the numbness facial and tingling sensation to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the numbness facial and tingling sensation to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.   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: 10-OCT-2023 This report was submitted via the online direct entry reporting system.  The patient stated that reaction to this vaccine was almost immediate.  The administering physician took my vitals and entered reaction information into their computer system, but why this happened was never resolved.  The patient still had slight numbness or tingling feeling on lower right side of my face or lip.  The patient had received flu vaccines every year since 2006 and this reaction had never happened to her before until this past year after receiving flu vaccine. Right side of face and throat went numb, felt as if she could taste the vaccine as it was being administered. The symptoms were not treated. The reporter agreed to follow up with GlaxoSmithKline (GSK).
Sex: F
Vaccine: VARZOS
Symptoms: Lip blister
Clinical narrative: Blister lip; This non-serious case was reported by a consumer and described the occurrence of lip blister in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-OCT-2023, the patient received Shingrix. On 12-OCT-2023, 5 days after receiving Shingrix, the patient experienced lip blister (Verbatim: Blister lip).  The outcome of the lip blister was not resolved.   It was unknown if the reporter considered the lip blister to be related to Shingrix.     It was unknown if the company considered the lip blister to be related to Shingrix.   Additional Information: GSK receipt date: 14-OCT-2023 The concomitant product too many to list. The reporter did not consente to follow up.
Sex: U
Vaccine: RSV
Symptoms: Headache
Clinical narrative: Headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced headache (Verbatim: Headache).  The outcome of the headache was not reported.   It was unknown if the reporter considered the headache to be related to Arexvy.     It was unknown if the company considered the headache to be related to Arexvy.   Additional Information: GSK receipt date: 09-OCT-2023 This case was reported the patient via interactive digital media. Follow-up not possible as no contact details provided.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: later to be diagnosed with shingles; Individual reports forgetting to get second shingles vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the patient did not receive 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: later to be diagnosed with shingles) and incomplete course of vaccination (Verbatim: Individual reports forgetting to get second shingles vaccine).  The outcome of the shingles was not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date:11-OCT-2023 The patient reported about forgetting to get second shingles vaccine. The patient had 1st dose and later to be diagnosed with shingles. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: reported his arm was sore; he had flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-OCT-2023, the patient received the 1st dose of Shingrix. In OCT-2023, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: reported his arm was sore) and influenza-like symptoms (Verbatim: he had flu like symptoms).  The outcome of the pain in arm and influenza-like symptoms were not reported.   It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the pain in arm and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt date: 12-OCT-2023 A reporter reported that his/her father in law got the first dose of shingrix Monday 09 October 2023 and reported his arm was sore and he had flu like symptoms. The reporter did not agree to follow up from GSK.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash
Clinical narrative: pain in the injection site; rash on her arm; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a female 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 injection site pain (Verbatim: pain in the injection site) and rash (Verbatim: rash on her arm).  The outcome of the injection site pain and rash were not reported.   It was unknown if the reporter considered the injection site pain and rash to be related to Shingrix.     It was unknown if the company considered the injection site pain and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-OCT-2023 The reporter vaccinated another (unspecified) that had pain in the injection site and developed a rash on her arm. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Breast discharge, Erythema, Rash
Clinical narrative: Rash; redness on left chest and under his left breast.; Breast discharge; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of erythema in a 84-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30-MAY-2023, the patient received Shingles vaccine. In JUN-2023, 2 weeks after receiving Shingles vaccine, the patient experienced erythema (Verbatim: redness on left chest and under his left breast.). On an unknown date, the patient experienced breast discharge (Verbatim: Breast discharge) and rash (Verbatim: Rash).  The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the erythema and rash were not reported and the outcome of the breast discharge was resolved (duration 2 months).   It was unknown if the reporter considered the erythema, breast discharge and rash to be related to Shingles vaccine.     