chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Postural orthostatic tachycardia syndrome, Sinus tachycardia, Syncope, Thyroid function test
Clinical narrative: POTS; Dysautonomia; syncope; constipation; Arm/Shoulder/Joint pain; Sinus tachycardia; Information has been received from a consumer via the Administration (# 857405) on 17-AUG-2022, regarding a 14-year-old non-pregnant female patient (also reported as male, inconsistent information). The patient's concurrent conditions included asthma. Previous drug reactions, or allergies reported were bee venom (also reported as honey bee, inconsistent information) and strawberries.  On 03-FEB-2018 at 15:00 (also reported as 15:36, inconsistent information), the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular (strength, dose, frequency, anatomical location, indication, lot number, and expiration date were not provided) indicated as prophylaxis. On the same fay, the patient was vaccinated with 1 dose of hepatitis A vaccine, inactivated (VAQTA)(also reported as hep a (HAVRIX), inconsistent information) intramuscular in the right arm (lot number N014945 has been verified to be a valid lot number, expiry date 17-JUN-2019) also indicated as prophylaxis.   On 06-MAR-2019 (also reported as 06-APR-2019, inconsistent information), the patient experienced POTS (postural orthostatic tachycardia syndrome), dysautonomia (autonomic nervous system imbalance), syncope, constipation, arm/shoulder/joint pain (arthralgia), and sinus tachycardia (hospitalization and disability criteria for ). Additional laboratory and diagnostical tests were performed: electrocardiogram (EKG), electroencephalogram (EEG), Holter Monitor 1 week; "Holter monitor" 30 days; medtronic LOOP monitor implant in chest wall; full laboratory panels, thyroid panels, genetics review and counseling to rule out potential for anything else that could have contributed.  The outcome of the aforementioned events was reported as not recovered.  The causality assessment was not provided.  Follow-up information has been received via telephone call to the physician office on 01-SEP-202 An unspecified reporter, stated that they could not help without a name and date of birth of the patient. The reporter was unable to find a healthcare provider who was completed the adverse event report. Additional information was not expected, all scheduled correspondence was canceled.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; TE evaluation on frozen products mentions 2 doses of PROQUAD were administered to 2 patients.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 19-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot number U039261 who had been verified to be a valid number, expiration date: 09-JUN-2023, administered for prophylaxis and sterile diluent (DILUENT MRK) (strength, dose, frequency, route of administration and anatomical location, were not provided).  The vaccines were stored at a temperature of 14 degrees Fahrenheit (F) up to 46 F (21F) for the time frame of 1 hour, 28 minutes 0 seconds (product storage error). There was no previous temperature excursion and no additional adverse events were reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2208USA008690:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: was '2 Months Late' on unknown, previous date for corresponding Patient's 3rd GARDASIL 9 dose; No additional AE reported.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown dates, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date and route of administration were not provided) for prophylaxis. As reported, the patient was vaccinated with the third dose of the suspect product 2 months late (inappropriate schedule of product administration). No adverse event was reported.
Age: 19.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient had no adverse side effects at time of call.; Pharmacist called asking for recommendations after it was discovered that two live vaccines were administered less than 28 days apart. Pharmacist states that a 19 year old patient needed VARIVAX and MMR-II for school purposes.; a 19 year old patient needed MMR-II; This spontaneous report was received from pharmacist and refers to a 19-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter subcutaneously, lot #T035400, expiration date: 16-OCT-2022 for prophylaxis. On 25-AUG-2022, less than 28 days from another live vaccine, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter subcutaneously, albumin status of recombinant human albumin (rHA) lot #U006486, expiration date: 26-FEB-2023 for prophylaxis (inappropriate schedule of product administration, product administered to patient of inappropriate age). The patient had no adverse side effects at time of call.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site discomfort, Vaccination site mass, Vaccination site swelling
Clinical narrative: arm swelling; Bump the size of a tennis ball; discomfort in the arm that received the injection; This spontaneous report has been received from pharmacist concerning a 64-year-old female patient. Her concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 23-AUG-2022, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe 0.5 ml/once, administered as prophylaxis, lot number U027357, expiration date 25-MAR-2023, route of administration was reported as "injection".  On the same date, the patient experienced arm swelling (Vaccination site swelling), a bump the size of a tennis ball (Vaccination site mass), and discomfort in the arm that received the injection (Vaccination site discomfort) which was all referred by the patient through a call to the provider's office on 25-AUG-2022, seeking for medical attention. The patient was advised to use warm compress and to take ibuprofen as needed. At the time of the report, she had not recovered from the events.    The Causal relationship between Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and all reported events was unknown.
