chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Irritability, Loss of personal independence in daily activities, Malaise, Palpitations
Clinical narrative: Fainted; He did not feel well; Chronic fatigue; anxiety; irritability; confusion; his body temperature was hot all the time; floaters; cramping; pain in his joints; stomach aches; double vision; He would sleep 15-17 hours a day but never felt rested.; dizzy; difficulty with his balance; Information has been received from a lawyer and refers to a 16-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the first and only dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, frequency, lot#, and expiry date was not reported) for prophylaxis. Patient's mother was exposed that vaccine was safe, prevented cancer, and teenagers must got it. Immediately after the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccination, patient fainted and when he came to, he did not feel well. Also experienced complete exhaustion and developed chronic fatigue. He would sleep 15-17 hours a day but never felt rested. He could not stay awake. He developed pain in his joints and generally felt unwell. He complained of stomach aches and cramping, which caused him to use the bathroom often at school, and at home. He started drinking one and a half to three gallons of water daily. Everyday tasks became difficult, including picking out clothes, taking a shower, choosing foods to eat, and brushing his teeth. He started experiencing confusion, anxiety, and irritability. His body temperature was hot all the time. Upon standing, he got dizzy, he had difficulty with his balance, and his heart would race. His vision was affected, and he experienced floaters and double vision. Patient was evaluated and treated by numerous specialists, including gastroenterologists, internal medicine doctors, dermatologists, psychologists, psychiatrists, cardiologists, sleep medicine doctors, neurologists, chiropractors, acupuncturists, immunologists, and Ear Nose and Throat doctors. He also received brain scans to determine the cause of his symptoms. At the reporting time, the outcome of the events was not reported. Causality assessment was related.  Upon internal review, the event of fainted was determined to be medically significant.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Scan brain, Somnolence, Syncope, Thirst, Vitreous floaters
Clinical narrative: Fainted; He did not feel well; Chronic fatigue; anxiety; irritability; confusion; his body temperature was hot all the time; floaters; cramping; pain in his joints; stomach aches; double vision; He would sleep 15-17 hours a day but never felt rested.; dizzy; difficulty with his balance; Information has been received from a lawyer and refers to a 16-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the first and only dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, frequency, lot#, and expiry date was not reported) for prophylaxis. Patient's mother was exposed that vaccine was safe, prevented cancer, and teenagers must got it. Immediately after the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccination, patient fainted and when he came to, he did not feel well. Also experienced complete exhaustion and developed chronic fatigue. He would sleep 15-17 hours a day but never felt rested. He could not stay awake. He developed pain in his joints and generally felt unwell. He complained of stomach aches and cramping, which caused him to use the bathroom often at school, and at home. He started drinking one and a half to three gallons of water daily. Everyday tasks became difficult, including picking out clothes, taking a shower, choosing foods to eat, and brushing his teeth. He started experiencing confusion, anxiety, and irritability. His body temperature was hot all the time. Upon standing, he got dizzy, he had difficulty with his balance, and his heart would race. His vision was affected, and he experienced floaters and double vision. Patient was evaluated and treated by numerous specialists, including gastroenterologists, internal medicine doctors, dermatologists, psychologists, psychiatrists, cardiologists, sleep medicine doctors, neurologists, chiropractors, acupuncturists, immunologists, and Ear Nose and Throat doctors. He also received brain scans to determine the cause of his symptoms. At the reporting time, the outcome of the events was not reported. Causality assessment was related.  Upon internal review, the event of fainted was determined to be medically significant.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: HCP calling to report an AE regarding the PNEUMOVAX 23 vaccine. HCP reported that a patient had a severe local reaction where their whole upper arm was very red and painful for a couple of days after administration of the PNEUMOVAX 23 vaccine. HCP st; HCP calling to report an AE regarding the PNEUMOVAX 23 vaccine. HCP reported that a patient had a severe local reaction where their whole upper arm was very red and painful for a couple of days after administration of the PNEUMOVAX 23 vaccine. HCP st; This spontaneous report was received from a pharmacist concerning a 57-year-old female patient.   The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On unspecified date in January 2020 (reported as ''5 years ago''), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), (strength, route, anatomical location, lot # and expiration date were not reported) for the treatment of prophylaxis.  On unspecified date in January 2020 (reported as ''5 years ago''), the patient had a severe local reaction where their whole upper arm was very red and painful (vaccination site erythema and vaccination site pain) for a couple of days after administration of the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) vaccine. The patient did not develop any hives. At the reporting time, the outcome of the events was unknown.  The causality was not provided.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: HPV9
