chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE information; a temperature excursion for PROQUAD/-10C; This spontaneous report was received from a office manager and refers to a 4 years old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 22-FEB-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin) (PROQUAD) dose: 0.5 ml, lot # T027111, expiration date 07-FEB-2022, for prophylaxis (route of administration was not reported).  The improperly stored dose of the suspect vaccine experienced a temperature excursion of minus 10 degree Celsius for 1 hour 15 minutes on 16-FEB-2021. No previous temperature excursions were reported.  No digital data logger was involved. No additional adverse events were reported.
Age: 1.0
Sex: M
Vaccine: FLU4, HIBV, MMRV
Symptoms: Death
Clinical narrative: the patient found deceased in bed (death); This spontaneous report was received from a physician via Sanofi (manufacturer control # 2020SA294858) on 15-MAR-2021, referring to a 13-month-old male patient. The patient's medical history included seizure and coronavirus disease of 2019 (COVID-19). He had no pre-existing physician-diagnosed allergies and birth defects and at the time of reporting. It was known if the patient had any additional medical history, concomitant disease or risk factor. Past medical treatment(s), vaccination(s) and family history were not reported.  On 23-SEP-2020 the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (albumin status recombinant Human albumin (rHA) (lot # S038146, expiration date was not reported, upon internal validation established as 25-MAY-2021, strength was not reported) 0.5 milliliter, subcutaneously in the left thigh for prophylactic vaccination. On the same date, the patient was also vaccinated with hib conj vaccine (tet toxoid) (ACTHIB) (lot # UJ185AA, expiration date, strength and route were unknown) 0.5 milliliter in right vastus lateralis for prophylactic vaccination. On 14-OCT-2020, the patient was vaccinated with influenza virus split virion 4v vaccine inactivated (FLUZONE) prefilled syringe (lot # UT7081JA, expiration date was 30-JUN-2021, strength was not reported) 0.5 milliliter intramuscularly in left vastus lateralis for prophylactic vaccination. Either on 14-OCT-2020 or 15-OCT-2020, the patient received a dose (once) of acetaminophen (PARACETAMOL) (lot #, expiration date, strength and route were not reported) 4 ml for an unknown indication and then the patient was put to bed at usual time. At that time the body temperature of the patient was 97.7 degrees Fahrenheit.  In the morning of 15-OCT-2020, the patient was found deceased in bed. No other illness and symptoms were reported. At the time of reporting, it was unknown if the autopsy was conducted, and the cause of death was not determined. The cation taken with acetaminophen(PARACETAMOL) was not applicable.   The causality assessment between death and all suspect therapies was not provided.; Reported Cause(s) of Death: unknown cause of death; cause of death was not determined
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; patient who was administered a PROQUAD vaccine which expired 03/02/2021 on 03/11/2021; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-MAR-2021, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) lot # S027460, expiration date: 02-MAR-2021 (formulation, strength, dose, frequency, route of administration were not reported) reconstituted in sterile diluent, for prophylaxis. No additional adverse event was reported.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Aphasia, Pyrexia
Clinical narrative: fever; aphasia/could not talk; This spontaneous report was received from a female patient of unknown age referring to herself. The patient's medical history included renal transplant. Her concomitant medications and drug reactions or allergies were not provided.  On an unspecified date in November 2011, the patient was vaccinated with either pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) or pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (formulation, strength, dose, anatomical dose, route of administration, lot # and expiration date were not reported for both) as prophylaxis (the patient could not remember which). She reported that she developed a fever about 3-4 hours after receiving the vaccine and had to be taken to the emergency room by ambulance after the fever continued to rise. She was hospitalized for 2-3 nights and was not able to remember much from the hospitalization. She reports that when she woke up in the hospital she could not talk and experienced aphasia that the doctor said could have been results of the high fever. Unspecified treatment was given for the events. The outcome of the events was reported as recovered about 1 week later.  The relatedness between the suspect therapies and the events was not provided.
