chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The patient received the Shingrix vaccine and two weeks later experienced shingles. The patient need to know the dosage.  The patient stated that, everything site he or she looked on did not provide the dosage.  The patient need the dosage for the report. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: severe bout of stomach upset today / severe stomach upset after shot; This case was reported by a consumer via  call center representative and described the occurrence of upset stomach in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2021, the patient received Shingrix. On 11th June 2021, 2 days after receiving Shingrix, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was unknown.   It was unknown if the reporter considered the upset stomach to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingrix shot 2 days ago of reporting date to prevent shingles and experienced severe reaction. The patient had a severe bout of stomach upset. The follow up would not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction, Arthritis, Gait disturbance, Mobility decreased, Pain
Clinical narrative: He has like crippling arthritis; He is in pain; can hardly bend or walk.; This case was reported by a consumer via media and described the occurrence of arthritis in a adult male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2021, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced arthritis, pain and walking difficulty. On an unknown date, the outcome of the arthritis, pain and walking difficulty were unknown.   It was unknown if the reporter considered the arthritis, pain and walking difficulty to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient´s cousin. The age at vaccination was not reported but patient was in his 50's. The patient received shingles vaccination about a month ago of the reporting date and had a bad reaction a few days after the shot. The patient had like crippling arthritis, He was in pain and could hardly bend or walk. The patient did not have this before the shot.  The patient could not get in to see a specialist for five months. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got shingles from the vaccine / case of shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient received the dose of Shingles vaccine and got shingles. The reporter stated that it only cost him/her 100.00 dollar for a case of shingles and months of his/her life. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Two patient / late for the second dose / first dose / on December 2019; 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose of Shingrix received in December 2019).   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. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. The reporter mentioned that, patient did not received the 2nd dose. The patient's identifiers, LOT number and expiration date was not provided for the first dose. No exact vaccination date was provided. The reporter did not consented to follow up. This is 2 of the 2 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021129027:Same reporter. Patient #1 of 2.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; now has shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient received the dose of Shingles vaccine and had shingles. The reporter stated that a shot was not a guarantee you would still get but not as bad. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: My arm was sore for a few days; I felt like I had the flu for the next day; This case was reported by a consumer via media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced pain in arm and influenza like illness. On an unknown date, the outcome of the pain in arm and influenza like illness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and influenza like illness to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient's arm was sore for a few days and he/she felt like he/she had the flu for the next day, but was fine after that. The reporter mentioned that he/she beats shingles. The follow-up would be not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed second dose. Can I go for it 12 months later; This case was reported by a consumer via interactive digital media 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).   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 case was reported for himself/herself. The age at vaccination was not applicable for this report. The patient missed the second dose and asked if he/she could go for it 12 months later. Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. The follow-up would not be possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; A friend of mine got the shingles shot and still got shingles; This case was reported by a consumer via  media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the friend of the patient. The age at vaccination was not reported. The patient developed shingles after receiving Shingles vaccination. The reporter stated that take a coin and flip it might help you to decide. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation test were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got the vaccine and got shingles anyway!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for himself or herself. The age at vaccination was not reported. The patient developed shingles after receiving Shingles vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation test were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My sister took the vaccine / got the shingles once per year/ Suspected Vaccination failure; My sister took the vaccine / got the shingles once per year; 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.   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.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional information was provided as follows: The case was reported by patient's sister. The age at vaccination was not reported. The patient took the vaccine and got the shingles once per year. The patient's physician told that it was one of the side effects. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shingles shot and have had shingles twice since then/ Suspected Vaccination failure; have had shingles twice; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient took the vaccine and had shingles twice since then. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Tiredness from the Shingrix vaccine.; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness 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 tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had tiredness.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; got shingles again; 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.   The patient's past medical history included shingles.   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. The patient was treated with comfrey. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles again. The patient stated that, there was something you could do. There was a plant named comfrey, health food stores knew about it. The patient suggested to find someone who had one and stated that, if you made a poultice using this common plant, it would heal within days. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chest discomfort, Chest pain, Heart rate increased
