chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/shot give me shingles; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/shot give me shingles) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 8-Mar-2023 The case was received from the patient via interactive digital media. The patient reported that the shot gave her shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter did not consent to follow-up. The suspect was coded as per narrative information.   Upon internal review the case was updated on 11-MAR-2024. The shingles vaccine was recoded again and additional tracking memo added to align the license with the GSK receipt date and for schedulation of correct report.  Summary of changes: Product details and narrative details were updated.   Upon internal review the case was updated on 22-MAR-2024. The new tracking of GSK date 8 Mar 2023, was added along with shingles vaccine was recoded again for scheduling reports. Summary of changes: Product details and narrative details were updated.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Hypoglycaemia, Syncope
Clinical narrative: Vaso vagal attack / vasovagal syncope; Hypoglycemia; anaphylaxis; This serious case was reported by a consumer and described the occurrence of anaphylaxis in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included arrhythmia, congestive heart failure and acute coronary syndrome.   On 14-MAR-2024, the patient received the 1st dose of Shingrix (unknown arm). On 14-MAR-2024, less than a day after receiving Shingrix, the patient experienced syncope vasovagal (Verbatim: Vaso vagal attack / vasovagal syncope) (serious criteria GSK medically significant). In MAR-2024, the patient experienced anaphylaxis (Verbatim: anaphylaxis) (serious criteria GSK medically significant) and hypoglycemia (Verbatim: Hypoglycemia). The outcome of the anaphylaxis and hypoglycemia were not reported and the outcome of the syncope vasovagal was resolving.   It was unknown if the reporter considered the anaphylaxis, syncope vasovagal and hypoglycemia to be related to Shingrix.     It was unknown if the company considered the anaphylaxis, syncope vasovagal and hypoglycemia to be related to Shingrix.   Additional Information: GSK Receipt date: 15-MAR-2024 The reporter was a Clinic manager. A reporter reported that the patient treated in emergency Room for vasovagal syncope, hypoglycemia, anaphylaxis. Vasovagal attack was recovering on 14 March 2024.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shots I still got them/Suspected vaccination failure; I got the shots I still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got the shots I still got them/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the shots I still got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she got the shots and still got them (shingles). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Impaired healing, Ulcer, Vaccination failure
Clinical narrative: ulcerations; Shingles broke out after vaccination/Suspected vaccination failure; Shingles broke out; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included electric shock sensation (last year in 2023, had an outbreak with electric shocks running down patient's leg. Took forever to clear up) and shingles (last year in 2023, had an outbreak). Previously administered products included Varicella zoster vaccine (15 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In MAR-2024, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Shingles broke out after vaccination/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles broke out). On an unknown date, the patient experienced ulcer (Verbatim: ulcerations). The patient was treated with lidocaine. The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the ulcer was resolving.   It was unknown if the reporter considered the vaccination failure, shingles and ulcer to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and ulcer to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 17-MAR-2024 This case was reported by a patient via interactive digital media. Got the Shingrix (2 shots) after that, and in the week of reporting broke out again. Not as bad, but the ulcerations took so long to heal. Lidocaine over the counter helped a bit. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Still got shingles after vaccine shot/Suspected vaccination failure; Neuropathy on the right leg, very painful; Shingles on the back of thigh; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Still got shingles after vaccine shot/Suspected vaccination failure) (serious criteria GSK medically significant), post herpetic neuralgia (Verbatim: Neuropathy on the right leg, very painful) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on the back of thigh). The outcome of the vaccination failure was unknown and the outcome of the post herpetic neuralgia and shingles were not resolved.   It was unknown if the reporter considered the vaccination failure, post herpetic neuralgia and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, post herpetic neuralgia and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she got the Shingles shot. It helped for a few years. The patient still got shingles and also got neuropathy on the right leg. After about 2 weeks with neuropathy the patient had shingles on the back of thighs. It was very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding 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, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Patient had all three shots and still had shingles/Suspected vaccination failure; Shingles; Hurt bad; Patient had 3 shots of vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient had all three shots and still had shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: Hurt bad) and extra dose administered (Verbatim: Patient had 3 shots of vaccine). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that they hurt so bad. The patient had all three shots and still had them from time to time. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Needless to say, Shingrix did not work for me. I have had 2 outbreaks since then / Suspected vaccination failure; I have had 2 outbreaks since then; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (since his/her mid 20's).   In APR-2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Needless to say, Shingrix did not work for me. I have had 2 outbreaks since then / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have had 2 outbreaks since then). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 15-MAR-2024 This case was reported by a patient via interactive digital media. The patient got 2nd Shingrix vaccine in April 2022 and needless to say, Shingrix did not work for him/her. The patient has had 2 outbreaks since then. The patient was thankful as he/she did not broke out as often as he/she did before taking Shingrix. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: It is something my mother in-law got after she got the vaccine / Suspected vaccination failure; It is something my mother in-law got after she got the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: It is something my mother in-law got after she got the vaccine / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: It is something my mother in-law got after she got the vaccine). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2024 This case was reported by a patient's relative via interactive digital media. The reporter reported that it was something his/her mother in-law (patient) got after she got the vaccine. She suffered horribly for a long time. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles / suspected vaccination failure; shingles 3 times after the shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: shingles / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles 3 times after the shot). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-Mar-2024 This case was reported by a reporter via interactive digital media. Reporter's friend got shingles 3 times after the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: I still have the pain; some itching; I had the vaccine in 2019, but broke out with them on my scalp last October / Suspected vaccination failure; broke out with them on my scalp last October; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In OCT-2023, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the vaccine in 2019, but broke out with them on my scalp last October / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: broke out with them on my scalp last October). On an unknown date, the patient experienced pain (Verbatim: I still have the pain) and itching (Verbatim: some itching). The patient was treated with gabapentin. The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain and itching were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and itching to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, pain and itching to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2024 This case was reported by a patient via interactive digital media. The patient got the vaccine in 2019 but broke out with them on his/her scalp last October. The patient stated miserable as the patient still had the pain and some itching. The patient went back on Gabapentin, which helps some. This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My brother in law got the shot and got shingles / Suspected vaccination failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: My brother in law got the shot and got shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2024 This case was reported by a patient's relative via interactive digital media. The reporter reported that his/her brother-in-law (patient) got the shot and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case has been linked to the case US2024AMR035735, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR035735:same reporter, different patients
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My friend got the shot and got shingles / Suspected vaccination failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: My friend got the shot and got shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2024 This case was reported by a patient's friend via interactive digital media. The reporter reported that his/her friend (patient) got the shot, and both got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case has been linked to the case US2024AMR035729, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR035729:same reporter, different patients
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Musculoskeletal disorder
Clinical narrative: leg issues again; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of musculoskeletal disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   The patient's past medical history included shingles (had it in 2012 after getting a whooping cough shot), unable to walk (patient took 12 weeks to be able to walk again), walker user (walk again with a walker) and musculoskeletal disorder (had leg issue). Previously administered products included Influenza vaccine with an associated reaction of herpes zoster (received Flu shot on an unknown date).   On an unknown date, the patient received the 1st dose of Shingles vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced musculoskeletal disorder (Verbatim: leg issues again). The outcome of the musculoskeletal disorder was not resolved.   It was unknown if the reporter considered the musculoskeletal disorder to be related to Shingles vaccine.     It was unknown if the company considered the musculoskeletal disorder to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2024 This case was reported by the patient via interactive digital media. The patient never did fully recovery. Then in 2021 he/she got the single Shingles shot and then the COVID shot, and patient was having leg issues again. It was unknown if the reporter considered the musculoskeletal disorder to be related to Covid-19 vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Got both shots and only had a sore arm for a day. Definitely do not want shingles; This non-serious 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Got both shots and only had a sore arm for a day. Definitely do not want shingles). The outcome of the pain in arm was resolved (duration 1 day).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2024 This case was reported by a patient via interactive digital media. The patient got both doses and only had a sore arm for a day. Definitely do not want shingles. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Impaired work ability, Pain
Clinical narrative: Everything hurt; had to call out of work; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had a small case of the shingles, so painful) and pain. Additional patient notes included patient's historical drug included Shingles vaccine with adverse reaction pain, reference case US2024AMR032032.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: Everything hurt) and activities of daily living impaired (Verbatim: had to call out of work). Rechallenge with Shingles vaccine was positive. The outcome of the general body pain and activities of daily living impaired were not reported.   It was unknown if the reporter considered the general body pain and activities of daily living impaired to be related to Shingles vaccine.     It was unknown if the company considered the general body pain and activities of daily living impaired to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2024AMR032032   Additional Information: GSK Receipt Date: 09-MAR-2024 This case was reported by a patient via interactive digital media. The patient got the 2nd shot and had to call out of work.  The patient stated, everything hurt.  The patient stated, he/she would rather have those 2 awful days to not have shingles again. This case had been link with US2024AMR032032, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR032032:Same patient (Case for 1st dose)
