chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discomfort, Injection site bruising, Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: Started noticing upper left arm pain 4 hours after injection, around 6pm. Left arm too painful to move for 24 hours. Pain was mostly in deltoid where shot was given. Injection site seemed unusually high on shoulder. Injection site never felt worse than a mild sports bruise. No visible inflammation or other external symptoms. After 48 hours still painful, but full motion of arm possible. After 96 hours most pain was gone, but not comfortable to lie on left side.
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Rash
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 67.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pruritus, Pyrexia
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Fever-Mild, Additional Details: all the symptoms gone away but pt wants to report events
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 3 complete doses were drawn out of a 6 dose vial of Pfizer vaccine. Reconstitution error expected and found after a dose was given to patient. Client notified of slightly larger dose and educated on possible side effects to expect, per CDC Covid-19 vaccine administration Errors/Deviations information. Spoke with wife and spouse verbalized understanding.
Age: 13.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event, Product administration error
Clinical narrative: administration error - pt. was given extra doses of IPV, MMR, and VZV. No immediate complications or adverse side effects.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; vaccinated with 3 doses of GARDASIL 9 and was administered a 4th dose of GARDASIL 9 as patient was unable to locate the shot records; This spontaneous report has been received from a healthcare professional (HCP) concerning a 14-year-old patient of unknown gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On unreported dates, the patient received the first, second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, route of administration and anatomical location were not provided for any of them) all as prophylaxis.  On 21-APR-2023, the patient was vaccinated with a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as the patient was unable to locate the shot records (extra dose administered). No additional events were reported. Also, the HCP wanted to know is there any side effect or precautions that should be noted.
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: A patient came back with negative tier on just the Mumps; This spontaneous report was received from a nurse and refers to a 44-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced came back with negative tier on just the Mumps (Mumps antibody test negative). At the time of reporting, the outcome of the event was not known.   The causal relationship between the event and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: I had three shots; Had three shots and just got it/suspected vaccination failure; Had three shots and just got it; 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 23-MAR-2023, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had three shots and just got it/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had three shots and just got it). On an unknown date, the patient experienced extra dose administered (Verbatim: I had three shots) (serious criteria GSK medically significant). The outcome of the vaccination failure and extra dose administered were 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, Shingles vaccine and Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that he/she got more than one shingles vaccine. The patient received three doses of shingles vaccine and diagnosed with shingles at the time of reporting. This case was considered as suspected vaccination failure since the details time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The patient received three doses of shingles vaccine, which led to extra dose administered. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: shot does not mean you won't get them/ suspected vaccination failure; Shingles; Worst Pain; 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: shot does not mean you won't get them/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Worst Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by patient via interactive digital media. The reporter reported that his or her friend received Shingles vaccine and she is absolutely in the worst pain now over the three months. The reporter stated that vaccine received does not mean that you did not experience 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. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had the 2 shots but still had Shingles/suspected vaccination failure; I had the 2 shots but still had Shingles; worst pain in life; 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.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the 2 shots but still had Shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had the 2 shots but still had Shingles) and pain (Verbatim: worst pain in life). The outcome of the vaccination failure was 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 and Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 24-MAR-2023  This case was reported by patient via interactive digital media. The reporter stated that it was scary. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: my husband did and was in awful pain. We both have our vaccines/suspected vaccination failure; my husband did and was in awful pain. We both have our vaccines; awful pain; 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 husband did and was in awful pain. We both have our vaccines/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: my husband did and was in awful pain. We both have our vaccines) and pain (Verbatim: awful pain). The outcome of the vaccination failure was 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.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-MAR-2023  This case was reported by patient's wife via interactive digital media.  The reporter never had shingles. The reporter stated that the patient had shingles and he was in awful pain.  The reporter stated that they both had Shingles vaccinations.  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 follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the shots and still got shingles/ Suspected vaccination failure; Shingles; Painful; 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: Had the shots and still got shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Painful). The outcome of the vaccination failure was 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.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 24-MAR-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received shingles vaccine and experienced shingles and it was most painful thing that he or she ever deal with. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. The follow-up could not be possible as the as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the Shingles that had the shot/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the Shingles that had the shot/Suspected vaccination failure) (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.   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: 24-APR-2023 This case was reported by consumer via interactive digital media. The reporter reported that he or she know the patients who received Shingles vaccine and still experienced shingles. The reporter stated that the vaccine was not 100 percent going to keep you safe from getting the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. The follow-up could not be possible as the as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rocky mountain spotted fever, Vaccination failure