It was unknown if the company considered the erythema, breast discharge and rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-OCT-2023 Patient advised he received the shingles vaccine and developed 2 weeks post vaccination some redness on left chest and under his left breast. When asked exact start date was unknown. Patient advised that he got an antiviral to counteract the symptoms of shingles 2 days after the rash appeared but no pain, when asked exact start date was unknown. Patient advised he has redness with slight discharge for 2 months, when asked exact start date was unknown and no further details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A friend got a shingles shot a year ago, she just got a second shot; 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 female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received first shot a year ago 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 drug dose administration interval too long (Verbatim: A friend got a shingles shot a year ago, she just got a second shot). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2023 The reporter stated that, the friend (patient) of him/her got a Shingles shot a year ago and she just got a second shot, which led to lengthening of the vaccination scheduled. The reporter wanted to know, did patient need an additional shot since she waited so long. The consent to follow up requested.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain, Rash, Swelling
Clinical narrative: Immediate swelling; rash; Pain; This non-serious case was reported by a nurse via sales rep and described the occurrence of swelling in a elderly female 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 swelling (Verbatim: Immediate swelling), rash (Verbatim: rash) and pain (Verbatim: Pain).  The outcome of the swelling, rash and pain were resolved.   The reporter considered the swelling, rash and pain to be related to Shingrix.     The company considered the swelling, rash and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-OCT-2023 The patient received a dose of Shingrix and had immediate swelling, rash, pain lasting past 1 week. The patient sought medical care after 1 week for symptoms related to injection. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthma, Dyspnoea, Inappropriate schedule of product administration, Pruritus
Clinical narrative: itching; Asthma; Breathing problem; Due to pandemic, she never received the 2nd dose; shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) solution for injection in pre-filled pen for asthma and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix, Nucala cyclically and the 2nd dose of Shingrix. In JUN-2023, more than 2 years after receiving Shingrix, an unknown time after starting Nucala and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). On an unknown date, the patient experienced pruritus (Verbatim: itching), asthma (Verbatim: Asthma), difficulty breathing (Verbatim: Breathing problem) and social problem (Verbatim: Due to pandemic, she never received the 2nd dose).  Nucala was continued with no change. The outcome of the shingles was resolved and the outcome of the pruritus was not resolved and the outcome of the asthma and difficulty breathing were not reported and the outcome of the social problem was unknown.   It was unknown if the reporter considered the shingles, pruritus, asthma and difficulty breathing to be related to Shingrix. It was unknown if the reporter considered the pruritus to be related to Nucala and Nucala Autoinjector Device.     It was unknown if the company considered the shingles, pruritus, asthma and difficulty breathing to be related to Shingrix. It was unknown if the company considered the pruritus to be related to Nucala and Nucala Autoinjector Device.   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: 09-SEP-2023 The patient self-reported this case. The patient stated that due to the pandemic and the loss of her husband, she never received the 2nd dose (inappropriate schedule of vaccine).  She also mentioned that during that time she started having trouble breathing and was later diagnosed with asthma.  The patient stated that she had Shingles in June 2023 and still had some residual itching now.  The patient started taking Nucala approximately 3 months ago.  She stated that she no longer had Shingles but still had itching, she called to inquire if this could be a side effect of the Nucala as she was unsure. The patient did not had time to continue the conversation so she did not provide HCP information during the call.  The patient stated the she received her dose of Shingrix at a pharmacy, however, she did not provide any additional details. The reporter consented to follow up.
Sex: M
Vaccine: RSV
Symptoms: Incorrect route of product administration, Wrong technique in product usage process
Clinical narrative: accidentally administered a dose of Arexvy using a shorter than recommended needle; Probable subcutaneous administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in product usage process in a 65-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy (subcutaneous). On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong technique in product usage process (Verbatim: accidentally administered a dose of Arexvy using a shorter than recommended needle) and intramuscular formulation administered by other route (Verbatim: Probable subcutaneous administration).  The outcome of the wrong technique in product usage process and intramuscular formulation administered by other route were unknown.   Additional Information: GSK receipt date: 9-Oct-2023 A pharmacist called in to report that an intern accidentally administered a dose of Arexvy using a shorter than recommended needle and wanted to know how to proceed.  The reporter gave partial information about the event and patient but consented to receive follow-up calls. The reporter consented to follow up. An intern accidentally administered a dose of Arexvy using a shorter than recommended needle probably subcutaneously, which led wrong technique in product usage process and intramuscular formulation administered by other route.