Clinical narrative: tightness and pain in the center of my chest; tightness and pain in the center of my hest; My heart is beating more rapidly as well.; This case was reported by a consumer via interactive digital media and described the occurrence of chest tightness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th June 2021, the patient received the 2nd dose of Shingrix. On 14th June 2021, less than a day after receiving Shingrix, the patient experienced chest tightness, chest pain and heartbeats increased. On an unknown date, the outcome of the chest tightness, chest pain and heartbeats increased were unknown.   It was unknown if the reporter considered the chest tightness, chest pain and heartbeats increased to be related to Shingrix.  Additional details was reported as follows: The age at vaccination was not reported. All the evening the patient had a tightness and pain in the center of  chest. The heart was beating more rapidly as well. The reporter thought was he/she having heart attack.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Woke up with a rash on my face this morning; This case was reported by a consumer via interactive digital media and described the occurrence of rash on face in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2021, the patient received Shingrix. On 14th June 2021, 7 days after receiving Shingrix, the patient experienced rash on face. On an unknown date, the outcome of the rash on face was unknown.   It was unknown if the reporter considered the rash on face to be related to Shingrix.  Additional details was reported as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient woke up with a rash on my face this morning (on the day of reporting). The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on my face 1 week after the Shingrix shot; This case was reported by a consumer via interactive digital media and described the occurrence of facial rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced facial rash. On an unknown date, the outcome of the facial rash was unknown.   It was unknown if the reporter considered the facial rash to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient experienced rash on face 1 week after the Shingrix shot. No further information reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Adjuvant was administered / without being reconstituted; Adjuvant was administered; This case was reported by a other health professional via patient support programs and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number K3YC7, expiry date 7th November 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 reporter mentioned that, only adjuvant was administered to the patient without being reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Two vaccine not a problem at all they are extremely painful; 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 unknown.   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 reporter stated that the vaccine was received, not a problem at all but was extremely painful. For tolerances of 2nd dose, refer case US2021AMR130065.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR130065:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: Two vaccine not a problem at all they are extremely painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles with an associated reaction of pain (received 1st dose, two years ago of reporting date, for tolerance refer case US2021AMR130051).   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 patient himself or herself. The age at vaccination was not reported. The patient stated that the he/she received vaccine over 2 years ago, there was not a problem at all but was extremely painful.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR130051:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had them once even though I had the vaccine for them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. Even though the patient received Shingles vaccine, he/she had shingles once. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; She got the shingles real bad; 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.   The patient's past medical history included shingles (Family History) (to the sibling).   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 information was received as follows: The case was reported by patient's sibling. The age at vaccination was not reported. The patient got the shot after the reporter had the shingles one year but the next spring the patient got the shingles really bad and she had the shingles shot. The patient had them worse than the reporter did and the reporter did not had the shot. The reporter stated that the shots do not keep people from getting the shingles. This case was considered as suspected vaccination failure since the details regarding the primary vaccination schedule, and laboratory confirmation for shingles was not reported. This case has been linked with the case US2021AMR130269 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR130269:Same reporter. "People's" case.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received an early second dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number BR7B3, expiry date 9th September 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 24th December 2020, the patient received the 2nd dose of Shingrix. On 24th December 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, less than the recommended interval, which led to shortening of vaccination schedule. The vaccine administration facility was same as primary reporter. The reporter consented to follow up.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 3year-old male patient received on 5/11/2021 a Kinrix vaccine by error; 3year-old male patient received on 5/11/2021 a Kinrix vaccine by error; received 2 Pediarix vaccines on 11/16/2018 (first dose) and on 7/19/2019 (second dose).; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 1st dose on 16th November 2018).   