Sex: M
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, and refers to a 49 years old male patient with chronic lymphocytic leukaemia. He received 2 courses of antibiotics in the year before enrollment. Prior to ibrutinib, the patient was on therapy with rituxinib.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 5. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 5. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Literature report:  Sender's Comments:  US-009507513-2103USA003406:
Sex: M
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 65 years old male patient with chronic lymphocytic leukaemia. He received no course of antibiotics in the year before enrollment. Prior to ibrutinib, the patient was on therapy with fludarabine (+) cyclophosphamide (+) rituximab.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 4. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 0. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Literature report: Sender's Comments:  US-009507513-2103USA003406:
Sex: M
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 66 years old male patient with chronic lymphocytic leukaemia. He received 2 courses of antibiotics in the year before enrollment. Prior to ibrutinib, the patient was on therapy with rituximab.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 19. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 6. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with # US-009507513-2103USA003406).  Sender's Comments:  US-009507513-2103USA003406:
Sex: M
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 72 years old male patient with chronic lymphocytic leukaemia. He received 2 courses of antibiotics in the year before enrollment. There was no therapy prior to ibrutinib.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 5. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 3. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Literature report:  Sender's Comments:  US-009507513-2103USA003406:
Sex: M
Vaccine: PPV
Symptoms: Blood immunoglobulin G decreased, Vaccination failure
Clinical narrative: none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 65 years old male patient with chronic lymphocytic leukaemia. He received 3 courses of antibiotics in the year before enrollment. There was no therapy prior to ibrutinib.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 11. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 11. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Sender's Comments:  US-009507513-2103USA003406:
Sex: F
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 60 years old female patient with chronic lymphocytic leukaemia. She received 2 courses of antibiotics in the year before enrollment. Prior to ibrutinib, the patient was on therapy with fludarabine (+) rituximab (+) lenalidomide.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 0. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 7. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Sender's Comments:  US-009507513-2103USA003406:
Sex: F
Vaccine: PPV
Symptoms: Pneumonia streptococcal, Streptococcus test positive
Clinical narrative: none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 62 years old female patient with chronic lymphocytic leukaemia. She received 6 courses of antibiotics in the year before enrollment. Prior to ibrutinib, the patient was on therapy with rituximab.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 11. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 11. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Sender's Comments:  US-009507513-2103USA003406:
Sex: M
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 68 years old male patient with chronic lymphocytic leukaemia. He received 4 courses of antibiotics in the year before enrollment. There was no therapy prior to ibrutinib.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 10. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 9. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The reporter considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Sender's Comments:  US-009507513-2103USA003406:
Sex: M
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 73 years old male patient with chronic lymphocytic leukaemia. He received two courses of antibiotics in the year before enrollment. There was no therapy prior to ibrutinib.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 11. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 1. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Sender's Comments:  US-009507513-2103USA003406:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Inappropriate schedule of product administration, Nausea
Clinical narrative: 1st dose in fall of 2018 / second dose was received 2/5/2021; Headache; Nausea; Stomach pain / colon wasn't calming down / still has some lingering stomach pain; Diarrhea / colon wasn't calming down / still has some / diarrhea; This case was reported by a consumer and described the occurrence of headache in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received in fall of 2018, reference case US2021034668).   On 5th February 2021, the patient received the 2nd dose of Shingrix. On 5th February 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In February 2021, the patient experienced headache, nausea, stomach pain and diarrhea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache and nausea were recovered/resolved and the outcome of the stomach pain and diarrhea were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the headache, nausea, stomach pain and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient experienced headache, nausea, stomach pain and diarrhea, less than a week after vaccination. The symptoms lasted for 2-3 days except for the stomach pain and diarrhea. The patient still had some lingering stomach pain and diarrhea at the time of reporting. The patient received 2nd dose delayed than the recommended schedule, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021034668:Same patient, Same reporter, 1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Woke up with chills; Woke up with / body aches; Woke up with / headache; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On 10th February 2021, the patient received the 2nd dose of Shingles vaccine. In February 2021, less than a day after receiving Shingles vaccine, the patient experienced chills, general body pain and headache. On an unknown date, the outcome of the chills, general body pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the chills, general body pain and headache to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporting for him/herself. The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient woke up with chills, body aches and headache. The patient asked, what could he/she took to help alleviate these symptoms.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Rash, Swelling
Clinical narrative: I decided not to have the second shot as my reaction was so severe.; 3 weeks of / rash / my reaction was so severe; 3 weeks of swelling / my reaction was so severe; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a female 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced rash, swelling and incomplete course of vaccination. On an unknown date, the outcome of the rash and swelling were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the rash and swelling to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination not reported. The patient took the first shot and had never had such a reaction to a shot prior to this. 3 weeks of swelling and rash. After discussion with a doctor the patient decided not to have the second shot as her reaction was so severe.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Musculoskeletal stiffness