Sex: F
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered
Clinical narrative: accidentally administered a partial dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 68-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4HY3A, expiry date 23-JAN-2025) for prophylaxis.   On 09-OCT-2023, the patient received Arexvy. On 09-OCT-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: accidentally administered a partial dose of Arexvy).  The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 09-OCT-2023 The pharmacist stated that a pharmacy tech accidentally administered a partial dose of Arexvy to a female patient because the patient moved during injection and the needle came out before injection was complete which led to incomplete dose administered. There was still 0.2mL remaining in the syringe when the needle was removed during injection. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.
Age: 29.0
Sex: M
Vaccine: COVID19, PNC20, RSV, UNK
Symptoms: Fatigue, Influenza like illness, Malaise, Pain, Product administered to patient of inappropriate age
Clinical narrative: patient under 60yoa received Arexvy along with Flucelvax PF, Prevnar 20, and Comirnaty on 6-Oct-2023.; more tired than normal; feeling a little flu like symptoms; achy; he stated he wasn't feeling well; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 29-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number b3302, expiry date 02-FEB-2025) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for prophylaxis, INFLUENZA VACCINE INACT (FLUCELVAX PFS (FLU VACCINE)) for prophylaxis and TOZINAMERAN (COMIRNATY) for prophylaxis.   On 06-OCT-2023, the patient received Arexvy (intramuscular, left arm), PREVNAR 20, FLUCELVAX PFS (FLU VACCINE) and COMIRNATY. On 06-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: patient under 60yoa received Arexvy along with Flucelvax PF, Prevnar 20, and Comirnaty on 6-Oct-2023.). In OCT-2023, the patient experienced tiredness (Verbatim: more tired than normal), influenza-like symptoms (Verbatim: feeling a little flu like symptoms), pain (Verbatim: achy) and feeling unwell (Verbatim: he stated he wasn't feeling well). The outcome of the tiredness, influenza-like symptoms, pain and feeling unwell were not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the tiredness, influenza-like symptoms, pain and feeling unwell to be related to Arexvy.  It was unknown if the company considered the tiredness, influenza-like symptoms, pain and feeling unwell to be related to Arexvy.   Additional Information: GSK Receipt Date: 9-OCT-2023 A pharmacist reported patient under 60 years age who received Arexvy along with Flucelvax PF, Prevnar 20, and Comirnaty.  When pharmacist spoke with patient a day before reporting, he stated he was not feeling well.  He was feeling a little flu like symptoms, achy and more tired than normal.   Pharmacist was unsure about timing of onset of symptoms but as of day before reporting he still had symptoms. The reporter consented to follow up. An under age patient received Arexvy, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: RSV
Symptoms: Underdose
Clinical narrative: patient jerked arm away during administration of Arexvy dose and didn't get the full dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: patient jerked arm away during administration of Arexvy dose and didn't get the full dose).The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 09-OCT-2023 The reporter called to inquire that how to proceed with patient receiving a partial dose. The reporter reported a patient jerked arm away during administration of Arexvy dose and did not get the full dose, which led to incomplete dose administered. The reporter unable to provide any vaccine or patient details.  The reporter did not consent to follow-up.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact
Clinical narrative: Patients received incomplete dose; Part of the liquid came out patient's arm.; liquid came out patient's arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G2MG3, expiry date 24-FEB-2025) for prophylaxis.   On 09-OCT-2023, the patient received Arexvy. On 09-OCT-2023, an unknown time after receiving Arexvy, the patient experienced accidental underdose (Verbatim: Patients received incomplete dose), inadvertent exposure to vaccine (Verbatim: Part of the liquid came out patient's arm.) and exposure via skin contact (Verbatim: liquid came out patient's arm). The outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 09-OCT-2023 The reporter reported that during administering Arexvy vaccine part of the liquid came out patient's arm, which led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact The reporter stated that the patient received incomplete dose.  Patient was not immunocompromised. The reporter consented to follow up via postal.