Symptoms: Flushing, Gaze palsy, Nausea, Skin warm
Clinical narrative: flushng on her face; warmth in her hole arm; nausea; Headache; This spontaneous report has been received from a consumer regarding a 10-year-old female patient. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On 02-APR-2025, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis (strength, dose, scheme, route of administration, anatomical site, lot number and expiration date not reported). On an unspecified day in April, 2025, the patient's mom has called stating that the patient has developed flushing on her face (flushing of face) , nausea, warmth in her whole arm (skin warm) and a headache. She states she is aware of all of the adverse events with the exception of flushing. At the time of the reporting, the outcome of the events is unknown.  Causal relationship between the suspect vaccine and the events was unknown.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: tested positive for HPV; This spontaneous report was received from a Consumer or other non health professional and referred to a female patient of unknown age.   The patient's medical history and concomitant therapies were not reported. The patient's concurrent conditions included Polycystic ovary syndrome (PCOS).  On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient tested positive for human papillomavirus (HPV).   At the reporting time, the outcome of tested positive for HPV was unknown.   The causal relationship between the event of tested positive for Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was not provided.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: severe localized cellulitis reaction, at injection site; Information has been received from other company on 09-Apr-2025.  This spontaneous report was received from a pharmacy student calling on behalf of facility referring 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 an unknown date (reported as 5 to 10 years ago), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (also reported as Pfizer product, conflicting information), administered in the deltoid (unknown if left or right) for prophylaxis (strength, route of administration, dose, lot # and expiration date were not reported).  On an unknown date after the vaccination (5 to 10 years ago), the patient had severe localized cellulitis reaction to the vaccine, at injection site in the deltoid, unknown if left or right (Vaccination site cellulitis). The treatment for the event was reported as unknown. The reporter was wondering if that was any information on that because they were looking to give Pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20) to her now.   At the reporting time, the outcome of vaccination site cellulitis was unknown.  The action taken with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was reported as not applicable.  The reporter considered the event of vaccination site cellulitis to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23).  Additional information is not expected.
Age: 11.0
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a/an Nurse and refers to a(n) 11-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 24-Mar-2025, the patient was vaccinated with improperly stored dose of with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015557, expiration date: 16-Sep-2026) administered by Unknown route, as Prophylaxis. No adverse event.   The vaccine underwent a temperature excursion of -7.8 Celsius Degrees, during a timeframe of 36 minutes, The vaccine underwent previous temperature excursion, at -14.4 Celsius Degrees up to -10.4 Celsius Degrees during 13 minutes. No adverse event was reported.
Sex: M
Vaccine: PNC21
Symptoms: Fatigue, Flushing, Headache, Paraesthesia
Clinical narrative: FLUSHING; FATIGUE; TINGLING; HEADACHE; This spontaneous report was received from a regulatory authority, CDC Wonder on 22-Apr-202, referring to a 59-year-old male patient.   The patient's medical history included allergy to sulfa. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date (reported as 27-Feb-2025, conflicting information), the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Y011819, expiration date: 01-Oct-2025), administered by intramuscular route in left arm as prophylaxis.  On 01-Feb-2025, the patient experienced fatigue, tingling, flushing and headache. At the reporting time, the outcome of the events was unknown.   The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was reported as not applicable.   The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown.
