chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion for PROQUAD administered to patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 08-SEP-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # T016990, expiration date 11-NOV-2021, subcutaneously (SQ), dose/frequency reported as 0.5 milliliter (mL) x 1 dose (dose number and anatomical location were not reported) for prophylaxis (product storage error).  The vaccine administered to the patient was stored improperly for the time frame of 37 minutes in the temperature of 7.3 degrees Fahrenheit (F) on 25-JUL-2021.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patient was administered with an improperly stored dose of VARIVAX; This spontaneous report as received from a registered nurse refers to a 4 year old patient. On 15-SEP-2021, the patient was vaccinated with an improperly store dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U010400 exp date 01-APR-2023) (dose and route not reported). The vaccine experienced an excursion of (4°C) for 20 minutes on 07-SEP-2021 during transport and (4°C) for 20 minutes on 09-SEP-2021 during transport.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005910: US-009507513-2109USA005742: US-009507513-2109USA005891: US-009507513-2109USA005964: US-009507513-2109USA005651: US-009507513-2109USA005918: US-009507513-2109USA005744: US-009507513-2109USA005648: US-009507513-2109USA005758: US-009507513-2109USA005628: US-009507513-2109USA005776: US-009507513-2109USA005901: US-009507513-2109USA005639: US-009507513-2109USA005662: US-009507513-2109USA005752: US-009507513-2109USA005641: US-009507513-2109USA005945: US-009507513-2109USA005618: US-009507513-2109USA005760: US-009507513-2109USA005881: US-009507513-2109USA005902:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; products experienced an excursion/have been administered to patients; This spontaneous report was received from a nurse referring to an 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-SEP-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 dose (Lot# U015682 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX), expiration date reported as 18-MAY-2023) (strength, dose, route, frequency, were not provided) for prophylaxis.  The nurse reported that the vaccine experienced an excursion of 4 Celsius degrees (C) from -10 C to 8 C for 20 minutes on 07-SEP-2021 during the transport; and of 4C from -10 C to 8 C for 20 minutes on 09-SEP-2021, again during transport. Previous temperature excursion included from -10°C to 8°C (4C) for 7 hours and 30 minutes. And no adverse events were reported.  This is one of 26 reports received from the same source.; Sender's Comments:  US-009507513-2109USA005628:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE's; inquire if an expired dose of PNEUMOVAX 23 was considered a valid dose; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.   On 23-SEP-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) as prophylaxis (dose and frequency reported as: one time as instructed) (route of administration and anatomical site of vaccination were not reported; lot number S006777 has been verified to be valid, expiration date reported and established as 28-NOV-2020) (expired product administered). The reporter inquired if an expired dose of the vaccine was considered a valid dose. No additional expired vaccines were administered, and no adverse events were reported (no adverse event). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S006777; expirationdate: 28-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: M
Vaccine: PPV
Symptoms: Exposure via skin contact, No adverse event
Clinical narrative: No additional AEs; the fluid dripped down his arm, onto his leg and onto the chair; This spontaneous report was received from a male patient of unknown age reporting on himself.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 23-SEP-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).     The patient stated the fluid dripped down his arm (exposure via skin contact), onto his leg and onto the chair.  No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PROQUAD was administered to a 15 year old patient; no additional adverse events were reported; This spontaneous report was received from a registered nurse, regarding a 15 year old patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications, was not provided.   On an unspecified date, the patient was vaccinated with varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter subcutaneously for prophylaxis, lot number T035393 and expiration date 14-SEP-2021. (strength was not reported). No additional adverse events were reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered after temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 20-SEP-2021, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) oral, lot number 1707457, expiration date 23-FEB-2022 (dose not reported) and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot number T026961, expiration date 02-APR-2023 (dose and route of administration not reported) both for prophylaxis.      The vaccines underwent a temperature excursion of 48.7 degrees Fahrenheit for 10 minutes. There were no previous temeprature excursions.
Sex: M
Vaccine: HPV4
Symptoms: Autoimmune disorder
Clinical narrative: autoimmune disease; other injuries; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 08-JAN-2018, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (strength, dose, route of administration, lot # and expiration date were not reported) as prophylaxis.  As a proximate result of wrongful acts and omission and it's negligent and fraudulent testing, labeling manufacturing, marketing and promotion of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), plaintiff had suffered and continues to suffer severe and permanent physical injuries and associated symptomatology and had suffered severe and permanent emotional injuries, including pain and suffering. Plaintiff also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at increased risk of cancer and future symptoms and harms associated with his autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). As a direct and proximate result of his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) induced injuries, plaintiff had suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and he would continue to incur these losses and expenses in the future. The outcome of the events was unknown.   The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).  Upon internal review, autoimmune disease was determined to be medically significant.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered after temperature excursion; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 17-SEP-2021, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T026961, expiration date: 02-APR-2023 (exact dose, injection site and route of administration were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1707457, expiration date: 23-FEB-2022, orally (exact dose was not provided) both for prophylaxis.  On 10-SEP-2021, the administered doses experienced a temperature excursion of 48.7 degrees Fahrenheit for 10 minutes. No previous temperature excursion had occurred.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-SEP-2021, the patient was vaccinated with improperly store rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot # 1707460, expiration date: 14-MAR-2022) and with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# T026961, expiration date: 02-APR-2023) (formulation, strength, dose and frequency were not reported for both) both for prophylaxis.  The nurse reported that the vaccine experienced an excursion of 48.7 degrees Fahrenheit for 10 minutes. There was no previous temperature excursion.
