chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: We had all 4 of the shots and the immunoglobulin for post exposure; This case was reported by a consumer via other manufacturer and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Previously administered products included Rabavert (1st dose received with immunoglobulins), Rabavert (On 25th November 2016,received  2nd dose), Rabavert (On 29th November 2016,received  3rd dose) and Rabavert (On 6th december 2016,received  4th dose).   On an unknown date, the patient received the 5th dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The patient's wife reported they had bat in the house and the patient received 4 shots with immunoglobulins. All 4 doses received in 2016 and the patient had not received 5th dose which led to incomplete course of vaccination. This was medication error without harm. The reporter consented for follow up.   On the follow up following internal review it was determined that the initial receipt date (26th August 2020) which is earlier than initially reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR163481: US-GLAXOSMITHKLINE-US2020AMR163473:
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was due for Day 7 vaccine on 8/24/2020 and she came into the health department today on 8/26/2020; This case was reported by a nurse via other manufacturer and described the occurrence of drug dose administration interval too long in a female patient who received Rabies NVS (RabAvert) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert) and Rabies NVS (RabAvert).   On 26th August 2020, the patient received the 3rd dose of RabAvert. On 26th August 2020, unknown after receiving RabAvert, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient received RabAvert vaccination for post exposure prophylaxis. The patient was due for Day 7 vaccine on 24th August 2020 and she came into the health department on 26th August 2020 for the vaccination hence nurse asked how to proceed with the dosing schedule. The reporter stated that for most minor deviations from the schedule, vaccinations could be resumed as though the patient were on schedule. For example, if a patient missed the dose scheduled for day 7 and presents for vaccination on day 10, the day 7 dose should be administered on day 10 and the schedule resumed, maintaining the same interval between doses. In this scenario, the remaining doses would be administered on days 17 and 31. The patient received 3rd dose of RabAvert, later than the recommended interval, which led to lengthtening of vaccination schedule.   On the follow up/following internal review it was determined that the initial receipt date (26th August 2020) which is earliar than initially reported.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: received 2 rabies vaccines and not sure which vaccine brand / this was last 2007; 1st: 01AUG2007 / 2nd: 31AUG2007; This case was reported by a nurse via licensee and described the occurrence of drug dose administration interval too long in a 46-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included Rabies NVS (RabAvert) for prophylaxis.   Previously administered products included Rabavert (1st dos ereceived on 1st August 2007).   On an unknown date, the patient received the 2nd dose of RabAvert and the 3rd dose of RabAvert. In August 2007, unknown after receiving RabAvert and not applicable after receiving RabAvert, 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.  Additional details were provided as follows: The age at vaccination was not applicable for 3rd dose of RabAvert. The patient received 2nd dose late than the recommended schedule, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive 3rd dose of RabAvert, which led to incomplete course of vaccination. The reporter stated that, the patient received 2 dose of unknown brand of Rabies vaccine for pre travel in 2007. The nurse reported that, the patient needed 3rd dose for pre travel.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: receive next dose on day 6 (not day 7); 3rd dose on 17OCT2020 (which would have been day 22 from day 0 dose; This case was reported by a pharmacist via licensee and described the occurrence of drug dose administration interval too short in a female patient who received Rabies NVS (RabAvert) (batch number ARBA731B, expiry date unknown) for prophylaxis.   Co-suspect products included Rabies NVS (RabAvert) (batch number ARBA731B, expiry date unknown) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On 1st October 2020, the patient received the 2nd dose of RabAvert. On 17th October 2020, the patient received the 3rd dose of RabAvert. On 1st October 2020, unknown after receiving RabAvert, not applicable after receiving RabAvert and an unknown time after receiving RabAvert, the patient experienced drug dose administration interval too short. In October 2020, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too short and drug dose administration interval too long were unknown.  Additional details were provided as follows: The age at vaccination was not provided. It was reported that patient for pre-exposure prophylaxis and it should be given 0, 7, 21 or 28.  It was reported that the patient received a shot on day 0 (batch number ARBA731B, expiry date unknown) and they received next dose on day 6 (not day 7) which led to shortening of vaccination schedule. The reporter asked if the does that count or they need another 2nd dose? He also stated that the patient received 3rd dose on 17th October 2020 (which would have been day 22 from day 0, instead of day 21, which led to lengthening of vaccination schedule. The patient did not experienced any adverse event.