Age: 50.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Blood glucose normal, Dizziness, Feeling abnormal, Nausea, Skin warm
Clinical narrative: syncope; dizziness; feeling abnormal; blood glucose normal; nausea; skin warm; This spontaneous report was received from a Regulatory Authority and refers to a 50-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions included diabetic. Concomitant therapies were not reported.   On 17-Nov-2024, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), Injection (lot #Y011819, expiration date: 01-Oct-2025), dose number 1, administered by Intramuscular route in Left Arm. On an unknown date, the patient started therapy with . On 17-Nov-2024, the patient started therapy with ADACEL administered by Intramuscular route (indication, expiration date, and lot # were not reported). The patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), for the treatment of prophylaxis.  On 17-Nov-2024, the patient experienced dizziness. On 17-Nov-2024, the patient experienced feeling abnormal. On 17-Nov-2024, the patient experienced blood glucose normal. On 17-Nov-2024, the patient experienced nausea. On 17-Nov-2024, the patient experienced skin warm. On 17-Nov-2024, the patient experienced syncope.   On an unknown date, Investigation showed Blood sugar (??-???-0000): 111 (unit not provided).   The patient recovered/resolved from the event of dizziness on an unspecified date. The patient recovered/resolved from the event of feeling abnormal on an unspecified date. The patient recovered/resolved from the event of blood glucose normal on an unspecified date. The patient recovered/resolved from the event of nausea on an unspecified date. The patient recovered/resolved from the event of skin warm on an unspecified date. The patient recovered/resolved from the event of syncope on an unspecified date.   The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable.  The action taken with Pneumococcal 21-valent Conjugate Vaccine Solution for injection was reported as not applicable.   The causal relationship between the event of dizziness and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.  The causal relationship between the event of feeling abnormal and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.  The causal relationship between the event of blood glucose normal and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.  The causal relationship between the event of nausea and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.  The causal relationship between the event of skin warm and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.  The causal relationship between the event of syncope and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.    The reporter considered the event(s) of syncope to be medically significant.  This is an amended report.  The patient's age was updated from 6 months to 50 years.
Age: 50.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Syncope
Clinical narrative: syncope; dizziness; feeling abnormal; blood glucose normal; nausea; skin warm; This spontaneous report was received from a Regulatory Authority and refers to a 50-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions included diabetic. Concomitant therapies were not reported.   On 17-Nov-2024, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), Injection (lot #Y011819, expiration date: 01-Oct-2025), dose number 1, administered by Intramuscular route in Left Arm. On an unknown date, the patient started therapy with . On 17-Nov-2024, the patient started therapy with ADACEL administered by Intramuscular route (indication, expiration date, and lot # were not reported). The patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), for the treatment of prophylaxis.  On 17-Nov-2024, the patient experienced dizziness. On 17-Nov-2024, the patient experienced feeling abnormal. On 17-Nov-2024, the patient experienced blood glucose normal. On 17-Nov-2024, the patient experienced nausea. On 17-Nov-2024, the patient experienced skin warm. On 17-Nov-2024, the patient experienced syncope.   On an unknown date, Investigation showed Blood sugar (??-???-0000): 111 (unit not provided).   The patient recovered/resolved from the event of dizziness on an unspecified date. The patient recovered/resolved from the event of feeling abnormal on an unspecified date. The patient recovered/resolved from the event of blood glucose normal on an unspecified date. The patient recovered/resolved from the event of nausea on an unspecified date. The patient recovered/resolved from the event of skin warm on an unspecified date. The patient recovered/resolved from the event of syncope on an unspecified date.   The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable.  The action taken with Pneumococcal 21-valent Conjugate Vaccine Solution for injection was reported as not applicable.   The causal relationship between the event of dizziness and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.  The causal relationship between the event of feeling abnormal and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.  The causal relationship between the event of blood glucose normal and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.  The causal relationship between the event of nausea and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.  The causal relationship between the event of skin warm and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.  The causal relationship between the event of syncope and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.    The reporter considered the event(s) of syncope to be medically significant.  This is an amended report.  The patient's age was updated from 6 months to 50 years.