On 11th May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th July 2019, the patient received Pediarix. On an unknown date, the patient started Pediarix Pre-Filled Syringe Device. In July 2019, not applicable after receiving Kinrix and Kinrix Pre-Filled Syringe Device and unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. In May 2021, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration and drug dose administration interval too long 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 age at vaccination was not reported for Pediarix. Pharmacy director reported that the patient received Kinrix vaccine by error instead of Pediarix, which led to  wrong vaccine administered, inappropriate age at vaccine administration. The patient had received 2 Pediarix vaccine first dose and second dose was received at an interval longer than recommended, which led to lengthening of vaccination schedule. The reporter consented to follow up by fax. Kinrix expiration date was not available at the moment of the call.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Supposed to receive the last dose of the Kinrix vaccine but was given Boostrix by mistake; Boostrix on 6/7/2021 to a four year old; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number BR352, expiry date 27th August 2022) for prophylaxis.   On 7th June 2021, the patient received Boostrix. On 7th June 2021, unknown after receiving Boostrix, 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.  Additional details were provided as follows: The patient was supposed to receive the last dose of the Kinrix vaccine but was given Boostrix by mistake at the age of 4 years which led to wrong vaccine administered and inappropriate age at vaccine administration. No further events were reported.  The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue, Wrong product administered
Clinical narrative: pharmacist used the diluent from a Shingrix vaccine to reconstitute an MMR vaccine (Merck product) and administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 5XP9M, expiry date 15th October 2022) for prophylaxis.   On 27th May 2021, the patient received Shingrix. On 27th May 2021, unknown after receiving Shingrix, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The reporter was pharmacist manager. The pharmacist used the diluent from a Shingrix vaccine to reconstitute an MMR vaccine (Merck product) and administered to the patient, which led to wrong vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose / in March 2020 / not received the second dose yet.; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2020).   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. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: patient went to the pharmacy with a prescription to get the first dose / at 37 years of age; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a 37-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 the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product prescribing error. On an unknown date, the outcome of the intercepted product prescribing error was unknown.  Additional details were provided as follows: The age at the vaccination was not applicable.  Not all patient's identifiers were provided.  The pharmacist reported that, the patient went to the pharmacy with a prescription to get the first dose of Shingrix at 37 years of age, which led to  intercepted product prescribing error. The health care professional informed that they might not administer the injection. The reporter did not consent to follow-up
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Paraesthesia, Rash papular
Clinical narrative: had neuropathy (tingling) in left shoulder and left thigh; had pox scattered on the body /pox as "bumps."; (tingling) in left shoulder and left thigh; This case was reported by a nurse via call center representative and described the occurrence of neuropathy in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, several days after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant), raised rash and tingling. On an unknown date, the outcome of the neuropathy was not recovered/not resolved and the outcome of the raised rash was unknown and the outcome of the tingling was recovering/resolving.   It was unknown if the reporter considered the neuropathy, raised rash and tingling to be related to Shingrix.  Additional details were reported as follows: The case reported by the patient herself. The patient received 2nd dose of Shingrix vaccine and couple of days later she had neuropathy (tingling) in left shoulder and left thing. She also had pox (bumps) scattered on the body. The patient stated that tingling was getting better on the left thigh and but the left shoulder and pox was in the same condition. The patient noticed the adverse event the couple of days after receiving the 2nd dose of Shingrix. The reporter gave the consent to follow up with the Health care professional, however, she did not have fax number or an email address to health care professional. The provided her personal email address. The reporter did not have the following information, lot number, expiration date and dose of Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Arthralgia, COVID-19 immunisation, Dizziness, Headache, Nausea
Clinical narrative: nausea; headache; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 22nd December 2020, the patient received the 1st dose of Shingrix (intramuscular), Influenza vaccine Quadrivalent 2020-2021 season and PNEUMONIA VACCINE. On an unknown date, less than 4 months after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced nausea and headache. On an unknown date, the outcome of the nausea and headache were recovered/resolved.   It was unknown if the reporter considered the nausea and headache to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional information was provided as follows: The age at vaccination was not reported. The reporter declined to provide demographics or additional information. The patient received 1st Shingrix shot on an unknown arm and on the same day received flu and pneumonia shot in different arm. The patient developed nausea and headache. At the end of March 2021, the patient got moderna covid vaccine and felt dizzy, had joint pain and sluggish.  The reporter did not consent to follow up. It was unknown if the reporter considered the nausea and headache to be related to Pneumonia Vaccine.