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: sterile water was used to reconstitute the lyophilized portion of Shingrix; sterile water was used to reconstitute the lyophilized portion of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-MAR-2024, the patient received Shingrix. On 05-MAR-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: sterile water was used to reconstitute the lyophilized portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: sterile water was used to reconstitute the lyophilized portion of Shingrix). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 05-MAR-2024 A medical assistant reported that sterile water was used to reconstitute the lyophilized portion of Shingrix and administered to a patient, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: swollen right arm at injection site; Right arm from elbow to shoulder is bright red; fever; infection; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2024, the patient received the 2nd dose of Shingrix (intramuscular, right deltoid). On 06-MAR-2024, less than a week after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swollen right arm at injection site), erythema of extremities (Verbatim: Right arm from elbow to shoulder is bright red) and fever (Verbatim: fever). In MAR-2024, the patient experienced infection (Verbatim: infection). The outcome of the injection site swelling, erythema of extremities and infection were resolving and the outcome of the fever was resolved.   It was unknown if the reporter considered the injection site swelling, erythema of extremities, fever and infection to be related to Shingrix.     It was unknown if the company considered the injection site swelling, erythema of extremities, fever and infection to be related to Shingrix.   Additional Information: GSK receipt date: 08-MAR-2024 and 11-MAR-2024 The patient reported that she had received her 2nd dose of Shingrix vaccine on either 4th March or 5th March 2024. She reported that the injection site had bad swelling and that her injected arm was bright red from elbow to shoulder. The reporter reported that the nurse the she spoke with answered all her questions. The reporter stated that the nurse was very informative and a delight to talk to, quite honestly, so she felt much better about this infections that she had or with the shot site. The reporter stated that now she was ready to head to vacation in about an hour. The reporter requested to the consented to the follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: wants to get vaccinated again with Shingrix needs to receive the full schedule; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient that received 1st dose of Shingrix on 10-OCT-2022 with batch number 4B53D).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: wants to get vaccinated again with Shingrix needs to receive the full schedule). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-MAR-2024.  The nurse wanted to know if a patient that received Shingrix 3 years ago and wanted to get vaccinated again with Shingrix needed to receive the full schedule or just one follow up dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 5th January 2022.).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-MAR-2024 Patient stated he received his first dose of Shingrix and never got a second dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: never received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In September 2020, received first dose) and Varicella zoster vaccine.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received the second dose ). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 12-MAR-2024 The reporter was patient. The reporter reported that she received first dose of Shingrix in September 202 no specific date provided and never received the second dose. The patient reported that she did go to receive her second dose, but she was given the previous shingles vaccine, not Shingrix (no information about this previous vaccine provided). The reporter consented to follow-up. Till the time of reporting patient did not received the Shingrix vaccine, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Shingrix with a sterile solution instead of with the adjuvant portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 88-year-old male patient who received Herpes zoster (Shingrix) (batch number 77H34, expiry date 06-DEC-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix with a sterile solution instead of with the adjuvant portion). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 12-MAR-2024 The reporter called and requested information on giving Shingrix with a sterile solution instead of with the adjuvant portion to a patient, which led to wrong solution used in drug reconstitution. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient did not received 2nd dose that got the first dose two years ago.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient did not received 2nd dose that got the first dose two years ago.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-Mar-2024 The reporter wanted to know the protocol for second dose application of Shingrix vaccine to the patient that got the first dose two years ago. The reporter stated that the information for adverse event was limited since first dose was not applied in the pharmacy and patient just went to the pharmacy to ask information of second dose of Shingrix. The reporter explained that she knew that there was a protocol from centers for disease control and prevention but she was not updated on the schedule application of Shingrix. Patient information was limited since was passing by to the pharmacy and no further information was provided. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Inappropriate preparation of medication; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 2F9C5, expiry date 18-APR-2026) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate preparation of medication) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-MAR-2024 The pharmacist stated site has ended up with a powder antigen component of Shingrix without an accompanying liquid adjuvant vial, so he believed a patient may have been administered the adjuvant only portion.  At this time, pharmacist did not knew which patient received the unreconstituted product or the date it was administered, but he was going to do some investigating.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received Shingrix with out reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter gave permission for follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Myocarditis