Sex: F
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: I Did Not Have Any Immunity; Initial report received on 13-Mar-2025.    A consumer reported that she, an 84-year-old female (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and did not have any immunity.   The patient has an allergy to penicillin that results in swelling under tongue.   No concomitant medications were reported.    On an unknown date, the patient received 2 doses of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available).  The patient stated that after having her hepatitis B vaccine, she did not have any immunity.  She was not completely sure she was given HEPLISAV-B, but she thought it was a 2-dose vaccine.    No other information was available.     Company Comment: The company assessed the event as non-serious and not immunologically confirmed for vaccine failure. The dosing schedule and serological marker and time to testing were not reported.; Sender's Comments: The company assessed the event as non-serious and not immunologically confirmed for vaccine failure. The dosing schedule and serological marker and time to testing were not reported.
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: shingles in eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster 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 ophthalmic herpes zoster (Verbatim: shingles in eye) (serious criteria GSK medically significant). The outcome of the ophthalmic herpes zoster was not reported.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingles vaccine.     The company considered the ophthalmic herpes zoster to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a patient via interactive digital media. Patient got Shingles right after the shot, got them in eye.; Sender's Comments: Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: RVX
Symptoms: Injection site pain
Clinical narrative: tiny bit of soreness at the injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injection site pain (Verbatim: tiny bit of soreness at the injection site). The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to RSV vaccine.     It was unknown if the company considered the injection site pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a patient via interactive digital media. The patient had a tiny bit of soreness at the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Severe rash on neck and chest; itchy; This non-serious case was reported by a consumer and described the occurrence of rash in a 50-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included menopause and progesterone. Concomitant products included estradiol and trazodone.   On 14-APR-2025, the patient received Shingles vaccine. On 15-APR-2025, 1 days after receiving Shingles vaccine, the patient experienced rash (Verbatim: Severe rash on neck and chest). In APR-2025, the patient experienced pruritus (Verbatim: itchy). The patient was treated with acrivastine (Benadryl). The outcome of the rash was not resolved and the outcome of the pruritus was not reported.   It was unknown if the reporter considered the rash and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the rash and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-APR-2025 The rash was mildly itchy and feels like a sunburn (Severe rash on neck and chest)  The symptoms were treated.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain
Clinical narrative: redness on the vaccinated arm; Injection site pain; Injection site redness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On 10-APR-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain) and injection site erythema (Verbatim: Injection site redness). On 13-APR-2025, the patient experienced erythema of extremities (Verbatim: redness on the vaccinated arm). In APR-2025, the outcome of the injection site pain and injection site erythema were resolved. The outcome of the erythema of extremities was not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and erythema of extremities to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema and erythema of extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-APR-2025 The reporter was the patient. The reporter reported that a patient received Shingrix vaccine and experienced redness which was worsened. The patient also experienced injection site pain, injection site redness. Three days after injection, she developed redness on the vaccinated arm.  This red area is about three or four inches from the injection site, on the inner arm, below the elbow. Nothing else was reported.
Age: 79.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Wrong schedule; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 79-year-old female patient who received HBV (Engerix B adult) (batch number Y5X9T, expiry date 30-SEP-2026) for prophylaxis.   Previously administered products included Engerix b adulto (received 1st dose on 22 Nov 2024) and Engerix b adulto (received 2nd dose on20 DEC 2024).   On 14-APR-2025, the patient received Engerix B adult (intramuscular). On 14-APR-2025, an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too short (Verbatim: Wrong schedule). The outcome of the drug dose administration interval too short was not applicable.   Additional Information: GSK Receipt Date: 16-APR-2025 The reporter was the patient who received her 3rd dose of Engerix-B outside of the prescribing information recommended schedule. Persons 20 years of age and older had a series of 3 doses (1 mL each) on a 0, 1, 6 month schedule. The patient was given doses on these dates, first dose on 22nd November 2024, second dose on 20th December 2024, and third dose on 14th April 2025. The patient did ask about efficacy of vaccine off schedule and recommendations. The reporter did not fit into any of the special populations listed in the PI. MI information was given for her physician reference. The patient received the 3rd dose of Engerix b adult esrlier than the recommended interval, which led to shortenings of vaccine schedule.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles on hip; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number 54TF4) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) (batch number 54TF4) for prophylaxis.   Concurrent medical conditions included blood pressure high.   On 26-MAY-2022, the patient received the 2nd dose of Shingles vaccine. On 24-MAR-2022, the patient received the 1st dose of Shingles vaccine. In JUN-2022, less than 2 months after receiving Shingles vaccine and between 2 and 4 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on hip). 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 and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 18-APR-2025 Consumer reported that she took two dose shingles vaccine and she get shingles 1 to 2x monthly on the hip area in JUNE 2022. This case was considered as suspected vaccination failure as details regarding laboratory test confirming 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  clinical description and  laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2).