Clinical narrative: had shot still got mild case/suspected vaccination failure; Rocky Mountain Spotted fever; got mild case; 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: had shot still got mild case/suspected vaccination failure) (serious criteria GSK medically significant), rocky mountain spotted fever (Verbatim: Rocky Mountain Spotted fever) (serious criteria GSK medically significant) and shingles (Verbatim: got mild case). The outcome of the vaccination failure was unknown and the outcome of the rocky mountain spotted fever and shingles were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, rocky mountain spotted fever and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, rocky mountain spotted fever and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-MAR-2023 The case was received from the patient via interactive digital media. The patient had a shot but still got a mild case. At the same time patient had rocky mountain spotted fever. The patient ok. 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 follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shots and have them right now/suspected vaccination failure; have them right now, they have been worse; 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.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had both shots and have them right now/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have them right now, they have been worse). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 24-MAR-2023 The case was received from the patient via interactive digital media. The patient have had both the shots and had them right now. The patient stated that they had been worse. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of 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: Herpes zoster, Vaccination failure
Clinical narrative: had shingles shot still got shingles/suspected vaccination failure; 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: had shingles shot still got shingles/suspected vaccination failure) (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.   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: 24-MAR-2023 The case was received from the patient via interactive digital media. The patient had his or her shingles shots also but still got the 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 follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain, Post herpetic neuralgia, Vaccination failure
Clinical narrative: My husband has it and we had the shingle set/ suspected vaccination failure; Shingles; Nerve damage Pain; you can get nerve damage for the shingles, my husband has it; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: My husband has it and we had the shingle set/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), post herpetic neuralgia (Verbatim: Nerve damage Pain) and nerve damage (Verbatim: you can get nerve damage for the shingles, my husband has it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia and nerve damage were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and nerve damage to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia and nerve damage to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by patient wife via interactive digital media. The reporter reported that patient received both doses of Shingles vaccine set. The reporter stated that you can experience nerve damage for the shingles.  Because her husband had it and had to see a specialist, they said that they are going to work on it so he can stand the pain. The patient will always had the pain. 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. Follow up was not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: never had shingles until she got the vaccine/suspected vaccination failure; had 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: never had shingles until she got the vaccine/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had 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: 24-MAR-2023  This case was reported by patient's sibling via  interactive digital media.  The patient never had shingles until she got the shingles vaccine. 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 follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness unilateral, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Getting shingles from the shot/ suspected vaccination failure; Eye getting shingles; Got blind in one eye; 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: Getting shingles from the shot/ suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Eye getting shingles) (serious criteria GSK medically significant) and unilateral blindness (Verbatim: Got blind in one eye) (serious criteria GSK medically significant). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and unilateral blindness were not reported.   The reporter considered the vaccination failure and ophthalmic herpes zoster to be possibly related to Shingles vaccine. It was unknown if the reporter considered the unilateral blindness to be related to Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be possibly related to Shingles vaccine. It was unknown if the company considered the unilateral blindness to be related to Shingles vaccine.   Additional Information: This case was reported by patient friend via interactive digital media. The reporter reported his or her friend received Shingles vaccine and experienced shingles in eye and hot blind in one eye. 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. Follow up was not possible, as no contact details were available. According to narrative verbatim the causality was conservatively captured as possible.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: A relative got vaccine, shingles, keeps reaccuring/suspected vaccination failure; 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: A relative got vaccine, shingles, keeps reaccuring/suspected vaccination failure) (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.   