chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: U
Vaccine: PNC15, PNC15, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; Rotateq  with ex date 21-APR-2024 administred IM; Improper storage of product in use; This spontaneous report was received from other health professional (a nurse practitioner) and refers to a 10-week-old patient of an unknown gender..  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 08-NOV-2023, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1933912, expiration date: 21-APR-2024, administered intramuscularly (Incorrect route of product administration) (strength, and dose was not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (formulation: pre-filled syringe), lot #x019438, expiration date: 07-NOV-2025, administered intramuscularly (strength, and dose was not provided); and with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, lot #U7535AA, expiration date: 23-SEP-2025 (strength, dose, and route of administration were not provided). On 27-DEC-2023, the patient was vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (formulation: pre-filled syringe), lot #x019438, expiration date: 07-NOV-2025, administered intramuscularly (strength, dose was not provided); with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1965641, expiration date: 19-SEP-2024 (strength, dose, and route of administration were not provided). All suspect vaccines were administered for prophylaxis.  Administered doses of vaccine were exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset dates: 08-NOV-2023 and 27-DEC-2023]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 0.33
Sex: U
Vaccine: PNC15, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; Rotateq  with ex date 21-APR-2024 administred IM; Improper storage of product in use; This spontaneous report was received from other health professional (a nurse practitioner) and refers to a 4-month-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 23-OCT-2023, the patient the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1933912, expiration date: 21-APR-2024, administered intramuscularly (Incorrect route of product administration) (strength, dose were not provided). On 20-DEC-2023, the patient the patient was vaccinated with an improperly stored doses of with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1965641, expiration date: 19-SEP-2024 (strength, dose, and route of administration were not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (formulation: pre-filled syringe) lot #x019438, expiration date: 07-NOV-2025, administered intramuscularly (strength, dose were not provided); and with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, lot #U7535AA, expiration date: 23-SEP-2025, administered (strength, dose, and route of administration were not provided). All suspect therapies were administered for prophylaxis.  Administered doses of vaccine were exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset dates: 23-OCT-2023 and 20-DEC-2023]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 0.17
Sex: U
Vaccine: PNC15, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from other health professional (a nurse practitioner) and refers to a 10-week-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 20-NOV-2023, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1965641, expiration date: 19-SEP-2024 (strength, dose, and route of administration were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, lot #U7535AA, expiration date: 23-SEP-2025, administered intramuscularly (strength, dose was not provided); and with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (formulation: pre-filled syringe), lot #x019438, expiration date: 07-NOV-2025, administered intramuscularly (strength, dose was not provided) all for prophylaxis.  Administered doses of vaccine were exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset date: 20-NOV-2023]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 0.25
Sex: U
Vaccine: PNC15, RV5, UNK
Symptoms: Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from other health professional (a nurse practitioner) and refers to a 12-week-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 24-JAN-2024, the patient the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1965641, expiration date: 19-SEP-2024 (strength, dose, and route of administration were not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (formulation: pre-filled syringe) lot #x019438, expiration date: 07-NOV-2025, administered intramuscularly (strength and dose were not provided); and with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, lot #U7623AA, expiration date: 08-DEC-2025, administered intramuscularly (strength, dose were not provided); all for prophylaxis.  Administered doses of vaccine were exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset date: 24-JAN-2024]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 0.58
Sex: U
Vaccine: PNC15, RV5, UNK
Symptoms: Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from other health professional (a nurse practitioner) and refers to a 7-month-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 17-JAN-2024, the patient the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1965641, expiration date: 19-SEP-2024, administered for prophylaxis (strength, dose, and route of administration were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, lot #U7535AA, expiration date: 23-SEP-2025 (strength, dose, and route of administration were not provided); and with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (formulation: pre-filled syringe) lot #x019438, expiration date: 07-NOV-2025, administered intramuscularly (strength, dose was not provided) all for prophylaxis.  Administered doses of vaccine were exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset dates: 17-JAN-2024). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 0.17
Sex: U
Vaccine: PNC15, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from other health professional (a nurse practitioner) and refers to a 10-week-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 10-JAN-2024, the patient the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1965641, expiration date: 19-SEP-2024 (strength, dose, and route of administration were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, lot #U7535AA, expiration date: 23-SEP-2025 (strength, dose, and route of administration were not provided); and with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (formulation: pre-filled syringe), lot #x019438, expiration date: 07-NOV-2025, administered intramuscularly for prophylaxis (strength and dose were not provided).  Administered doses of vaccine were exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset date: 10-JAN-2024]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 3.0
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from other health professional (a nurse practitioner) and refers to a 3-year-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 25-OCT-2023, the patient was vaccinated with an improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), injection, lot #X009734, expiration date: 30-SEP-2024 (strength, dose and route of administration were not provided); and with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, lot #U7535AA, expiration date: 23-SEP-2025 (strength, dose, and route of administration were not provided); both for prophylaxis.  Administered doses of vaccine were exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset date: 25-OCT-2023]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report has been received from a nurse practitioner and refers to a 3-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On an 25-OCT-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, subcutaneously  (valid lot number X017484 [expiration date 25-JUN-2025]) (dose, dose number, frequency, vaccination scheme, and anatomical location were not provided), after temperature excursion of 8 hours 32 minutes in the -14 to -10 degrees Celsius range. No previous temperature excursion.  No additional adverse event (AE).
