chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sinus tachycardia, Tachycardia, Troponin increased
Clinical narrative: is a 67 y/o F with a PMHx significant for hyperlipidemia, OSA (on CPAP), and osteoporosis who presented with chest pain and was ultimately found to have myocarditis, likely 2/2 her 3rd dose of the Moderna COVID vaccine. Her recent history is significant for 6 months of fatigue for which she has undergone workup with her PCP and felt to have CFS. On Saturday 10/23/21, she received the 3rd dose of the Moderna COVID vaccine around 1030 AM and began to notice full body myalgias by 3pm. She continued to experience severe, full body myalgias accompanied by fever/chills through that Sunday 10/24. She felt relatively well on Monday 10/25 however, on Tuesday 10/26 she developed severe central chest pressure that was pleuritic in nature. It was not positional nor exertional. Rated the pain as 5/10 at its worst. Pain radiates to back but not up her neck or down her L arm. There was no associated SOB, nausea/vomiting, diaphoresis. She did note DOE but this its unclear if this is related to her HPI or chronic, ongoing fatigue. She initially presented to urgent care and was noted to have a troponin elevation of 0.17 so she was sent to the ER. In the ER, she was mildly tachycardic to the low 100s. Repeat troponin was 0.26. ECG showed sinus tachycardia with slight PR depression in the inferior leads on my read. D-dimer was normal at 0.51. CRP was elevated at 7.3. Influenza, SARS-CoV-2, and RSV PCR testing was negative. CXR showed no acute cardiopulmonary abnormality. She was given aspirin, 1 L LR, and started on a heparin infusion for ACS r/o. Repeat troponin downtrended to 0.18-0.16. TTE demonstrated an LVEF 70%, grade I diastolic dysfunction, normal RV size and function, no wall motion or valvular abnormalities, trivial anterior pericardial effusion. Given suspicion for myocarditis, cMRI was obtained which showed normal LVEF and RVEF, non CAD scar (epicardial/midmyocardial) along the basal and mid inferior/inferolateral segments consistent with myocarditis and normal stress testing without evidence of inducible ischemia. She was initiated on Colchicine and discharged home with this. Pt's blood pressure not amendable to a BB. Follow up was scheduled with cardiology and primary care.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: I received the 1st COVID-19 Pfizer vaccine on 10/5/2021 and the returned on 10/27/201 to received the 2nd shot at the same location.  After completing their vaccine consent form and selecting the type of vaccine I was requesting (Pfizer) and even asking the pharmacist clerk if the vaccines could be mix and him responding that I could not unless it was a booster, the second pharmacist injected me with the Moderna vaccine instead of the one I should have received and that was marked in the form (Pfizer).
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: I received the 1st COVID-19 Pfizer vaccine on 10/5/2021 and the returned on 10/27/201 to received the 2nd shot at the same location.  After completing their vaccine consent form and selecting the type of vaccine I was requesting (Pfizer) and even asking the pharmacist clerk if the vaccines could be mix and him responding that I could not unless it was a booster, the second pharmacist injected me with the Moderna vaccine instead of the one I should have received and that was marked in the form (Pfizer).