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: 25-MAR-2023 This case was reported by a patient's relative via interactive digital media. The patient got shingles vaccine and shingles was keep reoccurring. 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 follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; My second time to have 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.   The patient's past medical history included shingles (years ago).   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) (serious criteria GSK medically significant) and shingles (Verbatim: My second time to have shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   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: 25-MAR-2023 This case was reported by a patient via interactive digital media. The patient took the shingles shot. The patient was just now getting over shingles and still on meds.  The patient second time to have shingles.  The patient had shingles years ago and for sure never hope to have them again. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Received shot and now have agonizing breakouts/ suspected vaccination failure; Agonizing breakouts of shingles; Agonizing; 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: Received shot and now have agonizing breakouts/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Agonizing breakouts) and pain (Verbatim: Agonizing). The outcome of the vaccination failure was 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.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAR-2023 This case was reported by a patient friend via interactive digital media. The reporter reported that the patient never had shingles before received shingles vaccine. The reporter stated that the patient now have agonizing breakouts of shingles. The reporter stated that probably there was nothing to pay attention to here. 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 had been linked with US2023AMR059716 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR059716:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Received shingles vaccine and experienced agonizing breakouts; Agoonizing breakouts of shingles; Agonizing breakouts; 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: Received shingles vaccine and experienced agonizing breakouts) (serious criteria GSK medically significant), shingles (Verbatim: Agoonizing breakouts of shingles) and pain (Verbatim: Agonizing breakouts). The outcome of the vaccination failure was 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.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAR-2023 This case was reported by a patient friend via interactive digital media. The reporter reported that the patient never had shingles before received shingles vaccine. The reporter stated that the patient now have agonizing breakouts of shingles. The reporter stated that probably there was nothing to pay attention to here. 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 had been linked with US2023AMR059715 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR059715:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Kidney infection, Nephrectomy, Sepsis
Clinical narrative: Got the shingles vaccine and only got a mild case/ Suspected vaccination failure; 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.   The patient's past medical history included kidney infection.   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: Got the shingles vaccine and only got a mild case/ Suspected vaccination failure) (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.   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: 25-MAR-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received shingles vaccine and experienced shingles. The reporter stated that it was worse than worse kidney infection that he or she ever had. The physician stated that the his or her case was mild because he or she received shingles vaccine. The reporter reported that the shingles was felt like his or her kidney went septic and had to be removed. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. The follow-up could not be possible as the as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Got the shingles vaccine and only got a mild case/ Suspected vaccination failure; 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.   The patient's past medical history included kidney infection.   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: Got the shingles vaccine and only got a mild case/ Suspected vaccination failure) (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.   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: 25-MAR-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received shingles vaccine and experienced shingles. The reporter stated that it was worse than worse kidney infection that he or she ever had. The physician stated that the his or her case was mild because he or she received shingles vaccine. The reporter reported that the shingles was felt like his or her kidney went septic and had to be removed. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. The follow-up could not be possible as the as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had 2 shots and had a bad case of shingles/Suspected vaccination failure; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In DEC-2022, between 1 and 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had 2 shots and had a bad case of shingles/Suspected vaccination failure) (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.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt date: 25-MAR-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received 2 doses of Shingles vaccine two years ago and experienced a bad case of shingles in december. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. The follow-up could not be possible as the as no contact details were available.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Not adverse affects... Pt received beyond use date Pfizer bivalent. Reported NO adverse affects.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events. Reporting  pt received beyond use date Pfizer bivalent
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event. Pt received Beyond use date Pfizer bivalent first dose. No symptoms reported.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events reported by patient. Patient received beyond use date Pfizer vaccine. Pt aware and no unusual symptoms reported.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events reported by patient. Patient received beyond use date Pfizer vaccine. Pt aware and no unusual symptoms reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Age: 0.58
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: NO ADVERSE EFFECT The MODERNA BIVALENT PINK TOP was given s the first dose vs the BLUE TOP BIVALENT
