chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; VARIVAX underwent a temperature excursion, and the VARlVAX was administered to a patient; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.       On 01-MAR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # U016063 with expiration date 20-MAY-2023, for prophylaxis (strength, dose, route of administration and anatomical location were not reported). No additional adverse event (AE) was reported. It was sated that the vaccine was exposed to a temperature of -14.3 °C for 40 minutes. There were not previous temperature excursions.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic product effect decreased
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-AMGEN INC-22-0039643-SR-01 (RA), US-AMGEN-USASP2022023116 (RA). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation; etanercept (ENBREL) (Batch/Lot number: unknown) for product used for unknown indication. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious), outcome "unknown", described as "when she got the COVID-19 vaccine, the Enbrel stopped working". The action taken for etanercept was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Received Engerix as 2nd Dose; Initial Report Received on 25-Jan-2022  A physician reported that a patient (age, gender, race and ethnicity unknown) received Engerix-B as a second dose.  No medical history was reported.   No concomitant medications were reported.  On an unknown date in 2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, injection site, and route unknown).   On 25-Jan-2022, 1 month after having received the first dose of HEPLISAV-B vaccination, the patient received Engerix-B as the second dose (Lot #, expiration date, NDC #, injection site, and route unknown) instead of HEPLISAV-B. No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: Titre Dropped; Initial Report Received on 26-Jan-2022 and 07-Feb-2022  A registered nurse reported that a patient (age, gender, race and ethnicity unknown) received 2 doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient's titer dropped.  No medical history was reported.   No concomitant medications were reported.  On 19-Jul-2021, the patient received the first dose of HEPLISAV-B (Lot # 934967, expiration date 11 APR 2022, NDC # 43528-003-01) intramuscularly in the right deltoid by the nurse reporter.   On 09-Aug-2021, 3 weeks after having received the first dose of HEPLISAV-B vaccination, the patient received the second dose of HEPLISAV-B (Lot # 934967, expiration date 11 APR 2022, NDC # 43528 003 01) intramuscularly in the right deltoid by the nurse reporter.   On 14-Jan-2202, the patient's titers dropped from 27 on 05-Oct-2021 to 9. No adverse reactions were reported. No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: 23 Weeks Pregnant and Currently Taking Hep Vaccine; Initial Report Received on 04-Jan-2022  A pregnancy patient (gestation period 23 weeks) reported that she (age, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization   No medical history was reported.   No concomitant medications were reported.  On an unknown date, the patient received a dose of HEPLISAV-B (Lot #, expiration date, NDC #, and injection site unknown).  No additional information was provided. Permission was not obtained for providing demographic information. There was no response to follow-up conducted by the registry and permission for Dynavax to follow-up with the HCP office was not obtained.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Pain
Clinical narrative: chills; very hot; achy feeling; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced pain, chills and feeling hot. On an unknown date, the outcome of the pain, chills and feeling hot were recovered/resolved.   It was unknown if the reporter considered the pain, chills and feeling hot to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The first 3 days the patient had achy feeling and seven days after that he/she would had chills then replaced by being very hot (but no fever) and then a couple of hours while he/she felt fine. The reporter asked if that was normal. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Feeling soreness in the arm at the injection site.; 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 22nd February 2022, the patient received the 2nd dose of Shingrix. On 22nd February 2022, less than a day 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 patient self-reported this case. The age at vaccination was not reported. The patient had second shot on an unknown arm on the reporting day.  The patient was feeling soreness in the arm at the injection site.  The patient asked was it okay to take an Aleve. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: My injection site is red and is sore.; My injection site is sore.; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received 1st dose of Shingrix. In February 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were Not Recovered/Not Resolved.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient's injection site was red and sore.  The day of reporting was the 3rd day after receiving the injection. The patient asked was this normal. The reporter asked should the patient be concerned about getting the second injection. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: DTAPHEPBIP, FLU3, RV1
Symptoms: Product storage error
Clinical narrative: The caller said these products may have been administered after a temperature excursion; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation, Rotarix Oral Applicator Device and Fluarix. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation, Rotarix Oral Applicator Device and Fluarix, 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 details were provided as follows: The age at vaccination was not reported. The reporter reported storage error for Fluari, Pediarix and Rotarix. These products might have been administered after a temperature excursion. The excursion occurred in the refrigerator and reached a maximum temperature of 8.98C. The reporter said the excursion lasted for 30 minutes. The reporter did not have any patient information or dates of administration. No further information provided. No other adverse event, no product quality complaint..