Clinical narrative: MAY HAVE HAD MYOCARDITIS; HEART FAILURE AFTER GETTING COVID VACCINE; This spontaneous report received from a patient via J&J managed social media from a patient concerned a 41 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis.  The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced heart failure after getting covid vaccine (dose series 1). Patient went into heart failure after getting covid vaccine. May have had myocarditis (dose series 1) from the vaccine which led to heart failure. Will be on meds for the rest of his life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart failure after getting covid vaccine and may have had myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Myocarditis, Cardiac failure. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HEART PROBLEMS; This spontaneous report received from a social media site and it was unknown if it was a J&J managed concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series1)(suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced heart problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart problems was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid test/ Positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid test/ Positive) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy from April 2021 to April 2023. Previously administered products included for Multiple myeloma: VENETOCLAX and Daratumumab. Past adverse reactions to the above products included No adverse event with Daratumumab and VENETOCLAX. Concurrent medical conditions included Multiple myeloma (received chemotherapy, Booster dose was administered to the patient due to weakened immune system which was due to current condition of cancer.) since 2003 and Immunodeficiency (Booster dose was administered to the patient due to weakened immune system which was due to current condition of cancer.).    On 18-Dec-2023 at 11:30 AM, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 06-Feb-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (covid test/ Positive) (seriousness criterion medically significant). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. On 20-Feb-2024, COVID-19 (covid test/ Positive) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2024, SARS-CoV-2 test: Positive.         No concomitant medications were reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a patient of unknown age and gender, with relevant medical condition of weakened immune system due to multiple myeloma, who experienced the unexpected and serious (due to medically significant) event of COVID-19, which occurred approximately 1 month and a half after the first dose of SPIKEVAX 2023-2024 vaccine. SARS-CoV-2 test was performed, with positive result. Patient received treatment with nirmatrelvir, ritonavir. The event resolved after 14 days. Underlying weakened immune system due to multiple myeloma could be a risk factor for COVID-19. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: Dementia; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEMENTIA (medically significant), outcome "unknown". Clinical course: Reporter called in 2020 when everyone was getting vaccines. She said she asked one of Pfizer's representative if Comirnaty was in the country but she was told it was not yet. Reporter said her father ended up taking a lot of vaccines which were not fda approved and caller wanted to knew why pfizer was getting non-fda approved vaccine. Reporter would like to knew if the Comirnaty causes Dementia because she believed her father developed Dementia after getting the Covid vaccines.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested negative but had symptoms, prescribed Paxlovid symptoms gone (partner tested positive); patient started having episodes of feeling like he can't breath mostly at Night; tested negative but had symptoms, prescribed Paxlovid symptoms gone (partner tested positive); patient started having episodes of feeling like he can't breath mostly at Night; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 69 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6204) intramuscular, in left arm, on 25Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 07Dec2021 as dose 3 (booster), single (Lot number: FJ8757), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: FJ4989) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Irritable bowel syndrome", start date: 2014 (ongoing); "Relax urinary tract" (ongoing); "acid reflux", start date: 2014 (ongoing); "chronic indigestion" (unspecified if ongoing); "belching" (unspecified if ongoing); "Hiatal hernia" (unspecified if ongoing), notes: Barium X-ray. Concomitant medication(s) included: TAMSULOSIN taken for urinary tract disorder, start date: 2014 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" (20Jul2023) and all described as "tested negative but had symptoms, prescribed Paxlovid symptoms gone (partner tested positive); patient started having episodes of feeling like he can't breath mostly at Night". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2023) Negative, notes: experienced symptoms; (20Jul2023) Negative, notes: prescribed Paxlovid symptoms gone. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes Paxlovid. Clinical course: It was reported that on 10Jul2023, patient tested negative but had symptoms. He was prescribed Paxlovid and was quickly symptom free.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400046346 Same reporter, patient, different dose/event;
Sex: U
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report received from a Pharmacist from medical information team.  A 70-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown". The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.  Additional information: This case was reported as non-Serious. Reporting Notes: the patient was in a nursing home. Question: Call was warm transferred from Pfizer vaccine customer service agent named (name withheld). HCP inquired about an older adult patient that they had few years ago who had a small reaction to Prevnar 13 it was like a little rash. Now, they wanted to give the same patient Abrysvo and they are worried if there's going to be any contraindication for that. That is why they wanted to know if it is safe to give Abrysvo to this patient who had a previous reaction to Prevnar 13. Caller then said that the nurse at the patient's nursing home is seeking contraindication information regarding the Abrysvo or if it is contraindicated if the patient had previously taken Prevnar 13 and had a reaction. They are determining the actual contraindication and reaction to provide information to the doctor for decision-making. When caller was asked if he knew the ingredient causing the reaction in the Prevnar 13 vaccine for reference in the Abrysvo information, the caller responded that he did not know. That is why caller asked If there is anything used in the making of the Abrysvo vaccine that might be common between the two vaccines.