chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dysphagia, Feeling abnormal, Feeling hot
Clinical narrative: I was not expecting any immediate adverse symptoms, given that my first two doses of Moderna only produced mild flu like symptoms after more than 24 hours. Five minutes after taking the shot I began feeling a bit lightheaded and like they were waves of heat going through my body. I continued grocery shopping at the Safeway to dispense the shot, but eventually told my brother that I was feeling bad enough that I needed to go talk to the pharmacist about what I was feeling. As I was walking back to the pharmacy counter, I began noticing what felt like a growing ball in the back of my throat. I described my symptoms to them and they said they would like me to sit and watch  me. I asked for water as it was becoming difficult to swallow. As the feeling grew stronger, I asked for the epipen wanting to make sure I would not get to the point of restricted breathing, and administered a dose. I had never had an anaphylactic reaction to anything before, but my younger brother has a severe allergy and I was familiar with the procedure. The pharmacist called the EMS unbeknownst to me and they convinced me to go to the emergency room. I was administered intravenous Benadryl and then more epinephrine after I mentioned it was beginning to feel like my tongue was too big for my mouth. After arriving at the hospital about 40 minutes later, I was feeling pretty fine and any noticeable swelling had abated but they kept me for observation for 4 hours. The only remark was that my uvula had stuck to the side of my throat, which may have increased a sensation of an anaphylactic response. I am not 100% confident that this was not a more mild response heightened by the power of suggestion to be completely honest. Though I will say that I had not read about any issues with tongue or throat swelling before I began experiencing it. No further issues have occurred.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Pharyngeal swelling, Sensation of foreign body, Swollen tongue, Uvula deviation
Clinical narrative: I was not expecting any immediate adverse symptoms, given that my first two doses of Moderna only produced mild flu like symptoms after more than 24 hours. Five minutes after taking the shot I began feeling a bit lightheaded and like they were waves of heat going through my body. I continued grocery shopping at the Safeway to dispense the shot, but eventually told my brother that I was feeling bad enough that I needed to go talk to the pharmacist about what I was feeling. As I was walking back to the pharmacy counter, I began noticing what felt like a growing ball in the back of my throat. I described my symptoms to them and they said they would like me to sit and watch  me. I asked for water as it was becoming difficult to swallow. As the feeling grew stronger, I asked for the epipen wanting to make sure I would not get to the point of restricted breathing, and administered a dose. I had never had an anaphylactic reaction to anything before, but my younger brother has a severe allergy and I was familiar with the procedure. The pharmacist called the EMS unbeknownst to me and they convinced me to go to the emergency room. I was administered intravenous Benadryl and then more epinephrine after I mentioned it was beginning to feel like my tongue was too big for my mouth. After arriving at the hospital about 40 minutes later, I was feeling pretty fine and any noticeable swelling had abated but they kept me for observation for 4 hours. The only remark was that my uvula had stuck to the side of my throat, which may have increased a sensation of an anaphylactic response. I am not 100% confident that this was not a more mild response heightened by the power of suggestion to be completely honest. Though I will say that I had not read about any issues with tongue or throat swelling before I began experiencing it. No further issues have occurred.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects from first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects from first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects from first shot). At the time of the report, VACCINATION COMPLICATION (Side effects from first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication  were reported. No treatment details were reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: MILD TINGLING SENSATION IN THE ARM; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcoholic, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On MAY-2021, the patient experienced mild tingling sensation in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild tingling sensation in the arm on MAY-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Sex: U
Vaccine: MMR, UNK
Symptoms: Product preparation error
Clinical narrative: No adverse event; INADVERTANTLY ADMINISTERED ONLY STERILE DILUENT TO A PATIENT WITHOUT MIXING IT WITH THE MMR-II; INADVERTANTLY ADMINISTERED ONLY STERILE DILUENT TO A PATIENT WITHOUT MIXING IT WITH THE MMR-II; This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's Medical history, concurrent conditions and concomitant medication were not reported.  On 29-NOV-2021, the patient was inadvertently administered only sterile diluent  ( MERCK STERILE DILUENT) 0.7 ml (lot# reported as T004403, internal validation not received, expiration date 13-OCT-2022)  (route of administration was not reported) without mixing it with Measles, Mumps, and rubella (wistar RA 27-3) virus vaccine, Live (M-M-R II) (product preparation error)  ( lot number- verification mail sent, expiry date: 13-OCT-2022). There was no other AE information reported.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: incorrect product storage; This spontaneous report was received from a nurse and refers to a patient of unknown age.  The patient's concurrent conditions, medical history, concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with 0.5 ml hepatitis A vaccine, inactivated(VAQTA)( lot # T031202 with expiration date: 14-JUN-2022)for prophylaxis. The vaccine was administered after temperature excursion (14.1 Celsius degrees in a timeframe of 14 hours). There was no previous temperature excursions (product storage error).