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Incomplete course of vaccination, Mobility decreased, Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis; first shot made me feel so bad, was on the sofa for a day; never went back for the second; This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rheumatoid arthritis (serious criteria medically significant), feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the rheumatoid arthritis, feeling bad and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rheumatoid arthritis and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported for 1st dose and it was not applicable for 2nd dose. Several years prior to the reporting date, the patient got the first vaccine but never got the second.  The patient asked could he/she get the second vaccine now or did he/she had to start all over. The patient was trying to get vaccinations in order before to start Actemra infusions next week for rheumatoid arthritis. The first shot made patient feel so bad that the patient never went back for the second like patient should had. The patient was on the sofa for a day and could not remember exact symptoms. The patient stated way better than having shingles, should had gone back. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The patient asked were there two shots were same and would it be dangerous to start over and if he/she get the vaccine now, how long should he/she wait before getting an Actemra infusion, was there information on that.
Sex: U
Vaccine: VARZOS
Symptoms: Product availability issue
Clinical narrative: first vaccine 5 years ago. then it became unavailble; This case was reported by a consumer via call center representative and described the occurrence of product availability issue in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, 5 years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product availability issue. On an unknown date, the outcome of the product availability issue was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient self-reported the case and stated that, he/she had first Shingrix vaccine at the age of 65 years. Then the vaccine became unavailable in his/her area for many months, which led to product availability issue. By then, the patient was very much involved in caring for a seriously ill family member. The patient did not receive 2nd dose and asked if he/she could get 2nd dose now or need to start over.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had your vaccine, had shingles/Suspected vaccination failure; 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.   On an unknown date, the patient received Shingrix. On an unknown date, unknown 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 case was reported by the patient. The age at vaccination was not reported. The patient had vaccine and had shingles in 2019-2021. The patient asked that if a patient was 50 years or older already had shingles, they could still vaccinated with Shingrix. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The patient asked if the patient needed another vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First shot two years ago; 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was it too late to receive 2nnd dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Failed to refrigerate.It is still viable?; This case was reported by a consumer via interactive digital media and described the occurrence of incorrect storage of drug 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 incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The reporter was patient's son/daughter. The age at vaccination was not applicable for this report. The reporter stated that, the patient picked up her shingles vaccine and failed to refrigerate it until 18 hours after pick up, which led to incorrect product storage. The reporter needed to know if it was still viable.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Shots did NOTHING! I still get shingles; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown 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 self-reported this case. The age at vaccination was not reported. The patient stated that the shots did nothing and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirmation for shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Product availability issue
Clinical narrative: First shingrix 5 years ago, then it became unavailble; This case was reported by a consumer via interactive digital media and described the occurrence of product availability issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 5 years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product availability issue. On an unknown date, the outcome of the product availability issue was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received first Shingrix vaccine when he/she turned 65 years of age. It then became unavailable in his/her area for many months, which led to product availability issue. By then, the patient was very much involved in caring for a seriously ill family member. The patient asked could he/she get 2nd dose now or need to start over.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got two shots, still get shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by the patient . The age at vaccination was not reported. The patient got the two shots of Shingrix and still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Age: 6.0
Sex: U
Vaccine: HEP
Symptoms: Dyskinesia, Musculoskeletal stiffness
Clinical narrative: involuntary facial movements; neck twisting; This case was reported by a physician and described the occurrence of movements involuntary in a 6-year-old patient who received Hepatitis B vaccine (batch number U32D9, expiry date 5th February 2022) for prophylaxis.   On 6th July 2021, the patient received Hepatitis B vaccine. On 20th July 2021, 14 days after receiving Hepatitis B vaccine, the patient experienced movements involuntary and stiff neck. On an unknown date, the outcome of the movements involuntary was not recovered/not resolved and the outcome of the stiff neck was unknown.   It was unknown if the reporter considered the movements involuntary and stiff neck to be related to Hepatitis B vaccine.  Additional details were provided as follows: The patient received dose of Hepatitis B vaccine and experienced involuntary facial movements and neck twisting. On 20th July 2021, the reporter saw the patient with the above complaints and told mother to observe.  The patient was still with involuntary movements. No further information reported. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Pain in arm; Rash down the arm; 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 24th February 2022, the patient received the 2nd dose of Shingrix. In February 2022, less than a week after receiving Shingrix, the patient experienced pain in arm and rash. On an unknown date, the outcome of the pain in arm and rash were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received Shingles vaccine on Thursday, and had pain and a rash down the same arm. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash from Shingles vaccine; This case was reported by a consumer via interactive digital media 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 26th February 2022 08:58, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated there was rash from the shingles vaccine. Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Zoster vaccine Aug 2019 and Oct 2019, had shingles last week/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 (Herpes Zoster vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Herpes Zoster vaccine) for prophylaxis.   In October 2019, the patient received the 2nd dose of Herpes Zoster vaccine. In August 2019, the patient received the 1st dose of Herpes Zoster vaccine. On 25th February 2022, more than 2 years after receiving Herpes Zoster vaccine and Herpes Zoster 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 Herpes Zoster vaccine and Herpes Zoster vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the Zoster vaccine in August 2019 and October 2019 but his/her physician told him/her that he/she had shingles last week Friday.  The reporter asked that how long did the vaccine last. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: break out with rash; This case was reported by a consumer via interactive digital media 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 11th January 2022, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had shingle shot in January. The patient broke out with rash on 11th January 2022. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after 1st dose Sep2021; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingrix. In September 2021, 1 day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had got shingles 1 day after got first Shingrix shot in early September 2021. The patient was due for second shot in early March.  The patient was asking about should they be concerned about getting the second shot. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Red rash 2x3 inches at point of vaccination; This case was reported by a consumer and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (First dose received on 19th October 2021).   On 22nd February 2022, the patient received the 2nd dose of Shingrix. On 24th February 2022, 2 days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient herself. The age of vaccination was not reported. The patient noticed red rash 2x3 inches at point of vaccination on right arm. No lot number information. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got one dose of shingrix on july 31; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in March). Previously administered products included Shingrix (1st dose received on 31st July).   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 patient self-reported this case. The age at vaccination was not applicable to this report. The patient received 1st dose of Shingrix on 31th July. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient asked if he/she could take the second dose now or if he/she needed to start over. The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Cardiac operation, Incomplete course of vaccination
Clinical narrative: I had major heart surgery; Didn´t get the 2nd shot; This case was reported by a consumer via interactive digital media and described the occurrence of cardiac operation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced cardiac operation and incomplete course of vaccination. On an unknown date, the outcome of the cardiac operation and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the cardiac operation to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine and It had been more than 6 months after that he/she had major heart surgery. Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient asked what were the consequences of getting the 2nd shot almost 9 months after the first, was it safe. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose over 2 years ago, did not get 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis..   Previously administered products included Shingles vaccine (received 1st dose over 2 years ago).   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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked for recommendation. The follow up would not be possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Rheumatoid arthritis
Clinical narrative: RA flare caused by 1st dose; This case was reported by a consumer via  interactive digital media and described the occurrence of rheumatoid arthritis flare up in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant). On an unknown date, the outcome of the rheumatoid arthritis flare up was unknown.   It was unknown if the reporter considered the rheumatoid arthritis flare up to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Shingrix 2nd dose after rheumatoid arthritis flare caused by 1st dose. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: first shot in 2020, Covid hit. Never got the second; This case was reported by a consumer via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose in December 2020).   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 social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not applicable for this report. The patient had received a shot of Shingles vaccine and due to Covid hit, the patient never got 2nd shot, which led to social problem. The reporter stated that (Centers for disease control and prevention) CDC said that get 2nd shot and did not need 3rd shot.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction
