chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia, SARS-CoV-2 test, Vaccination site swelling
Clinical narrative: chest pain; Muscle pain; vaccinated left arm swollen; fever; nausea; dizziness; wet cough (phlegm); abdominal pain; This is a spontaneous report from a contactable consumer or other non HCP (patient, self-reporting). A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH, formulation: solution for injection, Batch/Lot Number: EN 5318 and expiration date was not reported), via an unspecified route of administration in arm left on 27Jan2021 (at the age of 53-years-old) as 2ND dose, single dose for COVID-19 immunisation. Medical history included ongoing diabetes mellitus, ongoing hypertension, ongoing irritable bowel syndrome, intervertebral disc protrusion and chronic sinusitis. The patient had no known allergies. Concomitant medication(s) included metformin 750mg; glimepiride 4mg (AMARYL) and enalapril 2.5mg. The historical vaccine included first dose of BNT162B2 (PFIZER BIONTECH, Batch/Lot Number: EK 4176 and expiration date was not reported), via an unspecified route of administration in left arm on 07Jan2021 as single dose for COVID-19 immunisation. The patient did not have COVID prior vaccination. The patient had no other vaccines within four weeks. On 28Jan2021, the patient experienced chest pain, muscle pain, vaccinated left arm swollen, fever, nausea, dizziness, wet cough (phlegm) and abdominal pain. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Jul2020. Therapeutic measures were taken as a result of the events. The patient was treated with pain reliever and decongestant for the events. Facility type vaccine: Workplace clinic. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient recovered with sequelae from the events.  Follow-up (12Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: No new information updated.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash over body  Went to Dermologist for Predizone 20 mg, Hydroxyzine  50og and lotion Closetosac    Waited on phone for aver a hour; This is a spontaneous report from a contactable consumer (patient himself). A 65-years-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9810),via an unspecified route of administration in left arm on 27Feb2021 13:30 as a single dose for COVID-19 immunization and the patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9265),via an unspecified route of administration, administered in left arm on 01Feb2021 01:30 as 1st Dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks prior. On an unknown date, the patient experienced rash over body went to dermologist for predizone 20 mg, hydroxyzine 50og and lotion closetosac waited on phone for aver an hour. Therapeutic measures were taken as a result predizone 20 mg, hydroxyzine 50og and lotion closetosac. The outcome for the events was not recovered.  No follow-up attempts are possible. No further information is expected.  Follow-Up (15Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 0.58
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No additional AE; improperly stored temperature excursion / VARlVAX (-50°C to -15°C) (10.8 °C); DOB: 10/12/2020; This spontaneous report was received from a medical assistant concerning a 7-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not provided.  On an unspecified date, the patient was vaccinated (inappropriate age at vaccine administration) with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number S022755 and expiration date 22-JUL-2021 were verified as valid) (formulation, concentration, vaccination schemes frequency, route of administration, anatomical site of vaccination were not reported) for prophylaxis. The vaccine was exposed to a temperature excursion as it was improperly stored at 10.8 Centigrade degrees for 1 hour, 45 minutes (product storage error), which was detected by digital data logger. The recommended range temperature was minus 50 Centigrade degrees to minus 15 Centigrade degrees. There was no previous temperature excursion. No adverse events were reported.; Sender's Comments:  US-009507513-2105USA003927: US-009507513-2105USA004015: US-009507513-2106USA001126:
Age: 29.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse events were reported or noticed; administered IM instead of SC; This spontaneous report was received from a nurse practitioner concerning a 29-year-old male patient. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 18-MAY-2021, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliter intramuscular route instead of subcutaneous, lot number T012808, has been verified to be a valid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), expiration date reported as 14-AUG-2022, but upon internal validation established as 14-APR-2022 as prophylaxis.  No additional adverse events were reported.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No PQC or additional AEs reported; Patient had gardasil 4 x3 in 2011, given extra dose of gardasil 9 on 24-MAY-2021; This spontaneous report has been received from a nurse prescriber, concerning a 21-year-old female patient. The patient's historical vaccine included hpv vaccine vlp rl1 4v (yeast) (GARDASIL 4) three doses in 2011. The patient's medical history and concurrent conditions were not provided. Concomitant therapies included hepatitis a vaccine inact(HAVRIX).  On 24-MAY-2021, the patient was vaccinated with an extra dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R036912 with expiration date 23-SEP-2021, subcutaneously in the right deltoid (dose and frequency were not provided) for prophylaxis. No adverse effects noted. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R036912; expirationdate: 23-SEP-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE/PQC reported at this time; a temperature excursion on VAQTA; Information has been received from an other health professional referring to a 18 months old of patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 20-MAY-2021, the patient was vaccinated with improperly stored of hepatitis a vaccine, inactivated(VAQTA) (lot # T033304, expiration date: 02-APR-2022, strength, dose, frequency and route were unknown) for prophylaxis (incorrect product storage).  No adverse effects were reported.  The stored temperature was 36 to 46 Fahrenheit (48.2 F). The time frame was 15 minutes. There was a previous temperature excursion: 36 to 46 F (46.2 F) for 15 minutes. The temperature excursion was detected by a data logger.  This is one of the several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033304; expirationdate: 02-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA000591: US-009507513-2106USA000663: US-009507513-2106USA000689: US-009507513-2106USA000712: US-009507513-2106USA000775: US-009507513-2106USA000779: US-009507513-2106USA000988:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: varivax were administered on 27-05-2021 and expired on 20-05-2021; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. No information regarding medical history or concomitant medications was provided.  On 27-MAY-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), 0.5 milliliters (ml), once, lot number S015460, expiration date 20-MAY-2021 (anatomical site of vaccination and route of administration were not provided) as prophylaxis (expired product administered). The reporter stated the vaccine had never undergone a temperature excursion.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA001328:
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other AE was reported; The first dose was administered on 10-MAY-2021 and the second dose was administered on 28-MAY-2021; This spontaneous report was received from a certified medical assistant (C.M.A), referring to a 38-year-old female patient. No information regarding medical history or concomitant medications was provided.  On 10-MAY-2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and on 28-MAY-2021 with the second dose, both of 0.5 milliliter (ml) as prophylaxis (formulations, concentrations, anatomical sites of vaccination, lot numbers and expiration dates were not reported) (inappropriate schedule of product administration). No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE reported; The product was stored outside of the recommended storage range and administered to patients; This spontaneous report was received from a pharmacist and refers to a patient of unknown age (reported as adult and over the age of 13 years) and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.  On 12-MAY-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status rHA) (dose and route of administration not reported, lot # T028139, expiry date reported as 15-APR-2022 but upon internal validation established as 15-FEB-2022) for prophylaxis. The administered dose of vaccine was stored outside of the recommended storage range, in temperature of 43 degree Fahrenheit (F), for 21 days. Digital data logger was not involved. The vaccine did not experience any previous temperature excursions. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA003760: US-009507513-2106USA003759: US-009507513-2106USA003761:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: proquad improperly stored and administered/ -14 C for 35 h 43 minutes; This spontaneous report was received from a medical assistant and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.     On 01-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recoant Human albumin (rHA)(PROQUAD) lot # U002535, expiration date 24-JUL-2022 (dose and route of administration were not provided)  for prophylaxis. The dose was improperly stored in temperature excursion of -14 degress Celsius for 35 hours and 43 minutes. There was no previous temperature excursion. Data logger was involved.  The report is linked to MARRS # 2106USA001746, received from the same reporter.; Sender's Comments:  US-009507513-2106USA001746:
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events reported; administration of PROQU AD to a 19 year old female; This spontaneous report was received from a medical assistant and refers to a 19-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-JUN-2021, she was vaccinated at inappropriate age with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, recombinant human albumin (rha) (lot # T028296, expiration date 16-FEB-2022) (route of administration was not reported) for prophylaxis. No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported; temperature excursion on PROQUAD that was administered to a patient; This spontaneous report was received from a pharmacist and refers to a 4-year-old patient of an unknown gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided. On 09-JUN-2021 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 time dosage (lot # T027114, expiration date: 07-FEB-2022) (route of administration was not provided) for prophylaxis. No signs or symptoms were reported. According to the reporter, the temperature excursion was 15 degrees Celsius for a time frame of 5 hours, without any previous temperature excursion. Digital data logger was involved.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; she administered an M-M-R II dose via the intramuscular route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.    On 11-JUN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot# T007233 with an expiration date on 27-FEB-2021) reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# S007960 with an expiration date on 21-SEP-2021) by intramuscular route (strength, dose, and anatomical location were not reported) for prophylaxis (incorrect route of product administration).     