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Sluggishness
Clinical narrative: nausea; headache; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 22nd December 2020, the patient received the 1st dose of Shingrix (intramuscular), Influenza vaccine Quadrivalent 2020-2021 season and PNEUMONIA VACCINE. On an unknown date, less than 4 months after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced nausea and headache. On an unknown date, the outcome of the nausea and headache were recovered/resolved.   It was unknown if the reporter considered the nausea and headache to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional information was provided as follows: The age at vaccination was not reported. The reporter declined to provide demographics or additional information. The patient received 1st Shingrix shot on an unknown arm and on the same day received flu and pneumonia shot in different arm. The patient developed nausea and headache. At the end of March 2021, the patient got moderna covid vaccine and felt dizzy, had joint pain and sluggish.  The reporter did not consent to follow up. It was unknown if the reporter considered the nausea and headache to be related to Pneumonia Vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose / in November of 2019 and has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in November 2019).   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 reported as follows: The age at vaccination was not reported. Till the time of report, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent follow up.
Age: 19.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: received /hepatitis B vaccine in 2000 / Engerix-B on 07-Aug-2020 / didn´t receive any other doses after that; received a dose of hepatitis B vaccine in 2000 / received / Engerix-B on 07-Aug-2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 19-year-old female patient who received HBV (Engerix B) (batch number 4CL44, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Hepatitis B vaccine (might have received a dose of hepatitis B vaccine in 2000).   On 7th August 2020, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 7th August 2020, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device and not applicable after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination 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 follows: The age at the vaccination was not reported for the 2nd dose. The age at the vaccination was not applicable for 3rd dose. The patient received 2nd dose of Engerix B at an interval longer than the recommended which led to lengthening of vaccination schedule.  Till the time of reporting the patient did not received 3rd dose of Engerix B which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose / before Covid19 situation / did not receive 2nd shot yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received before Covid19 situation, about 1 year ago).   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 to this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAREs details pertains to 1st Shingrix dose. No further information was reported. The reporter consented to follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain
Clinical narrative: Feel lightheaded that has not resolved; Arm was sore at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 9th June 2021, 1 days after receiving Shingrix, the patient experienced injection site pain. On 11th June 2021, the patient experienced light headedness. On an unknown date, the outcome of the injection site pain and light headedness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and light headedness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself. The patient received 1st dose of Shingrix  in the left arm and his arm was sore at the injection site and has yet to resolve. The patient also began to feel lightheaded that did not resolve. The reporter would contact health care professional if the light headedness does not resolve by the afternoon, at the time of reporting. The reporter did not consent to follow-up. Note- there is discrepancy in the age at vaccination and administration. after adding age at vaccination as 57 year its still get auto coded as 56 year instead of 57 year
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / December 19th 2019 / second dose / not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th December 2019, from batch number 5552S with expiry date 26th February 2022).   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 follow: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. The healthcare professional was not sure about the lot number provided. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Injection site extravasation
Clinical narrative: Gave a patient his first dose / medicine ran down his arm; Gave a patient his first dose / medicine ran down his arm; This case was reported by a pharmacist via call center representative and described the occurrence of inadvertent exposure to vaccine in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number LL2G7, expiry date 31st October 2022) for prophylaxis.   On 13th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 13th June 2021, unknown after receiving Shingrix, the patient experienced inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the inadvertent exposure to vaccine and exposure via skin contact to be related to Shingrix.  Additional details were provided as follow: The reporter stated that she gave a patient dose of Shingrix in left deltoid and the medicine ran down his arm, which led to inadvertent exposure to vaccine and exposure via skin contact. The patient was not happy and wanted to know what steps needs to be taken. The reporter consented to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose/on December 20th 2019/ second dose has not been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 20th December 2019).   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. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The Vaers details were reported for 1st dose of Shingrix. The reporter did not consent to follow up.