chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral, Post herpetic neuralgia, Visual impairment
Clinical narrative: neuropathy; postherpetic neuralgia; vision problems; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a currently 78-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 17-OCT-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for herpes zoster, postherpetic neuralgia, neuropathy and vision problems. The outcome of herpes zoster, postherpetic neuralgia, neuropathy and vision problems were not reported. The reporter considered aforementioned events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, neuropathy peripheral was determined to be a medically significant event.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed with customer that no other AE ocurred; a dose of PROQUAD was administered afte experiencing a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  Information about the patient's pertinent medical history, concomitant medication and drug reactions or allergies was not provided.  On 24-MAR-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) (Lot No. t005404 has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA), expiration date reported as 24-MAR-2022, but upon internal validation established as 12-AUG-2021) 1 dose for prophylaxis (vaccination scheme frequency, route and anatomical location of vaccination were not provided).  The dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) experienced a temperature excursion of 37.2  degrees Fahrenheit for 3 hours and 28 minutes. There wasn't a previous temperature excursion, and this was called because of a data logger. No adverse events occurred.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; a dose of VAQTA expired on 04-JUN-2021 was administered on 09-JUN-2021; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 09-JUN-2021, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) 0.5 mL, lot # T008698, expiration date 04-JUN-2021 (route of administration and anatomical location were not provided) for prophylaxis. No adverse event (AE) was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: the patient received her first dose of GARDASIL 9 three years ago and has not received another one; No other AE reported; This spontaneous report was received from a registered pharmacist and refers to a female patient, who was 28 years old at the time of the report. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On an unspecified date in June 2018 (reported as three years ago), the patient was vaccinated with her first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). Since then, she has not received another dose of the vaccine (inappropriate schedule of vaccine administered). No adverse event (AE) was reported.  The pharmacist requested information regarding vaccination with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse events reported.; Physician reports the administration of a larger dose of VARIVAX to a 13 month old patient.; This spontaneous report was received from a physician and refers to a 13 months old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 09-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 mL, lot # T032319, expiration date was not reported but upon internal validation was established as 22-SEP-2022 (route of administration and anatomical location were not provided) for prophylaxis; the administered dose was larger than the patient should receive (incorrect dose administered). No adverse events were reported.  The physician asked for safety and viability information regarding the administered dose of the vaccine.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; dose of PROQUAD was administered after experiencing a temperature excursion.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 18-MAY-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status rHA) (PROQUAD) lot # t005404 has been verified to be a valid lot number, expiration date was reported as 24-MAR-2022, but upon internal validation established as 12-AUG-2021; 1 dose (exact dose, route of administration, anatomical location were not reported) for prophylaxis. Administered dose of vaccine was stored in 37.2 degrees Fahrenheit (F) for 3 hours. There was no previous temperature excursions reported. The digital data logger was involved. No adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; temperature excursion; This spontaneous report was received from a registered nurse and refers to 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 09-JUN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot # T037957, expiration date 09-MAY-2022 (exact dose, route of administration and anatomical location were not provided), for prophylaxis. Administered dose of vaccine experienced temperature excursion reported as -14 degrees Celsius to -10 degrees Celsius (-14.9 degrees Celsius) for 1 hour. There was previous temperature excursion reported as -50 degrees Celsius to -15 degrees Celsius (-15.1 degrees Celsius) for 30 minutes. Digital data logger was not involved. No additional adverse event was reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles almost a year after getting my second vaccine/suspected vaccination failure; I got shingles almost a year after getting my second vaccine; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix and more than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the 2nd Shingrix shot and almost a year after vaccination, got shingles. The reporter inquired that, it ever help prevent shingles or was this an indication that the vaccine did not work for him/her. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Loss of personal independence in daily activities, Musculoskeletal stiffness, Myalgia