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; VARIVAX was administered after a temperature excursion; This initial spontaneous report was received from an unspecified reporter concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were not reporte.      On 19-OCT-2021, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route and frequency not provided) Lot # T032315 and expiration date: 22-SEP-2022, for prophylaxis.     It was reported the vaccine was administered after a temperature excursion at -10 celcius for 7 hours. The vaccine had no previous excursion. No adverse events reported.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: PEDVAXHIB was administered after a temperature excursion; This initial spontaneous report as received from a Licensed Practical Nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were not reported.       On 01-DEC-2021, the patient was vaccinated with a dose haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose, frequency, and route not provided) Lot # T037651 and expiration date: 20-JUL-2023 for prophylaxis.  It was reported that the vaccine was administered after a temperature excursion at 46.9 F for 30 minutes. Additionally, it was stated that the vaccine had previous temperature excursion at 48F for 30 minutes.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no other adverse events reported; patient received an expired dose of GARDASIL 9; patient also had an interrupted schedule; This spontaneous report as received from a physician refers to a patient of unknown age. No information about medical history, concurrent conditions or concomitant therapy were provided regarding the patient.  On an unknown date in 2008, 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) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date in July 2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (Inappropriate schedule of product administration).   On 13-DEC-2021, the patient was vaccinated with an expired third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) pre-filled syringe, lot # S020255, expiration date 09-DEC-2021 (dose, site of administration, route of administration were not reported) for prophylaxis (Expired product administered).   No adverse events were reported (No adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; patient received on 12/15/2021 an expired dose of GARDASIL 9.; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 15-DEC-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter "once", lot #R029900 was confirmed to be valid, expiration date: 23-JUL-2021 for prophylaxis (anatomical location and route of administration were not provided) (expired product administered). No adverse effects were reported. .
Sex: U
Vaccine: VARZOS
Symptoms: Eye irritation, Eye pruritus, Ocular hyperaemia, Ophthalmic herpes zoster
Clinical narrative: The Patient suffered a red, irritated, and itching eye and was diagnosed with herpetic involvement and keratitis of the right eye; This spontaneous report was received from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  In or around 23-JAN-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for prevention of shingles.         On an unknown date (reported as "shortly after vaccination"), the patient experienced a red, irritated, and itching eye and was diagnosed with herpetic involvement and keratitis of the right eye (ophthalmic herpes zoster).  The outcome of ophthalmic herpes zoster was not recovered.     As a result of the vaccination, the patient had severe and permanent personal injuries, for that reason, the event was considered as a disabling event.   The reporter considered ophthalmic herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Upon internal review, the event of ophthalmic herpes zoster was considered as medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: The patient suffered a rash and a rash on the scalp, painful and itching blisters on the back of the neck and was later diagnosed with Herpes Zoster.; This spontaneous report was received from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  In or around 19-MAR-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for prevention of shingles.         On 22-MAR-2018 (reported as "4 days after vaccination"), the patient experienced a rash and a rash on the scalp, painful and itching blisters on the back of the neck and was later diagnosed with herpes zoster.  The outcome of herpes zoster was not recovered.     As a result of the vaccination, the patient had severe and permanent personal injuries, for that reason, the event was considered as a disabling event.   The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired product administered; No further information provided. No adverse event occurred; This spontaneous report as received from a consumer referring to a patient of unknown age and gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.  On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number, expiry date, dose, anatomical location, route of administration and dose description was not reported) for prophylaxis (expired product administered). Reporter stated measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was about 4 month expired but did not have lot number and expiration date and product did not have nay temperature excursions prior to administration. No further information provided. No adverse event occurred (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; Expired product administered; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.  On 15-DEC-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S039311, expiry date : 04-DEC-2021 (dose, anatomical location, route of administration and dose description was not reported) for prophylaxis (expired product administered).. No additional adverse event reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: M-M-R II was given via intramuscular route; No additional adverse event; This spontaneous report as received from a registered pharmacist, and refers to a patient of unknown age and gender. The information about patient's concurrent condition, medical and drug history and concomitant medications was not provided.  On 20-DEC-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), one dose/once, lot # T013728, expiration date: 21-APR-2022 intramuscularly (Incorrect route of product administration) as prophylaxis (anatomical location were not provided).  