Sex: M
Vaccine: RAB
Symptoms: Product storage error
Clinical narrative: left the Rabavert out / Patient has already used the dose; This case was reported by a pharmacist via licensee and described the occurrence of incorrect storage of drug in a 66-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Rabavert (first 2 dose were received on an unknown date).   On 10th November 2020, the patient received the 3rd dose of RabAvert and Rabavert Needle Device. On an unknown date, the patient started Rabavert Pre-Filled Syringe Device. On an unknown date, unknown after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 reporter wanted to know stability information.  The patient left the Rabavert out before taking to the MD office to get his injection. It was out about 18 hours. Patient hasd already used the dose, which led to incorrect storage of drug. The reporter did not know when the patient received his first 2 doses as they were given at the clinic, but stated a dose had not been missed.  The reporter stated the clinic did not have a dose in for the patient's 3rd dose and that was why the patient picked it up from the pharmacy to take to the clinic for 3rd dose. The reporter stated the pharmacy sold dose on 9th November 2020 thinks does was given on 10th November 2020 at MD office. It was unknown if exposure was for pre or post exposure prophylaxis
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: getting pre-exposure vaccines / second / on 11/13/2020 / for COVID / cannot get her third dose until 12/07/2020; second dose on 11/13/2020.; This case was reported by a pharmacist via licensee and described the occurrence of social problem in a 21-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis, rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis, Rabies NVS (RabAvert) for prophylaxis, rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Rabavert (1st dose received on 30th October 2020).   On an unknown date, the patient received the 3rd dose of RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On 13th November 2020, the patient received the 2nd dose of RabAvert. On an unknown date, the patient started Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On 13th November 2020, not applicable after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device and unknown after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the social problem 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 information was provided as follows: The age at vaccination was not applicable for this report. The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. The patient was in quarantine for COVID and she could not get the 3rd dose until 7th December 2020, which led social problem. The patient was a vet student. The reporter consented to follow up.
Sex: F
Vaccine: RAB
Symptoms: COVID-19, Product dose omission issue, Quarantine, Social problem
Clinical narrative: s to get a 2nd dose and is already late with that dose / they are in quarantine right now for COVID; This case was reported by a nurse and described the occurrence of social problem in a 31-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On an unknown date, the patient received the 2nd dose of RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On an unknown date, unknown after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device and an unknown time after receiving RabAvert, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received Rabavert vaccination for pre exposure prophylaxis. The nurse stated that the patient who was to get a 2nd dose of Rabavert was already late with that dose, as the patient was in quarantine right now for COVID. The patient's 2nd dose was due on the day of reporting. The nurse wanted to know that so with their schedule now was the patient able to get her 2nd dose next week or does she need to wait due to COVID, as she should be out of quarantine next Tuesday and so the patient should be able to come in then or should they wait on the physician. The reporter consent to follow up.
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Dysphagia, Dyspnoea, Feeding disorder, Herpes zoster, Malaise
Clinical narrative: Suspect vaccination Failure; Nowhe is in the hospital with a very bad case / Had them in mouth, ears, throat; In hospital very ill; Unable to eat; Difficult to swallow; Difficult to / breath; Side of face and head swollen big time; Side of face and head swollen big time; Excruciating pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included AD26 COV2 S VACCINE (COVID-19 VACCINE JOHNSON & JOHNSON) for prophylaxis.   The patient's past medical history included shingles (5 years ago from the date of reporting lasted about a month).   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE JOHNSON & JOHNSON. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), shingles (serious criteria hospitalization), unwell (serious criteria hospitalization), unable to eat (serious criteria hospitalization), swallowing difficult (serious criteria hospitalization), difficulty breathing (serious criteria hospitalization), facial swelling (serious criteria hospitalization), swelling (serious criteria hospitalization) and pain (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, shingles, unwell, unable to eat, swallowing difficult, difficulty breathing, facial swelling, swelling and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, unwell, unable to eat, swallowing difficult, difficulty breathing, facial swelling, swelling and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. On an unknown date, the patient received the Johnson and Johnson shot. After receiving Shingles shot and Johnson and Johnson shot, the patient had shingles in his mouth, ears and throat. The patient was in the hospital with a very bad case. The patient was unable to eat, had difficulty to swallow and breath. His side of face and head also swollen for big time. The patient was very ill and had excruciating pain. It was unknown if the reporter considered the shingles, unwell, unable to eat, swallowing difficult, difficulty breathing, facial swelling, swelling and pain to be related to COVID-19 VACCINE JOHNSON & JOHNSON. 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: M