Sex: M
Vaccine: MMR
Symptoms: Accidental exposure to product, Exposure via eye contact, No adverse event
Clinical narrative: The caller stated he is not experiencing any symptomatic side effects. No additional AE details; he was exposed to a reconstituted MMR-II which was inadvertently squirted in his eye; he was exposed to a reconstituted MMR-II which was inadvertently squirted in his eye; This spontaneous report was received from a pharmacist referring to himself, a male patient of unknown age. Information regarding his medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-AUG-2022, the patient reported he was exposed to a reconstituted measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, with lot #W001519, which upon internal validation was considered a valid lot# with expiration date reported as 13-JAN-2024, administered for prophylaxis, and to sterile diluent solution for injection/infusion, with lot #U034538, which upon internal validation was established as a valid lot#, with expiration date reported as 14-MAY-2024, which was inadvertently squirted in his eye. The reporter stated he was not experiencing any symptomatic side effects.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; one dose of VARIVAX and one dose of MMR II that experienced a temperature excursion was administered to a single patient; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.      On 25-AUG-2022, the patient was vaccinated with improperly store doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # U024765, expiration date 10-AUG-2023 and a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), lot # T034388, expiration date 08-OCT-2023 (dose and route were not reported) for prophylaxis (product storage error).  Concomitant therapies included sterile diluent. The vaccines were exposed to 10.1 Celsius for 1 hour and 30 minutes and to -11.5 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion.  There was no additional adverse event and nor product quality complain reported.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Rubella antibody negative, Vaccination failure, Viral titre
Clinical narrative: [she] does not appear to convert the vaccine to immunity/ she is not showing serological immunity/ she "may be part of a group of people that does not achive immunity/ "titer tests" performed "in 23-08-2022; [she] does not appear to convert the vaccine to immunity/ she is not showing serological immunity/ she "may be part of a group of people that does not achive immunity/ "titer tests" performed "in 23-08-2022; Caller states that she was also administered "booster" MMR on 1/6/2011 at 20 years of age and 2 more MMR vaccines; MMR stating she received MMR as a child on the following date: 31-JAN-1992; This spontaneous report has been received from a female medical assistant (also reported as a nurse) via a Merck employee, referring to herself when she was 15 months old. The patient's historical condition, current condition and concomitant drugs were not reported.  On 31-JAN-1992 (product administered to patient of inappropriate age) (the interval time was calculated as 465 days based on the patient's DOB and first vaccination date, which was more than 15 months of age) and 01-JUN-1995, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II), respectively. On 06-JAN-2011 at 20 years old and 11-FEB-2016, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (lot#: 1740Y has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 11-DEC-2011; lot#: K014832 with expiration date:14-SEP-2016) (extra dose administered), respectively. In 2017, she had had titer tests performed, which result was not provided. On 01-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (lot#: R001659 with expiration date: 17-JAN-2020). The indication for suspect vaccine was prophylaxis. The dose for suspect vaccine was 0.5 ml. The strength and route for suspect vaccine was not reported.  She recently had suspect vaccine titers drawn on 23-AUG-2022, which results showed rubella antibody was less than 0.90 AU/ml (rubella antibody negative), measles antibody was less than 13.5 AU/ml, mumps virus was 9.13 AU/ml. The patient was informed that she was not showing serological immunity (vaccination failure). She stated that a medical doctor informed her that she might be part of a group of people that does not achieve immunity. The patient stated she could be contacted via email. The outcome of the rubella antibody negative and vaccination failure was unknown. The causality assessment between the vaccination failure and suspect vaccine was related. The causality assessment between the rubella antibody negative and suspect vaccine was not provided.