Age: 52.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Inappropriate schedule of product administration, Serology abnormal, Therapy non-responder
Clinical narrative: due to test showing low to no titers; received 2nd dose on 28 Feb 2023 and 3rd dose in 5/1/2023; received 1st dose in Aug 2022 and 2nd in Feb 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 52-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) (batch number NT9X3, expiry date 09-SEP-2024) for prophylaxis and HBV (Engerix B adult) (batch number NT9X3, expiry date 09-SEP-2024) for prophylaxis.   On 01-MAY-2023, the patient received the 3rd dose of Engerix B adult. On 28-FEB-2023, the patient received the 2nd dose of Engerix B adult. In AUG-2022, the patient received the 1st dose of Engerix B adult. On 28-FEB-2023, not applicable after receiving Engerix B adult and Engerix B adult and an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: received 1st dose in Aug 2022 and 2nd in Feb 2023). On 01-MAY-2023, the patient experienced drug dose administration interval too short (Verbatim: received 2nd dose on 28 Feb 2023 and 3rd dose in 5/1/2023). On an unknown date, the patient experienced therapy non-responder (Verbatim: due to test showing low to no titers).  The outcome of the therapy non-responder, drug dose administration interval too long and drug dose administration interval too short were unknown.   Additional Information: GSK Receipt date: 09-OCT-2023 A pharmacist reported a patient was there to receive a dose of Engerix.  RPH explained that last year the patient received 2 shots (separate not same day) of Engerix around August 2022 (RPH was unaware of these), then one dose on 28 February 2023, and another Engerix on 01 May 2023.  HCP mentioned the patient stated they changed jobs and the job was requiring restart series due to test showing low to no titers.  Patient came in today for potentially another dose of Engerix. What to do. The patient received 2nd dose of Engerix later than the recommended interval, which led to lengthening of the vaccine schedule. The patient received 3rd dose of Engerix shorter than the recommended interval, which led to shortening the vaccine schedule. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: got sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a female 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 sickness (Verbatim: got sick).  The outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.     The company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 9-Oct-2023 The reporter was elderly.  She stated that she could not remember the details.   She had two female friends, she could not even remember who, who each got a shingles shot (she did not know if it was Shingrix or Zostavax) and both of them got sick. She did not provide any further details. She provided limited information. Did not consent to follow-up. The case was linked with case US2023138513 and US2023AMR143832, reported by the same reporter for different patients.; Sender's Comments:  US-GSK-US2023138513:same reporter US-GSK-US2023AMR143832:same reporter
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 18-SEP-2023, the patient received Arexvy. On 18-SEP-2023, less than a day after receiving Arexvy, the patient experienced pain in arm (Verbatim: Pain in left arm). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt date: 09-OCT-2023 The member of public received a dose of Arexvy and called in to request medical information stating she developed pain in left arm that had not receded. They were transferred to the correct department. The reporter denied the consent to follow up.
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Bexsero was administered to an 8-day old female; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-day-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 11-OCT-2023, the patient received Bexsero. On 11-OCT-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Bexsero was administered to an 8-day old female). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 11-OCT-2023 The healthcare professional (HCP) reported that a dose of Bexsero was administered to an 8-day old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 month old received the kinrix instead of Pentacel; 4 month old received the kinrix instead of Pentacel; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.   On 11-OCT-2023, the patient received Kinrix. On 11-OCT-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: 4 month old received the kinrix instead of Pentacel) and inappropriate age at vaccine administration (Verbatim: 4 month old received the kinrix instead of Pentacel). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 11-OCT-2023 A health care professional (HCP) reported that a 4 month old received the Kinrix instead of Pentacel, which led to wrong vaccine administered and inappropriate age at vaccine administration. No reactions reported. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site swelling, Skin haemorrhage
Clinical narrative: Potential subcutaneous administration; a bump suddenly appeared on her left deltoid at the injection site; patient started to bleed more than normal; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number ZS3D7, expiry date 08-OCT-2024) for prophylaxis.   On 11-OCT-2023, the patient received Shingrix (subcutaneous, left deltoid). On 11-OCT-2023, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Potential subcutaneous administration). In OCT-2023, the patient experienced injection site swelling (Verbatim: a bump suddenly appeared on her left deltoid at the injection site) and skin bleeding (Verbatim: patient started to bleed more than normal). The outcome of the injection site swelling and skin bleeding were not reported and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site swelling and skin bleeding to be related to Shingrix.     It was unknown if the company considered the injection site swelling and skin bleeding to be related to Shingrix.   Additional Information: GSK receipt date: 12-OCT-2023 The pharmacist requested data following potential SC (subcutaneous) injections of Shingrix.  HCP (health care professional) stated that patient started to bleed more than normal, and a bump suddenly appeared on her left deltoid at the injection site.  HCP called EMS (emergency medical service).  No sign of anaphylaxis and patient not on blood thinners. The reporter consented to follow up.