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report has been received from a nurse practitioner and refers to a 3-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On an 25-OCT-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, subcutaneously (valid lot number X017484 [expiration date 25-JUN-2025]) (dose, dose number, frequency, vaccination scheme, and anatomical location were not provided), after temperature excursion of 8 hours 32 minutes in the -14 to -10 degrees Celsius range. No previous temperature excursion.  No additional adverse event (AE).
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report has been received from a nurse practitioner and refers to a 13-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On an 01-NOV-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, subcutaneously (valid lot number X017484 [expiration date 25-JUN-2025]) (dose, dose number, frequency, vaccination scheme, and anatomical location were not provided), after temperature excursion of 8 hours 32 minutes in the -14 to -10 degrees Celsius range. No previous temperature excursion.  No additional adverse event (AE).
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report has been received from a nurse practitioner and refers to a 4-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On an 01-NOV-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, subcutaneously (valid lot number X017484 [expiration date 25-JUN-2025]) (dose, dose number, frequency, vaccination scheme, and anatomical location were not provided), after temperature excursion of 8 hours 32 minutes in the -14 to -10 degrees Celsius range. No previous temperature excursion.  No additional adverse event (AE).
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report has been received from a nurse practitioner and refers to a 15-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On an 01-NOV-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, subcutaneously (valid lot number X017484 [expiration date 25-JUN-2025]) (dose, dose number, frequency, vaccination scheme, and anatomical location were not provided), after temperature excursion of 8 hours 32 minutes in the -14 to -10 degrees Celsius range. No previous temperature excursion.  No additional adverse event (AE).
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: positive to serotype 16 too with presence of abnormal cells in her cervix; positive to serotype 16 too with presence of abnormal cells in her cervix; This spontaneous report was received from a company representative referring to a 25-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On unknown dates, the patient was totally vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.  On an unknown date, the patient was tested positive to serotype 16 with presence of abnormal cells in her cervix. The doctor was treating her with procedures. The outcome of the events was unknown at the time of reporting. The causal relationship between the events and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was not reported.    Lot# is being requested and will be submitted if received.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE, no PQC; Medical Assistant calling to report administration of PROQUAD after experiencing a temperature excursion. Temperature excursion assessment was supported. TE case 02568556 filed. Permission to contact HCP was granted. No additional information provide; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 28-FEB-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot #X021751, has been verified to be valid, expiration date: 23-FEB-2025) (albumin status: recombinant human albumin (rHa))  administered for prophylaxis (strength, and route of administration were not provided) after experiencing a temperature excursion (product storage error). No adverse event reported.   It was reported that the temperature was 5.6 degrees Celsius (C), with time frame 20 Hours 0 Minutes 0 Seconds with no previous temperature excursion.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Patient got both doses of the vaccine in 2019 and then got a bad case of shingles in 2023; This serious case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (unknown deltoid) and the 1st dose of Shingrix (unknown deltoid). On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Patient got both doses of the vaccine in 2019 and then got a bad case of shingles in 2023). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 12-MAR-2024 The patient got both doses of the vaccine in 2019 and then got a bad case of shingles in 2023 The reporter know Shingrix was not 100 percent effective, but after hearing about that from  the customer, and was pretty sure had to report it. This case was considered as suspected vaccination failure as details regarding completion laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had both shots and had shingles very bad/ Suspected vaccination failure; had shingles very bad; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had both shots and had shingles very bad/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles very bad). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2024 This case was reported by a patient via interactive digital media. The patient had both shots and had shingles very bad. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Vaccination failure