Clinical narrative: experienced / fatigue; muscle aches; stiff neck; pain in right part of her back / continues today/ on the right side of her lower back; next day she could not get out of bed.; This case was reported by a consumer via call center representative and described the occurrence of low back pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included apixaban (Eliquis) for atrial fibrillation.   The patient's past medical history included shingles (In September 2020, had full blown shingles), pain (In September 2020, experienced pain and rash on the lower left side, pain lasted for 3 months) and rash. Previously administered products included Shingrix with an associated reaction of atrial fibrillation (1st dose received at the end of January 2021, reference case US2021125167) and COVID Vaccine (received 2 doses on an unknown date (did not specify which one), sometime after receiving the 1st dose of Shingrix, but before receiving the 2nd dose of Shingrix.).   In May 2021, the patient received the 2nd dose of Shingrix and Eliquis at an unknown dose and frequency. In May 2021, 1 day after receiving Shingrix, the patient experienced low back pain and activities of daily living impaired. On an unknown date, the patient experienced fatigue, muscle pain and stiff neck. The action taken with Eliquis was unknown. On an unknown date, the outcome of the low back pain was not recovered/not resolved and the outcome of the activities of daily living impaired, fatigue, muscle pain and stiff neck were unknown.   It was unknown if the reporter considered the low back pain, activities of daily living impaired, fatigue, muscle pain and stiff neck to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for herself. The patient was prescribed Eliquis to treat atrial fibrillation and took her first dose of Eliquis on the same day prior to receiving the 2nd dose of the Shingrix vaccine. The patient received 2nd dose of Shingrix 3 weeks ago from the reporting date on an unknown arm. The next day patient could not get out of bed and stated that the day after she developed pain on the right side of her lower back and stated that the pain was the same type of pain that she experienced when she had Shingles in September 2020.  Less than 3 weeks after receiving Shingrix and Eliquis, the patient experienced fatigue, muscle pain and stiff neck. The patient was still in a lot of pain since receiving the 2nd dose. It was unknown if the reporter considered the low back pain, activities of daily living impaired, fatigue, muscle pain and stiff neck to be related to Eliquis. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021125167:same reporter, same patient - (1st dose)
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: first one sore; This case was reported by a consumer via media and described the occurrence of 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 pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received 1st dose of Shingles vaccine and experienced sore. The patient also had the second one which was sore but not both and one day it's good to get your single shot it helps keep itching bumps and everything away from you and patient feel fine. The reporter reported that some people can take the shingles shot some people cannot like patient for instance it was all right for patient. For tolerance with 2nd dose of Shingrix, refer case US2021AMR127226.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR127226:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: passed away one week after her shingles shot; This case was reported by a consumer via interactive digital media and described the occurrence of death 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, 1 week after receiving Shingles vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by reporter for his or her mother. The patient passed away one week after her shingles shot. The reporter stated it was sad but it happened. This case had been linked with case US2021AMR127094, as reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR127094:Same reporter; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: second one was sore; This case was reported by a consumer via media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (1st dose received on unknown date and experienced pain, for further tolerance refer case US2021AMR127114).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported.  The patient received 2nd dose of Shingles vaccine and experienced sore. The patient also had the second one which was sore but not both and one day it's good to get single shot as it helped keep itching bumps and everything away and feel fine. The reporter reported that some people can take the shingles shot some people cannot like him/her for instance it was all right for him/her. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR127114:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Given a dose / without / adjuvented solution, but used a sterile diluent instead; Given a dose / without / adjuvented solution, but used a sterile diluent instead; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution 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 wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant at a large in service notified that, the previously given a dose of Shingrix without using the adjuvanted solution, but used a sterile diluent instead to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter left the in service before the patient could get contact info.  The patient did not had further information.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Chronic headaches post 2nd dose of Shingrix; This case was reported by a consumer via media and described the occurrence of headache 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, unknown after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was wondering if there are any cases of chronic headaches post 2nd dose of Shingrix. No further information was reported. Follow up not possible as there was no contact details provided. GSK note- it was not clear if the patient experienced these adverse event or was just inquiring but since follow up was not possible, case kept valid with worst case approach.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pneumonia, Vaccination failure