No additional adverse events were reported.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: experienced fever; chills; malaise; diaphoresis; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic.   On 11th December 2020, the patient received the 1st dose of Shingrix (intraparietal) .5 ml. On 11th December 2020, less than a day after receiving Shingrix, the patient experienced fever, chills, malaise and diaphoresis. On 15th December 2020, the outcome of the fever, chills, malaise and diaphoresis were recovered/resolved.   It was unknown if the reporter considered the fever, chills, malaise and diaphoresis to be related to Shingrix.  Additional details were provided as follows: Upon follow up, this case considered as valid case. The case was reported by patient itself. The patient had first dose of Shingrix and experienced fever, chills, malaise and diaphoresis. All events recovered after 3 days of vaccination. The patient was bit by a bug on 21 May 2021 and seen in local emergency room and took sulfa antibiotic and had an anaphylactic reaction her throat was closing up. The patient may not get her second shot by 11 June 2021. The patient did not know was allergic to Bactrim of which was her first antibiotic of 3. The patient did not consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINxE-US2021125140:Same reporter US-GLAXOSMITHKLINE-US2021125130:FU3 DELETED
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: I took the vaccine and I was sick as a dog; This case was reported by a consumer via 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 unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient took shingles vaccine and was sick as a dog. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: He had flu-like symptoms from the Shingrix vaccine; This case was reported by a pharmacist via other manufacturer and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2021, the patient received Shingrix. On 14th May 2021, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   The reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms from Shingrix vaccine. The pharmacist reported that they had opened and diluted the vaccine at the pharmacy and when they received the vaccine, it was sealed and intact. The reporter consented to follow up. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; currently have the shingles; pain is terrible; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure 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 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, shingles and pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingrix doses in 2018. At the time of reporting, the patient was having shingles and stated that pain was terrible. The patient stated he or she could not imagine what shingles would have been if the patient had not been vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got the shot and still got shingles; This case was reported by a consumer via 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) 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 details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received shingles vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I'm suffering from singles; This case was reported by a contact via 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) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself or herself. The age at vaccination was not reported. The patient got Shingles vaccine 4 years ago and on the day of reporting, he or she was suffering from shingles.  This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot and still had the shingles/ Suspected vaccination failure; Shingles; This case was reported by a consumer via 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) 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 details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the Shingles vaccine and still had the shingles. The patient stated that it was not so serious but enough for him/her and was no fun. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My father was vaccinated yet still got shingles/Suspected vaccination failure; My father was vaccinated yet still got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a 82-year-old male 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) 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 details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I know afew people who got the shot n later got shingles/Suspected vaccination failure; I know afew people who got the shot n later got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in an unspecified number of patients 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) 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 details were provided as follows:  The age at vaccination was not reported.  The patients received Shingles vaccine and later got shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown. The reporter reported that dam if you do and dam if you dont. This case has been linked with US2021AMR128540, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR128540:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia
Clinical narrative: pain, all over the body; shivering; fever; not feeling good for 2 days; This case was reported by a pharmacist via call center representative and described the occurrence of generalized aching in a patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date 13th November 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized aching, shivering, fever and feeling bad. On an unknown date, the outcome of the generalized aching, shivering, fever and feeling bad were recovered/resolved.   It was unknown if the reporter considered the generalized aching, shivering, fever and feeling bad to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter called to report that a lot number for Shingrix has caused too many adverse events for patients and that they would stop administering this lot since this was very unusual. The patient received vaccine and reached back complaining about pain, all over the body, shivering, fever and not feeling good for 2 days. The reporter knew that these were common side effects and was aware that this happens but was concerned due to the fact that 3 patients received doses from the same lot and they all 3 felt bad enough to call the pharmacy. The reporter consented to follow up. The reporter stated that they can share patient information but during follow-up by safety. This is 1 of the 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021128010:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shingle shots and he got it anyway/ Suspected Vaccination failure; had both shingle shots and he got it anyway /it wasn't a real bad case; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male 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's wife. The age at vaccination was not reported. The patient received both doses of Shingles vaccine and got shingles. The reporter stated that at least it was not a real bad case. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: did get vaccinated, four months later I had the shingles, in my face,\ Suspected Vaccination failure; I had the shingles, in my face,; very painful; This case was reported by a consumer via 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, 4 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and 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 Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine and four months later experienced the shingles on face, very painful. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Got the first dose of the new vaccine / I couldn't afford it I didn't get the 2 dose; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (lasted for a solid year, ten years or more ago). Previously administered products included Shingles vaccine (received 1st dose on an unknown date) and Shingles vaccine (received a vaccine, a few years ago). Concurrent medical conditions included systemic lupus erythematosus.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The patient got a vaccine a few years ago, and a year later the patient's doctor said that vaccine was not a good vaccine and the patiet had to get the new vaccine that required 2 doses. The patient stated that, when he or she went to take the second dose they wanted to charge the patient for it because they said the patient had reached the donut hole of his or her insurance deductible and since couldn't afford it. The patient was a retired senior, so he or she had the dose that they said was no longer good.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain
Clinical narrative: had the shingles many years ago after having the first vaccine; Still get the horrible pain periodically from the damaged nerves; Still get / pain periodically from the damaged nerves / new shot doesn't help this damage; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 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 shingles, pain and nerve damage. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain and nerve damage were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain and nerve damage to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had the shingles many years ago after having the first vaccine. The reporter mentioned that, patient still get the horrible pain periodically from the damaged nerves.  The reporter also mentioned that, the new shot doesn't help this damage. No further information was reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got the 1st and 3nd shot and still got them/ Suspected vaccination failure; I got the 1st and 3nd shot and still got them; It was 3 months and still painful; This case was reported by a consumer via media 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 2nd dose of Shingles vaccine and the 1st 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), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient got the 1st and 2nd shot and still got shingles, it was 3 months and was painful till the time of reporting. The patient stated because shingle shot was received did not mean that he/she would not get shingles, they just would not be as bad. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had it 3 times after I took the shot!/ suspected vaccination failure; I had it 3 times; This case was reported by a consumer via 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) 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 details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient stated he/she had shingles 3 times after the patient took the shot. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Skin burning sensation
Clinical narrative: bad reaction / Chills; Fever; Aches; Skin was on fire; This case was reported by a consumer via media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chills, fever, pain and burning sensation skin. On an unknown date, the outcome of the chills, fever, pain and burning sensation skin were recovered/resolved.   It was unknown if the reporter considered the chills, fever, pain and burning sensation skin to be related to Shingles vaccine.  Additional details were provided as follow: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2nd dose of Shingles and had a pretty bad reaction included chills, fever, aches and his/her skin was on fire which lasted for couple of days. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Neuralgia, Paraesthesia, Post herpetic neuralgia