No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Received vaccine and still has outbreaks; Vaccination failure; This spontaneous report as received from a consumer refers to a patient of unknown age and gender. The patient had shingles when he/she was in 20s. The patient's allergies, drug reactions and concomitant medications were not provided.  On an unknown date the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (shingles vaccine) as prophylaxis. (dose, lot number, expiration date, route of administration and anatomical location were not provided)   The patient had shingles when he/she was in 20s. Ten years ago (unspecified date), patient finally able to get vaccine, but he/she still had occasional outbreaks (herpes zoster) (vaccination failure).  The outcome of herpes zoster was unknown. The reporter did not provide the causality assessment between zoster vaccine live(ZOSTAVAX) (shingles vaccine) and herpes zoster.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired product administered, Product dose omission issue, Pruritus, Sneezing
Clinical narrative: ITCHY; GIVEN EXPIRED FLUMIST; SNEEZED EVERYTHING OUT\NOT SURE HOW MUCH WAS SNEEZED OUT; A spontaneous report has been received from a health professional. The report concerns a male patient (age not provided) (height 105 cm, weight 17 kg).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist (influenza vaccine live reassort 3v) (batch number NH3062) (expiration date 14-DEC-2021) once/single administration, via nasal route, on 17-DEC-2021.     No malfunction has been reported for FLUMIST.    The report described a medication error for Flumist. The reported term was given expired flumist (Preferred term: Expired product administered). The reported term was sneezed everything out\not sure how much was sneezed out (Preferred term: Product dose omission issue).     On 17-DEC-2021, the patient experienced itchy (preferred term: Pruritus).     It is unknown if any action was taken with Flumist (influenza vaccine live reassort 3v).     The outcome of the event(s) of itchy, given expired flumist and sneezed everything out\not sure how much was sneezed out was unknown.     The events were considered non-serious.     The reporter considered that there was a reasonable possibility of a causal relationship between Flumist (influenza vaccine live reassort 3v)and the following event(s): itchy, given expired flumist and sneezed everything out\not sure how much was sneezed out.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray   Product Role: Suspect
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: This case was reported by a consumer via  interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received 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.  Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The reporter stated that he/she got one of the shingles vaccines and it made him/her sicker than a dog. The reporter stated he/she was not going back for another. The reporter stated that he/she did not believe anything they tell them anymore. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via interactive digital media 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, 4 days 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 patient self-reported this case. The age at vaccination was not reported. The reporter stated that he/she got shingles 4 days after booster, but it was better than getting covid. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Condition aggravated, Formication, Herpes zoster, Pain
Clinical narrative: las year I get the shots, 3 weeks ago another episode/suspected vaccination failure; another episode; more painful then ever.; 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.   The patient's past medical history included shingles (had mild case about 10 years ago, with just few rashes, then 3 years later got again with horrible pain).   On an unknown date, the patient received Shingles vaccine. In November 2021, less than 2 years 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 patient self-reported this case. The age at vaccination was not reported. The patient stated that 3 years later of first outbreak got it again and had no rash, just the horrible pain, which lasted for few weeks. The patient was getting shingles every 2 or 3 years, no rash, just the horrible back pain and had feeling that something was crawling on back.  The patient reported that last year from reporting date his/her physician insisted to get the Shingle shots and the patient got it. 3 weeks ago, from reporting date, the patient experienced another episode of Shingles more painful than ever. The patient really believed if you never had the shingles, the shot was good, but for people that kept having it, it was not worth it, because the virus was in your body already, received shots or not. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: las year I get the shots, 3 weeks ago another episode/suspected vaccination failure; another episode; more painful then ever.; 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.   The patient's past medical history included shingles (had mild case about 10 years ago, with just few rashes, then 3 years later got again with horrible pain).   On an unknown date, the patient received Shingles vaccine. In November 2021, less than 2 years 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 patient self-reported this case. The age at vaccination was not reported. The patient stated that 3 years later of first outbreak got it again and had no rash, just the horrible pain, which lasted for few weeks. The patient was getting shingles every 2 or 3 years, no rash, just the horrible back pain and had feeling that something was crawling on back.  The patient reported that last year from reporting date his/her physician insisted to get the Shingle shots and the patient got it. 3 weeks ago, from reporting date, the patient experienced another episode of Shingles more painful than ever. The patient really believed if you never had the shingles, the shot was good, but for people that kept having it, it was not worth it, because the virus was in your body already, received shots or not. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster
Clinical narrative: Just getting over it,It horrible, I was misarible; feeling miserable; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, unknown after receiving Shingles vaccine, the patient experienced shingles and feeling miserable. On an unknown date, the outcome of the shingles and feeling miserable were unknown.   It was unknown if the reporter considered the shingles and feeling miserable to be related to Shingles vaccine.  Additional details were provided are as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and had them. The patient stated that just getting over, they were horrible, get your shots. The patient stated he/she sure wish that he/she would of gotten his/her 2nd one, he/she was miserable. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Illness, Impaired work ability
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fatigue and sickness. On an unknown date, the outcome of the fatigue and sickness were recovered/resolved. It was unknown if the reporter considered the fatigue and sickness 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 reporter stated that the day after his/her second shingrix shot he/she woke feeling very fatigued and had to call out sick from work. The reporter wanted to know how long, on average, these side effects last. Consent to follow-up was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: vaccine did hurt some; 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.   The patient's past medical history included shingles.   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 injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain 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 stated the worst case of shingles in past. The patient stated that the vaccine did hurt some, but he/she would take the 2 shots any day over having shingles again. The follow-up would not be possible as no contact details were available. This case has been linked to US2021AMR259959, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR259959:Same patient different dose
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: never felt injection, Arm was sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm 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 reporter stated that, he/she never felt the initial injection, the arm was sore for a few days but nothing like the pain people have from shingles. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: 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 the 1st dose of 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 unknown.   It was unknown if the reporter considered the injection site pain 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 reporter stated that aside from some local pain at the injection site, he/she had no side effects and even that was only the first shot. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: chills; arm swollen; feverish; arm got red; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date and was fine).   In December 2021, the patient received the 2nd dose of Shingles vaccine. In December 2021, less than 2 weeks after receiving Shingles vaccine, the patient experienced chills, swelling arm, fever and erythema of extremities. On an unknown date, the outcome of the chills, swelling arm, fever and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the chills, swelling arm, fever and erythema of extremities 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 reporter stated that he/she was fine with his/her first shingles dose but he/she got the second one 9 days before the day of reporting and had a terrible reaction, chills for 3 days, arm got red and swollen and feverish, took a week to calm down. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes simplex, Herpes zoster, Rash, Vaccination failure
Clinical narrative: 2 shingles shots, had shingles/ suspected vaccination failure; shingles; simplex; rash; This case was reported by a consumer via call center representative 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 and gabapentin for shingles, herpes simplex and rash.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and gabapentin at an unknown dose 3 times daily. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, herpes simplex and rash. The action taken with gabapentin was unknown. On an unknown date, the outcome of the vaccination failure, herpes simplex and rash were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, herpes simplex and rash to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2 Shingles shots and had simplex. The patient had shingles this bad and now it was over 11 months. The patient also had rash but not open sores.  The patient was treated by his/her registered doctor plus specialist (neuro specialist) and was taking Gabapentin 3 times a day for over 2000 pills. The patient asked that why after taking the 2 shingles shots did he/she had it for this amount of time. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: got Gilliam Barre Syndrome from first shot; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome 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 guillain barre syndrome after first Shingle shot, rather gave shingles.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both the vaccines / came down with shingles again/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: The patient self-reported this case. The age at vaccination was not reported. The patient got both the Shingles vaccine and just came down with shingles again. The patient could not believe it. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Eye disorder, Herpes zoster, Illness, Pain, Pruritus