Age: 27.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inapproproate schedule; no adverse event; This spontaneous report was received from a pharmacist and refers to a currently 29-year-old male patient. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On an unknown date, the patient was vaccinated at age 27 with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) one dose for prophylaxis exact dose, route of administration, lot number and expiration date were not provided.  The reporter would like to know what to do moving forward with the series/requires and alternate dosing schedule (inappropriate schedule of vaccine administered).
Sex: F
Vaccine: BCG
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site scar
Clinical narrative: Old BCG scar red, itchy, tender to the touch.; Old BCG scar red, itchy, tender to the touch.; Old BCG scar red, itchy, tender to the touch.; Information has been received from Pfizer (MFR# 202101282108) on 29-SEP-2021.  This spontaneous report was received from a health professional refers to a female patient of unknown age with. The patient's concurrent condition include asthma. The patient's medical history included migraine.  There was no drug reactions or allergies.   On an unknown date, the patient was vaccinated at the left arm with a dose of bcg live(BCG VACCINE USP) (dose, lot #, expiration date and route were not reported) for tuberculosis bladder. Concomitant therapies included topiramate (TOPIRAMATE).     On an unknown date,  the patient experienced old BCG scar (vaccination site scar), which was red, itchy (itching scar) and tender to touch (scar pain).     At the time of the report, the patient had not recovered from the events.   The relationship between events and bcg live(BCG VACCINE USP) was not reported. combinationproductreport: Yes; brandname: BCG VACCINE USP PUNCTURE DEVICE (DEVICE); commondevicename: BCG live; productcode: LDH; devicetype: SYSTEM, DELIVERY, ALLERGEN AND VACCINE (LDH); manufacturername: Organon Teknika Corporation LLC; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: he developed an itchy rash on chest after receiving COVID vaccine; This is a spontaneous report from a contactable consumer based on information received by Pfizer, (manufacturer control number US-AMGEN-USASP2021138021),   This non-serious spontaneous report (USASP2021138021) was reported to Regulatory authority on 03/SEP/2021 by a consumer and involves a male patient who developed an itchy rash on chest after receiving COVID vaccine [PT: rash pruritic] while receiving Enbrel, Single Dose Prefilled Syringe. No historical medical condition was reported. The patient's current medical condition included psoriasis, unspecified. The patient's concomitant medications included calcipotriene, meloxicam and Tylenol (paracetamol). The patient's co-suspect medication included COVID-19 (Coronavirus disease 2019) Vaccine. The patient began Enbrel with Single Dose Prefilled Syringe on an unknown date. On an unknown date, the patient developed an itchy rash on chest after receiving COVID vaccine. Patient stated it was beginning to improve but still present. No treatment information was received. The outcome of the event rash pruritic was reported as recovering/resolving. Action taken with Enbrel and Single Dose Prefilled Syringe was reported as unknown for the event rash pruritic. The causal relationship between the event rash pruritic and Enbrel with Single Dose Prefilled Syringe was not provided by the consumer.   The reporter declined consent for follow up.   No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Illness, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Arm is a bit sore and red; Arm is a bit sore and red; even a bit of illness; This case was reported by a consumer via media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case US2021AMR202814).   In September 2021, the patient received the 2nd dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced erythema of extremities, pain in arm and illness. The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the erythema of extremities and pain in arm were not recovered/not resolved and the outcome of the illness was unknown.   It was unknown if the reporter considered the erythema of extremities, pain in arm and illness to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The reporter reported If he/she were vaccinated 5 plus years ago, they want to check with their doctor as the previous one had been found to not be effective. The patient received 2nd dose of Shingrix 2 months apart from the 1st dose and arm was bit sore and red.It was better than the 1st dose that hurt more. The patient stated that It was known to cause a sore arm, redness, and even a bit of illness. Follow-up would not be possible as no contact details available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202814:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got first shot and got shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a 81-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the first dose of shingle shot and got shingles. For tolerance with second dose, refer case US2021AMR202799, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202799:same reporter
Sex: U
Vaccine: HEPAB
Symptoms: Booster dose missed, Social problem
Clinical narrative: was not able to get out to get the booster due to Covid; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 61-year-old patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received rapid 3-doses in August- September 2019). Concomitant products included INFLUENZA VACCINE (SEASONAL FLU SHOT).   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   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 are as follows: The case was reported by patient himself/herself. The age at vaccination was not applicable for this report. The patient received rapid 4-dose course of Twinrix for Hepatitis A and B in August - September 2019 and was due for 12 month booster dose in September 2020, but due to Covid and various precaution was not able to get out to get the 12 month booster dose. The patient also received seasonal flu shot a week before reporting. The patient asked the pharmacist that if it was too late (24 months, rather than 12 months) to get the 4th and final Twinrix dose, to finish the series, and he/she did not know was there any value in getting the final booster at this point or would he/she need to went through the whole series again, the next time he/she travel. The patient stated that he/she was not planning on any International travel anytime in the foreseeable future, but if he/she finish the series now, would it offer him/her any basic protection.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Skin warm, Vaccination failure