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported; PNEUMOVAX23 underwent temperature excursions was administered; This spontaneous report has been received from a pharmacist referring to a currently 19 days old patient of unknown gender. Information about pertinent medical history, concomitant medication and drug reactions/allergies was not provided.  On an unknown date in September 2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T020639, for prophylaxis (strength, dose and route were not provided). The administered vaccine underwent temperature excursions (Product storage error). The storage temperature of the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was reported as below 36 degree Fahrenheit (34 degree Fahrenheit) for a time frame of 12 hours 57 minutes. There was no previous temperature excursion. No additional adverse effect reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2109USA007279:
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: adverse reaction or side effect was experienced: none; pneumonia vaccine on 2014 and 2016; This spontaneous report has been received from a lawyer, from a case in litigation for zoster vaccine live (ZOSTAVAX) (regulatory authority # 1907USA003436), concerning an elderly female patient.  On unspecified dates in 2014 and 2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (reported as pneumonia vaccine) (manufacturer unknown) (strengths, doses, routes, anatomical locations, lot numbers and expiration dates were not reported) as prophylaxis (inappropriate schedule of product administration). It was stated that no adverse reaction or side effect was experienced due to the patient's vaccination.; Sender's Comments:  US-009507513-2103USA001236:
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional adverse events reported; administered today via intramuscular route versus subcutaneous route.; This spontaneous report was received from a licensed practical nurse and refers to a 47-year-old patient of an unspecified gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not provided.   On 08-OCT-2021, also reported as "today", the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, at the dose of 0.5 ml, once, lot # T018892, expiration date was provided and also validated as 02-JUN-2022, via intramuscular route of administration, for prophylaxis (subcutaneous injection formulation administered by other route) (strength and anatomical location were not reported). No other information was given. No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: No known side effects reported; a nurse gave PROQUAD and reconstituted the vaccine with normal saline instead of Merck STERILE DILUENT; gave the PROQUAD intramuscularly instead of subcutaneously in the patient's left deltoid; This spontaneous report has been received from a pharmacist referring to a 6 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  It was reported on 12-OCT-2021, a nurse at the reporter's office reconstituted the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) with sodium chloride (NORMAL SALINE) instead of our Company sterile diluent (product preparation error). Then, after reconstituted, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) (0.5 mL (1 dose); lot# T034828 has been verified to be a valid lot number and expiration date was 11-APR-2022) was given to the patient intramuscularly instead of subcutaneously in the patient's left deltoid (incorrect route of product administration) for prevention of chickenpox, measles, mumps and rubella. No known side effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received expired MMR II vaccine; This spontaneous report was received from a physician refers to a patient of unknown age and gender. The concurrent conditions, medical history, concomitant therapies, drug reactions or allergies were not reported.  On 14-OCT-2021, the patient was vaccinated with an expired vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Lot # S028914, exportation date: 16-SEP-2021) for prophylaxis. No adverse event was reported. At the time of the report, the outcome of the event was not reported.  The causal relationship between the event and the expired suspect vaccine was not reported.
Age: 18.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse event; a dose of PEDVAX HIB was inadvertently administered to an 18 year old consumer; This spontaneous report as received from a Medical assistant refers to a 18-year-old patient of unknown gender. The patinet's concurrent condition, medical history and concomitant therapies were not provided.  On 07-OCT-2021, a dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)(LIQUID PEDVAXHIB) 0.5 (units not provided), lot# T037651 and expiration date of 20-JUL-2023 (route was not provided) was inadvertently administered to an 18 year old consumer for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs reported; MMRII that expired was administered to a patient; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 19-OCT-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (rHA) (M-M-R II) (0.5 mL; lot# S031483 has been verified to be a valid lot number and expiration date was 07-OCT-2021) for prophylaxis (expired product administered). The vaccine was reconstituted with our Company sterile diluent (0.5 mL; lot# U003874 has been verified to be a valid lot number and expiration date was 26-JUN-2023). The vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (rHA) (M-M-R II) had not had any temperature excursions. The reporter was provided with the expired supported disclaimer. No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; a limited adverse event on a dose of PROQU AD that was administered improperly stored during a temperature excursion found supported, on 09/14/2021; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications.  On 14-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T027115 with expiration date on 07-FEB-2022, at a dose of 0.5 mL, for prophylaxis (strength, route of administration and anatomical location were not reported).   The administered dose of the vaccine experienced a temperature excursion in the range between 6°F to 14°F(8.5°F) for 0 hours 18 minutes and 0 seconds; and in the range between 6°F to 14°F (11.9°F) for 1 hour 0 minutes and 0 seconds (Cumulative Timeframe: 1 hour and 18 minutes). The vaccine had not had any previous temperature excursions. No additional adverse events reported. No product quality complaint was involved.