Clinical narrative: I got the vaccine and a year later got the shingles/ Suspect vaccination failure; had pneumonia every year for 5 years; I got the vaccine and a year later got the shingles; Pain was worse than childbirth of all five of my kids at one time.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Pneumonia Vaccine with an associated reaction of pneumonia (received on an unknown date and had pneumonia every year for 5 years, sometimes more).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), pneumonia (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, pneumonia, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, pneumonia, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received Shingles vaccine and a year later got the shingles. The patient stated that the pain was worse than childbirth of all five of her kids at one time and also mentioned that do not do vaccines anymore.  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 and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shingle shot and a month later I got shingles / Suspect vaccination failure; I got the shingle shot and a month later I got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and a month later got the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: was sick as a dog for a week, got one more week of being sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follow: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient received dose of Shingles vaccine and was sick as a dog for a week, got one more week of being sick and would be vaccinated.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: a patient may have received just the liquid and not the powder; a patient may have received just the liquid and not the powder; This case was reported by a other health professional via sales rep 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 follow: The age at vaccination was not reported.  The reporter does not have a patient name or any other information. The patient may have received just the liquid and not the powder. The reporter wanted to know what exactly was the liquid that was used to reconstitute the powder of Shingrix.  She explained that they were not 100 percent sure but they thought that a patient might had received just the liquid and not the powder mentioned that she was not sure if the Shingrix vaccine was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. She thought it was never administered.  She said she checked with her staff and they said they believe it was not administered.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: who has received one of the shingles vaccines has gotten shingles / have a friend with it right now/ Suspected Vaccination failure; have a friend with it right now / she is in agony!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter stated that every single person (patients) he/she know who had received one of the shingles vaccines had gotten shingles.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked with US2021AMR127319, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR127319:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt "crappy" after it; This case was reported by a consumer via other manufacturer and described the occurrence of feels awful in a 60-year-old 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 feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient herself. The age at vaccination was not reported. The patient received the Shingles vaccine and after it patient felt crappy.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Hypersensitivity, Skin warm
Clinical narrative: On his left elbow / redness like a bug bite; The area is hot to the touch; Looks like possibly an allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd June 2021, the patient received the 1st dose of Shingrix. On 9th June 2021, 7 days after receiving Shingrix, the patient experienced erythema, feeling hot and allergic reaction. On an unknown date, the outcome of the erythema, feeling hot and allergic reaction were not recovered/not resolved.   It was unknown if the reporter considered the erythema, feeling hot and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received his 1st dose in the right arm. A week post vaccination, the patient had a reaction on his left elbow and described it as redness like a bug bite and the area was hot to the touch. The patient also said it looked like possibly an allergic reaction. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: had her first Shingrix shot / diagnosed with AFib about six weeks ago; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN) for prophylaxis.   The patient's past medical history included shingles (full blown case of shingles in September 2020 but on the left side), pain (in September 2020 had pain after four days of shingles on lower left side that lasted for 3 months) and rash (on the lower left side in September 2020). Concomitant products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN).   In January 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of COVID-19 VACCINE UNKNOWN. In April 2021, less than 4 months after receiving Shingrix, the patient experienced atrial fibrillation. The patient was treated with apixaban (Eliquis). On an unknown date, the outcome of the atrial fibrillation was unknown.   It was unknown if the reporter considered the atrial fibrillation to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient had her first Shingrix shot at the end of January 2021 and she had no problems after the first shot. The patient stated that she received 2 doses of the COVID Vaccine (did not specify which one) sometime after receiving the 1st dose of Shingrix. The patient mentioned she was diagnosed with atrial fibrillation about six weeks ago from the time of reporting. The patient was prescribed Eliquis to treat the atrial fibrillation and the patient took her first dose of Eliquis about three weeks ago from the time of reporting. It was unknown if the reporter considered the atrial fibrillation to be related to COVID Vaccine. For tolerance after 2nd dose, refer case US2021AMR125805.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR125805:same reporter, same patient - (2nd dose)