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: Fever; Diarrhea; Headache; Vomiting; body weakness; chills; This non-serious case was reported by a consumer and described the occurrence of fever in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included acetylsalicylic acid (Several).   On 11-APR-2025, the patient received Shingrix. On 12-APR-2025, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever), diarrhea (Verbatim: Diarrhea), headache (Verbatim: Headache), vomiting (Verbatim: Vomiting), weakness generalized (Verbatim: body weakness) and chills (Verbatim: chills). On 18-APR-2025, the outcome of the fever was resolving and the outcome of the diarrhea, headache, vomiting, weakness generalized and chills were resolving (duration 6 days).   It was unknown if the reporter considered the fever, diarrhea, headache, vomiting, weakness generalized and chills to be related to Shingrix.     It was unknown if the company considered the fever, diarrhea, headache, vomiting, weakness generalized and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-APR-2025 The reporter reported that a patient received Shingrix vaccine experienced fever, chills, body weakness, diarrhea, vomiting and headache.
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Fever; Diarrhea; Headache; Vomiting; body weakness; chills; This non-serious case was reported by a consumer and described the occurrence of fever in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included acetylsalicylic acid (Several).   On 11-APR-2025, the patient received Shingrix. On 12-APR-2025, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever), diarrhea (Verbatim: Diarrhea), headache (Verbatim: Headache), vomiting (Verbatim: Vomiting), weakness generalized (Verbatim: body weakness) and chills (Verbatim: chills). On 18-APR-2025, the outcome of the fever was resolving and the outcome of the diarrhea, headache, vomiting, weakness generalized and chills were resolving (duration 6 days).   It was unknown if the reporter considered the fever, diarrhea, headache, vomiting, weakness generalized and chills to be related to Shingrix.     It was unknown if the company considered the fever, diarrhea, headache, vomiting, weakness generalized and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-APR-2025 The reporter reported that a patient received Shingrix vaccine experienced fever, chills, body weakness, diarrhea, vomiting and headache.
Age: 7.0
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient received a dose of HIB which he was not due for. He has had 4 doses already.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: After receiving the Shingrix and at home, patient's wife informed the patient that he had already received 2 doses of Shingrix. This pharmacy only showed 1 dose of Shingrix in the patient imz profile and the patient verbally consented that he wished to receive the Shingrix immunization. Unable to confirm the validity of the patient's wifes claims that he had already received 2 doses. Patient waife concerned for patient receiving a third dose of Shingrix.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Crying, Pain in jaw, Pyrexia
Clinical narrative: Excessive crying and febrile, jaw pain, chills x 1 day
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Diarrhoea, Dizziness, Loss of consciousness, Nausea, Peripheral coldness
Clinical narrative: After 3 minutes of administration, patient felt dizziness and passed out , loss of  cosnsciuosness approximately 2 minutes. Her  extrmemities were  wet and cold.She became alert and oriented later , still felt  diziness, nausea and onset of diarrhea.-Patient refused EMS and left pharmacy  with family member
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient was in office for their 2 year physical 02/17/2025  and received  the third IPV (Polio) vaccine on right side of thigh at  11:00am. Mother states she noticed redness to injection site around 1:00pm and warm to touch with no other symptoms, Patient had a telemedicine apt. with an on call nurse practitioner  later that evening as it worsened and spread to opposite side of leg. Patient was advised to start Benadryl and if anaphylaxis develops head to Emergency Department.  Early am 02/18/2025 mother states it was clearing up and had gotten better. Patient returned to office 04/23/2025is doing much better and no other symptoms occurred since then.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head, Dysarthria, Dysphagia, Facial paresis, Laboratory test
Clinical narrative: Bilateral facial weakness, right worse than left. Involved upper and lower face. Dysphagia (oral phase). Speech was slurred. Sudden onset, progressed over the course of one week. Improved over the next 1-2 weeks.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging head