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On 27-APR-2022, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) once for prophylaxis (lot# U003306, expiry date 15-OCT-2022, strength, route of administration, vaccination scheme frequency, anatomical location, and dose were not reported) after a temperature excursion (occurred on 12-APR-2022, temperature: 62 Fahrenheit (F); time frame: 5 hours 12 minutes) (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).  This was one of four cases from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; received a 4th dose of ROTATEQ on 8/22/2022. Caller reports the 3rd dose was administered on 7/14/2022.; This spontaneous report has been received from a physician concerning a 6-month-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 22-AUG-2022, the patient was vaccinated with the 4th dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter (ml) (lot # 1879861, has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent [ROTATEQ], expiration date reported and upon internal validation established as 20-OCT-2023) (anatomical location and route of administration were not reported) for prophylaxis (Extra dose administered). The 3rd dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered on 14-JUL-2022.  No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; vaccine administered after temperature excursions; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-AUG-2022, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, dose: 0.5 ml, lot # W017567, expiration date: 29-NOV-2023, administered subcutaneously for prophylaxis (strength was not provided) (product storage error). Prior to being administered, the vaccine experienced a temperature excursion of 10.9 degrees Fahrenheit for 1 hour and 30 minutes. No additional adverse events reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller reported vaccine administered after temperature excursions.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 12-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 0.5 milliliter (ml) (lot # W017567, has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [rHA] [PROQUAD] expiration date reported and upon internal validation established as 29-NOV-2023) (anatomical location and route of administration were not reported). The vaccine was administered for prophylaxis after a temperature excursion (temperature 10.9 Fahrenheit [F] during 1 hour and 30 minutes) (Product storage error). The vaccine did not suffer previous temperature excursions.; Sender's Comments:  US-009507513-2209USA000437: US-009507513-2209USA000235: US-009507513-2209USA000438: US-009507513-2209USA000255:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller reported vaccine administered after temperature excursions; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for varicella virus vaccine live (oka/merck) (VARIVAX) in which the maximum temperature was 10.9 degrees Fahrenheit for a time frame of 1 hours and 25 minutes. There were not previous temperature excursions.  On 16-AUG-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0,5 ml, administered subcutaneous, lot # U024220, expiration date 04-AUG-2023 (anatomical location was not provided) for prophylaxis (product storage error).  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2209USA000437: US-009507513-2209USA000438:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; An improperly stored dose of PEDVAXHIB was administered to the patient on 12AUG2022; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender.  The patient's concurrent conditions, pertinent medical history, and historical drugs were not reported. Concomitant therapies included a dose of rotavirus vaccine live oral 1v (ROTARIX).  On 12-AUG-2022, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml (lot number U029145 has been verified to be a valid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), expiration date reported and confirmed as 30-MAR-2024) as prophylaxis (route of administration and anatomical location were not provided). The vaccine administered suffered a temperature excursion of 35.7 Fahrenheit degrees (F) for a time frame of 4 hours and 26 minutes (Product storage error). This vaccine had not suffered previous temperature excursions.  No additional information provided. No additional adverse events (AE) reported.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Chemotherapy, Incorrect route of product administration, Non-Hodgkin's lymphoma