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose of Shingrix in 2018 and has not received any further doses; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in 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: Age at vaccination was not applicable for this report. A pharmacy student reported that, the patient had not received any further doses after 1st dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Patient who is 48 who they are considering administering the vaccine to; Patient who is 48 who they are considering administering the vaccine to; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the inappropriate age at vaccine administration and off label use were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the 48 year old patient received Shingrix, which led to inappropriate age at vaccine administration and off label use. The reporter was asking if shingrix could be given to people with a history of shingles, under the age of 50. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dizziness, Headache, Incorrect dose administered, Product preparation issue
Clinical narrative: Headaches; Stomach aches; felt lightheaded; he was injected, with the adjuvant suspension only; he was injected, with the adjuvant suspension only; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix. In June 2021, less than a week after receiving Shingrix, the patient experienced headache, stomach pain, light headedness, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the headache, stomach pain and light headedness were not recovered/not resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the headache, stomach pain and light headedness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient received the first dose of shingrix one week ago of the reporting date. The patient stated that, after receiving the shot he developed headaches, stomach aches and felt lightheaded.  On 9th June 2021, his health care professional reached out to him to inform him that he was injected, with the adjuvant suspension only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient stated that, the symptoms did not resolve. The reporter consented to follow up
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, MNQ
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; first dose on 5/30/2017 / second dose on 5/20/2020 / third dose /(6/9/2021); This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA396A, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received 1st dose of Menveo on 30th May 2017). Concomitant products included Hepatitis A vaccine and GARDASIL.   On 9th June 2021, the patient received the 3rd dose of Menveo. On 20th May 2020, the patient received the 2nd dose of Menveo. On 20th May 2020, not applicable after receiving Menveo and Hepatitis A vaccine and unknown after receiving Menveo, the patient experienced extra dose administered. On 9th June 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.  Additional details were provided as follows: The reporter was a physician assistant. The patient received 2nd and 3rd dose of Menveo, which led to extra dose administered and also received Gardasil and Hepatitis A vaccine along with 3rd dose of Menveo. The reporter consented to follow up. The reported batch number AMBA396A was not found in sales data sheet, hence was updated to AMVA396A.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: severe headache / had to go to the emergency room; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number AL734, expiry date 8th October 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date).   On 12th April 2021, the patient received the 2nd dose of Shingrix. On 12th April 2021, less than a day after receiving Shingrix, the patient experienced headache. On 7th June 2021, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows,: The patient had received 2 nd dose of Shingrix and since that day, started developing severe headache.  On 7th June 2021, the patient had to go to the emergency room due to severe headache.  The same symptoms were not reported after the administration of the first dose of Shingrix. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the Shingrix diluent without reconstitution with powder.; received only the Shingrix diluent without reconstitution with powder.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number Y37L9, expiry date 10th October 2022) 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 patient received only the Shingrix diluent without reconstitution with powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case has been linked with US2021126512, reported with same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021126512:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the Shingrix diluent without reconstitution with powder; received only the Shingrix diluent without reconstitution with powder; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number Y37L9, expiry date 10th October 2022) 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 patient received only the Shingrix diluent without reconstitution with powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case had been linked with US2021126507, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021126507:Same reporter
Sex: F
Vaccine: TDAP
Symptoms: Product preparation issue
Clinical narrative: Received / shot 2 years ago / believes it was not shaken before administration; This case was reported by a consumer via call center representative and described the occurrence of inappropriate reconstitution technique in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix (intramuscular). On an unknown date, unknown after receiving Boostrix, the patient experienced inappropriate reconstitution technique. On an unknown date, the outcome of the inappropriate reconstitution technique was unknown.  Additional case details were reported as follows: The patient reported case for herself. The age at vaccination was not reported. In 2018, the patient received Boostrix shot 2 years before day of reporting and believes it was not shaken before administration, which led to inappropriate reconstitution technique.  The reporter did not consent to follow up.