Clinical narrative: Bilateral facial weakness, right worse than left. Involved upper and lower face. Dysphagia (oral phase). Speech was slurred. Sudden onset, progressed over the course of one week. Improved over the next 1-2 weeks.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: The day after the injection (4/18), it felt like a big (several centimeter) knot but wasn't red.  Two days after the injection (4/19), the knot started to improve but redness started to spread.  Redness started higher on the arm and spread downward while it cleared higher up.  4/20, noticed warmth and spreading redness.  Started topical hydrocortisone and ibuprofen.  Seen by PCP office on 4/21 and noted "Well-demarcated 15cmx17cm area of warmth and erythema of the left upper arm as shown in photos below.  There is a 2-3cm mobile mass felt at the top center of the area of erythema that is likely the site of the injection."  It was itchy but not painful.  No fevers, chills, difficulty breathing.   On 4/21, topical steroid was increased in strength to clobetasol 0.05% BID and home cetirizine was increased from 10mg daily to 10mg BID.  By 4/23, symptoms were resolving.   No antibiotics were required.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Urticaria
Clinical narrative: Hives on right arm, then other arm 30 min later fever on 4/23/25 about 99F headache. Took Atertec.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: pentacel being administered to the patient past the expiration date with no reported adverse event; Initial information received on 02-Apr-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 4 months old male patient who received an expired dose of diphtheria/tetanus/5 hybrid AC pertussis/Ipv(Vero)/Hib(Prp/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine (Pneumococcal 20) for Immunisation.  On 01-Apr-2025, the patient received 0.5ml (Dose 1) (once) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/Ipv(Vero)/Hib(Prp/T) vaccine, Strength Standard, Expiry date 28-Mar-2025 and lot UK007AA via intramuscular route in the left vastus lateralis for immunization, past its expiration date with no reported adverse event (expired product administered) (Latency same day).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: 4 big losses appeared like 3 in a row and then around the other one like in the form of a J; arm just start to itch; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Apr2025 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (DOSE 1, SINGLE), administration date: 2020, for COVID-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 1, SINGLE, Right arm), administration date: Oct2024, for COVID-19 Immunization, reaction(s): "No adverse event". The following information was reported: SKIN DISORDER (non-serious) with onset Apr2025, 450 min after the suspect product(s) administration, outcome "recovering", described as "4 big losses appeared like 3 in a row and then around the other one like in the form of a J"; PRURITUS (non-serious) with onset Apr2025, 450 min after the suspect product(s) administration, outcome "recovering", described as "arm just start to itch". Therapeutic measures were taken as a result of skin disorder, pruritus.  Additional information: Patient stated, He called because any of these Pfizer COVID Vaccine since 2020, every booster every 6 months and this was the first one he had a little bit of adverse side effect. Patient stated, About 7 and half hours after he had this shot (Comirnaty), all of a sudden his arm just start to itch and 4 big losses appeared like 3 in a row and then around the other one like in the form of a J. So, there are about 4 of them about the size of the quarter. It was like crazy and everything, but it really expands. He was sitting there and it was like he felt it coming. He could feel them actually burst out. So, he had been putting on this anti-itch cream and everything for the last 2 and half days and they had gone down slightly inside. He stated, he requested the booster after 6 months. He had one last October. Patient did not take any other vaccine on the same date with Pfizer vaccine.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Skin disorder
Clinical narrative: 4 big losses appeared like 3 in a row and then around the other one like in the form of a J; arm just start to itch; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Apr2025 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (DOSE 1, SINGLE), administration date: 2020, for COVID-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 1, SINGLE, Right arm), administration date: Oct2024, for COVID-19 Immunization, reaction(s): "No adverse event". The following information was reported: SKIN DISORDER (non-serious) with onset Apr2025, 450 min after the suspect product(s) administration, outcome "recovering", described as "4 big losses appeared like 3 in a row and then around the other one like in the form of a J"; PRURITUS (non-serious) with onset Apr2025, 450 min after the suspect product(s) administration, outcome "recovering", described as "arm just start to itch". Therapeutic measures were taken as a result of skin disorder, pruritus.  