Clinical narrative: Administered 'ZOSTAVAX' for the 'Prevention of Shingles' in the 'muscle, just like a regular shot; Non-Hodgkin's Lymphoma; This spontaneous report has been received from an 85-year-old male patient, regarding himself.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 09-FEB-2022, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, anatomical location, lot number, and expiration date were not provided) administered intramuscularly (reported as " in the muscle, just like a regular shot") for the Prevention of Shingles, by a pharmacist (Incorrect route of product administration). The patient did not experience any reactions following the administration of zoster vaccine live (ZOSTAVAX).   On an unspecified date in 2022, the patient experienced Non-Hodgkin's Lymphoma, for which he received an unknown chemotherapy from unknown manufacturer every 6 weeks. The patient was currently off of the unknown chemotherapy for a couple weeks.   The outcome of the Non-Hodgkin's Lymphoma event and its causal relationship with zoster vaccine live (ZOSTAVAX) were not reported.   At current call time, the patient affirmed and confirmed "how affected product was zoster vaccine live (ZOSTAVAX)", however he was unable to further clarify these statements at current call time. No further information was provided.  Upon internal review, the event Non-Hodgkin's Lymphoma was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller reported vaccine administered after temperature excursions.  No other information provided.  No PQC reported. Previous AE filed 02236682 was updated with new excursion information. Related AEs filed 02237157, 02237190, 02237201, 02237212, 0223; 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 therapies were not reported.   On 12-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #W017567, expiration date: 29-NOV-2023, administered subcutaneously as prophylaxis (strength was not provided), after a temperature excursion of 1 hour and 30 minutes at a temperature of 10.9 Fahrenheit degrees (product storage error). No previous temperature excursions were reported.   This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2209USA000235: US-009507513-2209USA000438: US-009507513-2209USA000179: US-009507513-2209USA000350: US-009507513-2209USA000177: US-009507513-2209USA000361: US-009507513-2209USA000255: US-009507513-2209USA000374:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional advers events; Caller reported vaccine administered after temperature excursions.  No other information provided.  No additional AEs or PQC reported.  ?    Names of vaccines involved (including lot/exp) PROQUAD W017567  11/29/2023        ?    Temperature 10.9F; 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 therapies were not reported.   On 08-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #W017567, expiration date: 29-NOV-2023, administered subcutaneously as prophylaxis (strength was not provided), after a temperature excursion of 1 hour and 30 minutes at a temperature of 10.9 Fahrenheit degrees (product storage error). No previous temperature excursions and no additional adverse events were reported.   This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2209USA000437: US-009507513-2209USA000235: US-009507513-2209USA000179: US-009507513-2209USA000350: US-009507513-2209USA000177: US-009507513-2209USA000361: US-009507513-2209USA000255: US-009507513-2209USA000374:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Employee states that he is reporting adverse event due to misuse as he believe that the  Provider self administered GARDASIL 9 outside of age indication.; No additional adverse events reported.; This spontaneous report was received from a female physician of unknown age, via company representative, referring to herself. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On an unknown date, the patient self-administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (doses, dose numbers, routes of administration, anatomical locations, lot numbers and expiration dates were not reported for both) for prophylaxis outside of age indication (product administered to patient of inappropriate age).  The company representative was unable to confirm if the patient self-administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The company representative was unable to confirm the patient's age. No additional adverse events were reported (no adverse event).