Clinical narrative: I had the shots and still got it on my face and in my ears/ Suspected vaccination failure; I had the shots and still got it on my face and in my ears; I had the shots and still got it on my face; 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: I had the shots and still got it on my face and in my ears/ Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: I had the shots and still got it on my face and in my ears) (serious criteria GSK medically significant) and shingles (Verbatim: I had the shots and still got it on my face). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster otitis externa and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, herpes zoster otitis externa and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2024 This case was reported by a patient via interactive digital media. The patient had the shots and still got it on his/her face and in ears. 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. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Patient had mild shingles after vaccination/Suspected vaccination failure; shingles/just had it again/this time much milder; 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.   The patient's past medical history included shingles (had shingles 20 years ago, all over the face), ophthalmic herpes zoster (had shingles 20 years ago, into the eye), visual disturbance, sickness (for two solid weeks in bed) and pain (had weeks of pain afterward ).   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: Patient had mild shingles after vaccination/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/just had it again/this time much milder). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2024 This case was reported by a patient via interactive digital media. The patient just had them again that time much milder, and the patient attributed it all to having taken the vaccine.  It did not forestall it altogether, but that time around was tolerable and did not slow down the patient. 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.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: shingles/suspected vaccination failure; shingles; woman who had 3 shingles shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and extra dose administered (Verbatim: woman who had 3 shingles shots). The outcome of the vaccination failure and extra dose administered were unknown 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, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK received date: 12-Mar-2024 This case was reported by a reporter via interactive digital media. Reporter knew a woman who had 3 shingles shots and was experiencing shingles. Apparently these shots did not work. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Vaccine shots di not prevent from getting shingles/Suspected vaccination failure; Shingles; Pain; 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, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Vaccine shots di not prevent from getting shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she received the shots two years ago and now had shingles also. The patient had been dealing with the pain for 2 weeks. The shots did not prevent from getting shingles. 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.
Sex: F
Vaccine: FLU3, RSV
Symptoms: Gingival bleeding, Immune thrombocytopenia, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: immune thrombocytopenia; diffuse petechiae; bleeding from the gums; This serious case was reported by a consumer via regulatory authority and described the occurrence of immune thrombocytopenia in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number HF5021) for prophylaxis.   Co-suspect products included Influenza vaccine inact split 3v (Fluzone high dose) (batch number UT8131DA) for prophylaxis.   The patient's past medical history included hypertension, chronic kidney disease stage 3, chronic obstructive pulmonary disease, pre-diabetes, hyperlipidemia, lung cancer, hypomagnesemia and iron deficiency anemia. Additional patient notes included no known drug allergies.   On 22-SEP-2023, the patient received Arexvy and Fluzone high dose. On an unknown date, 10 days after receiving Arexvy, the patient experienced immune thrombocytopenia (Verbatim: immune thrombocytopenia) (serious criteria hospitalization, GSK medically significant and other: serious as per reporter), petechia (Verbatim: diffuse petechiae) (serious criteria GSK medically significant) and gingival bleeding (Verbatim: bleeding from the gums). The patient was treated with dexamethasone sodium succinate (Dexamethasone). The outcome of the immune thrombocytopenia was resolving and the outcome of the petechia and gingival bleeding were unknown.   It was unknown if the reporter considered the immune thrombocytopenia, petechia and gingival bleeding to be related to Arexvy.     It was unknown if the company considered the immune thrombocytopenia, petechia and gingival bleeding to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-MAR-2024 It was reported that the patient developed severe thrombocytopenia to a level of 3K, whereas she had previously had a normal platelet count 3 weeks prior. She presented with diffuse petechiae and bleeding from the gums. The patient was hospitalized and diagnosed with immune thrombocytopenia and received platelet transfusion followed by high-dose dexamethasone and intravenous immunoglobulin, resulting in resolution of the thrombocytopenia. It was unknown if the reporter considered the immune thrombocytopenia, petechia and gingival bleeding to be related to Fluzone high dose influenza vaccine.