Clinical narrative: had anaphylactic reaction, went to ER; This case was reported by a other health professional via sales rep and described the occurrence of anaphylactic reaction in a 4-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and PROQUAD for prophylaxis.   On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device and PROQUAD. On an unknown date, less than a year after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced anaphylactic reaction (serious criteria medically significant). On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved.   It was unknown if the reporter considered the anaphylactic reaction to be related to Kinrix and Kinrix Pre-Filled Syringe Device.This report is made 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 an Epidemiologist. The patient had anaphylactic reaction less than a year after receiving Kinrix and ProQuad at 4-year-old visit, the patient went to emergency room to be treated and recovered. It was unknown if the reporter considered the anaphylactic reaction to be related to ProQuad. The reporter agreed to follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: oral shingles. Currently hospitalized; This case was reported by a other health professional via sales rep and described the occurrence of oral herpes in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included throat cancer (had history of throat cancer).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced oral herpes (serious criteria hospitalization). On an unknown date, the outcome of the oral herpes was unknown.   It was unknown if the reporter considered the oral herpes to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but the patient was 50 years plus. The patient received a dose of Shingrix and developed oral shingles. The patient was currently hospitalized, not sure of condition. Offered Medical informer to person who reported the incidence. The reporter did not agree to follow-up from GlaxoSmithKline.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date January 2022) 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 22nd February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 22nd February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and unknown after starting Bexsero and Bexsero 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 age at vaccination was not reported. Medical Assistant inquired about re-administration of Bexsero They inadvertently administered an expired Bexsero to the patient on the day before reporting, which led to expired vaccine used. The reporter declined follow-up from safety.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2020) and Shingrix (received 2nd dose in December 2020).   In February 2021, the patient received the 3rd dose of Shingrix. In February 2021, 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 received 3rd dose of Shingrix, which led to extra dose administered, at their doctor's office, not the pharmacy.  No patient identifiers were provided except that it was a male patient.  The reporter stated that, there was a 2 months or greater interval between dose 1 and dose 2 of Shingrix.  No reactions were reported. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: itchy rash on her stomach and back; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles prior to vaccination).   In December 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In February 2022, between 1 and 3 months after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received dose of Shingrix on left arm and about a week ago from the date of reporting, the patient experienced an itchy rash on her stomach and back. The patient had shingles prior to getting the vaccine and stated that it appeared to be similar to what she experienced with shingles. The reporter did not consent to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd February 2022, the patient received Shingrix. On 23rd February 2022, less than a day after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix vaccine and experienced dizziness. No further information reported. The follow-up would not possible as no contact details were available.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Expired product administered
Clinical narrative: received expired twinrix and havrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received DTPa (Infanrix) (batch number KG4M7, expiry date 6th February 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) (batch number Y4FL4, expiry date 28th January 2022) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd February 2022, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Havrix and Havrix Pre-Filled Syringe Device. On 22nd February 2022, unknown after receiving Infanrix, Infanrix Pre-Filled Syringe Device, Havrix and Havrix 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: Registered nurse reported that, the patient received expired dose of Infarnix on 22th February 2022 which was expired on 6th February 2022 The same patient received an expired dose of Havrix on the same day. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022033881:FU1 - Deleted
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 24th February 2022, 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the administration of an expired dose of Kinrix vaccine to the patient. The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Extra dose administered, Influenza like illness, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Painful arm; Hot to touch arm; Red arm; Flu like symptoms; Received 2 shots 3 months apart; Some site reaction; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a 57-year-old male patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number 579C9, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Concomitant products included Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season).   On 21st February 2022, the patient received FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device and PNEUMONIA VACCINE. On 21st February 2022, less than a day after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site reaction, influenza-like symptoms and extra dose administered. On 23rd February 2022, the patient experienced injection site pain, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site reaction and influenza-like symptoms were recovered/resolved and the outcome of the injection site pain, injection site warmth, injection site erythema and extra dose administered were unknown.   It was unknown if the reporter considered the injection site reaction, injection site pain, injection site warmth, injection site erythema and influenza-like symptoms to be related to FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. 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 received FluLaval Quadrivalent 2021-2022 season and Pneumonia vaccine on an unknown same arm. The patient received 2nd dose of FluLaval Quadrivalent 2021-2022 season, which led to extra dose administered. After receiving FluLaval Quadrivalent 2021-2022 season, the patient developed some site reaction and flu like symptoms at the end of day which was resolved in 24 hrs. The patient was also complained of painful hot to touch and red arm. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. It was unknown if the reporter considered the injection site reaction, injection site pain, injection site warmth, injection site erythema and influenza-like symptoms to be related to Pneumonia vaccine.