Age: 40.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: Patient / 40 years old  / Shingrix / with a prescription from his gastroenterologist; Patient who is 40 years old received the first dose of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 40-year-old male patient who received Herpes zoster (Shingrix) (batch number AP545, expiry date 25th January 2023) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. In April 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced drug prescribing error. On an unknown date, the outcome of the inappropriate age at vaccine administration and drug prescribing error were unknown.  Additional case details were reported as follows: The patient received the first dose of Shingrix in April 2021, which led to inappropriate age at vaccine administration. The patient went to the facility with a prescription from his gastroenterologist, which led to drug prescribing error. The reporter consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: 7 years old / has received / vaccination / in July 24th 2015 / has to restart the series all over again?; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 7-year-old female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (1st dose received on 24th July 2015 (batch no: AHAVB703AA, expiry date:5th October 2015).).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report.. Till the time of reporting patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The reporter were wondering if patient need to restart the series all over again. All patient identifiers were provided. The reporter mentioned that, no further clarification were performed. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Gait inability, Insomnia
Clinical narrative: Couldn't sleep.; Couldn't walk.; severe pain in his right hip; This case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 9th June 2021, 2 hrs after receiving Shingrix, the patient experienced sleeplessness, unable to walk and pain in hip. On 10th June 2021, the outcome of the unable to walk was recovered/resolved. On an unknown date, the outcome of the sleeplessness was unknown and the outcome of the pain in hip was not recovered/not resolved.   It was unknown if the reporter considered the sleeplessness, unable to walk and pain in hip to be related to Shingrix.  Additional details was reported as follows: The age at vaccination was not reported. The patient received Shingrix and couldn't sleep, couldn't walk, and had severe pain in his right hip. The reporter was given medical disclaimer and was referred to Health care professional. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a late second dose / first dose was administered on 06April2018 and the second dose on 08Mar2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th April 2018).   On 8th March 2021, the patient received the 2nd dose of Shingrix. On 8th March 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details was reported as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. No vaccine data was available. The reporter declined follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 56 year old (Caribbean) female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 25-MAY-2021) 1 total, dose was not reported, administered on left arm on 21-MAR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism.  It was reported that, the patient was testing weekly to determine if she had been exposed or acquired COVID-19. On 08-MAY-2021, the patient was tested positive for Ig-G (Immunoglobulin G) but not Ig-M Immunoglobulin M) upon rapid antibody test (confirmed immunological vaccine failure). On 05-JUN-2021, the patient tested again which showed negative for Ig-G and Ig-M.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210612287. This report was associated with a product quality complaint: 90000181865.; Sender's Comments: V0: 20210612254-COVID-19 VACCINE AD26.COV2.S- Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Movement disorder, Muscle spasms
Clinical narrative: CRAMPING IN LEFT THIGH JUST IN THE BACK; NUMB LEFT ARM AND BACK FROM WHERE MY BRA STRAP CONNECTS ALL THRU MY BUTT CHEEK TO MY SPINE; COULDNT STOP STRETCHING LIKE A FORCED STRETCH; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 numbers. No concomitant medications were reported. On MAY-2021, the subject experienced couldnt stop stretching like a forced stretch. On JUN-2021, the subject experienced numb left arm and back from where my bra strap connects all thru my butt cheek to my spine. On 05-JUN-2021, the subject experienced cramping in left thigh just in the back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the couldnt stop stretching like a forced stretch, numb left arm and back from where my bra strap connects all thru my butt cheek to my spine and cramping in left thigh just in the back was not reported. This report was non-serious.