Sex: F
Vaccine: FLU3, RSV
Symptoms: Platelet transfusion
Clinical narrative: immune thrombocytopenia; diffuse petechiae; bleeding from the gums; This serious case was reported by a consumer via regulatory authority and described the occurrence of immune thrombocytopenia in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number HF5021) for prophylaxis.   Co-suspect products included Influenza vaccine inact split 3v (Fluzone high dose) (batch number UT8131DA) for prophylaxis.   The patient's past medical history included hypertension, chronic kidney disease stage 3, chronic obstructive pulmonary disease, pre-diabetes, hyperlipidemia, lung cancer, hypomagnesemia and iron deficiency anemia. Additional patient notes included no known drug allergies.   On 22-SEP-2023, the patient received Arexvy and Fluzone high dose. On an unknown date, 10 days after receiving Arexvy, the patient experienced immune thrombocytopenia (Verbatim: immune thrombocytopenia) (serious criteria hospitalization, GSK medically significant and other: serious as per reporter), petechia (Verbatim: diffuse petechiae) (serious criteria GSK medically significant) and gingival bleeding (Verbatim: bleeding from the gums). The patient was treated with dexamethasone sodium succinate (Dexamethasone). The outcome of the immune thrombocytopenia was resolving and the outcome of the petechia and gingival bleeding were unknown.   It was unknown if the reporter considered the immune thrombocytopenia, petechia and gingival bleeding to be related to Arexvy.     It was unknown if the company considered the immune thrombocytopenia, petechia and gingival bleeding to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-MAR-2024 It was reported that the patient developed severe thrombocytopenia to a level of 3K, whereas she had previously had a normal platelet count 3 weeks prior. She presented with diffuse petechiae and bleeding from the gums. The patient was hospitalized and diagnosed with immune thrombocytopenia and received platelet transfusion followed by high-dose dexamethasone and intravenous immunoglobulin, resulting in resolution of the thrombocytopenia. It was unknown if the reporter considered the immune thrombocytopenia, petechia and gingival bleeding to be related to Fluzone high dose influenza vaccine.
Sex: F
Vaccine: RSV
Symptoms: Contusion, Immune thrombocytopenia, Platelet count decreased
Clinical narrative: Platelet dropped to 3; immune thrombocytopenia; bruising on stomach; bruising on shoulder and leg; This serious case was reported by a consumer via regulatory authority and described the occurrence of immune thrombocytopenia in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 24-SEP-2023, the patient received Arexvy. In OCT-2023, 21 days after receiving Arexvy, the patient experienced immune thrombocytopenia (Verbatim: immune thrombocytopenia) (serious criteria GSK medically significant and other: Serious as per reporter), gastrointestinal organ contusion (Verbatim: bruising on stomach) (serious criteria GSK medically significant) and contusion of shoulder region (Verbatim: bruising on shoulder and leg). On an unknown date, the patient experienced platelet count decreased (Verbatim: Platelet dropped to 3). The outcome of the immune thrombocytopenia was unknown and the outcome of the gastrointestinal organ contusion, contusion of shoulder region and platelet count decreased were not reported.   It was unknown if the reporter considered the immune thrombocytopenia, gastrointestinal organ contusion, contusion of shoulder region and platelet count decreased to be related to Arexvy.     It was unknown if the company considered the immune thrombocytopenia, gastrointestinal organ contusion, contusion of shoulder region and platelet count decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-MAR-2024 This report described the occurrence of immune thrombocytopenia in a patient who received Arexvy.  The patient received Arexvy (batch not stated) and experienced immune thrombocytopenia 21 days later.  It was reported that she developed bruising on shoulder, leg and stomach three weeks after vaccine and that platelets dropped to 3.
