chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain, Pruritus, Rash
Clinical narrative: got vaccine. had rash, pain, itch, numbness in spots / suspected vaccination failure; rash, pain, itch, numbness in spots; rash; pain for nearly 2 months; itch on that side; numbness on that side in spots; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID 19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and the 2nd dose of COVID 19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, pain, pruritus and numbness. On an unknown date, the outcome of the vaccination failure, shingles, rash, pruritus and numbness were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, pain, pruritus and numbness to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had pain for nearly 2 months and still itch on that side. The patient also had numbness on that side in spots. The patient got about 10 days after his or her second dose of covid vaccine and stated that might not be related to the vaccine. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Vaccination failure
Clinical narrative: got vaccine. had rash, pain, itch, numbness in spots / suspected vaccination failure; rash, pain, itch, numbness in spots; rash; pain for nearly 2 months; itch on that side; numbness on that side in spots; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID 19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and the 2nd dose of COVID 19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, pain, pruritus and numbness. On an unknown date, the outcome of the vaccination failure, shingles, rash, pruritus and numbness were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, pain, pruritus and numbness to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had pain for nearly 2 months and still itch on that side. The patient also had numbness on that side in spots. The patient got about 10 days after his or her second dose of covid vaccine and stated that might not be related to the vaccine. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Computerised tomogram normal, Enema administration, Intestinal obstruction
Clinical narrative: Pinched colon; abdominal pain; This case was reported by a other health professional via sales rep and described the occurrence of intestinal obstruction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced intestinal obstruction (serious criteria GSK medically significant) and abdominal pain. The patient was treated with enema preparations (nos) (Enema (Unknown)). On an unknown date, the outcome of the intestinal obstruction was unknown and the outcome of the abdominal pain was recovered/resolved.   It was unknown if the reporter considered the intestinal obstruction and abdominal pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. Negative CT scan in Oct 2020. The Enema relieved patient's pain  For tolerance of 2nd dose, refer case US2021AMR207269. The case has been linked with case US2021AMR206873, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR206873:same reporter US-GLAXOSMITHKLINE-US2021AMR207269:same patient
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Rash, Vaccine positive rechallenge
Clinical narrative: breakout Herpes Simplex rash; rash; This case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number P7N2H, expiry date 30th January 2023) for prophylaxis.   The patient's past medical history included herpes simplex. Previously administered products included Shingrix with an associated reaction of herpes simplex (1st dose received on 16th July 2021, refer case US2021205534).   On 20th September 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 27th September 2021, 7 days after receiving Shingrix, the patient experienced herpes simplex and rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the herpes simplex and rash were unknown.   It was unknown if the reporter considered the herpes simplex and rash to be related to Shingrix.  Additional information was provided as follows: The reporter was the patient.  She received her 2nd shingrix dose and 7 days later developed a rash that she describes as breakout Herpes Simplex rash on her her right side. No additional information was provided. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021205534:same patient
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: moderate pain at injection site; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was provided as follows: The physician self reported the case was himself. The age at vaccination was not reported. The patient was approximately 59 years of age. The patient experienced moderate pain at injection site. For tolerance of 2nd dose, refer case US2021AMR206649, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR206649:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Influenza like illness, Malaise, Peripheral swelling
Clinical narrative: ill; flu like symptoms; arm swelled/  Immune cells migrating; This case was reported by a physician via sales rep and described the occurrence of unwell in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on an unknown date, refer case US2021AMR206638).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced unwell, influenza-like symptoms and swelling arm. On an unknown date, the outcome of the unwell, influenza-like symptoms and swelling arm were recovered/resolved.   It was unknown if the reporter considered the unwell, influenza-like symptoms and swelling arm to be related to Shingrix.  Additional details provided were as follows: The doctor self-reported this case. The age at vaccination was not reported but the patient could be approximately 59 years old at the time of reporting. The patient received 2nd dose of Shingrix and had flu like symptoms, fairly ill and arm swelled right after vaccination and it looked like Moderna arm and resolved within a week. One month later the patient received Pfizer Covid booster and his arm swelled 2 to 3 times worse than with Shingrix vaccine and lasted longer for 2 weeks. He thought that the Shingrix previously received one month before contributed to the adverse drug reaction (ADR) with the Covid booster. Immune cells migrating to skin were probably still there. He found that very interesting. He also had lymphadenopathy after Pfizer booster, but had no real issues with 1st and 2nd of Pfizer series. The reporter denied to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR206638:same reporter,same patient,1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Dermatitis contact, Rash