Clinical narrative: got the shingles shot and still got the shingles/ mine didn't get as bad with the shingles shot/ suspected vaccination failure; got the shingles/ mine didn't get as bad; tingling nerve pain on my left shoulder blade /I still have nerve pain from the shingles.; This case was reported by a consumer via 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 and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient got the shingles shot and still got the shingles. The patient stated that nine months later he/she still had nerve pain from it. The patient stated that his/her did not get as bad with the shingles shot as it would have without it. The physician said that the patient had tingling nerve pain on my left shoulder blade from the shingles till the time of reporting. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: got the shingles shot and still got the shingles/ mine didn't get as bad with the shingles shot/ suspected vaccination failure; got the shingles/ mine didn't get as bad; tingling nerve pain on my left shoulder blade /I still have nerve pain from the shingles.; This case was reported by a consumer via 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 and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient got the shingles shot and still got the shingles. The patient stated that nine months later he/she still had nerve pain from it. The patient stated that his/her did not get as bad with the shingles shot as it would have without it. The physician said that the patient had tingling nerve pain on my left shoulder blade from the shingles till the time of reporting. 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.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Condition aggravated, Incomplete course of vaccination
Clinical narrative: has not received his second Shingrix vaccine. (late dose); approximately 6 hours after he received his Shingrix vaccine his heart felt strange; defibrillator/pacemaker placed in February 2020 / no events recorded / 2 days before / first Shingrix vaccine / one event recorded / 2 hours later his defibrillator began recording events that totaled 8 events in 12 hours; This case was reported by a consumer via call center representative and described the occurrence of chest discomfort in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included artificial cardiac pacemaker user (placed in February 2020). Concurrent medical conditions included defibrillator/pacemaker insertion.   On 23rd November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 23rd November 2020, 6 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chest discomfort and condition aggravated. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with amiodarone. On an unknown date, the outcome of the chest discomfort was recovered/resolved and the outcome of the condition aggravated and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the chest discomfort and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The age at vaccination was reported for 1st dose and it was not applicable for 2nd dose. 6 hours after receiving 1st dose of Shingrix, patient experienced chest discomfort and 2 hours after receiving Shingrix his defibrillator began to recode events that totally recorded 8 events in 12 hours.  The patient had a defibrillator/pacemaker placed in February 2020 with no events recorded initially. Two days before patient received his first Shingrix vaccine he had one event recorded on the defibrillator. The patient had reported  his Health care professional and put him on Amiodarone that he was still taking. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consented to follow up.
Age: 19.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: First dose: April 6th 2021/Third dose: Jun 8th 2021; second dose / 2 days apart form the first/First dose: April 6th 2021/Second dose: April 8th 2021; adolescent female patient received Engerix-B adult dose/  instead of a pediatric dose; adolescent female patient received Engerix-B adult dose/  instead of a pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received HBV (Engerix B pediatric) (batch number KC57F, expiry date 4th September 2021) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   Previously administered products included ENGERIX-B PEDIATRIC with an associated reaction of no adverse event (received 1st dose on 6th April 2021).   On 8th April 2021, the patient received the 3rd dose of Engerix B pediatric. On 8th June 2021, the patient received the 2nd dose of Engerix B adult. In April 2021, not applicable after receiving Engerix B pediatric and unknown after receiving Engerix B adult, the patient experienced drug dose administration interval too short, overdose and adult product administered to child. In June 2021, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short, drug dose administration interval too short, overdose and adult product administered to child were unknown.  Additional details were provided as follows: The patient received Engerix-B adult dose as a second dose instead of a pediatric dose 2 days apart from the first Engerix-B, which led to shortening of vaccination schedule. The patient received 3rd dose Engerix-B adult dose after 2months, which led to shortening of vaccination schedule, overdose, adult product administered to child. The reporter consented to follow up.    Upon QC review below correction are done on 15th June 2021: On 8th June 2021, the patient received the 3rd dose of Engerix B pediatric.  On 8th April 2021, the patient received the 2nd dose of Engerix B adult.