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Patient was administered expired PNEUMOV AX 23 on 10/07/2021; This spontaneous report as received from a nurse practitioner and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications  On 07-OCT-2021, the patient was vaccinated with and expired dose of  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T021329 with expiration date on 03-OCT-2021 (Confirmed to be a vial formulation), for prophylaxis (strength, dose, frequency and route of administration were not reported). No additional adverse events and no temperature excursion reported.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; vaccines were administered after experiencing temperature excursion; This spontaneous report as received from a Medical Assistant refers to a 15-month-old-patient of unknown gender.      The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 29-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (Lot # T032317, expiration date 22-SEP-2022) (dose, route of administration, and anantomical location were not reported) for prophylaxis.       The vaccine was administered after experiencing temperature excursion (product storage error). Temperature 6°F to 14°F (8.5F) for 0 hours 18 minutes 0 seconds; 6°F to 14°F (11.9F) for 1 hour 0 minutes 0 seconds. Time frame: Cumulative Timeframe: 1 hour and 18 minutes. There was no previous temperature excursion. No additional adverse events (AE) details available. No PQC was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; dose of PROQU AD that was administered improperly stored; This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On an unspecified date in 2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at a dose of 0.5 milliliter, lot number T027115 and expiration date of 07-FEB-2022 for prophylaxis (route of administration and anatomical location were unknown).   The vaccine was exposed to a temperature excursion 6°F to 14°F (8.5°F) for 0 hours 18 minutes and 0 seconds; 6°F to 14°F (11.9°F) for 1 hour 0 minutes and 0 seconds with a time frame of 45 minutes (Cumulative Timeframe: 1 hour and 18 minutes). There was no previous temperature excursion. No additional adverse events were reported.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: 27 year old recieved pediatric dose; 27 year old recieved pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 27-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2021, the patient received Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 7th October 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were 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 as follows: The medical assistant reported that, the adult patient received Engerix B pediatric, which led to underdose and adult use of a child product. No symptoms were reported. The reporter consented to follow up. This case was linked with case US2021215523, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215523:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm is hurting; 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 22nd October 2021, the patient received the 1st dose of Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   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 patient received dose of Shingles vaccine day before reporting and his/her arm was hurting like crazy. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/both shots and he has shingles; shingles on his head and forehead and around his eye; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient took both shots and he had shingles on his head and forehead and around his eye.  On 25th October 2021, the patient was taken to the doctor and they gave him medication to help dry it up. Follow-up would not be possible as not contact details available. 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.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure/he 2 shots and still got a mild case of Shingles; shingles; just the pain; 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), 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 and Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient was vaccinated with the two doses of Shingles vaccine and still got a mild case of shingles and did not experienced rash, but pain was there. The follow-up would not be possible as no contact details available. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure/received the Shingrix vaccine last Summer, still got it this third time; shingles, three times had them internally; pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 2 times before Shingrix vaccination).   On an unknown date, the patient received Shingrix. In August 2021, less than 2 years after receiving Shingrix, the patient experienced pain. On an unknown date, 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 and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the shingles vaccine last summer and experienced shingles for the 3rd time. All the three times he/she had them internally. The patient experienced the pain since early August 2021. The patient could totally sympathize. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Dry skin, Herpes zoster, Oxygen saturation decreased, Pain, Rash
Clinical narrative: oxygen level severely drop; pain was so bad; rash is dry; shingles; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingles vaccine. On 7th September 2021, 8 days after receiving Shingles vaccine, the patient experienced pain (serious criteria hospitalization) and shingles. On an unknown date, the patient experienced oxygen saturation decreased (serious criteria hospitalization) and rash. On an unknown date, the outcome of the pain and rash were not recovered/not resolved and the outcome of the oxygen saturation decreased and shingles were unknown.   It was unknown if the reporter considered the pain, oxygen saturation decreased, shingles and rash to be related to Shingles vaccine.  Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported. The doctor said the patient to get the Shingles shot so that he/she could stay healthier. The patient did and got the full-blown bad case of shingles and experienced deep bad pain. The patient stated that less than 2 months after vaccination, the rash was very dry at the time of reporting and the pain was very intense at times.  The patient stated that it was day 56 at the time of reporting and did not know when it would end. Less than 2 months after vaccination, the patient had spent 2 days in hospital because pain was so bad it was causing his/her oxygen level to severely drop, as he/she live on oxygen 24/7. The patient stated that there was a second shot in the series, that was not supposed to have live virus. The patient stated that doctor was apologizing, and they could not believe the patient got the Shingles.  The patient stated that not to get the shot. Follow-up would not be possible as not contact details available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain in extremity, Vaccination failure