Vaccine: COVID19, VARZOS
Symptoms: Pain, Swelling, Swelling face, Vaccination failure
Clinical narrative: Suspect vaccination Failure; Nowhe is in the hospital with a very bad case / Had them in mouth, ears, throat; In hospital very ill; Unable to eat; Difficult to swallow; Difficult to / breath; Side of face and head swollen big time; Side of face and head swollen big time; Excruciating pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included AD26 COV2 S VACCINE (COVID-19 VACCINE JOHNSON & JOHNSON) for prophylaxis.   The patient's past medical history included shingles (5 years ago from the date of reporting lasted about a month).   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE JOHNSON & JOHNSON. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), shingles (serious criteria hospitalization), unwell (serious criteria hospitalization), unable to eat (serious criteria hospitalization), swallowing difficult (serious criteria hospitalization), difficulty breathing (serious criteria hospitalization), facial swelling (serious criteria hospitalization), swelling (serious criteria hospitalization) and pain (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, shingles, unwell, unable to eat, swallowing difficult, difficulty breathing, facial swelling, swelling and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, unwell, unable to eat, swallowing difficult, difficulty breathing, facial swelling, swelling and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. On an unknown date, the patient received the Johnson and Johnson shot. After receiving Shingles shot and Johnson and Johnson shot, the patient had shingles in his mouth, ears and throat. The patient was in the hospital with a very bad case. The patient was unable to eat, had difficulty to swallow and breath. His side of face and head also swollen for big time. The patient was very ill and had excruciating pain. It was unknown if the reporter considered the shingles, unwell, unable to eat, swallowing difficult, difficulty breathing, facial swelling, swelling and pain to be related to COVID-19 VACCINE JOHNSON & JOHNSON. 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: COVID19, VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: my hot flashes disappeared/from the time the reactions began/ did not reappear for 1-3 days after symptoms disappeared; This case was reported by a consumer via other manufacturer and described the occurrence of unexpected therapeutic effect in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID 19 VACCINE PFIZER for covid-19 prophylaxis.   Concurrent medical conditions included hot flashes.   On an unknown date, the patient received Shingrix and COVID 19 VACCINE PFIZER. On an unknown date, unknown after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.  Additional details were provided as follows: The patient reported case for him/herself The age at vaccination was not reported. The patient reported that, a few days after receiving both the Shingrix and the Pfizer Covid vaccinations, the hot flashes disappeared. The patient had moderate reactions to both vaccinations that lasted 12 and 36 hours respectively. The patient reported hot flashes disappeared from the time the reactions began and they did not reappear for 1 to 3 days after symptoms disappeared, which led to unexpected therapeutic effect for Shingrix and Pfizer Covid vaccinations . The patient requested if GlaxoSmithKline could find the correlation and eventually provide a permanent treatment for hot flashes. The patient consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Got the vaccine / within two months had a nasty case of shingles and have had several bouts since; Had a nasty case of shingles and have had several bouts since; 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, less than 2 months after receiving Shingles vaccine and an unknown time after starting Valacyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). 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 patient itself. The age at vaccination was not reported. The patient got a nasty case of Shingles after vaccination within 2 months and  had several bouts since. It was recommended by patient's doctor to get vaccinated for shingles for several reasons. The patient never personally had shingles but knew people who did. The patient had a standing prescription for Valacyclovir HCL 1gram tablet to take immediately after the shingles starting. If the patient had choice, the patient would never have gotten this vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Painful Shingrix vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received vaccine and was painful.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: I had 3 shot of Shingrix vaccine; This case was reported by a consumer via interactive digital media (GSK Chatbot) and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient had 3 shot of Shingrix vaccine, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: When is the onset of Guillain-Barre symptoms after a Shingrix shot?; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was asked about onset of Guillain-Barre symptoms after a Shingrix shot.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the Shingrix vaccine in summer - 2018 / now in May I have the shingles/ Suspected Vaccination failure; now in May I have the shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 MRNA VACCINE MODERNA for prophylaxis.   Concomitant products included COVID-19 MRNA VACCINE MODERNA.   On an unknown date, the patient received Shingrix. In February 2021, the patient received the 2nd dose of COVID-19 MRNA VACCINE MODERNA. In May 2021, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient had Shingrix vaccine in the summer of 2018. The patient had Moderna 2 shot Covid vaccines in January and February this year. The patient at the time of reporting in the May 2021 had the shingles. The patient asked were there many reports of this happening. It was unknown if the reporter considered the shingles to be related to COVID-19 MRNA VACCINE MODERNA. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule and laboratory confirmation for shingles were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had the shingles shot ,a month later I got shingles/Suspected vaccination failure; I had the shingles shot ,a month later I got shingles; Diagnosed wrong, still have the pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and a month later he/she got shingles from the waist down and the patient stated that it was diagnosed wrong, he/she still had the pain, that was 4 years ago. The patient take treatment with a high dose of gabapentin. The patient stated that some doctors should not be practicing. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My arm is very painful after Shingrix vaccine.; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient stated that his/her arm was very painful after Shingrix vaccine. The patient asked what would help.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles shot and got bad case of shingles/Suspected Vaccination failure; Got shingles shot and got bad 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 reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and got bad case of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got the shot and still got 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient got the shot and still got shingles. The patient stated that he/she was told that 2 shots were needed. The patient felt mislead.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the vaccine, got shingles/Suspected Vaccination failure; I had the vaccine, 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 reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and got shingle and stated it as bad staff. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. 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...a few years later I had one giant shingle on my thigh/Suspected Vaccination failure; Had the shot...a few years later I had one giant shingle on my thigh; 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, several 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and a few years later he/she had one giant shingle on his/her thigh. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available
Sex: U
Vaccine: FLUX, HEPA
Symptoms: Induration, Pruritus, Skin discolouration
Clinical narrative: Lump / on both thighs; Itching / on both thighs; Discoloration on both thighs; This case was reported by a consumer via other manufacturer and described the occurrence of mass in a patient who received HAV (Havrix) (batch number 94J24, expiry date 26th September 2021) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 25th October 2019, the patient received Havrix .5 ml and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 2 years after receiving Havrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced mass, itchy legs and skin discoloration. On an unknown date, the outcome of the mass, itchy legs and skin discoloration were unknown.   It was unknown if the reporter considered the mass, itchy legs and skin discoloration to be related to Havrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient received Havrix and Flu vaccine and reported lump, itching and discoloration on both thighs. The reporter initially stated that the patient received 'hepatitis A vaccine', but when asked for lot number, he or she stated that the vaccine was not a MERCK product. No additional adverse events or product complaint was reported. No additional information was available at the time of reporting.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gait inability, Hypoaesthesia, Muscular weakness, Myelitis transverse, Urinary retention
Clinical narrative: could not walk; could not urinate on his own; Transverse Myelitis; weakness in his legs; numbness in his legs; This case was reported by a lawyer and described the occurrence of myelitis transverse in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 27 May 2021 via medical record (case is now medically confirmed). As per the medical records plaintiff had received Shingrix on 16 February 2020 for Prophylaxis. Around 18 March 2020 he was started feeling weakness and numbness in his legs progressing over several days to the point that he could not walk or urinate on his own. he started to experienced further progression of LE weakness with further difficulty ambulating. Then was diagnosed with Traverse Myelitis, cannot walk and was on wheelchair.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Wheelchair user
Clinical narrative: could not walk; could not urinate on his own; Transverse Myelitis; weakness in his legs; numbness in his legs; This case was reported by a lawyer and described the occurrence of myelitis transverse in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 27 May 2021 via medical record (case is now medically confirmed). As per the medical records plaintiff had received Shingrix on 16 February 2020 for Prophylaxis. Around 18 March 2020 he was started feeling weakness and numbness in his legs progressing over several days to the point that he could not walk or urinate on his own. he started to experienced further progression of LE weakness with further difficulty ambulating. Then was diagnosed with Traverse Myelitis, cannot walk and was on wheelchair.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bradycardia, Cerebrovascular accident, Eyelid function disorder, Unresponsive to stimuli
Clinical narrative: Stroke; Hemorrhagic Stroke; Intermittent bradycardia; thrombotic stroke; Intracranial hemorrhage; aneurysm; This case was reported by a lawyer and described the occurrence of stroke in a female patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 24th April 2022) for prophylaxis.   The initial information was received on 27 May 2021 via medical record (case is now medically confirmed). As per the medical records plaintiff had received Shingrix on 14 February 2020 and 22 May 2020 for Prophylaxis. The patient had stroke , the date of injury was 22 may 2018. On Emergency department visit patient reported intermittent bradycardia and she was no longer opening eyes to voice or even noxious stimuli. Differential diagnoses consider for patient includes intracranial hemorrhage, Aneurysm, Thrombotic stroke and carotid dissection.