Sex: M
Vaccine: RSV
Symptoms: Ecchymosis, Epistaxis, Haemorrhage, Immune thrombocytopenia, Immunoglobulin therapy
Clinical narrative: immune thrombocytopenia; ecchymoses; Epistaxis; Bleeding/ Ongoing mild bleedson and off; This serious case was reported by a consumer via regulatory authority and described the occurrence of immune thrombocytopenia in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4AK57) for prophylaxis.   Concomitant products included atorvastatin, vibegron, dorzolamide hydrochloride, timolol maleate (Cosopt), metoprolol, morniflumate (Flomax), sildenafil citrate (Sildenafil) and clopidogrel bisulfate (Plavix).   On 04-NOV-2023, the patient received Arexvy. On 07-NOV-2023, 3 days after receiving Arexvy, the patient experienced immune thrombocytopenia (Verbatim: immune thrombocytopenia) (serious criteria GSK medically significant and other: Serious as per reporter). In NOV-2023, the patient experienced ecchymosis (Verbatim: ecchymoses), epistaxis (Verbatim: Epistaxis) and hemorrhage (Verbatim: Bleeding/ Ongoing mild bleedson and off). The patient was treated with romiplostim. The outcome of the immune thrombocytopenia was unknown and the outcome of the ecchymosis and epistaxis were not reported and the outcome of the hemorrhage was not resolved.   It was unknown if the reporter considered the immune thrombocytopenia, ecchymosis, epistaxis and hemorrhage to be related to Arexvy.     It was unknown if the company considered the immune thrombocytopenia, ecchymosis, epistaxis and hemorrhage to be related to Arexvy.   Additional Information: GSK receipt date: 12-MAR-2024 The patient received Arexvy and experienced immune thrombocytopenia 3 days later. There was no information on platelet count 3 days after vaccination but stated that he had been having ongoing ecchymoses and bleeding (epistaxis), and it was reported that labs on 20 November showed platelets of 1.  He has been refractory to corticosteroids as well as IVIG 1g/kg daily x2 given in conjunction with corticosteroids.  He has now received romiplostim 1mcg/kg on 14th November.  Lack of response so far on platelets.  The patient had ongoing mild bleeds on and off.  Medications at time of vaccination included atorvastatin 80 mg nightly, vibegr on 75 mg daily, cosopt 22.3-6.8 1 gtt both eyes twice daily, metoprolol er 12.5 mg nightly, flomax 0.8 mg daily, sildenafil 50- 100 mg as needed for sexual activity, plavix 75 mg daily.
Sex: M
Vaccine: RSV
Symptoms: Platelet count decreased
Clinical narrative: immune thrombocytopenia; ecchymoses; Epistaxis; Bleeding/ Ongoing mild bleedson and off; This serious case was reported by a consumer via regulatory authority and described the occurrence of immune thrombocytopenia in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4AK57) for prophylaxis.   Concomitant products included atorvastatin, vibegron, dorzolamide hydrochloride, timolol maleate (Cosopt), metoprolol, morniflumate (Flomax), sildenafil citrate (Sildenafil) and clopidogrel bisulfate (Plavix).   On 04-NOV-2023, the patient received Arexvy. On 07-NOV-2023, 3 days after receiving Arexvy, the patient experienced immune thrombocytopenia (Verbatim: immune thrombocytopenia) (serious criteria GSK medically significant and other: Serious as per reporter). In NOV-2023, the patient experienced ecchymosis (Verbatim: ecchymoses), epistaxis (Verbatim: Epistaxis) and hemorrhage (Verbatim: Bleeding/ Ongoing mild bleedson and off). The patient was treated with romiplostim. The outcome of the immune thrombocytopenia was unknown and the outcome of the ecchymosis and epistaxis were not reported and the outcome of the hemorrhage was not resolved.   It was unknown if the reporter considered the immune thrombocytopenia, ecchymosis, epistaxis and hemorrhage to be related to Arexvy.     It was unknown if the company considered the immune thrombocytopenia, ecchymosis, epistaxis and hemorrhage to be related to Arexvy.   Additional Information: GSK receipt date: 12-MAR-2024 The patient received Arexvy and experienced immune thrombocytopenia 3 days later. There was no information on platelet count 3 days after vaccination but stated that he had been having ongoing ecchymoses and bleeding (epistaxis), and it was reported that labs on 20 November showed platelets of 1.  He has been refractory to corticosteroids as well as IVIG 1g/kg daily x2 given in conjunction with corticosteroids.  He has now received romiplostim 1mcg/kg on 14th November.  Lack of response so far on platelets.  The patient had ongoing mild bleeds on and off.  Medications at time of vaccination included atorvastatin 80 mg nightly, vibegr on 75 mg daily, cosopt 22.3-6.8 1 gtt both eyes twice daily, metoprolol er 12.5 mg nightly, flomax 0.8 mg daily, sildenafil 50- 100 mg as needed for sexual activity, plavix 75 mg daily.