Clinical narrative: The area is red and spreading; Severe stiff neck; Severe headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unkknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema, stiff neck and headache. On an unknown date, the outcome of the injection site erythema, stiff neck and headache were unknown.   It was unknown if the reporter considered the injection site erythema, stiff neck and headache to be related to Shingrix.  Additional details were provided as follows: The patient was reporting for herself. The age at vaccination was not reported. After receiving Shingrix, the patient's injection site area was red and spreading with stiff neck and severe headache. The patient asked is that normal.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Cardiovascular function test normal, Computerised tomogram abdomen normal, Electrocardiogram normal, Pain
Clinical narrative: Developed constant band like burning around upper abdomen; Radiating pain around ribs / left chest under arm and radiating to upper back / bilaterally; Light itch with clothes or fingers worsening; Worsening with touch; HCP says / Post herpetic neuralgia; This case was reported by a nurse via sales rep and described the occurrence of burning sensation in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd November 2020, the patient received the 1st dose of Shingrix .5 ml. On 22nd November 2020, 2 weeks after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced burning sensation, pain, pruritus, tenderness and post herpetic neuralgia. The patient was treated with acyclovir and tramadol. On an unknown date, the outcome of the burning sensation, pain, pruritus, tenderness and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the burning sensation, pain, pruritus, tenderness and post herpetic neuralgia to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of 0.5ml shingrix on 22nd November 2020 at left arm. Patient developed constant burning around upper abdomen with radiating pain around ribs. After 2 weeks patient noted light itch with clothes and fingers worsening, pain moved up to left chest under arm and radiating to upper back bilaterally; again burning sensation and worsening with touch. Patient had CT scan abdomen which did not show anything, also had cardiac catheterization showing no significant obstructive cad, while ECG was normal. Patient had been on cymbals now, Acyclovir did not help for patient, Tramadol worked for pain. Hcp reported that his pain resembles post herpetic neuralgia .  No presentation of vesicles and never hospitalized. Symptoms still present and constant.  No other vaccines given same time or since admin of shingrix.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Pruritus, Tenderness
Clinical narrative: Developed constant band like burning around upper abdomen; Radiating pain around ribs / left chest under arm and radiating to upper back / bilaterally; Light itch with clothes or fingers worsening; Worsening with touch; HCP says / Post herpetic neuralgia; This case was reported by a nurse via sales rep and described the occurrence of burning sensation in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd November 2020, the patient received the 1st dose of Shingrix .5 ml. On 22nd November 2020, 2 weeks after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced burning sensation, pain, pruritus, tenderness and post herpetic neuralgia. The patient was treated with acyclovir and tramadol. On an unknown date, the outcome of the burning sensation, pain, pruritus, tenderness and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the burning sensation, pain, pruritus, tenderness and post herpetic neuralgia to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of 0.5ml shingrix on 22nd November 2020 at left arm. Patient developed constant burning around upper abdomen with radiating pain around ribs. After 2 weeks patient noted light itch with clothes and fingers worsening, pain moved up to left chest under arm and radiating to upper back bilaterally; again burning sensation and worsening with touch. Patient had CT scan abdomen which did not show anything, also had cardiac catheterization showing no significant obstructive cad, while ECG was normal. Patient had been on cymbals now, Acyclovir did not help for patient, Tramadol worked for pain. Hcp reported that his pain resembles post herpetic neuralgia .  No presentation of vesicles and never hospitalized. Symptoms still present and constant.  No other vaccines given same time or since admin of shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Little swelling on my lip; This case was reported by a consumer via interactive digital media and described the occurrence of lip swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced lip swelling. On an unknown date, the outcome of the lip swelling was unknown.   It was unknown if the reporter considered the lip swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient had shingles before. The patient received the dose of Shingrix and experienced almost all of the symptoms including a little swelling on lip. The doctor told patient that to not to take the 2nd dose.  The patient asked about any protection with 1st dose.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Nausea
Clinical narrative: Experienced headache; Experienced / nausea; This case was reported by a other health professional via sales rep and described the occurrence of headache in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced headache and nausea. On an unknown date, the outcome of the headache and nausea were unknown.   It was unknown if the reporter considered the headache and nausea to be related to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient  has experienced nausea and headache for 2 weeks after  administration of vaccines. The patient received Manveo and Bexsero vaccine on same day.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced flu-like symptoms. The reporter stated that, the patient experienced adverse event months ago (exact date unknown) and he also reported the adverse event already to GlaxoSmithKline months ago. No further information reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: brother-in-law received Shingrix and developed Shingles on 3/6/2021/ Suspected vaccination failure; her brother-in-law received Shingrix and developed Shingles on 3/6/2021.; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 6th March 2021, unknown after receiving Shingrix, 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 Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and developed Shingles. The reporter does not know if the patient received one or two doses of Shingrix. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. The reporter does not wish to share her brother-in-law's (patient) initials or birth date stating, her sister would be mad at me if she reports this, I would give her their number to report it. The reporter consented to follow up.  This case has been linked with the case US2021060562, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021060562:same reporter
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Urticaria