Age: 1.17
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No adverse event; Medical Assistant reporting improperly stored PROQUAD was administered to a patient on 02Sep2022. No additional AE reported. No PQC. No additional information provided.  Names of vaccines involved (including lot/exp) PROQUAD Lot: W017567 11/29/2023; This spontaneous report was received from a certified medical assistant referring to a 14-month-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 02-SEP-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA) (1 dose) lot number W017567 and expiration date of 29-NOV-2023 for prophylaxis (dose, route of administration, and anatomical location were not reported). The vaccine was exposed to a temperature excursion of -10°C up to 8°C (-9.6C) for 1 hour and 0 minutes and 0 seconds, there was no previous temperature excursion. No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Medical Assistant reporting improperly stored VARIVAX was administered to a patient; This spontaneous report was received from a certified medical assistant referring to a 12-month-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 25-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck)(VARIVAX) (1 dose) lot number U007475 and expiration date of 03-AUG-2022 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). The vaccine was exposed to a temperature excursion of -10°C up to 8°C (-9.6C) for 1 hour and 0 minutes and 0 seconds, there was no previous temperature excursion. No additional adverse event was reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: more painful; Suspected vaccination failure/had 2nd dose, had another outbreak; had another outbreakthis month/outbreak was actually worse this time; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had been getting shingles since mid 20s).   In January 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In August 2022, between 7 and 8 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 30-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had been getting shingles since his/her 20s. The patient finally decided to get Shingrix vaccine at 56 of age. The patient had the 2nd dose of the vaccine in January 2022 and this vaccine did not work for him/her. The patient had the another outbreak this month (August 2022). The patient stated that so did not thought this was a cure all, the manufacturer stated this was only 90 percent effective, unfortunate for he/she among the 10 percent. The patient stated that the outbreak was actually worse this time and a lot more painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had vaccine and has shingles/Suspected vaccination failure; Shingles; This 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporters wife had vaccine 1 year ago and had shingles.  The reporter stated that kind of hard saying it could be worse because that was speculation.  But still advise people to get vaccine but remember vaccine had no guarantee you would not get shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain at the site; redness at the site; swelling at the site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comment: The patient received a vaccine a week ago and  still had pain, redness and swelling at the site.  The patient was wondering if this was a normal reaction after a week. The patient read a lots of information and most say the reactions last 2-3 days and The patient had for a week. The patient was a nurse and patient's physician doctors look at my arm and it was still red ,swollen and warm after a week and the patient did not  know if this was normal or not.
Sex: U
Vaccine: VARZOS
Symptoms: Muscle discomfort, Musculoskeletal discomfort
Clinical narrative: Still have a little muscle; Still have a little joint; This case was reported by a consumer via interactive digital media and described the occurrence of muscle discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (the patients niece had shingles the worst painful experience in her life and never ever go through that again).   In August 2022, the patient received Shingles vaccine. In August 2022, less than a day after receiving Shingles vaccine, the patient experienced muscle discomfort and discomfort in joints. On an unknown date, the outcome of the muscle discomfort and discomfort in joints were not recovered/not resolved.   It was unknown if the reporter considered the muscle discomfort and discomfort in joints to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Aug-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got the Shingles shot a few days ago from reporting, the side effects were tough to take on the first night it diminished the next day still had a little muscle and joint. The patient was sure it goes away soon. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: The shot itself made my arm hurt horrible,; still bad sore; This 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.   In August 2022, the patient received Shingles vaccine. In August 2022, less than a day after receiving Shingles vaccine, the patient experienced pain in arm and pain. On an unknown date, the outcome of the pain in arm and pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-AUG-2022 Reporter's comments; This case was reported by a patient via interactive digital media. He/she just had his/her first vaccine and was not sure if He/she will do the second one. The shot itself made his/her arm hurted horrible and it had been 24 hours now and it was still bad sore. Additional supportive information: Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: still get terrible pain/getting worse; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. He/She had got the Shingrix vaccines, but still get terrible pain and it's getting worse. The patient was asking that could you be prescribed pain medication if you had pain but no blisters or sores.  Additional supportive information: Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: developed a rash on my upper abdomen; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Aug-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient developed a rash on my upper abdomen. The patient asked if this could be a side effect of the shingles shot. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: got sick from the shot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovering/resolving.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-AUG-2022 Reporter's Comment: This case was reported by the consumer via interactive digital media. The patient received a dose of Shingles vaccine and felt sick from the shot and felt better soon. Additional Supportive Information: This case was linked with case US2022AMR126039 reported by same reporter. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR126039:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: Body aches; headache; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27th August 2022, the patient received Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced general body pain and headache. On an unknown date, the outcome of the general body pain and headache were unknown.   It was unknown if the reporter considered the general body pain and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient just got the 1st shot the day before reporting and it had knocked them on his/her butt. He/She had body aches, headache etc. However, it was better than getting shingles. Additional supportive information: Follow-up would not possible, as no contact, details were available. The verbatim - Knocked me on my butt was not captured as an event because it was just a Idiom used by the reporter while reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Spent a day in bed; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles for many years). Concurrent medical conditions included nerve pain.   In July 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient had shingles many years and still had the nerve pain. The reporter stated that the patient received Shingle vaccine in July 2022. The reporter reported that after received Shingles vaccine the patient spent a day in bed. The patient needs to receive second dose in September, patient asked should he gave the second vaccination. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Vaccine hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a 65-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (In 2019 had shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK receipt date : 26-Aug-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received shingle vaccine and the vaccine hurt for 5 days since he/she was 65 years old The patient stated that in 2019 he/she suffered very painful disease lasted more than 6 months he /she got it on top of his/her belly button reaching up to the back of his/her spine on the right side that was a horrible fire Additional Supportive information: The duration  of event was 5 days. In 2022 Patient received shingle vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Lymph node pain
Clinical narrative: Is lymph node tenderness a side effect of Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of lymph node tenderness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced lymph node tenderness. On an unknown date, the outcome of the lymph node tenderness was unknown.   It was unknown if the reporter considered the lymph node tenderness to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The patient want to know that lymph node tenderness a side effect of Shingrix. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: HEP, HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: Has not received the 2nd/3rd doses so far; Has not received the 2nd/3rd doses so far; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 22-year-old female patient who received Hepatitis A vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis A vaccine (received 1st dose on 19th August 2020) and Hepatitis B vaccine (received 1st dose on 08th July 2020).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis A vaccine and the 2nd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination and incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's comment: The pharmacist reported that the patient received doses in unknown facility and not sure if were doses of GlaxoSmithKline vaccines and till the time of reporting, patient has not received the second doses. The reporter asked should restart the series. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Hepatitis A vaccine and Hepatitis B vaccine, which led to incomplete course of vaccination. The case US2022124286 was identified as duplicate of this case. The case US2022124286 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number B23EA, expiry date 15th May 2022) for prophylaxis.   On 9th August 2022, the patient received Havrix. On 9th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comment: The reporter reported that, a patient was administered a expired dose of Havrix. The reporter declined to provide information about the patient. At the time of reporting, the dose had not been repeated. The reporter gave permission for follow-up but declined to provide any patient information. The reporter consented to follow up. Additional Supportive Information: The patient was administered with expired dose of Havrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Product prescribing error
Clinical narrative: 46 YO prescribed Shingrix by physician; This case was reported by a pharmacist via call center representative and described the occurrence of drug prescribing error in a 46-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (Family History) (had family history of herpes zoster (several family members had suffered from zoster)).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug prescribing error. On an unknown date, the outcome of the drug prescribing error was unknown.   Additional Information: GSK receipt date: 26-Aug-2022 Reporter's comment: The pharmacist reported that the patient with a family history of herpes zoster (several family members had suffered from zoster) was prescribed Shingrix by the primary physician.  As far as the reporting pharmacist was aware that the patient did not suffer from any immunocompromising condition. The reporter consented to follow-up. Additional supportive information: The patient was prescribed Shingrix by the primary physician when she had the family history of herpes zoster, which led to drug prescribing error. As it was not clear that the patient had received the vaccine or not so in worst approach case was kept valid for prescribing error and follow-up request was raised for further clarification.
Sex: M
Vaccine: HIBV
Symptoms: Product prescribing error
Clinical narrative: 65-66 YO with splenectomy was recommended Hiberix; This case was reported by a pharmacist via call center representative and described the occurrence of drug prescribing error in a elderly male patient who received Hib (Hiberix) for prophylaxis.   Previously administered products included Hiberix (received 2 doses on an unknown date ). Concurrent medical conditions included splenectomy.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced drug prescribing error. On an unknown date, the outcome of the drug prescribing error was unknown.   Additional Information: GSK receipt date: 26-Aug-2022 Reporter's comment: The pharmacist reported that he had the patient who was around 65-66 years old who underwent splenectomy and was recommended to receive Hiberix.  The reporter did not obtained permission for follow-up. Additional supportive information: The patient was recommended to receive Hiberix when the patient underwent splenectomy, which led to drug prescribing error.