Clinical narrative: I have spots that fit shingles but I had 2 shots about 2 years ago; I have spots that fit shingles/ I have symptoms; spots where there is a blister; fever of 99.5 at spots; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly 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, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and skin warm. On an unknown date, the outcome of the vaccination failure, shingles, blister and skin warm were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, blister and skin warm to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient had spots that fitted shingles. The patient also had fever of 99.5 degree Fahrenheit at spots where there is a blister. The patient received the shots about 2 years ago. The patient asked if there were over the counter medications for treating the symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Impaired quality of life, Vaccine positive rechallenge
Clinical narrative: My life was on pause with the vaccination; 9 months of illness; This case was reported by a consumer via  interactive digital media and described the occurrence of illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (the patient received 1st dose on an unknown date and also experienced impaired quality of life, refer case US2021AMR202901).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced illness and impaired quality of life. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the illness and impaired quality of life were recovered/resolved.   It was unknown if the reporter considered the illness to be related to Shingles vaccine. The reporter considered the impaired quality of life to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient reported that his/her life was on pause with the vaccination and had 9 months of illness. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202901:same reporter, same patient, same suspect, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster
Clinical narrative: very sore shoulder; shingles like symptoms; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles flared up on three occasions, the cases were mild and addressed by patient's doctor earlier).   In September 2021, the patient received the 1st dose of Shingrix. In September 2021, several weeks after receiving Shingrix, the patient experienced shingles and shoulder soreness. On an unknown date, the outcome of the shingles and shoulder soreness were recovered/resolved.   It was unknown if the reporter considered the shingles and shoulder soreness to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received a dose of Shingrix vaccine a few weeks ago and had shingles like symptoms for a day and a very sore shoulder for few days. The patient thought that it was worth receiving because after the booster in a few months and the virus stays locked up indefinitely. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Impaired quality of life
Clinical narrative: my life was on pause with the vaccinations; illness; This case was reported by a consumer via interactive digital media and described the occurrence of illness 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 illness and impaired quality of life. On an unknown date, the outcome of the illness was recovered/resolved and the outcome of the impaired quality of life was unknown.   It was unknown if the reporter considered the illness and impaired quality of life to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient reported that after taking shingles vaccine his/her life was paused with the vaccinations and was ill for 9 months. For the tolerance of 2nd dose refer case, US2021AMR202892.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202892:same reporter, same patient, same suspect, different dose
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: suspected vaccination failure; mild case near eye; Rash; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster and rash. The patient was treated with antivirals nos. On an unknown date, the outcome of the vaccination failure, herpes zoster and rash were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and rash to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's wife. The reporter stated that her 90 year old father had shingles and it was brutal. He was frail but doing ok. The patient had the Shingles vaccine and he got a very mild case near his eye. It responded rapidly to antivirals and there was no pain. The doctor said had he not been vaccinated he could have lost his eye, a complication of shingles when the rash was near the eyes. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: shot area is painful; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain 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 injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received a shot and had painful shot area for days after. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: lost use of his left arm; This case was reported by a consumer and described the occurrence of mobility decreased in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (wife had shingles and no shot and had pain for over 4 years, but pass on the shot.). Previously administered products included Shingles vaccine with an associated reaction of mobility decreased (1st shot received on an unknown date, for tolerance, refer case US2021AMR202714).   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 mobility decreased. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the mobility decreased was unknown.   It was unknown if the reporter considered the mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient had a shot and lost use of his left arm. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202714:same reporter same patient
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: gotten both vaccinations and shingles/ suspected vaccination failure; shingles; 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.   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) 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 provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had gotten both Shingles vaccinations and still break out with the Shingles. The follow-up would not possible as no contact details were available. 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.