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Gait disturbance, Malaise, SARS-CoV-2 test positive
Clinical narrative: Developed weakness and feeling unwell on 4/27/23. Presented to ER on 4/30 with difficulty ambulating and wife not able to care for him.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure
Clinical narrative: RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy, Sensory loss
Clinical narrative: Patient developed no sensation in his left lower lip on 4/27/23 at noon. It continued to worsen and patient went to the hospital on 4/28/23. He was kept overnight for observation and  tests were performed. Patient was diagnosed with Bell's Palsy and was released from the hospital on 4/29/23.  Patient's condition at this time is unresolved.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Injection site erythema
Clinical narrative: Pt received beyond use date Pfizer vaccine. Reported redness at injection spot.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: MULTIPLE SUBSEGMENTAL PULMONARY EMBOLI WITHOUT ACUTE COR PULMONALE ACUTE PULMONARY EMBOLISM
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure acute, Death, Intensive care, Pleural effusion
Clinical narrative: 8/8/22 pt had a positive COVID test; admitted to hospital from SNF; did not require supplemental O2 during admission; given ABX and was to complete them in rehab when dc'd to rehab facility; 9/8/22 - 9/18/22 another hospitalization; aspiration pneumonia; ARF; septic shock; acute decompensated diastolic heart failure; IV ABX; O2 supplementation via NC; poor prognosis; discussed hospice but pt  needed more time to think about it; 9/25/22 - 9/26/22 another hospitalization from SNF with respiratory distress; EMS called: O2 saturation in the 80s on RA; CXR showed moderate left pleural effusion and probable aspiration, pneumonia; DNR/DNI; ICU; given IV ABX and fluids; O2 supplementation; transitioned to comfort measures and dc'd to hospice facility where he passed away
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia aspiration, Respiratory distress, SARS-CoV-2 test positive, Septic shock
Clinical narrative: 8/8/22 pt had a positive COVID test; admitted to hospital from SNF; did not require supplemental O2 during admission; given ABX and was to complete them in rehab when dc'd to rehab facility; 9/8/22 - 9/18/22 another hospitalization; aspiration pneumonia; ARF; septic shock; acute decompensated diastolic heart failure; IV ABX; O2 supplementation via NC; poor prognosis; discussed hospice but pt  needed more time to think about it; 9/25/22 - 9/26/22 another hospitalization from SNF with respiratory distress; EMS called: O2 saturation in the 80s on RA; CXR showed moderate left pleural effusion and probable aspiration, pneumonia; DNR/DNI; ICU; given IV ABX and fluids; O2 supplementation; transitioned to comfort measures and dc'd to hospice facility where he passed away
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Facial paresis, Hemiparesis
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE NON ST ELEVATION MI LEFT FACIAL MUSCLE WEAKNESS
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bell's palsy, Magnetic resonance imaging normal, SARS-CoV-2 test negative
Clinical narrative: I developed Bells? Palsy. I did not have any prior symptoms. I went to the doctor on 02/17/2023. I tested negative for COVID-19 twice and Lyme?s disease so we do not know why I got it. They also did an MRI to rule out anything else but everything was fine. I am still recovering from it.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: My symptoms started on 3/30/2023 which started in the morning. I was coughing, congested, fatigue and sore all over on my muscles. I had sore throat and did not have a fever. This was 3 days. On 3/31/2023 I called the telehealth and the nurse practitioner have me PAXLOVID. The symptoms improved by 4/3/23 and on 4/4/23 I felt normal. On the 4/6/23. I tested negative.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: My symptoms started on 3/30/2023 which started in the morning. I was coughing, congested, fatigue and sore all over on my muscles. I had sore throat and did not have a fever. This was 3 days. On 3/31/2023 I called the telehealth and the nurse practitioner have me PAXLOVID. The symptoms improved by 4/3/23 and on 4/4/23 I felt normal. On the 4/6/23. I tested negative.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM HYPOXEMIA
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment, Quality of life decreased, Tinnitus
Clinical narrative: continuous ringing in my ears.  I will never hear quiet again.  This has altered my life
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given a vaccine with the beyond use date of 4/27/23.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received a beyond use date vaccine of 4/27/23.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Chest X-ray, Chills, Diarrhoea
Clinical narrative: I had a breakthrough case of Covid-19 started with a head and fatigue and massive diarrhea for about 12 hour  I was prescribed Paxlovid it went away after a few days but then I had a rebound case and had full symptoms congestion, fever chills muscle aches. I also tested positive for the flu as well.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza virus test positive, Malaise, Myalgia
Clinical narrative: I had a breakthrough case of Covid-19 started with a head and fatigue and massive diarrhea for about 12 hour  I was prescribed Paxlovid it went away after a few days but then I had a rebound case and had full symptoms congestion, fever chills muscle aches. I also tested positive for the flu as well.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Vaccine breakthrough infection
Clinical narrative: I had a breakthrough case of Covid-19 started with a head and fatigue and massive diarrhea for about 12 hour  I was prescribed Paxlovid it went away after a few days but then I had a rebound case and had full symptoms congestion, fever chills muscle aches. I also tested positive for the flu as well.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received a beyond use date vaccine of 4/27/2023.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case. Moderna 3/2/21 025A21A, 03/30/2021 028A21A and 12/12/21 031H21A
Age: 25.0
Sex: M
Vaccine: VARCEL
Symptoms: Bell's palsy, Eye movement disorder, Facial paralysis
Clinical narrative: about 30 minutes after vaccination, noted slight facial droop and right eye was not blinking. was seen and treated at UC. diagnosed with Bell's Palsy.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received a beyond use date of 4/27/2023.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI  1/28/2022  --  RECURRENCE OF SAME SYMPTOMS
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  OBSTRUCTIVE SLEEP APNEA  7/13/2022  --  RECURRENCE OF SAME SYMPTOMS