Sex: F
Vaccine: COVID19, RSV
Symptoms: Platelet count, Thrombocytopenia
Clinical narrative: thrombocytopenia; This serious case was reported by a consumer via regulatory authority and described the occurrence of thrombocytopenia in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number EP5FD) for prophylaxis.   Co-suspect products included COVID-19 vaccine (batch number GH9693) for prophylaxis.   The patient's past medical history included hyperlipidemia, pre-diabetes and aneurysm of abdominal aorta. Concurrent medical conditions included hypertension. Concomitant products included calcium carbonate (Tums), colecalciferol (Vitamin D3), furosemide (Lasix), lisinopril, macrogol 3350 (Glycolax), plantago ovata husk (Psyllium Husk), simvastatin, acetylsalicylic acid (Aspirin 81) and bupropion hydrochloride (Wellbutrin).   On 15-SEP-2023, the patient received Arexvy and COVID-19 vaccine. In OCT-2023, 26 days after receiving Arexvy, the patient experienced thrombocytopenia (Verbatim: thrombocytopenia) (serious criteria GSK medically significant and other: Serious as per reporter). The patient was treated with dexamethasone phosphate (Decadron). The outcome of the thrombocytopenia was unknown.   It was unknown if the reporter considered the thrombocytopenia to be related to Arexvy.     It was unknown if the company considered the thrombocytopenia to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-FEB-2024 This report described the occurrence of thrombocytopenia in a patient who received Arexvy.and covid vaccine and experienced thrombocytopenia 26 days later. It was reported that patient developed thrombocytopenia with platelets of 10 on 17 October 2023. She was treated with decadron for 3 days with improvement in platelets to 115 on 20 October 2023. Medications at time of vaccination included wellbutrin, tums, vitamin D3, multivitamin, lasix, lisinopril, glycolax, psyllium husk, simvastatin, aspirin 81. Medical history included hypertension, hyperlipidemia, prediabetes, abdominal aortic aneurysm, Bee venom protein (honeybee) allergy. It was unknown if the reporter considered the thrombocytopenia to be related to covid vaccine. The follow-up could not be possible as no contact details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: died from shingle shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male 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 unknown cause of death (Verbatim: died from shingle shot) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   The reporter considered the unknown cause of death to be related to Shingles vaccine.     The company considered the unknown cause of death to be related to Shingles vaccine.   Additional Information: GSK received date: 15-Mar-2024 This case was reported by a reporter via interactive digital media. Reporter stated, a niece friend husband died from shingle shot. He was healthy man. The follow-up could not be possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Wrong diluent used; Wrong diluent used; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   In MAR-2024, the patient received Menveo. In MAR-2024, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Wrong diluent used) and inappropriate dose of vaccine administered (Verbatim: Wrong diluent used). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 08-MAR-2024 The reporter reported that the wrong diluent was used for the preparation of Menveo vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consider wrong solution used in drug reconstitution and inappropriate dose of vaccine administered not related to Menveo. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: my arm is a little sore/ I had a sore arm for 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (grandmother and brother both had shingles).   On 02-MAR-2024, the patient received the 2nd dose of Shingles vaccine. In MAR-2024, less than a week after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: my arm is a little sore/ I had a sore arm for 3 days). In MAR-2024, the outcome of the pain in arm was resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2024 and 09-MAR-2024 This case was reported by a patient via interactive digital media. The reporter paid insurance for it, no co-pay. The patient stated that just had his/her 2nd shot on Saturday and his/her arm was a little sore, but shingles was worse. The patient was not going to take any chances. The patient had a sore arm for 3 days and at the time of reporting was fine and had no side effects. The reporter felt sad that people were being charged so much for this vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pain, Peripheral swelling, Pyrexia
Clinical narrative: allergic reactions; my arm swelled; heated up with fever; hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles twice).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergic reaction (Verbatim: allergic reactions), swelling arm (Verbatim: my arm swelled), fever (Verbatim: heated up with fever) and pain (Verbatim: hurt). Shingles vaccine was discontinued. The outcome of the allergic reaction, swelling arm, fever and pain were not reported.   It was unknown if the reporter considered the allergic reaction, swelling arm, fever and pain to be related to Shingles vaccine.     It was unknown if the company considered the allergic reaction, swelling arm, fever and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2024 This case was reported by the patient via interactive digital media. The reporter stated, please be aware of allergic reactions, because he/she had one, his/her arm swelled, heated up with fever and hurt. The patient won't took another.