Clinical narrative: pain in my rite legs; Had 2 shots still end up with the 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. In June 2021, 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 patient experienced leg pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the leg pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and leg pain 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 had 2 shingles vaccine shot and still end up with shingles, the patient had it since June 2021. Till the time of reporting, the patient still had a lot of pain in his/her right leg. 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.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Vaccination failure
Clinical narrative: he had shingles vaccination, shingles/suspected vaccination failure; just had shingles; pain for about 10 days; miserable for about 10 days; 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), shingles, pain and feeling miserable. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain and feeling miserable were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and feeling miserable to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient had the shingles vaccination and had shingles.  The patient was in pain and miserable for about 10 days.  The reporter stated that it was not transferable to another person. 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 confirmation for shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Herpes zoster, Hypertension, Injection site pain, Vaccination failure
Clinical narrative: The shot is painful, mother got shingles/suspected vaccination failure; blood pressure was so high she had a stroke; shingles; high blood pressure; shot is painful; 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), stroke (serious criteria GSK medically significant), shingles, blood pressure high and injection site pain. On an unknown date, the outcome of the vaccination failure, stroke, shingles, blood pressure high and injection site pain were unknown.   It was unknown if the reporter considered the vaccination failure, stroke, shingles, blood pressure high and injection site pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's child. The age at vaccination was not reported. The reporter stated that the Shingles shot was painful. The patient got shingles, then her blood pressure was so high she had a stroke. 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 confirmation for shingles were unknown at the time of reporting. The case had been linked with US2021AMR222596, reporter's case.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR222596:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Insomnia, Pain, Pain in extremity, Vaccination failure
Clinical narrative: Just getting over the Shingles. Got the shot/ suspected vaccination failure; Just getting over the Shingles.; the pain was unbearable/ non ending pain; could not sleep; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and insomnia. On an unknown date, the outcome of the vaccination failure, pain and insomnia were unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, pain and insomnia to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was unknown. The patient got the shot couple years ago, after seeing what shingles did to a couple of his/her friends and the patient was just getting over the shingles. The doctor said that, the patient could get the shingles again as the patient painfully found out and without the shot, shingles would have been worse. The patient stated he/she was thankful to get the shot then, cause the pain was unbearable. The patient stated he/she could not sleep and experienced non ending pain and his/her right arm was (unspecified). The patient prayed to never get shingles again and recommended to get the Shingles shot.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Product availability issue, Product dose omission issue
Clinical narrative: availability issue; This case was reported by a consumer via call center representative and described the occurrence of product availability issue in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 20th June 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product availability issue. On an unknown date, the outcome of the product availability issue was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The patient did not receive 2nd dose of shingrix due to availability issue, which led to product availability issue. The reporter consented to follow up with health care professional, however did not have an email address to health care professional.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2021, the patient received Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash 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 dose of Shingrix and a month later she developed a rash (Adverse event was symptomatic). The patient enquired if patients typically experienced a rash sooner or later.  Patient also enquired how long after receiving the Shingrix vaccine the rash might last.  The patient was provided Shingrix FAQ's information in content regarding side effects.  The reporter did not want to provide additional details.  The reporter did not consent to follow-up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Livedo reticularis, Rash, Rheumatoid factor
Clinical narrative: mid size leg vasculitis; Livedo reticularis; rash on both legs; This case was reported by a pharmacist via call center representative and described the occurrence of vasculitis legs in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number E9y5M, expiry date unknown) for prophylaxis.   On 17th August 2021, the patient received the 1st dose of Shingrix. On 19th August 2021, 2 days after receiving Shingrix, the patient experienced vasculitis legs, livedo reticularis and rash. On an unknown date, the outcome of the vasculitis legs, livedo reticularis and rash were unknown.   It was unknown if the reporter considered the vasculitis legs, livedo reticularis and rash to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient had new onset rash on both legs, which appeared to be a vasculitis type of rash.  The patient consulted dermatology and rheumatology.  ANA, RF and Cyclic Citrullinated antibodies were ordered and results were pending.  As per the rheumatologist notes, livedo reticularis rash suggesting a mid-size leg vasculitis.  No signs of systemic vasculitis were present. The patient reported experience to pharmacist on 18th October 2021. The pharmacist stated that, till the time of reporting, the patient had not received the second dose of Shingrix.  The pharmacist was unable to provide expiration date of vaccine.  The reporter did not consent to follow-up
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Vasculitic rash, Vasculitis