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. 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), herpes zoster, sickness, pain, pruritus and eye disorder. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the herpes zoster was recovering/resolving and the outcome of the sickness, pain, pruritus and eye disorder were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, herpes zoster, sickness, pain, pruritus and eye disorder 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 experienced a severe case trigeminal herpes zoster. It had been six weeks and was still quite sick with a lot of pain and itching. The patient stated that eye was a disaster. The patient asked if what was the point of getting the vaccine and why did he/she got the trigeminal herpes zoster even after he/she had the vaccine. At the time of reporting the patient was recovering from a severe case trigeminal herpes zoster. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. 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), herpes zoster, sickness, pain, pruritus and eye disorder. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the herpes zoster was recovering/resolving and the outcome of the sickness, pain, pruritus and eye disorder were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, herpes zoster, sickness, pain, pruritus and eye disorder 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 experienced a severe case trigeminal herpes zoster. It had been six weeks and was still quite sick with a lot of pain and itching. The patient stated that eye was a disaster. The patient asked if what was the point of getting the vaccine and why did he/she got the trigeminal herpes zoster even after he/she had the vaccine. At the time of reporting the patient was recovering from a severe case trigeminal herpes zoster. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoacusis, Illness
Clinical narrative: This case was reported by a consumer via  interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and hearing decreased. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the hearing decreased was not recovered/not resolved.   It was unknown if the reporter considered the sickness and hearing decreased 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 reporter stated that he/she took the shingles shot 4 or 5 years before the date of reporting and was sick for a while, also his/her hearing was terrible and the hearing had continually gotten worse. The follow-up would not be possible as no contact details were available.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Condition aggravated, Herpes zoster, Pruritus
Clinical narrative: received both doses 4 years ago, shingles is currently recurring/suspected vaccination failure; shingles is currently recurring now about once a month; small clumps of a 5-6 blisters / patch on palm of her hand and on lower back; itch; blisters burn; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly 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 (recurrent Shingles prior to any doses of either Shingles vaccine). Previously administered products included Zostavax (received 7 years ago from reporting date).   On 15th February 2018, the patient received the 2nd dose of Shingrix (intramuscular). In December 2017, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, pruritus and burning sensation. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, pruritus and burning sensation were unknown and the outcome of the shingles and blister were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister, pruritus and burning sensation to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient had received both doses of Shingrix in her right arm approximately 4 years ago from reporting date.  The patient stated that after the 2 doses of Shingrix, she was symptom free of shingles for 4 years, but her shingles was currently recurring now about once a month. The patient described her shingles outbreaks were small clumps of a 5 to 6 blisters that itch and then burn and last a month before healing, before another patch pops up on a different location.  At the time of reporting, the patient had a patch on the palm of her hand and on her lower back near her tailbone. The patient routinely takes acyclovir for outbreaks.  Reporter did not have the lot or expiration date of the Shingrix administered.  She gave consent to contact her or health care professional. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: received both doses 4 years ago, shingles is currently recurring/suspected vaccination failure; shingles is currently recurring now about once a month; small clumps of a 5-6 blisters / patch on palm of her hand and on lower back; itch; blisters burn; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly 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 (recurrent Shingles prior to any doses of either Shingles vaccine). Previously administered products included Zostavax (received 7 years ago from reporting date).   On 15th February 2018, the patient received the 2nd dose of Shingrix (intramuscular). In December 2017, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, pruritus and burning sensation. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, pruritus and burning sensation were unknown and the outcome of the shingles and blister were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister, pruritus and burning sensation to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient had received both doses of Shingrix in her right arm approximately 4 years ago from reporting date.  The patient stated that after the 2 doses of Shingrix, she was symptom free of shingles for 4 years, but her shingles was currently recurring now about once a month. The patient described her shingles outbreaks were small clumps of a 5 to 6 blisters that itch and then burn and last a month before healing, before another patch pops up on a different location.  At the time of reporting, the patient had a patch on the palm of her hand and on her lower back near her tailbone. The patient routinely takes acyclovir for outbreaks.  Reporter did not have the lot or expiration date of the Shingrix administered.  She gave consent to contact her or health care professional. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: was administered and one of the vials was expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA379A, expiry date 31st July 2022) and (batch number AMAA379A, expiry date 31st August 2021) for prophylaxis.   On 16th December 2021, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 16th December 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacy technician reported that, the nurse at the clinic administered Menveo vaccine noticed after the vaccine was administered that one of the vials was expired, which led to expired vaccine used. The reporter wanted to know if any adverse events have been reported after an expired Menveo vaccine was administered. The reporter did not have outer carton at the time of reporting.