Clinical narrative: rash; Could be poison ivy; This case was reported by a consumer and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 hours after receiving Shingles vaccine, the patient experienced rash and poison ivy rash. On an unknown date, the outcome of the rash and poison ivy rash were not recovered/not resolved.   It was unknown if the reporter considered the rash and poison ivy rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had received the shingles shot 3 years ago from reporting date and now had the rash. the patient would be going to the doctor and hoped it was not shingles. The patient stated that it could be poison ivy. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Overdose
Clinical narrative: Overdose; This case was reported by a consumer via media and described the occurrence of overdose 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 overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient had an overdose on Shingrix.  The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot 2018, broke out 5 weeks ago/ suspected vaccination failure; Shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years 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 was unknown and the outcome of the shingles was not recovered/not resolved.   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 the patient. The age at vaccination was not reported. In 2018, the patient received the shingles shot and broke out with shingles 5 weeks before the date of reporting and still have them. The patient stated that shingles was the most horrible thing the patient ever had. The patient stated believe him/her that they did not want to get them. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Vaccination failure
Clinical narrative: got shingles even though she got the shot/ suspected vaccination failure; Shingles; Sick bad; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and sickness. The action taken with Shingles vaccine was unknown. On an unknown date, the outcome of the vaccination failure, shingles and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.  Additional details were reported as follows: The patient was reporter's mother. The age at vaccination was not reported. The patient got shingles even though she got the Shingles shot and she was sick bad. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot first then the shingles/ suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine).   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 case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot first then the shingles. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: never had shingles until I got the shot!/ suspected vaccination failure; never had shingles until I got the shot! it lasted over a month.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months 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 was unknown and the outcome of the shingles was recovered/resolved.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient never had shingles until the patient got the Shingles vaccine. Shingles lasted over a month and the patient would never get a vaccine again. The patient stated that he/she did not need to read anything to know the truth. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and laboratory confirmation for were unknown.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administered expired doses; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number G3Z3N, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported. The patient received vaccine which was already expired on 30th June 2021. This is 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR207378:same reporter US-GLAXOSMITHKLINE-US2021AMR207379:same reporter US-GLAXOSMITHKLINE-US2021AMR207380:same reporter US-GLAXOSMITHKLINE-US2021206979:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administered expired doses; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number G3Z3N, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported. The patient received vaccine which was already expired on 30th June 2021. This is 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021206979:same reporter US-GLAXOSMITHKLINE-US2021AMR207379:same reporter US-GLAXOSMITHKLINE-US2021AMR207380:same reporter US-GLAXOSMITHKLINE-US2021AMR207377:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administered expired doses; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number G3Z3N, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported. The patient received vaccine which was already expired on 30th June 2021. This is 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR207378:same reporter US-GLAXOSMITHKLINE-US2021206979:same reporter US-GLAXOSMITHKLINE-US2021AMR207380:same reporter US-GLAXOSMITHKLINE-US2021AMR207377:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administered expired doses; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number G3Z3N, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported. The patient received vaccine which was already expired on 30th June 2021. This is 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021206979:same reporter US-GLAXOSMITHKLINE-US2021AMR207379:same reporter US-GLAXOSMITHKLINE-US2021AMR207377:same reporter US-GLAXOSMITHKLINE-US2021AMR207378:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: was vaccinated and still got it/ suspected vaccination failure; still got it. Brakout was triggered; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patient was reporter's mother. The age at vaccination was not reported. The patient was vaccinated with Shingles vaccine and still got shingles. The reporter stated that the breakout was triggered. So please educate yourself on the triggers and take better care of yourself. No need for vaccine. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt like crab; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 feeling abnormal. On an unknown date, the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and stated that he/she felt like crab for a day, but way better than he/she would had felt with shingles. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had a Shingle shot and a bad case of shingles/ suspected vaccination failure; bad case of shingles; painful Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received Shingles shot and had a very bad case of painful Shingles. The reporter stated that guess what those vaccines did not stop Shingles. They did not tell that they could still get a mild case of Shingles. The reporter stated that the vaccines are not worth the risk. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Guillain-Barre syndrome, Paralysis