Clinical narrative: mid size leg vasculitis; Livedo reticularis; rash on both legs; This case was reported by a pharmacist via call center representative and described the occurrence of vasculitis legs in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number E9y5M, expiry date unknown) for prophylaxis.   On 17th August 2021, the patient received the 1st dose of Shingrix. On 19th August 2021, 2 days after receiving Shingrix, the patient experienced vasculitis legs, livedo reticularis and rash. On an unknown date, the outcome of the vasculitis legs, livedo reticularis and rash were unknown.   It was unknown if the reporter considered the vasculitis legs, livedo reticularis and rash to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient had new onset rash on both legs, which appeared to be a vasculitis type of rash.  The patient consulted dermatology and rheumatology.  ANA, RF and Cyclic Citrullinated antibodies were ordered and results were pending.  As per the rheumatologist notes, livedo reticularis rash suggesting a mid-size leg vasculitis.  No signs of systemic vasculitis were present. The patient reported experience to pharmacist on 18th October 2021. The pharmacist stated that, till the time of reporting, the patient had not received the second dose of Shingrix.  The pharmacist was unable to provide expiration date of vaccine.  The reporter did not consent to follow-up
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Infanrix vaccination instead of Boostrix; Inappropriate age at vaccine administration; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th October 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th October 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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 as follows: The 12 years old patient received Infanrix vaccination instead of Boostrix vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. At the time of call, the patient had not received Boostrix vaccine. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: received post-exposure prophylactic covid-19 monoclonal antibody treatment; This case was reported by a nurse via call center representative and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced covid-19. The patient was treated with monoclonal antibody (nos). On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix, the patient had Covid 19. On 07th September 2021, the patient received post-exposure prophylactic covid-19 monoclonal antibody treatment.  On the date of reporting, the patient was in clinic due for dose 2 of Shingrix. It was unknown if patient received 2nd dose of Shingrix on 22nd October 2021. The reporter did not consent to follow-up. The reporter attempted to call healthcare professional regarding additional details but unable to reached healthcare professional.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: May have been given only the diluent; May have been given only the diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA585A, expiry date 1st April 2023) for prophylaxis.   On 14th October 2021, the patient received Menveo (intramuscular). On 14th October 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The healthcare professional reported that the patient might have received only the diluent component of Menvo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error, Product preparation issue, Underdose
Clinical narrative: administered only diluent; administered only diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the nurse from nursing home administered only diluent of Shingrix and not powder component to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  No other details of vaccine or patient were available. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received second dose; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th June 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The retire physician reported that, the patient received Shingrix first dose and she had never receive Shingrix second dose, which led to incomplete course of vaccination. The reporter consented to follow up by email. No information about lot number for Shingrix first dose.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: late for their third dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 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.   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 reported as follows: The age at vaccination was not applicable for this report. The pharmacist reported that via online chat that a patient was late for third dose of Twinrix (standard schedule), which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: in the same month received Fluarix and an Influenza vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 15-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number NS775, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season).   On 22nd October 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device and an unknown time after receiving Influenza vaccine Quadrivalent 2021-2022 season, 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 pharmacist reported that the patient was administered Fluarix QIV and after administration it was discovered the patient already received an influenza vaccine on 11th October 2021 at a different facility which led to extra dose of vaccine administered. Pharmacist was not sure which influenza vaccine did the patient received. The Pharmacist stated that the patient seems fine at the time of reporting. The reporter consented to follow-up.
Age: 17.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Kinrix instead of Boostrix; received Kinrix instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received DTPa-IPV (Kinrix) (batch number PX27D, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th October 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 20th October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follow: The reporter was a medical assistant. The reporter stated that a 17 years old patient received Kinrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The healthcare professional reported that it should had been an IPV catch-up, but patient was given DTAP-IPV by mistake. Parent of the patient pulled records from April from this year (no exact date given, and not clear if records were pulled on that date or if DTAP was given on that month). The reporter stated that he/she would be out next week with very limited access to email and if any questions about this case please contact the case owner or there medical information group box. The reporter consented to follow up. This case had been linked with US2021211507, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021211507:Same reporter