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the 4th dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Rabies NVS (RabAvert) for prophylaxis.   Previously administered products included Rabavert (1st dose received on 4th May 2020), Rabavert (2nd dose received on 7th May 2020) and Rabavert (3rd dose received on 11th May 2020).   On an unknown date, the patient received the 4th dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 4th dose of RabAvert, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Rabies NVS (RabAvert) for prophylaxis.   Previously administered products included RabAvert (1st dose received on 24th June 2020).   On an unknown date, the patient received the 2nd dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was 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 RabAvert, which led to incomplete course of vaccination. This was post exposure of vaccine case. The reporter did not consent to follow up.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: 20Jun2020 along with immunoglobulin and dose 2 on 27Jun2020; Incomplete course of vaccination; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 9-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included Rabies NVS (RabAvert) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On 27th June 2020, the patient received the 2nd dose of RabAvert. On an unknown date, the patient received RabAvert. On an unknown date, unknown after receiving RabAvert and not applicable after receiving RabAvert, the patient experienced drug dose administration interval too long and 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.  Additional details were reported as follows: The patient received 1st dose of post exposure RabAvert vaccine on 20th June 2020 (on day 0) and 2nd dose received along with immunoglobulin on day 7th instead of day 3 which led to drug dose administration interval too long and till the time of reporting the patient did not received 3rd dose which led to incomplete course of vaccination.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Received 1st dose of Rabavert on June 30th 2020 under pre exposure schedule; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Rabies NVS (RabAvert) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On an unknown date, the patient received the 2nd dose of RabAvert. On an unknown date, unknown after receiving RabAvert and an unknown time after receiving RabAvert, 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 received 1st dose of Rabavert on 30th June  2020 under pre exposure schedule but already passed the 7 days for next dose, which led to  incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed 5th dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included swelling (had bumps on fingures and was going to be tested for TB). Previously administered products included Rabavert (received doses on an unknown date).   On an unknown date, the patient received the 5th dose of RabAvert. On an unknown date, unknown after receiving RabAvert, 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 bumps on fingures and was going to be tested for TB. The reporter stated that, ther patient missed 5th dose of RabAvert as the pharmacy was closed and was 5 days late on getting it. till the time of reporting, the patient did not receive 5th dose of RabAvert, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Product administered at inappropriate site
Clinical narrative: 1st dose on Jun/25/2020 / 2nd dose on Jul/02/2020 / 3rd dose on Jul/09/2020; Vaccine administered at inappropriate site; 1st dose on Jun/25/2020 / 2nd dose on Jul/02/2020 / 3rd dose on Jul/09/2020; 1st and 2nd dose was administered at left gluteus Medius; This case was reported by a nurse via call center representative and described the occurrence of vaccine administered at inappropriate site in a 44-year-old female patient who received Rabies NVS (RabAvert) (batch number 639011C, expiry date 1st July 2020) for prophylaxis.   Co-suspect products included Rabies NVS (RabAvert) (batch number ARB6621B, expiry date 1st October 2021) for prophylaxis and Rabies NVS (RabAvert) (batch number ARB6621B, expiry date 31st October 2021) for prophylaxis.   On 25th June 2020, the patient received the 1st dose of RabAvert. On 2nd July 2020, the patient received the 2nd dose of RabAvert. On 9th July 2020, the patient received the 3rd dose of RabAvert. On 25th January 2020, unknown after receiving RabAvert and not applicable after receiving RabAvert and RabAvert, the patient experienced vaccine administered at inappropriate site. On 2nd July 2020, the patient experienced vaccine administered at inappropriate site and drug dose administration interval too long. On 9th July 2020, the patient experienced drug dose administration interval too long. The action taken with RabAvert was unknown. On an unknown date, the outcome of the vaccine administered at inappropriate site, vaccine administered at inappropriate site, drug dose administration interval too long and drug dose administration interval too long were unknown.  Additional case details were reported as follows: On 25th January 2020, the patient received 1st dose of  RabAvert via left gluteus Medius, which led to vaccine administered at inappropriate site. On 2nd July 2020, the patient received 2nd dose of  RabAvert via left gluteus Medius, which led to lengthening of the vaccination schedule and vaccine administered at inappropriate site. On 9th July 2020, the patient received 3rd dose of  RabAvert via left gluteus Medius, which led to lengthening of the vaccination schedule.
Sex: M
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of post exposure Rabavert  on 14JUL2020 but has missed the 2nd; 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 male patient who received Rabies NVS (RabAvert) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert) and immunoglobulins nos (Immunoglobulin).   On an unknown date, the patient received the 2nd dose of RabAvert. On an unknown date, unknown after receiving RabAvert and an unknown time after receiving RabAvert, the patient experienced incomplete course of vaccination. The action taken with RabAvert was unknown. 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 reporter stated that, the patient received dose of post exposure Rabavert and the immunoglobulin on 14th July 2020, but has missed the 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Rabavert, which led to incomplete course of vaccination.