Age: 3.0
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Extra dose administered
Clinical narrative: received unnecessary dose; This case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a 3-year-old patient who received Hib (Hiberix) (batch number 5ep38, expiry date unknown) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number J953N, expiry date unknown) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix (received the primary schedule on an unknown date before 21st September 2021) and hiberix (received the primary schedule on an unknown date before 21st September 2021).   On 21st September 2021, the patient received Hiberix, Infanrix and Infanrix Pre-Filled Syringe Device. On 21st September 2021, unknown after receiving Hiberix, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: Age at vaccination was not reported. The patient received unnecessary dose of Infanrix and Hiberix which led to extra dose administered.The patient's family was informed. The patient had already received the appropriate doses of these vaccines prior to 21st September 2021. No known adverse events due to error. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Pruritus, Rash
Clinical narrative: itching; breaking out with places; flu like symptoms; This case was reported by a consumer via media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine, the patient experienced influenza-like symptoms, pruritus and skin breakout. The patient was treated with steroids nos (Steroid Shot (Nos)). On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the pruritus and skin breakout were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, pruritus and skin breakout to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 1st shingles vaccine few weeks ago and had flu like symptoms for 2 days. The patient then started breaking out with places all over that look like ant bites.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got shingles; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got shingles 1 week after he/she got the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: before the pandemic and not being able to receive dose two; This case was reported by a consumer via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of herpes zoster (received first dose of Shingrix in October 2019 and experienced shingles, for tolerance of 1st dose refer case US2021202974). Concurrent medical conditions included tingling, scar and shingles.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received the 1st dose before the pandemic and did not receive the dose two till the time of reporting. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021202974:same reporter, same patient
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles breakout each year/may had shingles after  1st dose also; This case was reported by a consumer and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (In the past 20 years, the patient had a shingles breakout each year).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.   Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. In the past 20 years the patient had a shingles breakout each year so in the 1st dose of Shingrix also may have shingles breakout. This is 1 of 3 case reported by same reporter. Permission to follow up was denied.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203694:Same patient, possible breakout 2020 post-1st dose
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: breakout in March2021/suspected vaccination failure; breakout in March2021; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (In the past 20 years the patient had a shingles breakout each year and had been anxiously awaiting the vaccine).   On 25th February 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In March 2021, less than 2 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the 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 and Shingrix.   Additional details were reported as follows: The case was reported by the patient. The patient had 2nd Shingrix vaccination and had a breakout in March of 2021.  Permission denied for follow up. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation for shingles were unknown at the time of reporting. This was 1 of 3 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203694:Same patient, 2nd dose and breakout March2021
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and then got shingles/Suspected vaccination failure; got the shot and then got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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 case was reported by patient's friend. The age at vaccination was not reported. The patient got the Shingles shot and got shingles. The patient was not happy. The reporter said everybody was different no one can be guaranteed of anything. 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.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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 was the mother of the reporter. The age at vaccination was not reported. The reporter stated that, his/her mother(patient) got shingles after getting the Shingle shot. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided. This is 1 of the 2 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205258:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: didn't mention a 2nd shot and did not follow up to give me one.; shingles; 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.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In September 2021, between 7 and 8 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine and had contracted shingles.  The patient's doctor did not mention a 2nd dose and did not follow up to give him/her one, and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient asked what the recommendation was on what he/she should do now. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: I got so very very sick from the first shot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of 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.   The reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and got so very sick from the 1st shot. The patient stated that when you ask why you got so sick, they tell you it was a coincidence. The follow-up would not possible as no contact details were available. For 2nd dose refer case US2021AMR205295, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205295:same reporter US-GLAXOSMITHKLINE-US2021AMR205296:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had my shot, Then got them.\ suspected vaccination failure; shingles; 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) 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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shots and got Shingles but not very bad. The follow-up would not possible as no contact details were available. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: I got very sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's mother had shingles two times).   On an unknown date, the patient received the 1st dose of 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: The reporter was the patient. The age at vaccination was not reported.  The patient saw his/her mother had shingles 2 times and hence decided to take the vaccine and got very sick but thought that it was worth it.  The patient stated that having shingles was worse than the effects of the vaccine. The follow-up would not possible as no contact details were available. For tolerance of the second dose, refer US2021AMR205345 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205345:Same patient, same reporter, same suspect, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Vaccine positive rechallenge
Clinical narrative: I got very sick; 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.   Previously administered products included Shingles vaccine with an associated reaction of illness (patient received 1st dose on an unknown date and experienced sickness, refer case US2021AMR205339).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. 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: The reporter was the patient. The age at vaccination was not reported.  The patient saw his/her mother had shingles 2 times and hence decided to take the vaccine and got very sick but thought that it was worth it.   The patient stated that having shingles was worse than the effects of the vaccine. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205339:Same reporter, same patient, same suspect, different dose US-GLAXOSMITHKLINE-US2021AMR205339:Same patient, same reporter, same suspect, different dose