Clinical narrative: Guillain Barre syndrome; paralysis; weakness; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), paralysis (serious criteria hospitalization and GSK medically significant) and weakness (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome, paralysis and weakness were unknown.   It was unknown if the reporter considered the guillain barre syndrome, paralysis and weakness to be related to Shingrix.  Additional information: The following receipt of the Shingrix vaccine injections, the patient suffered significant weakness to the point of paralysis, diagnosed by his treating neurologist as Guillain-Barre Syndrome following administration of the shingles medication Shingrix. As a result the patient had undergone substantial hospitalizations and extensive testing and was permanently restricted from receiving any other vaccines.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got Shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In 2020, the patient received Shingrix. On an unknown date, 2 days 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 provided were as follows: The case was reported for patient's friend. Age at vaccination was not reported. Pharmacy Intern had reported that a patient came in wanting the Shingrix vaccine. The patient mentioned that his/her friend received their Shingrix vaccine last year in 2020 and 2 days later experienced Shingles. Patient was curious to know more before Shingrix. Pharmacy Intern confirmed that the patient had not started the Shingrix series. Pharmacy intern was unable to provide any of the friends details or vaccine information. Pharmacy intern called to inquire if any studies performed on Shingrix and Shingles after first dose. The pharmacy intern declined to follow-up.
Age: 3.0
Sex: U
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: received Infanrix instead of Pediarix; received Infanrix at 23 months of age and Pediarix at 3 years old; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix 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 (1st dose received 2 months of age).   On an unknown date, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device and not applicable after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and drug dose administration interval too long. On an unknown date, the outcome of the wrong vaccine administered 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 patient was 5 years and 10 months at the time of reporting. The patient received a dose of Infanrix instead of Pediarix, which led to wrong vaccine administered. The patient then received  a dose of Pediarix later then the recomended interval, which led to lengthening of vaccine schedule. The patient wanted to receive a dose of Kinrix to complete the schedule.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not gotten 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 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 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. The patient had not gotten the second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter was advised as per frequently asked questions and PI (product leaflet) that the patient should just go ahead and get the second dose and did not need to restart the series. The reporter did not consent to follow up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: administered two doses of vaccine to a consumer; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number TP2N2, expiry date 10th February 2023) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 28th September 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 28th September 2021, unknown after receiving Shingrix and SHINGRIX, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details provided were as follows: The registered pharmacist stated that he/she on the previous night shift administered two doses of vaccine to a patient in unknown deltoid, which led to overdose. The registered pharmacist stated that both the doses were from the same lot. The registered pharmacist stated that one dose was administered in each deltoid respectively. The reporter consented to follow-up. This case is linked to the case US2020216289, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020216289:same reporter
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Maternal exposure during pregnancy
Clinical narrative: 11 weeks and received her fluarix vaccine; This prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine exposure during pregnancy in a 37-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number PD237, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season. On 29th September 2021, the patient started Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2021-2022 season at week 14 of the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was lost to follow up.   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 patient self-reported this case. The NDC number was provided as 5816088752. The patient reported that the she was pregnant and received Fluarix vaccine yesterday, which led to exposure during pregnancy. The last menstruation period and due date was unknown. No additional information was provided. The reporter did not consent to follow up as FU NO - Permission Denied, hence the outcome of pregnancy was considered as lost to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Condition aggravated, Herpes zoster, Muscle twitching, Pain