Clinical narrative: also experienced hives the next day in the same areas after the second dose; 1st dose on 1/27/2021 / second dose which she received on 3/10/2021; This case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 10th March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 10th March 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On 11th March 2021, the patient experienced generalized urticaria. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the generalized urticaria was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the generalized urticaria to be related to Shingrix.  Additional details were provided as follows: This case was reported by a patient herself.  The patient experienced hives behind ears, thoracic region, belly region and a couple behind knees and on arms, on the next day after vaccination. The reporter consented to follow up. This is 1 of the 3 cases, reported by same reporter. For tolerance of 1st dose refer case US2021061356.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021061360:same reporter US-GLAXOSMITHKLINE-US2021061356:same patient
Sex: M
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: hives; This case was reported by a physician via sales rep and described the occurrence of hives in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th March 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 12th March 2021, 1 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   The reporter considered the hives to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age group not reported but as per birth year patient could be adolescent or adult. The age at vaccination was not reported, but it could be 17 or 18 years. The patient developed hives morning after the vaccine was given. The reporter thought it was related to the vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: last fall I took the Shingrix shots / Four weeks ago I came down with shingles/ suspected vaccination failure; shingles; terribly painful; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In February 2021, less than 6 months after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not 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 reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Last fall the patient received the Shingrix vaccine, as physician and everyone said the patient need to get them. Four weeks before the date of reporting, the patient came down with shingles, that was terribly painful, and it was still painful. The patient was very disappointed with the results patient have had, it's so painful. The patient stated that patient had to pay full price for shots out of pocket 100 percent and know it was not 100 percent but 96 percent. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Itchy; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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 vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient had the shot and had shingles for few months. The patient mentioned that, it was not too bad, just very itchy in an uncomfortable place. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory test confirming shingles and time to onset were unknown at the time of reporting. No further information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; one of the first thing I got; Painful; I thought i die; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and feeling abnormal. On an unknown date, the outcome of the vaccination failure, shingles, pain and feeling abnormal were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The reporter reported for himself or herself. The age at vaccination was not reported. The patient stated that, it was the 1st thing the patient got and the patient thought he or she would die.  It was painful and patient stated that he or she would not want anyone to get it. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Herpes zoster, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: Suspected vaccination failure; Shingles; little patch of blisters about two inches wide; deep pain in my shoulder before I even broke out; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and shoulder pain. The patient was treated with steroids nos (Steroid Shot (Nos)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure, shingles, blister and shoulder pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, blister and shoulder pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated anyone could get shingles from both vaccines. The patient got shingles after receiving the Shingrix vaccine. The patient noticed the little patch of blisters about two inches wide. The patient went to urgent care and they said it was shingles and gave a steroid shot and a steroid prescription. Shingles were on shoulder and patient had deep pain in shoulder before the shingles even broke out.  The reporter stated that sooner you get a shot and medicines the better it was. The patient never got any worse. The shingles without the vaccine would be way worse. The reporter stated the key was did not wait if you suspect you have them. Get treated immediately. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and exact time to onset were unknown. For tolerance of 1st dose of Shingrix, refer case US2021AMR063231.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063231:same patiet
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I did. I broke out from the second one; This case was reported by a consumer and described the occurrence of suspected 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient. The age at vaccination was not reported. It was reported that the patient broke out with shingles from the second one. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation and exact time to onset for shingles were unknown.
Age: 81.0
Sex: M
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Balance disorder, Brain scan normal, Dizziness, Incomplete course of vaccination
Clinical narrative: Incomplete course of vaccination; lost his balance / balance issues; dizziness; This case was reported by a consumer via call center representative and described the occurrence of loss of balance in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 6th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 6th September 2019, the patient received PNEUMONIA VACCINE. On 7th September 2019, 1 days after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after starting Meclizine, the patient experienced loss of balance and dizziness. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with meclozine hydrochloride (Meclizine). On an unknown date, the outcome of the loss of balance and dizziness were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the loss of balance and dizziness to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The patient received an unspecified pneumonia vaccine together with the Shingrix and the next morning, he was dizzy and lost his balance.   The patient went to the emergency department and had an unspecified brain scan, which ruled out stroke or other anomaly.  The patient was given Meclizine and monitored, and then released. The patient was followed up by a neurologist who recommended balance therapy for 6 weeks and 12 sessions.   The patient reported that this did not ease the dizziness or balance issues. The patient reported that the dizziness was more apparent after meals. He was continuing to report dizziness and loss of balance. It was unknown if the reporter considered the loss of balance and dizziness to be related to Pneumonia vaccine. The reporter consented to follow up.