Additional information: Patient stated, He called because any of these Pfizer COVID Vaccine since 2020, every booster every 6 months and this was the first one he had a little bit of adverse side effect. Patient stated, About 7 and half hours after he had this shot (Comirnaty), all of a sudden his arm just start to itch and 4 big losses appeared like 3 in a row and then around the other one like in the form of a J. So, there are about 4 of them about the size of the quarter. It was like crazy and everything, but it really expands. He was sitting there and it was like he felt it coming. He could feel them actually burst out. So, he had been putting on this anti-itch cream and everything for the last 2 and half days and they had gone down slightly inside. He stated, he requested the booster after 6 months. He had one last October. Patient did not take any other vaccine on the same date with Pfizer vaccine.
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: the site was red and felt hot for about 3 days; experienced diffuse redness around and below the injection site; This spontaneous report was received from a consumer referring to a male patient, age was not provided.  Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On an unknown date, the patient was vaccinated with pneumococcal 21-valent conjugate (CAPVAXIVE) injection, administered intramuscularly as a dose of 0.5 ml for prophylaxis (anatomical location, lot number and expiration date were not reported).  On an unknown date, reported as 1 day after vaccination, the patient experienced diffuse redness around and below the injection site (Redness), the site was red and felt hot (Vaccination site warmth) for about 3 days and then subsided without intervention or medication. At the time of the reporting, the outcome of the event was recovered.  The causal relationship between the events and the suspect therapy was not provided.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got the shingles so painful.; 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: still got the shingles so painful.). 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 and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-APR-2025 This case was reported by a patient via interactive digital media. The patient reported to have had the vaccine and still got the shingles and was so painful. 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.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Furuncle
Clinical narrative: Boils; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of boil in a 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 boil (Verbatim: Boils). The outcome of the boil was not reported.   It was unknown if the reporter considered the boil to be related to Shingrix.     It was unknown if the company considered the boil to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-APR-2025 This case was reported by a patient via interactive digital media. The patient got the Shingrix vaccine and had boils  The reporter asked can you develop boils after taken the vaccine. The case is 1 of the 6 linked case, by same reporter.; Sender's Comments:  US-GSK-US2025AMR046237:same reporter US-GSK-US2025AMR046239:same reporter US-GSK-US2025AMR046242:same reporter US-GSK-US2025AMR046246:same reporter US-GSK-US2025AMR046250:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: injected only the diluent portion of the vaccine; injected only the diluent portion of the vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication (Verbatim: injected only the diluent portion of the vaccine) and inappropriate dose of vaccine administered (Verbatim: injected only the diluent portion of the vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 14-APR-2025 Pharmacist reported that if a patient got accidentally injected only the diluent portion of the vaccine, without mixing the powder, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. And also enquiring how they would go about getting an extra diluent, so that the patient can be injected the whole thing. This case is linked with US2025AMR046222, reported by same reporter.; Sender's Comments:  US-GSK-US2025AMR046222:same reporter
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 85 years old male patient accidentally received a dose of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 85-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: A 85 years old male patient accidentally received a dose of Menveo). The outcome of the inappropriate age at vaccine administration was not applicable.   Additional Information: GSK receipt date: 15-APR-2025 The Pharmacist reported that they accidentally administered a dose of Menveo (could be the 2-vial presentation) to an 85 year old patient which led to, Inappropriate age at vaccine administration. The reporter had a questioned should they revaccinate with the correct vaccine.