Clinical narrative: PAIN ON THE BACK; twitches before onset of pain; still having pain from shingles off and on; This case was reported by a other health professional via call center representative and described the occurrence of back pain in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (Active case of shingles a year and half ago from the date of reporting) and neuralgia (Occurred a year and half ago from the date of reporting).   In September 2021, the patient received the 1st dose of Shingrix. In September 2021, 3 days after receiving Shingrix, the patient experienced back pain, twitching and pain. The patient was treated with tramadol. On an unknown date, the outcome of the back pain and pain were not recovered/not resolved and the outcome of the twitching was unknown.   It was unknown if the reporter considered the back pain and twitching to be related to Shingrix. The reporter considered the pain to be unrelated to Shingrix.   Additional details were reported as follows: The age at vaccination was not reported. 2 weeks ago, from the date of reporting, the patient received Shingrix. Less than 2 weeks after vaccination, a year later the patient still had pain from shingles off and on.  The patient complained pain on her back triggered 3 days from 1st dose of Shingrix which was 3 weeks ago (from another pharmacy).  Less than a weeks after vaccination, the patient twitches before onset of pain.  The patient taken tramadol to ease pain and had to take more pills. The reporter consented to follow up. No other details of vaccine available. Note: Event pain was conservatively added as it was not clear if it was started before or after vaccination and causality not related as it was related to shingles (medical history).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles for about 8 months, had to visit ER; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in may 2020, three and a half months before the vaccination).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's spouse. The age at vaccination was not reported. The reporter stated that 3 days after the Shingrix vaccine patient had developed a horrific case of shingles. The patient had to visit the emergency room.. The reporter stated patient had the shingles for about 8 months. The patient was very concerned about getting the second Shingrix dose.  Reporter never clarified if spouse did or did not get the second dose. No further information was available. The demographics of patient and date of birth were not obtained. No lot or expiration date information was provided. The reporter stated that no one told patient any different about getting the vaccine or that he should have waited even more time to get the vaccine after the Shingles episode. Patient's health care professional was aware of patient's previous case of Shingles three and half months before. The health care professional that provided the injection to patient was also aware that patient had a previous case of Shingles three and half months before. According to the reporter the adverse event was reported to the CDC. Consent for follow up was not obtained.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received an expired  pediatric ENGERIX-B vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B pediatric) (batch number HN5BE, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th September 2021, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On 29th September 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the certified medical assistant called from a doctors office. The age at vaccination was not reported. The reporter stated that, the patient received an expired pediatric Engerix B vaccine, which led to expired vaccine used. The reporter did not have the chart in front of her therefore did not have the patient's date of birth and failed to ask for the patient's initials.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: received 2 consecutive doses of fluarix; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 15-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 54C23, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX QUADRIVALENT).   On 29th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 29th September 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The clinical manager reported that a patient had received two consecutive doses of Fluarix quadrivalent vaccine, which led to overdose. The reporter consent to follow up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose in May2018 and no other doses adminstered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 37-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose in May 2018, batch number NL4J9, expiry date 6th October 2019).   On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient started the Engerix B series and got 1st dose. No other doses administered to the patient till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow up via postal and declined to provide email address.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: it was administered just the adjuvant; it was administered just the adjuvant and then the correct reconstituted dose; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 57ljn, expiry date 14th April 2023) for prophylaxis.   On 30th September 2021, the patient received the 2nd dose of Shingrix. On 30th September 2021, 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 patient was inadvertently administered just the adjuvant alone of shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient wanted to know what was in the adjuvant and was it safe. The health care professional mentioned that, correct reconstituted dose was already administered immediately after error. The reporter consented to follow up.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: powder component of Menveo was expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA380A, expiry date 31st August 2021) for prophylaxis.   On 30th September 2021, the patient received Menveo. On 30th September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was administered the expired powder component of Menveo, which led to expired vaccine used. The reporter consented to follow up.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Kinrix expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was vaccinated with an expired dose of Kinrix, which led to expired vaccine used. The reporter consented to follow up.
Age: 50.0
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: given Bexsero instead of MCV4; 50 yo was given Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 50-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 50 year old patient was given Bexsero instead of MCV4 inadvertently, which led to wrong vaccine administered and inappropriate age at vaccine administration. The vaccine was administered at health department.  Health care professional had no information on the patient at this time. The reporter consented to follow up.